Leaflet: information for the user

Ebastina Qualigen 20 mg film-coated tablets

Read this leaflet carefully before you start taking the 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Ebastina Qualigen

3. How to take Ebastina Qualigen

4. Possible side effects

5. Storage of Ebastina Qualigen

6. Contents of the pack and additional information

Ebastina, the active component of Ebastina Qualigen, belongs to a group of medications known as antihistamines. Ebastina Qualigen does not have sedative effects nor does it potentiate the effects of alcohol.

Ebastina Qualigen is indicated for the treatment of allergic processes such as seasonal or perennial allergic rhinitis associated or not with allergic conjunctivitis (such as nasal discharge, nasal itching, eye itching, tearing, urge to sneeze), chronic urticaria and allergic dermatitis.

Do not take EbastinaQualigen

• If you are allergic to ebastina or any of the other components of this medication (listed in section 6).
• If you have severe liver 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 starting to takeEbastina Qualigen:

• If you present an acute allergic emergency, as Ebastina Qualigen takes effect from1 to3 hours.
• Due to the content of ebastina, it is recommended not to perform skin allergy tests until 5-7 days after discontinuing treatment. 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 liver insufficiency, no dose adjustment is necessary. In patients with severe liver insufficiency, do not exceed a dose of 10 mg/day of ebastina, therefore it is recommended to use Ebastina Qualigen 10 mg tablets.

Other medications and Ebastina Qualigen

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

Ebastina may interact with erythromycin (antibiotic medication) or ketoconazole (medication for fungal infections).

Taking Ebastina Qualigen with food and beverages

The tablets can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

No experience has been reported in pregnant women, so it is recommended to consult a doctor before taking this medication.

The medication's passage into breast milk is unknown.

Driving and operating machinery

In men, no effects on psychomotor function or 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 drowsiness has been reported at usual doses. If this occurs, refrain from driving and operating hazardous machinery.

Ebastina Qualigen contains sodium

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

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

Your doctor will inform you of the duration of your treatment with Ebastina Qualigen. Do not discontinue treatment beforehand, as your symptoms may worsen.

Remember to take your medication.

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

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

If you estimate that the action of Ebastina Qualigen is too strong or too weak, inform your doctor or pharmacist.

If you take more Ebastina Qualigen than you should

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

If you forgot to take Ebastina Qualigen

In case of forgotten dose, wait for the next one.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Ebastina Qualigen

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

Like all medications, Ebastina Qualigen may produce adverse effects, although not all people will experience them.

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

The described adverse effects are as follows:

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

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

Rare (may affect between 1 and 10 of every 1,000 patients):

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

Unknown frequency (cannot be estimated from available data):

• weight gain,
• increased appetite.

If you notice adverse effects not mentioned in this prospectus or if you experience one of the described adverse effects severely, inform your doctor or pharmacist.

Reporting 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 prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Ebastina Qualigen after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at your local SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Ebastina CompositionQualigen

• The active ingredient is Ebastina. Each tablet contains 20 mg of ebastina.
• 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 content of the container

EbastinaQualigen20 mg tablets are round and white.

The containers contain 20 tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible manufacturer:

Generis Farmacêutica, S.A.

Rua João de Deus nº 19, Venda Nova

2700-487 Amadora (Portugal)

Last review date of this leaflet:May 2021

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es