Ebastine Alprofarma 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ebastine Alprofarma 10 mg

Film-coated tablets EFG

Read all of this 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 could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Ebastine Alprofarma is and what it is used for

2. What you need to know before taking Ebastine Alprofarma

3. How to take Ebastine Alprofarma

4. Possible side effects

5. How to store Ebastine Alprofarma

6. Contents of the pack and other information

1. What Ebastina Alprofarma is and what it is used for

Ebastina Alprofarma belongs to a group of medicines known as antihistamines (antiallergic agents).

Ebastina Alprofarma 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, and sneezing), chronic urticaria, and allergic dermatitis.

2. What you need to know before starting Ebastine Alprofarma

Do not take Ebastine Alprofarma

• 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 Alprofarma.

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 Ebastine Alprofarma”).
• 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 Alprofarma with other medicines”).
• if you are being treated with rifampicin, a type of medicine used to treat tuberculosis.

Do not use this medicine if you have an acute allergic emergency, since ebastine (the active substance in this medicine) takes 1 to 3 hours to take effect.

Taking Ebastine Alprofarma with other medicines

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

• Ebastine Alprofarma may increase the effect of other medicines used to treat allergies (antihistamines).
• Ebastine Alprofarma 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 antihistaminic effect of Ebastine Alprofarma 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

Ebastine Alprofarma may interfere with skin allergy test results; therefore, such tests should not be performed until 5–7 days after stopping treatment.

Taking Ebastine Alprofarma with food and drink

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 Alprofarma. Your doctor will decide whether or not treatment should be started.

Breastfeeding

It is unknown whether this 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 drowsiness and dizziness are listed among the adverse effects, you should assess your response to the medication before driving or operating machinery.

Ebastine Alprofarma contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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

3. How to take Ebastine Alprofarma

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 determine the duration of your treatment with Ebastine Alprofarma. Do not stop treatment early, as your symptoms may worsen.

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 may be taken with or without food and should be swallowed whole, without chewing, with a glass of liquid, preferably water.

If you feel that the effect of Ebastine Alprofarma is too strong or too weak, inform your doctor or pharmacist.

If you take more Ebastine Alprofarma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, call the Toxicology Information Service at telephone number 91 562 04 20 (indicating the medicine and 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 Ebastine Alprofarma

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 your 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, Ebastine Alprofarma may produce 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 of 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, 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 System for Pharmacovigilance of 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 Alprofarma

Keep this medicine out of the 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 is 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. If you are in doubt, 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 Alprofarma

• The active substance is ebastine. Each tablet contains 10 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

Ebastine Alprofarma is presented as film-coated tablets for oral administration, packaged in PVC/aluminum blisters. The tablets are circular, white in colour, and marked with "E10" on one side.

Each pack contains 20 film-coated tablets.

Other presentations

Ebastine Alprofarma 20 mg Film-coated tablets EFG

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Almirall, S.L.

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 revision of this leaflet: February 2022

Detailed and up-to-date 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/