Ebastine Teva 10 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the patient
Ebastine Teva 10 mg film-coated tablets EFG
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 you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if these are effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Ebastine Teva is and what it is used for
- What you need to know before taking Ebastine Teva
- How to take Ebastine Teva
- Possible side effects
- How to store Ebastine Teva
- Contents of the pack and other information
1. What Ebastina Teva is and what it is used for
Ebastine belongs to a group of medicines known as antihistamines (antiallergic agents).
Ebastine is indicated for the symptomatic treatment of 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 Ebastine Teva
Do not take Ebastine Teva
- 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 ebastine:
This medicine should be used with caution:
- if your electrocardiogram (ECG) results are abnormal (QT interval prolongation),
- if you have high levels of potassium in your blood,
- if you suffer from severe liver disease (see section “How to take Ebastine Teva”),
- 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 Teva 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
Ebastine must not be given to children under 12 years of age.
Other medicines and Ebastine Teva
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 adjust the dose or discontinue treatment with one of them:
- ebastine may enhance the effect of other medicines used to treat allergies (antihistamines),
- ebastine should be used with caution in patients taking medicines called ketoconazole and itraconazole, used to treat fungal infections, or with a macrolide antibiotic called erythromycin used to treat certain infections (as they may cause changes in your electrocardiogram),
- the antihistamine effect of ebastine may be reduced in patients being treated with 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
Ebastine may interfere with the results of skin allergy tests; therefore, it is recommended not to perform such tests until 5 to 7 days after stopping treatment.
Taking Ebastine Teva with food and drink
This medicine may 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. 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 humans, no effects on psychomotor function or on the ability to drive or use machines have been observed at the recommended therapeutic doses. However, since somnolence and dizziness are among the possible adverse effects, you should assess your response to the medication before driving or using machines.
Ebastine Teva contains lactose
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Ebastine Teva
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.
Remember to take your medicine.
Your doctor will advise you on the duration of your treatment with ebastine.
Ebastine is not suitable for administration at doses lower than 10 mg, nor for patients who have difficulty swallowing.
Dosage
Use in adults and adolescents over 12 years of age:
The recommended dose is 1 tablet (10 mg of ebastine) once daily, although some patients may require a dose of 20 mg once daily.
Use in patients with severe liver disease:
The dose must not exceed 10 mg of ebastine per day (1 tablet).
Method of administration
This medicine is for oral use.
The tablets may be taken with or without food, taken with a glass of water.
If you think that the effect of ebastine is too strong or too weak, inform your doctor or pharmacist.
If you take more Ebastine Teva than you should
In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone: 91 562 04 20, stating the name of the medicine and the amount ingested. Bring any remaining tablets, the carton, and the complete packaging so that healthcare personnel 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 Ebastine Teva
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 dosing schedule. However, if it is almost time for your next dose, skip the missed dose and take the next dose at the scheduled time.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can 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 to 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 or pharmacist, 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Ebastine Teva
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at 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 Ebastine Teva
- The active substance is ebastine. Each tablet contains 10 mg of ebastine.
- The other components (excipients) are:
Core: monohydrate lactose, microcrystalline cellulose, pregelatinized starch (from maize), povidone 30, polysorbate 80, magnesium stearate.
Coating: hypromellose, titanium dioxide (E171), glyceryl triacetate.
Appearance of the product and contents of the pack
Ebastine Teva is presented as white, film-coated, lens-shaped tablets.
Each PVC/aluminum blister pack contains 20 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Pharma, S.L.U.
Anabel Segura, 11, Edificio Albatros B, 1st Floor
Alcobendas, 28108 Madrid
Spain
Manufacturer
Laboratorios ALTER, S.A.
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 package leaflet: March 2022
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
You can access detailed information about this medicine by scanning the QR code included in the packaging using your mobile phone (smartphone). You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/67810/P_67810.html