PATIENT INFORMATION LEAFLET

Rinialer 1mg/ml oral solution

Rupatadina

Read this 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 anydoubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet (see section 4).

1. What Rinialer is and what it is used for

2. What you need to know before taking Rinialer

3. How to take Rinialer

4. Possible side effects

5. Storage of Rinialer

6. Contents of the pack and additional information

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

Rinialer 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 aged2 to11 years.

Rinialer 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 aged2 to11 years.

Do not take Rinialer

- 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 Rinialer.

If you have kidney or liver insufficiency, consult your doctor. The use of Rinialer 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 Rinialer

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

If you are taking Rinialer, do not take medications that contain 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 Rinialer.

Taking Rinialer with food, drinks, and alcohol

Rinialer can be taken with or without food.

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

Rinialer, at a dose of 10 mg, does not increase the drowsiness caused by alcohol.

Pregnancy and breastfeeding

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

Driving and operating machinery

It is not expected that the recommended dose of Rinialer will affect your ability to drive vehicles or operate machinery. However, when you first use Rinialer, be cautious and see how it affects you before driving or operating machinery.

Rinialer 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 in each ml.

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

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

Rinialer oral solution is administered orally.

Dosage 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.

Dosage in children with a weight of 10 kg or more and 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 Rinialer.

Instructions for use

- To open the bottle, press the cap and turn in a direction opposite to the clock hands.

- Insert the syringe into the cap's perforated opening 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 Rinialer 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 Rinialer

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

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

Rare adverse effects (may affect up to 1 in 100 patients) are influenza, nasopharyngitis, upper respiratory tract infections, eosinophilia, neutropenia, dizziness, nausea, eczema, nocturnal sweating, and fatigue.

Reporting 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 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 conditions for conservation.

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 of the medication after its first opening is the same as indicated on the box and on the label of the bottle.

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 of 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 Rinialer

–The active ingredient is rupatadina. Each ml contains 1mg of rupatadina (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 “Rinialer contains saccharose, parahydroxybenzoate of methyl and propylene glycol”.

Appearance of the product and contents of the packaging

Rinialer is a transparent yellow solution.

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

Marketing Authorization Holder

NOUCOR HEALTH, 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)

or

NOUCOR HEALTH, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans (Barcelona-Spain)

For more information about this medication, please contact the local representative of the marketing authorization holder:

Laboratorios BIAL, S.A.

C/ Alcalá 265, Edificio 2, Planta 2ª

28027 Madrid (Spain)

Last review date of this leaflet: November 2020

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