Ebastine Qualigen 20 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Ebastina Qualigen 20 mg Film-coated Tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Ebastine, the active component of Ebastina Qualigen, belongs to a group of medicines known as antihistamines. Ebastina Qualigen does not cause sedative effects nor does it enhance the effects of alcohol.

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

2. What you need to know before taking Ebastina Qualigen

Do not take Ebastina 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).
• Should not be administered to children under 12 years of age, as its safety has not been established in this age group.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ebastina Qualigen:

• If you are experiencing an acute allergic emergency, since Ebastina Qualigen takes 1 to 3 hours to take effect.
• Due to its ebastine content, skin allergy testing should not be performed until 5–7 days after discontinuation of treatment. Antihistamine therapy may interfere with the results of such tests.
• It may enhance the effects of other antihistamines.
• In patients with mild or moderate hepatic insufficiency, dose adjustment is not required. In patients with severe hepatic insufficiency, the dose of ebastine should not exceed 10 mg/day; therefore, Ebastina Qualigen 10 mg tablets are recommended.

Other medicines and Ebastina Qualigen

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any 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 used to treat fungal infections).

Taking Ebastina Qualigen with food and drink

The tablets may be taken with or without food.

Pregnancy and breastfeeding

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

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

It is unknown whether the medicine passes into breast milk.

Driving and using machines

In men, no effects on psychomotor function or on the ability to drive or operate machinery have been observed at the recommended therapeutic doses. However, monitor your response to the medication, as drowsiness has occurred in some cases at usual doses. If this occurs, refrain from driving and operating dangerous machinery.

Ebastina Qualigen contains sodium

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

3. How to take Ebastina Qualigen

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate how long you should take Ebastina Qualigen. Do not stop treatment earlier, 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 daily.

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

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

If you take more Ebastina Qualigen than you should

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

If you forget to take Ebastina Qualigen

If you miss a dose, wait until the next scheduled dose.

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

If you stop treatment with Ebastina Qualigen

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

4. Possible adverse effects

Like all medicines, Ebastine Qualigen may produce adverse effects, although not everyone experiences them.

In clinical studies, this medicine was well tolerated. Adverse reactions were mild or moderate, transient, and resolved spontaneously without specific treatment.

The adverse effects reported are as follows:

Frequent (may affect between 1 and 10 out of 100 patients):

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

Uncommon (may affect between 1 and 10 out of 1,000 patients):

• abdominal pain,
• dyspepsia,
• epistaxis,
• sinusitis,
• nausea,
• insomnia.

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

• weight gain,
• increased appetite.

If you notice any adverse effects not listed in this leaflet, or if you experience any of the described adverse effects severely, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 packaging. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE Point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of EbastinaQualigen

• The active substance is Ebastine. Each tablet contains 20 mg of ebastine.
• The other components are microcrystalline cellulose (E-460i), stearoyl macrogol glyceride, sodium starch glycolate (from potato), magnesium stearate (E-572), purified water, and Opadry White [hydroxypropylmethyl cellulose (E-464), polyethylene glycol (E-1521), titanium dioxide (E-171)].

Appearance of the product and contents of the pack

Ebastine Qualigen 20 mg tablets are round and white.

The packs contain 20 tablets.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturing Responsible Party:

Generis Farmacêutica, S.A.

Rua João de Deus nº 19, Venda Nova

2700-487 Amadora (Portugal)

Date of the most recent review of this summary: May 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es