Ebastine/levocetirizine Combix 10 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Ebastina Combix 10 mg Film-Coated Tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• 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 must not be given to other people, even if they have the same symptoms as you, since it could 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 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 adverse effects
5. How to store Ebastina Combix
6. Contents of the pack and other information

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

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

This medicine is used to treat 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 starting Ebastina Combix

Do not take Ebastina Combix

• if you are allergic to ebastine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor before starting Ebastina Combix:

• If you are experiencing an acute allergic emergency, as this medicine takes 1 to 3 hours to take effect.
• This medicine may interfere with the results of skin allergy tests; therefore, it is recommended not to carry out such tests until 5–7 days after stopping treatment.
• It may enhance the effects of other antihistamines.
• In patients with mild or moderate hepatic impairment, dose adjustment is not necessary. In patients with severe hepatic impairment, the dose should not exceed 10 mg/day of ebastine.

Children

This medicine must not be given to children under 6 years of age.

Taking Ebastina Combix with other medicines

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

Ebastine may interact with erythromycin (an antibiotic) or ketoconazole (a medicine used to treat fungal infections).

Taking Ebastina Combix with food and drink

The tablets may be taken with or without food.

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

It is unknown whether the medicine passes into breast milk; therefore, it is recommended to consult a doctor before taking this medicine.

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.

3. How to take Ebastina Combix

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

Your doctor will tell you how long to take this medicine. Remember to take your medicine regularly.

The recommended normal dose is:

• Adults and adolescents over 12 years of age: 1 tablet (10 mg of ebastine) once daily.
• Children between 6 and 11 years of age: half a tablet (5 mg of ebastine) once daily. The tablet may be divided into equal doses.

Ebastina Combix 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 this medicine is too strong or too weak, tell your doctor or pharmacist.

If you take more Ebastina Combix than you should

Contact your doctor or pharmacist immediately or go to a hospital. Treatment for poisoning with this medicine consists of gastric lavage and administration of appropriate medication. Take this leaflet with you.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Ebastina Combix

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

If you interrupt treatment with Ebastina Combix

Do not stop treatment earlier than indicated by your doctor, as your symptoms may worsen.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The adverse effects reported in adults and adolescents over 12 years of age are as follows:

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

• Uncommon (may affect up to 1 in 100 people): abdominal pain, indigestion, nosebleed, rinitis, sinusitis, nausea, and insomnia.

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

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

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

• Uncommon (may affect up to 1 in 100 people): increased appetite, diarrhoea, skin rash, nervousness, affective disturbance, excessive motor activity, taste disturbances, and fatigue.

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 can 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 Combixs

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ebastina Combix

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

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

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

Appearance of the product and contents of the pack

Film-coated tablets, white in color, oval-shaped, biconvex, and scored.

Ebastina Combix is available in packs of 20 tablets.

Marketing Authorization Holder and Manufacturing Responsible Party:

Marketing Authorization Holder:

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturing Responsible Party:

Generis Farmaceutica, S.A.

Rua Joao de Deus nº 19,

Venda Nova 2700-487 Amadora

Portugal

Date of the most recent review of this leaflet: April 2019

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