Rupafin
Poland
Table of Contents
Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Rupafin, 1 mg/ml, oral solution
Rupatadinum
Please read the 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, please consult 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 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 kidney or liver 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 diseases,
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.
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Rupafin and other medicines
You must inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
If the patient is taking Rupafin, they should not take medications containing ketoconazole (a medicine used for fungal infections) or erythromycin (a medicine used for 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 medicine), 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 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 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 response to the medicine.
Rupafin contains sucrose, methyl parahydroxybenzoate (E 218), and propylene glycol
This medicine contains sucrose, which may have harmful effects 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, which may cause allergic reactions (including delayed-type reactions).
The medicine contains 200 mg of propylene glycol in each ml.
Before administering this medicine to a child under 5 years of age, contact 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 medicinal product contains less than 1 mmol (23 mg) of sodium per 1 ml, i.e. the medicine is considered "sodium-free".
3. How to take Rupafin
Rupafin must always be taken according to the doctor's instructions. In case of doubts, please
contact your doctor or pharmacist.
Rupafin oral solution is intended for oral use.
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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.
Your doctor will inform you 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.
Taking more Rupafin than prescribed
If you accidentally take a larger than recommended dose of the medicine, you should contact your doctor
or pharmacist immediately.
Missing a dose of Rupafin
Do not take a double dose to make up for a missed dose.
4. Possible adverse reactions
Like any medicine, the Rupafin 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, pharmacist, or nurse. 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 further information on the safety of this medicine to be collected.
5. How to store Rupafin
No special storage instructions are required.
Keep the medicine out of the sight and reach of children.
Do not use Rupafin 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.
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Medicines must not be disposed of via wastewater or household waste. Ask your 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, 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".
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 an LDPE tamper-evident closure, HDPE child-resistant cap, and includes an oral dosing syringe made of PP/PE with a capacity of 5 ml and graduations of 0.25 ml accuracy, all contained in a cardboard box.
For further information, contact the marketing authorisation holder or parallel importer.
Marketing Authorisation Holder in Bulgaria, 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation Number in Bulgaria, country of export: 20130384
Parallel Import Licence Number: 110/20
This medicinal product is authorised in the European Economic Area countries 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
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