Dinid Gem

Leaflet attached to the packaging: information for the user

Dynid Gem, 5 mg, tablets

Desloratadine

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

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Dynid Gem and what is it used for

What is Dynid Gem, 5 mg, tablets

Dynid Gem contains desloratadine, which is an antihistamine.

How Dynid Gem works

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

When to take Dynid Gem

• Dynid Gem relieves symptoms associated with allergic rhinitis(rhinitis caused by an allergy, e.g., hay fever or dust mite allergy) in adults and adolescents aged 12 and over. Symptoms include: sneezing, runny or itchy nose, itchy palate, and itchy, red, or watery eyes.
• Dynid Gem is also used to relieve symptoms associated with urticaria(a skin condition caused by an allergy). Symptoms include: itchy skin and hives.

Relief from these symptoms lasts throughout the day, making it easier to return to normal daily activities and normal sleep.
If there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before taking Dynid Gem

When not to take Dynid Gem

• if the patient is allergic to desloratadine or any of the other ingredients of this medicine (listed in section 6), or to loratadine.

Warnings and precautions

Before taking Dynid Gem, the patient should discuss it with their doctor, pharmacist, or nurse:

• if the patient has kidney problems.
• if the patient has a history of seizures or a family history of seizures.

Use in children and adolescents

This medicine should not be given to children under 12 years of age.

Dynid Gem and other medicines

No interactions with other medicines are known.
The patient should inform their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.

Taking Dynid Gem with food, drink, and alcohol

Dynid Gem, 5 mg, tablets can be taken with or without food.
Care should be taken when taking Dynid Gem with alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult their doctor or pharmacist before taking this medicine.
Dynid Gem should not be taken during pregnancy or breastfeeding.

Fertility

There are no available data on the effect on fertility in men and women.

Driving and using machines

It is unlikely that this medicine will affect the ability to drive or use machines. Although most people do not experience drowsiness, it is recommended to avoid activities that require concentration, such as driving or using machines, until it is known how the medicine affects them.

Dynid Gem, 5 mg, tablets contain lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Dynid Gem

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Adults and adolescents aged 12 and over

The recommended dose is one tablet once a day, taken with water, with or without food.
This medicine is for oral use.
The tablet should be swallowed whole.
The doctor will determine the duration of treatment with Dynid Gem based on the type of allergic rhinitis the patient has.
If the patient has seasonal allergic rhinitis (symptoms that occur for less than 4 days a week or for less than 4 weeks), the doctor will recommend a treatment schedule based on the patient's medical history.
If the patient has chronic allergic rhinitis (symptoms that occur for at least 4 days a week and for more than 4 weeks), the doctor may recommend longer use of the medicine.
In urticaria, the duration of treatment may vary from patient to patient, and the patient should follow the doctor's recommendations.

Taking a higher dose of Dynid Gem than recommended

Dynid Gem should be taken as recommended in the leaflet. If the patient accidentally takes more than the recommended dose, they should inform their doctor, pharmacist, or nurse immediately.

Missing a dose of Dynid Gem

If a dose is missed, it should be taken as soon as possible, and then the patient should return to their regular dosing schedule.
A double dose should not be taken to make up for a missed dose.

Stopping treatment with Dynid Gem

If the patient has any further questions about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Dynid Gem can cause side effects, although not everybody gets them.
After desloratadine was introduced, very rare but serious allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling of the face, tongue, or throat) have been reported. If any of these serious side effects occur, the patient should stop taking the medicine and see a doctor immediately.
In clinical studies, side effects in adults were almost the same as with a placebo. However, fatigue, dry mouth, and headache were reported more often than with a placebo. In adolescents, the most commonly reported side effect was headache.
The following side effects have been reported in clinical studies of desloratadine:

Common:may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache

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

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

• serious allergic reactions
• rash
• palpitations and irregular heartbeat
• rapid heartbeat
• abdominal pain
• nausea
• vomiting
• gastrointestinal upset
• diarrhea
• dizziness
• drowsiness
• insomnia
• muscle pain
• hallucinations
• seizures
• restlessness with excessive
• hepatitis
• abnormal liver function test results

Frequency not known:frequency cannot be estimated from the available data

• unusual weakness
• jaundice and/or yellowing of the skin and eyes
• increased sensitivity of the skin to sunlight, even on cloudy days, and to UV radiation, such as in a solarium
• changes in heart rhythm
• abnormal behavior
• aggressive behavior
• weight gain
• increased appetite
• low mood
• dry eyes

Children
Frequency not known:frequency cannot be estimated from the available data.

• slow heartbeat
• change in heart rhythm
• abnormal behavior
• aggressive behavior

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Dynid Gem

The medicine should be stored out of sight and reach of children.
Do not take this medicine after the expiry date stated on the carton after "EXP" and on the blister after "EXP".
The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
Do not take this medicine if the patient notices any change in the appearance of the tablet.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

What Dynid Gem 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 Gem looks like and what the pack contains

Dynid Gem is a almost white to light pink, round, biconvex tablet with "L5" engraved on one side and smooth on the other.
Dynid Gem is available in blisters of 10 tablets in a cardboard box.

Marketing authorization holder

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

Manufacturer/Importer

Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoké Mýto
Czech Republic

To obtain more detailed information about the medicine, the patient should 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 leaflet: