Ebastine Alprofarma 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ebastine Alprofarma 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 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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 adverse 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 called antihistamines (antiallergic agents).

Ebastina Alprofarma 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 to take Ebastina Alprofarma

Do not take Ebastina 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 Ebastina 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 the blood.
• if you suffer from severe liver disease (see section “How to take Ebastina 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 Ebastina Alprofarma with other medicines”).
• if you are being treated with rifampicin, a type of medicine used to treat tuberculosis.

Do not use this medicine in case of an acute, urgent allergic reaction, as ebastine (the active substance in this medicine) takes 1 to 3 hours to take effect.

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

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

Ebastina Alprofarma may interfere with the results of skin allergy tests; therefore, it is recommended not to perform such tests until 5–7 days after stopping treatment.

Taking Ebastina 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, so it is recommended to consult a doctor before taking Ebastina Alprofarma. 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 use of 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.

Ebastina Alprofarma contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult 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 Ebastine Alprofarma

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

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 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 must not exceed 10 mg of ebastine per day. In this case, it is recommended to use the 10 mg formulation (Ebastine Alprofarma 10 mg Film-coated Tablets EFG).

Method of administration

This medicine is for oral use.

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

If you think 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, contact your doctor or pharmacist immediately, call the Toxicology Information Service at 91 562 04 20 (indicating the medicine and the amount ingested), or go to the nearest hospital. Bring any remaining tablets, the outer 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 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 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, Ebastina Alprofarma 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 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 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 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 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 containers at the SIGRE collection 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 Ebastine Alprofarma

• 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 6,000 and titanium dioxide (E-171).

Appearance of the product and contents of the container

Ebastine Alprofarma is presented as film-coated tablets for oral administration, packed in PVC/aluminum blisters. The tablets are circular, white in colour, with one face marked with "E20".

Each pack contains 20 film-coated tablets.

Other presentations

Ebastine Alprofarma 10 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 review 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 Medical Devices (AEMPS) http://www.aemps.gob.es/