EBASTINE QUALIGEN 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ebastina Qualigen 10 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before starting to take the medication.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

Ebastina, the active ingredient of Ebastina Qualigen, belongs to a group of medications called antihistamines.

Ebastina 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 taking Ebastina Qualigen

Do not take Ebastina Qualigen

• If you are allergic to ebastina or any of the other components of this medication (listed in section 6).
• It should not be administered to children under 6 years of age, as its safety has not been established at these ages.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Ebastina Qualigen:

• If you have an acute allergic emergency, as Ebastina Qualigen takes 1 to 3 hours to take effect.
• Ebastina Qualigen may interfere with the results of skin allergy tests, so it is recommended not to perform them until 5-7 days have passed since the treatment was discontinued.
• 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 ebastina should not be exceeded.

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 products, herbal remedies, and other health-related products, as it may be necessary to discontinue treatment or adjust the dose of one of them.

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

Taking Ebastina 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 medication.

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

It is unknown whether the medication passes into breast milk.

Driving and Using Machines

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

3. How to Take Ebastina Qualigen

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

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

Remember to take your medication.

The recommended dose in adults and children over 12 years of age is 1 tablet (10 mg) once a day.

Use in Children

In children between 6 and 11 years of age, the normal recommended dose is half a tablet (5 mg) once a day.

The tablets of Ebastina Qualigen 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 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Ebastina Qualigen

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

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

4. Possible Side Effects

Like all medications, Ebastina Qualigen can cause side effects, although not everyone will experience them.

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

The side effects described in adults and children over 12 years of age are as follows:

Frequent (may affect 1 to 10 in every 100 patients):

• headache,
• sleepiness,
• dry mouth.

Uncommon (may affect 1 to 10 in every 1000 patients):

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

In children under 12 years of age, the adverse events described are as follows:

Frequent (may affect 1 to 10 in every 100 patients):

• headache,
• dry mouth,
• sleepiness.

Uncommon (may affect 1 to 10 in every 1000 patients):

• increased appetite,
• diarrhea,
• skin rash,
• nervousness,
• affective imbalance,
• excessive mobility,
• taste disorders,
• fatigue.

Frequency Not Known (cannot be estimated from the available data):

• weight gain,
• increased appetite.

If you notice side effects not mentioned in this package leaflet or if you experience any of the side effects described in a severe form, inform 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 is not listed in this package leaflet. You can also report them directly through the Spanish Medication Pharmacovigilance System: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ebastina Qualigen

Keep out of the reach and sight of children.

No special storage conditions are required.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point in your usual pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Ebastina Qualigen

• The active ingredient is Ebastina. Each tablet contains 10 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 white opadry [hydroxypropyl methyl cellulose (E-464), polyethylene glycol (E-1521), titanium dioxide (E-171)].

Appearance of the Product and Contents of the Pack

The tablets of Ebastina Qualigen 10 mg are oval with a score line and white in color.

The packaging contains 20 tablets.

Marketing Authorization Holder and Manufacturer

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 the Last Revision of this Package Leaflet:May 2021

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