5 mg tablets
desloratadine
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