Rupafin

Package Leaflet: Information for the User

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Rupafin, 1 mg/ml, Oral Solution

Rupatadine

Read the Leaflet Carefully Before Taking the Medicinal Product, as it Contains Important Information for the Patient.

• Keep this leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicinal product has been prescribed to you by a doctor. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Rupafin and What is it Used For
• 2. Important Information Before Taking Rupafin
• 3. How to Take Rupafin
• 4. Possible Side Effects
• 5. How to Store Rupafin
• 6. Contents of the Packaging and Other Information

1. What is Rupafin and What is it Used For

Rupafin contains the active substance rupatadine, which is an antihistamine.
Rupafin oral solution relieves the symptoms of allergic rhinitis, such as sneezing, runny nose, nasal congestion, itchy eyes and nose in children aged 2 to 11 years.
Rupafin is also used to relieve symptoms associated with urticaria (allergic skin rash), such as itching and hives (local skin redness and swelling) in children aged 2 to 11 years.

2. Important Information Before Taking Rupafin

When Not to Take Rupafin

• If the patient is allergic to rupatadine or any of the other ingredients of this medicinal product (listed in section 6).

Warnings and Precautions

Before taking Rupafin, the patient should discuss it with their doctor or pharmacist.
If the patient has kidney or liver failure, they should consult their doctor.
Rupafin is not recommended for patients with kidney or liver impairment.
If the patient has low potassium levels in the blood and/or an abnormal heart rhythm (known as QTc interval prolongation in the ECG), which may occur in some heart diseases, they should consult their doctor.

Children

This medicinal product is not intended for use in children under 2 years of age or weighing less than 10 kg.

Rupafin and Other Medicinal Products

The patient should inform their doctor or pharmacist about all medicinal products they are taking or have recently taken, as well as any medicinal products they plan to take.
If the patient is taking Rupafin, they should not take medicinal products containing ketoconazole (an antifungal medicinal product) or erythromycin (an antibacterial medicinal product).
If the patient is taking central nervous system depressants, statins (medicinal products used to treat high cholesterol) or midazolam (a short-acting sedative and hypnotic medicinal product), they should consult their doctor before taking Rupafin.

Rupafin with Food, Drink, and Alcohol

Rupafin can be taken with or without food.
Rupafin should not be taken with grapefruit juice, as it may increase the levels of Rupafin in the body.
A dose of 10 mg of Rupafin does not increase the sedative effect of alcohol.

Pregnancy and Breast-feeding

If the patient is pregnant or breast-feeding, thinks they may be pregnant or is planning to have a baby, they should consult their doctor or pharmacist before taking this medicinal product.

Driving and Using Machines

Rupafin is not expected to affect the ability to drive or use machines. However, if the patient is taking Rupafin for the first time, they should be cautious and observe their reaction to the medicinal product before driving or using machines.

Rupafin Contains Sucrose, Methyl Parahydroxybenzoate (E 218), and Propylene Glycol (E 1520)

This medicinal product contains sucrose, which may be harmful to teeth. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicinal product.
This medicinal product contains methyl parahydroxybenzoate (E 218), which may cause allergic reactions (possible late reactions).
The medicinal product contains 200 mg of propylene glycol (E 1520) per ml.
Before administering this medicinal product to a child under 5 years of age, the patient should consult their doctor or pharmacist, especially if the child is taking other medicinal products containing propylene glycol or alcohol.
Women who are pregnant or breast-feeding should not take this medicinal product without consulting their doctor.
The doctor may decide to perform additional tests on such patients.
Patient with liver or kidney impairment should not take this medicinal product without consulting their doctor. The doctor may decide to perform additional tests on such patients.
The medicinal product contains less than 1 mmol (23 mg) of sodium per ml, which means it is essentially 'sodium-free'.

3. How to Take Rupafin

Rupafin should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Rupafin oral solution is intended for oral use.
Dosage for children weighing 25 kg or more:
5 ml (5 mg of rupatadine) of oral solution once daily, with or without food.
Dosage for children weighing 10 kg or more but less than 25 kg:
2.5 ml (2.5 mg of rupatadine) of oral solution once daily, with or without food.
The doctor will inform the patient how long the treatment with Rupafin will last.

Method of Administration:

• To open the bottle, press the cap and turn it in the opposite direction of the clock hands.
• Take the dosing syringe and place it in the perforated stopper, turn the bottle upside down.
• Fill the syringe with the prescribed dose.
• Administer the solution directly from the dosing syringe.
• After use, wash the syringe.

Overdose of Rupafin

If the patient has accidentally taken a large dose of Rupafin, they should immediately consult their doctor or pharmacist.

Missed Dose of Rupafin

The patient should not take a double dose to make up for a missed dose.

4. Possible Side Effects

Like all medicinal products, Rupafin can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people) include headache and somnolence. Uncommon side effects (may affect up to 1 in 100 people) include influenza, pharyngitis, upper respiratory tract infection, eosinophilia, neutropenia, dizziness, nausea, rash, night sweats, and fatigue.

Reporting Side Effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, it is possible to gather more information on the safety of the medicinal product.

5. How to Store Rupafin

Keep the medicinal product out of the sight and reach of children.
There are no special precautions for storage.
Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
The shelf life after first opening is the same as the expiry date stated on the packaging.
Medicinal products should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicinal products they no longer use. This will help protect the environment.

6. Contents of the Packaging and Other Information

What Rupafin Contains

• The active substance is rupatadine. Each ml contains 1 mg of rupatadine (as rupatadine fumarate).
• The other ingredients are: propylene glycol (E 1520), citric acid, disodium phosphate, sodium saccharin, sucrose, methyl parahydroxybenzoate (E 218), quinoline yellow (E 104), banana flavor, purified water. See section 2 "Rupafin contains sucrose, methyl parahydroxybenzoate (E 218), and propylene glycol (E 1520)".

What Rupafin Looks Like and Contents of the Packaging

Rupafin is a clear, yellow oral solution.
Rupafin is packaged in a 120 ml brown PET bottle with a perforated LDPE stopper and a yellow HDPE child-resistant closure, and a 5 ml PP/PE oral dosing syringe with 0.25 ml gradations, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in Italy, the Country of Export:

NOUCOR HEALTH, S.A.
Av. Camí Reial, 51-57
E-08184 Palau-solità i Plegamans
Barcelona, Spain

Manufacturer:

Italfarmaco S.A.
San Rafael, 3
Pol. Ind. Alcobendas
E-28108 Alcobendas, Spain
NOUCOR HEALTH, S.A.
Av. Camí Reial, 51-57
E-08184 Palau-solitá i Plegamans
Barcelona, Spain

Parallel Importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorization Number in Italy, the Country of Export:037880097

Parallel Import Authorization Number: 97/25

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Rupatall
Belgium, Luxembourg
Rinialer
Malta, Portugal
Rupafin
Austria, Bulgaria, Croatia, Cyprus, Denmark, Estonia, Greece, Spain, Netherlands, Ireland, Iceland, Liechtenstein, Lithuania, Latvia, Germany, Norway, Poland, Slovakia, Slovenia, Italy
Wystamm
France
Tamalis
Czech Republic, Romania, Hungary
Pafinur
Finland, Sweden

Date of Approval of the Leaflet: 14.03.2025

[Information on Trademark]