Package Leaflet: Information for the user

Ebastina STADA 10 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 pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4

1. What Ebastina Stada 10 mg Tablets are and what they are used for

1. What you need to know before you start taking Ebastina Stada 10 mg Tablets
2. How to take Ebastina Stada 10 mg Tablets
3. Possible side effects

5. Storage of Ebastina Stada 10 mg Tablets

6. Contents of the pack and additional information

Ebastina, the active ingredient of Ebastina Stada 10 mg, belongs to a group of drugs called antihistamines (antiallergics).

Ebastina Stada 10 mg is indicated for the 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 and allergic dermatitis.

Do not take Ebastina Stada 10 mg:

• if you are allergic to the active ingredient or to 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 Stada.

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 severe liver disease (see section “How to take Ebastina Stada”).
• if you are being treated with a type of medication used to treat fungal infections called azole antifungals or with medications used to treat certain infections called macrolide antibiotics (see section “Other medications and Ebastina Stada 10 mg”).
• if you are being treated with rifampicin, a type of medication used to treat tuberculosis.

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

Children

Ebastina Stada should not be administered to children under 12 years old.

Other medications and Ebastina Stada 10 mg

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

The following medications may interact with ebastina; in these cases, 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 used to treat certain infections 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 Stada may interfere with the results of skin allergy tests, so it is recommended not to perform them until 5-7 days after discontinuing treatment.

Taking Ebastina Stada 10 mg with food and drinks

The tablets 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 Stada. The doctor will decide whether it is advisable 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.

Important information about one of the components of Ebastina Stada

This medication does not contain gluten.

Ebastina Stada 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 for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will inform you of the duration of your treatment with Ebastina Stada 10 mg. Do not discontinue treatment beforehand, as your symptoms may worsen.

Remember to take your medication.

Dosage

Use in adults and children over 12 years:The recommended dose is 1 tablet (10 mg of ebastina) once a day.

Use in children between 6 and 11 years:The recommended dose is half a tablet (5 mg) once a day.

Use in patients with severe liver disease:Do not exceed a dose of 10 mg of ebastina per day (1 tablet).

Administration Form

This medication is for oral administration.

The tablets should be swallowed whole, without chewing, with the help of a liquid, preferably water.

If you estimate that the action of Ebastina Stada 10 mg is too strong or too weak, inform your doctor or pharmacist.

If you take more Ebastina Stada 10 mg than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount taken.

The treatment of this medication overdose consists of gastric lavage and administration of the appropriate medication. Carry this leaflet with you.

If you forgot to take Ebastina Stada 10 mg

Do not take a double dose to compensate for the missed doses. Take the missed dose when you remember and then continue with your regular 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 everyone will experience them.

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

Very common (may affect more than 1 in 10 people):

• Headache

Common (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 of touch or sensitivity, decreased or altered taste
• Palpitations, tachycardia
• Abdominal pain, vomiting, nausea, digestive problems
• Inflammation of the liver (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 Medicinal Products 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.

This medication does not require special storage conditions.

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.

Do not dispose of medications through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. 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 Stada 10 mg

• The active ingredient is ebastina. Each tablet contains 10 mg of ebastina.

• The other components are microcrystalline cellulose, stearoyl macrogolglycerides, sodium glycolate starch (potato starch) gluten-free, magnesium stearate, purified water, and opadry white.

Appearance of the product and content of the packaging

Ebastina Stada 10 mg tablets are oblong, biconvex, white in color, and have a notch. The tablet can be divided into two equal halves.

The packaging contains 20 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) Spain

[email protected]

Responsible for manufacturing:

Generis Farmacêutica S.A.

Rua João de Deus nº 19, Venda Nova

2700-487 Amadora

Portugal

Last review date of this leaflet:May 2019

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