Summary of Product Characteristics: Information for the Patient

Ebastina Teva-ratiopharm 10 mg Buccodispersible Tablets EFG

Ebastina Teva-ratiopharm 20 mg Buccodispersible Tablets EFG

Read this summary of product characteristics carefully before you start taking this medicine, as

it contains important information for you.

- Keep this summary of product characteristics, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medicine has been prescribed for you only and should not be given to other people,

even if they have the same symptoms of disease 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 summary of product characteristics. See section 4

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

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

3. How to take Ebastina Teva-ratiopharm

4. Possible side effects

5. Storage of Ebastina Teva-ratiopharm

6. Contents of the pack and additional information.

Ebastina is an antihistamine that helps to relieve allergy symptoms such as sneezing,

nasal discharge, itchy eyes, and skin rashes with itching.

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

For adults 18 years of age or older, Ebastina Teva-ratiopharm 10 mg is also used to relieve itching and the development of rashes, urticaria (hives).

Do not take Ebastina Teva:

- If you are allergic (hypersensitive) to ebastina or to any of the other components of Ebastina Teva (listed in section 6)

Warnings and precautions

Consult your doctor before starting to take Ebastina Teva if:

- You have low levels of potassium in your blood

- You have an abnormal heart rhythm pattern (known as QTc prolongation in the ECG), which can occur in some types of heart disease

- You are already taking certain antibiotics or medications used to treat fungal infections: see the section “Ebastina Teva with other medicines” below

- You have severe liver function impairment (liver insufficiency)

• Ebastina may cause dry mouth. Therefore, in a prolonged treatment with ebastina, it is essential to maintain good oral hygiene (you should brush your teeth twice a day) to reduce the risk of tooth decay.

Children and adolescents

This medicine should only be used by children aged 12 years or older. Do not administer this medicine to children under 12 years of age as its safety and efficacy have not been established in this age group.

Taking Ebastina Teva with other medicines

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

Ebastina Teva may affect or be affected by other medicines containing the following active ingredients:

- Ketoconazole, itraconazole (active ingredients for the treatment of fungal infections)

- Erythromycin (antibiotic)

- Rifampicin (medication used to treat tuberculosis)

Taking Ebastina Teva with food and drinks

The tablets can be taken with or without food.

Pregnancy, breastfeeding, and fertility

The experience with the use of ebastina in pregnant women is limited, so it is recommended to consult a doctor before taking Ebastina Teva.

The excretion of ebastina in breast milk is unknown. Ebastina Teva is contraindicated during breastfeeding

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

Driving and operating machinery

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

Ebastina Teva contains aspartame

Ebastina Teva 10 mg contains 2.5 mg of aspartame in each tablet. Ebastina Teva 20 mg contains 5 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Ebastina Teva contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

Ebastina Teva contains sodium

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

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

The recommended dose is:

No dose adjustment is necessary in patients with renal insufficiency.

No dose adjustment is necessary in patients with mild to moderate hepatic insufficiency.

No experience with doses greater than 10 mg in patients with severe hepatic 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 tablets separated by perforations in blisters. Separate one blister with your tablet by the dotted line (Figure 1)

With care, remove the backing paper, starting from the corner 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 ebastina regardless of meals.

Your doctor will decide the duration of treatment.

If you take more Ebastina Teva than you should

There is no specific antidote for the active ingredient ebastina.

If you suspect an overdose with ebastina, inform your doctor. Depending on the severity of the poisoning, he/she will initiate the necessary measures (monitoring of vital functions of the body, 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 Toxicological Information Service. Telephone 915 620 420 indicating the name of the medication and the amount ingested.

If you forgot to take Ebastina Teva

Do not take a double dose to compensate for the missed doses.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

• Itching, hives, and swelling of the face, tongue, or throat that may cause difficulty swallowing or breathing. This may be a sign of an allergic 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

• Nasal bleeding.
• Sore throat (pharyngitis),
• Nasal discharge (rhinitis),

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

• Nervousness.
• Insomnia.
• Drowsiness.
• Dizziness.
• Alterations or decrease in sense of touch.
• Alteration of sense of taste.
• Palpitations (rapid heartbeat, irregular heartbeat).
• Fast pulse.
• Abdominal pain.
• Vomiting.
• Nausea.
• Indigestion.
• Hepatitis (inflammation of the liver).
• Biliary dyskinesia (altered bile flow).
• Abnormal liver function test.
• Rash, hives, widespread diffuse urticaria.
• M menstrual cramps.
• Edema (accumulation of fluid in tissues).
• Weakness (asthenia).

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

• Hyperesthesia (abnormal sensitivity).
• Eczema, skin inflammation.
• M menstrual cramps.

Unknown frequencycannot be estimated from available data

-Weight gain,

-Increased appetite.

Reporting of side effects

If you experience any type of side effect, consult your doctor, even if it is a side effect that does not appear in this leaflet. You can also report them through the Spanish System for Pharmacovigilance of Medicines for Human Use Website:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• 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.
• Store in the original packaging to protect it from light.
• Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at your local SIGRE collection point.Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Ebastina Teva-ratiopharm Composition

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

Appearance of the product and contents of the package

• Buccal dispersible tablets.
• Ebastina Teva-ratiopharm 10 mg: white, biconvex, round tablets, engraved with “E10” on one face and flat on the other.

Ebastina Teva-ratiopharm 20 mg: white, biconvex, round tablets, engraved with “E20” on one face and flat on the other.

• Available package sizes:

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

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

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor, Alcobendas

28108 Madrid

Responsible manufacturer:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor, Alcobendas

28108 Madrid

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

Republic of Czech

or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

Last review date of this leaflet: September 2024

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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