Ebastine Alter 10 mg film-coated tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package leaflet: Information for the patient
Ebastina Alter 10 mg film-coated tablets EFG
ebastine
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- 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 be harmful to them.
- 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.
Leaflet contents:
- What Ebastina Alter is and what it is used for
- What you need to know before taking Ebastina Alter
- How to take Ebastina Alter
- Possible side effects
- How to store Ebastina Alter
- Contents of the pack and other information
1. What Ebastine Alter is and what it is used for
Ebastine belongs to a group of medicines known as antihistamines (antiallergic agents).
Ebastine 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, sneezing)
- chronic urticaria
- allergic dermatitis
2. What you need to know before starting to take Ebastine Alter
Do not take Ebastine Alter
- if you are allergic to the active substance of this medicine 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 ebastine.
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.
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if you suffer from severe liver disease (see section “How to take Ebastine Alter”).
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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 ebastine with other medicines”).
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if you are being treated with rifampicin, a medicine used to treat tuberculosis.
Do not use this medicine if you have an acute allergic emergency, as ebastine (the active substance in this medicine) takes 1 to 3 hours to take effect.
Children
Ebastine 10 mg Tablets should not be given to children under 12 years of age.
Other medicines and Ebastine Alter
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 ebastine; in such cases it may be necessary to change the dose or discontinue treatment with one of them:
??Ebastine may enhance the effect of other medicines used to treat allergy (antihistamines).
- Ebastine should be used with caution in patients taking medicines called ketoconazole and itraconazole, used to treat fungal infections, or with an antibiotic used to treat certain infections called erythromycin (as they may cause changes in your electrocardiogram).
- The antihistaminic effect of ebastine 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, and alcohol.
Interference with diagnostic tests
Ebastine may interfere with the results of skin allergy tests; therefore, such tests should not be performed until 5–7 days after stopping treatment.
Ebastine Alter with food and drinks
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 Ebastine Alter. The doctor will decide whether or not treatment should be initiated.
Breastfeeding
It is unknown whether the medicine passes into breast milk; therefore, it should not be used during breastfeeding.
Driving and using machines
In men, 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.
Ebastine Alter contains lactose
This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Ebastina Alter
Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Remember to take your medicine.
Your doctor will advise you on the duration of your treatment with ebastine.
Ebastina 10 mg Film-coated Tablets are not suitable for administering 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 feel that the effect of ebastine is too strong or too weak, inform your doctor or pharmacist.
If you take more Ebastina Alter than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20 (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 more easily identify the medicine you have taken.
Treatment of poisoning with this medicine consists of gastric lavage and administration of appropriate medication.
If you forget to take Ebastina Alter
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, skip the missed dose and take the next one at the scheduled time.
If you stop taking Ebastina Alter
Your doctor will advise you on the duration of your treatment with ebastine. Do not stop treatment early, as your symptoms may worsen.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, ebastine may 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, loss or alteration of taste
- Palpitations, tachycardia
- Abdominal pain, vomiting, nausea, digestive disorders
- Liver inflammation (hepatitis), cholestasis, abnormal liver function tests (elevated 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 Ebastine Alter
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use ebastine after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Ebastine Alter 10 mg film-coated tablets
- The active substance is ebastine. Each tablet contains 10 mg of ebastine.
- The other components (excipients) are: Monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, povidone 30, polysorbate 80, magnesium stearate, hypromellose, titanium dioxide (-171) and glyceryl triacetate.
Appearance of the product and contents of the pack
Ebastine Alter is presented as white, film-coated tablets for oral administration. Each PVC/aluminum blister pack contains 20 tablets of 10 mg.
Other presentations
Ebastine Alter 20 mg film-coated tablets EFG
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorios Alter, S.A.
C/Mateo Inurria, 30
28036, Madrid
Spain
Manufacturers
Laboratorios Alter, S.A.
C/Mateo Inurria, 30
28036, Madrid
Spain
or
Laboratorios Alter, S.A.
C/ Zeus, 6 Polígono Industrial R2
28880, Meco (Madrid)
Spain
Date of the most recent revision of this leaflet: November 2024
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/