ALERGOLIBER 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Alergoliber 10 mg Tablets

Rupatadine

Read the entire package leaflet carefully before starting to take this medication, as it contains

important information for you.

• 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 only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Alergoliber is and what it is used for
2. What you need to know before taking Alergoliber
3. How to take Alergoliber
4. Possible side effects
5. Storage of Alergoliber
6. Package Contents and Additional Information

1. What Alergoliber is and what it is used for

Rupatadine is an antihistamine.

Alergoliber is indicated for the relief of symptoms of allergic rhinitis such as sneezing, runny nose, itchy eyes, and itchy nose.

Alergoliber is indicated for the relief of symptoms associated with urticaria (allergic skin rash) such as itching and skin hives (redness and swelling of the skin).

2. What you need to know before taking Alergoliber

Do not take Alergoliber:

• If you are allergic to rupatadine 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 Alergoliber.

If you have kidney or liver failure. In this case, consult your doctor. The use of Alergoliber 10 mg tablets is not currently recommended in patients with kidney or liver failure.

If you have low potassium levels in your blood and/or if you have a certain abnormal heart rhythm pattern (known QTc interval prolongation on the ECG) that may occur in certain heart diseases, consult your doctor.

If you are over 65 years old, consult your doctor or pharmacist.

Children

This medication should not be used in children under 12 years of age.

Other Medications and Alergoliber

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

If you are taking Alergoliber, do not take medications that contain ketoconazole (a medication for fungal infections) or erythromycin (a medication for bacterial infections).

If you are taking medications that depress the central nervous system, medications with statins (medications used to treat high cholesterol), or midazolam (a medication used for short-term sedation), consult your doctor before taking Alergoliber.

Taking Alergoliber with Food, Drinks, and Alcohol

Do not take Alergoliber in combination with grapefruit juice, as it may increase the level of rupatadine in your body.

Alergoliber, at the recommended dose of 10 mg, does not increase the drowsiness caused by alcohol.

Pregnancy and Breastfeeding

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

Driving and Using Machines

It is unlikely that the recommended dose of Alergoliber will affect your ability to drive or operate machinery. However, when you first use Alergoliber, you should be cautious and see how the treatment affects you before driving or operating machinery.

Alergoliber contains Lactose

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medication.

3. How to Take Alergoliber

Follow the administration instructions for this medication exactly as indicated by your doctor.

In case of doubt, consult your doctor or pharmacist again.

Alergoliber is administered to adolescents (from 12 years of age) and adults. The recommended dose is one tablet (10 mg of rupatadine) once a day, with or without food. Swallow the tablet with a sufficient amount of liquid (e.g., a glass of water).

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

If you take more Alergoliber than you should

In case of accidental ingestion of high doses of the medication, consult your doctor or pharmacist immediately, or contact the Toxicology Information Service, phone 915 620 420.

If you forget to take Alergoliber

Take your dose as soon as possible and continue with your tablets at the usual times. Do not take a double dose to make up for forgotten doses.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Common side effects (may affect up to 1 in 10 patients) are drowsiness, headache, dizziness, dry mouth, feeling of weakness, and fatigue. Uncommon side effects (may affect up to 1 in 100 patients) are increased appetite, irritability, difficulty concentrating, nosebleeds, dry nose, sore throat, cough, dry throat, rhinitis, nausea, abdominal pain, diarrhea, indigestion, vomiting, constipation, rash, back pain, joint pain, muscle pain, thirst, discomfort, fever, abnormal liver function tests, and weight gain.

Rare side effects (may affect up to 1 in 1,000 patients) are palpitations, increased heart rate, and allergic reactions (itching, urticaria, and swelling of the face, lips, tongue, or throat).

If you notice side effects not mentioned in this package leaflet or if you experience any of the side effects described in a severe form, inform your doctor or pharmacist.

Reporting Side Effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in the package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Alergoliber

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

Do not use this medication after the expiration date stated on the box and blister. The expiration date is the last day of the month indicated.

Keep the blister in the outer packaging to protect it from light.

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. Package Contents and Additional Information

Alergoliber Composition

• The active ingredient is rupatadine. Each tablet contains 10 mg of rupatadine (as fumarate).
• The other ingredients are pregelatinized cornstarch, microcrystalline cellulose, red iron oxide (E-172), yellow iron oxide (E-172), lactose monohydrate, and magnesium stearate. See section 2 "Alergoliber contains lactose".

Product Appearance and Package Contents

Alergoliber are light salmon-colored, round tablets and are presented in unit-dose blisters containing 3, 7, 10, 15, 20, 30, 50, or 100 tablets. Not all packages are marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Urquima, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans (Barcelona-Spain)

Manufacturer

NOUCOR HEALTH, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans (Barcelona-Spain)

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Paseo Club Deportivo 1, Edif 4

28223 Pozuelo de Alarcón

Madrid, Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

Alergoliber 10 mg Tablets Spain,

Pafinur 10 mg Tablets Italy

Urtimed 10 mg Tablets Germany

Date of the last revision of this package leaflet 08/2020

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