BACTIL 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Bactil 10 mg Film-Coated Tablets

Ebastine

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

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days of treatment.

Contents of the Package Leaflet:

1. What is Bactil and what is it used for
2. What you need to know before taking Bactil
3. How to take Bactil
4. Possible side effects
5. Storage of Bactil

1. Contents of the pack and further information

1. What is Bactil and what is it used for

Bactil belongs to a group of medicines called antihistamines (antiallergics).

Bactil is indicated for the relief of allergic rhinoconjunctivitis (sneezing, nasal itching, nasal discharge, nasal congestion, and red and watery eyes) and urticaria (hives) that occur with mild symptoms, in adults and adolescents from 12 years of age.

You should consult a doctor if it worsens or does not improve after 7 days.

2. What you need to know before taking Bactil

Do not take Bactil

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

Warnings and precautions

Consult your doctor or pharmacist before taking Bactil:

• if your electrocardiogram results are altered.
• if you have high potassium levels in your blood.
• if you suffer from severe liver disease (see "How to take Bactil").
• if you are being treated with a type of medicine used to treat fungal infections called azole antifungals or with medicines used to treat certain infections called macrolide antibiotics (see "Taking Bactil with other medicines").
• if you are being treated with rifampicin, a type of medicine used to treat tuberculosis.

Do not use this medicine if you have an acute allergic emergency, as ebastine (the active ingredient of this medicine) takes 1 to 3 hours to take effect.

In case you experience symptoms such as throat tightness, difficulty breathing, hoarseness, or difficulty speaking, wheezing, low blood pressure, repeated vomiting, and/or loss of consciousness, you should seek urgent medical attention due to the risk of anaphylaxis.

Children

Bactil should not be administered to children under 12 years of age.

Taking Bactil with other medicines

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

Especially if you are being treated with any of the medicines mentioned below, as it may be necessary to change the dose or interrupt treatment with any of them:

• medicines used to treat allergies (antihistamines) because Bactil may increase their effect.
• ketoconazole and itraconazole, used to treat fungal infections, or erythromycin, an antibiotic used to treat certain infections, as they may cause an alteration in your electrocardiogram.
• rifampicin, used to treat tuberculosis, as it may decrease the antihistamine effect of Bactil.

Interference with diagnostic tests

Bactil may interfere with the results of skin allergy tests, so it is recommended not to perform them until 5-7 days after stopping treatment.

Taking Bactil with food and drinks

Taking the medicine with food or drinks does not affect its efficacy.

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 medicine.

Pregnancy

There is limited data on the use of the medicine in pregnant women. As a precaution, it is recommended to avoid the use of Bactil during pregnancy.

Breastfeeding

It is not known if the medicine passes into breast milk, so it should not be used during breastfeeding.

Driving and using machines

No effects on psychomotor function or the ability to drive or use machinery have been observed at the recommended therapeutic doses. However, since drowsiness and dizziness are among the side effects, observe your response to the medication before driving or using machinery.

Bactil contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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

3. How to take Bactil

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Dosage

Use in adults and adolescents over 12 years of age

1 tablet (10 mg of ebastine) once a day.

However, in some cases, a dose of 20 mg of ebastine once a day may be necessary to control symptoms. In these cases, it is recommended to take 2 Bactil tablets (10 mg of ebastine) once a day.

Use in patients with severe liver disease

The dose should not exceed 10 mg of ebastine per day (1 tablet).

Method of administration

This medicine is taken orally.

The tablets can be taken with or without food, with the help of a glass of water.

You should consult a doctor if it worsens or does not improve after 7 days.

If you take more Bactil than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been observed in clinical trials and post-marketing experience:

Very common (may affect more than 1 in 10 people):

• Headache

Common (may affect up to 1 in 10 people):

• Drowsiness
• Dry mouth

Rare (may affect up to 1 in 1,000 people):

• Hypersensitivity reactions: allergic reactions (such as anaphylaxis and angioedema)
• Nervousness, insomnia
• Dizziness, decreased sensation of touch or sensitivity, decreased or altered taste
• Palpitations, tachycardia
• Abdominal pain, vomiting, nausea, digestive problems
• Hepatitis, cholestasis, abnormal liver function tests (increased transaminases, gamma-GT, alkaline phosphatase, and bilirubin)
• Urticaria, skin rash, dermatitis
• Menstrual disorders
• Edema (swelling due to fluid accumulation), fatigue

Frequency not known (cannot be estimated from the available data):

• Weight gain
• Increased appetite

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bactil

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

Do not store above 30°C.

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

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. If in doubt, consult your pharmacist on how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Bactil

• The active ingredient is ebastine. Each tablet contains 10 mg of ebastine.
• The other ingredients (excipients) are: Core of the tablet:microcrystalline cellulose (E-460i), pregelatinized corn starch, lactose monohydrate, sodium croscarmellose (E-468), and magnesium stearate (E-572). Coating: hypromellose (E-464), macrogol 6,000, and titanium dioxide (E-171).

Appearance of the product and pack contents

Bactil is presented in the form of film-coated tablets for oral administration, packaged in PVC/Aluminum blisters. The tablets are circular, white, and marked with E10 on one side.

Each pack contains 10 or 20 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Almirall, S.L.

Ronda General Mitre, 151

08022 – Barcelona (Spain)

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca - Barcelona (Spain)

Date of the last revision of this package leaflet:September 2022

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