Package Insert: Information for the Patient

Bactil Forte 20 mg Film-Coated Tablets

Ebastina

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

Follow exactly the medication administration instructions contained in this package insert or those indicated by your doctor or pharmacist.

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

6.Contents of the pack and additional information

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

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

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

Do not takeBactil Forte

• if you are allergic to ebastine or any of the other ingredients of this medication (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 levels of potassium in your blood.
• if you have severe liver disease (see “How to take Bactil Forte” section).
• if you are being treated with certain types of medications used to treat fungal infections called azole antifungals or with medications used to treat certain infections called macrolide antibiotics (see “Taking Bactil Forte with other medications” section).
• if you are being treated with rifampicin, a type of medication used to treat tuberculosis.

Do not use this medication if you are experiencing an acute allergic emergency, as ebastine (active ingredient of this medication) 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 while breathing), low blood pressure, repeated vomiting, and/or loss of consciousness, seek urgent medical assistance due to the risk of anaphylaxis.

Children

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

Taking Bactil Forte with other medications

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

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

• allergy medications (antihistamines) because Bactil Forte may increase their effect.
• ketoconazole and itraconazole, used to treat fungal infections, or erythromycin 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.

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 discontinuing treatment.

Taking Bactil Fortewith food and drinks

The taking of the medication 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 medication.

Pregnancy

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

Breastfeeding

It is unknown whether the medication 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 contains lactose and sodium

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

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

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

Administration form

This medication is taken orally.

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

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

If you take Bactil Forteyou 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
• M 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.

Do not store at a temperature above30°C.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is thelastday of the month indicated.

Medicines should not be thrown into the drains or trash.Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Bactil Forte

• The active ingredient is ebastina. Each tablet contains 20 mg of ebastina.

• The other components (excipients) are:Tablet core:cellulose microcrystalline (E-460i), pregelatinized cornstarch, lactose monohydrate, croscarmellose sodium (E-468) and magnesium stearate (E-572).Coating: hypromellose (E-464), macrogol 6.000 and titanium dioxide (E-171).

Appearance of the product and contents of the packaging

Bactil Forte is presented in the form of coated tablets for oral administration, packaged in PVC/Aluminum blisters. The tablets areround, white in color, and have one face marked with E20.

Each package contains 10 or 20 coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holderof the marketing authorization

Almirall, S.L.

Ronda General Mitre, 151 08022–Barcelona (Spain)

Responsible for manufacturing

Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca–Barcelona (Spain)

Date of the last review of this leaflet:December 2022

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