Package Insert: Information for the Patient

Ebastina Alprofarma 10 mg

Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6.Contents of the Package and Additional Information

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

Ebastina Alprofarma 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 nasal discharge, nasal itching, eye itching, tearing, urge to sneeze), chronic urticaria and allergic dermatitis.

Do not take Ebastina Alprofarma

• if you are allergic to ebastina or 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 Alprofarma.

This medication should be used with caution:

• if your electrocardiogram results are altered (prolongation of the QT interval).
• if you have high levels of potassium in your blood.
• if you have severe liver disease (see “How to take Ebastina Alprofarma”).
• if you are being treated with a type of antifungal medication called azoles or with a type of antibiotic called macrolides (see “Taking Ebastina Alprofarma 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 are experiencing an acute allergic emergency, as ebastina (active ingredient of this medication) takes 1 to 3 hours to take effect.

Taking Ebastina Alprofarma with other medications

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

The medications listed below may interact with Ebastina Alprofarma; in these cases, it may be necessary to adjust the dose or discontinue treatment with one of them:

• Ebastina Alprofarma may increase the effect of other medications used to treat allergies (antihistamines).
• Ebastina Alprofarma should be used with caution in patients being treated with medications called ketoconazole and itraconazole, used to treat fungal infections, or with an antibiotic called erythromycin (as they may cause an alteration in your electrocardiogram).
• The antihistamine effect of Ebastina Alprofarma 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 Alprofarma may interfere with the results of skin allergy tests, so it is recommended not to perform them until 5-7 days after discontinuing treatment.

Taking Ebastina Alprofarmawith food and beverages

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 Alprofarma. They will decide whether to start treatment or not.

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 on psychomotor function, or on the ability to drive or operate machinery, have been observed at the recommended therapeutic doses.However, given that drowsiness and dizziness are among the adverse effects, observeyour response to the medication before driving or operating machinery.

Ebastina Alprofarma contains lactose

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

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

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

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Ebastina Alprofarma. Do not suspend treatment beforehand, as your symptoms may worsen.

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 isfor oral administration.

The tabletscan be taken with or without foodand should be swallowed whole, without chewing, with the help of a liquid container, preferably water.

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

If you take more Ebastina Alprofarma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately,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 healthcare personnel can identify the medication you have 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 Alprofarma

Do not take a double dose to compensate for the missed doses. Take the missed dose when you remember andthen 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 have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Ebastina Alprofarma may 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 frequent (may affect more than 1 in 10 people):

• Headache

Frequent (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
• 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 for Pharmacovigilance of Medicinal Products 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.

Do not store at a temperature above30°C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need.This way, you will help protect the environment.

Composition of Ebastina Alprofarma

• The active ingredient is ebastina. Each tablet contains 10 mg of ebastina.
• The other components (excipients) are: Nucleus of the tablet: microcrystalline cellulose (E-460i), pregelatinized cornstarch, 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 content of the packaging

Ebastina Alprofarma is presented in the form of coated tablets with a film for oral administration, packaged in PVC/Aluminum blisters. The tablets are circular, white in color, and have a face marked with E10.

Each package contains 20 coated tablets.

Other presentations

Ebastina Alprofarma 20 mg Coated tablets EFG

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Almirall, S.L.

General Mitre, 151

08022 Barcelona (Spain)

Responsible for manufacturing

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca - Barcelona (Spain)

Date of the last review of this prospectus: February 2022

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