RUPATADINUM NOUCOR

Package leaflet: Information for the user

Rupatadinum Noucor, 10 mg, tablets
Rupatadinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Rupatadinum Noucor is and what it is used for

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

2. Important information before taking Rupatadinum Noucor

When not to take Rupatadinum Noucor

• 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 Rupatadinum Noucor, discuss it with your doctor or
pharmacist.
If the patient has kidney or liver impairment, medical advice should be sought. Currently, the use of Rupatadinum Noucor is not recommended in patients with kidney or liver function disorders.
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.
Rupatadinum Noucor and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription.
If the patient is taking Rupatadinum Noucor, 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, statins (medicines used to treat high cholesterol levels), or midazolam (a short-acting sedative and hypnotic medicine), they should consult a doctor before using Rupatadinum Noucor.
Rupatadinum Noucor with food, drink and alcohol
Rupatadinum Noucor should not be taken together with grapefruit juice,
as this may lead to increased levels of Rupatadinum Noucor in the body.
Rupatadinum Noucor at the recommended dose (10 mg) does not increase alcohol-induced drowsiness.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Driving and using machines
It is not expected that Rupatadinum Noucor, when used at recommended doses, affects the ability to drive or operate machinery. However, if the patient is taking Rupatadinum Noucor for the first time, they should exercise caution and observe their response to the medicine before driving or operating machinery.
Rupatadinum Noucor contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.

3. How to take Rupatadinum Noucor

This medicine should always be taken as directed by the physician. In case of doubt, consult a doctor
or pharmacist.
Rupatadinum Noucor 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. The tablet should be swallowed with an adequate amount of liquid (e.g. a glass of water).
The physician will inform the patient how long the treatment with Rupatadinum Noucor should last.
Taking more Rupatadinum Noucor than recommended
If the patient accidentally takes a larger than recommended dose, they should immediately contact a doctor
or pharmacist.
Missing a dose of Rupatadinum Noucor
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 all medicines, Rupatadinum Noucor may cause adverse reactions, although not everyone experiences them.
Common adverse reactions (may occur in up to 1 in 10 patients) include:
drowsiness, headache, dizziness, dry mouth, feeling of weakness and fatigue.
Uncommon adverse reactions (may occur in up to 1 in 100 patients) include:
increased appetite, irritability, difficulty concentrating, nosebleeds, dryness of the 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 reactions (may occur in up to 1 in 1000 patients) include:
palpitations, tachycardia and allergic reactions (itching, urticaria, swelling of the face, lips, tongue or throat).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your 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 181 C, 02-222 Warsaw, tel.: +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 authorisation holder or its representative.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Rupatadinum Noucor
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and blister pack. 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 the sewage system 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 Rupatadinum Noucor contains

• The active substance is rupatadine. Each tablet contains 10 mg of rupatadine (as rupatadine fumarate).
• The other ingredients are: pregelatinized corn starch, microcrystalline cellulose, ferric oxide red (E 172), ferric oxide yellow (E 172), lactose monohydrate and magnesium stearate. See section 2 "Rupatadinum Noucor contains lactose".

What Rupatadinum Noucor looks like and contents of the pack
Rupatadinum Noucor tablets are round, light grey-blue tablets, available in blisters divided into single-dose units, packed in outer packaging containing 10, 15, 20, 30, 50 or 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
NOUCOR HEALTH, S.A.
Av. Cami Reial, 51-57
08184 Palau-solitá i Plegamans
Spain

This medicinal product is authorised for marketing in the European Economic Area member states under the following names:
Poland Rupatadinum Noucor
Portugal Rupatadina Noucor 10 mg comprimidos
Slovak Republic Rupatadin Vivax 10 mg tablety
Italy Rupatadina Noucor 10 mg compresse

For further information, please contact the Marketing Authorisation Holder's representative:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. (22) 375 92 00