Rupafin

Package Leaflet: Information for the User

Rupafin, 1 mg/ml, Oral Solution

Rupatadine

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Have Any Further Questions, Ask Your Doctor or Pharmacist.
• This Medication Has Been Prescribed for You Only. 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 Those Not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

• 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 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 the Symptoms of Urticaria (Allergic Skin Rash), Such as Itching and Hives (Local 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 You are Allergic to Rupatadine or Any of the Other Ingredients of this Medication (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.
Rupafin is Not Recommended for Patients with Kidney or Liver Impairment.
If You Have Low Potassium Levels in the Blood and/or Abnormal Heart Rhythm (Known as Prolonged QTc Interval in the ECG), Which May Occur in Certain Heart Conditions, Consult Your Doctor.

Children

This Medication is Not Intended for Use in Children Under 2 Years of Age or Weighing Less than 10 kg.

Rupafin and Other Medications

Tell Your Doctor or Pharmacist About All Medications You are Currently Taking or Have Recently Taken, as Well as Any Medications You Plan to Take.
If You are Taking Rupafin, Do Not Take Medications Containing Ketokonazole (an Antifungal Medication) or Erythromycin (an Antibiotic).
If You are Taking Medications that Affect the Central Nervous System, Statins (Cholesterol-Lowering Medications), 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 Medication.

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 Medication Before Driving or Using Machines.

Rupafin Contains Sucrose, Methyl Parahydroxybenzoate, and Propylene Glycol

This Medication Contains Sucrose, Which May be Harmful to Teeth. If You Have Been Diagnosed with Intolerance to Some Sugars, Consult Your Doctor Before Taking this Medication.
This Medication Contains Methyl Parahydroxybenzoate, Which May Cause Allergic Reactions (Possible Late-Stage Reactions).
The Medication Contains 200 mg of Propylene Glycol in Each ml.
Before Administering this Medication to a Child Under 5 Years of Age, Consult Your Doctor or Pharmacist, Especially if the Child is Taking Other Medications Containing Propylene Glycol or Alcohol.
Pregnant or Breastfeeding Women Should Not Take this Medication Without Medical Advice. The Doctor May Decide to Perform Additional Tests on Such Patients.
Patient with Liver or Kidney Impairment Should Not Take this Medication Without Medical Advice. 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, i.e., the Medication is Considered "Sodium-Free".

3. How to Take Rupafin

Always Take Rupafin Exactly as Your Doctor Has Told You. If You are Not Sure, Ask Your Doctor or Pharmacist.
Rupafin Oral Solution is for Oral Use Only.
Dosing in Children Weighing 25 kg or More:
5 ml (5 mg of Rupatadine) of Oral Solution Once a Day, with or Without Food.
Dosing in Children Weighing 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.
Your Doctor Will Tell You How Long to Take Rupafin.
Method of Administration:

• To Open the Bottle, Press the Cap and Turn it in the Opposite Direction of the Clockwise Movement.
• 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 Measuring Syringe.
• Wash the Syringe After Use.

Taking More than the Recommended Dose of Rupafin

If You Have Taken More than the Recommended Dose of Rupafin, Contact Your Doctor or Pharmacist Immediately.

Missing a Dose of Rupafin

Do Not Take a Double Dose to Make Up for a Forgotten Dose.

4. Possible Side Effects

Like All Medications, 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 Those Not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist, or Nurse. Side Effects Can be Reported Directly to the Department of Medicinal Product Monitoring, 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
Side Effects Can Also be Reported to the Marketing Authorization Holder or Its Representative in Poland.
Reporting Side Effects Will Help to Gather More Information on the Safety of this Medication.

5. How to Store Rupafin

Keep this Medication Out of the Sight and Reach of Children.
There are No Special Precautions for Storage of the Medicinal Product.
Do Not Use this Medication 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 on the Carton and Bottle.
Medications Should Not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medications 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).
• The Other Ingredients are: Propylene Glycol (E 1520), Citric Acid Anhydrous, Disodium Phosphate Anhydrous, 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 Package Contains

Rupafin is a Clear, Yellow Oral Solution.
Rupafin is Packaged in PET Bottles with an LDPE Connector and an HDPE Child-Resistant Closure in a Cardboard Box. Each Bottle Contains 120 ml of Rupafin Solution. The Package Includes a 5 ml PP/PE Measuring Syringe with 0.25 ml Gradations.

Marketing Authorization Holder

NOUCOR HEALTH, S.A.
Av. Camí Reial, 51-57
08184 Palau-solitá i Plegamans
Barcelona, Spain

Manufacturer

Italfarmaco S.A.
San Rafael, 3
Pol. Ind. Alcobendas
28108 Alcobendas
Spain
NOUCOR HEALTH, S.A.
Av. Camí Reial, 51-57
08184 Palau-solitá i Plegamans
Barcelona, Spain
For More Information, Contact the Marketing Authorization Holder's Representative:
Zentiva Polska Sp. z o. o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. (22) 375 92 00

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 Last Revision of the Package Leaflet:April 2024