Alerdes

Package Leaflet: Information for the Patient

Alerdes, 5 mg, Film-Coated Tablets

Desloratadine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, including any not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

• 1. What is Alerdes and what is it used for
• 2. Important information before taking Alerdes
• 3. How to take Alerdes
• 4. Possible side effects
• 5. How to store Alerdes
• 6. Contents of the pack and other information

1. What is Alerdes and what is it used for

What is Alerdes

Alerdes contains desloratadine, which is an antihistamine.

How Alerdes works

Alerdes is an anti-allergic medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.

When to use Alerdes

Alerdes relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, such as hay fever or allergy to dust mites) in adults and adolescents 12 years of age and older. Symptoms include sneezing, itching or runny nose, itching of the palate, and itching, redness, or tearing of the eyes. Alerdes is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). Symptoms of this condition include skin itching and urticaria. Relief of these symptoms persists throughout the day, making it easier to return to normal daily activities and normal sleep. If after 3 days there is no improvement or you feel worse, you should contact your doctor.

2. Important information before taking Alerdes

When not to take Alerdes

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

Warnings and precautions

Before taking Alerdes, discuss with your doctor or pharmacist:

• if you have kidney problems,
• if you have a history of seizures or a family history of seizures.

Children and adolescents

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

Alerdes with other medicines

No interactions with other medicines are known. Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.

Alerdes with food, drink, and alcohol

Alerdes can be taken with or without food. Be cautious when taking Alerdes with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is not recommended to take Alerdes during pregnancy or breastfeeding.

Fertility

There are no available data on the effect on fertility in men and women.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive or use machines. Although most people do not experience drowsiness, it is recommended to avoid activities that require concentration, such as driving or operating machinery, until you know how this medicine affects you.

Alerdes contains lactose

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

3. How to take Alerdes

Always take this medicine exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.

Adults and adolescents 12 years of age and older

The recommended dose is one tablet once daily, taken with water, with or without food. This medicine is for oral use. Swallow the tablet whole. If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Do not take Alerdes for more than 10 days without consulting your doctor.

Overdose of Alerdes

Take Alerdes only as described in the package leaflet or as directed by your doctor. In case of accidental overdose, serious disorders are unlikely to occur. However, if you take more than the recommended dose of Alerdes, contact your doctor or pharmacist.

Missed dose of Alerdes

If you miss a dose, take it as soon as possible, then continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.

Stopping Alerdes

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

4. Possible side effects

Like all medicines, Alerdes can cause side effects, although not everybody gets them. After desloratadine was made available, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, urticaria, and swelling) have been reported. If you experience any of these severe side effects, stop taking the medicine and seek medical help immediately. In clinical studies in adults, side effects were almost the same as with a placebo. However, fatigue, dry mouth, and headache were reported more frequently than with a placebo. In adolescents, the most commonly reported side effect was headache. In clinical studies of desloratadine, the following side effects were reported:

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

Adults

After desloratadine was made available, the following side effects have been reported:

• Very rare: may affect up to 1 in 10,000 people
• severe allergic reactions,
• rapid heartbeat,
• vomiting,
• dizziness,
• muscle pain,
• restlessness with excessive physical activity,
• rash,
• abdominal pain,
• upset stomach,
• drowsiness,
• hallucinations,
• hepatitis,
• palpitations or irregular heartbeat,
• nausea,
• diarrhea,
• insomnia,
• seizures,
• abnormal liver function tests.

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

• unusual weakness,
• yellowing of the skin and/or eyes,
• increased sensitivity of the skin to sunlight, even when cloudy, and to UV radiation (e.g., from sunlamps),
• change in heart rhythm,
• abnormal behavior,
• aggressive behavior,
• weight gain,
• increased appetite.

Children

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

• slow heartbeat,
• abnormal behavior,
• aggressive behavior,
• change in heart rhythm,
• weight gain,
• increased appetite.

Reporting side effects

If you experience any side effects, including any not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected]. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Alerdes

Keep this medicine out of the sight and reach of children. 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 the month. There are no special precautions for storage. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Alerdes contains

• The active substance is desloratadine. Each tablet contains 5 mg of desloratadine.
• The other ingredients are: Core: lactose anhydrous, microcrystalline cellulose, calcium hydrogen phosphate anhydrous, hypromellose, magnesium stearate, silica colloidal anhydrous. Coating: hypromellose 6 mPa·s, titanium dioxide (E 171), talc, indigo carmine (E 132), lacquer, macrogol 6000.

What Alerdes looks like and contents of the pack

Alerdes 5 mg film-coated tablets are blue, round, and biconvex. The pack contains 10 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Symphar Sp. z o.o., ul. Koszykowa 65, 00-667 Warsaw

Manufacturer

LABORATORIOS NORMON, S.A., Ronda de Valdecarrizo, 6, 28760 Tres Cantos, Madrid, Spain

Date of last revision of the leaflet: