Desloratadine Teva

Package leaflet: Information for the patient

Desloratadine Teva 5 mg film-coated tablets

Desloratadine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effect, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Desloratadine Teva is and what it is used for
2. What you need to know before taking 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 is Desloratadine Teva and what is it used for

What is Desloratadine Teva
Desloratadine Teva contains desloratadine, which is an antihistamine.
How Desloratadine Teva works
Desloratadine Teva is an antiallergic medicine that does not cause drowsiness. 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 allergy, such as hay fever or dust mite allergy) in adults and adolescents aged 12 years and older. These symptoms include sneezing, runny or itchy nose, itching of the palate, and itchy, red or watery eyes.
Desloratadine Teva is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives (wheals).
Relief from these symptoms lasts throughout the day and helps you resume your normal daily activities and improve your sleep.

2. What you need to know before taking Desloratadine Teva

Do not take Desloratadine Teva

• if you are allergic to desloratadine or to 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 Teva:

• if you have reduced kidney function.
• if you have a personal or family history of seizures.

Use in children and adolescents
Do not give this medicine to children under 12 years of age.
Other medicines and Desloratadine Teva
No interactions between Desloratadine Teva and other medicines are known.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Desloratadine Teva with food, drinks and alcohol
Desloratadine Teva can be taken with or without food.
Use caution when taking Desloratadine Teva with alcohol.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of Desloratadine Teva is not recommended if you are pregnant or breastfeeding.
Fertility
There are no data available on male/female fertility.
Driving and using machines
At the recommended dose, this medicine is not expected to affect the ability to drive or operate machinery. Although most people do not experience drowsiness, it is recommended not to engage in activities requiring mental alertness, such as driving a vehicle or operating machinery, until you know how this medicine affects you.
Desloratadine Teva contains lactose
Desloratadine Teva contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Desloratadine Teva

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.
Adults and adolescents aged 12 years and older
The recommended dose is one tablet once daily 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 have
and how long you should take Desloratadine Teva.
If your allergic rhinitis is intermittent (symptoms present for less than 4 days per week or for less than 4 weeks),
your doctor will prescribe a treatment regimen based on an assessment of your medical history.
If your allergic rhinitis is persistent (symptoms present for 4 or more days per week and for more than 4 weeks),
your doctor may prescribe long-term treatment.
In the case of urticaria, the duration of treatment may vary from patient to patient, so you must follow your doctor's instructions.
If you take more Desloratadine Teva than you should
Take Desloratadine Teva only if it has been prescribed for you. Serious problems following accidental overdose are unlikely.
However, if you take more Desloratadine Teva than prescribed, inform your doctor, pharmacist or nurse immediately.
If you forget to take Desloratadine Teva
If you forget to take your dose at the prescribed time, take it as soon as possible and then continue your treatment as usual.
Do not take a double dose to make up for the missed dose.
If you stop treatment with Desloratadine Teva
If you have any questions about using this medicine, consult 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, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported. If you experience any of these serious side effects, stop taking the medicine immediately and contact a doctor straight away.

In clinical studies in adults, side effects were similar to those observed with an inactive tablet (placebo). However, fatigue, dry mouth, and headache were reported more frequently than with an inactive tablet (placebo). In adolescents, headache was the most commonly reported side effect.

In clinical studies with Desloratadine Teva, the following side effects have been reported as:

Common: may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache

Adults
During the marketing of Desloratadine Teva, the following side effects have been reported as:

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

• severe allergic reactions ● rash ● pounding or irregular heartbeat
• fast heartbeat ● stomach discomfort ● feeling unwell (nausea)
• vomiting ● stomach disorders ● diarrhoea
• dizziness ● drowsiness ● difficulty sleeping (insomnia)
• muscle pain ● hallucinations ● seizures
• restlessness with increased body movement ● liver inflammation ● changes in liver function tests

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 sunlight, even on cloudy days, and to UV (ultraviolet) light, for example from UV lamps in sunbeds
• changes in heart rhythm
• abnormal behaviour
• aggression
• weight gain
• increased appetite
• depressed mood
• dry eyes

Children
Not known: frequency cannot be estimated from the available data

• slowing of the heartbeat ● changes in heart rhythm
• abnormal behaviour ● aggression

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex 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 stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice any changes in the appearance of the tablets.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Desloratadina Teva contains

• The active substance is desloratadine 5 mg.
• The other components are microcrystalline cellulose, pregelatinized corn starch, talc, anhydrous colloidal silica, lactose monohydrate, hypromellose, titanium dioxide (E171), macrogol 400, indigo carmine (E132).

Description of the appearance of Desloratadina Teva and package contents

Film-coated blue, round, biconvex tablet, smooth on both sides.
Desloratadina Teva 5 mg film-coated tablets are available in blisters 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 x 1 film-coated
tablets (unit dose).
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturer
Teva Pharmaceutical Works Private Limited Company
Pallagi út 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 further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД Teva Pharma Belgium N.V./S.A./AG
Teл: +359 24899585 Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf: +45 44985511 L-Irlanda
Tel: +44 2075407117

Deutschland Nederland
TEVA GmbH Teva Nederland B.V.
Tel: +49 73140208 Tel: +31 8000228400

Eesti Norge
Teva Norway AS
UAB Teva Baltics Eesti filiaal Tlf: +47 66775590
Tel: +372 6610801

Ελλάδα Österreich
Specifar A.B.E.E. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel: +48 223459300

France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos, Lda.
Tél: +33 155917800 Tel: +351 214767550

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Alvogen ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5222900 Tel: +421 257267911

Italia Suomi/Finland
Teva Italia S.r.l. SanoSwiss UAB
Tel: +39 028917981 Puh/Tel: +370 70001320

Κύπρος Sverige
Specifar A.B.E.E. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000

Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Teva Pharmaceuticals Ireland
Tel: +371 67323666 Ireland
Tel: +44 2075407117

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.