Rupurix

Package Leaflet: Information for the Patient

Rupurix, 10 mg, Tablets

Rupatadine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Rupurix and what is it 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 pack and other information

1. What is Rupurix and what is it used for

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

2. Important information before taking Rupurix

When not to take Rupurix

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

Warnings and precautions

Before taking Rupurix, discuss it with your doctor or pharmacist.

• If you have kidney or liver problems, consult your doctor. Currently, it is not recommended to take Rupurix 10 mg if you have kidney or liver problems.
• If you have low potassium levels and (or) have an abnormal heart rhythm (known as QTc interval prolongation in the ECG), which may occur in some heart conditions, consult your doctor.
• If you are over 65 years old, 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 the medicines you are taking now or have taken recently, including those obtained without a prescription.

• If you are taking Rupurix, do not take medicines containing ketoconazole (an antifungal medicine) or erythromycin (an antibiotic).
• If you are taking medicines that affect the central nervous system, statins (medicines used to lower 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 it may increase the level of Rupurix in your body.

Rupurix 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 plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

Rupurix contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Rupurix

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Rupurix is for use in adolescents (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 tell you how long to take Rupurix for.

If you take more Rupurix than you should

If you have taken too much of this medicine, contact your doctor or pharmacist immediately.

If you forget to take Rupurix

Take the dose as soon as you remember, and then continue taking the tablets as scheduled. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rupurix can cause side effects, although not everybody gets them.
Common side effects(may affect up to 1 in 10 people):
Drowsiness, headache, dizziness, dry mouth, feeling weak and tired.
Uncommon side effects(may affect up to 1 in 100 people):
Increased appetite, irritability, difficulty concentrating, nosebleeds, dryness of the nasal mucosa, sore throat, cough, dry throat, nasal mucositis, nausea, abdominal pain, diarrhea, indigestion, vomiting, constipation, rash, back pain, joint pain, muscle pain, increased thirst, general malaise, fever, abnormal liver function tests, and weight gain.
Rare side effects(may affect up to 1 in 1,000 people):
Palpitations, rapid heartbeat, and allergic reactions (itching, hives, swelling of the face, lips, tongue, or throat).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring, 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 Rupurix

Keep this medicine out of the 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 month.
Store the blister in the outer packaging to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer 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: lactose monohydrate, microcrystalline cellulose, maize 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 round, biconvex, salmon-colored, uncoated tablet, 6.35 mm ± 0.1 mm in diameter, smooth on both sides.
Pack sizes: 10, 20, or 30 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Italy:
Rupatadina Aurobindo
Poland:
Rupurix
Portugal:
Rupatadina Generis Phar
Spain:
Rupatadina Aurovitas 10 mg comprimidos EFG

Date of last revision of the leaflet: 12/2022