Rupiron

Package leaflet: Information for the user

Rupiron 10 mg tablets
Rupatadine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this 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 only. Do not give it 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.

Contents of the leaflet

1. What Rupiron is and what it is used for
2. What you need to know 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 Rupiron is and what it is used for

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

2. Important information before taking Rupiron

When not to take Rupiron

• 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 treatment with Rupiron, discuss with your doctor or pharmacist:

• if the patient has kidney or liver impairment, medical advice should be sought. Currently, the use of Rupiron is not recommended in patients with renal or hepatic dysfunction.
• if the patient has low blood potassium levels and/or has an abnormal heart rhythm (known as QTc prolongation on ECG), which may occur in certain heart conditions, medical consultation is required.
• if the patient is over 65 years of age.

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 medicines the patient is currently taking, has recently taken, or plans to take.

• If the patient is taking Rupiron, 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 central nervous system depressants, statins (medicines used to treat high cholesterol), or midazolam (a short-acting sedative and hypnotic), they should consult their doctor before taking Rupiron.

Taking Rupiron with food, drink and alcohol
Do not take Rupiron with grapefruit juice or grapefruits,
as this may lead to increased concentration of Rupiron in the body.
Rupiron at a dose of 10 mg does not increase alcohol-induced drowsiness.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
Rupiron, when used at recommended doses, is not expected to affect the ability to drive or operate machinery. However, if the patient is taking Rupiron for the first time, caution should be exercised and the patient should observe their response to the medicine before driving or operating machinery.
Rupiron contains lactose
This medicine contains 55 mg of lactose (as monohydrate). If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to take Rupiron

This medicine should always be taken as directed by the doctor. If in doubt, consult
your doctor or pharmacist.
Rupiron is intended for use in adolescents (aged 12 years and older) and adults.
The recommended dose of the medicine is one tablet (10 mg rupatadine) once daily, with or without food.
The tablet should be swallowed with an adequate amount of liquid (e.g. a glass of water).
Your doctor will inform you how long treatment with Rupiron should continue.
Taking more Rupiron than recommended
If you accidentally take a large dose of the medicine, contact your doctor or pharmacist immediately.
Missing a dose of Rupiron
Take the missed dose as soon as possible, then continue taking the tablets according to the recommended dosing schedule. Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should contact your doctor immediately and stop taking the medicine if the following occur:
Rare ( may occur in fewer than 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 adverse reactions include:
Common ( may occur in fewer than 1 in 10 people ):

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

Uncommon ( may occur in fewer than 1 in 100 people ):

• pharyngitis, nasal mucositis
• increased appetite
• difficulty concentrating
• nosebleeds, dryness of the nasal mucosa, cough, dry throat, sore throat
• nausea, abdominal pain, diarrhoea, indigestion, vomiting, constipation
• rash
• back pain, joint pain, muscle pain
• increased thirst, general malaise, fever, irritability
• abnormal liver function test results, weight gain.

Rare ( may occur in fewer than 1 in 1,000 people ):

• rapid heartbeat, palpitations.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Rupiron

Keep this medicine out of 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 cardboard packaging and blister. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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 rupatadine fumarate equivalent to 10 mg of rupatadine.
• Other ingredients: monohydrate lactose (see section 2 “Rupiron contains lactose”), microcrystalline cellulose, maize starch, pregelatinized 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, light blue tablets with the imprint “R10” on one side.
The tablets are packed in blisters, in packages containing 15 or 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation 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

For further information on this medicinal product, please contact the local representative of the marketing authorisation holder:
Orion Pharma Poland Sp. z o.o.
[email protected]