Package leaflet: Information for the user

Rupaxa
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 a specific individual. 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, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

What Rupaxa is and what it is used for
Before you take Rupaxa
How to take Rupaxa
Possible side effects
How to store Rupaxa
Contents of the pack and other information

1. What Rupaxa is and what it is used for

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

2. Important information before using Rupaxa

When not to use Rupaxa

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 to take Rupaxa, discuss it with your doctor or pharmacist.
If the patient has kidney or liver impairment, medical advice should be sought. The use of Rupaxa is not recommended in patients with renal or hepatic dysfunction.
In case of low blood potassium levels and/or abnormal heart rhythm (known as QTc prolongation on ECG), which may occur in certain heart diseases, medical advice must be sought.
If the patient is over 65 years of age, they should consult their doctor or pharmacist.
Children and adolescents
Rupaxa must not be used in children under 12 years of age.
Rupaxa and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take, including those available without a prescription.
If the patient is taking Rupaxa, they should not take medicines containing ketoconazole (a medicine used for fungal infections) or erythromycin (a medicine used for bacterial infections).
If the patient is taking medicines that suppress the central nervous system, or statins (medicines used to treat high cholesterol levels), or midazolam (a short-acting sedative and hypnotic medicine), they should consult their doctor before using Rupaxa.
Rupaxa with food, drink and alcohol
Rupaxa must not be taken together with grapefruit juice, as this may increase the concentration of Rupaxa in the body.
Rupaxa at the recommended dose (10 mg) does not enhance 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.
Rupaxa must not be taken during pregnancy or breastfeeding unless clearly indicated by a doctor.
Before taking any medicine, consult your doctor or pharmacist.
Driving and using machines
Rupaxa, when used at the recommended dose, should not affect the ability to drive or operate machinery. However, if the patient is taking Rupaxa for the first time, they should exercise caution and observe their response to the medicine.
Rupaxa contains 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 use Rupaxa

This medicine should always be taken exactly as directed by the doctor. If in doubt, consult the doctor or pharmacist.
Rupaxa 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. The tablet should be swallowed whole with an adequate amount of liquid (e.g. a glass of water).
The doctor will inform the patient how long the treatment with Rupaxa should last.
Taking more Rupaxa than recommended
If a patient accidentally takes more than the prescribed dose, they should contact a doctor or pharmacist immediately.
If a dose of Rupaxa is missed
The missed dose should be taken 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.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone will experience them.
Common adverse reactions (may affect up to 1 in 10 people):

drowsiness, headache, dizziness, dry mouth, feeling of weakness and fatigue.

Uncommon adverse reactions (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 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 affect up to 1 in 1,000 people):

palpitations, tachycardia, and allergic reactions (itching, urticaria, facial swelling, lip swelling, tongue swelling, or throat swelling).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Rupaxa

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the blister pack and carton.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. 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 ) in the form of rupatadine fumarate.
Other ingredients are: monohydrate lactose, microcrystalline cellulose PH 102, pregelatinized starch (corn), iron oxide red (E 172), iron oxide yellow (E 172), and magnesium stearate.

What Rupaxa looks like and contents of the pack
Rupaxa is a round, light grey tablet with a diameter of 6.35 mm, packed in blisters contained in packaging with: 15, 20, 30, 50 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:
Poland: Rupaxa