Desloratadine Zentiva

Desloratadine Zentiva

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Desloratadine Zentiva 5 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Desloratadine Zentiva is and what it is used for
2. What you need to know before taking Desloratadine Zentiva
3. How to take Desloratadine Zentiva
4. Possible side effects
5. How to store Desloratadine Zentiva
6. Contents of the pack and other information

1. What Desloratadina Zentiva is and what it is used for

What Desloratadina Zentiva is
Desloratadina Zentiva contains desloratadine, which is an antihistamine.
How Desloratadina Zentiva works
Desloratadina Zentiva is an antiallergic medicine that does not cause drowsiness. It helps control your allergic reaction and its symptoms.
When Desloratadina Zentiva should be used
Desloratadina Zentiva relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or dust mite allergy) in adults and adolescents aged 12 years and older. These symptoms include sneezing, runny nose, itchy nose, itchy palate, and itchy, red or watery eyes.
Desloratadina Zentiva is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives.
Relief from these symptoms lasts for a full day, helping you carry on with your normal daily activities and sleep.

2. What you need to know before taking Desloratadina Zentiva

Do not take Desloratadina Zentiva:

• if you are allergic to desloratadine, to any of the other ingredients of this medicine (listed in section 6), or to loratadina.

Warnings and precautions
Talk to your doctor or pharmacist before taking Desloratadina Zentiva if you have

• impaired renal function.

Desloratadina Zentiva

• a personal or family history of seizures.

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

Other medicines and Desloratadina Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
There are no known interactions between Desloratadina Zentiva and other medicines.

Desloratadina Zentiva with food, drinks and alcohol
Desloratadina Zentiva can be taken regardless of meals.
Use caution when taking Desloratadina Zentiva with alcohol.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or breastfeeding, the use of Desloratadina Zentiva is not recommended.
There are no available data 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 machinery.
Although most people do not experience drowsiness, it is recommended not to undertake activities requiring mental alertness, such as driving a vehicle or operating machinery, until you know how this medicine affects you.

Desloratadina Zentiva contains isomalto
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Desloratadine Zentiva

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults and adolescents aged 12 years and older
The recommended dose is one tablet once daily with water, with or without food.
This medicine is for oral use.
Swallow the tablet whole.

Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you have and advise you on how long you should take Desloratadine Zentiva. If you have intermittent allergic rhinitis (symptoms present for less than 4 days per week or for less than 4 weeks), your doctor will recommend a dosing regimen based on an assessment of your medical history. If you have persistent allergic rhinitis (symptoms present for 4 or more days per week and for more than 4 weeks), your doctor may recommend a longer-term treatment.

For urticaria, the duration of treatment may vary from patient to patient, so you must follow your doctor's instructions.
Desloratadine Zentiva

If you take more Desloratadine Zentiva than you should
Take Desloratadine Zentiva only if it has been prescribed for you. Serious problems are not expected following accidental overdose. However, if you take more Desloratadine Zentiva than prescribed, contact your doctor or pharmacist immediately.

If you forget to take Desloratadine Zentiva
If you forget to take a dose at the scheduled time, take it as soon as possible and then continue with your regular dosing schedule.
Do not take a double dose to make up for the missed dose.

If you stop taking Desloratadine Zentiva
If you have any doubts about using this medicine, consult 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 desloratadine (the active substance in Desloratadine Zentiva), very rare cases of 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 contact a doctor immediately.

In clinical studies in adults, side effects were approximately the same as those occurring with a placebo tablet. However, effects related to fatigue, dry mouth, and headache were reported more frequently than with a placebo tablet. In adolescents, headache was the most commonly reported side effect.

In clinical studies with desloratadine, the following side effects have been reported as:
Common (may affect up to 1 in 10 people):

• Headache
• Dry mouth
• Fatigue.

Adults
During the marketing of desloratadine, the following side effects have been reported as:
Very rare (may affect up to 1 in 10,000 people):

• Hallucinations
• Dizziness, drowsiness, difficulty sleeping, restlessness with increased body movement, seizures
• Fast heartbeat, pounding or irregular heartbeat
• Stomach discomfort, feeling unwell (nausea), vomiting, stomach problems, diarrhoea
• Changes in liver function tests and liver inflammation
• Muscle pain
• Skin rash.

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

• Abnormal behaviour
• Aggressiveness
• Changes in heart rhythm
• Yellowing of the skin and/or eyes
• Increased sensitivity of the skin to sunlight, even on cloudy days, or to UV light, for example UV light from sunbeds
• Unusual weakness
• Weight gain, increased appetite.

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

• Slow heartbeat
• Changes in heart rhythm
• Abnormal behaviour
• Aggressiveness.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Desloratadine Zentiva

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Store in the original packaging to protect the medicine from moisture.
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 that month.
Do not use this medicine if you notice any changes in the appearance of the tablets.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

What Desloratadina Zentiva Contains
The active substance is desloratadine.
Each tablet contains 5 mg of desloratadine.
The other components of the tablet are:
Tablet core:
Isomalt (E953)
Pregelatinized starch (maize)
Microcrystalline cellulose
Magnesium oxide, heavy
Hydroxypropylcellulose
Crospovidone (type A)
Magnesium stearate
Tablet coating:
Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol/PEG 3350
Talc
Desloratadina Zentiva
FD&C Blue #2/Indigo Carmine Aluminum Lake (E132)

Description of the Appearance of Desloratadina Zentiva and Package Contents
Desloratadina Zentiva 5 mg film-coated tablets are blue, round, biconvex film-coated tablets with a diameter of approximately 6.5 mm.
Desloratadina Zentiva 5 mg film-coated tablets are packaged in blisters made of polychlorotrifluoroethylene (PCTFE)/polyvinyl chloride (PVC)/aluminum.
Desloratadina Zentiva 5 mg film-coated tablets are available in unit-dose blisters in pack sizes of 7, 10, 15, 20, 21, 28, 30, 50, 90 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Zentiva Italia S.r.l.
Viale L. Bodio, 37/B - 20158 Milano, Italy

Manufacturer
Specifar S.A.
1, 28 Octovriou str., Ag. Varvara
123 51 Athens, Greece

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
Czech Republic: Desloratadin Zentiva
Bulgaria: Деслоратадин Зентива 5 mg филмирани таблетки
Slovakia: DEZLORATADIN ZENTIVA 5 mg, filmom obalené tablety
Lithuania: Desloratadine Zentiva 5 mg plėvele dengtos tabletės
Italy: Desloratadina Zentiva