Ebastine Teva 20 mg film-coated tablets EFG
Spain
Table of Contents
Package Leaflet: Information for the User
Introduction
Package Leaflet: Information for the Patient
Ebastine Teva 20 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, because it may harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions 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 adverse effects
- How to store Ebastine Teva
- Contents of the pack and other information
1. What Ebastine Teva is and what it is used for
Ebastine belongs to a group of medicines called 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 taking 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
Talk to your doctor or pharmacist before taking ebastine:
This medicine should be used with caution:
- if your electrocardiogram (ECG) results are abnormal (prolonged QT interval),
- if you have high blood potassium levels,
- if you have 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 allergic emergency, 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. In this patient group, ebastine 1 mg/ml oral solution is recommended.
Other medicines and Ebastine Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
The following medicines may interfere with ebastine; in such cases it may be necessary to adjust the dose or discontinue treatment with one of them:
- ebastine may increase the effect of other medicines used to treat allergies (antihistamines),
- ebastine should be used with caution in patients being treated with 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 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, such tests should not be performed until 5 to 7 days after stopping treatment.
Taking Ebastine Teva with food and drinks
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 to start treatment.
Breastfeeding
It is unknown whether this 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 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.
Ebastine Teva contains lactose
This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Ebastine Teva
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Remember to take your medicine.
Your doctor will determine the duration of your treatment with ebastine.
Dosage
Use in adults and adolescents over 12 years of age:
The recommended dose is 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 should not exceed 10 mg of ebastine per day. In this case, the 10 mg formulation (ebastine 10 mg tablets) is recommended.
Method of administration
This medicine is for oral use.
The tablets can 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: 91 562 04 20, indicating the medicine and the amount ingested. Bring any remaining tablets, the carton, and the full pack 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 schedule. However, if it is almost time for the next dose, do not take the missed dose and wait to 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 may produce 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 to 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 or pharmacist, 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 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 pack after EXP. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, 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 Teva
- The active substance is ebastine. Each tablet contains 20 mg of ebastine.
- The other components (excipients) are:
Core: monohydrate lactose, microcrystalline cellulose, pregelatinized starch (from corn), 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, biconvex 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 review of this leaflet: March 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/
You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/67811/P_67811.html