5 mg tablets 
desloratadine

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor, pharmacist, or nurse.

– This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Desloratadine Glenmark is and what it is used for 
2. What you need to know before you take Desloratadine Glenmark 
3. How to take Desloratadine Glenmark 
4. Possible side effects 
5. How to store Desloratadine Glenmark 
6. Package contents and other information 

What Desloratadine Glenmark is and what it is used for

What Desloratadine Glenmark is

Desloratadine Glenmark contains desloratadine which is an antihistamine .

How Desloratadine Glenmark works

Desloratadine Glenmark is an antiallergic medicine that does not make you drowsy. It helps keep your allergic reactions and their symptoms under control.

When to use Desloratadine Glenmark

Desloratadine Glenmark relieves the symptoms of allergic rhinitis ( inflammation of the nasal mucosa caused by allergies, such as hay fever or allergies to dust mites) in adults and adolescents 12 years of age and older. These symptoms include sneezing, runny or itchy nose, palate itching, and itchy, red, or watery eyes.

Desloratadine Glenmark is also used to relieve the symptoms of urticaria (a skin condition caused by allergies ). These symptoms include itching and hives.

Relieving these symptoms lasts all day and helps you maintain normal daily activities and normal sleep.

What you need to know before you take Desloratadine Glenmark

Do not take Desloratadine Glenmark

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

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before taking Desloratadine Glenmark:

  • if you have impaired kidney function
  • if you or someone in your family has had seizures

Children and young people

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

Other medicines and Desloratadine Glenmark

There is no known interaction between Desloratadine Glenmark and other medicines.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Desloratadine Glenmark with food, drink, and alcohol

Desloratadine Glenmark can be taken with or without food.

Be careful if you take Desloratadine Glenmark with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Taking Desloratadine Glenmark is not recommended if you are pregnant or breast-feeding.

Fertility

There are no fertility data for men and women.

Driving and using machines

At the recommended dose, this medicine is not expected to affect your ability to drive or use machines. Although most people do not feel drowsy, it is recommended that you do not perform activities that require sharp attention, such as driving a vehicle or using machinery until you know how you react to the medicine.

Desloratadine Glenmark contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Desloratadine Glenmark

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Adults and adolescents 12 years and older

The recommended dose is one tablet once a day with water, with or without food.

This medicine should be swallowed.

The tablet is swallowed whole.

Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you are suffering from and decide how long to take Desloratadine Glenmark.

If your allergic rhinitis is recurrent (presence of symptoms for less than 4 days a week or less than 4 weeks), your doctor will recommend a treatment schedule based on the assessment of your medical history.

If your allergy is persistent (presence of symptoms for 4 days or more per week and more than 4 weeks) then your doctor may recommend a longer-term treatment.

In urticaria, the duration of treatment may vary from patient to patient and you should therefore follow your doctor’s prescription.

If you take more Desloratadine Glenmark then you should

Take Desloratadine Glenmark as prescribed for you. No serious problems are to be expected in case of accidental overdose. However, if you take more Desloratadine Glenmark than you are prescribed, talk to a doctor, pharmacist, or nurse immediately.

If you forget to take Desloratadine Glenmark

If you forget to take your dose on time, take it as soon as possible and then go back to your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.

If you stop taking Desloratadine Glenmark

If you have any further questions on the use of this product, ask 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 Glenmark, cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling of the face, tongue, or throat) have been reported in very rare cases. If you have any of these serious side effects is, stop taking the drug and seek immediate emergency medical attention.

In clinical trials in adults, the side effects were about the same as with an inactive tablet. However, fatigue, dry mouth, and headache were reported more often than with an inactive tablet. In adolescents, headache was the most commonly reported side effect.

In clinical trials with Desloratadine Glenmark, the following side effects have been reported:

Common (the following may affect up to 1 in 10 people)

  • fatigue
  • dry mouth
  • headache

Adults

During the marketing of Desloratadine Glenmark, the following side effects have been reported:

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

severe allergic reactions rash palpitations or throbbing/irregular heartbeats
fast heartbeat stomach ache nausea
vomiting upset stomach diarrhea
dizziness drowsiness difficulty sleeping
muscle pain hallucinations seizures
restlessness with increased body movement hepatitis abnormal liver function tests

Has been reported (occurs in an unknown number of users)

  • unusual weakness
  • yellowing of the skin and/or eyes
  • increased sensitivity of the skin to sunlight, even in sunlight and to UV light, for example for UV light in solarium
  • changes in how the heartbeats
  • aggression
  • weight gain
  • increased appetite

Children

Has been reported (occurs in an unknown number of users)

  • slow heartbeat
  • changes in how the heartbeats
  • abnormal behavior
  • aggression

5. How to store Desloratadine Glenmark

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after “EXP” and on the blister after “EXP”. The expiration date is the last day of the specified month.

No special storage instructions.

Do not use this medicine if you notice any change in the appearance of the tablets.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is desloratadine. Each tablet contains 5 mg of desloratadine.

The other ingredients in the tablet are microcrystalline cellulose, lactose monohydrate, corn starch, colloidal anhydrous silica, magnesium stearate.

What the medicine looks like and the contents of the pack

Desloratadine Glenmark is white or light pink, round, biconvex tablets marked “L5” engraved on one side and the other without the label.

Desloratadine Glenmark is available in blister packs containing 7, 10, 14, 15, 20, 28, 30, 50, or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Glenmark Arzneimittel GmbH

Industries. 31, 82194 Gröbenzell,

Germany

Manufacturer

Glenmark Pharmaceuticals sro

Fibichova 143,566 17 Vysoké Mýto,

Czech Republic

This medicinal product is authorized under the European Economic Area under the names:

Denmark: Desloratadine Glenmark 5 mg tablets

Finland: Desloratadine Glenmark 5 mg tablet 

France: Desloratadine Glenmark 5 mg compresses

Greece: Pylodes

Ireland: Desloratadine Glenmark 5 mg tablets

Netherlands: Desloratadine Glenmark 5 mg tablet

Poland: Pylodes

Portugal: Desloratadina Glenmark 5 mg compressed

Romania: Pylodes 5 mg compress

Spain: Desloratadina Viso Pharmacéutica 5 mg compressed EFG

United Kingdom: Desloratadine Glenmark 5 mg tablets

Germany: Desloratadine Glenmark 5 mg tablet

Hungary: Pylodes 5 mg

Muhammad Nadeem

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