Package Leaflet: Information for the Patient

Ebastina Combix 10 mg Film-Coated Tablets

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this package 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, talk to your doctor or pharmacist. See section 4.

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

2. What you need to know before you take Ebastina Combix

3. How to take Ebastina Combix

4. Possible side effects

5. Storage of Ebastina Combix

6. Contents of the pack and additional information

Ebastina, the active component of Ebastina Combix, belongs to a group of drugs known as antihistamines.

This medication is used in the treatment of allergic processes such as seasonal or perennial allergic rhinitis associated or not with allergic conjunctivitis (such as runny nose, nasal itching, eye itching, tearing, urge to sneeze), chronic urticaria and allergic dermatitis.

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 skin allergy test results, so it is recommended not to perform them until 5-7 days after discontinuing treatment.
• 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 daily dose of 10 mg of ebastina.

Children

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

Taking Ebastina Combix with other medications

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

Ebastina may interact with erythromycin (antibiotic medication) or ketoconazole (medication for 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, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

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

Breastfeeding

The medication's passage into breast milk is unknown, so it is recommended to consult a doctor before taking this medication.

Driving and operating machinery

In men, no effects on psychomotor function or ability to drive or operate machinery have been observed at 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.

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

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

The usual recommended dose is:

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

Ebastina Combix 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 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 the hospital. The treatment for this medication overdose consists of gastric lavage and administration of the appropriate medication. Bring this leaflet with you.

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

If you forgot to take Ebastina Combix

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

If you interrupt treatment with Ebastina Combix

Do not discontinue treatment before your doctor indicates, as your symptoms may worsen.

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

Like all medications,this medicationcan produce adverse effects, although not all people will experience them.

The adverse effects described in adults and adolescents over 12 years old are as follows:

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

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

• Unknown frequency (cannot be estimated from available data):weight gain and increased appetite.

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

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

• Rare (may affect up to 1 in 100 people): increased appetite, diarrhea, skin eruptions, nervousness, affective imbalance, excessive mobility, taste alterations, and fatigue.

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 the Spanish 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 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 that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Composition of Ebastina Combix

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

Tablet core: microcrystalline cellulose (E460i), stearoyl macrogolglycerides, carboxymethyl sodium starch (type A) (from potato), magnesium stearate (E470b).

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

Appearance of the product and content of the packaging

Coated tablets with a film, white in color, oval, biconvex, and with a notch.

Ebastina Combix is available in packs of 20 tablets.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing:

Generis Farmaceutica, S.A.

Rua Joao de Deus nº 19,

Venda Nova 2700-487 Amadora

Portugal

Last review date of this leaflet: April 2019

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