Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Rupafin, 1 mg/ml, oral solution
Rupatadinum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Table of contents:

What Rupafin is and what it is used for
Important information before taking Rupafin
How to take Rupafin
Possible side effects
How to store Rupafin
Contents of the pack and other information

1. What Rupafin is and what it is used for

Rupafin contains the active substance rupatadine, which is an antihistamine medicine.
Rupafin oral solution relieves symptoms of allergic rhinitis such as sneezing, runny nose, blocked nose, itching of the 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 (localized redness and swelling of the skin) 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 medicine (listed in section 6).

Warnings and precautions
Before starting to take Rupafin, discuss this with your doctor or pharmacist.
If the patient has kidney or liver impairment, medical advice should be sought.
Currently, the use of Rupafin is not recommended in patients with kidney or liver function disorders.
If the patient has low blood potassium levels and/or has an abnormal heart rhythm (known as QTc prolongation on ECG), which may occur in certain heart conditions, they should consult their doctor.

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

Rupafin with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
If the patient is taking Rupafin, they should not take medicines containing ketoconazole (a medicine used for fungal infections) or erythromycin (a medicine used for bacterial infections).
If the patient is taking medicines that suppress the central nervous system, statins (medicines used to treat high cholesterol), or midazolam (a short-acting sedative and hypnotic medicine), 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 together with grapefruit juice, as this may lead to increased levels of Rupafin in the body.
Rupafin at a dose of 10 mg does not increase alcohol-induced drowsiness.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before taking this medicine.

Driving and operating machinery
Rupafin, when used at recommended doses, is not expected to affect the ability to drive or operate machinery. However, if the patient is taking Rupafin for the first time, they should exercise caution and observe their response to the medicine before driving or operating machinery.

Rupafin contains sucrose, methyl parahydroxybenzoate (E 218), and propylene glycol (E 1520)
This medicine contains sucrose, which may have a harmful effect on teeth. If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.
This medicine contains methyl parahydroxybenzoate (E 218), which may cause allergic reactions (including delayed-type reactions).
The medicine contains 200 mg of propylene glycol (E 1520) per ml.
Before administering this medicine to a child under 5 years of age, contact a doctor or pharmacist, particularly if the child is taking other medicines containing propylene glycol or alcohol.
Women who are pregnant or breastfeeding should not take this medicine without medical advice. The doctor may decide to perform additional monitoring in such patients.
Patients with liver or kidney function disorders should not take this medicine without medical advice. The doctor may decide to perform additional monitoring in such patients.
This medicine contains less than 1 mmol (23 mg) of sodium per 1 ml, meaning the medicine is considered "sodium-free".

3. How to take Rupafin

Rupafin should always be taken exactly as directed by the physician. In case of doubts, contact your doctor or pharmacist.
Rupafin oral solution is intended for oral use.
Dosage for children with body weight of 25 kg or more:
5 ml (5 mg of rupatadine) of oral solution once daily, with or without food.
Dosage for children with body weight of 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.
Your doctor will inform you how long the treatment with Rupafin should last.
Administration instructions:

To open the bottle, press down on the cap and turn it counterclockwise.
Take the syringe and insert it into the perforated stopper; then 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.

If you take more Rupafin than you should
If you accidentally take a larger than recommended dose of this medicine, contact your doctor or pharmacist immediately.
If you forget to take Rupafin
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Common adverse reactions (may occur in up to 1 in 10 patients) include: headache and somnolence.
Uncommon adverse reactions (may occur in up to 1 in 100 patients) include: influenza, nasopharyngitis, upper respiratory tract infection, eosinophilia, neutropenia, dizziness, nausea, rash, night sweats, and fatigue.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Rupafin

Keep this medicine out of the sight and reach of children.
There are no special storage instructions.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
The shelf life after first opening is the same as the expiry date indicated on the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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).
Other ingredients are: propylene glycol (E 1520), citric acid, disodium phosphate, sodium saccharin, sucrose, methyl parahydroxybenzoate (E 218), quinoline yellow (E 104), banana flavour, 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 supplied in a 120 ml brown PET bottle with an integrated, perforated stopper made of LDPE, a yellow HDPE screw cap with child-resistant safety feature, and a 5 ml oral dosing syringe made of PP/PE with graduations of 0.25 ml accuracy, all contained in a cardboard carton.
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in Spain, 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
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, Poland
Repackaged at:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Spanish marketing authorisation number, country of export: 688748.6
Parallel import authorisation number: 273/23
This medicinal product is authorised in the European Economic Area countries under the following trade names:
Rupatall Belgium, Luxembourg
Rinialer Malta, Portugal
Rupafin Austria, Bulgaria, Croatia, Cyprus, Denmark, Estonia, Greece, Spain, the Netherlands,
Ireland, Iceland, Liechtenstein, Lithuania, Latvia, Germany, Norway, Poland, Slovakia,
Slovenia, Italy
Wystamm France
Tamalis Czech Republic, Romania, Hungary
Pafinur Finland, Sweden