Rupaxa

Package Leaflet: Information for the User

Rupaxa

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. 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, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Rupaxa and what is it used for

Rupatadine, the active substance of Rupaxa, has antihistamine properties.
Rupaxa relieves the symptoms of allergic rhinitis, such as sneezing, runny nose, itchy eyes and nose.
Rupaxa is also used to relieve the symptoms of urticaria (allergic skin rash), such as itching and hives (local redness and swelling of the skin).
Rupaxa is intended for use in adults and adolescents (12 years and older).

2. Important information before taking Rupaxa

When not to take Rupaxa

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

Warnings and precautions

Before taking Rupaxa, discuss it with your doctor or pharmacist.
If you have kidney or liver problems, consult your doctor. Rupaxa is not recommended for patients with kidney or liver disorders.
In case of low potassium levels in the blood and/or 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, you should consult your doctor or pharmacist.

Children and adolescents

Rupaxa should not be taken by children under 12 years of age.

Rupaxa and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take, including those obtained without a prescription.
If you are taking Rupaxa, you should 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), you should consult your doctor before taking Rupaxa.

Rupaxa with food, drink, and alcohol

Rupaxa should not be taken with grapefruit juice, as it may increase the level of Rupaxa in the body.

Rupaxa 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 become pregnant, consult your doctor or pharmacist before taking this medicine.
Rupaxa should not be taken during pregnancy and breastfeeding, unless clearly indicated by your doctor.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

Rupaxa, taken at the recommended dose, should not affect your ability to drive or operate machines. However, if you are taking Rupaxa for the first time, you should be cautious and observe your reaction to the medicine.

Rupaxa contains lactose

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

3. How to take Rupaxa

This medicine should always be taken exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Rupaxa is intended 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. The tablet should be swallowed with a sufficient amount of liquid (e.g., a glass of water).
Your doctor will inform you how long the treatment with Rupaxa will last.

Taking a higher dose of Rupaxa than recommended

If you have accidentally taken a large dose of the medicine, you should immediately consult your doctor or pharmacist.

Missing a dose of Rupaxa

Take the missed dose as soon as possible, and then continue taking the tablets as directed.
Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Rupaxa 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 inflammation, nausea, abdominal pain, diarrhea, indigestion, vomiting, constipation, rash, back pain, joint pain, muscle pain, increased thirst, general malaise, fever, abnormal liver function test results, 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 any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 Rupaxa

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the blister and carton.
The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
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 Rupaxa contains

• The active substance is rupatadine. Each tablet contains 10 mg of rupatadine (Rupatadinum) as rupatadine fumarate.
• The other ingredients are lactose monohydrate, microcrystalline cellulose PH 102, pregelatinized starch (maize), red iron oxide (E 172), yellow iron oxide (E 172), and magnesium stearate.

What Rupaxa looks like and contents of the pack

Rupaxa is a round, light orange tablet with a diameter of 6.35 mm, packaged in blisters contained in packs of 15, 20, 30, 50, or 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań

Manufacturer/Importer

MEIJI PHARMA SPAIN S.A
Avda de Madrid, 94
28802 Alcala de Henares, Madrid
Spain
MARTIN DOW PHARMACEUTICALS
Goualle Le Puy, Champ de Lachaud
19250 Meymac
France

This medicinal product is authorized in the Member States of the European

Economic Area under the following names:

Poland:
Rupaxa
Date of last revision of the leaflet:04.08.2023