Rupoclar

Package Leaflet: Information for the Patient

Rupoclar, 10 mg, Tablets

Rupatadine

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. 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 Rupoclar and what is it 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 is Rupoclar and what is it used for

Rupatadine is an antihistamine.
Rupoclar relieves the symptoms of allergic rhinitis, such as sneezing,
runny nose, itchy eyes and nose.
Rupoclar 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 Rupoclar

When not to take Rupoclar:

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

Warnings and precautions

Before taking Rupoclar, discuss it with your doctor or pharmacist.
If you have kidney or liver failure, consult your doctor. Currently, it is not recommended to use Rupoclar in patients with impaired kidney or liver function.
If you have low potassium levels and (or) have an abnormal heart rhythm (known as prolonged QTc interval 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.

Rupoclar 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 Rupoclar, do not take medicines containing ketoconazole or erythromycin.
If you are taking medicines that affect the central nervous system or statins, you should consult your doctor before taking Rupoclar.

Rupoclar with food, drink, and alcohol

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

Rupoclar 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

Rupoclar contains lactose

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

3. How to take Rupoclar

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

If you take more Rupoclar than you should

If you have taken more than the recommended dose, contact your doctor or go to the nearest hospital immediately. Take the medicine pack with you, even if it is empty.

If you forget to take Rupoclar

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 a forgotten dose.

4. Possible side effects

Like all medicines, Rupoclar 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 test results, 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. You can also report side effects directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rupoclar

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 that month.
Store in a temperature below 30°C. 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 pack and other information

What Rupoclar contains

• The active substance is rupatadine. Each tablet contains 10 mg of rupatadine (as rupatadine fumarate).
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, maize starch, red iron oxide (E 172), yellow iron oxide (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-colored tablets.
The outer packaging contains 10, 15, or 30 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Vitama S.A.
ul. Bonifraterska 17
00-203 Warsaw

Importer / Manufacturer

MEDICOFARMA S.A.
ul. Tarnobrzeska 13
26-613 Radom

Date of last revision of the leaflet: February 2022