Bactil Forte 20 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Bactil Forte 20 mg Film-coated tablets
Ebastine
Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.
Follow exactly the instructions for use of this medicine as described 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 any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if you worsen or do not improve after 7 days of treatment.
Leaflet contents:
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What Bactil Forte is and what it is used for
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What you need to know before taking Bactil Forte
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How to take Bactil Forte
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Possible side effects
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How to store Bactil Forte
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Contents of the pack and other information
1. What Bactil Forte is and what it is used for
Bactil Forte belongs to a group of medicines called antihistamines (antiallergic agents).
Bactil Forte is indicated for the relief of mild symptoms of allergic rhinoconjunctivitis (sneezing, nasal itching, nasal discharge, nasal congestion, and red, watery eyes) and urticaria (hives) in adults and adolescents aged 12 years and older, when a 10 mg dose 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 to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Bactil Forte:
- if your electrocardiogram (ECG) results are abnormal.
- if you have high levels of potassium in your blood.
- if you have severe liver disease (see section “How to take Bactil Forte”).
- 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 section “Taking Bactil Forte with other medicines”).
- if you are being treated with rifampicin, a medicine used to treat tuberculosis.
Do not use this medicine if you are experiencing an acute, urgent allergic reaction, as ebastine (the active substance in this medicine) takes 1 to 3 hours to take effect.
If you experience symptoms such as throat tightness, difficulty breathing, hoarseness, difficulty speaking, wheezing (“whistling” 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 must not be given to children under 12 years of age.
Taking Bactil Forte with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Especially if you are taking any of the following medicines, as it may be necessary to adjust the dose or discontinue treatment with one of them:
- medicines used to treat allergies (antihistamines), because Bactil Forte may enhance their effect;
- ketoconazole and itraconazole, used to treat fungal infections, or erythromycin, an antibiotic used to treat certain infections, as they may cause abnormalities in your electrocardiogram;
- rifampicin, used to treat tuberculosis, as it may reduce the antihistaminic effect of Bactil Forte.
Interference with diagnostic tests
Bactil Forte may interfere with the results of skin allergy tests; therefore, it is recommended not to perform such tests until 5–7 days after stopping treatment.
Taking Bactil Forte with food and drink
Taking the medicine with food or drink does not affect its efficacy.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
Limited data are available on the use of this medicine in pregnant women. As a precautionary measure, it is preferable to avoid using Bactil Forte during pregnancy.
Breastfeeding
It is unknown whether the medicine passes into breast milk; therefore, it should not be used during breastfeeding.
Driving and using machines
No effects on psychomotor function or on the ability to drive or operate machinery have been observed at the recommended therapeutic doses. However, since somnolence and dizziness are listed among the adverse effects, you should assess your response to the medication before driving or operating machinery.
Bactil Forte contains lactose and sodium
This medicine contains lactose. If your doctor has informed 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; i.e., it is essentially “sodium-free”.
3. How to take Bactil Forte
Follow exactly the dosage instructions for this medicine as described in this leaflet or as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Dosage
Use in adults and adolescents over 12 years of age
1 tablet (20 mg of ebastine) once daily. Usually, 1 tablet containing 10 mg of ebastine once daily 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 formulation (Bactil 10 mg Film-coated Tablets).
Method of administration
This medicine is taken orally.
The tablets may be taken with or without food, with a glass of water.
Consult a doctor if your condition worsens or if you do 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 at telephone number 915 620 420, indicating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The following adverse 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 of touch or sensitivity, decreased or altered taste
- Palpitations, tachycardia
- Abdominal pain, vomiting, nausea, digestive problems
- Liver inflammation (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 of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Bactil Forte
Keep this medicine out of sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater drains or household waste. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy. If you are unsure, please consult your pharmacist on how to dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Bactil Forte
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The active substance is ebastine. Each tablet contains 20 mg of ebastine.
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The other components (excipients) are: Tablet core: 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).
Nature of the product and pack contents
Bactil Forte is presented as film-coated tablets for oral administration, packed 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 most recent revision of this leaflet: December 2022
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/