Rupafin
Poland
Table of Contents
Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Rupafin
1 mg/ml, oral solution
Rupatadinum
Please read the entire 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, please consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not share it with others. This medicine 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 a doctor or pharmacist. See section 4.
Table of contents of the leaflet
- What is Rupafin and what is it 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 is Rupafin and what is it 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 to 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 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 and 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 (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 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 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 reaction 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) 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.
The medicine contains less than 1 mmol (23 mg) of sodium per 1 ml; therefore, the medicine is considered "sodium-free".
3. How to take Rupafin
Rupafin should always be taken exactly as your doctor has told you. If you are unsure, you should contact your doctor or pharmacist.
Rupafin oral solution is for oral use.
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.
Your doctor will inform you how long the treatment with Rupafin should last.
Method of administration:
- 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.
- Draw up the recommended dose into the syringe.
- 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 large dose of this medicine, you should contact your doctor or pharmacist immediately.
If you forget to take Rupafin
Do not take a double dose to make up for the missed dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may occur in not more than 1 in 10 patients) are: headache and somnolence.
Uncommon side effects (may occur in not more than 1 in 100 patients) are: influenza, nasopharyngitis, upper respiratory tract infection, eosinophilia, neutropenia, dizziness, nausea, rash, night sweats, and fatigue.
Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side 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.
By reporting side effects, additional information on the safety of the medicine can be collected.
5. How to store the medicine Rupafin
Keep the medicine out of sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
The shelf life after first opening is the same as the expiry date printed on the packaging.
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 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 a perforated stopper made of LDPE, a child-resistant closure made of HDPE, and an oral dosing syringe made of PP/PE with a capacity of 5 ml and graduations of 0.25 ml accuracy, packed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Bulgaria, the country of export:
J. Uriach y Compañia 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:
InPharm Sp. z o.o.
Strumykowa 28/11
03-138 Warsaw
Repackaged by:
Pharma Innovations Sp. z o.o.
Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Bulgaria, the country of export: 20130384
Parallel Import Authorisation Number: 369/18
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, 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