Desloratadine Ratiopharm

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Desloratadine ratiopharm 5 mg film-coated tablets

desloratadine
For adults
Please read this entire leaflet carefully before taking this medicine, as it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, please consult your pharmacist.
• If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 7 days.

Contents of this leaflet:

1. What Desloratadine ratiopharm is and what it is used for
2. What you need to know before taking Desloratadine ratiopharm
3. How to take Desloratadine ratiopharm
4. Possible side effects
5. How to store Desloratadine ratiopharm
6. Contents of the pack and other information

1. What Desloratadina ratiopharm is and what it is used for

What Desloratadina ratiopharm is
Desloratadina ratiopharm contains desloratadine, which is an antihistamine.
How Desloratadina ratiopharm works
Desloratadina ratiopharm is an antiallergic medicine that does not cause drowsiness. It helps control your allergic reaction and its symptoms.
When Desloratadina ratiopharm should be used
Desloratadina ratiopharm relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by allergy, such as hay fever or dust mite allergy) in adults.
These symptoms include sneezing, runny or itchy nose, itching of the palate, and itchy, red or watery eyes.
Desloratadina ratiopharm is also used to relieve symptoms associated with chronic idiopathic urticaria (a skin condition of unknown origin), initially diagnosed by a doctor.
These symptoms include itching and hives (wheals).
Relief from these symptoms lasts throughout the day, helping you resume your normal daily activities and improving sleep.
Consult your doctor if you do not notice improvement or if your symptoms worsen after 7 days.
If you experience difficulty breathing or swelling of the lips, tongue or throat, seek immediate medical attention.

2. What you need to know before taking Desloratadine ratiopharm

Do not take Desloratadine ratiopharm

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Desloratadine ratiopharm:

• if you have reduced kidney function or severe liver disease.
• if you or a family member has a history of seizures.

If you suffer from chronic idiopathic urticaria, the condition must have been diagnosed by a doctor before taking Desloratadine ratiopharm.
Use in children and adolescents
Do not give this medicine to adolescents or children under 18 years of age.
Other medicines and Desloratadine ratiopharm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions between Desloratadine ratiopharm and other medicines are known.
Desloratadine ratiopharm with food, drink and alcohol
Desloratadine ratiopharm can be taken with or without food.
Use caution when taking Desloratadine ratiopharm with alcohol.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breast-feeding, consult your doctor or pharmacist before taking this medicine.
The use of Desloratadine ratiopharm is not recommended during pregnancy.
Your doctor will decide whether you should discontinue breast-feeding or discontinue treatment with Desloratadine ratiopharm.
There are no available data 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 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 you react to this medicine.
Desloratadine ratiopharm contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Desloratadina ratiopharm

Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet once daily with water.
The tablet can be taken with or without food. Swallow the tablet whole.
The duration of treatment depends on the type, duration and course of your symptoms. Consult your doctor if you do not notice any improvement or if your symptoms worsen after 7 days. If you experience difficulty breathing or swelling of the lips, tongue or throat, seek immediate medical attention.
If in the past your allergic rhinitis symptoms lasted for less than 4 days during a week or for less than 4 weeks, use this medicine until symptoms resolve. You may restart taking this medicine if symptoms reappear.
If in the past your allergy symptoms lasted longer (4 or more days per week and for more than 4 weeks), you may require continuous treatment during the period of allergen exposure.
In the case of chronic idiopathic urticaria, treatment lasting more than 6 weeks may be required, depending on symptoms. If symptoms reappear after stopping treatment, you may take this medicine again.
If you take more Desloratadina ratiopharm than you should
Serious problems due to accidental overdose are not expected. However, if you take more Desloratadina ratiopharm than you should, inform your doctor or pharmacist immediately.
If you forget to take Desloratadina ratiopharm
If you forget to take your dose at the prescribed time, take it as soon as possible, then continue your treatment as usual. Do not take a double dose to make up for the forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The side effects listed below are very rare. However, if you notice any of these, you must stop taking
the medicine and contact a doctor immediately:

• severe allergic reactions (difficulty breathing, wheezing, itching, hives and swelling)

Other possible side effects
Common (may affect up to 1 in 10 people)

• tiredness
• dry mouth
• headache

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

• rash
• pounding or irregular heartbeat
• stomach ache, feeling unwell (nausea), vomiting, stomach discomfort, diarrhoea
• dizziness, drowsiness, difficulty sleeping (insomnia), seizures, restlessness with increased body movement
• muscle pain
• hallucinations
• 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 UV lamps in sunbeds
• slow heartbeat, changes in the way the heart beats
• abnormal behaviour, aggression
• weight gain, increased appetite
• depressed mood
• dry eyes

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system detailed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Desloratadina ratiopharm

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.
Do not store above 30 °C.
Keep in the original packaging to protect the medicine from moisture.
Do not use this medicine if you notice any changes in the appearance of the tablets.
Do not dispose of any medicine 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 Desloratadine ratiopharm contains

• The active substance is desloratadine. Each film-coated tablet contains 5 mg of desloratadine.
• Other components are: Tablet core: poloxamer type 188, citric acid monohydrate, microcrystalline cellulose, corn starch, sodium croscarmellose, lactose monohydrate (see section 2 “Desloratadine ratiopharm contains lactose and sodium”), talc.
  Coating: polyvinyl alcohol (partially hydrolysed), titanium dioxide (E171), macrogol/PEG 3350, talc, indigo carmine aluminium lake (E132).

Description of the appearance of Desloratadine ratiopharm and package contents
Blue, round, biconvex film-coated tablets.
Desloratadine ratiopharm 5 mg film-coated tablets are available in PVC/PVdC/aluminium blister packs containing 7, 10, 14, 15, 20 and 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
ratiopharm GmbH
Graf-Arco-Straße 3
89079 Ulm
Germany

Manufacturer
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany
or
Teva Pharmaceutical Works Private Limited Company
Pallagi út 13
4042 Debrecen
Hungary
or
Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
or
Teva Czech Industries s.r.o.
Ostravaská 29, c.p. 305
74770 Opava-Komárov
Czech Republic
or
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Poland

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation 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 ratiopharm GmbH
Тел: +359 24899585 Allemagne/Deutschland
Tél/Tel: +49 73140202

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
ratiopharm GmbH Teva Nederland B.V.
Tel: +49 73140202 Tel: +31 8000228400

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

Ελλάδα Österreich
Specifar Α.Β.Ε.Ε. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
ratiopharm España, S.A. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel: +48 223459300

France Portugal
Teva Santé ratiopharm - Comércio e Industria de Produtos
Tél: +33 155917800 Farmacêuticos, Lda.
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
Teva Finland Oy TEVA Pharmaceuticals Slovakia s.r.o.
Finnland Tel: +421 257267911
Sími: +358 201805900

Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900

Κύπρος Sverige
Specifar Α.Β.Ε.Ε. 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.