Package Insert: Information for the User

Ebastina TecniGen 20 mg Tablets EFG

Read this package insert carefully before starting to use the medication.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist.

6. Additional Information

Ebastina belongs to a group of medicines called antihistamines.

Ebastina TecniGen 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 and allergic dermatitis.

Do not take Ebastina 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 especially careful with Ebastina TecniGen

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

• It may potentiate the effects of other antihistamines.
• In patients with mild or moderate liver insufficiency, no dose adjustment is necessary. In patients with severe liver insufficiency, the dose should not exceed 10 mg/day of ebastina.

Use of other medications

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

Ebastina may interact with erythromycin (antibiotic medication) or ketoconazole (medication for fungal infections).

Use of Ebastina 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 Ebastina TecniGen.

It is unknown whether the medication passes into breast milk.

Consult your doctor or pharmacist before using a medication.

Driving and operating machinery

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

Important information about one of the components of Ebastina TecniGen

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication. This medication does not contain gluten.

Follow these instructions unless your doctor has given you different instructions. In these cases, it is advisable to ask your doctor for written instructions and make sure you understand them well.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Ebastina TecniGen. Do not discontinue treatment beforehand, as your symptoms may worsen.

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

Ebastina TecniGen tablets are 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 TecniGen is too strong or too weak, inform your doctor or pharmacist.

If you take more Ebastina TecniGen than you should

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

If you forgot to take Ebastina TecniGen

In case of a missed dose, wait for the next one. However, do not take a double dose to compensate for the missed dose.

Like all medications, Ebastina TecniGen may produce adverse effects, although not all people will experience them.

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

The described adverse effects are as follows:

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

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

Unknown frequency (cannot be estimated from available data):weight gain, increased appetite.

If these adverse effects or any other not described in this prospectus are observed, consult with your doctor or pharmacist.

Keep out of reach and sight of children.

No special storage conditions are required.

Expiration Date

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. This will help protect the environment.

Composition of Ebastina TecniGen 20 mg tablets

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

The other components (excipients) are: Lactose monohydrate, microcrystalline cellulose, pregelatinized starch, povidone 30, polisorbate 80, magnesium stearate, hypromellose, titanium dioxide, and triacetin.

Appearance of the product and contents of the package

Ebastina TecniGen is presented in the form of coated film tablets for oral administration. The tablets are biconvex and white in color. Each package contains 20 tablets of 20 mg.

Other presentations

Ebastina TecniGen 10 mg tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder

TECNIMEDE ESPAÑA INDUSTRIA FARMACEUTICA, S.A.

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

28108 Alcobendas, Spain

Responsible for manufacturing:

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid (Spain)

This leaflet has been approved inApril 2019

The detailed information of this medication is available on the website oftheSpanish Agency of Medicamentsand Health Products (AEMPS)(http://www.aemps.gob.es/)