Ebastine Teva-Ratiopharm 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ebastine Teva-ratiopharm 10 mg orodispersible tablets EFG

Ebastine Teva-ratiopharm 20 mg orodispersible 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

reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Ebastine Teva-ratiopharm is and what it is 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. How to store Ebastine Teva-ratiopharm
6. Contents of the pack and other information

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

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

In adults and children aged 12 years and over, Ebastina 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 of age, Ebastina Teva-ratiopharm 10 mg is also used to relieve itching and the development of hives, urticaria (wheals).

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 to any of the other ingredients of Ebastine Teva-ratiopharm (listed in section 6)

Warnings and precautions

Consult your doctor before taking Ebastine Teva-ratiopharm if:

• You have low levels of potassium in your blood
• You have an abnormal heart rhythm pattern (known as QTc interval prolongation on ECG), which may occur in certain types of heart disease
• You are already taking certain antibiotics or medications used to treat fungal infections: see section "Ebastine Teva-ratiopharm with other medicines" below
• You have severe impairment of liver function (hepatic insufficiency)
  • Ebastine may cause dry mouth. Therefore, during prolonged treatment with ebastine, it is important to maintain good oral hygiene (you should brush your teeth twice daily) to reduce the risk of dental caries.

Children and adolescents

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

Taking Ebastine Teva-ratiopharm with other medicines

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

Ebastine Teva-ratiopharm may be affected by, or may affect, other medicines containing the following active substances:

• Ketoconazole, itraconazole (active substances used to treat fungal infections)
• Erythromycin (antibiotic)
• Rifampicin (medicine used to treat tuberculosis)

Taking Ebastine Teva-ratiopharm with food and drink

The tablets may be taken with or without food.

Pregnancy, breastfeeding and fertility

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

It is unknown whether ebastine is excreted in human 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 medicine.

Driving and using machines

Most patients treated with Ebastine Teva-ratiopharm can drive or perform other activities requiring good reaction ability. However, as with all other medicines, you should assess your individual response after taking Ebastine Teva-ratiopharm before driving or performing complex tasks, since some patients may experience drowsiness or dizziness.

Ebastine Teva-ratiopharm contains aspartame

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

Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

Ebastine Teva-ratiopharm contains lactose

If your doctor has informed you of an intolerance to certain sugars, consult with him or her before taking this medicine.

Ebastine Teva-ratiopharm contains sodium

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

3. How to take Ebastine Teva-ratiopharm

Follow exactly the administration instructions for ebastine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

In patients with renal impairment, dose adjustment is not necessary.

In patients with mild to moderate hepatic impairment, dose adjustment is not necessary.

There is no experience with doses exceeding 10 mg in patients with severe hepatic impairment; 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. Detach one blister with its tablet along the dotted line (Figure 1).

Carefully peel off the backing foil starting from the corner indicated by the arrow (Figures 2 and 3).

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

Place the tablet on the tongue, where it will disperse: water or any other liquid is not necessary.

Ebastine may be taken regardless 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 substance ebastine.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915 620 420, indicating the name of the medicine and the amount ingested.

If you forget to take Ebastine Teva-ratiopharm

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

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

4. Possible adverse effects

Like all medicines, this medicine may have adverse effects, although not everyone experiences 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 may cause difficulty swallowing or breathing. These may be signs of a hypersensitivity reaction such as anaphylaxis and angioedema, which are uncommon side effects (may affect up to 1 in 1,000 people).

Other adverse effects

Very common adverse effects may affect more than 1 in 10 people

• Headache

Common adverse effects may affect up to 1 in 10 people

• Drowsiness
• Dry mouth

Uncommon adverse effects may affect up to 1 in 100 people

• Nosebleed
• Sore throat (pharyngitis)
• Nasal discharge (rhinitis)

Rare adverse effects may affect up to 1 in 1,000 people

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

Very rare adverse effects may affect up to 1 in 10,000 people

• Dysaesthesia (abnormal sensation)
• Eczema, skin inflammation
• Menstrual cramps

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, even if it is an adverse effect not listed in this leaflet. You may also report them via the Spanish Pharmacovigilance System for Human Medicinal Products at: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ebastine Teva-ratiopharm

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
• Store in the original packaging to protect from light.
• Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your usual pharmacy. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the container and additional information

Composition of Ebastine Teva-ratiopharm

• The active substance is ebastine. Each orodispersible tablet contains 10 mg of ebastine. Each orodispersible tablet contains 20 mg of ebastine.
• The other components (excipients) are microcrystalline cellulose, lactose monohydrate, maize starch, sodium croscarmellose, aspartame (E951), mint flavor, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and contents of the package

• Orodispersible 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 orodispersible tablets

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor, 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 most recent review of this leaflet: September 2024

Detailed 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/

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