Package leaflet: Information for the user

Rupatadine Genoptim, 10 mg, tablets
Rupatadinum
Read the entire leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any further questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Rupatadine Genoptim is and what it is used for
What you need to know before taking Rupatadine Genoptim
How to take Rupatadine Genoptim
Possible side effects
How to store Rupatadine Genoptim
Contents of the pack and other information

1. What Rupatadine Genoptim is and what it is used for

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

2. Important information before taking Rupatadine Genoptim

When not to take Rupatadine Genoptim

if the patient is allergic to rupatadine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting Rupatadine Genoptim, discuss it with your doctor or
pharmacist. If the patient has kidney or liver impairment, medical advice should be sought.
The use of Rupatadine Genoptim is not recommended in patients with renal or hepatic impairment.
If the patient has low potassium levels and/or has an abnormal heart rhythm
(known as QTc interval prolongation on ECG), which may occur in
certain heart conditions, medical advice must be sought.
If the patient is over 65 years of age, they should consult their doctor or pharmacist.
Children
This medicine is not intended for use in children under 12 years of age.
Rupatadine Genoptim and other medicines
Inform your doctor or pharmacist about all the medicines the patient is currently taking or has recently taken, including those obtained without a prescription.
If the patient is taking Rupatadine Genoptim, they should not take medicines containing
ketoconazole or erythromycin.
If the patient is taking central nervous system depressants or statins, they should consult their
doctor before using Rupatadine Genoptim.
Rupatadine Genoptim with food, drink and alcohol
Rupatadine Genoptim should not be taken together with grapefruit juice,
as this may lead to increased levels of Rupatadine Genoptim in the body.
Rupatadine Genoptim at the recommended dose (10 mg) does not increase 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.
Driving and operating machinery
Rupatadine Genoptim, when used at recommended doses, is not expected to affect the ability to
drive or operate machinery. However, if the patient is taking Rupatadine Genoptim for the first time,
they should exercise caution and observe their individual response to the medicine before driving or operating machinery.
Rupatadine Genoptim 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 take Rupatadine Genoptim

This medicine should always be taken as directed by the physician. If in doubt, consult
your doctor or pharmacist.
Rupatadine Genoptim 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 fluid (e.g. a glass of water).
Your doctor will inform you how long treatment with Rupatadine Genoptim should last.
Taking more Rupatadine Genoptim than prescribed
If you accidentally take a large dose of this medicine, contact your doctor or pharmacist immediately.
If you forget to take Rupatadine Genoptim
Take the missed dose as soon as possible, then continue taking the tablets according to the prescribed schedule. Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, Rupatadine Genoptim may cause adverse effects, although not everyone will experience them.
Common adverse effects (may occur in up to 1 in 10 patients)
include: drowsiness, headache, dizziness, dry mouth, feeling of weakness and fatigue.
Uncommon adverse effects (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 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 effects (may occur in up to 1 in 1000 patients)
include: palpitations, rapid heartbeat, and allergic reactions (itching, urticaria, facial swelling, swelling of lips, tongue or throat).
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Rupatadine Genoptim
Keep the medicine out of the 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 (EXP) 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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Rupatadine Genoptim contains

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

What Rupatadine Genoptim looks like and contents of the pack
Rupatadine Genoptim tablets are round, light pink tablets with a diameter of 6.35 mm, packed in blisters and cardboard boxes. The packaging contains 15, 20, 30, 50 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
Poland

Manufacturer/Importer
Martin Dow Pharmaceuticals
Goualle Le Puy, Champ de Lachaud
19250 Meymac
France
Meiji Pharma Spain S.A.
Avda de Madrid, 94
28802 Alcalá de Henares, Madrid
Spain
Medreich PLC
Warwick House, Plane Tree Crescent, Feltham
Middlesex TW13 7HF
United Kingdom

This medicinal product is authorised for marketing in the European Economic Area under the following names:
Poland: Rupatadine Genoptim