Desloratadine Teva - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Desloratadine Teva 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 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 Desloratadine Teva is and what it is used for

• 2. What you need to know before you take Desloratadine Teva

• 3. How to take Desloratadine Teva

• 4. Possible side effects

• 5. How to store Desloratadine Teva

• 6. Contents of the pack and other information

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

What Desloratadine Teva is

Desloratadine Teva contains desloratadine which is an antihistamine.

How Desloratadine Teva works

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

When Desloratadine Teva should be used

Desloratadine Teva 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 Teva 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 Teva

Do not take Desloratadine Teva

• 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 or pharmacist before taking Desloratadine Teva

• 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 Teva

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

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

Desloratadine Teva with food, drink and alcohol

Desloratadine Teva may be taken with or without a meal.

Use caution when taking Desloratadine Teva 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 Teva 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.

Desloratadine Teva contains lactose

Desloratadine Teva contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Desloratadine Teva

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 Teva.

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 Teva than you should

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

If you forget to take Desloratadine Teva

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 Teva

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.

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

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

severe allergic reactions
body 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
• weight increased
• increased appetite

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 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 Desloratadine Teva

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 and blister after “EXP”. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not use this medicine 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 Teva contains

• – The active substance is 5 mg desloratadine.

• – The other ingredients are microcrystalline cellulose, pregelatinised maize starch, talc, silica colloidal anhydrous, lactose monohydrate, hypromellose, titanium dioxide (E171), macrogol 400, indigo carmine (E132).

What Desloratadine Teva looks like and contents of the pack

Blue, round, biconvex film-coated tablet, plain on both sides. Desloratadine Teva 5 mg film-coated tablets are supplied in blister packs of 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 90, 100 and 105 film-coated tablets and in perforated blister packs of 50 × 1 film-coated tablet (unit dose). Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Manufacturer

TEVA Pharmaceutical Works Private Limited Company

Pallagi ut 13,

4042 Debrecen,

Hungary or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem, The Netherlands or

Merckle GmbH

Ludwig-Merckle-Strasse 3

D-89143 Blaubeuren

Germany

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

Belgie/Belgiqu­e/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373	Lietuva UAB Teva Baltics Tel: +370 52660203
Etnrapua TeBa OapMa EAfl Ten: +359 24899585	Luxembourg/Lu­xemburg Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien Tel/Tel: +32 38207373
Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111	Magyarorszag Teva Gyogyszergyar Zrt. Tel: +36 12886400
Danmark Teva Denmark A/S Tlf: +45 44985511	Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117
Deutschland TEVA GmbH Tel: +49 73140208	Nederland Teva Nederland B.V. Tel: +31 8000228400
Eesti	Norge Teva Norway AS
UAB Teva Baltics Eesti filiaal	Tlf: +47 66775590

Tel: +372 6610801

EXÀàôa Specifar A.B.E.E. Tql: +30 2118805000	Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
España Teva Pharma, S.L.U. Tel: +34 913873280	Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
France Teva Santé Tél: +33 155917800	Portugal Teva Pharma – Produtos Farmacéuticos, Lda. Tel: +351 214767550
Hrvatska Pliva Hrvatska d.o.o. Tel: + 385 13720000	Romania Teva Pharmaceuticals S.R.L. Tel: +40 212306524
Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407117	Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890390

Slovenská republika

TEVA Pharmaceuticals Slovakia s.r.o.

Tel: +421 257267911

Suomi/Finland

SanoSwiss UAB

Puh/Tel: +370 70001320

Sverige

Teva Sweden AB

Tel: +46 42121100

United Kingdom (Northern Ireland)

Teva Pharmaceuticals Ireland

Ireland

Tel: +44 2075407117

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:

23