BACTIL FORTE 20 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Bactil Forte 20 mg Film-Coated Tablets

Ebastine

Read this leaflet carefully before starting to take this medicine, as it contains important information for you

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

• Keep this leaflet, as 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 leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days of treatment.

Contents of the Leaflet:

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

1. Package contents and additional information

1. What Bactil Forte is and what it is used for

Bactil Forte belongs to a group of medicines called antihistamines (anti-allergics).

Bactil Forte is indicated for the relief of allergic rhinoconjunctivitis (sneezing, nasal itching, nasal discharge, nasal congestion, and red and itchy eyes) and urticaria (hives) that occur with mild symptoms in adults and adolescents over 12 years old, when a dose of 10 mg is not sufficient.

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

2. What you need to know before taking Bactil Forte

Do not take Bactil Forte

• 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 starting to take Bactil Forte:

• 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 Forte").
• if you are being treated with a type of antifungal medication called azoles or with antibiotics used to treat certain infections (see "Taking Bactil Forte with other medicines").
• if you are being treated with rifampicin, a type of medication 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.

If 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 Forte should not be administered to children under 12 years old.

Taking Bactil Forte 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 following medicines, as it may be necessary to change the dose or discontinue treatment with one of them:

• medicines used to treat allergies (antihistamines) because Bactil Forte 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 Forte.

Interference with diagnostic tests

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

Taking Bactil Forte 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 using Bactil Forte during pregnancy.

Breastfeeding

It is unknown whether 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 somnolence and dizziness are among the side effects, observe your response to the medication before driving or using machinery.

Bactil Forte 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; it is essentially "sodium-free".

3. How to take Bactil Forte

Follow the administration instructions for the medicine contained in this leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Dosage

Use in adults and adolescents over 12 years old

1 tablet (20 mg of ebastine) once a day. Generally, 1 tablet of 10 mg of ebastine, once a day, is sufficient to control symptoms.

Use in patients with severe liver disease

The dose should not exceed 10 mg of ebastine per day. In this case, it is recommended to use the 10 mg presentation (Bactil 10 mg Film-Coated Tablets).

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 your condition worsens or does not improve after 7 days.

If you take more Bactil Forte 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 everyone 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):

• Somnolence
• 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 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 available data):

• Weight gain
• Increased appetite

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bactil Forte

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

Do not store above 30°C.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Bactil Forte composition

• The active ingredient is ebastine. Each tablet contains 20 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 package contents

Bactil Forte 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 E20 on one side.

Each package 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 leaflet:December 2022

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