Desloratadine ratiopharm
desloratadine
desloratadine For adults
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
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.
You must talk to a doctor if you do not feel better or if you feel worse after 7 days.
What Desloratadine ratiopharm is and what it is used for
What you need to know before you take Desloratadine ratiopharm
How to take Desloratadine ratiopharm
Possible side effects
How to store Desloratadine ratiopharm
Contents of the pack and other information
Desloratadine ratiopharm contains desloratadine which is an antihistamine.
Desloratadine ratiopharm is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms.
Desloratadine ratiopharm 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. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.
Desloratadine ratiopharm is also used to relieve the symptoms associated with chronic idiopathic urticaria (a skin condition with unknown cause), initially diagnosed by your doctor. 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.
You must talk to a doctor if you do not feel better or if you feel worse after 7 days. If you notice difficulties in breathing or swelling of lips, tongue or throat you must talk to a doctor immediately.
if you are allergic to desloratadine, loratadine or any of the other ingredients of this medicine (listed in section 6).
Talk to your doctor or pharmacist before taking Desloratadine ratiopharm:
if you have poor kidney function or severe liver disease.
if you have medical or familial history of seizures.
If you suffer from chronic idiopathic urticaria, this should be diagnosed by your doctor before taking Desloratadine ratiopharm.
Do not give this medicine to adolescents and children below 18 years of age.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
There are no known interactions of Desloratadine ratiopharm with other medicines.
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 ratiopharm is not recommended if you are pregnant.
Your doctor will decide if you should stop breast-feeding your baby or stop treatment with Desloratadine ratiopharm.
There is no data available on male/female fertility.
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.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one tablet once a day with water.
The tablet may be taken with or without food. Swallow the tablet whole.
The duration of treatment depends on the type, duration and course of your complaints. You must talk to a doctor if you do not feel better or if you feel worse after 7 days. If you notice difficulties in breathing or swelling of lips, tongue or throat you must talk to a doctor immediately.
If your symptoms of allergic rhinitis used to last for less than 4 days per week or for less than 4 weeks in the past, please use this medicine until your symptoms are resolved. You can start again to use this medicine, when the symptoms return.
If your allergic symptoms used to last for a longer period in the past (4 days or more per week and for more than 4 weeks), continued treatment during the allergen exposure period may be necessary.
For chronic idiopathic urticaria, a treatment for more than 6 weeks may be necessary, depending on your symptoms. If symptoms return after stopping the treatment, you can take this medicine again.
No serious problems are expected with accidental overdose. However, if you take more Desloratadine ratiopharm than you should, tell your doctor or pharmacist immediately.
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 have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling)
Other side effects that may occur:
fatigue
dry mouth
headache
rash
pounding or irregular heartbeat, fast heartbeat
stomach ache, feeling sick (nausea), vomiting, upset stomach, diarrhoea
dizziness, drowsiness, inability to sleep, seizures, restlessness with increased body movement
muscle pain
hallucinations
liver inflammation, abnormal liver function tests
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
slow heartbeat, changes in the way the heart beats
abnormal behaviour, aggression
weight increased, increased appetite
depressed mood
dry eyes
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.
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.
Do not store above 30°C.
Store in the original package in order to protect from moisture.
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.
The active substance is desloratadine. Each film-coated tablet contains 5 mg desloratadine.
The other ingredients are:
Tablet core: poloxamer type 188, citric acid monohydrate, microcrystalline cellulose, maize starch, croscarmellose sodium, lactose monohydrate (see section 2 “Desloratadine ratiopharm contains lactose and sodium”), talc.
Film-coating: polyvinyl alcohol (part. hydrolysed), titanium dioxide (E171), macrogol/PEG 3350, talc and indigo carmine aluminium lake (E132).
Round, biconvex, blue film-coated tablets.
Desloratadine ratiopharm 5 mg film-coated tablets are supplied in PVC/PVdC/aluminium blister packs of 7, 10, 14, 15, 20 and 30 film-coated tablets.
Not all pack sizes may be marketed.
ratiopharm GmbH Graf-Arco-Straße 3
89079 Ulm
Germany
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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373
UAB Teva Baltics Tel: +370 52660203
Тева Фарма ЕАД Тел: +359 24899585
Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111
Teva Gyógyszergyár Zrt. Tel: +36 12886400
Teva Denmark A/S Tlf: +45 44985511
Teva Pharmaceuticals Ireland L-Irlanda
Tel: +44 2075407117
Teva Nederland B.V. Tel: +31 8000228400
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801
Teva Norway AS Tlf: +47 66775590
Specifar Α.Β.Ε.Ε. Τηλ: +30 2118805000
ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
Teva Pharma, S.L.U. Tel: +34 913873280
Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
Teva Santé
Tél: +33 155917800
ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.
Tel: +351 214767550
Pliva Hrvatska d.o.o. Tel: +385 13720000
Teva Pharmaceuticals S.R.L. Tel: +40 212306524
Teva Pharmaceuticals Ireland Tel: +44 2075407117
Pliva Ljubljana d.o.o. Tel: +386 15890390
Teva Pharma Iceland ehf.
Sími: +354 5503300
TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911
Teva Italia S.r.l.
Tel: +39 028917981
Teva Finland Oy
Puh/Tel: +358 201805900
Specifar Α.Β.Ε.Ε. Ελλάδα
Τηλ: +30 2118805000
Teva Sweden AB Tel: +46 42121100
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117