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Desloratadine Sandoz 5 Mg Film-Coated Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT


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Desloratadine 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.


What is in this leaflet

1.    What Desloratadine is and what it is used for

2.    What you need to know before you take Desloratadine

3.    How to take Desloratadine

4.    Possible side effects

5.    How to store Desloratadine

6.    Contents of the pack and other information


A SANDOZ


What Desloratadine is and what it is used for


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

Desloratadine relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites). These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.

Desloratadine 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.

Desloratadine is indicated for adults and adolescents (12 years of age and older).


Desloratadine with food and drink

Desloratadine may be taken with or without a meal.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine during pregnancy and breastfeeding.

If you are pregnant or nursing a baby, taking Desloratadine is not recommended.

Driving and using machines

At the recommended dose, Desloratadine is not expected to cause you to be drowsy or less alert. However, very rarely some people experience drowsiness, which may affect their ability to drive or use machines.


3 How to take Desloratadine


What you need to know before you take Desloratadine


Do not take Desloratadine

•    if you are allergic (hypersensitive) to desloratadine, to any of the other ingredients of Desloratadine or to loratadine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Desloratadine:

•    if you have poor kidney function.

If this applies to you, or if you are not sure, please check with your doctor before taking Desloratadine.


Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is:

Adults and adolescents (12 years of age and older): take one tablet once a day.

Swallow the tablet with or without food.

Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Desloratadine.

•    If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less than 4 weeks), your physician 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 physician may recommend you a longer term treatment.


Other medicines and Desloratadine

There are no known interactions of Desloratadine with other medicines.


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• For urticaria, the duration of treatment may be variable from patient to patient and therefore you should follow the instructions of your physician.

If you take more Desloratadine than you should

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

If you forget to take Desloratadine

If you forget to take your dose on time, take it as soon as possible, 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.


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 to protect the environment.


Contents of the pack and other information


4 Possible side effects


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

•    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.

During the marketing of Desloratadine, following side effects have been reported very rarely (may affect up to 1 in 10,000 people):

   Severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) and rash. Stop taking the medicine and seek medical help immediately if you experience any of these symptoms.

•    Palpitations, rapid heartbeat,

•    Stomach pain, nausea (feeling sick), vomiting, upset stomach, diarrhoea,

•    Dizziness, drowsiness, inability to sleep,

•    Muscle pain, hallucinations, seizures, restlessness with increased body movement,

•    Liver inflammation and abnormal liver function tests.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.


5 How to store Desloratadine


Keep this medicine out of the sight and reach of children.

Do not use Desloratadine 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.


What Desloratadine contains

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

•    The other ingredients are:

Film-coated tablet core: Maize starch,

Cellulose, microcrystalline, Hypromellose, Silica Colloidal anhydrous, Hydrogenated vegetable oil (Type 1).

Film-coated tablet coating: Opadry Blue 03B50689 (Hypromellose E464, Titanium dioxide E171, Macrogol 400 E1521, Indigo Carmine Aluminum Lake E132)

What Desloratadine looks like and contents of the pack

Desloratadine is a Light blue, round shaped, biconvex film coated tablets, with “5” debossed on one side. Diameter 6.50 ±0.10 mm.

Desloratadine is supplied in blister pack comprising of OPA/ALU/ PVC/ALU and in blister pack comprising of PVC/Aclar/ALU)

Pack sizes (unit dose):

1,2, 3, 5, 7, 10, 14, 15, 20, 21,30, 50, 90 and 100 film coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Sandoz Ltd,

Frimley Business Park, Frimley,

Camberley, Surrey, GU16 7SR, UK.

Manufacturer:

Lek Pharmaceuticals d.d.,

Verovskova 57,

1526 Ljubljana,

Slovenia

or

Salutas Pharma GmbH,

Otto-von-Guericke-Allee 1,

39179 Barleben,

Germany

or

LEK S.A.,

ul. Domaniewska 50 C,

02-672 Warszawa,

Poland.

This leaflet was last approved in 03/2012 (to be

amended upon approval).


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