Rupatadine Genoptim

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the user

Rupatadine Genoptim, 10 mg, tablets

Rupatadine

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

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

2. Important information before taking Rupatadine Genoptim

When not to take Rupatadine Genoptim

Warnings and precautions

Before taking Rupatadine Genoptim, discuss it with your doctor or pharmacist. If you have kidney or liver problems, consult your doctor.
Rupatadine Genoptim should not be taken by patients with kidney or liver problems. If you have low potassium levels and/or an abnormal heart rhythm (known as a prolonged QTc interval in the ECG), which may occur in some heart conditions, consult your doctor.
If you are over 65 years old, consult your doctor or pharmacist.

Children

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

Rupatadine Genoptim and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, including those obtained without a prescription.
If you are taking Rupatadine Genoptim, do not take medicines containing ketokonazole or erythromycin.
If you are taking medicines that affect the central nervous system or statins, consult your doctor before taking Rupatadine Genoptim.

Rupatadine Genoptim with food, drink, and alcohol

Do not take Rupatadine Genoptim with grapefruit juice, as it may increase the level of Rupatadine Genoptim in your body.

Rupatadine Genoptim 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 have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Rupatadine Genoptim is unlikely to affect your ability to drive or use machines. However, if you are taking Rupatadine Genoptim for the first time, be cautious and observe your reaction to the medicine before driving or using machines.

Rupatadine Genoptim contains lactose

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

3. How to take Rupatadine Genoptim

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Rupatadine Genoptim 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 Rupatadine Genoptim.

If you take more Rupatadine Genoptim than you should

If you accidentally take too much of the medicine, contact your doctor or pharmacist immediately.

If you forget to take Rupatadine Genoptim

Take the dose as soon as you remember, and then continue taking the tablets as scheduled. Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, Rupatadine Genoptim 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 congestion, 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 1,000 people)
include: 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 those not listed in this leaflet, tell your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
Reporting side effects will help to gather more information on the safety of this 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 carton and blister.
The expiry date (EXP) is the last day of the month stated.
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 Rupatadine Genoptim contains

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

What Rupatadine Genoptim looks like and contents of the pack

Rupatadine Genoptim tablets are round, light orange tablets, 6.35 mm in diameter, packaged in blisters and a carton. The pack contains 15, 20, 30, 50, or 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Synoptis Pharma Sp. z o. o.
ul. Krakowiaków 65
02-255 Warsaw

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 authorized in the Member States of the European

Economic Area under the following names:

Poland
Rupatadine Genoptim

Date of last revision of the leaflet: 09/2020