EBASTINE TECNIGEN 20 mg TABLETS

Introduction

Package Leaflet: Information for the User

Ebastine TecniGen 20 mg tablets EFG

Read the entire package leaflet carefully before starting to use the medication.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Contents of the Package Leaflet

1. What Ebastine TecniGen 20 mg tablets are and what they are used for
2. Before taking Ebastine TecniGen 20 mg tablets
3. How to take Ebastine TecniGen 20 mg tablets
4. Possible side effects
5. Storage of Ebastine TecniGen 20 mg tablets

1. Additional Information

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

Ebastine belongs to a group of medications called antihistamines.

Ebastine TecniGen is indicated for the symptomatic treatment of allergic processes such as seasonal or perennial allergic rhinitis, with or without allergic conjunctivitis (such as nasal discharge, itching of the nose, itching of the eyes, tearing, urge to sneeze), chronic urticaria, and allergic dermatitis.

2. Before taking Ebastine TecniGen 20 mg tablets

Do not take Ebastine TecniGen

If you are allergic or have had an allergic reaction to the active ingredient of this medication or to any of its components.

Be careful with Ebastine TecniGen

• If you have an acute allergic emergency, as Ebastine TecniGen takes 1 to 3 hours to take effect.
• Ebastine TecniGen may interfere with the results of skin allergy tests, so it is recommended not to perform them until 5-7 days have passed since the treatment was discontinued.

• It may enhance the effects of other antihistamines.
• In patients with mild or moderate hepatic insufficiency, it is not necessary to adjust the dose. In patients with severe hepatic insufficiency, the dose of ebastine should not exceed 10 mg/day.

Use of other medications

Tell your doctor or pharmacist if you are using, or have recently used, other medications, including those purchased without a prescription.

Ebastine may interact with erythromycin (an antibiotic medication) or ketoconazole (a medication for the treatment of fungal infections).

Use of Ebastine TecniGen with food or beverages:

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

Pregnancy and breastfeeding

There is no experience in pregnant women, so it is recommended to consult a doctor before taking Ebastine TecniGen.

It is not known if the medication passes into breast milk.

Consult your doctor or pharmacist before using a medication.

Driving and using machines

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

Important information about some of the components of Ebastine TecniGen

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. This medication does not contain gluten.

3. How to take Ebastine TecniGen 20 mg tablets

Follow these instructions unless your doctor has given you different instructions. In these cases, it is advisable to ask the doctor for the instructions in writing and make sure you have understood them well.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Ebastine TecniGen. Do not stop the treatment before, as your symptoms may worsen.

The recommended dose in adults and children over 12 years is 1 tablet (20 mg) once a day, regardless of food intake.

The Ebastine TecniGen tablets are for oral administration. The tablets should be swallowed whole, without chewing, with the help of a glass of liquid, preferably water.

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

If you take more Ebastine TecniGen than you should

If you have taken more Ebastine TecniGen than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Ebastine TecniGen

In case of forgetting a dose, wait for the next one. But do not take a double dose to make up for the forgotten dose.

4. Possible side effects

Like all medications, Ebastine TecniGen can cause side effects, although not everyone will experience them.

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

The side effects described are as follows:

Frequent (more than one in 100, but less than one in 10 patients): headache, drowsiness, dry mouth, pharyngitis, rhinitis, and fatigue.

Uncommon (more than one in 1,000, but less than one in 100 patients): abdominal pain, digestive discomfort, nasal bleeding, sinusitis, nausea, and insomnia.

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

If you observe these side effects or any other not described in this package 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.

Expiration date

Do not use Ebastine TecniGen tablets after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Additional information

Composition of Ebastine TecniGen 20 mg tablets

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

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

Appearance of the product and packaging content

Ebastine TecniGen is presented in the form of film-coated tablets for oral administration. The tablets are lenticular and white. Each package contains 20 tablets of 20 mg.

Other presentations

Ebastine TecniGen 10 mg tablets.

Marketing authorization holder and manufacturer

Holder

TECNIMEDE ESPAÑA INDUSTRIA FARMACEUTICA, S.A.

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

28108 Alcobendas, España

Manufacturer:

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid (España)

This package leaflet was approved inApril 2019

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