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
Rupatadinum
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

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

Table of 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 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, nasal congestion, 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 renal or hepatic impairment, medical advice should be sought. Currently,
the use of Rupafin is not recommended in patients with renal or hepatic dysfunction.
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 a 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
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan 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.
Rupafin should not be taken 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 drowsiness caused by alcohol.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using 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, caution should be exercised before driving or operating machinery, and the patient should observe their individual response 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 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) in each 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 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; therefore, it is considered "sodium-free".

3. How to take Rupafin

Rupafin should always be taken according to the doctor's instructions. If in doubt, contact your doctor or pharmacist.
Rupafin oral solution is intended for oral use.
Dosing 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.
Dosing 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 doctor will inform the patient how long the treatment with Rupafin should 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; 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.

Accidental overdose of Rupafin
If the patient has accidentally taken a larger than recommended dose of the medicine, they should contact a doctor or pharmacist immediately.
Missed dose of Rupafin
Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Common adverse effects (may occur in up to 1 in 10 patients) are: headache and drowsiness.
Uncommon adverse effects (may occur in up to 1 in 100 patients) are: influenza, inflammation of the nasal pharynx, upper respiratory tract infection, eosinophilia, neutropenia, dizziness, nausea, rash, night sweats, and fatigue.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse effects 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 effects helps to provide more information on the safety of the medicine.

5. How to store Rupafin
Keep the medicine out of sight and reach of children.
No special storage instructions are required.
Do not use the 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 the sewage system or household waste. Ask a pharmacist how to dispose of medicines no longer in use. 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).
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 brown PET bottles with a perforated stopper made of LDPE, closed with a child-resistant yellow cap made of HDPE, and packed in a cardboard box. Each bottle contains 120 ml of Rupafin oral solution. An oral dosing syringe made of PP/PE with a capacity of 5 ml and graduations of 0.25 ml is included in the pack.
For further information, contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Bulgaria, the country of export:
Noucor Health, S.A.
Av. Camí Reial, 51-57
08184 Palau-solità i Plegamans (Barcelona)
Spain
Manufacturer:
Italfarmaco S.A.
San Rafael, 3
Pol. Ind. Alcobendas
28108 Alcobendas (Madrid)
Spain
Recipharm Parets S.L.
Ramón y Cajal, 2
08150 Parets del Vallés
Spain
Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation Number in Bulgaria, the country of export: 20130384
Parallel Import Licence Number: 277/24
This medicinal product is authorised in the European Economic Area (EEA) Member States 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