Patient Information Leaflet

Ebastina Alter 10 mg Film-Coated Tablets

ebastina

Read 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. Do not give it to others, even if they have the same symptoms of illness as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Ebastina belongs to a group of medications known as antihistamines (antiallergics).

Ebastina is indicated for the treatment of symptoms of allergic processes such as:

• seasonal or perennial allergic rhinitis associated or not with allergic conjunctivitis (such as runny nose, nasal itching, eye itching, tearing, urge to sneeze)
• chronic urticaria
• allergic dermatitis

Do not take Ebastina Alter

• if you are allergic to the active ingredient of this medication or to any of the other components of this medication (listed in section 6)

Warnings and precautions

Consult your doctor or pharmacist before starting to take ebastina.

This medication should be used with caution:

• if your electrocardiogram results are altered (prolongation of the QT interval).
• if you have altered potassium levels in your blood.
• if you suffer from severe liver disease (see section “How to take Ebastina Alter”).

if you are being treated with a type of medication used to treat fungal infections called azole antifungals or with medications used to treat certain infections called macrolide antibiotics (see section “Taking ebastina with other medications”).

• if you are being treated with rifampicin, a type of medication used to treat tuberculosis.

Do not use this medication if you have an acute allergic emergency, as ebastina (active ingredient of this medication) takes 1 to 3 hours to take effect.

Children

Ebastina 10 mg Tablets should not be administered to children under 12 years old.

Other medications and Ebastina Alter

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication.

The following medications may interact with ebastina; in these cases, it may be necessary to change the dose or discontinue treatment with one of them:

??Ebastina may increase the effect of other medications used to treat allergies (antihistamines).

• Ebastina should be used with caution in patients being treated with medications called ketoconazole and itraconazole, used to treat fungal infections, or with an antibiotic used to treat certain infections called erythromycin (as they may cause an alteration in your electrocardiogram).
• The antihistamine effect of ebastina may be reduced in patients being treated with a medication called rifampicin used to treat tuberculosis.

No interactions have been described between ebastina and theophylline, warfarin, cimetidine, diazepam, and alcohol.

Interference with diagnostic tests

Ebastina may interfere with the results of skin allergy tests, so it is recommended not to perform them until 5-7 days after discontinuing treatment.

Ebastina Alter with food and drinks

The tablets can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

There is no experience in pregnant women, so it is recommended to consult a doctor before taking Ebastina Alter. This will decide whether or not to start treatment.

Breastfeeding

It is unknown whether the medication passes into breast milk, so it should not be used during breastfeeding.

Driving and operating machinery

In men, no effects have been observed on psychomotor function, or on the ability to drive or operate machinery at the recommended therapeutic doses. However, given that drowsiness and dizziness are among the adverse effects, observe your response to the medication before driving or operating machinery.

Ebastina Alter contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will inform you of the duration of your ebastina treatment.

Ebastina 10 mg Film-Coated Tablets are not suitable for administration of doses lower than 10 mg of ebastina, nor for patients with swallowing difficulties.

Dosage:

Use in adults and children over 12 years:The recommended dose is 1 tablet (10 mg of ebastina) once a day.

Use in patients with severe liver disease:Do not exceed a dose of 10 mg of ebastina per day (1 tablet).

Administration Form:

This medication is for oral administration.

The tablets can be taken with or without food, with the help of a glass of water.

If you estimate that the action of ebastina is too strong or too weak, inform your doctor or pharmacist.

If you take more Ebastina Alter than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, (indicating the medication and the amount ingested) or go to the nearest hospital. Bring the remaining tablets, the packaging, and the complete box so that the healthcare staff can identify the medication taken more easily.

The treatment of intoxication by this medication consists of gastric lavage and administration of the appropriate medication.

If you forgot to take Ebastina Alter

Do not take a double dose to compensate for the missed doses. Take the missed dose as soon as you remember and then continue with your regular schedule. However, if there are only a few hours left before the next dose, do not take the missed dose and wait for the next dose at the scheduled time.

If you interrupt treatment with Ebastina Alter

Your doctor will inform you of the duration of your ebastina treatment. Do not discontinue treatment prematurely, as your symptoms may worsen.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, ebastina can produce adverse effects, although not all people may experience them.

In clinical trials and post-marketing experience, the following adverse effects have been observed:

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):

-Allergic reactions: hypersensitivity 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

-Inflammation of the liver (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

Unknown frequency(cannot be estimated from available data):

- Weight gain

- Increased appetite

Reporting 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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use ebastina after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Ebastina Alter 10 mg Tablet Composition

• The active ingredient is ebastina. Each tablet contains 10 mg of ebastina.
• The other components (excipients) are: Lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, povidone 30, polisorbate 80, magnesium stearate, hypromellose, titanium dioxide (-171), and triacetin.

Product appearance and packaging content

Ebastina Alter is presented in the form of coated tablets with a white film coating for oral administration. Each PVC/Aluminum blister pack contains 20 tablets of 10 mg.

Other presentations

Ebastina Alter 20 mg coated tablets

Marketing authorization holder and manufacturer

Laboratorios ALTER, S.A.

Mateo Inurria, 30

28036 Madrid (Spain)

Last review date of this leaflet:November 2024

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/