Rupafin

PATIENT INFORMATION LEAFLET: USER INFORMATION

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Rupafin(Tamalis)

1 mg/ml, oral solution

Rupatadine
Rupafin and Tamalis are different trade names for the same medicine.

It is necessary to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Rupafin and what is it used for
• 2. Important information before taking Rupafin
• 3. How to take Rupafin
• 4. Possible side effects
• 5. How to store Rupafin
• 6. Contents of the packaging and other information

1. What is Rupafin and what is it 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, stuffy nose, itchy 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 (local skin redness and swelling) 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, the doctor or pharmacist should be consulted.
If the patient has kidney or liver failure, they should consult their doctor. Currently, it is not recommended to use Rupafin in patients with kidney or liver function disorders.
If the patient has low potassium levels in the blood and/or an abnormal heart rhythm (known as QTc interval prolongation in the ECG), which may occur in some heart diseases, they should consult their 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

The doctor or pharmacist should be informed 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 (a medicine used to treat fungal infections) or erythromycin (a medicine used to treat bacterial infections).
If the patient is taking medicines that affect the central nervous system, statins (medicines used to treat high cholesterol levels) or midazolam (a short-acting sedative), they should consult their doctor before taking Rupafin.

Rupafin with food, drink, and alcohol

Rupafin can be taken with or without food.
Rupafin should not be taken at the same time as grapefruit juice, as this may increase the level 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, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

It is not expected that Rupafin, when used as recommended, will affect the ability to drive or use machines. However, if the patient is taking Rupafin for the first time, they should be cautious and observe their reaction to the medicine before driving or using machines.
Rupafin contains sucrose, methyl parahydroxybenzoate, and propylene glycolThis medicine contains sucrose, which may have a harmful effect on teeth. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.
This medicine contains methyl parahydroxybenzoate, which may cause allergic reactions (possible late reactions).
The medicine contains 200 mg of propylene glycol in each ml.
Before administering this medicine to a child under 5 years of age, the doctor or pharmacist should be consulted, 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 consulting their doctor.
The doctor may decide to perform additional tests on such patients.
Patients with liver or kidney function disorders should not take this medicine without consulting their doctor. The doctor may decide to perform additional tests on such patients.
The medicinal product contains less than 1 mmol (23 mg) of sodium per 1 ml, which means the medicine is considered "sodium-free".

3. How to take Rupafin

Rupafin should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
Rupafin oral solution is intended for oral use.
Dosing in children with a body weight of 25 kg or more:
5 ml (5 mg of rupatadine) of oral solution once a day, with or without food.
Dosing in children with a body weight of 10 kg or more, but less than 25 kg:
2.5 ml (2.5 mg of rupatadine) of oral solution once a day, with or without food.
The doctor will inform the patient how long the treatment with Rupafin will last.
Method of administration:

• To open the bottle, the cap should be pressed and turned in the opposite direction to the clockwise direction.
• Take the syringe and place it in the perforated cork, 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 a higher dose of Rupafin than recommended

If the patient has accidentally taken a large dose of the medicine, they should immediately consult their doctor or pharmacist.

Missing a dose of Rupafin

A double dose should not be taken to make up for a missed dose.

4. Possible side effects

Like all medicines, Rupafin can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people) include headache and drowsiness. Uncommon side effects (may affect up to 1 in 100 people) include flu, pharyngitis, upper respiratory tract infection, eosinophilia, neutropenia, dizziness, nausea, rash, night sweats, and fatigue.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: + 48 22 49 21 301,
fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Rupafin

The medicine should be stored out of sight and reach of children.
There are no special precautions for storage of the medicinal product.
The medicine should not be used after the expiry date stated on the bottle and carton after EXP. The expiry date refers to the last day of the month stated.
The shelf life after first opening is the same as the expiry date stated on the carton and bottle.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Rupafin contains

• The active substance of the medicine is rupatadine. Each ml contains 1 mg of rupatadine (as rupatadine fumarate).
• Other ingredients of the medicine are: propylene glycol, citric acid, disodium phosphate, sodium saccharin, sucrose, methyl parahydroxybenzoate (E 218), quinoline yellow (E 104), banana flavor, purified water. See section 2 "Rupafin contains sucrose, methyl parahydroxybenzoate, and propylene glycol".

What Rupafin looks like and what the pack contains

Rupafin is a clear, yellow oral solution.
Rupafin is packaged in brown PET bottles with a perforated cork made of LDPE, with a closure made of HDPE that is child-resistant, and a 5 ml oral dosing syringe made of PP/PE with a graduation of 0.25 ml, in a cardboard box.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Romania, the country of export:

• J. Uriach y Compañia, S.A. Av. Camí Reial, 51-57 08184 Palau-solità i Plegamans 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:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Romania, the country of export: 9661/2017/01
Parallel import authorization number: 125/19

This medicinal product is authorized in the Member States of the European Economic Area 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

Date of approval of the leaflet: 25.03.2024

[Information about the trademark]