Leaflet: information for the patient

Bactil Forte Flas 20 mg Lyophilized oral tablets

Ebastina

Read this 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 leaflet or those 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 any 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.

1. What isBactil Forte Flas 20 mgand what it is used for

2. What you need to know before starting to takeBactil Forte Flas 20 mg

3. How to takeBactil Forte Flas 20 mg

4. Possible side effects

5. Storage ofBactil Forte Flas 20 mg

6. Contents of the pack and additional information

Bactil Forte Flas 20 mg belongs to a group of medicines called antihistamines (antiallergics).

Bactil Forte Flas is indicated for the relief of allergic rhinoconjunctivitis (stuffy nose, itchy nose, nasal discharge, nasal congestion, and red, watery eyes) and urticaria (hives) with mild symptoms in adults and adolescents 12 years and older, when a 10 mg dose is insufficient.

Consult a doctor if symptoms worsen or do not improve after 7 days.

Do not takeBactil ForteFlas 20 mg

• if you are allergic to ebastine or to any of theother ingredients of this medicine (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 levels of potassium in your blood.
• if you have severe liver disease (see the section “How to take Bactil Forte Flas 20 mg”).
• if you are being treated with a type of antifungal medication called azoles or with a type of antibiotic called macrolides (see the section “Taking Bactil Forte Flas 20 mg 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 constriction, difficulty breathing, hoarseness, or difficulty speaking, wheezing (“popping” sounds when breathing), low blood pressure, repeated vomiting, and/or loss of consciousness, seek urgent medical assistance 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 medicines

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

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

• allergy medications (antihistamines) because Bactil Forte Flas 20 mg 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 reduce 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 discontinuing treatment.

Taking Bactil Forte Flas 20 mg with food and drinks

The taking of the medicine with food or drinks does not affect its efficacy.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be 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 Flas 20 mg during pregnancy.

Breastfeeding

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

Driving and operating machinery

No effects on psychomotor function or on the ability to drive or operate machinery have been observed at the recommended therapeutic doses. However, given that drowsiness and dizziness are among the adverse effects, observe your response to the medication before driving or operating machinery.

Bactil Forte Flas 20 mg contains aspartame

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

Follow exactly the medication administration instructions contained in this leaflet or those 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 lyophilisate (20 mg of ebastine), once a day.

Usually, 1 oral lyophilisate of 10 mg of ebastine, once a day is sufficient to control symptoms.

Use in patients with severe liver disease

Do not exceed the dose of 10 mg of ebastine per day. In this case, it is recommended to use the 10 mg presentation (Bactil Flas 10 mg Oral Lyophilisates).

Administration Form

This medication is taken orally.

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 packaging by carefully lifting the flap at 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.Extract the lyophilisate carefully (Figure 4).

6.The dose should be taken immediately after opening the blister packaging. 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 1Figure 2Figure 3Figure 4

You should consult a doctor if symptoms worsen or do 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 Toxicological Information Service, phone 915 620 420 indicating the medication and the amount ingested.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

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
• Inflammation of the liver (hepatitis), cholestasis, abnormal liver function test results (elevated transaminases, gamma-GT, alkaline phosphatase, and bilirubin)
• Urticaria, skin rash, dermatitis
• Menstrual disorders
• Edema (swelling due to fluid accumulation), fatigue

Unknown frequency (cannot be estimated from available data):

• Weight gain
• Increased appetite

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and unused medications at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Bactil Forte Flas 20 mg

• The active principle is ebastina. Each lyophilized oral contains 20 mg of ebastina.
• The other components (excipients) are gelatine (E-441), mannitol (E-421), aspartame (E-951) and peppermint aroma.

Appearance of the product and content of the packaging

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

Each package contains 10 oral lyophilizates.

Other presentations

Bactil Flas 10 mg Oral lyophilizates.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Almirall, S.L.

General Mitre, 151

08022 – Barcelona (Spain)

Responsible for manufacturing

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca - Barcelona (Spain)

Last review date of this leaflet: December 2022

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/