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 Medicine

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine 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, pharmacist, or nurse. 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 from 2 to 11 years of age.
Rupafin is also used to relieve the symptoms of urticaria (hives), such as itching and hives (local skin redness and swelling) in children from 2 to 11 years of age.

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 medicine (listed in section 6).

Warnings and Precautions

Before taking Rupafin, discuss it with your doctor or pharmacist.
If you have kidney or liver problems, 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, consult your doctor.

Children

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

Rupafin and Other Medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
Do not take Rupafin if you are taking medicines containing ketoconazole (used to treat fungal infections) or erythromycin (used to treat bacterial infections).
If you are taking medicines that affect the central nervous system, statins (used to treat high cholesterol), or midazolam (a short-acting sedative), consult your doctor before taking Rupafin.

Rupafin with Food, Drink, and Alcohol

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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, be cautious and observe your reaction to the medicine before driving or using machines.

Rupafin Contains Sucrose, Methyl Parahydroxybenzoate, and Propylene Glycol

This medicine 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 medicine.
This medicine contains methyl parahydroxybenzoate, which may cause allergic reactions (possible late reactions).
The medicine contains 200 mg of propylene glycol in each ml.
Before administering this medicine to a child under 5 years of age, consult your doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.
Pregnant or breastfeeding women should not take this medicine without consulting their doctor.
Your doctor may decide to perform additional tests on such patients.
Patient with liver or kidney problems should not take this medicine without consulting their doctor. Your doctor may decide to perform additional tests on such patients.
The medicinal product contains less than 1 mmol (23 mg) of sodium per 1 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 for Children Weighing 25 kg or More:
5 ml (5 mg rupatadine) of oral solution once daily, with or without food.
Dosing for Children Weighing 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 tell you how long you should take Rupafin.
Method of Administration:

• To open the bottle, press the cap and turn it in the opposite direction of the arrow.
• 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.
• Wash the syringe after use.

Overdose of Rupafin

If you accidentally take too much of the medicine, 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 medicines, Rupafin can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people) include headache and drowsiness. 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 you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to Store Rupafin

Keep the medicine out of the sight and reach of children.
No special precautions for storage are necessary.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
The shelf life after first opening is the same as the expiry date on the carton and bottle.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines 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, citric acid, disodium phosphate, sodium saccharin, sucrose, methyl parahydroxybenzoate, quinoline yellow (E 104), banana flavor, purified water. See section 2 "Rupafin contains sucrose, methyl parahydroxybenzoate, and propylene glycol".

What Rupafin Looks Like and Contents of the Pack

Rupafin is a clear, yellow oral solution.
Rupafin is packaged in PET bottles with an LDPE adapter and an HDPE child-resistant closure in a cardboard box. Each bottle contains 120 ml of Rupafin solution. A 5 ml PP/PE dosing syringe with 0.25 ml gradations is included in the packaging.
For more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in Spain, the Country of Export:

LABORATORIOS ERN, S.A.
Perú, 228, 08020 Barcelona, Spain

Manufacturer:

Italfarmaco, S.A.
San Rafael, 3 - Pol. Ind. Alcobendas, E-28108 Alcobendas, Spain

Parallel Importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Spanish export authorization number: 688748.6

Parallel Import Authorization Number: 254/24

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
Rupatadine
United Kingdom
Wystamm
France
Tamalis
Czech Republic, Romania, Hungary
Pafinur
Finland, Sweden

Date of Approval of the Leaflet: 25.06.2024

[Information about the trademark]