Package leaflet: Information for the user

Dynid Gem, 5 mg, tablets
Desloratadinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet, or as directed
by your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
If your symptoms do not improve or if you feel worse, contact your doctor.

Leaflet contents

What Dynid Gem is and what it is used for
Important information before taking Dynid Gem
How to take Dynid Gem
Possible side effects
How to store Dynid Gem
Contents of the pack and other information

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

What is Dynid Gem 5 mg tablets
Dynid Gem contains desloratadine, which is an antihistamine medicine.
How Dynid Gem 5 mg tablets work
Dynid Gem is an antiallergic medicine that does not cause drowsiness. It helps control
allergic reactions and their symptoms.
When to use Dynid Gem 5 mg tablets

Dynid Gem relieves symptoms associated with allergic rhinitis (inflammation of the nasal mucosa caused by allergy, e.g. hay fever or dust mite allergy) in adults and adolescents aged 12 years and older. Symptoms include: sneezing, watery or itchy nose, itchy palate, as well as itchy, red or watery eyes.
Dynid Gem is also used to relieve symptoms associated with urticaria (a skin condition caused by allergy). Symptoms include: itchy skin and hives.

Relief from these symptoms lasts throughout the day, helping you return to normal
daily activities and enabling normal sleep.
If your symptoms do not improve or if you feel worse, consult your doctor.

2. Important information before using Dynid Gem

When not to use 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 starting to use Dynid Gem, discuss this with your doctor, pharmacist, or
nurse:

if the patient has kidney function disorders.
if the patient has a history or 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 between Dynid Gem and other medicines are known.
You should tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Taking Dynid Gem with food, drink, and alcohol
Dynid Gem 5 mg tablets can be taken with or between meals.
Caution should be exercised when taking Dynid Gem with alcohol.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult her doctor or pharmacist before using this medicine.
The use of Dynid Gem is not recommended during pregnancy or breastfeeding.
Fertility
There are no available data on the effect on fertility in men and women.
Driving and operating machinery
It is not expected that this medicine, when used at the recommended dose, affects the ability to drive
or operate machinery. Although drowsiness does not occur in most people, it is recommended to refrain from activities requiring concentration, such as
driving or operating machinery, until the patient's response to this medicine is known.
Dynid Gem 5 mg tablets contain lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should
consult their doctor before taking this medicine.

3. How to use Dynid Gem

This medicine should always be taken exactly as described in the patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult 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 intended for oral use.
The tablet should be swallowed whole.
Your doctor will determine the duration of treatment with Dynid Gem after establishing the type of allergic rhinitis affecting the patient.
If the patient has intermittent allergic rhinitis (symptoms lasting less than 4 days per week or for less than 4 weeks), the doctor will recommend a treatment regimen based on the previous course of the disease.
If the patient has persistent allergic rhinitis (symptoms occurring for at least 4 days per week and for more than 4 weeks), the doctor may recommend longer-term treatment.
In the case of urticaria, the duration of treatment may vary between individual patients, so the patient should follow the doctor's instructions.
Taking more Dynid Gem than recommended
Dynid Gem should be taken according to the instructions provided in the leaflet. After accidental overdose, serious adverse effects are not expected. However, if a dose higher than recommended is taken, inform your doctor, pharmacist, or nurse immediately.
If you forget to take Dynid Gem
If a dose is missed at the scheduled time, take it as soon as possible, then return to the regular dosing schedule.
Do not take a double dose to make up for a missed dose.
Stopping Dynid Gem
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Since desloratadine has been marketed, severe allergic reactions have been reported very rarely
(difficulty breathing, wheezing, itching, hives, and swelling of the face, tongue, or
throat). If any of these severe adverse effects occur, treatment should be discontinued immediately
and medical advice should be sought without delay.
In clinical trials in adult patients, adverse effects were almost the same as with placebo tablets. However, fatigue, dry mouth, and headache were reported more frequently than with placebo tablets. In adolescents, headache was the most commonly reported adverse effect.
The following adverse effects have been reported in clinical trials with desloratadine:
Common: may affect up to 1 in 10 people

fatigue
dry mouth
headache

The following adverse effects have been reported since desloratadine has been marketed:
Very rare: may affect up to 1 in 10,000 people

severe allergic reactions ● rash ● palpitations and irregular heartbeat
rapid heartbeat ● abdominal pain ● nausea
vomiting ● stomach discomfort ● diarrhoea
dizziness ● somnolence ● insomnia
muscle pain ● hallucinations ● seizures
restlessness with excessive motor activity ● hepatitis ● abnormal liver function test results

Frequency 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 sunlight, even on cloudy days, and to UV (ultraviolet) radiation, for example UV radiation in sunbeds
changes in heart rhythm
unusual behaviour
aggressive behaviour
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
unusual behaviour
aggressive behaviour

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Dynid Gem

Keep this medicine out of the sight and reach of children.
Do not use 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 stated month.
No special storage instructions apply for this medicine.
Do not use 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. 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 Gem contains

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

What Dynid Gem looks like and contents of the pack
Dynid Gem is an almost white to light pink, round, biconvex tablet with the imprint "L5" on one side and smooth on the other side.
Dynid Gem is available in blisters of 10 tablets per cardboard box.

Marketing Authorisation Holder
Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic

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

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Glenmark Pharmaceuticals Sp. z o.o.
Dziekońskiego 3 Street
00-728 Warsaw
Email: [email protected]