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.

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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. Package contents 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 taking Rupafin, discuss it with your doctor or pharmacist.
If the patient has kidney or liver failure, they should consult their doctor.
Rupafin is not recommended for 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

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
If you are taking Rupafin, do not take medicines containing ketoconazole (a medicine used to treat fungal infections) or erythromycin (a medicine used to treat bacterial infections).
If you are taking medicines that affect the central nervous system, statins (medicines used to treat high cholesterol), or midazolam (a short-acting sedative), consult your doctor before taking Rupafin.

Rupafin with food, drink, and alcohol

Rupafin can be taken with or without food.
Do not take Rupafin with grapefruit juice, as it may increase the level of Rupafin in the body.
Rupafin 10 mg does not increase drowsiness caused by alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Rupafin is not expected to affect the ability to drive or use machines. However, if you are taking Rupafin for the first time, be cautious and observe your reaction to the medicine before driving or using machines.

Rupafin contains sucrose, methyl parahydroxybenzoate (E 218), and propylene glycol (E 1520)

This medicine contains sucrose, which may be harmful to teeth. If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.
This medicine contains methyl parahydroxybenzoate (E 218), which may cause allergic reactions (possible late reactions).
The medicine contains 200 mg of propylene glycol (E 1520) per ml.
Before administering this medicine to a child under 5 years of age, consult your doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.
Pregnant or breastfeeding women should not take this medicine without consulting their doctor.
The doctor may decide to perform additional tests on such patients.
Patient with liver or kidney disorders should not take this medicine without consulting their doctor. The doctor may decide to perform additional tests on such patients.
The medicine 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

Always take Rupafin exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Rupafin oral solution is for oral use.
Dosing for children weighing 25 kg or more:
5 ml (5 mg rupatadine) of oral solution once a day, with or without food.
Dosing for children weighing 10 kg or more, but less than 25 kg:
2.5 ml (2.5 mg rupatadine) of oral solution once a day, with or without food.
Your doctor will tell you how long the treatment with Rupafin will last.
Method of administration:

• To open the bottle, press the cap and turn it in the opposite direction of the clock hands.
• Take the dosing syringe and place it in the perforated cap, turn the bottle upside down.
• Fill the syringe with the prescribed dose.
• Administer the solution directly from the dosing syringe.
• Wash the syringe after use.

Taking a higher dose of Rupafin than recommended

If you have taken more Rupafin than 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 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 influenza, pharyngitis, upper respiratory tract infection, eosinophilia, neutropenia, dizziness, nausea, rash, night sweats, and fatigue.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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, you can help provide more information on the safety of this medicine.

5. How to store Rupafin

Keep the medicine out of the sight and reach of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the packaging. 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 packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents 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 flavor, purified water. See section 2 "Rupafin contains sucrose, methyl parahydroxybenzoate (E 218), and propylene glycol (E 1520)".

What Rupafin looks like and what the pack contains

Rupafin is a clear, yellow oral solution.
Rupafin is packaged in a 120 ml brown PET bottle with a perforated LDPE cap, a HDPE child-resistant closure, and a 5 ml PP/PE oral dosing syringe with a 0.25 ml graduation, in a cardboard box.
For more detailed information, contact the marketing authorization holder or the parallel importer.

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:

Italfarmaco S.A.
San Rafael, 3
28108 Alcobendas
Spain
Recipharm Parets S.L.
Ramón y Cajal, 2
08150 Parets del Vallés
Spain

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Romania, the country of export:9661/2017/01
Parallel import authorization number:352/18

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Other 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: 23.11.2023

[Information about the trademark]