EBASTINE COMBIX 10 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Ebastina Combix 10 mg film-coated tablets EFG

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the leaflet:

1. What Ebastina Combix is and what it is used for
2. What you need to know before taking Ebastina Combix
3. How to take Ebastina Combix
4. Possible side effects
5. Storage of Ebastina Combix
6. Package contents and additional information

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

Ebastina, the active component of Ebastina Combix, belongs to a group of medications called antihistamines.

This medication is used in 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 Combix

Do not take Ebastina Combix

• if you are allergic to ebastina or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor before starting to take Ebastina Combix:

• If you have an acute allergic emergency, as this medication takes 1 to 3 hours to take effect.
• This medication may interfere with the results of skin allergy tests, so it is recommended not to perform them until 5-7 days have passed since treatment was discontinued.
• It may enhance the effects of other antihistamines.
• In patients with mild or moderate liver impairment, it is not necessary to adjust the dose. In patients with severe liver impairment, the dose should not exceed 10 mg/day of ebastina.

Children

This medication should not be administered to children under 6 years of age.

Taking Ebastina Combix with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

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

Taking Ebastina Combix 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.

Pregnancy

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

Breastfeeding

It is unknown whether the medication passes into breast milk, so it is recommended to consult with a doctor before taking this medication.

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 in some cases at usual doses. If this happens, avoid driving and operating hazardous machinery.

3. How to take Ebastina Combix

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

Your doctor will indicate the duration of your treatment with this medication. Remember to take your medication.

The normal recommended dose is:

• Adults and adolescents over 12 years: 1 tablet (10 mg of ebastina) once a day.
• Children between 6 and 11 years: half a tablet (5 mg of ebastina) once a day. The tablet can be divided into two equal doses.

The Ebastina Combix 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 this medication is too strong or too weak, inform your doctor or pharmacist.

If you take more Ebastina Combix than you should

Consult your doctor or pharmacist immediately or go to a hospital. The treatment of overdose of this medication consists of gastric lavage and administration of appropriate medication. Bring this leaflet with you.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Ebastina Combix

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

If you stop taking Ebastina Combix

Do not stop treatment before it is indicated by your doctor, as your symptoms may worsen.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The side effects described in adults and adolescents over 12 years are the following:

• Frequent (may affect up to 1 in 10 people): headache, somnolence, and dry mouth.

• Uncommon (may affect up to 1 in 100 people): abdominal pain, digestive discomfort, nasal bleeding, rhinitis, sinusitis, nausea, and insomnia.

• Frequency not known (cannot be estimated from available data): weight gain and increased appetite.

In children under 12 years, the adverse events described are the following:

• Frequent (may affect up to 1 in 10 people): headache, dry mouth, and somnolence.

• Uncommon (may affect up to 1 in 100 people): increased appetite, diarrhea, skin rash, nervousness, mood swings, excessive mobility, taste disturbances, and fatigue.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this 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 Combix

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date stated on the packaging after CAD. 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 pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Ebastina Combix composition

• The active ingredient is ebastina. Each tablet contains 10 mg of ebastina.
• The other components (excipients) are:

Core of the tablet:microcrystalline cellulose (E460i), stearyl macroglycerides, sodium carboxymethylcellulose (type A) (from potato), magnesium stearate (E470b).

Coating: purified water and white opadry (hydroxypropylmethylcellulose (E464), polyethylene glycol, and titanium dioxide (E171)).

Appearance of the product and package contents

Film-coated tablets, white, oval, biconvex, and scored.

Ebastina Combix is available in packages of 20 tablets.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer:

Generis Farmaceutica, S.A.

Rua Joao de Deus nº 19,

Venda Nova 2700-487 Amadora

Portugal

Date of the last revision of this leaflet: April 2019

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/