ALERGOLIBER 1 mg/ml ORAL SOLUTION

Introduction

Patient Information: Summary of Product Characteristics

Alergoliber 1 mg/ml Oral Solution

Rupatadine

Read this entire leaflet carefully before starting to take this medication, 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 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 leaflet. See section 4.

Contents of the 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

Alergoliber contains the active ingredient rupatadine, which is an antihistamine.

Alergoliber oral solution is indicated for the relief of symptoms of allergic rhinitis such as sneezing, nasal discharge, nasal congestion, itching of the nose and eyes in children from 2 to 11 years old.

Alergoliber is also indicated for the relief of symptoms associated with urticaria (allergic skin rash) such as itching and skin wheals (redness and swelling of the skin) in children from 2 to 11 years old.

2. What you need to know before taking Alergoliber

Do not take Alergoliber:

• If you are allergic (hypersensitive) to rupatadine or any of the other ingredients 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, consult your doctor. The use of Alergoliber 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 (known QTc interval prolongation on the ECG) that may occur in certain heart diseases, consult your doctor.

Children

This medication should not be used in children under 2 years old or weighing less than 10 kg.

Other medications and Alergoliber

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

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, 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

Alergoliber can be taken with or without food.

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

Alergoliber at a dose of 10 mg does not increase the drowsiness produced by alcohol.

Pregnancy and breastfeeding

Do not use Alergoliber during pregnancy or breastfeeding, unless your doctor considers it essential.

Consult your doctor or pharmacist before taking any medication.

Driving and using machines

It is not expected that the recommended dose of Alergoliber will have an effect on your ability to drive vehicles or operate machinery. However, when you first use Alergoliber, you should be cautious and observe how the treatment affects you before driving or operating machinery.

Alergoliber contains sucrose, methylparaben, and propylene glycol.

If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medication. It may cause tooth decay.

It may cause allergic reactions (possibly delayed) because it contains methylparaben.

This medication contains 200 mg of propylene glycol per ml.

If your child is under 5 years old, talk to your doctor or pharmacist before giving them this medication, especially if they are using other medications that contain propylene glycol or alcohol.

If you are pregnant or breastfeeding, do not take this medication unless your doctor recommends it. Your doctor may perform additional checks while you are taking this medication.

If you have liver or kidney disease, do not take this medication unless your doctor recommends it. Your doctor may perform additional checks while you are taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per ml, which is essentially "sodium-free".

3. How to take Alergoliber

Follow the instructions for administration of this medication exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

Alergoliber oral solution is administered orally.

Dosing in children with a weight of 25 kg or more: 5 ml (5 mg of rupatadine) of oral solution once a day, administered with or without food.

Dosing in children with a weight of 10 kg to less than 25 kg: 2.5 ml (2.5 mg of rupatadine) of oral solution once a day, administered with or without food.

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

Instructions for use

• To open the bottle, press the cap and turn it counterclockwise.
• Insert the syringe into the hole in the cap and invert the bottle.
• Fill the syringe with the prescribed dose.
• Administer directly with the dosing syringe.
• Wash the syringe after each use.

If you take more Alergoliber than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If you forget to take Alergoliber

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

Like all medications, Alergoliber oral solution may cause side effects, although not everyone will experience them.

Common side effects (may affect up to 1 in 10 patients) are headache and drowsiness.

Uncommon side effects (may affect up to 1 in 100 patients) are flu, nasopharyngitis, upper respiratory tract infections, increased eosinophils, decreased neutrophils, dizziness, nausea, eczema, night sweats, and fatigue.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in the leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Alergoliber

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

This medication does not require special storage conditions.

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

Medications should not be disposed of through wastewater or household waste. Dispose of the packaging and any unused medication in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Alergoliber

• The active ingredient is rupatadine. Each ml contains 1 mg of rupatadine (as fumarate).
• The other ingredients are: propylene glycol (E-1520), anhydrous citric acid, anhydrous disodium phosphate, sodium saccharin, sucrose, methylparaben (E-218), quinoline yellow (E-104), banana flavor, and purified water. See section 2 "Alergoliber contains sucrose, methylparaben, and propylene glycol".

Appearance and package contents:

Alergoliber is a clear yellow solution.

Alergoliber is available in topaz plastic bottles with a built-in perforated stopper and child-resistant cap. Each package contains a bottle with 120 ml of oral solution and includes a 5 ml oral syringe graduated to 0.25 ml.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Urquima, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans (Barcelona-Spain)

Manufacturer

Italfarmaco, S.A.

San Rafael, 3

Pol. Ind. Alcobendas

E-28108 Alcobendas (Spain)

Or

NOUCOR HEALTH, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans (Barcelona-Spain)

You can request more information about this medication from 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 1mg/ml oral solution Spain

Urtimed 1mg/ml oral solution Germany

Pafinur 1mg/ml oral solution Italy

Date of the last revision of this 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