Rupafin 10 mg

Package Leaflet: Information for the User

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Rupafin 10 mg (Rupatall), 10 mg, Tablets

Rupatadine
Rupafin 10 mg and Rupatall are different trade names for the same medicine.

You Should Carefully Read the Contents of the Leaflet Before Taking the Medicine, as it Contains Important Information for the Patient.

• You Should Keep this Leaflet, so that You can Read it Again if Necessary.
• If You have any Further Questions, You Should Consult a Doctor or Pharmacist.
• This Medicine has been Prescribed to You by a Doctor. Do not Pass it on to Others. The Medicine may Harm them, even if their Symptoms are the Same as Yours.
• If You Experience any Side Effects, including those not Listed in this Leaflet, You Should Tell Your Doctor or Pharmacist. See Section 4.

Table of Contents of the Leaflet

• 1. What is Rupafin 10 mg and what is it Used for
• 2. Important Information Before Taking Rupafin 10 mg
• 3. How to Take Rupafin 10 mg
• 4. Possible Side Effects
• 5. How to Store Rupafin 10 mg
• 6. Contents of the Packaging and Other Information

1. What is Rupafin 10 mg and what is it Used for

Rupatadine is an Antihistamine Medicine.
Rupafin 10 mg Relieves the Symptoms of Allergic Rhinitis, such as Sneezing,
Nasal Discharge, Itching of the Eyes and Nose.
Rupafin 10 mg is also Used to Relieve the Symptoms of Urticaria (Allergic Skin Rash), such as Itching and Urticaria (Local Redness and Swelling of the Skin).

2. Important Information Before Taking Rupafin 10 mg

When not to Take Rupafin 10 mg

• 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 10 mg, You Should Discuss it with Your Doctor or Pharmacist.
If You have Kidney or Liver Failure, You Should Consult a Doctor. Currently, it is not Recommended to Use Rupafin 10 mg in Patients with Kidney or Liver Function Disorders.
If You have Low Potassium Levels and (or) Abnormal Heart Rhythm (Known as Prolonged QTc Interval in the ECG), which may Occur in some Heart Diseases, You Should Consult a Doctor.
If You are Over 65 Years Old, You Should Consult a Doctor or Pharmacist.

Children

This Medicine is not Intended for Use in Children Under 12 Years of Age.

Rupafin 10 mg and other Medicines

You Should Tell Your Doctor or Pharmacist about all Medicines You are Currently Taking or have Recently Taken, including those that are Available Without a Prescription.
If You are Taking Rupafin 10 mg, You Should not Take Medicines Containing Ketokonazole (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), You Should Consult a Doctor Before Taking Rupafin 10 mg.

Rupafin 10 mg with Food, Drink, and Alcohol

Rupafin 10 mg Should not be Taken at the Same Time as Grapefruit Juice, as it may Increase the Level of Rupafin 10 mg in the Body.

Rupafin 10 mg at the Recommended Dose (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 Child, You Should Consult a Doctor or Pharmacist Before Taking this Medicine.

Driving and Operating Machines

It is not Believed that Rupafin 10 mg at the Recommended Dose Affects the Ability to Drive or Operate Machines. However, if You are Taking Rupafin 10 mg for the First Time, You Should be Cautious and Observe Your Reaction to the Medicine Before Driving or Operating Machines.

Rupafin 10 mg Contains Lactose Monohydrate

If You have been Diagnosed with an Intolerance to some Sugars, You Should Consult a Doctor Before Taking this Medicine.

3. How to Take Rupafin 10 mg

This Medicine Should Always be Taken as Directed by Your Doctor. If You are in Doubt, You Should Consult a Doctor or Pharmacist.
Rupafin 10 mg is Intended for Use in Adolescents (12 Years and Older) and Adults. The Usual Dose is one Tablet (10 mg of Rupatadine) Once a Day, with or Without Food. The Tablet Should be Swallowed with a Sufficient Amount of Liquid (e.g., a Glass of Water).
Your Doctor will Inform You how Long the Treatment with Rupafin 10 mg will Last.

Taking a Higher Dose of Rupafin 10 mg than Recommended

If You have Accidentally Taken a Large Dose of the Medicine, You Should Immediately Consult a Doctor or Pharmacist.

Missing a Dose of Rupafin 10 mg

You Should Take the Next Dose as Soon as Possible and then Continue Taking the Tablets as Directed. Do not Take a Double Dose to Make up for the Missed Dose.

4. Possible Side Effects

Like all Medicines, Rupafin 10 mg can Cause Side Effects, although not Everybody gets them.
Common Side Effects (may Affect up to 1 in 10 People) include:
Drowsiness, Headache, Dizziness, Dry Mouth, Feeling of Weakness and Fatigue.
Uncommon Side Effects (may Affect up to 1 in 100 People) include: Increased Appetite, Irritability, Difficulty Concentrating, Nosebleeds, Dryness of the Nasal Mucosa, Sore Throat, Cough, Dryness of the Throat, Nasal Congestion, Nausea, Abdominal Pain, Diarrhea, Indigestion, Vomiting, Constipation, Rash, Back Pain, Joint Pain, Muscle Pain, Increased Thirst, General Feeling of Being Unwell, Fever, Abnormal Liver Function Test Results and Weight Gain.
Rare Side Effects (may Affect up to 1 in 1000 People) include: Palpitations, Rapid Heartbeat and Allergic Reactions (Itching, Urticaria, Swelling of the Face, Lips, Tongue or Throat).

Reporting Side Effects

If You Experience any Side Effects, including those not Listed in this Leaflet, You Should Tell Your Doctor or Pharmacist. 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.
By Reporting Side Effects, You can Help Provide more Information on the Safety of this Medicine.

5. How to Store Rupafin 10 mg

The Medicine Should be Stored in a Place that is not Visible and not Accessible to Children.
Do not Use this Medicine after the Expiration Date Stated on the Packaging. The Expiration Date refers to the Last Day of the Specified Month.
Store the Blister in the Outer Packaging to Protect it from Light.
Medicines Should not be Disposed of via Wastewater or Household Waste Containers. You Should Ask a Pharmacist 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 10 mg Contains

• The Active Substance of the Medicine is Rupatadine. Each Tablet Contains 10 mg of Rupatadine (in the Form of Rupatadine Fumarate).
• The other Ingredients are: Corn Starch, Microcrystalline Cellulose, Red Iron Oxide (E 172), Yellow Iron Oxide (E 172), Lactose Monohydrate and Magnesium Stearate. See Section 2 "Rupafin 10 mg Contains Lactose Monohydrate".

What Rupafin 10 mg Looks like and what the Packaging Contains

Rupafin 10 mg Tablets are Round, Light Orange Tablets, Packaged in Blisters of 10 Tablets.
The Outer Packaging Contains 10, 20, 30, 50 or 100 Tablets.
For more Detailed Information, You Should Contact the Marketing Authorization Holder or the Parallel Importer.

Marketing Authorization Holder in Belgium, the Country of Export:

Noucor Health S.A.
Av. Cami Reial, 51-57
E-08184 Palau-solita i Plegamans, Barcelona
Spain

Manufacturer:

Noucor Health S.A.
Av. Cami Reial, 51-57
E-08184 Palau-solita i Plegamans, Barcelona
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 Belgium, the Country of Export:BE272045
Parallel Import Authorization Number:46/19

This Medicinal Product is Authorized for Marketing in the Member States of the European

Economic Area under the Following Names:

Rupatall 10 mg
Belgium, Luxembourg
Rinialer 10 mg
Malta, Portugal
Rupafin 10 mg
Austria, Bulgaria, Croatia, Cyprus, Denmark, Estonia, Greece, Spain,
Netherlands, Ireland, Iceland, Lithuania, Liechtenstein,
Latvia, Germany, Norway, Poland, Slovakia, Slovenia, Italy
Rupatadine 10 mg United Kingdom
Wystamm 10 mg
France
Tamalis 10 mg
Czech Republic, Romania, Hungary
Pafinur 10 mg
Finland, Sweden

Date of Approval of the Leaflet: 23.01.2024

[Information about the Registered Trademark]