Package leaflet: Information for the patient

Rupaller, 10 mg, tablets
Rupatadine
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Rupaller is and what it is used for
Important information before taking Rupaller
How to take Rupaller
Possible side effects
How to store Rupaller
Contents of the pack and other information

1. What Rupaller is and what it is used for

Rupatadine, the active substance in Rupaller, is an antihistamine medicine.
Rupaller relieves symptoms of allergic rhinitis, such as sneezing, runny nose, and itching of the eyes and nose.
Rupaller 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. Information before taking Rupaller

When not to take Rupaller:

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 to take Rupaller, consult your doctor or pharmacist.
If the patient has kidney or liver impairment, medical advice should be sought. The use of Rupaller 10 mg tablets is currently not recommended in patients with kidney or liver dysfunction.
If the patient has low blood potassium levels and/or an abnormal heart rhythm (known as QTc prolongation on ECG), which may occur in certain heart conditions, they should consult a doctor.
If the patient is over 65 years of age, they should consult a doctor or pharmacist.

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

Rupaller with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient intends to take.
If the patient is taking Rupaller, they should not take medicines containing ketoconazole (a medicine used for fungal infections) or erythromycin (a medicine used for bacterial infections).
If the patient is taking medicines that depress the central nervous system, statins (medicines used to treat high cholesterol levels), or midazolam (a short-acting sedative and hypnotic medicine), they should consult a doctor before using Rupaller.

Rupaller with food, drink, and alcohol
Rupaller should not be taken with grapefruit juice, as this may increase the concentration of Rupaller in the body.
Rupaller 10 mg, at the recommended dose (10 mg), does not increase drowsiness caused by alcohol.

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 a doctor or pharmacist before using this medicine.
Rupaller should not be used during pregnancy or breastfeeding unless otherwise directed by a doctor.

Driving and using machines
Rupaller, when used at recommended doses, is not expected to affect the ability to drive or operate machinery. However, if the patient is taking Rupaller for the first time, they should exercise caution and observe their response to the medicine before driving or operating machinery.

Rupaller 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 Rupaller

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Rupaller is intended for use in adolescents (aged 12 years and older) and adults.
The recommended dose is one tablet (10 mg of rupatadine) once daily, with or without food. The tablet should be swallowed with an adequate amount of liquid (e.g. a glass of water).
The doctor will inform the patient how long treatment with Rupaller should continue.
Taking more than the recommended dose of Rupaller
If a patient accidentally takes a larger dose than recommended, they should contact a doctor or pharmacist immediately.
Missing a dose of Rupaller
The missed dose should be taken as soon as possible, and then the regular dosing schedule should be continued. A double dose should not be taken to make up for the missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Common adverse reactions (may occur in fewer than 1 in 10 patients) include:
drowsiness, headache, dizziness, dry mouth, feeling of weakness and feeling of fatigue.
Uncommon adverse reactions (may occur in fewer than 1 in
100 patients) include:
increased appetite, irritability, difficulty concentrating, nosebleeds, nasal dryness, 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 reactions (may occur in fewer than 1 in 1,000 patients) include:
palpitations, increased heart rate and hypersensitivity reactions (itching, urticaria, swelling
of the face, lips, tongue or throat).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions 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 181C, 02-222 Warsaw
tel.: + 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 to provide more information on the safety of the medicine.

5. How to store Rupaller

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and cardboard
pack after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
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 packaging 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: monohydrate lactose, microcrystalline cellulose PH 102, pregelatinized corn starch, iron oxide red (E 172), iron oxide yellow (E 172), and magnesium stearate.

What Rupaller looks like and contents of the pack
Rupaller is a round, light lilac-coloured tablet with a diameter of 6.35 mm, packed in blisters containing: 20, 30, 50, and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:
Poland Rupaller