EBASTINE STADA 10 MG FILM-COATED TABLETS EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ebastina STADA 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; 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 harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Ebastina STADA 10 mg tablets are and what they are used for

2. What you need to know before taking Ebastina STADA 10 mg tablets

3. How to take Ebastina STADA 10 mg tablets

4. Possible side effects

5. How to store Ebastina STADA 10 mg tablets

6. Contents of the pack and other information

1. What Ebastina Stada 10 mg tablets are and what they are used for

Ebastine, the active component of Ebastina Stada 10 mg, belongs to a group of medicines known as antihistamines (antiallergic agents).

Ebastina Stada 10 mg is indicated for the treatment of allergic conditions such as seasonal or perennial allergic rhinitis associated or not with allergic conjunctivitis (such as runny nose, nasal itching, eye itching, tearing, sneezing), chronic urticaria, and allergic dermatitis.

2. What you need to know before taking Ebastina Stada 10 mg tablets

Do not take Ebastina Stada 10 mg:

• if you are allergic to the active substance 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 Ebastina Stada.

This medicine should be used with caution:

• if your electrocardiogram (ECG) results are abnormal (prolongation of the QT interval).
• if you have high levels of potassium in your blood.
• if you suffer from severe liver disease (see section “How to take Ebastina Stada”).
• 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 “Other medicines and Ebastina Stada 10 mg”).
• 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 ingredient in this medicine) takes 1 to 3 hours to take effect.

Children

Ebastina Stada must not be given to children under 12 years of age.

Other medicines and Ebastina Stada 10 mg

Tell 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 increase 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 an antibiotic used to treat certain infections called erythromycin (as they may cause changes in your ECG).
• 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, or alcohol.

Interference with diagnostic tests

Ebastina Stada may interfere with the results of skin allergy tests; therefore, such tests should not be performed until 5–7 days after stopping treatment.

Taking Ebastina Stada 10 mg 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 Ebastina Stada. 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

At the recommended therapeutic doses, no effects on psychomotor function or on the ability to drive or operate machinery have been observed in humans. However, since somnolence and dizziness are listed among the adverse effects, you should assess your response to the medication before driving or operating machinery.

Important information about some of the ingredients of Ebastina Stada

This medicine does not contain gluten.

Ebastina Stada contains sodium

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

3. How to take Ebastine Stada 10 mg tablets

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the duration of your treatment with Ebastine Stada 10 mg. Do not stop the treatment prematurely, as your symptoms may worsen.

Remember to take your medicine.

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 children between 6 and 11 years of age: The recommended dose is half a tablet (5 mg) 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 should be swallowed whole, without chewing, with a glass of liquid, preferably water.

If you think that the effect of Ebastine Stada 10 mg is too strong or too weak, inform your doctor or pharmacist.

If you take more Ebastine Stada 10 mg than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount taken.

Treatment of poisoning with this medicine consists of gastric lavage and administration of appropriate medication. Take this leaflet with you.

If you forget to take Ebastine Stada 10 mg

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, this medicine 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 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 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 Stada 10 mg Tablets

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

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 should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. 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 Ebastina Stada 10 mg

• The active substance is ebastine. Each tablet contains 10 mg of ebastine.

• The other components are microcrystalline cellulose, stearoyl macroglycolide glycerides, sodium starch glycolate (potato starch) gluten-free, magnesium stearate, purified water, Opadry white.

Appearance of the product and contents of the pack

Ebastina Stada 10 mg tablets are oblong, biconvex, white tablets with a score line. The tablet can be divided into equal halves.

Packs contain 20 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona), Spain

[email protected]

Manufacturer:

Generis Farmacêutica S.A.

Rua João de Deus nº 19, Venda Nova

2700-487 Amadora

Portugal

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 for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/