Leaflet: information for the user

Ebastinaratiopharm20 mg buccodispersible tablets EFG

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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, 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.

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.

In adults and children 12 years of age or older, Ebastinaratiopharmis used to relieve symptoms of seasonal allergic rhinitis and perennial allergic rhinitis, including cases with allergic conjunctivitis.

Do not take Ebastinaratiopharm

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 before starting to take Ebastinaratiopharmif:

• You have low levels of potassium in your blood.
• You are already taking certain antibiotics or medications used to treat fungal infections: see the section “Taking Ebastinaratiopharmwith other medications” below.
• You have severe liver function disorders (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 with a fluoride toothpaste) to reduce the risk of caries.

Children and adolescents

This medication should only be taken by children aged 12 and above. Do not administer to children under 12 years as the safety and efficacy have not been demonstrated in this age group.

Taking Ebastinaratiopharmwith other medications

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

When taking Ebastinaratiopharmand erythromycin (antibiotic) or ketoconazole, itraconazole (active principles for the treatment of fungal infections), it may lead to higher levels of ebastina in the blood.

The administration of ebastina with rifampicin (tuberculosis medication) at the same time may lead to lower levels of ebastina in the blood, resulting in a reduction of effects.

It is not recommended to use Ebastinaratiopharmat the same time as clarithromycin or josamycin (antibiotics).

Taking Ebastinaratiopharmwith food and drinks

You can take Ebastinaratiopharmregardless of meal times.

Pregnancy and breastfeeding

Up to the present, the existing experience regarding safety for the human fetus is limited. For this reason, you should only take this medication during pregnancy if your doctor considers that the expected benefit outweighs the possible risks.

Do not take Ebastinaratiopharmif you are breastfeeding as it is unknown whether the active substance passes into breast milk.

If you are pregnant or breastfeeding, believe you might be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Most patients treated with Ebastinaratiopharmcan drive or perform other activities requiring good reaction capacity. However, like with other medications, you should check your individual reaction after taking Ebastinaratiopharmbefore driving or performing complex activities, as some patients experience drowsiness or dizziness.

Ebastina ratiopharm contains aspartame

This medication contains 5 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

Ebastinaratiopharmcontains lactose

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

Ebastina ratiopharm contains sodium

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

Follow exactly the administration instructions of this medication 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 higher than 10 mg in patients with severe hepatic insufficiency, so these patients should not take more than 10 mg per day.

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 ratiopharm regardless of meals.

Your doctor will decide the duration of treatment.

If you take more Ebastina ratiopharm than you should

There is no specific antidote for the active ingredient ebastina.

If you suspect an overdose with Ebastina ratiopharm, inform your doctor. Depending on the severity of the 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 necessary.

If you have taken a dose higher than the one prescribed by your doctor or in case of overdose, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount used.

If you forgot to take Ebastina ratiopharm

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

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

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

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

• Severe allergic reaction that causes swelling of the face, tongue, or throat and may cause difficulty swallowing or breathing.

Other side effects include:

Very common (may affect more than 1 in 10 patients)

-Headache

Common (may affect up to 1 in 10 patients):

• Drowsiness.
• Mouth dryness.

Uncommon (may affect up to 1 in 100 patients):

• Sore throat (pharyngitis), nasal discharge (rhinitis), nosebleed.
• Abdominal pain, nausea, indigestion.
• Weakness (asthenia), dizziness, insomnia.

Rare (may affect up to 1 in 10,000 patients):

• Nervousness, insomnia.
• Alterations or decrease in sense of touch.
• Touch disorders
• Palpitations, rapid pulse.
• Abdominal pain, nausea, indigestion
• Vomiting.
• Abnormal liver function test.
• Liver inflammation
• Bile elimination problems causing itching, yellow eyes and skin
• Rash, itchy rash, skin inflammation.
• Menstrual disorders.
• Edema (fluid accumulation in tissues), weakness (asthenia)
• Dizziness.

Very rare (may affect up to 1 in 10,000 patients)

• Urticaria, eczema
• Dysmenorrhea

Unknown frequency (cannot be estimated from available data)

-Weight gain,

-Increased appetite.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medication for Human Use Pharmacovigilance System: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 in the trash. Dispose of the packaging and medications you no longer needat the SIGREpharmacy drop-off point.In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Ebastina Compositionratiopharm

The active ingredient is ebastina.

Each buccal dispersible tablet contains 20 mg of ebastina.

The other components are: microcrystalline cellulose, lactose monohydrate, cornstarch, sodium croscarmellose, aspartame (E-951), peppermint aroma, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and contents of the packaging

Buccal dispersible tablet.

White, biconvex, round tablets, engraved with “E20” on one face and smooth on the other.

Packaging sizes available: 10, 15, 20, 30, 40, 50, 98, and 100 buccal dispersible tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/AnabelSegura11,EdificioAlbatrosB,1stfloor

Alcobendas28108Madrid(Spain)

Responsible manufacturer

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

This medicine is authorized in the member states of the European Economic Area with the following names:

ES: Ebastina ratiopharm 20 mg buccal dispersible tablets EFG

IT: Ebakest 20 mg orodispersible tablets

SE: Ebateva 20 mgmelted tablets

Last review date of this leaflet: September 2023

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