Ebastine Viatris 20 mg orodispersible tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Ebastine Viatris 20 mg orodispersible tablets EFG
Read the entire leaflet carefully before you start taking this medicine, as 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 and must not be given to others, even if they have the same symptoms, as it could harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Ebastine Viatris is and what it is used for
- What you need to know before taking Ebastine Viatris
- How to take Ebastine Viatris
- Possible adverse effects
- How to store Ebastine Viatris
Pack contents and other information
1. What Ebastina Viatris 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 older, ebastine is used to relieve symptoms of seasonal allergic rhinitis (hay fever) and perennial allergic rhinitis, including cases with allergic conjunctivitis.
2. What you need to know before taking Ebastina Viatris
Do not take Ebastina Viatris
- If you are allergic to ebastine or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor before starting to take Ebastina Viatris
- If you are already taking certain antibiotics or medicines used to treat fungal infections: see section "Other medicines and Ebastina Viatris" below.
- If you have severe impairment of liver function (hepatic insufficiency).
Ebastine may cause dry mouth. Therefore, for long-term treatment, good oral hygiene is important (teeth should be brushed twice daily with fluoride toothpaste) to prevent the risk of dental caries.
Children and adolescents
This medicine is only for use in children aged 12 years and older. Do not administer to children under 12 years of age, as safety and efficacy have not been established in this age group.
Other medicines and Ebastina Viatris
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Taking ebastine at the same time as erythromycin (an antibiotic) or ketoconazole, itraconazole (active substances used to treat fungal infections) may lead to higher levels of ebastine in the blood.
Concurrent administration of ebastine with rifampicin (a medicine for tuberculosis) may reduce the levels of ebastine in the blood and, therefore, reduce its effects.
It is not advisable to use ebastine together with clarithromycin or josamycin (antibiotics).
Taking Ebastina Viatris with food and drinks
You may take ebastine regardless of meal times.
Pregnancy and breastfeeding
To date, experience regarding safety for the human fetus is limited. For this reason, you should only take this medicine during pregnancy if the expected benefit outweighs the possible risks.
Do not take ebastine if you are breastfeeding, as it is unknown whether the active substance passes into breast milk.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Most patients treated with ebastine can drive or perform other activities requiring good reaction ability. However, as with other medicines, you should assess your individual response after taking ebastine before driving or performing complex tasks, as some patients may experience drowsiness or dizziness.
Ebastina Viatris contains lactose
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
Ebastina Viatris contains aspartame (E-951)
This medicine 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 properly eliminate it.
3. How to take Ebastine Viatris
Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose is:
Allergic rhinitis | Age | Dosage |
In case of severe symptoms | Children 12 years and older and adults | One ebastine 10 mg tablet (10 mg of ebastine) daily. Two ebastine 10 mg tablets or one Ebastine Viatris 20 mg tablet (20 mg of ebastine) daily. |
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, these patients should not take more than 10 mg per day.
Do not push the tablet out of the blister pocket, as this will crush it.
Each strip contains tablets separated by perforations in pockets. Separate one pocket with its tablet along the dotted line (Figure 1).
Carefully peel back the foil from the blister pack starting at the corner indicated by the arrow (Figures 2 and 3).
Keep hands dry and remove the tablet from the strip.
Place the tablet on the tongue, where it will disperse within seconds: water or any other liquid is not required.
Ebastine may be taken regardless of meals.
Your doctor will decide the duration of treatment.
If you take more Ebastina Viatris than you should
There is no specific antidote for the active substance ebastine.
If you have taken more than prescribed by your doctor or in case of overdose, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and amount taken. Depending on the severity of intoxication, appropriate measures will be initiated (monitoring of vital functions, including ECG monitoring for at least 24 hours, symptomatic treatment, and gastric lavage), if necessary.
If you forget to take Ebastina Viatris
Do not take a double dose to make up for missed doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Stop taking ebastine and contact your doctor immediately or go to the nearest hospital if the following occurs:
- Severe allergic reaction causing swelling of the face, tongue or throat, which may cause difficulty swallowing or breathing.
Other adverse effects include:
Very common (may affect more than 1 in 10 people)
- Headache.
Common (may affect up to 1 in 10 people)
- Drowsiness.
- Dry mouth.
Uncommon (may affect up to 1 in 100 people)
- Sore throat (pharyngitis), runny nose (rhinitis), nosebleed.
Rare (may affect up to 1 in 1,000 people)
- Nervousness, insomnia.
- Altered or reduced sense of touch.
- Taste disturbances.
- Palpitations, rapid heartbeat.
- Abdominal pain, nausea, indigestion.
- Vomiting.
- Abnormal liver function test.
- Liver inflammation.
- Problems with bile excretion causing itching, yellowing of the 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 people)
- Urticaria, eczema.
- Painful menstruation.
Frequency not known (cannot be estimated from available data)
- Increased appetite.
- Weight gain.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Ebastine Viatris
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after CAD or EXP. The expiry date refers to the last day of the month indicated.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Ebastine Viatris
The active substance is ebastine. Each orodispersible tablet contains 20 mg of ebastine.
The other components are: microcrystalline cellulose, lactose monohydrate, maize starch, sodium croscarmellose, aspartame (E-951), mint flavour, colloidal anhydrous silica and magnesium stearate.
Appearance of the product and contents of the pack
Orodispersible tablets.
White, biconvex, round tablets, engraved with "E20" on one side and flat on the other.
Available pack sizes:
Continuous blisters containing 10, 15, 20, 30, 40, 50, 98 and 100 orodispersible tablets.
Perforated unit-dose blisters containing 10, 15, 20, 30, 40, 50, 98 and 100 orodispersible tablets.
Only some pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland
Manufacturer
Teva Pharmaceutical Works Private Limited Company
Pallagi út 13
4042 Debrecen
Hungary
or
Teva Pharma, S.L.U.
C/ C, 4 - Polígono Industrial Malpica
50016 – Zaragoza
Spain
Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:
Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain
This medicinal product is authorized in the European Economic Area member states under the following names:
Spain: Ebastine Viatris 20 mg orodispersible tablets EFG
Italy: Ebastina Mylan Pharma
Sweden: Ebastine Generics 20 mg munsönderfallande tablett
Date of the most recent revision of this leaflet: November 2020
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): https://www.aemps.gob.es/