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PACKAGE LEAFLET

Package leaflet: Information for the patient

Dynid 5mg 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, pharmacist or nurse.

-    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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Dynid 5mg Tablets is and what it is used for

2.    What you need to know before you take Dynid 5mg Tablets

3.    How to take Dynid 5mg Tablets

4.    Possible side effects

5.    How to store Dynid 5mg Tablets

6.    Contents of the pack and other information

1. What Dynid 5mg Tablets is and what it is used for What Dynid 5mg Tablets is

Dynid 5mg Tablets contains desloratadine which is an antihistamine.

How Dynid 5mg Tablets works

Dynid 5mg Tablets is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms.

When Dynid 5mg Tablets should be used

Dynid 5mg Tablets 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 and adolescents 12 years of age and older. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.

Dynid 5mg Tablets is also used for 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.

2. What you need to know before you take Dynid 5mg Tablets Do not take Dynid 5mg Tablets

-    if you are allergic to desloratadine, or 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 Dynid 5mg Tablets:

-    if you have poor kidney function.

Use in children and adolescents

Do not give this medicine to children less than 12 years of age.

Other medicines and Dynid 5mg Tablets

There are no known interactions of Dynid 5mg Tablets with other medicines.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Dynid 5mg Tablets with food, drink and alcohol

Dynid 5mg Tablets may be taken with or without a meal.

Use caution when taking Dynid 5mg Tablets 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 Dynid 5mg Tablets is not recommended if you are pregnant or nursing a baby.

Fertility

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.

Dynid 5mg Tablets contains lactose

Dynid 5mg Tablets tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Dynid 5mg Tablets

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

Adults and adolescents 12 years of age and over

The recommended dose is one tablet once a day with water, with or without food.

This medicine is for oral use.

Swallow the tablet whole.

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 Dynid 5mg Tablets.

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.

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 Dynid 5mg Tablets than you should

Take Dynid 5mg Tablets only as it is prescribed for you. No serious problems are expected with accidental overdose. However, if you do take more Dynid 5mg Tablets than you were told to, tell your doctor, pharmacist or nurse immediately.

If you forget to take Dynid 5mg Tablets

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 stop taking Dynid 5mg Tablets

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

During the marketing of Dynid 5mg Tablets, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely. If you notice any of these serious side effects, stop taking the medicine and seek urgent medical advice straight away.

In clinical studies 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.

In clinical studies with desloratadine, the following side effects were reported as:

Common: the following may affect up to 1 in 10 people

•    fatigue

•    dry mouth

•    headache

Adults

During the marketing of desloratadine, the following side effects were reported as:

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

•    severe allergic reactions

•    fast heartbeat

•    vomiting

•    dizziness

•    muscle pain

• restlessness with increased • liver inflammation body movement

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

•    change in the way the heart beats

Children

Not known: frequency cannot be estimated from the available data • slow heartbeat    • change in the way the heart beats

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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

Yellow Card Scheme Website: www.mhra.gov.uk/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Dynid 5mg Tablets

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.

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 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.

6.    Contents of the pack and other information What Dynid 5mg Tablets contains

The active substance is desloratadine. Each tablet contains 5 mg desloratadine

The other ingredients of the tablet are Microcrystalline Cellulose, Lactose Monohydrate, Maize Starch, Silica Colloidal Anhydrous, Magnesium Stearate

What Dynid 5mg Tablets looks like and contents of the pack

Dynid 5mg Tablets are off white to light-pink, circular, biconvex tablets with ‘L5’ engraved on one side and plain on the other side.

Dynid 5mg Tablets is available in blister packs containing

7,    10, 14, 15, 20, 28, 30, 50, 90 or 100 tablets (UK/H/3055//01/DC).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Glenmark Pharmaceuticals s.r.o. Hvezdova 1716/2b, 140 78 Praha 4, Czech Republic

This medicinal product is authorised in the Member States of the EEA under the following names:

Czech Republic Dynid 5 mg tablety Poland    Dynid

Romania    Dynid    5    mg    comprimate

Slovak Republic Dynid 5 mg tablety United Kingdom Dynid 5 mg Tablets

This leaflet was last approved in 07/2015

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