Package leaflet: Information for the user

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Rupafin (Tamalis), 1 mg/ml, oral solution
Rupatadinum
Rupafin and Tamalis are different trade names for the same medicine.
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 give it to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. 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.
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 treatment with 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 their doctor.

Children
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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, has recently taken, or 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), 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.
Do not take Rupafin 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 response to the medicine before driving or operating machinery.

Rupafin contains sucrose, methyl parahydroxybenzoate, 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 per 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 medicinal product 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
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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.
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 recommended
If you have taken too much medicine, contact your doctor or pharmacist immediately.
If you miss a dose of Rupafin
Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Common side effects (may occur in up to 1 in 10 patients) include: headache and drowsiness.
Uncommon side effects (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 side effects
If any side effects occur, including any side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects 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
By reporting side effects, you help provide more information on the safety of this medicine.

5. How to store Rupafin

No special storage instructions are required.
Keep the medicine out of sight and reach of children.
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Do not use this medicine after the expiry date stated on the container.
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 carton and bottle.
Medicines should 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 pack 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, citric acid, disodium phosphate, sodium saccharin, sucrose, methyl parahydroxybenzoate, quinoline yellow (E 104), banana flavour, purified water. See section 2 "Rupafin contains sucrose, methyl parahydroxybenzoate and propylene glycol".

What Rupafin looks like and contents of the pack
Rupafin is a clear yellow oral solution.
Rupafin is supplied in PET bottles with LDPE adapter and HDPE child-resistant closure,
packaged in a cardboard box. Each bottle contains 120 ml of Rupafin 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, please contact the marketing authorisation holder or parallel importer.
Marketing Authorisation Holder in Romania, country of export:
J. Uriach y Compañia., S.A.
Av. Camí Reial, 51-57
08184 Palau-solitá i Plegamans, Barcelona
Spain
Manufacturer:
Recipharm Parets S.L.
Ramón y Cajal, 2
08150 Parets del Vallés
Spain
Italfarmaco S.A.
San Rafael, 3
Alcobendas 28108
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
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Marketing Authorisation Number in Romania, country of export: 9661/2017/01
Parallel Import Licence Number: 102/17
This medicinal product is authorised for marketing 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
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