Bactil 10 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Bactil 10 mg Film-coated tablets
Ebastine
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
Follow exactly the instructions for use of this medicine contained in this leaflet or those provided by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further 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 your condition worsens or if you do not improve after 7 days of treatment.
Contents of the leaflet:
-
What Bactil is and what it is used for
-
What you need to know before taking Bactil
-
How to take Bactil
-
Possible side effects
-
How to store Bactil
-
Contents of the pack and other information
1. What Bactil is and what it is used for
Bactil belongs to a group of medicines called antihistamines (antiallergic agents).
Bactil is indicated for the relief of mild 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.
You should consult a doctor if your condition worsens or does not improve after 7 days.
2. What you need to know before starting to take Bactil
Do not take Bactil
- if you are allergic to ebastine or to 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:
- if your electrocardiogram (ECG) results are abnormal.
- if you have high levels of potassium in your blood.
- if you suffer from severe liver disease (see section “How to take Bactil”).
- 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 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 must not be administered to children under 12 years of age.
Taking Bactil with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Especially if you are being treated with any of the following medicines, because it may be necessary to adjust the dose or discontinue treatment with one of them:
- medicines used to treat allergies (antihistamines), because Bactil 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 abnormalities in your electrocardiogram.
- rifampicin, used to treat tuberculosis, as it may reduce the antihistaminic effect of Bactil.
Interference with diagnostic tests
Bactil may interfere with the results of skin allergy tests. Therefore, it is advised not to perform these tests until 5–7 days after stopping treatment.
Taking Bactil 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 might 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 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, observe your response to the medication before driving or operating machinery.
Bactil contains lactose and sodium
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially “sodium-free”.
3. How to take Bactil
Follow exactly the dosage instructions for the medicine provided in this leaflet or those given 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 (10 mg of ebastine) once daily.
However, in some cases a dose of 20 mg of ebastine once daily may be required to control symptoms. In such cases, 2 tablets of Bactil (10 mg of ebastine) once daily are recommended.
Use in patients with severe liver disease
The dose should not exceed 10 mg of ebastine per day (1 tablet).
Method of administration
This medicine is taken orally.
The tablets can be taken with or without food, with a glass of water.
You should consult a doctor if your condition worsens or does not improve after 7 days.
If you take more Bactil 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 may cause adverse effects, although not everyone will experience 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 System of Pharmacovigilance 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
Keep this medicine out of the 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 is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Bactil
- The active substance is ebastine. Each tablet contains 10 mg of ebastine.
- 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 6000 and titanium dioxide (E-171).
Appearance of the product and pack contents
Bactil is available as film-coated tablets for oral administration, packed in PVC/aluminum blisters. The tablets are circular, white in colour, with one side marked with E10.
Each pack 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: September 2022
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/