Rupafin

Package Leaflet: Information for the User

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

Rupafin

1 mg/ml, oral solution

Rupatadine

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 to you by a doctor. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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 pack 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 the symptoms of allergic rhinitis, such as sneezing, runny nose, nasal congestion, itchy eyes, and itchy 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 you are 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 you have kidney or liver failure, consult your doctor. Currently, it is not recommended to use Rupafin in patients with kidney or liver function disorders.
If you have low potassium levels in the blood and (or) have an abnormal heart rhythm (known as QTc interval prolongation in the ECG), which may occur in some heart diseases, consult your 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 might take.
Do not take Rupafin if you are taking medicines containing ketoconazole (used to treat fungal infections) or erythromycin (used to treat bacterial infections).
If you are taking medicines that affect the central nervous system, statins (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 levels of Rupafin in the body.
Rupafin at a dose of 10 mg does not increase drowsiness caused by alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Rupafin is unlikely to affect your 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 been told that you have an 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 that contain propylene glycol or alcohol.
Pregnant or breastfeeding women should not take this medicine without consulting their doctor.
Your doctor may decide to perform additional tests on such patients.
Patients with liver or kidney disorders should not take this medicine without consulting their doctor. Your doctor may decide to perform additional tests on such patients.
The medicine contains less than 1 mmol (23 mg) of sodium per ml, which means it is essentially "sodium-free".

3. How to take Rupafin

Always take Rupafin exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Rupafin, oral solution, is for oral use.
Dosing for children weighing 25 kg or more:
5 ml (5 mg rupatadine) oral solution once daily, with or without food.
Dosing for children weighing 10 kg or more, but less than 25 kg:
2.5 ml (2.5 mg rupatadine) oral solution once daily, 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 to the arrow.
• Take the dosing syringe and place it in the perforated stopper, 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.

Overdose of Rupafin

If you have taken more than the prescribed dose, contact your doctor or pharmacist immediately.

Missed dose of Rupafin

Do not take a double dose to make up for a forgotten 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 you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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, you can help provide more information on the safety of this medicine.

5. How to store Rupafin

Keep this medicine out of the sight and reach of children.
No special precautions for storage are necessary.
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. Contents of the pack and other information

What Rupafin contains

• The active substance is rupatadine. Each ml contains 1 mg rupatadine (as rupatadine fumarate).
• The 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 contents of the pack

Rupafin is a clear, yellow oral solution.
Rupafin is packed in brown PET bottles with a perforated stopper and a yellow HDPE child-resistant closure, in a cardboard box. Each bottle contains 120 ml of Rupafin solution. A 5 ml PP/PE dosing syringe with 0.25 ml gradations is also included.
For more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the 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:

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 Bulgaria, the country of export: 20130384

Parallel import authorization number: 277/24

This medicine 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
Wystamm
France
Tamalis
Czech Republic, Romania, Hungary
Pafinur
Finland, Sweden

Date of revision of the leaflet: 04.07.2024

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