Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Rupafin 10 mg (Rupatall), tablets
Rupatadinum
Rupafin 10 mg and Rupatall are different trade names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.

Table of contents

What Rupafin 10 mg is and what it is used for
Important information before taking Rupafin 10 mg
How to take Rupafin 10 mg
Possible side effects
How to store Rupafin 10 mg
Contents of the pack and other information

1. What Rupafin 10 mg is and what it is used for

Rupatadine is an antihistamine medicine.
Rupafin 10 mg relieves symptoms of allergic rhinitis, such as sneezing,
runny nose, itchy eyes and nose.
Rupafin 10 mg 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 taking Rupafin 10 mg

When not to take Rupafin 10 mg

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 Rupafin 10 mg, consult with your doctor or pharmacist.
If the patient has kidney or liver impairment, medical advice should be sought. Currently, the use of Rupafin 10 mg is not recommended in patients with kidney or liver 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 diseases, 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.
Rupafin 10 mg and other medicines
Inform 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 Rupafin 10 mg, 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 their doctor before using Rupafin 10 mg.
Rupafin 10 mg with food, drink and alcohol
Rupafin 10 mg should not be taken with grapefruit juice, as this may lead to increased levels of Rupafin 10 mg in the body.
Rupafin 10 mg 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
Rupafin 10 mg, when used at recommended doses, is not expected to affect the ability to drive or operate machinery. However, if the patient is taking Rupafin 10 mg for the first time, they should exercise caution before driving or operating machinery and observe their reaction to the medicine.
Rupafin 10 mg contains monohydrate lactose
If the patient has been previously diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to take Rupafin 10 mg

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure,
you should consult your doctor or pharmacist.
Rupafin 10 mg 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 whole with an adequate amount of liquid (e.g. a glass of water).
Your doctor will inform you how long the treatment with Rupafin 10 mg should continue.
Taking more Rupafin 10 mg than recommended
If you accidentally take more than the prescribed dose, contact your doctor or pharmacist
immediately.
If you forget to take Rupafin 10 mg
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 the missed dose.

4. Possible adverse effects

Like all medicines, Rupafin 10 mg may cause adverse effects, although not everyone will experience them.

Common adverse effects (may occur in up to 1 in 10 patients) include:
drowsiness, headache, dizziness, dry mouth, feeling of weakness and fatigue.

Uncommon adverse effects (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 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 effects (may occur in up to 1 in 1000 patients) include:
palpitations, tachycardia, and allergic reactions (itching, urticaria, swelling of the face, lips, tongue or throat).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: + 48 22 49 21 301,
fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Rupafin 10 mg

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store the blister pack 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 Rupafin 10 mg contains

The active substance is rupatadine. Each tablet contains 10 mg of rupatadine (as rupatadine fumarate).
The other ingredients are: pregelatinized corn starch, microcrystalline cellulose, red iron oxide (E 172), yellow iron oxide (E 172), monohydrate lactose, and magnesium stearate. See section 2 "Rupafin 10 mg contains monohydrate lactose".

What Rupafin 10 mg looks like and contents of the pack
Rupafin 10 mg tablets are round, light grey-blue tablets, packed in blisters containing 10 tablets.
The outer packaging contains 30 tablets.
For more detailed information, please contact the responsible party or parallel importer.

Marketing Authorisation Holder in Belgium, country of export:
J. Uriach y Compañia S.A.
Av. Camí Reial, 51-57
08184 Palau-solità i Plegamans, Spain

Manufacturer:
J. Uriach y Compañia S.A.
Av. Camí Reial, 51-57
08184 Palau-solità i Plegamans, Spain

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland

Belgian Marketing Authorisation Number, country of export: BE272045
Parallel Import Authorisation Number: 259/18

This medicinal product is authorised in the European Economic Area countries under the following names:
Rupatall 10 mg – Belgium, Luxembourg
Rinialer 10 mg – Malta, Portugal
Rupafin 10 mg – Austria, Bulgaria, Croatia, Cyprus, Denmark, Estonia, Greece, Spain, the Netherlands, Ireland, Iceland, Lithuania, Liechtenstein, Latvia, Germany, Norway, Poland, Slovakia, Slovenia, Italy
Rupatadine 10 mg – United Kingdom
Wystamm 10 mg – France
Tamalis 10 mg – Czech Republic, Romania, Hungary
Pafinur 10 mg – Finland, Sweden