EBASTINE TEVA-RATIOPHARM 20 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the Patient

Ebastine Teva-ratiopharm 10 mg Oral Dispersible Tablets EFG

Ebastine Teva-ratiopharm 20 mg Oral Dispersible Tablets EFG

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

Keep this package leaflet, as you may need to read it again.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms of illness as you, as it may harm them.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Ebastine Teva-ratiopharm and what is it used for?
2. What you need to know before taking Ebastine Teva-ratiopharm?
3. How to take Ebastine Teva-ratiopharm?
4. Possible side effects?
5. Storage of Ebastine Teva-ratiopharm?
6. Contents of the pack and further information.

1. What is Ebastine Teva-ratiopharm and what is it used for?

Ebastine is an antihistamine that helps relieve allergy symptoms such as sneezing, runny nose, itchy eyes, and itchy skin rashes.

In adults and children 12 years and older, Ebastine Teva-ratiopharm is used to relieve symptoms of seasonal allergic rhinitis (hay fever) and perennial allergic rhinitis, including cases with allergic conjunctivitis.

In adults over 18 years, Ebastine Teva-ratiopharm 10 mg is also used to relieve itching and the development of hives, urticaria (hives).

2. What you need to know before taking Ebastine Teva-ratiopharm

Do not take Ebastine Teva-ratiopharm:

• If you are allergic (hypersensitive) to ebastine or any of the other ingredients of Ebastine Teva-ratiopharm (listed in section 6).

Warnings and precautions

Consult your doctor before starting to take Ebastine Teva-ratiopharm if:

• you have low potassium levels in your blood.
• you have an abnormal heart rhythm (known as QTc interval prolongation in the ECG), which can occur in some types of heart disease.

If you are already taking certain antibiotics or medications used to treat fungal infections: see the section "Ebastine Teva-ratiopharm with other medications" below.

• If you have severe liver function impairment (liver failure).
• Ebastine may cause dry mouth. Therefore, during prolonged treatment with ebastine, it is essential to maintain good oral hygiene (brush your teeth twice a day) to reduce the risk of caries.

Children and adolescents

This medication should only be used by children 12 years and older. Do not give this medication to children under 12 years, as safety and efficacy have not been established in this age group.

Taking Ebastine Teva-ratiopharm with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medication.

Ebastine Teva-ratiopharm may affect or be affected by other medications that contain the following active ingredients:

• ketoconazole, itraconazole (active ingredients for the treatment of fungal infections).
• erythromycin (antibiotic).
• rifampicin (medication used to treat tuberculosis).

Taking Ebastine Teva-ratiopharm with food and drinks

The tablets can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Experience with the use of ebastine in pregnant women is limited, so it is recommended to consult a doctor before taking Ebastine Teva-ratiopharm.

It is unknown whether ebastine is excreted in breast milk. Ebastine Teva-ratiopharm is contraindicated during breastfeeding.

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

Driving and using machines

Most patients treated with Ebastine Teva-ratiopharm can drive or perform other activities that require good reaction ability. However, as with all other medications, you should check your individual reaction after taking Ebastine Teva-ratiopharm before driving or performing complex activities, as some patients experience drowsiness or dizziness.

Ebastine Teva-ratiopharm contains aspartame

Ebastine Teva-ratiopharm 10 mg contains 2.5 mg of aspartame in each tablet. Ebastine Teva-ratiopharm 20 mg contains 5 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine, which may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body cannot eliminate it properly.

Ebastine Teva-ratiopharm contains lactose

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

Ebastine Teva-ratiopharm contains sodium

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

3. How to take Ebastine Teva-ratiopharm

Follow the administration instructions of ebastine indicated by your doctor or pharmacist exactly. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

In patients with renal insufficiency, no dose adjustment is necessary.

In patients with mild to moderate liver insufficiency, no dose adjustment is necessary.

There is no experience with doses greater than 10 mg in patients with severe liver insufficiency; therefore, the dose should not exceed 10 mg in these patients.

Do not push the tablet out of the blister, as this will crush it.

Each strip contains separate tablets separated by perforations in blisters. Separate one blister with its tablet along the dotted line (Figure 1)

Carefully remove the peel-off foil from the edge indicated by the arrow (Figures 2 and 3)

Keep your hands dry and take the tablet from the strip.

Place the tablet on the tongue where it will disperse: no water or other liquid is needed.

You can take ebastine independently of meals.

Your doctor will decide the duration of treatment.

If you take more Ebastine Teva-ratiopharm than you should

There is no specific antidote for the active ingredient ebastine.

If you suspect an overdose with ebastine, inform your doctor. Depending on the severity of the poisoning, he/she will initiate the necessary measures (control of the body's vital functions, including ECG monitoring for at least 48 hours, symptomatic treatment, and gastric lavage), if necessary.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Phone 915 620 420 indicating the name of the medication and the amount ingested.

If you forget to take Ebastine Teva-ratiopharm

Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medications, this medication can have side effects, although not everyone gets them.

Stop taking Ebastine Teva-ratiopharm and contact your doctor immediately or go to the nearest hospital if the following occurs:

• Itching, hives, and swelling of the face, tongue, or throat that can cause difficulty swallowing or breathing. These can be signs of a hypersensitivity reaction such as anaphylaxis and angioedema, which are rare side effects (may affect up to 1 in 1,000 people).

Other side effects

Very common side effectsmay affect more than 1 in 10 people

• Headache.

Common side effectsmay affect up to 1 in 10 people

• Drowsiness.
• Dry mouth.

Uncommon side effectsmay affect up to 1 in 100 people

• Nosebleeds.
• Sore throat (pharyngitis).
• Nasal discharge (rhinitis).

Rare side effectsmay affect up to 1 in 1,000 people

• Nervousness.
• Insomnia.
• Drowsiness.
• Dizziness.
• Abnormal or decreased sense of touch.
• Abnormal sense of taste.
• Palpitations (rapid or irregular heartbeat).
• Fast heartbeat.
• Abdominal pain.
• Vomiting.
• Nausea.
• Indigestion.
• Hepatitis (liver inflammation).
• Cholestasis (altered bile flow).
• Abnormal liver function tests.
• Rash, hives, widespread diffuse urticaria.
• Menstrual cramps.
• Edema (fluid accumulation in tissues).
• Weakness (asthenia).

Very rare side effectsmay affect up to 1 in 10,000 people

• Dysesthesia (abnormal sensitivity).
• Eczema, skin inflammation.
• Menstrual cramps.

Frequency not knowncannot be estimated from the available data

• Weight gain.
• Increased appetite.

Reporting side effects

If you experience any side effects, consult your doctor, even if they are side effects not listed in this package leaflet. You can also report them through the Spanish Medicines Monitoring System Website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ebastine Teva-ratiopharm

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.
• Store in the original packaging to protect it from light.
• Medications should not be disposed of via wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Ebastine Teva-ratiopharm

• The active ingredient is ebastine. Each oral dispersible tablet contains 10 mg of ebastine. Each oral dispersible tablet contains 20 mg of ebastine.
• The other ingredients (excipients) are microcrystalline cellulose, lactose monohydrate, cornstarch, sodium croscarmellose, aspartame (E951), peppermint flavor, colloidal anhydrous silica, and magnesium stearate.

Appearance of the product and contents of the pack

• Oral dispersible tablets.
• Ebastine Teva-ratiopharm 10 mg: white, biconvex, round tablets, engraved with "E10" on one side and flat on the other.

Ebastine Teva-ratiopharm 20 mg: white, biconvex, round tablets, engraved with "E20" on one side and flat on the other.

• Available pack sizes:

10 mg: 10, 20, 30, 40, 50, 90, 98, and 100 oral dispersible tablets.

20 mg: 10, 15, 20, 30, 40, 50, 98, and 100 oral dispersible tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta, Alcobendas.

28108 Madrid.

Manufacturer:

Teva Pharma, S.L.U.

C/ C, n 4 Polígono Industrial Malpica.

Zaragoza 50016.

Spain.

or

Teva Pharmaceutical Works Private Limited Company.

Pallagi út 13, 4042 Debrecen.

Hungary.

or

Teva Czech Industries S.R.O.

Ostravska 29, c.p. 305, - Opava-Komarov - 747 70.

Czech Republic.

or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem.

Netherlands.

Date of the last revision of this package leaflet:September 2024.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

You can access detailed and updated information about this medication by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74991/P_74991.html.