Desloratadine ratiopharm - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Desloratadine ratiopharm 5 mg film-coated tablets desloratadine For adults

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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 is in this leaflet

• 1. What Desloratadine ratiopharm is and what it is used for

• 2. What you need to know before you take 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 Desloratadine ratiopharm is and what it is used for

What Desloratadine ratiopharm is

Desloratadine ratiopharm contains desloratadine which is an antihistamine.

How Desloratadine ratiopharm works

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

When Desloratadine ratiopharm should be used

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.

2. What you need to know before you take 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 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.

Use in children and adolescents

Do not give this medicine to adolescents and children below 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.

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

Desloratadine ratiopharm with food, drink and alcohol

Desloratadine ratiopharm may be taken with or without a meal.

Use caution when taking Desloratadine ratiopharm 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 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.

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 ratiopharm contains lactose and sodium

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’.

3. How to take Desloratadine ratiopharm

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.

If you take more Desloratadine ratiopharm than you should

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 Desloratadine ratiopharm

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.

4. Possible side effects

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

The following side effects are very rare, but you must stop taking this medicine and seek urgent medical advice straight away if you notice them:

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

Other side effects that may occur:

Common (may affect up to 1 in 10 people)

• fatigue
• dry mouth
• headache

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

• 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

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
• slow heartbeat, changes in the way the heart beats
• abnormal behaviour, aggression
• weight increased, increased appetite

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 ratiopharm

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.

6. Contents of the pack and other information

What Desloratadine ratiopharm contains

• – The active substance is desloratadine. Each film-coated tablet contains 5 mg desloratadine.

• – The other ingredients are:

What Desloratadine ratiopharm looks like and contents of the pack

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.

Marketing Authorisation Holder

ratiopharm GmbH

Graf-Arco-StraBe 3

89079 Ulm

Germany

Manufacturer

Merckle GmbH

Ludwig-Merckle-StraBe 3

89143 Blaubeuren

Germany

or

Teva Pharmaceutical Works Private Limited Company

Pallagi ut 13

4042 Debrecen

Hungary

or

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

or

Teva Czech Industries s.r.o.

Ostravaska 29, c.p. 305

74770 Opava-Komarov

Czech Republic

or

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80

31–546 Krakow

Poland

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

Sími: +358 201805900

Tql: +30 2118805000

This leaflet was last revised in

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

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