Desloratadine Mylan Generics

Patient Information Leaflet

Desloratadina Mylan Generics 5 mg film-coated tablets

Generic Medicine
desloratadine
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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Desloratadina Mylan Generics is and what it is used for

Desloratadina Mylan Generics is a non-sedating antihistamine medicine. It helps control your allergic reaction and its symptoms.
Desloratadina Mylan Generics is indicated in adults and adolescents (aged 12 years and older) for the relief of symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, such as hay fever or dust mite allergy). These symptoms include sneezing, runny nose, itchy nose, itchy palate, and itchy, red or watery eyes.
Desloratadina Mylan Generics 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 throughout the day, helping you to resume your normal daily activities and improving your sleep.
If you do not feel better or if you feel worse, you should speak to your doctor.

2. What you need to know before taking Desloratadine Mylan Generics

Do not take Desloratadine Mylan Generics

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Desloratadine Mylan Generics if:

• you have a personal or family history of seizures
• you have reduced kidney function.

If this applies to you or you are unsure, consult your doctor or pharmacist.
Children
Desloratadine tablets must not be used in children under 12 years of age.
Other medicines and Desloratadine Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Desloratadine Mylan Generics and alcohol
Caution is advised when taking desloratadine together with alcohol.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, the use of Desloratadine Mylan Generics is not recommended.
Driving and using machines
At the recommended dose, Desloratadine Mylan Generics is not expected to cause drowsiness or impair attention. However, drowsiness has very rarely occurred in some individuals, which may affect the ability to drive or operate machinery.
Desloratadine Mylan Generics contains Sunset Yellow Aluminium Lake (E110) and Sodium.
Sunset Yellow Aluminium Lake (E110) may cause allergic reactions.
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. essentially "sodium-free".

3. How to take Desloratadine Mylan Generics

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose for adults and adolescents (aged 12 years and older) is one tablet once daily.
Swallow the tablet whole with water, with or without food.
Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you have and how long you should take Desloratadine Mylan Generics.
If your allergic rhinitis is intermittent (symptoms present for less than 4 days per week or for less than 4 weeks), your doctor will prescribe a dosing schedule based on an assessment of your medical history.
If your allergic rhinitis is persistent (symptoms present for 4 or more days per week and for more than 4 weeks), your doctor may prescribe long-term treatment.
In the case of urticaria, the duration of treatment may vary from patient to patient, so you must follow your doctor’s instructions.
If you take more Desloratadine Mylan Generics than you should
Take Desloratadine Mylan Generics only if it has been prescribed for you. Serious problems due to accidental overdose are not expected. However, if you take more Desloratadine Mylan Generics than prescribed, contact your doctor or pharmacist.
If you forget to take Desloratadine Mylan Generics
If you forget to take your dose at the prescribed time, take it as soon as possible, then continue your treatment as usual. Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. In adults, side effects were similar to those observed with a tablet containing no active ingredient (placebo). However, fatigue, dry mouth, and headache have been reported more frequently than with the placebo tablet. In adolescents, headache was the most commonly reported side effect.

If you experience any of the following side effects, stop taking this medicine immediately and contact your doctor or go to the nearest emergency room:

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

• Severe allergic reactions such as difficulty breathing, shortness of breath, wheezing, itching, hives, swelling of the face, lips, tongue or other parts of the body, and skin rash
• Seizures (convulsions)
• Liver problems (nausea, vomiting, loss of appetite, general feeling of being unwell, fever, itching, yellowing of the skin and eyes, pale stools, dark urine)

Not known (frequency cannot be estimated from available data):

• Changes in heart rhythm, which may cause dizziness or fainting. This may be detected by a recording of the electrical activity of the heart ("electrocardiogram" or ECG)

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

• Fatigue
• Dry mouth
• Headache

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

• Fast heartbeat
• Malaise (vomiting)
• Dizziness
• Muscle pain
• Restlessness with increased body movements
• Stomach pain
• Stomach discomfort
• Drowsiness
• Seeing, sensing, or hearing things that are not real (hallucinations)
• Pounding or irregular heartbeat
• Feeling of nausea
• Diarrhea
• Insomnia
• Abnormal liver function tests

Not known (frequency cannot be estimated from available data):

• Abnormal behaviour
• Aggressiveness
• Unusual weakness
• Increased sensitivity of the skin to sunlight, even on cloudy days, and to UV light, for example from UV lamps in sunbeds
• Weight gain, increased appetite
• Depressed mood
• Dry eyes

Additional side effects in children and adolescents
Not known (frequency cannot be estimated from available data):

• Slow heartbeat

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Desloratadine Mylan Generics

Keep out of the sight and reach of children.
Blister pack: Store below 30°C.
Bottle: This medicine does not require any special storage conditions.
Do not use Desloratadine Mylan Generics after the expiry date stated on the carton, blister and bottle after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Desloratadine Mylan Generics contains

• The active substance is desloratadine. Each tablet contains 5 mg of desloratadine.
• The other ingredients of the tablet are: magnesium stearate, sodium lauryl sulfate, anhydrous colloidal silica, microcrystalline cellulose and pregelatinized maize starch. The tablet coating contains: polyvinyl alcohol, indigo carmine aluminium lake (E132), sunset yellow aluminium lake (E110), macrogol, talc (E553b) and titanium dioxide (E171). See section 2 "Desloratadine Mylan Generics contains Sunset Yellow Aluminium Lake (E110) and Sodium".

Description of the appearance of Desloratadine Mylan Generics and contents of the pack
Desloratadine Mylan Generics tablets are blue, round, biconvex,
with the imprint: “DE 5” on one side and “M” on the other.
Desloratadine Mylan Generics 5 mg film-coated tablets are supplied in blister packs containing
10, 15, 20, 30, 50, 60, 90, 100 tablets and in bottles of 30 and 250 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan, Italy

Manufacturer
McDermott Laboratories Limited t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road
Dublin 13, Dublin, Ireland
Mylan Hungary Kft./Mylan Hungary Ltd.
Mylan utca 1., Komárom, 2900, Hungary
VIATRIS SANTE
360 Avenue Henri Schneider, 69300 Meyzieu, France

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: