Package leaflet: Information for the user

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

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

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 package 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, nasal congestion, itching of the eyes and nose in children aged 2 to 11 years.
Rupafin is also used to relieve symptoms of 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, consult a doctor.
Currently, Rupafin is not recommended for patients with impaired kidney or liver function.
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, medical advice should be sought.

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
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
If the patient is taking Rupafin, they should not take medicines containing ketoconazole (used to treat fungal infections) or erythromycin (used to treat bacterial infections).
If the patient is taking medicines that depress the central nervous system, statins (medicines used to treat high cholesterol levels), or midazolam (a short-acting sedative and hypnotic), they should consult their doctor before using Rupafin.

Rupafin with food, drink and alcohol
Rupafin can be taken with or without food.
Do not take Rupafin together with grapefruit juice, as this may increase the concentration 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 using this medicine.

Driving and using machines
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, caution should be exercised before driving or operating machinery, and the patient should observe their reaction to the medicine.

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 consult 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) in each ml.
Before administering this medicine to a child under 5 years of age, consult a doctor or pharmacist, especially 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 impaired liver or kidney function 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
the physician or pharmacist.
Rupafin oral solution is intended for oral administration.
Dosage in 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 in 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.
The physician will inform the patient how long the treatment with Rupafin will last.
Administration method:

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.

Overdose of Rupafin
If the patient has accidentally taken an excessive dose of the medicine, they should contact a physician
or pharmacist immediately.
Missed dose of Rupafin
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like any medicine, this medicinal product may 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, inflammation of the nose and throat, 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 be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 enables better assessment of the medicine's safety profile and helps to gather further information on its safe use.

5. How to store Rupafin

Keep the 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. 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).
Other components of the medicine 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 brown PET bottle with a perforated stopper made of LDPE, closed with a child-resistant yellow cap made of HDPE, with a capacity of 120 ml, together with an oral dosing syringe made of PP/PE with a capacity of 5 ml and graduated in 0.25 ml increments, packed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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-solità i Plegamans
Barcelona, Spain
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing authorisation number in Italy, the country of export: 037880097
Parallel import authorisation number: 97/25
This medicinal product is authorised in the European Economic Area member states under the following 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