Package leaflet: Information for the patient

Rupurix, 10 mg, tablets
Rupatadine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are similar.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

What Rupurix is and what it is used for
Important information before taking Rupurix
How to take Rupurix
Possible side effects
How to store Rupurix
Contents of the pack and other information

1. What Rupurix is and what it is used for

Rupurix is an antihistamine medicine.
Rupurix relieves symptoms of allergic rhinitis, such as sneezing,
runny nose, itchy eyes and nose.
Rupurix is also used to relieve symptoms associated with urticaria
(allergic skin rash), such as itching and hives (localized redness and swelling
of the skin).

2. Important information before taking Rupurix

When not to take Rupurix
Do not take Rupurix if you are allergic to rupatadine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting Rupurix, discuss with your doctor or pharmacist:

If you have kidney or liver impairment, consult your doctor. Currently, the use of Rupurix 10 mg is not recommended in patients with renal or hepatic dysfunction.
If you have low potassium levels and/or an abnormal heart rhythm (known as QTc prolongation on ECG), which may occur in certain heart conditions, you should consult your doctor.
If you are over 65 years of age, you should consult your doctor or pharmacist.

Children
This medicine is not intended for use in children under 12 years of age.

Rupurix and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including over-the-counter medicines.

If you are taking Rupurix, do not take medicines containing ketoconazole (an antifungal medicine) or erythromycin (an antibiotic).
If you are taking medicines that depress the central nervous system, statins (medicines used to treat high cholesterol), or midazolam (a medicine used for short-term sedation), consult your doctor before taking Rupurix.

Taking Rupurix with food, drink and alcohol
Do not take Rupurix with grapefruit juice, as this may increase the concentration of Rupurix in the body.
Rupurix at the recommended dose (10 mg) does not increase alcohol-induced drowsiness.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Driving and using machines
Rupurix, when taken at recommended doses, is not expected to affect your ability to drive or operate machinery. However, if you are taking Rupurix for the first time, you should exercise caution and observe your reaction to the medicine before driving or operating machinery.

Rupurix contains lactose
If you have been previously diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Rupurix

Always take this medicine exactly as your doctor has instructed. If in doubt, consult your doctor or pharmacist. Rupurix is intended for use in adolescents (aged 12 years and older) and adults. The usual dose is one tablet (10 mg rupatadine) once daily, with or without food. Swallow the tablet with a sufficient amount of liquid (e.g. a glass of water).

Your doctor will inform you how long your treatment with Rupurix should last.

If you take more Rupurix than you should
If you accidentally take more than the recommended dose, contact your doctor or pharmacist immediately.

If you forget to take Rupurix
Take the missed dose as soon as possible, then continue taking the tablets as directed. Do not take a double dose to make up for a forgotten tablet.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
Common adverse effects (may occur in fewer than 1 in 10 people):
Drowsiness, headache, dizziness, dry mouth, feeling weak and fatigue.
Uncommon adverse effects (may occur in fewer than 1 in 100 people):
Increased appetite, irritability, difficulty concentrating, nosebleeds, dryness of nasal mucosa, sore throat, cough, dry throat, nasal mucositis, nausea, abdominal pain, diarrhoea, indigestion, vomiting, constipation, rash, back pain, joint pain, muscle pain, increased thirst, general malaise, fever, abnormal liver function test results and weight gain.
Rare adverse effects (may occur in fewer than 1 in 1,000 people):
Palpitations, tachycardia, and allergic reactions (itching, urticaria, facial swelling, swelling of lips, tongue or throat).
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder. Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Rupurix

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after:
"EXP". The expiry date refers to the last day of the stated month.
Store the blister in the outer packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Rupurix contains

The active substance is rupatadine. Each tablet contains 10 mg of rupatadine in the form of rupatadine fumarate.
Other ingredients are: monohydrate lactose, microcrystalline cellulose, maize starch gelatinized, magnesium stearate, iron oxide red (E 172), iron oxide yellow (E 172).

What Rupurix looks like and contents of the pack
Tablet.
Rupurix is salmon-coloured, uncoated, round, biconvex tablets, smooth on both sides, with dimensions of 6.35 mm ± 0.1 mm.
Pack sizes: 10, 20 or 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa Street 13D, local 27
01-909 Warsaw
e-mail: [email protected]
Manufacturer/Importer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal
This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: Rupatadina Aurobindo
Poland: Rupurix
Portugal: Rupatadina Generis Phar
Spain: Rupatadina Aurovitas 10 mg comprimidos EFG