RINIALER 1 mg/ml ORAL SOLUTION

Introduction

PATIENT INFORMATION LEAFLET

Rinialer 1mg/ml oral solution

Rupatadine

Read this leaflet carefully before starting to take 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 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 side effects not listed in this leaflet (see section 4).

Contents of the leaflet

1. What is Rinialer and what is it 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. Package contents and additional information

1. What is Rinialer and what is it used for

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, itching of the nose and eyes in children from 2 to 11 years old.

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

2. What you need to know before taking Rinialer

Do not take Rinialer

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rinialer.

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

Children

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

Other medicines and Rinialer

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

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

If you are taking medicines that depress the central nervous system, statins (medicines used to treat high cholesterol levels) or midazolam (a medicine used for short-term sedation), 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 produced 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 medicine.

Driving and using machines

It is unlikely that Rinialer will affect your ability to drive or use machines at the recommended dose. However, when you first use Rinialer, you should be cautious and see how the treatment affects you before driving or using machines.

Rinialer contains sucrose, methyl parahydroxybenzoate, and propylene glycol

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

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate

This medicine 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 medicine, especially if they use other medicines that contain propylene glycol or alcohol

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

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

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

3. How to take Rinialer

Follow exactly the administration instructions of this medicine 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 it counterclockwise.
• Insert the syringe into the hole in the cap and turn the bottle upside down.
• 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 Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount ingested.

If you forget to take Rinialer

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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.

Reporting side effects:

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

5. Storage of Rinialer

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

This medicine does not require special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Rinialer

• 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, methyl parahydroxybenzoate (E-218), quinoline yellow (E-104), banana flavor, and purified water. See section 2 "Rinialer contains sucrose, methyl parahydroxybenzoate, and propylene glycol".

Appearance and package contents

Rinialer is a clear yellow solution.

Rinialer is available in topaz plastic bottles with a built-in perforated stopper and child-resistant cap. Each pack contains a bottle with 120 ml of oral solution 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)

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 medicine by contacting the local representative of the marketing authorization holder:

Laboratorios BIAL, S.A.

C/ Alcalá 265, Edificio 2, Planta 2ª

28027 Madrid (Spain)

Date of last revision of this leaflet: November 2020

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