Package leaflet: Information for the user

Dynid, 5 mg, tablets
Desloratadinum
Please read this leaflet carefully before taking this medicine, because it contains important information for you.

Keep this leaflet for future reference.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual only. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

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

1. What Dynid is and what it is used for

What Dynid is
Dynid contains desloratadine, which is an antihistamine medicine.
How Dynid works
Dynid is an antiallergy medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.
When Dynid should be used
Dynid relieves symptoms associated with allergic rhinitis (inflammation of the nasal mucosa caused by allergy, e.g. hay fever or allergy to house dust mites) 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 is also used to relieve symptoms associated with urticaria (a skin condition caused by allergy). Symptoms include: skin itching and hives.
Relief from these symptoms lasts throughout the day, helping patients return to normal daily activities and sleep normally.

2. Important information before taking Dynid

When not to take Dynid

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

Warnings and precautions
Before starting to take Dynid, consult your doctor, pharmacist, or nurse:

if the patient has kidney function disorders.
if the patient has a personal or family history of seizures.

Children and adolescents
This medicine should not be given to children under 12 years of age.
Dynid and other medicines
No interactions between Dynid and other medicines are known.
You should tell your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
Taking Dynid with food, drink and alcohol
Dynid may be taken during or between meals.
Caution is advised when taking Dynid with alcohol.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
The use of Dynid is not recommended 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 not expected that this medicine, when used at the recommended dose, affects the ability to drive or operate machinery. Although most patients do not experience drowsiness, it is recommended to refrain from activities requiring concentration, such as driving or operating machinery, until the patient knows how this medicine affects them.
Dynid contains lactose
Dynid tablets contain lactose. If the patient has been previously diagnosed with an intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Dynid

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts,
please 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.
The duration of treatment with Dynid will be determined by your doctor after identifying the type of allergic
rhinitis affecting the patient.
If the patient has intermittent allergic rhinitis (symptoms lasting less than 4 days per week or less than 4 weeks),
the treating doctor will recommend a treatment regimen based on the previous course of the disease.
If the patient has persistent allergic rhinitis (symptoms occurring on at least 4 days per week and for more than
4 weeks), the treating doctor may recommend longer-term use of the medicine.
In cases of urticaria, the duration of treatment may vary between individual patients. Therefore,
the patient should follow the treating doctor's instructions.
Taking more than the recommended dose of Dynid
Dynid should only be taken as prescribed by your doctor. After accidental overdose,
serious adverse effects are not expected. However, if a higher than recommended dose of Dynid
is taken, inform your doctor, pharmacist, or nurse immediately.
Missed dose of Dynid
If a dose is missed, take it as soon as possible, then continue with the regular dosing schedule.
Do not take a double dose to make up for the missed tablet.
Stopping Dynid treatment
If you have any further questions about the use of this medicine, consult your doctor,
pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Very rarely, severe allergic reactions have been reported since desloratadine has been marketed
(difficulty breathing, wheezing, itching, hives, and swelling). If any of these severe adverse reactions occur, treatment must be discontinued immediately and medical advice must be sought without delay.

In clinical trials in adult patients, adverse reactions were almost the same as with placebo tablets. However, fatigue, dry mouth, and headache were reported more frequently than with placebo. In adolescents, headache was the most commonly reported adverse reaction.

The following adverse reactions have been reported in clinical trials with desloratadine:
Common: may occur in up to 1 in 10 patients

fatigue
dry mouth
headache

The following adverse reactions have been reported since desloratadine has been marketed:
Very rare: may occur in up to 1 in 10,000 patients

severe allergic reactions ● rash ● palpitations and irregular heartbeat
rapid heartbeat ● abdominal pain ● nausea
vomiting ● stomach discomfort ● diarrhoea
dizziness ● somnolence ● insomnia
muscle pain ● hallucinations ● convulsions
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 from sunbeds
changes in heartbeat
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 heartbeat
unusual behaviour
aggressive behaviour

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine Dynid

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: Expiry (EXP) and on the blister after: "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Do not use this medicine if you notice any change in the appearance of the tablet.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging 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, maize starch, colloidal anhydrous silica, magnesium stearate.

What Dynid looks like and contents of the pack
Dynid is an almost white to light pink, round, biconvex tablet with the imprint "L5" on one side and smooth on the other.
Dynid is available in blister packs of 10, 14, 28, 30, 60 tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation 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 further information about the medicinal product and its names in other European Economic Area countries, please contact the local representative of the Marketing Authorisation Holder:
Glenmark Pharmaceuticals Sp. z o.o.
ul. Dziekonińskiego 3
00-728 Warsaw
Email: [email protected]