Dinid

Package Leaflet: Information for the User

Dynid, 5 mg, Tablets

Desloratadine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Dynid and what is it used for
• 2. Important information before taking Dynid
• 3. How to take Dynid
• 4. Possible side effects
• 5. How to store Dynid
• 6. Contents of the pack and other information

1. What is Dynid and what is it used for

What is Dynid

Dynid contains desloratadine, which is an antihistamine.

How Dynid works

Dynid is an anti-allergic medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.

When to take Dynid

Dynid relieves symptoms associated with allergic rhinitis (hay fever or allergy to dust mites) in adults and adolescents aged 12 years and older. Symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red, or watery eyes. Dynid is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). Symptoms include itchy skin and hives. Relief of these symptoms persists throughout the day, making it easier to return to normal daily activities and normal sleep.

2. Important information before taking Dynid

When not to take Dynid

Warnings and precautions

Before taking Dynid, discuss with your doctor, pharmacist, or nurse:

Children and adolescents

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

Dynid and other medicines

No interactions with other medicines are known. Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and any you plan to take.

Taking Dynid with food, drink, and alcohol

Dynid can be taken with or without food. Be cautious when taking Dynid with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Dynid is not recommended during pregnancy or breastfeeding.

Fertility

No data are available on the effect of Dynid on male and female fertility.

Driving and using machines

Dynid is unlikely to affect your ability to drive or use machines at the recommended dose. Although most people do not experience drowsiness, it is recommended to avoid activities that require concentration, such as driving or operating machinery, until you know how you react to the medicine.

Dynid contains lactose

Dynid tablets contain lactose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Dynid

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Adults and adolescents aged 12 years and older

The recommended dose is one tablet once daily, taken with water, with or without food. This medicine is for oral use. Swallow the tablet whole. The duration of treatment with Dynid will be determined by your doctor, depending on the type of allergic rhinitis you have. If you have intermittent allergic rhinitis (symptoms that occur for less than 4 days a week or for less than 4 weeks), your doctor will recommend a treatment schedule based on your medical history. If you have persistent allergic rhinitis (symptoms that occur for more than 4 days a week and for more than 4 weeks), your doctor may recommend longer-term use of the medicine. In urticaria, the duration of treatment may vary from patient to patient. Therefore, you should follow your doctor's advice.

Taking too much Dynid

Take Dynid only as directed by your doctor. If you accidentally take more than the recommended dose, you may not experience severe side effects. However, if you take more than the recommended dose of Dynid, tell your doctor, pharmacist, or nurse immediately.

Missing a dose of Dynid

If you miss a dose, take it as soon as you remember, and then continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten tablet.

Stopping Dynid treatment

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, Dynid can cause side effects, although not everybody gets them. After desloratadine was made available, very rare but serious allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported. If you experience any of these serious side effects, stop taking the medicine and seek medical attention immediately. In clinical studies, side effects were almost the same as with a placebo. However, fatigue, dry mouth, and headache were reported more frequently than with a placebo. In adolescents, the most commonly reported side effect was headache. The following side effects have been reported in clinical studies with desloratadine:

• Common (may affect up to 1 in 10 people): fatigue, dry mouth, headache

After desloratadine was made available, the following side effects have been reported:

• Very rare (may affect up to 1 in 10,000 people): severe allergic reactions, rash, palpitations, irregular heartbeat, fast heartbeat, abdominal pain, nausea, vomiting, stomach upset, diarrhea, dizziness, drowsiness, insomnia, muscle pain, hallucinations, seizures, restlessness, liver inflammation, abnormal liver function tests

Unknown 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 when cloudy, and to UV (ultraviolet) radiation, such as in a solarium, changes in heart rhythm, unusual behavior, aggressive behavior, weight gain, increased appetite, low mood, dry eyes

• Children: Unknown frequency (cannot be estimated from the available data): slow heartbeat, changes in heart rhythm, unusual behavior, aggressive behavior

Reporting side effects

If you experience any side effects, including any not listed in this package leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw; tel.: +48 22 49 21 301; fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dynid

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 the month. There are no special storage requirements. Do not use this medicine if you notice any change in the appearance of the tablet. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Dynid contains

• The active substance is desloratadine. Each tablet contains 5 mg of desloratadine.
• The other ingredients are microcrystalline cellulose, lactose monohydrate, corn starch, colloidal anhydrous silica, magnesium stearate.

What Dynid looks like and contents of the pack

Dynid is a almost white to light pink, round, biconvex tablet with "L5" engraved on one side and a smooth surface on the other. Dynid is available in blisters of 10, 14, 28, 30, and 60 tablets in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer

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

For more information about this medicine and its authorized names in other EU languages, contact the local representative of the marketing authorization holder:

Glenmark Pharmaceuticals Sp. z o. o., ul. Dziekońskiego 3, 00-728 Warsaw, Email: [email protected]

Date of last revision of the package leaflet: