Patient Information Leaflet: Package Insert

Ebastina Tevagen 20 mg Film-Coated Tablets

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms 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 leaflet. See section 4.

1. What Ebastina Tevagen is and what it is used for

2. What you need to know before you start taking Ebastina Tevagen

3. How to take Ebastina Tevagen

4. Possible side effects

5. Storage of Ebastina Tevagen

6. Contents of the pack and additional information

Ebastina belongs to a group of medications known as antihistamines (antiallergics).

Ebastina is indicated for the symptomatic treatment of allergic processes such as:

• seasonal or perennial allergic rhinitis associated or not with allergic conjunctivitis (such as runny nose, nasal itching, eye itching, tearing, urge to sneeze),
• chronic urticaria,
• allergic dermatitis.

Do not take Ebastina Tevagen

• 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 or pharmacist before starting to take ebastina:

This medication should be used with caution:

• if your electrocardiogram results are altered (prolongation of the QT interval),
• if you have high levels of potassium in your blood,
• if you have a severe liver disease (see section “How to take Ebastina Tevagen”),
• if you are being treated with a type of antifungal medication called azoles or with a type of antibiotic called macrolides (see section “Taking Ebastina Tevagen with other medications”),
• if you are being treated with rifampicin, a type of medication used to treat tuberculosis.

Do not use this medication if you have an acute allergic emergency, as ebastina (active ingredient of this medication) takes 1 to 3 hours to take effect.

Children

Ebastina should not be administered to children under 12 years of age. In this group of patients, ebastina 1 mg/ml oral solution is recommended.

Other medications and Ebastina Tevagen

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

The following medications may interact with ebastina, in which case it may be necessary to change the dose or discontinue treatment with one of them:

• ebastina may increase the effect of other medications used to treat allergies (antihistamines),
• ebastina should be used with caution in patients being treated with medications called ketoconazole and itraconazole, used to treat fungal infections, or with an antibiotic called erythromycin (as they may cause an alteration in your electrocardiogram),
• the antihistamine effect of ebastina may be reduced in patients being treated with a medication called rifampicin used to treat tuberculosis.

No interactions have been described between ebastina and theophylline, warfarin, cimetidine, diazepam, and alcohol.

Interference with diagnostic tests

Ebastina may interfere with the results of skin allergy tests, so it is recommended not to perform them until 5 to 7 days after discontinuing treatment.

Taking Ebastina Tevagen with food and drinks

This medication can be taken with or without food.

Pregnancy and breastfeeding

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

Pregnancy

There is no experience in pregnant women, so it is recommended to consult a doctor before taking ebastina. The doctor will decide whether or not to start treatment.

Breastfeeding

It is unknown whether the medication passes into breast milk, so it should not be used during breastfeeding.

Driving and operating machinery

In men, no effects have been observed on psychomotor function, or on the ability to drive or operate machinery at the recommended therapeutic doses. However, given that drowsiness and dizziness are among the adverse effects, observe your response to the medication before driving or operating machinery.

Ebastina Tevagen contains lactose

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

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

Remember to take your medication.

Your doctor will indicate the duration of your treatment with ebastina.

Dosage

Use in adults and adolescents over 12 years:

The recommended dose is 10 mg of ebastina once a day, although some patients may require a dose of 20 mg once a day.

Use in patients with severe liver disease:

No more than 10 mg of ebastina should be taken per day. In this case, it is recommended to use the 10 mg presentation (ebastina 10 mg tablets).

Administration form

This medication is for oral administration.

Tablets can be taken with or without food, with the help of a glass of water.

If you estimate that the action of ebastina is too strong or too weak, inform your doctor or pharmacist.

If you take more Ebastina Tevagen than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Bring the remaining tablets, the box, and the complete packaging so that healthcare personnel can identify the medication taken more easily.

The treatment of intoxication by this medication consists of gastric lavage and administration of the appropriate medication.

If you forgot to take Ebastina Tevagen

Do not take a double dose to compensate for the missed doses. Take the missed dose when you remember and then follow your usual schedule. However, if there are only a few hours left before the next dose, do not take the missed dose and wait for the next dose at the scheduled time.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

In clinical trials and post-marketing experience, the following adverse effects have been observed:

Very Frequent(may affect more than 1 in 10 people)

• Headache.

Frequent(may affect up to 1 in 10 people)

• Drowsiness,
• Dry mouth.

Rare(may affect up to 1 in 1,000 people)

• Hypersensitivity reactions: allergic reactions (such as anaphylaxis and angioedema),
• Nervousness, insomnia,
• Dizziness, decreased sensation to touch or sensitivity, decreased or altered taste,
• Palpitations, tachycardia,
• Abdominal pain, vomiting, nausea, digestive problems,
• Liver inflammation (hepatitis), cholestasis, abnormal liver function test results (elevated transaminases, gamma-GT, alkaline phosphatase, and bilirubin),
• Urticaria, skin rash, dermatitis,
• Menstrual disorders,
• Edema (swelling due to fluid accumulation), fatigue.

Unknown Frequency(cannot be estimated from available data):

-Weight gain,

-Increased appetite.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in 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.

Composition of Ebastina Tevagen

• The active ingredient is ebastina. Each tablet contains 20 mg of ebastina.
• The other components (excipients) are:

Core : lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, povidone 30, polisorbate 80, magnesium stearate,

Coating : hypromellose, titanium dioxide (E171), triacetin.

Product Appearance and Packaging Content

Ebastina Tevagen is presented in the form of film-coated white, lenticular tablets.

Each PVC/Aluminum blister pack contains 20 tablets.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

Anabel Segura, 11 Edificio Albatros B 1st Floor

Alcobendas, 28108 Madrid

Spain

Responsible Manufacturer

Laboratorios ALTER, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Last Review Date of this Leaflet: March 2022

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