Rupurix

Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Rupurix (Rupatadine arrow), 10 mg, tablets
Rupatadinum
Rupurix and Rupatadine arrow are different trade names of the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Rupurix is and what it is used for
2. Important information before taking Rupurix
3. How to take Rupurix
4. Possible side effects
5. How to store Rupurix
6. Contents of the package 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, and itching of the 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 the patient is allergic to rupatadine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Rupurix, discuss it with your doctor or pharmacist.

• If the patient has renal or hepatic impairment, consult a doctor. Currently, the use of Rupurix 10 mg is not recommended in patients with renal or hepatic dysfunction.
• If the patient has low potassium levels and/or has an abnormal heart rhythm (known as QTc prolongation on ECG), which may occur in certain heart conditions, they should consult a doctor.
• If the patient is over 65 years of age, they should consult a 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 the patient is currently taking or has recently taken, as well as any medicines they plan to use, including those available without a prescription.

• If the patient is taking Rupurix, they should not use medicines containing ketoconazole (an antifungal medicine) or erythromycin (an antibiotic for bacterial infections).
• If the patient is taking central nervous system depressants, statins (medicines used to treat high cholesterol levels), or midazolam (a medicine used for short-term sedation), they should consult a doctor before using Rupurix.

Taking Rupurix with food, drink and alcohol
Rupurix should not be taken together with grapefruit juice, as this may lead to increased levels of Rupurix in the body.
Rupurix at the recommended dose (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 baby, she should consult her doctor or pharmacist before using this medicine.

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

Rupurix contains monohydrate lactose
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 Rupurix

This medicine should always be taken according to the doctor's instructions. 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 of rupatadine) once daily, with or without food. Swallow the tablet with an adequate amount of liquid (e.g. a glass of water).

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

Taking more Rupurix than recommended
If the patient accidentally takes a large dose of the medicine, they should contact a doctor or pharmacist immediately.

Missing a dose of Rupurix
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 everybody will experience them.
Common adverse reactions (may occur in less than 1 in 10 people):
Drowsiness, headache, dizziness, dry mouth, feeling weak and fatigue.
Uncommon adverse reactions (may occur in less than 1 in 100 people):
Increased appetite, irritability, difficulty concentrating, nosebleeds, dryness of the nasal mucosa, sore throat, cough, dry throat, nasal mucosal inflammation, 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 reactions (may occur in less than 1 in 1,000 people):
Palpitations, tachycardia, and allergic reactions (itching, urticaria, facial swelling, swelling of lips, tongue or throat).
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.
By reporting adverse reactions, additional information regarding the safety of the medicine can be collected.

5. How to store Rupurix

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store the blister pack in the outer packaging to protect it from light.
Medicines should 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 Rupurix contains

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

What Rupurix looks like and contents of the pack
Tablet.
Rupurix is a salmon-coloured, round, biconvex, uncoated tablet, smooth on both sides, with dimensions of 6.35 mm ± 0.1 mm.
Pack sizes: 10, 20 or 30 tablets.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in France, country of export:
ARROW Génériques
26 Avenue Tony Garnier
69007 Lyon
France
Manufacturer:
Martin Dow Pharmaceuticals
Goualle Le Puy, Champ de Lachaud
19250 Meymac
France
Meiji Pharma Spain S.A.
Avda. De Madrid, 94
28802 Alcalá de Henares, Madrid
Spain
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation Number in France, country of export: 34009 300 776 6 5
Parallel Import Licence Number: 98/26
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