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Sonata (zaleplon) – Package leaflet - N05CF03

Updated on site: 10-Oct-2017

Medication nameSonata
ATC CodeN05CF03
Substancezaleplon
ManufacturerMeda AB

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sonata 5 mg hard capsules zaleplon

Read all of this leaflet carefully before you 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. 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

authorised

1.

What Sonata is and what it is used for

2.

What you need to know before you take Sonata

3.

How to take Sonata

4.

Possible side effects

5.

How to store Sonata

6.

Contents of the pack and other information

1.

What Sonata is and what it is used for

longer

 

 

Sonata belongs to a class of substances called benzodiazepi e-related medicinal products, which

consists of preparations with hypnotic actions.

 

 

no

 

Sonata will help you to sleep. Sleeping problems do n t usually last long, and most people only need a

 

product

 

short course of treatment. The duration of trea me t should usually vary from a few days to two weeks. If you still have problems sleeping af er you have finished your capsules, contact your doctor again.

2. What you need to know before you take Sonata

ifMedicinalyou are allerg c to zaleplon or any of the other ingredients of this medicine (listed in section 6).

if you have sleep apnoea syndrome (stopping breathing for short periods while asleep).

if you have severe kidney or liver problems.

if you have myasthenia gravis (very weak or tired muscles).

if you have severe breathing or chest problems.

If you are in any doubt about whether you have any of these conditions, do ask your doctor. Children and adolescents under 18 years of age must not take Sonata.

Warnings and precautions

Talk to your doctor or pharmacist before taking Sonata.

Never drink alcohol while you are being treated with Sonata. Alcohol can increase the undesirable effects of any medicine taken to help you sleep.

Use with extreme caution if you have ever been addicted to medicines or alcohol.

If you are taking any medicines belonging to the sleep inducing group, including Sonata, there is a possibility that you may become dependent on them. Once physical dependence has developed, abrupt termination of treatment may be accompanied by withdrawal symptoms.

These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability.

Do not use Sonata or any other sleeping medicine for longer than your doctor tells you to.Do not use a second dose of Sonata within a single night.

If your sleeplessness persists or worsens after a short course of Sonata treatment contact your doctor.

There is a chance that you may experience a certain type of temporary memory loss (amnesia) and lack of coordination when taking sleep medicines. This can usually be avoided if you remain inactive for at least 4 hours after taking Sonata.

There is a chance that you may experience somnambulism (sleepwalking), including eating or driving while not fully awake with no memory of the event. If you experience these events, contact your doctor immediately.

 

Reactions like restlessness, agitation, irritability, aggressiveness, abnormal thinking, delusion,

 

rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate behaviour,

 

extroversion that seems out of character and other behavioural effects have been r ported

 

following use of any medicines belonging to the sleep inducing group, including Sonata. These

 

reactions may be active substance-induced, spontaneous in origin, or a result of an underlying

 

psychiatric or physical disorder. They are more likely to occur in the elderly. If you experience

 

these events, contact your doctor immediately.

 

Rare cases of severe allergic reactions have been reported. An allergic reaction may include a

 

rash, itching, difficulty breathing or swelling of the face, lips, thro t or tongue, or nausea and

 

vomiting. If you experience any of these events, contact your doctor immediately.

 

 

authorised

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age.

Other medicines and Sonata

longer

 

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

includes medicines that can be bought without a prescription. Some can cause drowsiness and should not be taken while taking Sonata.

no medicines. Do not take any otherproductmedicines wi hout asking your doctor or pharmacist first. This

When Sonata is taken with other medicines that act on the brain, the combination may make you more drowsy than it should. Be awa e that such combinations may cause you to feel drowsy the next day. These medicines include: substances used in the treatment of mental conditions (antipsychotics, hypnotics,Medicinalanxiolytics/sed tives, antidepressants), medicines used for strong pain relief (narcotic analgesics), medici es used for the treatment of seizures/convulsions (antiepileptic medicines), medicines used for loss of feeling/ insensibility (anaesthetics), and medicines used in the treatment of allergies (sedat ve antihistamines). Drinking alcohol while being treated with Sonata may also cause you to feel drowsy the next day. Never drink alcohol while you are being treated with Sonata (see “Warnings and precautions”).

You should tell your doctor or pharmacist if you are taking cimetidine (a stomach medicine) or erythromycin (an antibiotic).

Sonata with food, drink and alcohol

It is not recommended that you take Sonata with or immediately after eating a large meal as it may work more slowly. Swallow the capsule(s) with a small glass of water. Never drink alcohol while you are being treated with Sonata (see “Warnings and precautions”).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Sonata should not be taken at these times because there are not enough clinical data available to assess its safety during pregnancy and breast-feeding.

Driving and using machines

Sonata may make you feel drowsy, cause loss of concentration or memory or muscle weakness. This feeling may be even worse when you sleep for less than 7 to 8 hours after taking your medication or if you are already taking another central nervous system depressant or if you are drinking alcohol (see ‘other medicines and Sonata’). If affected do not drive or operate machinery.

Sonata contains lactose.

authorised

 

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 Sonata

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

The usual dose for adults is 10 mg just before going to bed, or after you have gone to bed and you are having difficulty falling asleep. You should not take a sec nd dose within a single night.

longer

There are different doses for people who are 65

r lder, and those who have mild to moderate liver

problems:

no

If you take more Sonata thanproductyou should

65 or older: Take one 5 mg capsule

Mild to moderate liver problems: Take one 5 mg capsule

Sonata has been designed, so that if the contents of the capsule are dissolved in liquid, the liquid will change colour and become cloudy.

ContactMedicinala doctor immediately and say how many capsules you have taken. Do not go unaccompanied to seek medical help.

If an overdose has been taken you may become increasingly drowsy very quickly, with high doses probably l ading to a coma.

If you forget to take Sonata

Just take your next capsule at the usual time, then go on as before. Do not try and catch up on the doses you have missed.

If you stop taking Sonata

On stopping treatment, your original sleeplessness may return and you may experience symptoms such as mood changes, anxiety, and restlessness. If you suffer from these symptoms, ask your doctor for advice.

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. If you notice any of the following, or any other changes in your health, do tell your doctor as soon as possible.

The frequency of possible side effects listed below is defined using the following convention:

very common (affects more than 1 user in 10)

 

common (affects 1 to 10 users in 100)

 

uncommon (affects 1 to 10 users in 1,000)

 

rare (affects 1 to 10 users in 10,000)

 

very rare (affects less than 1 user in 10,000)

authorised

not known (frequency cannot be estimated from the available data)

 

Side effects that may occur commonly: drowsiness; memory difficulties; sensations l ke tingling, e.g. in the extremities (paraesthesia); painful menstruation.

Uncommon side effects include: dizziness; weakness; reduced coordination of movements; unsteadiness and/or falls (ataxia); decreased concentration; apathy; restlessness; depression; agitation; irritability; confusion; abnormal thinking and behaviour (extroversion th t seems out of character,

decreased inhibition, aggressiveness, rages, delusion, depersonalisation,longer psychosis); nightmares;

hallucinations; double vision or other sight problems; increased s nsitivity to noise (hyperacusis); smell disorder (parosmia); speech disorders, including slurred speech; numbness, e.g. in the extremities (hypoaesthesia); nausea; decreased appetite; i creased sensitivity to light (sunlight, UV light); feeling vaguely ill (malaise).

In very rare cases, allergic reactions, some severe,nos metimes with difficulty in breathing, have been

reported and may require immediate medical care. An allergic reaction may also include a rash, itching, or swelling of the face,productlips, throat or ongue.

Increases in transaminases (a group of liver enzymes occurring naturally in the blood) have been reported, which may be a sign of liver problems.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please

Reporting of side effects

tell yourMedicinaldoctor or pharmacist.

If you get any s de 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 App ndix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store Sonata

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special temperature storage conditions.

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

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 Sonata contains

The active substance in each Sonata hard capsule is zaleplon 5 mg.

The other ingredients are microcrystalline cellulose, pregelatinised starch, silicon dioxide, sodium lauryl sulphate, magnesium stearate, lactose monohydrate, indigo carmine (E132), titanium dioxide (E171).

Ingredients of the capsule shell: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172) and sodium lauryl sulphate. Printing inks on the sh ll contain the following (gold ink SB-3002): shellac, ammonium hydroxide, yellow iron oxide (E172).

What Sonata looks like and contents of the pack

Sonata 5 mg hard capsules, which contain a light blue powder, have a light brown cap and white body, with gold imprint “5 mg”. They are packed in blisters. Each pack cont ins 7, 10 or 14 hard capsules.

Not all pack sizes may be marketed.

authorised

 

 

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder:

Manufacturer:

Meda AB

 

MEDAlongerManufacturing GmbH

Pipers väg 2A

 

Neurather Ring 1

S-170 73 Solna

 

51063 Cologne

Sweden

product

no

Germany

 

 

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

België/Belgique/Belg en

Lietuva

MEDA Pharma S.A./N.V.

Meda Pharma SIA

Chaussée de la Hulpe 166/

Veiverių 134

Terhulpsesteenweg 166

LT – 46352 Kaunas

B-1170 Bruss ls

Tel.: +370 37 330 509

Tél/Tel: +32 2 5 04 08 11

 

Medicinal

Luxembourg/Luxemburg

България

ТП Меда Фармасойтикалс

MEDA Pharma S.A./N.V.

Ул. Одрин 71-75, ет.2, ап 7

Chaussée de la Hulpe 166/

1303 София

Terhulpsesteenweg 166

Тел.: +359 2 4177977

B-1170 Brussels

 

Belgique/Belgien

 

Tél/Tel: +32 2 5 04 08 11

Česká republika MEDA Pharma s.r.o. Kodaňská 1441/46 CZ 100 10 Praha 10 Tel: +420 234 064 203

Danmark

Meda A/S

Solvang 8

DK-3450 Allerød

Tlf: +45 44 52 88 88

Deutschland

MEDA Pharma GmbH & Co. KG

Benzstraße 1

D-61352 Bad Homburg v.d.H.

Tel: + 49 6172 888 01

Eesti

Meda Pharma SIA

Narva mnt 11D

EE - 10151 Tallinn, Eesti

Tel. + 372 6261 025

Ελλάδα

MEDA Pharmaceuticals AE

Ευρυτανίας 3

GR-15231 Χαλάνδρι-Αττική Τηλ: +30 210 6 77 5690

España

MEDA Pharma S.A.U.

Avenida de Castilla, 2

Parque Empresarial San Fernando

Edificio Berlin

E-28830 San Fernando de Henares (Madrid)

Tel: +34 91 669 93 00

product

MEDA PHARMA SAS 25 Bd. de l´Am ral Bruix F-75016 Paris

France Medicinal

Tél : +33 156 64 10 70

Hrvatska

Medical Intertrade d.o.o. Dr. Franje Tudmana 3 10431 Sveta Nedelja Tel: +385 1 3374 010

Magyarország

MEDA PHARMA Hungary Kereskedelmi Kft. H-1139 Budapest

Váci ut 91

Tel.: +36 1 236 3410

Malta

Alfred Gera & Sons Ltd. 10, Triq il-Masġar Qormi QRM 3217

Tel: +356 2092 4000

Nederland

MEDA Pharma B.V.

authorised

Krijgsman 20

NL-1186 DM Amstelveen

Tel: +31 20 751 65 00

Norge

Meda A/S

Askerveien 61

N-1384 Asker

Gug gasse 15

A-1110 Wien

Tlf: +47 66 75 33 00 Österreichlonger MEDA Pharma GmbH

noTel: + 43 1 86 390 0

Polska

Meda Pharmaceuticals Sp. z o.o.

Al. Jana Pawła II nr 15

PL-00-828 Warszawa

Tel: +48 22 697 7100

Portugal

MEDA Pharma Produtos Farmacêuticos SA Rua do Centro Cultural 13

P-1749-066 Lisboa Tel: +351 21 842 0300

România

MEDA Pharmaceuticals Switzerland GmbH Reprezentanta Romania

Calea Floreasca 141-143, et.4 014467 Bucuresti

Tel.: +40 21 230 90 30

Ireland

Slovenija

Meda Health Sales Ireland Limited,

MEDA Pharmaceuticals Switzerland GmbH,

Unit 34/35, Block A,

Podružnica Ljubljana

Dunboyne Business Park,

Cesta 24. junija 23

Dunboyne

Ljubljana

Co. Meath

Tel: +386 59 096 951

Tel: +353 1 802 66 24

 

Ísland

Slovenská republika

Meda AB

MEDA Pharma spol. s r.o..

Box 906

Trnavská cesta 50

S-170 09 Solna

SK-821 02 Bratislava

Svíþjóð.

Tel: +421 2 4914 0171

Sími: +46 8 630 1900

 

Italia

 

Suomi/Finland

authorised

 

 

Meda Pharma S.p.A.

 

Meda Oy

 

Viale Brenta, 18

 

Vaisalantie 4/ Vaisalavägen 4

I-20139 Milano

 

FI-02130 Espoo/ Esbo

Tel: +39 02 57 416 1

 

Puh/Tel: +358 20 720 9550

Κύπρος

 

Sverige

 

MEDA Pharmaceuticals AE

 

Meda AB

 

Ευρυτανίας 3

 

Box 906

 

GR-15231 Χαλάνδρι-Αττική

 

longer

 

 

S-170 09 Solna

 

Ελλάδα

 

Tel: +46 8 630 1900

Τηλ: +30 210 6 77 5690

 

 

 

Latvija

 

United Kingdom

 

Meda Pharma SIA

 

Meda Pharmaceuticals Ltd.

Vienības gatve 109

product

Skyway House

 

LV-1058 Riga, Latvia

noParsonage Road

 

Tel.: +371 67616137

 

Takeley

 

 

 

Bishop's Stortford

 

 

 

CM22 6PU - UK

 

Medicinal

 

Tel: +44 845 460 0000

 

 

 

This leaflet was last approved in

 

 

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

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sonata 10 mg hard capsules zaleplon

Read all of this leaflet carefully before you 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. 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:

authorised

1.

What Sonata is and what it is used for

2.

What you need to know before you take Sonata

3.

How to take Sonata

4.

Possible side effects

5.

How to store Sonata

6.

Contents of the pack and other information

1.

What Sonata is and what it is used for

longer

 

 

Sonata belongs to a class of substances called benzodiazepi e-related medicinal products, which

consists of preparations with hypnotic actions.

 

 

no

 

Sonata will help you to sleep. Sleeping problems do n t usually last long, and most people only need a

 

product

 

short course of treatment. The duration of trea me t should usually vary from a few days to two weeks. If you still have problems sleeping af er you have finished your capsules, contact your doctor again.

2. What you need to know before you take Sonata

ifMedicinalyou are allerg c to zaleplon or any of the other ingredients of this medicine (listed in section 6).

if you have sleep apnoea syndrome (stopping breathing for short periods while asleep).

if you have severe kidney or liver problems.

if you have myasthenia gravis (very weak or tired muscles).

if you have severe breathing or chest problems.

If you are in any doubt about whether you have any of these conditions, do ask your doctor. Children and adolescents under 18 years of age must not take Sonata.

Warnings and precautions

Talk to your doctor or pharmacist before taking Sonata.

Never drink alcohol while you are being treated with Sonata. Alcohol can increase the undesirable effects of any medicine taken to help you sleep.

Use with extreme caution if you have ever been addicted to medicines or alcohol.

If you are taking any medicines belonging to the sleep inducing group, including Sonata, there is a possibility that you may become dependent on them. Once physical dependence has developed, abrupt termination of treatment may be accompanied by withdrawal symptoms.

These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability.

Do not use Sonata or any other sleeping medicine for longer than your doctor tells you to.Do not use a second dose of Sonata within a single night.

If your sleeplessness persists or worsens after a short course of Sonata treatment contact your doctor.

There is a chance that you may experience a certain type of temporary memory loss (amnesia) and lack of coordination when taking sleep medicines. This can usually be avoided if you remain inactive for at least 4 hours after taking Sonata.

There is a chance that you may experience somnambulism (sleepwalking), including eating or driving while not fully awake with no memory of the event. If you experience these events, contact your doctor immediately.

 

Reactions like restlessness, agitation, irritability, aggressiveness, abnormal thinking, delusion,

 

rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate behaviour,

 

extroversion that seems out of character and other behavioural effects have been r ported

 

following use of any medicines belonging to the sleep inducing group, including Sonata. These

 

reactions may be active substance-induced, spontaneous in origin, or a result of an underlying

 

psychiatric or physical disorder. They are more likely to occur in the elderly. If you experience

 

these events, contact your doctor immediately.

 

Rare cases of severe allergic reactions have been reported. An allergic reaction may include a

 

rash, itching, difficulty breathing or swelling of the face, lips, thro t or tongue, or nausea and

 

vomiting. If you experience any of these events, contact your doctor immediately.

 

 

authorised

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age.

Other medicines and Sonata

longer

 

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

includes medicines that can be bought without a prescription. Some can cause drowsiness and should not be taken while taking Sonata.

no medicines. Do not take any otherproductmedicines wi hout asking your doctor or pharmacist first. This

When Sonata is taken with other medicines that act on the brain, the combination may make you more drowsy than it should. Be awa e that such combinations may cause you to feel drowsy the next day. These medicines include: substances used in the treatment of mental conditions (antipsychotics, hypnotics,Medicinalanxiolytics/sed tives, antidepressants), medicines used for strong pain relief (narcotic analgesics), medici es used for the treatment of seizures/convulsions (antiepileptic medicines), medicines used for loss of feeling/insensibility (anaesthetics), and medicines used in the treatment of allergies (sedat ve antihistamines). Drinking alcohol while being treated with Sonata may also cause you to feel drowsy the next day. Never drink alcohol while you are being treated with Sonata (see “Warnings and precautions”).

You should tell your doctor or pharmacist if you are taking cimetidine (a stomach medicine) or erythromycin (an antibiotic).

Sonata with food, drink and alcohol

It is not recommended that you take Sonata with or immediately after eating a large meal as it may work more slowly. Swallow the capsule(s) with a small glass of water. Never drink alcohol while you are being treated with Sonata (see “Warnings and precautions”).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Sonata should not be taken at these times because there are not enough clinical data available to assess its safety during pregnancy and breast-feeding.

Driving and using machines

Sonata may make you feel drowsy, cause loss of concentration or memory or muscle weakness. This feeling may be even worse when you sleep for less than 7 to 8 hours after taking your medication or if you are already taking another central nervous system depressant or if you are drinking alcohol (see ‘other medicines and Sonata’). If affected do not drive or operate machinery.

Sonata contains lactose.

authorised

 

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 Sonata

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

The usual dose for adults is 10 mg just before going to bed, or after you have gone to bed and you are having difficulty falling asleep. You should not take a sec nd dose within a single night.

longer

There are different doses for people who are 65

r lder, and those who have mild to moderate liver

problems:

no

If you take more Sonata thanproductyou should

65 or older: Take one 5 mg capsule

Mild to moderate liver problems: Take one 5 mg capsule

Sonata has been designed, so that if the contents of the capsule are dissolved in liquid, the liquid will change colour and become cloudy.

ContactMedicinala doctor immediately and say how many capsules you have taken. Do not go unaccompanied to seek medical help.

If an overdose has been taken you may become increasingly drowsy very quickly, with high doses probably l ading to a coma.

If you forget to take Sonata

Just take your next capsule at the usual time, then go on as before. Do not try and catch up on the doses you have missed.

If you stop taking Sonata

On stopping treatment, your original sleeplessness may return and you may experience symptoms such as mood changes, anxiety, and restlessness. If you suffer from these symptoms, ask your doctor for advice.

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. If you notice any of the following, or any other changes in your health, do tell your doctor as soon as possible.

The frequency of possible side effects listed below is defined using the following convention:

very common (affects more than 1 user in 10)

 

common (affects 1 to 10 users in 100)

 

uncommon (affects 1 to 10 users in 1,000)

 

rare (affects 1 to 10 users in 10,000)

 

very rare (affects less than 1 user in 10,000)

authorised

not known (frequency cannot be estimated from the available data)

 

Side effects that may occur commonly: drowsiness; memory difficulties; sensations l ke tingling, e.g. in the extremities (paraesthesia); painful menstruation

Uncommon side effects include: dizziness; weakness; reduced coordination of movements; unsteadiness and/or falls (ataxia); decreased concentration; apathy; restlessness; depression; agitation; irritability; confusion; abnormal thinking and behaviour (extroversion th t seems out of character,

decreased inhibition, aggressiveness, rages, delusion, depersonalisation,longer psychosis); nightmares;

hallucinations; double vision or other sight problems; increased s nsitivity to noise (hyperacusis); smell disorder (parosmia); speech disorders, including slurred speech; numbness, e.g. in the extremities (hypoaesthesia); nausea; decreased appetite; i creased sensitivity to light (sunlight, UV light); feeling vaguely ill (malaise).

In very rare cases, allergic reactions, some severe,nos metimes with difficulty in breathing, have been

reported and may require immediate medical care. An allergic reaction may also include a rash, itching, or swelling of the face,productlips, throat or ongue.

Increases in transaminases (a group of liver enzymes occurring naturally in the blood) have been reported, which may be a sign of liver problems.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please

Reporting of side effects

tell yourMedicinaldoctor or pharmacist.

If you get any s de 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 App ndix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store Sonata

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special temperature storage conditions.

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

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 Sonata contains

The active substance in each Sonata hard capsule is zaleplon 10 mg.

The other ingredients are microcrystalline cellulose, pregelatinised starch, silicon dioxide, sodium lauryl sulphate, magnesium stearate, lactose monohydrate, indigo carmine (E132), titanium dioxide (E171).

Ingredients of the capsule shell: gelatin, titanium dioxide (E171) and sodium lauryl sulphate. Printing inks on the shell contain the following (pink ink SW-1105): shellac, titanium dioxide (E171), ammonium hydroxide, red iron oxide (E172), yellow iron oxide (E172).

What Sonata looks like and contents of the pack

Sonata 10 mg hard capsules, which contain a light blue powder, have a white cap and white body, with pink imprint “10 mg”. They are packed in blisters. Each pack contains 7, 10 or 14 hard capsules.

Not all pack sizes may be marketed.

 

 

authorised

 

 

 

 

Marketing Authorisation Holder and Manufacturer

 

Marketing Authorisation holder:

Manufacturer:

 

Meda AB

 

MEDA Manufacturing GmbH

Pipers väg 2A

 

 

longer

 

 

Neurather Ring 1

 

S-170 73 Solna

 

51063 Cologne

 

Sweden

product

no

 

 

Germany

 

 

 

 

 

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

Authorisation Holder.

 

 

 

 

België/Belgique/Belgien

 

Lietuva

 

MEDA Pharma S.A./N.V.

 

Meda Pharma SIA

Chaussée de la Hulpe 166/

 

Veiverių 134

 

Terhulpsesteenweg 166

 

LT – 46352 Kaunas

B-1170 Bruss ls

 

Tel.: +370 37 330 509

Tél/Tel: +32 2 5 04 08 11

 

 

 

 

Medicinal

 

Luxembourg/Luxemburg

България

 

ТП Меда Фармасойтикалс

 

MEDA Pharma S.A./N.V.

Ул. Одрин 71-75, ет.2, ап 7

 

Chaussée de la Hulpe 166/

1303 София

 

Terhulpsesteenweg 166

Тел.: +359 2 4177977

 

B-1170 Brussels

 

 

 

Belgique/Belgien

 

 

 

Tél/Tel: +32 2 5 04 08 11

Česká republika MEDA Pharma s.r.o. Kodaňská 1441/46 CZ 100 10 Praha 10 Tel: +420 234 064 203

Danmark

Meda A/S

Solvang 8

DK-3450 Allerød

Tlf: +45 44 52 88 88

Deutschland

MEDA Pharma GmbH & Co. KG

Benzstraße 1

D-61352 Bad Homburg v.d.H.

Tel: + 49 6172 888 01

Eesti

Meda Pharma SIA

Narva mnt 11D

EE - 10151 Tallinn, Eesti

Tel. + 372 6261 025

Ελλάδα

MEDA Pharmaceuticals AE

Ευρυτανίας 3

GR-15231 Χαλάνδρι-Αττική Τηλ: +30 210 6 77 5690

España

MEDA Pharma S.A.U.

Avenida de Castilla, 2

Parque Empresarial San Fernando

Edificio Berlin

E-28830 San Fernando de Henares (Madrid)

Tel: +34 91 669 93 00

product

MEDA PHARMA SAS 25 Bd. de l´Am ral Bruix F-75016 Paris

France Medicinal

Tél : +33 156 64 10 70

Hrvatska

Medical Intertrade d.o.o. Dr. Franje Tudmana 3 10431 Sveta Nedelja Tel: +385 1 3374 010

Magyarország

MEDA PHARMA Hungary Kereskedelmi Kft. H-1139 Budapest

Váci ut 91

Tel.: +36 1 236 3410

Malta

Alfred Gera & Sons Ltd. 10, Triq il-Masġar Qormi QRM 3217

Tel: +356 2092 4000

Nederland

MEDA Pharma B.V.

authorised

Krijgsman 20

NL-1186 DM Amstelveen

Tel: +31 20 751 65 00

Norge

Meda A/S

Askerveien 61

N-1384 Asker

Gug gasse 15

A-1110 Wien

Tlf: +47 66 75 33 00 Österreichlonger MEDA Pharma GmbH

noTel: + 43 1 86 390 0

Polska

Meda Pharmaceuticals Sp. z o.o.

Al. Jana Pawła II nr 15

PL-00-828 Warszawa

Tel: +48 22 697 7100

Portugal

MEDA Pharma Produtos Farmacêuticos SA Rua do Centro Cultural 13

P-1749-066 Lisboa Tel: +351 21 842 0300

România

MEDA Pharmaceuticals Switzerland GmbH Reprezentanta Romania

Calea Floreasca 141-143, et.4 014467 Bucuresti

Tel.: +40 21 230 90 30

Ireland

Slovenija

Meda Health Sales Ireland Limited,

MEDA Pharmaceuticals Switzerland GmbH,

Unit 34/35, Block A,

Podružnica Ljubljana

Dunboyne Business Park,

Cesta 24. junija 23

Dunboyne

Ljubljana

Co. Meath

Tel: +386 59 096 951

Tel: +353 1 802 66 24

 

Ísland

Slovenská republika

Meda AB

MEDA Pharma spol. s r.o..

Box 906

Trnavská cesta 50

S-170 09 Solna

SK-821 02 Bratislava

Svíþjóð.

Tel: +421 2 4914 0171

Sími: +46 8 630 1900

 

Italia

 

Suomi/Finland

authorised

 

 

Meda Pharma S.p.A.

 

Meda Oy

 

Viale Brenta, 18

 

Vaisalantie 4/ Vaisalavägen 4

I-20139 Milano

 

FI-02130 Espoo/ Esbo

Tel: +39 02 57 416 1

 

Puh/Tel: +358 20 720 9550

Κύπρος

 

Sverige

 

MEDA Pharmaceuticals AE

 

Meda AB

 

Ευρυτανίας 3

 

Box 906

 

GR-15231 Χαλάνδρι-Αττική

 

longer

 

 

S-170 09 Solna

 

Ελλάδα

 

Tel: +46 8 630 1900

Τηλ: +30 210 6 77 5690

 

 

 

Latvija

 

United Kingdom

 

Meda Pharma SIA

 

Meda Pharmaceuticals Ltd.

Vienības gatve 109

product

Skyway House

 

LV-1058 Riga, Latvia

noParsonage Road

 

Tel.: +371 67616137

 

Takeley

 

 

 

Bishop's Stortford

 

 

 

CM22 6PU - UK

 

Medicinal

 

Tel: +44 845 460 0000

 

 

 

This leaflet was last approved in

 

 

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

Annex IV

authorised

 

Scientific conclusions and grounds recommending the variation to he erms of the Marketing Authorisation

 

 

no

longer

 

product

 

Medicinal

 

 

 

 

 

Scientific conclusions

Taking into account the PRAC Assessment Report on the PSUR for zaleplon, the scientific conclusions of CHMP are as follows:

Literature articles regarding next day effects on driving and mental alertness were published during the reporting period which examined these effects with zaleplon and other agents of the class. While there were no significant findings in relation to zaleplon, a small number of cases have been reported in the post-marketing setting, although mostly in combination with other CNS depressant agents and at doses greater than 10mg.

Warnings already exist in the zaleplon product information however based on the available information the PRAC considered it prudent within this procedure to strengthen the wording in SmPC and PL to ensure clear information is available for patients and healthcare professionals given the potentially serious consequences of next day psychomotor impairment.

Therefore, in view of available data regarding next day effects on driving and mental alertness, the PRAC considered that changes to the product information were warranted.

The CHMP agrees with the scientific conclusions made by the PRAC.

authorised

 

 

 

 

 

Grounds recommending the variation to the terms f the Marketing Authorisation

On the basis of the scientific conclusions for zalepl

n the CHMP is of the opinion that the benefit-risk

balance of the medicinal product containing zalepl

 

longer

 

is favourable subject to the proposed changes to the

product information

 

no

 

 

The CHMP recommends that the terms of the Marketing Authorisation should be varied.

Medicinal

product

 

 

 

 

 

 

 

 

 

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