EBASTEL FORTE 20 MG FILM-COATED TABLETS

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ebastel Forte 20 mg film-coated tablets

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 you must not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet.

Contents of the leaflet:

1. What Ebastel Forte is and what it is used for
2. What you need to know before taking Ebastel Forte
3. How to take Ebastel Forte
4. Possible adverse effects
5. How to store Ebastel Forte
6. Contents of the pack and other information

1. What Ebastel Forte is and what it is used for

Ebastel Forte belongs to a group of medicines called antihistamines (antiallergic agents).

Ebastel Forte is indicated for the treatment of symptoms of 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 Ebastel Forte

Do not take Ebastel Forte

• 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 Forte.

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 Forte”).
• 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 Forte 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

Ebastel Forte must not be administered to children under 12 years of age. In this patient group, Ebastel 1 mg/ml Oral Solution is recommended.

Other medicines and Ebastel Forte

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 Forte; in such cases, it may be necessary to adjust the dose or discontinue treatment with one of them:

• Ebastel Forte may increase the effect of other medicines used to treat allergy (antihistamines).
• Ebastel Forte 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 abnormalities in your electrocardiogram).
• The antihistaminic effect of Ebastel Forte 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 Forte may interfere with the results of skin allergy tests; therefore, it is recommended not to perform these tests until 5–7 days after discontinuation of treatment.

Taking Ebastel Forte with food and drink

The tablets 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 Ebastel Forte. 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 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.

Ebastel Forte 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.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; thus, it is essentially “sodium-free”.

3. How to take Ebastel Forte

Follow exactly the instructions for use provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will determine the duration of your treatment with Ebastel Forte.

Dosage

Use in adults and children over 12 years of age: The usual 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, it is recommended to use the 10 mg formulation (Ebastel 10 mg Film-coated Tablets).

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 feel that the effect of Ebastel Forte is too strong or too weak, inform your doctor or pharmacist.

If you take more Ebastel Forte than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, call the Toxicology Information Service at telephone 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 personnel can 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 Ebastel Forte

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, do not take the missed dose; wait 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, Ebastel Forte 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):

• Drowsiness
• 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 (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 Ebastel Forte

Keep this medicine out of 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 unused medicines and their packaging at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ebastel Forte

• The active substance is ebastine. Each tablet contains 20 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 contents of the pack

Ebastel Forte 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 "E20".

Each pack contains 20 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 review of this leaflet: May 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/