BACTIL FORTE 20 mg ORAL LYOPHILIZED

Introduction

Package Leaflet: Information for the Patient

Bactil Forte Flas 20 mg Oral Lyophilizates

Ebastine

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

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

• Keep this package 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 package 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 Package Leaflet

1. What Bactil Forte Flas 20 mg is and what it is used for
2. What you need to know before taking Bactil Forte Flas 20 mg
3. How to take Bactil Forte Flas 20 mg
4. Possible side effects
5. Storage of Bactil Forte Flas 20 mg
6. Package Contents and Additional Information

1. What Bactil Forte Flas 20 mg is and what it is used for

Bactil Forte Flas 20 mg belongs to a group of medications called antihistamines (anti-allergics).

Bactil Forte Flas 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 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 Flas 20 mg

Do not takeBactil ForteFlas 20 mg

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Bactil Forte Flas 20 mg:

• if your electrocardiogram results are altered.
• if you have high potassium levels in your blood.
• if you have severe liver disease (see "How to take Bactil Forte Flas 20 mg").
• if you are being treated with a type of medication used to treat fungal infections called azole antifungals or with medications used to treat certain infections called macrolide antibiotics (see "Taking Bactil Forte Flas 20 mg with other medications").
• if you are being treated with rifampicin, a type of medication used to treat tuberculosis.

Do not use this medication if you have an acute allergic emergency, as ebastine (the active ingredient of this medication) 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 Flas 20 mg should not be administered to children under 12 years old.

Taking Bactil Forte Flas 20 mg with other medications

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

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

• medications used to treat allergies (antihistamines) because Bactil Forte Flas 20 mg may increase their effect.
• ketoconazole and itraconazole, used to treat fungal infections, or with 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 Flas 20 mg.

Interference with diagnostic tests

Bactil Forte Flas 20 mg may interfere with the results of skin allergy tests, so it is recommended not to perform them until 5-7 days after treatment is discontinued.

Taking Bactil Forte Flas 20 mg with food and drinks

Taking the medication 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 medication.

Pregnancy

There is limited data on the use of the medication in pregnant women. As a precaution, it is recommended to avoid using Bactil Forte Flas 20 mg during pregnancy.

Breastfeeding

It is unknown whether the medication passes into breast milk, so it should not be used during breastfeeding.

Driving and Using Machines

No effects have been observed on psychomotor function or the ability to drive or use machinery 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 Flas 20 mg contains aspartame

This medication contains 2 mg of aspartame in each oral lyophilizate. Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

3. How to take Bactil Forte Flas 20 mg

Follow the administration instructions for the medication 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 old

1 oral lyophilizate (20 mg of ebastine), 1 time a day.

Generally, 1 oral lyophilizate of 10 mg of ebastine, 1 time 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 Flas 10 mg Oral Lyophilizates).

Method of Administration

This medication is taken orally.

The oral lyophilizates can be taken with or without food.

1. Do not remove the oral lyophilizate from the package until you are going to take it.
2. Do not extract the dose from the oral lyophilizate by pressing on it. Immediately before taking, with dry hands, open the blister package by carefully lifting the lamina from one alveolus at the point where it is detached (Figure 1).
3. Stretch the tab to detach it (Figure 2).
4. Press the lyophilizate carefully upwards (without touching it) (Figure 3).
5. Remove the lyophilizate carefully (Figure 4).
6. The dose should be taken immediately after opening the blister. Place the oral lyophilizate on the tongue, where it will dissolve quickly, and swallow it with saliva. Do not take water or any other liquid.

Figure 1 Figure 2 Figure 3 Figure 4

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

If you take more Bactil Forte Flas 20 mg 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 medication and the amount ingested.

4. Possible Side Effects

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

In clinical trials and post-marketing experience, the following side effects have been observed:

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 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 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 package leaflet. You can also report them directly through the Spanish Medication Surveillance System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Bactil Forte Flas 20 mg

Keep this medication out of sight and reach of children.

No special storage conditions are required.

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

6. Package Contents and Additional Information

Composition of Bactil Forte Flas 20 mg

• The active ingredient is ebastine. Each oral lyophilizate contains 20 mg of ebastine.
• The other components (excipients) are gelatin (E-441), mannitol (E-421), aspartame (E-951), and peppermint flavor.

Appearance of the Product and Package Contents

Bactil Forte Flas 20 mg is presented in the form of an oral lyophilizate. The lyophilizate is round, white, and has a peppermint flavor.

Each package contains 10 oral lyophilizates.

Other Presentations

Bactil Flas 10 mg Oral Lyophilizates.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Almirall, S.L.

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: December 2022

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/