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Keppra (levetiracetam) – Package leaflet - N03AX14

Updated on site: 08-Oct-2017

Medication nameKeppra
ATC CodeN03AX14
Substancelevetiracetam
ManufacturerUCB Pharma SA

Package Leaflet: Information for the patient

Keppra 250 mg film-coated tablets

Keppra 500 mg film-coated tablets

Keppra 750 mg film-coated tablets

Keppra 1000 mg film-coated tablets

Levetiracetam

Read all of this leaflet carefully before you or your child start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What Keppra is and what it is used for

2.What you need to know before you take Keppra

3.How to take Keppra

4.Possible side effects

5.How to store Keppra

6.Contents of the pack and other information

1.What Keppra is and what it is used for

Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Keppra is used:

on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition where the patients have repeated fits (seizures). Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation). Levetiracetam has been given to you by your doctor to reduce the number of fits.

as an add-on to other antiepileptic medicines to treat:

partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age;

myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;

primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

2.What you need to know before you take Keppra

Do not take Keppra

If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in Section 6).

Warnings and precautions

Talk to your doctor before taking Keppra

If you suffer from kidney problems, follow your doctor’s instructions. He/she may decide if your dose should be adjusted.

If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor.

A small number of people being treated with anti-epileptics such as Keppra have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.

Children and adolescents

Keppra is not indicated in children and adolescents below 16 years on its own (monotherapy).

Other medicines and Keppra

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking levetiracetam as this may results in a loss of its effect.

Pregnancy and breast-feeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Keppra should not be used during pregnancy unless clearly necessary. A risk of birth defects for your unborn child cannot be completely excluded. Keppra has shown unwanted reproductive effects in animal studies at dose levels higher than you would need to control your seizures.

Breast-feeding is not recommended during treatment.

Driving and using machines

Keppra may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy. This is more likely at the beginning of treatment or after an increase in the dose. You should not drive or use machines until it is established that your ability to perform such activities is not affected.

Keppra 750 mg tablets contain Sunset Yellow FCF (E110).

Sunset Yellow FCF (E110) colouring agent may cause allergic reactions.

3.How to take Keppra

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Take the number of tablets following your doctor’s instructions.

Keppra must be taken twice a day, once in the morning and once in the evening, at about the same time each day.

Monotherapy

Dose in adults and adolescents (from 16 years of age):

General dose: between 1000 mg and 3,000 mg each day.

When you will first start taking Keppra, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.

Example: if your daily dose is 1000 mg, your reduced starting dose is 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.

Add-on therapy

Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more:

General dose: between 1,000 mg and 3,000 mg each day.

Example: if your daily dose is 1,000 mg, you might take 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.

Dose in infants (1 month to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of Keppra according to the age, weight and dose.

Keppra 100 mg/ml oral solution is a formulation more appropriate to infants and children under the age of 6 years and to children and adolescent (from 6 to 17 years) weighing less than

50kg and when tablets don’t allow accurate dosage.

Method of administration

Swallow Keppra tablets with a sufficient quantity of liquid (e.g. a glass of water). You may take Keppra with or without food.

Duration of treatment

Keppra is used as a chronic treatment. You should continue Keppra treatment for as long as your doctor has told you.

Do not stop your treatment without your doctor’s advice as this could increase your seizures.

If you take more Keppra than you should

The possible side effects of an overdose of Keppra are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.

Contact your doctor if you took more tablets than you should. Your doctor will establish the best possible treatment of overdose.

If you forget to take Keppra:

Contact your doctor if you have missed one or more doses.

Do not take a double dose to make up for a forgotten tablet.

If you stop taking Keppra:

If stopping treatment, Keppra should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your Keppra treatment, he/she will instruct you about the gradual withdrawal of Keppra.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately, or go to your nearest emergency department, if you experience:

weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction

swelling of the face, lips, tongue and throat (Quincke’s oedema)

flu-like symptoms and a rash on the face followed by an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS])

symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling in the legs, ankles or feet, as this may be a sign of sudden decrease of kidney function

a skin rash which may form blisters and look like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)

a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)

a more severe form of rash causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)

signs of serious mental changes or if someone around you notices signs of confusion, somnolence (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements. These could be symptoms of an encephalopathy.

The most frequently reported side effects are nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness. At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common.These effects should however decrease over time.

Very common: may affect more than 1 user in 10 people

nasopharyngitis;

somnolence (sleepiness), headache.

Common: may affect 1 to 10 users in 100 people

anorexia (loss of appetite);

depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;

convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness),lethargy (lack of energy and enthusiasm), tremor (involuntary trembling);

vertigo (sensation of rotation);

cough;

abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;

rash;

asthenia/fatigue (tiredness).

Uncommon: may affect 1 to 10 users in 1000 people

decreased number of blood platelets, decreased number of white blood cells;

weight decrease, weight increase;

suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger, confusion, panic attack, emotional instability/mood swings, agitation;

amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration);

diplopia (double vision), vision blurred;

elevated/abnormal values in a liver function test;

hair loss, eczema, pruritus;

muscle weakness, myalgia (muscle pain);

injury.

Rare: may affect 1 to 10 users in 10,000 people

infection;

decreased number of all blood cell types;

severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke’s oedema [swelling of the face, lips, tongue and throat]);

decreased blood sodium concentration;

suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate);

uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);

pancreatitis;

liver failure, hepatitis;

sudden decrease in kidney function

skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens– Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis).

rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase increase. Prevalence is significantly higher in Japanese patients when compared to non- Japanese patients.

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store Keppra

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton box and blister after EXP. The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.Contents of the pack and other information

What Keppra contains

The active substance is called levetiracetam.

One tablet of Keppra 250 mg contains 250 mg of levetiracetam.

One tablet of Keppra 500 mg contains 500 mg of levetiracetam.

One tablet of Keppra 750 mg contains 750 mg of levetiracetam.

One tablet of Keppra 1,000 mg contains 1,000 mg of levetiracetam.

The other ingredients are:

Tablet core: croscarmellose sodium, macrogol 6000, silica colloidal anhydrous, magnesium stearate. Film-coating: Polyvinyl alcohol-part. hydrolyzed, titanium dioxide (E171), macrogol 3350, talc, colourants*.

* The colourants are:

250 mg tablet: indigo carmine aluminium lake (E132)

500 mg tablet: iron oxide yellow (E172)

750 mg tablet: sunset yellow FCF (E110), iron oxide red (E172)

What Keppra looks like and contents of the pack

Keppra 250 mg film-coated tablets are blue, 13 mm oblong, scored and debossed with the code “ucb” and “250” on one side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Keppra 500 mg film-coated tablets are yellow, 16 mm oblong, scored and debossed with the code

“ucb” and “500” on one side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Keppra 750 mg film-coated tablets are orange, 18 mm oblong, scored and debossed with the code

“ucb” and “750” on one side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Keppra 1000 mg film-coated tablets are white, 19 mm oblong, scored and debossed with the code

“ucb” and“1000” on one side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Keppra tablets are packaged in blister packs supplied in cardboard boxes containing:

250 mg: 20, 30, 50, 60, 100 x 1, 100 film-coated tablets and multipacks containing 200 (2 packs of 100) film-coated tablets

500 mg: 10, 20, 30, 50, 60, 100 x 1, 100, 120 film-coated tablets and multipacks containing 200 (2 packs of 100) film-coated tablets

750 mg: 20, 30, 50, 60, 80, 100 x 1, 100 film-coated tablets and multipacks containing 200 (2 packs of 100) film-coated tablets

1000 mg: 10, 20, 30, 50, 60, 100 x 1, 100 film-coated tablets and multipacks containing 200 (2 packs of 100) film-coated tablets

The 100 x 1 tablet packs are available in aluminium/PVC perforated unit dose blisters. All other packs are available in standard aluminium/PVC blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

UCB Pharma SA, Allée de la Recherche 60, B-1070 Brussels, Belgium.

Manufacturer

 

UCB Pharma SA, Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium.

or

Aesica Pharmaceuticals S.r.l., Via Praglia 15, I-10044 Pianezza, Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien

Lietuva

UCB Pharma SA/NV

UCB Pharma Oy Finland

Tel/Tél: + 32 / (0)2 559 92 00

Tel: +358 9 2514 4221 (Suomija)

България

Luxembourg/Luxemburg

Ю СИ БИ България ЕООД

UCB Pharma SA/NV

Teл.: + 359 (0) 2 962 30 49

Tél/Tel: + 32 / (0)2 559 92 00

Česká republika

Magyarország

UCB s.r.o.

UCB Magyarország Kft.

Tel: + 420 221 773 411

Tel.: + 36-(1) 391 0060

Danmark

Malta

UCB Nordic A/S

Pharmasud Ltd.

Tlf: + 45 / 32 46 24 00

Tel: + 356 / 21 37 64 36

Deutschland

Nederland

UCB Pharma GmbH

UCB Pharma B.V.

Tel: + 49 /(0) 2173 48 4848

Tel.: + 31 / (0)76-573 11 40

Eesti

Norge

UCB Pharma Oy Finland

UCB Nordic A/S

Tel: +358 9 2514 4221 (Soome)

Tlf: + 45 / 32 46 24 00

Ελλάδα

Österreich

UCB Α.Ε.

UCB Pharma GmbH

Τηλ: + 30 / 2109974000

Tel: + 43 (0)1 291 80 00

España

Polska

UCB Pharma, S.A.

UCB Pharma Sp. z o.o.

Tel: + 34 / 91 570 34 44

Tel: + 48 22 696 99 20

France

Portugal

UCB Pharma S.A.

UCB Pharma (Produtos Farmacêuticos), Lda

Tél: + 33 / (0)1 47 29 44 35

Tel: + 351 / 21 302 5300

Hrvatska

România

Medis Adria d.o.o.

UCB Pharma Romania S.R.L.

Tel: +385 (0) 1 230 34 46

Tel: + 40 21 300 29 04

Ireland

Slovenija

UCB (Pharma) Ireland Ltd.

Medis, d.o.o.

Tel: + 353 / (0)1-46 37 395

Tel: + 386 1 589 69 00

Ísland

Slovenská republika

Vistor hf.

UCB s.r.o., organizačná zložka

Tel: + 354 535 7000

Tel: + 421 (0) 2 5920 2020

Italia

Suomi/Finland

UCB Pharma S.p.A.

UCB Pharma Oy Finland

Tel: + 39 / 02 300 791

Puh/Tel: +358 9 2514 4221

Κύπρος

Sverige

Lifepharma (Z.A.M.) Ltd

UCB Nordic A/S

Τηλ: + 357 22 34 74 40

Tel: + 46 / (0) 40 29 49 00

Latvija

United Kingdom

UCB Pharma Oy Finland

UCB Pharma Ltd.

Tel: +358 9 2514 4221 (Somija)

Tel : + 44 / (0)1753 534 655

This leaflet was last revised in {month/YYYY}

 

Other sources of information

 

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

Package Leaflet: Information for the patient

Keppra 100 mg/ml oral solution

Levetiracetam

Read all of this leaflet carefully before you or your child start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What Keppra is and what it is used for

2.What you need to know before you take Keppra

3.How to take Keppra

4.Possible side effects

5.How to store Keppra

6.Contents of the pack and other information

1. What Keppra is and what it is used for

Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Keppra is used:

on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition where the patients have repeated fits (seizures). Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation). Levetiracetam has been given to you by your doctor to reduce the number of fits.

as an add-on to other antiepileptic medicines to treat:

partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age

myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy

primary generalised tonic-clonic seizures(major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

2. What you need to know before you take Keppra

Do not take Keppra

If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in Section 6).

Warnings and precautions

Talk to your doctor before taking Keppra

If you suffer from kidney problems, follow your doctor’s instructions. He/she may decide if your dose should be adjusted.

If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor.

A small number of people being treated with anti-epileptics such as Keppra have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.

Children and adolescents

Keppra is not indicated in children and adolescents below 16 years on it’s own (monotherapy)

Other medicines and Keppra

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking levetiracetam as this may results in a reduction of its effect.

Pregnancy and breast-feeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine..

Keppra should not be used during pregnancy unless clearly necessary. A risk of birth defects for your unborn child cannot be completely excluded. Keppra has shown unwanted reproductive effects in animal studies at dose levels higher than you would need to control your seizures.

Breast-feeding is not recommended during treatment.

Driving and using machines

Keppra may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy. This is more likely at the beginning of treatment or after an increase in the dose. You should not drive or use machines until it is established that your ability to perform such activities is not affected.

Keppra contains methyl parahydroxybenzoate, propyl parahydroxybenzoate and maltitol

Keppra oral solution includes methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).

Keppra oral solution also contains maltitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Keppra

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Keppra must be taken twice a day, once in the morning and once in the evening, at about the same time each day.

Take the oral solution following your doctor’s instructions.

Monotherapy

Dose in adults and adolescents (from 16 years of age):

Measure the appropriate dosage using the 10 ml syringe included in the package for patients 4 years and above.

General dose: Keppra is taken twice daily, in two equally divided doses, each individual dose being measured between 5 ml (500mg) and 15 ml (1500mg).

When you will first start taking Keppra, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.

Add-on therapy

Dose in adults and adolescents (12 to 17 years):

Measure the appropriate dosage using the 10 ml syringe included in the package for patients of 4 years and above.

General dose: Keppra is taken twice daily, in two equally divided doses, each individual dose being measured between 5 ml (500mg) and 15 ml (1500mg).

Dose in children 6 months and older :

Your doctor will prescribe the most appropriate pharmaceutical form of Keppra according to the age, weight and dose.

For children 6 months to 4 years, measure the appropriate dosage using the 3 ml syringe included in the package.

For children above 4 years, measure the appropriate dosage using the 10 ml syringe included in the package.

General dose: Keppra is taken twice daily, in two equally divided doses, each individual dose being measured between 0.1 ml (10mg) and 0.3 ml (30mg), per kg bodyweight of the child. (see table below for dose examples).

Dose in children 6 months and older:

Weight

Starting dose: 0.1 ml/kg twice daily

Maximum dose: 0.3 ml/kg twice daily

6 kg

0.6 ml twice daily

1.8 ml twice daily

8 kg

0.8 ml twice daily

2.4 ml twice daily

10 kg

1 ml twice daily

3 ml twice daily

15 kg

1.5 ml twice daily

4.5 ml twice daily

20 kg

2 ml twice daily

6 ml twice daily

25 kg

2.5 ml twice daily

7.5 ml twice daily

From 50 kg

5 ml twice daily

15 ml twice daily

Dose in infants (1 month to less than 6 months):

For infants 1 month to less than 6 months, measure the appropriate dosage using the 1 ml syringe included in the package.

General dose: Keppra is taken twice daily, in two equally divided doses, each individual dose being measured between 0.07 ml (7mg) and 0.21 ml (21mg), per kg bodyweight of the infant. (see table below for dose examples).

Dose in infants (1 month to less than 6 months):

Weight

Starting dose: 0.07 ml/kg twice daily

Maximum dose: 0.21 ml/kg twice daily

4 kg

0.3 ml twice daily

0.85 ml twice daily

5 kg

0.35 ml twice daily

1.05 ml twice daily

6 kg

0.45 ml twice daily

1.25 ml twice daily

7 kg

0.5 ml twice daily

1.5 ml twice daily

Method of administration:

After measuring the correct dosage with an appropriate syringe, Keppra oral solution may be diluted in a glass of water or baby’s bottle. You may take Keppra with or without food.

Instructions for use:

Open the bottle: press the cap and turn it anticlockwise (figure 1)

Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure 3). Ensure it is well fixed.

Take the syringe and put it in the adaptor opening (figure 4). Turn the bottle upside down (figure 5).

Fill the syringe with a small amount of solution by pulling the piston down (figure 5A), then push the piston upward in order to remove any possible bubble (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (figure 5C).

Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).

Empty the contents of the syringe in a glass of water or baby’s bottle by pushing the piston to the bottom of the syringe (figure 7).

Drink the whole contents of the glass/baby’s bottle.

Close the bottle with the plastic screw cap.

Wash the syringe with water only (figure 8).

Duration of treatment:

Keppra is used as a chronic treatment. You should continue Keppra treatment for as long as your doctor has told you.

Do not stop your treatment without your doctor’s advice as this could increase your seizures.

If you take more Keppra than you should

The possible side effects of an overdose of Keppra are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.

Contact your doctor if you took more Keppra than you should. Your doctor will establish the best possible treatment of overdose.

If you forget to take Keppra:

Contact your doctor if you have missed one or more doses.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Keppra:

If stopping treatment, Keppra should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your Keppra treatment, he/she will instruct you about the gradual withdrawal of Keppra.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately, or go to your nearest emergency department, if you experience:

weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction

swelling of the face, lips, tongue and throat (Quincke’s oedema)

flu-like symptoms and a rash on the face followed by an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]),.

symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling in the legs, ankles or feet, as this may be a sign of sudden decrease of kidney function

a skin rash which may form blisters and look like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)

a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)

a more severe form of rash causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)

signs of serious mental changes or if someone around you notices signs of confusion, somnolence (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements. These could be symptoms of an encephalopathy.

The most frequently reported adverse reactions were nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness. At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common. These effects should however decrease over time.

Very common: may affect more than 1 user in 10 people

nasopharyngitis;

somnolence (sleepiness), headache.

Common: may affect 1 to 10 users in 100 people

anorexia (loss of appetite);

depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;

convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary trembling);

vertigo (sensation of rotation);

cough;

abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;

rash;

asthenia/fatigue (tiredness).

Uncommon: may affect 1 to 10 users in 1000 people

decreased number of blood platelets, decreased number of white blood cells;

weight decrease, weight increase;

suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger, confusion, panic attack, emotional instability/mood swings, agitation;

amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration);

diplopia (double vision), vision blurred;

elevated/abnormal values in a liver function test;

hair loss, eczema, pruritus;

muscle weakness, myalgia (muscle pain);

injury.

Rare: may affect 1 to 10 users in 10,000 people

infection;

decreased number of all blood cell types;

severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke’s oedema [swelling of the face, lips, tongue and throat]);

decreased blood sodium concentration;

suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate);

uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);

pancreatitis;

liver failure, hepatitis;

sudden decrease in kidney function

skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash

with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens- Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis).

rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase increase. Prevalence is significantly higher in Japanese patients when compared to non- Japanese patients.

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Keppra

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the cardboard box and bottle after EXP: The expiry date refers to the last day of the month.

Do not use after 7 months of first opening the bottle.

Store in the original bottle, in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Keppra contains

The active substance is called levetiracetam. Each ml contains 100 mg of levetiracetam.

The other ingredients are: sodium citrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ammonium glycyrrhizate, glycerol (E422), maltitol liquid (E965), acesulfame potassium (E950), grape flavour, purified water.

What Keppra looks like and contents of the pack

Keppra 100 mg/ml oral solution is a clear liquid.

The 300 ml glass bottle of Keppra (for children aged 4 years and above, adolescents and adults) is packed in a cardboard box containing a 10 ml oral syringe (graduated every 0.25 ml) and an adaptor for the syringe.

The 150 ml glass bottle of Keppra (for infants and young children aged from 6 months to less than 4 years) is packed in a cardboard box containing a 3 ml oral syringe (graduated every 0.1 ml) and an adaptor for the syringe.

The 150 ml glass bottle of Keppra (for infants aged 1 month to less than 6 months) is packed in a cardboard box containing a 1 ml oral syringe (graduated every 0.05 ml) and an adaptor for the syringe.

Marketing Authorisation Holder

UCB Pharma S.A. Allée de la Recherche 60, B-1070 Brussels, Belgium.

Manufacturer

NextPharma SAS, 17 Route de Meulan, F-78520 Limay, France.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien

Lietuva

UCB Pharma SA/NV

UCB Pharma Oy Finland

Tel/Tél: + 32 / (0)2 559 92 00

Tel: +358 9 2514 4221 (Suomija)

България

Luxembourg/Luxemburg

Ю СИ БИ България ЕООД

UCB Pharma SA/NV

Teл.: + 359 (0) 2 962 30 49

Tél/Tel: + 32 / (0)2 559 92 00

Česká republika

Magyarország

UCB s.r.o.

UCB Magyarország Kft.

Tel: + 420 221 773 411

Tel.: + 36-(1) 391 0060

Danmark

Malta

UCB Nordic A/S

Pharmasud Ltd.

Tlf: + 45 / 32 46 24 00

Tel: + 356 / 21 37 64 36

Deutschland

Nederland

UCB Pharma GmbH

UCB Pharma B.V.

Tel: + 49 /(0) 2173 48 4848

Tel.: + 31 / (0)76-573 11 40

Eesti

Norge

UCB Pharma Oy Finland

UCB Nordic A/S

Tel: +358 9 2514 4221 (Soome)

Tlf: + 45 / 32 46 24 00

Ελλάδα

Österreich

UCB Α.Ε.

UCB Pharma GmbH

Τηλ: + 30 / 2109974000

Tel: + 43 (0)1 291 80 00

España

Polska

UCB Pharma, S.A.

UCB Pharma Sp. z o.o.

Tel: + 34 / 91 570 34 44

Tel: + 48 22 696 99 20

France

Portugal

UCB Pharma S.A.

UCB Pharma (Produtos Farmacêuticos), Lda

Tél: + 33 / (0)1 47 29 44 35

Tel: + 351 / 21 302 5300

Hrvatska

România

Medis Adria d.o.o.

UCB Pharma Romania S.R.L.

Tel: +385 (0) 1 230 34 46

Tel: + 40 21 300 29 04

Ireland

Slovenija

UCB (Pharma) Ireland Ltd.

Medis, d.o.o.

Tel: + 353 / (0)1-46 37 395

Tel: + 386 1 589 69 00

Ísland

Slovenská republika

Vistor hf.

UCB s.r.o., organizačná zložka

Tel: + 354 535 7000

Tel: + 421 (0) 2 5920 2020

Italia

Suomi/Finland

UCB Pharma S.p.A.

UCB Pharma Oy Finland

Tel: + 39 / 02 300 791

Puh/Tel: +358 9 2514 4221

Κύπρος

Sverige

Lifepharma (Z.A.M.) Ltd

UCB Nordic A/S

Τηλ: + 357 22 34 74 40

Tel: + 46 / (0) 40 29 49 00

 

Latvija

United Kingdom

UCB Pharma Oy Finland

UCB Pharma Ltd.

Tel: +358 9 2514 4221 (Somija)

Tel : + 44 / (0)1753 534 655

This leaflet was last revised in {month/YYYY}

 

Other sources of information

 

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

Package Leaflet: Information for the patient

Keppra 100 mg/ml concentrate for solution for infusion

Levetiracetam

Read all of this leaflet carefully before you or your child start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What Keppra is and what it is used for

2.What you need to know before you are given Keppra

3.How Keppra is given

4.Possible side effects

5.How to store Keppra

6.Contents of the pack and other information

1. What Keppra is and what it is used for

Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Keppra is used:

on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition where the patients have repeated fits (seizures). Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation). Levetiracetam has been given to you by your doctor to reduce the number of fits.

as an add-on to other antiepileptic medicines to treat:

partial onset seizures with or without generalisation in in adults, adolescents and children from 4 years of age

myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy.

primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

Keppra concentrate for solution for infusion is an alternative for patients when administration of the antiepileptic oral Keppra medicine is temporarily not feasible.

2. What you need to know before you are given Keppra

Do not use Keppra

If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in Section 6).

Warnings and precautions

Talk to your doctor before you are given Keppra

If you suffer from kidney problems, follow your doctor’s instructions. He/she may decide if your dose should be adjusted.

If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor.

A small number of people being treated with anti-epileptics such as Keppra have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.

Children and adolescents

Keppra is not indicated in children and adolescents below 16 years on it’s own (monotherapy)

Other medicines and Keppra

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking levetiracetam as this may results in a reduction of its effect.

Pregnancy and breast-feeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Keppra should not be used during pregnancy unless clearly necessary. A risk of birth defects for your unborn child cannot be completely excluded. Keppra has shown unwanted reproductive effects in animal studies at dose levels higher than you would need to control your seizures.

Breast-feeding is not recommended during treatment.

Driving and using machines

Keppra may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy. This is more likely at the beginning of treatment or after an increase in the dose. You should not drive or use machines until it is established that your ability to perform such activities is not affected.

Keppra contains sodium

One maximum single dose of Keppra concentrate contains 2.5 mmol (or 57 mg) of sodium (0.8 mmol (or 19 mg) of sodium per vial). This should be taken into consideration if you are on a controlled sodium diet.

3.How Keppra is given

A doctor or a nurse will administer you Keppra as an intravenous infusion.

Keppra must be administered twice a day, once in the morning and once in the evening, at about the same time each day.

The intravenous formulation is an alternative to your oral administration. You can switch from the film-coated tablets or from the oral solution to the intravenous formulation or reverse directly without dose adaptation. Your total daily dose and frequency of administration remain identical.

Monotherapy

Dose in adults and adolescents (from 16 years of age):

General dose: between 1000 mg and 3,000 mg each day.

When you will first start taking Keppra, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.

Add-on therapy

Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more:

General dose: between 1,000 mg and 3,000 mg each day.

Dose in children (4 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:

General dose: between 20 mg per kg bodyweight and 60 mg per kg bodyweight each day.

Method and route of administration:

Keppra is for intravenous use.

The recommended dose must be diluted in at least 100 ml of a compatible diluent and infused over 15-minutes.

For doctors and nurses, more detailed direction for the proper use of Keppra is provided in section 6.

Duration of treatment:

There is no experience with administration of intravenous levetiracetam for a longer period than 4 days.

If you stop using Keppra:

If stopping treatment, as with other antiepileptic medicines, Keppra should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your Keppra treatment, he/she will instruct you about the gradual withdrawal of Keppra.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately, or go to your nearest emergency department, if you experience:

weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction

swelling of the face, lips, tongue and throat (Quincke’s oedema)

flu-like symptoms and a rash on the face followed by an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]),.

symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling in the legs, ankles or feet, as this may be a sign of sudden decrease of kidney function

a skin rash which may form blisters and look like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)

a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)

a more severe form of rash causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)

signs of serious mental changes or if someone around you notices signs of confusion, somnolence (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements. These could be symptoms of an encephalopathy.

The most frequently reported adverse reactions were nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness. At the beginning of the treatment or at dose increase side effects like

sleepiness, tiredness and dizziness may be more common. These effects should however decrease over time.

Very common: may affect more than 1 user in 10 people

nasopharyngitis;

somnolence (sleepiness), headache.

Common: may affect 1 to 10 users in 100 people

anorexia (loss of appetite);

depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;

convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary trembling);

vertigo (sensation of rotation);

cough;

abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;

rash;

asthenia/fatigue (tiredness).

Uncommon: may affect 1 to 10 users in 1000 people

decreased number of blood platelets, decreased number of white blood cells;

weight decrease, weight increase;

suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger, confusion, panic attack, emotional instability/mood swings, agitation;

amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration);

diplopia (double vision), vision blurred;

elevated/abnormal values in a liver function test;

hair loss, eczema, pruritus;

muscle weakness, myalgia (muscle pain);

injury.

.

Rare: may affect 1 to 10 users in 10,000 people

infection;

decreased number of all blood cell types;

severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke’s oedema [swelling of the face, lips, tongue and throat]);

decreased blood sodium concentration;

suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate);

uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);

pancreatitis;

liver failure, hepatitis;

sudden decrease in kidney function

skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens- Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis).

rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase increase. Prevalence is significantly higher in Japanese patients when compared to non- Japanese patients.

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Keppra

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the vial and carton box after EXP: The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions.

6. Contents of the pack and other information

What Keppra contains

The active substance is called levetiracetam. Each ml contains 100 mg of levetiracetam.

The other ingredients are: sodium acetate, glacial acetic acid, sodium chloride, water for injections.

What Keppra looks like and contents of the pack

Keppra concentrate for solution for infusion (sterile concentrate) is a clear, colourless liquid.

Keppra concentrate for solution for infusion is packed in a cardboard box containing 10 vials of 5 ml.

Marketing Authorisation Holder

UCB Pharma SA, Allée de la Recherche 60, B-1070 Brussels, Belgium.

Manufacturer

UCB Pharma SA, Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium

orAesica Pharmaceuticals S.r.l., Via Praglia, 15, I-10044 Pianezza, Italy.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien

Lietuva

UCB Pharma SA/NV

UCB Pharma Oy Finland

Tel/Tél: + 32 / (0)2 559 92 00

Tel: +358 9 2514 4221 (Suomija)

България

Luxembourg/Luxemburg

Ю СИ БИ България ЕООД

UCB Pharma SA/NV

Teл.: + 359 (0) 2 962 30 49

Tél/Tel: + 32 / (0)2 559 92 00

Česká republika

Magyarország

UCB s.r.o.

UCB Magyarország Kft.

Tel: + 420 221 773 411

Tel.: + 36-(1) 391 0060

Danmark

Malta

UCB Nordic A/S

Pharmasud Ltd.

Tlf: + 45 / 32 46 24 00

Tel: + 356 / 21 37 64 36

Deutschland

Nederland

UCB Pharma GmbH

UCB Pharma B.V.

Tel: + 49 /(0) 2173 48 4848

Tel.: + 31 / (0)76-573 11 40

 

Eesti

Norge

UCB Pharma Oy Finland

UCB Nordic A/S

Tel: +358 9 2514 4221 (Soome)

Tlf: + 45 / 32 46 24 00

Ελλάδα

Österreich

UCB Α.Ε.

UCB Pharma GmbH

Τηλ: + 30 / 2109974000

Tel: + 43 (0)1 291 80 00

España

Polska

UCB Pharma, S.A.

UCB Pharma Sp. z o.o.

Tel: + 34 / 91 570 34 44

Tel: + 48 22 696 99 20

France

Portugal

UCB Pharma S.A.

UCB Pharma (Produtos Farmacêuticos), Lda

Tél: + 33 / (0)1 47 29 44 35

Tel: + 351 / 21 302 5300

Hrvatska

România

Medis Adria d.o.o.

UCB Pharma Romania S.R.L.

Tel: +385 (0) 1 230 34 46

Tel: + 40 21 300 29 04

Ireland

Slovenija

UCB (Pharma) Ireland Ltd.

Medis, d.o.o.

Tel: + 353 / (0)1-46 37 395

Tel: + 386 1 589 69 00

Ísland

Slovenská republika

Vistor hf.

UCB s.r.o., organizačná zložka

Tel: + 354 535 7000

Tel: + 421 (0) 2 5920 2020

Italia

Suomi/Finland

UCB Pharma S.p.A.

UCB Pharma Oy Finland

Tel: + 39 / 02 300 791

Puh/Tel: +358 9 2514 4221

Κύπρος

Sverige

Lifepharma (Z.A.M.) Ltd

UCB Nordic A/S

Τηλ: + 357 22 34 74 40

Tel: + 46 / (0) 40 29 49 00

Latvija

United Kingdom

UCB Pharma Oy Finland

UCB Pharma Ltd.

Tel: +358 9 2514 4221 (Somija)

Tel : + 44 / (0)1753 534 655

This leaflet was last revised in {month/YYYY}

 

Other sources of information

 

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

---------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only: Directions for the proper use of Keppra is provided in section 3.

One vial of Keppra concentrate contains 500 mg levetiracetam (5 ml concentrate of 100 mg/ml). See Table 1 for the recommended preparation and administration of Keppra concentrate to achieve a total daily dose of 500 mg, 1000 mg, 2000 mg, or 3000 mg in two divided doses.

Table 1. Preparation and administration of Keppra concentrate

Dose

Withdrawal Volume

Volume of

Infusion

Frequency of

Total Daily

 

 

Diluent

Time

administration

Dose

250 mg

2.5 ml (half 5 ml vial)

100 ml

15 minutes

Twice daily

500 mg/day

500 mg

5 ml (one 5 ml vial)

100 ml

15 minutes

Twice daily

1000 mg/day

1000 mg

10 ml (two 5 ml vials)

100 ml

15 minutes

Twice daily

2000 mg/day

1500 mg

15 ml (three 5 ml vials)

100 ml

15 minutes

Twice daily

3000 mg/day

This medicinal product is for single use only, any unused solution should be discarded.

In use shelf life: from a microbiological point of view, the product should be used immediately after dilution. If not used immediately, in-use storage time and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Keppra concentrate was found to be physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in PVC bags at controlled room temperature 15- 25°C.

Diluents:

Sodium chloride 9 mg/ml (0.9%) solution for injection

Lactated Ringer’s solution for injection

Dextrose 50 mg/ml (5%) solution for injection

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