EBASTINE QUALIGEN 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ebastine Qualigen 20 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Ebastine Qualigen and what is it used for
2. What you need to know before you take Ebastine Qualigen
3. How to take Ebastine Qualigen
4. Possible side effects
5. Storage of Ebastine Qualigen
6. Contents of the pack and other information

1. What is Ebastine Qualigen and what is it used for

Ebastine, the active ingredient of Ebastine Qualigen, belongs to a group of medicines called antihistamines. Ebastine Qualigen does not have sedative effects or potentiate the effects of alcohol.

Ebastine Qualigen is indicated for the treatment of allergic processes such as seasonal or perennial allergic rhinitis, with or without allergic conjunctivitis (such as nasal discharge, itching of the nose, itching of the eyes, tearing, sneezing), chronic urticaria, and allergic dermatitis.

2. What you need to know before you take Ebastine Qualigen

Do not take Ebastine Qualigen

• If you are allergic to ebastine or any of the other ingredients of this medicine (listed in section 6).
• If you have severe hepatic insufficiency (see warnings).
• It should not be administered to children under 12 years of age, as its safety has not been established at these ages.

Warnings and precautions

Consult your doctor or pharmacist before taking Ebastine Qualigen:

• If you have an acute allergic emergency, as Ebastine Qualigen takes 1 to 3 hours to take effect.
• Due to the content of ebastine, it is advised not to perform skin allergy tests until 5-7 days have passed since the treatment was interrupted. Treatment with antihistamines may interfere with the results of these tests.
• It may potentiate the effects of other antihistamines.
• In patients with mild or moderate hepatic insufficiency, it is not necessary to adjust the dose. In patients with severe hepatic insufficiency, the dose of 10 mg/day of ebastine should not be exceeded, so it is recommended to use Ebastina Qualigen 10 mg tablets.

Other medicines and Ebastine Qualigen

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription, homeopathic medicines, herbal remedies, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them.

Ebastine may interact with erythromycin (an antibiotic) or ketoconazole (a medicine for the treatment of fungal infections).

Taking Ebastine Qualigen with food and drinks

The tablets can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There is no experience in pregnant women, so it is recommended to consult with a doctor before taking this medicine.

It is not known whether the medicine passes into breast milk.

Driving and using machines

In humans, no effects on psychomotor function or the ability to drive or operate machinery have been observed at the recommended therapeutic doses. However, observe your response to the medication because in some cases, somnolence has occurred at usual doses. If this happens, refrain from driving and operating hazardous machinery.

Ebastine Qualigen contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

3. How to take Ebastine Qualigen

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of your treatment with Ebastine Qualigen. Do not stop treatment before, as your symptoms may worsen.

Remember to take your medicine.

The recommended dose in adults and children over 12 years of age is 1 tablet (20 mg) once a day.

The Ebastina Qualigen tablets are for oral administration. The tablets should be swallowed whole, without chewing, with the help of a glass of liquid, preferably water.

If you think the effect of Ebastine Qualigen is too strong or too weak, tell your doctor or pharmacist.

If you take more Ebastine Qualigen than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ebastine Qualigen

In case of forgetting a dose, wait for the next one.

Do not take a double dose to make up for forgotten doses.

If you stop taking Ebastine Qualigen

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

4. Possible side effects

Like all medicines, Ebastine Qualigen can cause side effects, although not everybody gets them.

In the studies carried out, this medicine was well tolerated. The adverse reactions were mild or moderate, transient, and resolved spontaneously without specific treatment.

The side effects described are the following:

Common (may affect up to 1 in 10 people):

• somnolence,
• dry mouth,
• headache,
• pharyngitis,
• rhinitis,
• fatigue.

Uncommon (may affect up to 1 in 100 people):

• abdominal pain,
• digestive disorders,
• nasal bleeding,
• sinusitis,
• nausea,
• insomnia.

Frequency not known (cannot be estimated from the available data):

• weight gain,
• increased appetite.

If you notice any side effects not mentioned in this leaflet or if you suffer from one of the side effects described in a severe form, tell your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ebastine Qualigen

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Ebastine Qualigen after the expiry date stated on the pack. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the empty pack and any unused medicine in the SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the pack and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ebastine Qualigen

• The active ingredient is Ebastine. Each tablet contains 20 mg of ebastine.
• The other ingredients are microcrystalline cellulose (E-460i), stearyl macrogol glyceride, sodium starch glycolate (from potato), magnesium stearate (E-572), purified water, and white opadry [hydroxypropyl methyl cellulose (E-464), polyethylene glycol (E-1521), titanium dioxide (E-171)].

Appearance of the product and pack contents

The Ebastine Qualigen 20 mg tablets are white and round.

The packs contain 20 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer:

Generis Farmacêutica, S.A.

Rua João de Deus nº 19, Venda Nova

2700-487 Amadora (Portugal)

Date of last revision of this leaflet:May 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es