DESLORADERM

DESLORADERM 5 mg film-coated tablets

Important notes (mandatory information)

Desloraderm 5 mg film-coated tablets. Active ingredient: Desloratadine. Areas of application: For adults and adolescents aged 12 and over to improve symptoms of allergic rhinitis and urticaria.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Desloraderm 5 mg film-coated tablets, used for adults and adolescents aged 12 and over to improve symptoms of allergic rhinitis and urticaria
Active ingredient: Desloratadine

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 10 days, contact your doctor.

What this package leaflet contains

1. WHAT ARE DESLORADERM 5 MG FILM-COATED TABLETS AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING DESLORADERM 5 MG FILM-COATED TABLETS?
3. HOW TO TAKE DESLORADERM 5MG FILM-COATED TABLETS?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE DESLORADERM 5 MG FILM-COATED TABLETS?
6. CONTENTS OF THE PACK AND OTHER INFORMATION.

1. WHAT ARE DESLORADERM 5MG FILM-COATED TABLETS AND WHAT ARE THEY USED FOR?

Desloraderm is an anti-allergic medicine that does not make you tired. It relieves your allergic reaction and its symptoms. Desloraderm relieves symptoms that occur with an allergic cold (inflammation of the nasal mucous membranes due to an allergy, e.g. hay fever or allergy to house dust mites). These include sneezing, runny or itchy nose, itchy palate and itchy, red or watery eyes. Desloraderm is also used to relieve symptoms associated with hives (urticaria) (a skin reaction caused by an allergy). These include itching and hives. Relief from these symptoms lasts for a whole day, allowing you to go about your usual daily activities and sleep.

Desloraderm is indicated for adults and adolescents (aged 12 years and over).

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING DESLORADERM 5 MG FILM-COATED TABLETS?

Desloraderm 5 mg film-coated tablets should not be taken if you are allergic to desloratadine, loratadine or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Talk to your doctor or pharmacist before taking Desloraderm 5mg film-coated tablets, - if you have impaired kidney function - if you have a history of seizures in your medical or family history. If this applies to you, or if you are unsure, check with your doctor before taking Desloraderm.

Use in children and adolescents

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

Taking Desloraderm 5mg film-coated tablets with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. Desloraderm 5 mg film-coated tablets have no known interactions with other medicines.

Taking Desloraderm 5 mg film-coated tablets with food, drink and alcohol

Desloraderm 5 mg film-coated tablets can be taken with or without meals. You should only drink alcohol with caution during treatment with Desloraderm.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Taking Desloraderm is not recommended if you are pregnant or breastfeeding. There are no data on male fertility/female fertility.

Driving and using machines

At the recommended dosage, this medicine is not expected to affect your ability to drive or use machines. Although most people do not experience drowsiness, it is recommended that you refrain from activities that require mental alertness such as driving or operating machinery until you have established your personal response to the medicine.

3. HOW TO TAKE DESLORADERM 5 MG FILM-COATED TABLETS?

Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is

Adults and adolescents (aged 12 years and over):
Take one tablet once a day. Swallow the tablets whole with water, with or without food.

Duration of treatment

Your doctor will determine what type of allergic rhinitis you have and, depending on this, will determine how long you need to take Desloraderm.

If your allergic rhinitis is intermittent (symptoms that occur on less than 4 days per week or for less than 4 weeks), your doctor will recommend a treatment regimen that will depend on the previous course of your illness.

If your allergic rhinitis is persistent (symptoms that occur on 4 or more days per week and for more than 4 weeks), your doctor may recommend longer-term treatment.

For hives, the duration of treatment may vary from patient to patient, so you should follow your doctor's instructions.

If you have taken more Desloraderm 5 mg film-coated tablets than you should:
Always take Desloraderm as prescribed. No serious consequences are expected from accidental overdose. However, if you have taken more Desloraderm than you should, contact your doctor or pharmacist.

If you forget to take Desloraderm 5mg film-coated tablets

If you forget to take your dose on time, take it as soon as possible and then continue with your usual treatment regimen. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives and swelling) have been reported after marketing of desloratadine. If you notice any of these serious side effects, stop taking the medicine immediately and seek medical attention immediately.

In clinical studies in adults, side effects were similar to placebo. However, fatigue, dry mouth and headache were reported more frequently than with placebo. In adolescents, headache was the most commonly reported side effect.

The following side effects have been reported in clinical studies with desloratadine

Common (may affect up to 1 in 10 people): Chronic fatigue, dry mouth, headache.

The following side effects have been reported during the marketing of desloratadine

Adults

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

Severe allergic reactions, rash, palpitations or irregular heartbeat, rapid heartbeat, abdominal pain, nausea, vomiting, upset stomach, diarrhoea, dizziness, light-headedness, insomnia, muscle pain, hallucinations, seizures, restlessness with increased physical activity, liver inflammation, abnormal liver function tests.

Not known (frequency and basis of available data cannot be estimated)

Unusual fatigue, yellowing of the skin and/or eyes, increased skin sensitivity to sunlight, even in hazy sunlight and to UV light e.g. UV lamps in a solarium, abnormal behaviour, aggression, depressed mood, weight gain, increased appetite, altered heartbeat, dry eyes.

Children

Not known (frequency and basis of available data cannot be estimated)

Slow heartbeat, altered heartbeat, abnormal behaviour, aggression.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE DESLORADERM 5 MG FILM-COATED TABLETS?

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister pack after "use by". The expiry date refers to the last day of the month indicated.

Store in the original package to protect from moisture and light. Do not store above 30°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION.

What Desloraderm 5 mg film-coated tablets contain

The active substance is 5 mg desloratadine.

The other ingredients are

Microcrystalline cellulose, mannitol (E421) (Ph.Eur.), magnesium stearate (Ph.Eur.) [vegetable], hypromellose, hydroxypropylcellulose, titanium dioxide (E171), indigo carmine aluminium lake.

What Desloraderm 5 mg film-coated tablets look like and contents of the pack

Desloraderm 5 mg film-coated tablets are light blue, round, biconvex film-coated tablets. Desloraderm 5 mg film-coated tablets are available in packs (blisters) of 1, 5, 7, 10, 15, 20, 30, 50 or 100 film-coated tablets.

Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

Dermapharm AG
Lil-Dagover-Ring 7
82031 Grünwald
Phone: 089/641860
Fax: 089/64186130
E-mail: service@dermapharm.de

Manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
(a subsidiary of Dermapharm AG)

This package leaflet was last revised in June 2022.

Source: Package leaflet information
Status: 11/2024
Active ingredient: Desloratadine. Areas of application: For adults and adolescents aged 12 and over to improve symptoms of allergic rhinitis and urticaria.