Package Insert: Information for the Patient

Alergoliber 1 mg/ml Oral Solution

Rupatadina

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

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

1. What is Alergoliber and for what it is used

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

3. How to take Alergoliber

4. Possible adverse effects

5. Storage of Alergoliber

6. Contents of the package and additional information

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, nasal itching, and eye itching in children aged 2 to 11 years.

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

Do not take Alergoliber:

- If you are allergic (hypersensitive) to rupatadine or to 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 insufficiency, consult your doctor. The use of Alergoliber is not currently recommended in patients with kidney or liver insufficiency.

If you have low potassium levels in your blood and/or if you have a certain abnormal heart rhythm pattern (prolongation of the QTc interval 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 of age or weighing less than 10 kg.

Other medications and Alergoliber

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

If you are taking Alergoliber, do not take medications containing ketoconazole (antifungal medication) or erythromycin (bacterial infection medication).

If you are taking central nervous system depressants, statins (medications used to treat high cholesterol levels) or midazolam (sedation medication for short duration), 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 caused by alcohol.

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before taking a medication.

Driving and operating machinery

It is not expected that the recommended dose of Alergoliber will affect your ability to drive vehicles or operate machinery. Nevertheless, when you first use Alergoliber, be cautious and observe how the treatment may affect you before driving or operating machinery.

Alergoliber contains saccharose, methylparahydroxybenzoate, and propylene glycol.

If your doctor has indicated 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 methylparahydroxybenzoate.

This medication contains 200 mg of propylene glycol per ml.

If your child is under 5 years old, consult your doctor or pharmacist before administering this medication, particularly if they use other medications containing 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".

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Alergoliber oral solution is administered orally.

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

Dosage in children with a weight of 10 kg or more and less than 25 kg: 2.5 ml (2.5 mg of rupatadina) 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 in the opposite direction to the clock hands.

- Insert the syringe into the cap's perforated hole 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 Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If you forgot to take Alergoliber

Do not take a double dose to compensate for the missed doses.

Like all medications, Alergoliber oral solution may produce adverse effects, although not all people may experience them.

The frequent adverse effects (may affect up to 1 in 10 patients) are headache and drowsiness.

The infrequent adverse effects (may affect up to 1 in 100 patients) are flu, nasopharyngitis, upper respiratory tract infections, eosinophil increase, neutrophil decrease, dizziness, nausea, eczema, nocturnal sweating, and fatigue.

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

Adverse Effect Reporting:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is possible adverse effects not listed in the prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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 that appears on the box and on the bottle after CAD. The expiration date is the last day of the month indicated. The expiration date of the medication after its first opening is the same as the one indicated on the box and on the bottle label.

Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Alergoliber

–The active ingredient is rupatadine. Each ml contains 1mg of rupatadine (as fumarate).

–The other components are: propylene glycol (E-1520), anhydrous citric acid, anhydrous disodium phosphate, sodium saccharin, sucrose, methyl parahydroxybenzoate (E-218), quinoline yellow (E-104), banana flavor, and purified water.See section 2 “Alergoliber contains sucrose, parahidroxibenzoate of methyl and propylene glycol”.

Appearance of the product and contents of the container:

Alergoliber is a transparent yellow solution.

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

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Urquima, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans (Barcelona-Spain)

Responsible for manufacturing

Italfarmaco, S.A.

San Rafael, 3

Pol. Ind. Alcobendas

E-28108 Alcobendas (Spain)

O

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 with the following names:

Alergoliber 1mg/ml oral solutionSpain

Urtimed 1mg/ml oral solutionGermany

Pafinur 1mg/ml oral solutionItaly

Date of the last review of this leaflet: 08/2020

The detailed and updated information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es