Rupafin

Package Leaflet: Information for the User

Warning! Keep the leaflet. Information on the immediate packaging 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 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, 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 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, 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 impairment.
If the patient has low potassium levels in the blood and (or) has 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 the patient is 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 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), 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 with grapefruit juice, as it 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

Rupafin is not expected to 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 glycol

This medicine contains sucrose, which may be harmful to 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, consult a 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 a doctor.
The doctor may decide to perform additional tests on such patients.
Patients with liver or kidney disorders should not take this medicine without consulting a 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 according to the doctor's instructions. If in doubt, consult a doctor or pharmacist.
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, press the cap and turn it in the opposite direction to the arrow.
• 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 a doctor or pharmacist.

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: flu, pharyngitis, upper respiratory tract infection, eosinophilia, neutropenia, dizziness, nausea, rash, night sweats, and fatigue.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, tell a doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
Reporting side effects will help to gather more information on the safety of the 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 on the carton and bottle.
Medicines should not be disposed of via wastewater or household waste. Ask a 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 of rupatadine (as rupatadine fumarate).
• Other ingredients are: propylene glycol, citric acid, disodium phosphate, sodium saccharin, sucrose, methyl parahydroxybenzoate, quinoline yellow (E 104), banana flavor, 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 packaged in brown PET bottles with an LDPE connector, with an HDPE child-resistant closure, in a cardboard box. Each bottle contains 120 ml of Rupafin solution. The pack includes a 5 ml PP/PE oral syringe with 0.25 ml gradations.
For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Greece, the country of export:

Olvos Science A.E.
Eleftherias 4, 145 64 Kifissia, Greece

Manufacturer:

Italfarmaco, S.A.
San Rafael, 3, Pol. Ind. Alcobendas, E-28108 Alcobendas, Spain
Recipharm Parets S.L.
Ramón y Cajal, 2, 08150 Parets del Vallès, Spain

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Greek marketing authorization number: 104670/24-11-2017

Parallel import authorization number: 253/24

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 revision of the leaflet: 25.06.2024

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