BACTIL FLAS 10 mg ORAL LYOPHILIZED

Introduction

Patient Information Leaflet

Bactil Flas 10 mg Oral Lyophilisates

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 symptoms worsen or do not improve after 7 days of treatment.

Contents of the Leaflet

1. What Bactil Flas 10 mg is and what it is used for
2. What you need to know before taking Bactil Flas 10 mg
3. How to take Bactil Flas 10 mg
4. Possible side effects
5. Storage of Bactil Flas 10 mg
6. Package contents and additional information

1. What Bactil Flas 10 mg is and what it is used for

Bactil Flas 10 mg belongs to a group of medicines called antihistamines (anti-allergics).

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

You should consult a doctor if your symptoms worsen or do not improve after 7 days.

2. What you need to know before taking Bactil Flas 10 mg

Do not takeBactil Flas 10mg

• 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 Flas 10 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 Flas 10 mg").
• 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 Flas 10 mg 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.

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 Flas 10 mg should not be administered to children under 12 years of age.

Taking Bactil Flas 10 mg with other medicines

Tell 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 one of them:

• medicines used to treat allergies (antihistamines) because Bactil Flas 10 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 Flas 10 mg.

Interference with diagnostic tests

Bactil Flas 10 mg 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 Flas 10 mg 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 Flas 10 mg 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 Flas 10 mg contains aspartame

This medicine contains 1 mg of aspartame in each oral lyophilisate. 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 properly.

3. How to take Bactil Flas 10 mg

Follow the administration instructions for the medicine contained in this 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 oral lyophilisate (10 mg of ebastine), 1 time a day.

However, in some cases, a dose of 20 mg of ebastine 1 time a day may be necessary to control symptoms. In these cases, 2 Bactil Flas 10mg oral lyophilisates (10 mg of ebastine) 1 time a day are recommended.

Use in patients with severe liver disease

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

Method of administration

This medicine is taken orally.

The oral lyophilisates can be taken with or without food.

1. Do not remove the oral lyophilisate from the packaging until you are ready to take it.
2. Do not extract the dose from the oral lyophilisate by pressing on it. Immediately before taking, with dry hands, open the blister pack by carefully lifting the foil from the point where it is detached (Figure 1).
3. Stretch the tab to detach it (Figure 2).
4. Press the lyophilisate carefully upwards (without touching it) (Figure 3).
5. Remove the lyophilisate carefully (Figure 4).
6. The dose should be taken immediately after opening the blister pack. Place the oral lyophilisate 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 symptoms worsen or do not improve after 7 days.

If you take more Bactil Flas 10 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 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 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 Medicines and Healthcare Products Agency's 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 Flas 10 mg

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 CAD. The expiry 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 pharmacy's SIGRE collection point. 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

Composition of Bactil Flas 10 mg

• The active ingredient is ebastine. Each oral lyophilisate contains 10 mg of ebastine.
• The other ingredients (excipients) are gelatin (E-441), mannitol (E-421), aspartame (E-951), and peppermint flavor.

Appearance of the product and package contents

Bactil Flas 10 mg is presented in the form of oral lyophilisates. The lyophilisate is round, white, and has a peppermint flavor.

Each package contains 10 oral lyophilisates.

Other presentations

Bactil Forte Flas 20 mg Oral Lyophilisates

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 last revision of this leaflet: December 2022

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