Rupatadinum Noucor

Package Leaflet: Information for the User

Rupatadinum Uriach, 10 mg, Tablets

Rupatadinum

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you by your doctor. Do not give it 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 package leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

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

Rupatadine is an antihistamine.
Rupatadinum Uriach relieves the symptoms of allergic rhinitis, such as
sneezing, runny nose, itchy eyes and nose.
Rupatadinum Uriach is also used to relieve the 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 Uriach

When not to take Rupatadinum Uriach

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

Warnings and precautions

Before taking Rupatadinum Uriach, discuss it with your doctor or pharmacist.
If you have kidney or liver failure, consult your doctor. Currently, it is not recommended to use Rupatadinum Uriach in patients with kidney or liver disorders.
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 diseases, you should consult your doctor.
If you are over 65 years old, you should consult your doctor or pharmacist.

Children

This medicine is not intended for use in children under 12 years of age.

Rupatadinum Uriach and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, including those that are available without a prescription.
If you are taking Rupatadinum Uriach, you should not take medicines containing ketokonazole (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, statins (medicines used to treat high cholesterol) or midazolam (a short-acting medicine with sedative and hypnotic effects), you should consult your doctor before taking Rupatadinum Uriach.

Rupatadinum Uriach with food, drink, and alcohol

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

Rupatadinum Uriach at the recommended dose (10 mg) does not increase sleepiness caused by alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Rupatadinum Uriach is unlikely to affect your ability to drive or use machines at the recommended dose. However, if you are taking Rupatadinum Uriach for the first time, you should be cautious and observe your reaction to the medicine before driving or using machines.

Rupatadinum Uriach contains lactose

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

3. How to take Rupatadinum Uriach

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Rupatadinum Uriach is intended for use in adolescents (12 years and older) and adults. The usual dose is one tablet (10 mg rupatadine) once a day, 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 Rupatadinum Uriach.

Taking more than the recommended dose of Rupatadinum Uriach

If you accidentally take a large dose, contact your doctor or pharmacist immediately.

Missing a dose of Rupatadinum Uriach

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

4. Possible side effects

Like all medicines, Rupatadinum Uriach can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people) include:
drowsiness, headache, dizziness, dry mouth, feeling weak and tired.
Uncommon side effects (may affect up to 1 in 100 people) include: 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 tests, and weight gain.
Rare side effects (may affect up to 1 in 1000 people) include: palpitations, rapid heartbeat, and allergic reactions (itching, urticaria, swelling of the face, lips, tongue, or throat).

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Rupatadinum Uriach

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.
The expiry date refers to the last day of the month.
Store the blister in the outer packaging to protect from light.
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 package and other information

What Rupatadinum Uriach contains

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

What Rupatadinum Uriach looks like and contents of the package

Rupatadinum Uriach tablets are round, light orange tablets, available in blister packs divided into single doses, packaged in outer packaging containing 15, 20, 30, 50, or 100 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

• J. Uriach y Compañía, S.A. Av. Cami Reial, 51-57 08184 Palau-solitá i Plegamans Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland
Rupatadinum Uriach, 10 mg, tablets
Portugal
Rupatadina Uriach 10 mg comprimidos
Slovak Republic
Rupatadin Vivax 10 mg tablets
Italy
Rupatadina Uriach 10 mg compresse

For further information, contact the representative of the marketing authorization holder:

Zentiva Polska Sp. z o. o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. (22) 375 92 00
Date of last revision of the package leaflet:February 2021