Rupaller

Package Leaflet: Information for the Patient

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

1. What is Rupaller and what is it used for

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

When not to take Rupaller:

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

Warnings and precautions

Before taking Rupaller, discuss it with your doctor or pharmacist.
If you have kidney or liver failure, consult your doctor. Currently, it is not recommended to use Rupaller, 10 mg, tablets in patients with impaired kidney or liver function.
If you have low potassium levels in your blood 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 and adolescents

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

Rupaller and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
If you are taking Rupaller, you should not take medicines containing ketoconazole (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 sedative and anxiolytic), you should consult your doctor before taking Rupaller.

Rupaller with food, drink, and alcohol

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

Rupaller, 10 mg, 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 plan to have a child, consult your doctor or pharmacist before taking this medicine.
Rupaller should not be used during pregnancy and breastfeeding, unless your doctor decides otherwise.

Driving and using machines

Rupaller is not expected to affect the ability to drive or use machines at the recommended doses. However, if you are taking Rupaller for the first time, you should be cautious and observe your reaction to the medicine before driving or using machines.

Rupaller 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 Rupaller

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Rupaller is intended for use in adolescents (12 years and older) and adults.
The recommended dose is one tablet (10 mg rupatadine) once a day, with or without food. The tablet should be swallowed with a sufficient amount of liquid (e.g., a glass of water).
Your doctor will tell you how long to take Rupaller.

If you take more Rupaller than you should

If you have taken too much of this medicine, contact your doctor or pharmacist immediately.

Forget to take Rupaller

Take the dose as soon as possible and then continue taking the tablets at the usual time. Do not take a double dose to make up for the forgotten dose.

4. Possible side effects

Like all medicines, Rupaller 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 feeling tired.
Uncommon side effects(may affect up to 1 in 100 people) include:
increased appetite, irritability, difficulty concentrating, nosebleeds, dry nose, 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, increased heart rate, and hypersensitivity 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.
Side effects can be reported 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
Side effects can also be reported 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 Rupaller

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month.
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 Rupaller contains

• The active substance is rupatadine. Each tablet contains 10 mg of rupatadine (as 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 Rupaller looks like and contents of the pack

Rupaller is light orange, round tablets, 6.35 mm in diameter, packaged in blisters of: 20, 30, 50, and 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
tel. +48 22 822 93 06
e-mail: [email protected]

Importer

Meiji Pharma Spain S.A.
Avda de Madrid, 94
Alcala de Henares
Madrid, 28802
Spain
Martin Dow Pharmaceuticals
Goualle Le Puy,
Champ de Lachaud,
19250 Meymac,
France

This medicinal product is authorized in the Member States of the European

Economic Area under the following names:

Poland
Rupaller
Date of last revision of the leaflet:June 2025