RUPAFIN 1 mg/ml ORAL SOLUTION

Introduction

Patient Information Leaflet

Rupafin 1 mg/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 any questions, ask 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 any 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 is Rupafin and what is it used for
2. What you need to know before taking Rupafin
3. How to take Rupafin
4. Possible side effects
5. Storage of Rupafin
6. Package contents and additional information

1. What is Rupafin and what is it used for

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

Rupafin 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.

Rupafin 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 Rupafin

Do not take Rupafin:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rupafin.

If you have kidney or liver failure, consult your doctor. The use of Rupafin 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 medicine should not be used in children under 2 years old or weighing less than 10 kg.

Other medicines and Rupafin

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

If you are taking Rupafin, 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 Rupafin.

Taking Rupafin with food, drinks, and alcohol

Rupafin can be taken with or without food.

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

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

Rupafin 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 in each 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 Rupafin

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

Rupafin 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 Rupafin.

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 Rupafin 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 Rupafin

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 everyone 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 not listed in this 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 medicine.

5. Storage of Rupafin

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. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Rupafin

• 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 "Rupafin contains sucrose, methyl parahydroxybenzoate, and propylene glycol".

Appearance and packaging of the product:

Rupafin is a clear yellow solution.

Rupafin 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

LABORATORIOS ERN, S.A.

Perú, 228

08020 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)

This medicine is authorized in the Member States of the European Economic Area under the following names:

Rupatall 1 mg/ml oral solution Belgium, Luxembourg

Rinialer 1 mg/ml oral solution Portugal, Malta

Rupafin 1mg/ml oral solution Austria, Bulgaria, Croatia, Cyprus, Denmark, Estonia, Germany, Greece, Iceland, Italy, Ireland, Latvia, Liechtenstein, Lithuania, Netherlands, Norway, Poland, Slovenia, Slovakia, Spain

Rupatadine 1 mg/ml oral solution United Kingdom

Wystamm 1mg/ml oral solution France

Tamalis 1mg/ml oral solution Hungary, Czech Republic, Romania

Pafinur 1mg/ml oral solution Finland, Sweden

Date of last revision of this leaflet: 08/2020

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