Leaflet: information for the patient

Rupafin 1 mg/ml oral solution

Rupatadina

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, 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 Rupafin is and what it is used for

2. What you need to know before you start taking Rupafin

3. How to take Rupafin

4. Possible side effects

5. Storage of Rupafin

6. Contents of the pack and additional information

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, nasal itch, and eye itch in children aged2 to11 years.

Rupafin is also indicated for the relief of symptoms associated with urticaria (allergic skin eruption) such as itch and skin hives (redness and swelling of the skin) in children aged2 to11 years.

Do not take Rupafin:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rupafin.

If you have kidney or liver insufficiency, consult your doctor. The use of Rupafin is not currently recommended in patients with kidney or liver insufficiency.

If you have low levels of potassium in the 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 Rupafin

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

If you are taking Rupafin, 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 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 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 Rupafin will affect your ability to drive vehicles or operate machinery. Nevertheless, when you first use Rupafin, be cautious and see how it affects you before driving or operating machinery.

Rupafin 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, 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.

Rupafin 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 Rupafin.

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 Rupafin 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 Rupafin

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.

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.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines 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 date of the medication after its first opening is the same as the one 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 that 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 that you no longer need. In this way, you will help protect the environment.

Composition of Rupafin

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

Appearance of the product and contents of the package:

Rupafin is a transparent yellow solution.

Rupafin 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

LABORATORIOS ERN, S.A.

Perú, 228

08020 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)

This medicine is authorized in the member states of the European Economic Area with the following names:

Rupatall 1 mg/ml oral solutionBelgium, Luxembourg

Rinialer 1 mg/ml oral solutionPortugal, Malta

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

Rupatadine 1 mg/ml oral solutionUnited Kingdom

Wystamm 1mg/ml oral solutionFrance

Tamalis 1mg/ml oral solutionHungary, Czech Republic, Romania

Pafinur 1mg/ml oral solutionFinland, Sweden

Last review date of this leaflet: 08/2020

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