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Desloratadine Actavis (desloratadine) – Package leaflet - R06AX27

Updated on site: 06-Oct-2017

Medication nameDesloratadine Actavis
ATC CodeR06AX27
Substancedesloratadine
ManufacturerActavis Group PTC ehf

Package leaflet: Information for the patient

Desloratadine Actavis 5 mg film-coated tablets desloratadine

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, pharmacist or nurse.

-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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What Desloratadine Actavis is and what it is used for

2.What you need to know before you take Desloratadine Actavis

3.How to take Desloratadine Actavis

4.Possible side effects

5.How to store Desloratadine Actavis

6.Contents of the pack and other information

1.What Desloratadine Actavis is and what it is used for

What Desloratadine Actavis is

Desloratadine Actavis contains desloratadine which is an antihistamine.

How Desloratadine Actavis works

Desloratadine Actavis is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms.

When Desloratadine Actavis should be used

Desloratadine Actavis relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) in adults and adolescents 12 years of age and older. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.

Desloratadine Actavis is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives.

Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and sleep.

2.What you need to know before you take Desloratadine Actavis

Do not take Desloratadine Actavis:

if you are allergic to desloratadine, or any of the other ingredients of this medicine (listed in section 6) or to loratadine.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Desloratadine Actavis:

if you have poor kidney function.

if you have medical or familial history of seizures.

Use in children and adolescents

Do not give this medicine to children less than 12 years of age.

Other medicines and Desloratadine Actavis

There are no known interactions of Desloratadine Actavis with other medicines.

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

Desloratadine Actavis with food, drink and alcohol

Desloratadine Actavis may be taken with or without a meal.

Use caution when taking Desloratadine Actavis with alcohol.

Pregnancy, breast-feeding and fertility

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.

Taking Desloratadine Actavis is not recommended if you are pregnant or nursing a baby.

Fertility

There is no data available on male/female fertility.

Driving and using machines

At the recommended dose, this medicine is not expected to affect your ability to drive or use machines. Although most people do not experience drowsiness, it is recommended not to engage in activities requiring mental alertness, such as driving a car or operating machinery until you have established your own response to the medicinal product.

3.How to take Desloratadine Actavis

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

Adults and adolescents 12 years of age and over

The recommended dose is one tablet once a day with water, with or without food.

This medicine is for oral use.

Swallow the tablet whole.

Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Desloratadine Actavis.

If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less than 4 weeks), your doctor will recommend you a treatment schedule that will depend on the evaluation of the history of your disease.

If your allergic rhinitis is persistent (presence of symptoms for 4 days or more per week and for more than 4 weeks), your doctor may recommend you a longer term treatment.

For urticaria, the duration of treatment may be variable from patient to patient and therefore you should follow the instructions of your doctor.

If you take more Desloratadine Actavis than you should

Take Desloratadine Actavis only as it is prescribed for you. No serious problems are expected with accidental overdose. However, if you take more Desloratadine Actavis than you were told to, tell your doctor, pharmacist or nurse immediately.

If you forget to take Desloratadine Actavis

If you forget to take your dose on time, take it as soon as possible and then go back to your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.

If you stop taking Desloratadine Actavis

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

4.Possible side effects

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

During the marketing of desloratadine, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely. If you notice any of these serious side effects, stop taking the medicine and seek urgent medical advice straight away.

In clinical studies in adults, side effects were about the same as with a dummy tablet. However, fatigue, dry mouth and headache were reported more often than with a dummy tablet. In adolescents, headache was the most commonly reported side effect.

In clinical studies with desloratadine, the following side effects were reported as:

Common: the following may affect up to 1 in 10 people

fatigue

dry mouth

headache

Adults

During the marketing of desloratadine, the following side effects were reported as:

Very rare: the following may affect up to 1 in 10,000 people

 

 

severe allergic reactions

rash

• pounding or irregular heartbeat

fast heartbeat

stomach ache

feeling sick (nausea)

vomiting

upset stomach

diarrhoea

dizziness

drowsiness

inability to sleep

muscle pain

hallucinations

seizures

• restlessness with increased body

liver inflammation

• abnormal liver function tests

 

movement

 

 

 

 

Not known: frequency cannot be estimated from the available data

 

 

unusual weakness

• yellowing of the skin and/or eyes

increased sensitivity of the skin to the sun, even in case of hazy sun, and to UV light, for instance to UV lights of a solarium

changes in the way the heart beats

abnormal behaviour

aggression

Children

Not known: frequency cannot be estimated from the available data

slow heartbeat

change in the way the heart beats

abnormal behaviour

aggression

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Desloratadine Actavis

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, bottle label and blister after ‘EXP’. The expiry date refers to the last day of that month.

Blisters:

This medicine does not require any special storage conditions.

Bottles:

This medicine does not require any special temperature storage conditions. Keep the bottle tightly closed in order to protect from light.

Tell your pharmacist if you notice any change in the appearance of the tablets.

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 Desloratadine Actavis contains

-The active substance is desloratadine. Each film-coated tablet (tablet) contains 5 mg desloratadine.

-The other ingredients are:

Tablet core: Microcrystalline cellulose, starch (pregelatinised), mannitol, talc, magnesium stearate. Tablet coating: Hypromellose 6cP, titanium dioxide (E171), macrogol 6000, indigo carmine aluminum lake (E132).

What Desloratadine Actavis looks like and contents of the pack

Blue coloured, round, with diameter of 6 mm, biconvex, film-coated tablets with the marking ‘LT’ engraved on one side.

Desloratadine Actavis 5 mg film-coated tablets are packed in:

Blister packs: 7, 10, 14, 20, 21, 30, 50, 90 or 100 tablets.

Plastic bottles containing a desiccant and closed with a plastic cap: 30 or 100 tablets. Do not swallow the desiccant.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Actavis Group PTC ehf. Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Manufacturer

Actavis Ltd.

BLB 016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

Manufacturing Packaging Farmaca (MPF) B.V.

Appelhof 13, 8465 RX Oudehaske,

The Netherlands

Manufacturing Packaging Farmaca (MPF) B.V.

Neptunus 12, 8448 CN Heerenveen,

The Netherlands

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

België/Belgique/Belgien

Lietuva

Aurobindo Pharma B.V.

UAB “Actavis Baltics”

Nederland / Pays-Bas / Niederlande

Tel: +370 5 260 9615

Tél/Tel: +31 (0)35 542 99 33

 

България

Luxembourg/Luxemburg

Актавис ЕАД

Aurobindo Pharma B.V.

Teл.: +359 2 9321 861

Pays-Bas / Niederlande

 

Tél/Tel: +31 (0)35 542 99 33

Česká republika

Magyarország

Actavis CZ a.s.

Actavis Hungary Kft.

Tel: +420 251 113 002

Tel.: +36 1 501 7001

Danmark

Malta

Actavis A/S

Actavis Ltd.

Tlf: +45 72 22 30 00

Tel: +35621693533

Deutschland

Nederland

PUREN Pharma GmbH & Co. KG

Aurobindo Pharma B.V.

Telefon: +49 (0)89 558909 0

Tel: +31 (0)35 542 99 33

Eesti

Norge

UAB “Actavis Baltics” Eesti Filiaal

Actavis Norway AS

Tel: +372 6100 565

Tlf: +47 815 22 099

Ελλάδα

Österreich

Specifar ABEE

Actavis GmbH

Τηλ: +30 210 5401500

Tel: +43 (0)662 435 235 00

España

Polska

Aurovitas Spain, S.A.U.

Actavis Export Int. Ltd., Malta.

Tfno.: +34 91 630 86 45

Kontakt w Polsce:

 

Tel.: (+48 22) 512 29 00

France

Portugal

Arrow Génériques

Aurovitas, Unipessoal, Lda

Tél: +33 4 72 72 60 72

Tel: +351 214 185 104

Hrvatska

România

PharmaVigil d.o.o.

Actavis SRL

Tel: +385(1)3890676

Tel: +40 21 318 17 77

Ireland

Slovenija

 

Actavis Ireland Limited

Apta Medica Internacional d.o.o.

Tel: +353 (0)21 4619040

Tel: +386 51 615 015

Ísland

Slovenská republika

Actavis Group PTC ehf.

Actavis s.r.o.

Sími: +354 550 3300

Tel: +421 2 3255 3800

Italia

Suomi/Finland

Aurobindo Pharma (Italia) s.r.l.

Actavis Oy

Tel: +39 0296392601

Puh/Tel: +358 (0)9 348 233

Κύπρος

Sverige

A. Potamitis Medicare Ltd

Actavis AB

Τηλ: +357 22583333

Tel: +46 8 13 63 70

Latvija

United Kingdom

UAB “Actavis Baltics” Latvijas filiāle

Actavis UK Limited

Tel.: +371 67304300

Tel: +44 1271 385257

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

Annex IV

Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Scientific conclusions

Taking into account the PRAC Assessment Report on the PSUR(s) for desloratadine, the scientific conclusions of CHMP are as follows:

Two literature reports identified a possible relationship between aggressive reaction/abnormal behaviour and desloratadine use with supportive temporal relationships, positive dechallenges and some with positive rechallenges. Similar cases were reported in Eudravigilance for the reference period. Considering the potential seriousness of these events in children, and the number of reported cases with positive dechallenge and rechallenge, the ‘abnormal behaviour’ and ‘aggression’ should be added to the list of adverse drug reactions (ADRs) of desloratadine.

A literature article published during the reference period describes 4 cases of epilepsy in children with a family history of epilepsy or relevant medical history. The causality was assessed as possible for each case, based on temporal association and positive dechallenge. Based on these new data, it could be concluded that desloratadine may aggravate pre-existing seizures in patients (and mainly in children) with medical history of seizures, and that caution should be recommended in treating epileptic patients or those susceptible to convulsions with desloratadine.

Based on 4 new publications regarding a possible association between desloratadine and QT prolongation were reported in the literature and the fact that ‘QT prolongation’ is already listed as an ADR of desloratadine-containing products, this adverse reaction should be listed as an ADR of any desloratadine-containing product.

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

Grounds for the variation to the terms of the marketing authorisation(s)

On the basis of the scientific conclusions for desloratadine the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing desloratadine is unchanged subject to the proposed changes to the product information.

The CHMP recommends that the terms of the marketing authorisation(s) should be varied.

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