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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicinal product has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your 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 Pack 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 or itchy nose, and itchy eyes in children aged 2 to 11 years.
Rupafin is also used to relieve the symptoms of urticaria (hives), 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 you are allergic to rupatadine or any of the other ingredients of this medicinal product (listed in section 6).

Warnings and Precautions

Before taking Rupafin, you should discuss it with your doctor or pharmacist.
If you have kidney or liver problems, you should consult your doctor.
Rupafin is not recommended for patients with kidney or liver problems.
If you have low potassium levels in your blood and/or an abnormal heart rhythm (known as QTc interval prolongation in the ECG), which may occur in some heart conditions, you should consult your doctor.

Children

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

Rupafin and Other Medicinal Products

Tell your doctor or pharmacist about all the medicinal products you are taking or have recently taken, as well as any you plan to take.
If you are taking Rupafin, you should not take medicinal products containing ketoconazole (used to treat fungal infections) or erythromycin (used to treat bacterial infections).
If you are taking medicinal products that affect the central nervous system, statins (used to treat high cholesterol levels), or midazolam (a short-acting sedative), you should consult your 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 your body.
A dose of 10 mg of Rupafin does not increase the sedative effect of alcohol.

Pregnancy and Breast-Feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicinal product.

Driving and Using Machines

Rupafin is unlikely to affect your ability to drive or use machines. However, if you are taking Rupafin for the first time, you should be cautious and observe your 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 your teeth. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicinal product contains methyl parahydroxybenzoate (E 218), which may cause allergic reactions (possibly delayed 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, consult your 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 problems 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

Always take Rupafin exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Rupafin oral solution is for oral use only.
Dosing in children with a body weight of 25 kg or more:
5 ml (5 mg rupatadine) of oral solution once daily, with or without food.
Dosing in children with a body weight of 10 kg or more, but less than 25 kg:
2.5 ml (2.5 mg rupatadine) of oral solution once daily, with or without food.
Your doctor will inform you 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 to the arrow.
• Take the dosing syringe and insert it into the perforated stopper, turn the bottle upside down.
• Fill the syringe with the prescribed dose.
• Administer the solution directly from the dosing syringe.
• Wash the syringe after use.

Overdose of Rupafin

If you accidentally take too much of the medicinal product, contact your doctor or pharmacist immediately.

Missed Dose of Rupafin

Do not take a double dose to make up for a forgotten 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, nocturnal hyperhidrosis, and fatigue.

Reporting of Side Effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported to the Department of Pharmacovigilance of the 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, you can help provide more information on the safety of this medicinal product.

5. How to Store Rupafin

Keep this medicinal product out of the sight and reach of children.
No special precautions for storage are necessary.
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. Ask your pharmacist how to dispose of medicinal products no longer required. This will help protect the environment.

6. Contents of the Pack 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 Pack

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

Marketing Authorization Holder in Greece, the Country of Export:

Galenica AE
Eleftherias 4, 145 64 Kifisia
Greece

Manufacturer:

Italfarmaco S.A.
San Rafael, 3
Pol. Ind. Alcobendas
E-28108 Alcobendas
Spain
Recipharm Parets S.L.
Ramón y Cajal, 2
08150 Parets del Vallés
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 Greece, the Country of Export:104670/24-11-2017

Parallel Import Authorization Number: 307/23

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 Revision of the Leaflet: 22.12.2023

[Information on Trademark]