ALERGOLIBER 10 MG TABLETS

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Alergoliber 10 mg tablets

Rupatadine

Read the entire leaflet carefully before you start taking this medicine, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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. How to store Alergoliber
6. Contents of the pack and other 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, rhinorrhea, itching of the eyes and nose.

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

2. What you need to know before starting to take Alergoliber

Do not take Alergoliber:

• If you are allergic to rupatadine or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Alergoliber

If you have renal or hepatic impairment. In such cases, consult your doctor. The use of Alergoliber 10 mg tablets is currently not recommended in patients with renal or hepatic impairment.

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

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

Children

This medicine must not be used in children under 12 years of age.

Other medicines and Alergoliber

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

If you are taking Alergoliber, do not take medicines containing ketoconazole (a medicine for fungal infections) or erythromycin (a medicine for bacterial infections).

If you are taking central nervous system depressants, statins (medicines used to treat high cholesterol levels), or midazolam (a medicine used for short-term sedation), consult your doctor before taking Alergoliber.

Taking Alergoliber with food, drinks and alcohol

Do not take Alergoliber 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

The recommended dose of Alergoliber is not expected to affect your ability to drive vehicles or operate machinery. However, when you first use Alergoliber, you should take caution and observe how the treatment affects you before driving or operating machinery.

Alergoliber contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Alergoliber

Follow exactly the instructions for use of this medicine given by your doctor.

If in 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 daily, with or without food. Swallow the tablet with a sufficient amount of liquid (e.g., a glass of water).

Your doctor will determine 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 medicine, consult your doctor or pharmacist immediately, or contact the Toxicology Information Service at telephone number 915 620 420.

If you forget to take Alergoliber

Take your dose as soon as possible and then continue taking your tablets at your regular times. Do not take a double dose to make up for missed doses.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Frequent adverse effects (may affect up to 1 in 10 patients) are somnolence, headache, dizziness, dry mouth, feeling of weakness and fatigue. Uncommon adverse effects (may affect up to 1 in 100 patients) are increased appetite, irritability, difficulty concentrating, nosebleed, nasal dryness, sore throat, cough, dry throat, rinitis, nausea, abdominal pain, diarrhoea, indigestion, vomiting, constipation, rash, back pain, joint pain, muscle pain, thirst, malaise, fever, abnormal liver function tests and weight gain.

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

If you notice any adverse effects not listed in this leaflet or if you experience any of the described effects severely, inform your doctor or pharmacist.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Alergoliber

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

Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month indicated.

Store the blister pack in the outer packaging to protect it from light.

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

6. Contents of the pack and other information

Composition of Alergoliber

• The active substance is rupatadine. Each tablet contains 10 mg of rupatadine (as fumarate).
• The other components are: pregelatinized corn starch, microcrystalline cellulose, red iron oxide (E-172), yellow iron oxide (E-172), monohydrate lactose and magnesium stearate. See section 2 “Alergoliber contains lactose”.

Presentation of the product and contents of the pack

Alergoliber are round, light salmon-coloured tablets, available in unit-dose blisters containing 3, 7, 10, 15, 20, 30, 50 or 100 tablets. Not all pack sizes 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)

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1

28224 Pozuelo de Alarcón

Madrid, Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Alergoliber 10 mg Tablets Spain,

Pafinur 10 mg Tablets Italy

Urtimed 10 mg Tablets Germany

Date of the most recent review of this leaflet: 08/2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es