Ebastine Tecnigen 20 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ebastina TecniGen 20 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• 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 should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents

1. What Ebastina TecniGen 20 mg tablets are and what they are used for

2. Before you take Ebastina TecniGen 20 mg tablets

3. How to take Ebastina TecniGen 20 mg tablets

4. Possible side effects

5. How to store Ebastina TecniGen 20 mg tablets

6. Further information

1. What Ebastina TecniGen 20 mg tablets is and what it is used for

Ebastine belongs to a group of medicines known as antihistamines.

Ebastina TecniGen is indicated for the symptomatic treatment of allergic conditions such as seasonal or perennial allergic rhinitis, with or without allergic conjunctivitis (including nasal discharge, nasal itching, eye itching, tearing, and sneezing), chronic urticaria, and allergic dermatitis.

2. Before taking Ebastine TecniGen 20 mg tablets

Do not take Ebastina TecniGen

If you are allergic or have had any allergic reaction to the active substance in this medicine or to any of its components.

Take special care with Ebastina TecniGen

• If you are experiencing an acute allergic emergency, since Ebastina TecniGen takes 1 to 3 hours to take effect.

• Ebastina TecniGen may interfere with the results of skin allergy tests; therefore, it is advised not to perform these tests until 5–7 days after stopping treatment.

• It may enhance the effects of other antihistamines.

• Dose adjustment is not necessary in patients with mild or moderate liver impairment. In patients with severe liver impairment, the dose of ebastine must not exceed 10 mg/day.

Use of other medicines

Inform your doctor or pharmacist if you are currently using, or have recently used, any other medicines, including those obtained without a prescription.

Ebastine may interact with erythromycin (an antibiotic) or ketoconazole (a medicine used to treat fungal infections).

Use of Ebastina TecniGen with food or drinks:

The tablets should be taken with a glass of water, with or without food.

Pregnancy and breastfeeding

There is no experience in pregnant women; therefore, it is recommended to consult your doctor before taking Ebastina TecniGen.

It is unknown whether the medicine passes into breast milk.

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

In humans, no effects on psychomotor function or on the ability to drive or operate machinery have been observed at the recommended therapeutic doses. However, observe your response to the medication, as drowsiness has occurred in some cases at usual doses. If this occurs, refrain from driving and operating dangerous machinery.

Important information about some of the components of Ebastina TecniGen

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him or her before taking this medicine. This medicine does not contain gluten.

3. How to take Ebastina TecniGen 20 mg tablets

Follow these instructions unless your doctor has given you different ones. In such cases, it is advisable to request written instructions from your doctor and make sure you have fully understood them.

Remember to take your medicine.

Your doctor will indicate how long you should continue treatment with Ebastina TecniGen. Do not stop treatment earlier, as your symptoms may worsen.

The recommended dose for adults and children over 12 years of age is 1 tablet (20 mg) once daily, regardless of food intake.

Ebastina TecniGen tablets are for oral use. The tablets should be swallowed whole, without chewing, with a glass of liquid, preferably water.

If you think that the effect of Ebastina TecniGen is too strong or too weak, tell your doctor or pharmacist.

If you take more Ebastina TecniGen than you should

If you have taken more Ebastina TecniGen than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medication and the amount taken.

If you forget to take Ebastina TecniGen

If you miss a dose, wait until the next scheduled dose. Do not take a double dose to make up for the missed dose.

4. Possible adverse effects

Like all medicines, Ebastina TecniGen may cause adverse effects, although not everyone will experience them.

The adverse reactions were mild or moderate, transient, and resolved spontaneously without specific treatment.

The adverse effects described are as follows:

Common (affects more than 1 in 100 but less than 1 in 10 patients): headache, somnolence, dry mouth, pharyngitis, rhinitis, and fatigue.

Uncommon (affects more than 1 in 1,000 but less than 1 in 100 patients): abdominal pain, dyspepsia, epistaxis, sinusitis, nausea, and insomnia.

Frequency not known (cannot be estimated from the available data): weight gain, increased appetite.

If you experience any of these adverse effects or any others not listed in this leaflet, consult your doctor or pharmacist.

5. Storage of Ebastine TecniGen 20 mg Tablets

Keep out of the reach and sight of children.

No special storage conditions are required.

Expiry

Do not use Ebastine TecniGen tablets after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Additional information

Composition of Ebastine TecniGen 20 mg tablets

The active substance is ebastine. Each tablet contains 20 mg of ebastine.

The other components (excipients) are: monohydrate lactose, microcrystalline cellulose, pregelatinized starch, povidone 30, polysorbate 80, magnesium stearate, hypromellose, titanium dioxide, and glyceryl triacetate.

Appearance of the product and contents of the pack

Ebastine TecniGen is presented as film-coated tablets for oral administration. The tablets are biconvex and white in colour. Each pack contains 20 tablets of 20 mg.

Other presentations

Ebastine TecniGen 10 mg tablets.

Marketing Authorization Holder and Manufacturer

Holder

TECNIMEDE ESPAÑA INDUSTRIA FARMACÉUTICA, S.A.

Avda. de Bruselas, 13, 3º D.Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas, Spain

Manufacturer:

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid (Spain)

or

Laboratorios Alter, S.A

C/ Zeus 6, Polígono Industrial R2

28880 Meco (Madrid)

Spain

This leaflet was approved inApril 2019**

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)