Ebastel 10 mg film-coated tablets
Spain
Table of Contents
Package Leaflet: Information for the User
Introduction
Package leaflet: information for the patient
Ebastel 10 mg film-coated tablets
ebastine
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Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
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Keep this leaflet, as you may need to read it again.
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If you have any questions, consult your doctor or pharmacist.
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This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
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If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
Leaflet contents:
- What Ebastel is and what it is used for
- What you need to know before taking Ebastel
- How to take Ebastel
- Possible side effects
- How to store Ebastel
- Contents of the pack and other information
1. What Ebastel is and what it is used for
Ebastel belongs to a group of medicines known as antihistamines (antiallergic agents).
Ebastel is indicated for the treatment of symptoms associated with allergic conditions, such as seasonal or perennial allergic rhinitis, with or without allergic conjunctivitis (such as runny nose, nasal itching, eye itching, tearing, and sneezing), chronic urticaria, and allergic dermatitis.
2. What you need to know before starting to take Ebastel
Do not take Ebastel
- if you are allergic to ebastine or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take Ebastel.
This medicine should be used with caution:
- if your electrocardiogram (ECG) results are abnormal (prolongation of the QT interval).
- if you have abnormal blood potassium levels.
- if you suffer from severe liver disease (see section “How to take Ebastel”).
- 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 Ebastel with other medicines”).
- if you are being treated with rifampicin, a medicine used to treat tuberculosis.
Do not use this medicine if you have an acute, urgent allergic reaction, as ebastine (the active substance in this medicine) takes 1 to 3 hours to take effect.
Children
Ebastel 10 mg Tablets should not be administered to children under 12 years of age.
Other medicines and Ebastel
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
The following medicines may interact with Ebastel; in such cases it may be necessary to adjust the dose or discontinue treatment with one of the medicines:
- Ebastel may increase the effect of other medicines used to treat allergies (antihistamines).
- Ebastel should be used with caution in patients taking medicines called ketoconazole and itraconazole, used to treat fungal infections, or with a macrolide antibiotic used to treat certain infections called erythromycin (as they may cause changes in your electrocardiogram).
- The antihistaminic effect of Ebastel may be reduced in patients taking a medicine called rifampicin, used to treat tuberculosis.
No interactions have been reported between ebastine and theophylline, warfarin, cimetidine, diazepam, or alcohol.
Interference with diagnostic tests
Ebastel 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 Ebastel with food and drink
The tablets can be taken with or without food.
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
There is no experience in pregnant women; therefore, it is recommended to consult a doctor before taking Ebastel. The doctor will decide whether or not treatment should be started.
Breastfeeding
It is unknown whether the medicine passes into breast milk; therefore, it should not be used during breastfeeding.
Driving and using machines
In clinical studies, 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 individual response to the medication before driving or operating machinery.
Ebastel contains lactose
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 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.
3. How to take Ebastel
Follow exactly the instructions for using this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.
Remember to take your medicine.
Your doctor will advise you on how long to continue treatment with Ebastel.
Ebastel 10 mg Film-coated Tablets are not suitable for doses lower than 10 mg of ebastine, nor for patients who have difficulty swallowing.
Dosage
Use in adults and children over 12 years of age: The recommended dose is 1 tablet (10 mg of ebastine) once daily.
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 for oral use.
The tablets can be taken with or without food, with a glass of water.
If you think that the effect of Ebastel is too strong or too weak, tell your doctor or pharmacist.
If you take more Ebastel than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, call the Toxicology Information Service at telephone number 915 620 420 (indicating the medicine and the amount ingested), or go to the nearest hospital. Bring any remaining tablets, the outer carton, and the full packaging so that healthcare professionals can identify the medicine you have taken more easily.
Treatment of poisoning with this medicine consists of gastric lavage and administration of appropriate medication.
If you forget to take Ebastel
Do not take a double dose to make up for missed doses. Take the missed dose as soon as you remember, then continue with your regular schedule. However, if it is almost time for your next dose, do not take the missed dose and wait until the next scheduled dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Ebastel 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 disturbances
- 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 through 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 Ebastel
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 refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Ebastel
- 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 6,000 and titanium dioxide (E-171).
Appearance of the product and contents of the pack
Ebastel is presented as film-coated tablets for oral administration, packed in PVC/aluminum blisters. The tablets are circular, white in colour, with one side marked "E10".
Each pack contains 20 film-coated tablets.
Other presentations
Ebastel 1 mg/ml Oral Solution
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Almirall, S.A.
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: May 2019
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/