Rupiron

Package Leaflet: Information for the User

Rupiron, 10 mg, tablets

Rupatadine

Read the package leaflet carefully before taking the medicine, 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 medicine has been prescribed for you. 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 or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Rupiron and what is it used for
• 2. Important information before taking Rupiron
• 3. How to take Rupiron
• 4. Possible side effects
• 5. How to store Rupiron
• 6. Contents of the pack and other information

1. What is Rupiron and what is it used for

Rupatadine, the active substance of Rupiron, is an antihistamine.
Rupiron relieves the symptoms of allergic rhinitis, such as sneezing,
runny nose, itchy eyes and nose.
Rupiron is also used to relieve the symptoms of urticaria
(allergic skin rash), such as itching and rash (local redness and swelling of the skin).

2. Important information before taking Rupiron

When not to take Rupiron

• if you are allergic to rupatadine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Rupiron, discuss with your doctor or pharmacist:

• if you have kidney or liver failure, consult your doctor. Currently, it is not recommended to use Rupiron 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.
• if you are over 65 years old.

Children and adolescents

Rupiron is not intended for use in children under 12 years of age.

Rupiron and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.

• If you are taking Rupiron, 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 or statins (medicines used to treat high cholesterol) or midazolam (a short-acting sedative and anxiolytic), consult your doctor before taking Rupiron.

Taking Rupiron with food, drink, and alcohol

Do not take Rupiron with grapefruit juice and grapefruits,
as it may increase the level of Rupiron in the body.
Rupiron 10 mg does not increase the sedative effect of 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

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

Rupiron contains lactose

This medicine contains 55 mg of lactose (as monohydrate). If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Rupiron

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Rupiron is intended for use in adolescents (12 years and older) and adults. The recommended dose is one tablet (10 mg rupatadine) once a day with or without food. Swallow the tablet with a sufficient amount of liquid (e.g., a glass of water).
Your doctor will tell you how long to take Rupiron.

Taking more Rupiron than recommended

If you accidentally take a large dose, contact your doctor or pharmacist immediately.

Missing a dose of Rupiron

Take the missed dose as soon as possible, then continue taking the tablets as recommended. Do not take a double dose to make up for the missed dose.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rupiron can cause side effects, although not everybody gets them.

Stop taking Rupiron and contact your doctor immediately if you experience:

Rarely (may affect up to 1 in 1,000 people):

• allergic reactions (itching, urticaria, swelling of the face, lips, tongue, or throat, and difficulty breathing, as these may be symptoms of a severe allergic reaction).

Other side effects include:

Commonly (may affect up to 1 in 10 people):

• drowsiness, headache, dizziness
• dry mouth
• fatigue, feeling weak.

Uncommonly (may affect up to 1 in 100 people):

• pharyngitis, rhinitis
• increased appetite
• difficulty concentrating
• epistaxis, dryness of the nasal mucosa, cough, dry throat, sore throat
• nausea, abdominal pain, diarrhea, dyspepsia, vomiting, constipation
• rash
• back pain, arthralgia, myalgia
• increased thirst, general malaise, fever, irritability
• abnormal liver function tests, weight gain.

Rarely (may affect up to 1 in 1,000 people):

• palpitations, tachycardia.

Reporting side effects

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

5. How to store Rupiron

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the month stated.
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 Rupiron contains

• The active substance is rupatadine. Each tablet contains 10 mg of rupatadine (as rupatadine fumarate).
• The other ingredients are: lactose monohydrate (see section 2 "Rupiron contains lactose"), microcrystalline cellulose, maize starch, magnesium stearate, yellow iron oxide (E 172), red iron oxide (E 172).

What Rupiron looks like and contents of the pack

Rupiron tablets are round (6.5 mm in diameter), flat tablets, light orange in color, with "R10" engraved on one side.
The tablets are packaged in blisters, in packs of 15 or 30 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer:

Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
Laboratoris Normon S.A.
Ronda de Valdecarrizo 6
28760 Tres Cantos, Madrid
Spain
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
kontakt@orionpharma.info.pl
Date of last revision of the leaflet:17.10.2023