RUPOCLAR

Patient Information Leaflet

Rupoclar, 10 mg, tablets
Rupatadine
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any 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.

Leaflet Contents:

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

1. What Rupoclar is and what it is used for

Rupatadine is an antihistamine medicine.
Rupoclar relieves symptoms of allergic rhinitis, such as sneezing, nasal discharge, and itching of the eyes and nose.
Rupoclar 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 using Rupoclar

When not to take Rupoclar:

• 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 Rupoclar, discuss this with your doctor or pharmacist.
If the patient has kidney or liver impairment, medical advice should be sought. Currently, the use of Rupoclar is not recommended in patients with renal or hepatic dysfunction.
If the patient has low potassium levels and/or an abnormal heart rhythm (known as QTc prolongation on ECG), which may occur in certain heart conditions, they should consult their doctor.
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.
Rupoclar 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 Rupoclar, they should not take medicines containing ketoconazole or erythromycin.
If the patient is taking medicines that depress the central nervous system or statins, they should consult their doctor before using Rupoclar.
Rupoclar with food, drink and alcohol
Rupoclar should not be taken together with grapefruit juice, as this may lead to increased levels of Rupoclar in the body.
Rupoclar 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
Rupoclar, when used at recommended doses, is not expected to affect the ability to drive or operate machinery. However, if the patient is taking Rupoclar for the first time, they should exercise caution and observe their response to the medicine before driving or operating machinery.
Rupoclar contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before starting this medicine.

3. How to use Rupoclar

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
Rupoclar 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 with
an adequate amount of liquid (e.g. a glass of water).
Your doctor will inform you how long treatment with Rupoclar should continue.
Taking more Rupoclar than prescribed
If you take more Rupoclar than recommended, contact a doctor immediately or go to the nearest
hospital. Take the medicine package with you, even if there are no tablets left in it.
Missed dose of Rupoclar
Take the missed dose 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, this medicine can cause adverse reactions, although not everyone will experience them.

Common adverse reactions (may occur in up to 1 in 10 patients) include:
drowsiness, headache, dizziness, dry mouth, feeling weak 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, facial swelling, swelling of lips, tongue or throat).

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products at 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 provide more information on the safety of this medicine.

5. How to store Rupoclar

Keep this 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 below 30°C. Keep the blister in the outer packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Rupoclar contains

• The active substance is rupatadine. Each tablet contains 10 mg of rupatadine (as rupatadine fumarate).
• Other ingredients are: microcrystalline cellulose, monohydrate lactose, maize starch, iron oxide red (E 172), iron oxide yellow (E 172), and magnesium stearate.

What Rupoclar looks like and contents of the pack
Rupoclar tablets are round, biconvex, uncoated, smooth on both sides, salmon-coloured tablets.
The outer packaging contains 10, 15 or 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Vitama S.A.
ul. Bonifraterska 17
00-203 Warsaw
Importer / Manufacturer
MEDICOFARMA S.A.
ul. Tarnobrzeska 13
26-613 Radom