C O N F I D E N T I A L

Module 1.3.1.4    Package Leaflet - English version

RUPATADINE SUBSTIPHARM 10 mg tablets

Rupatadine

What is in this leaflet

1.    What RUPATADINE SUBSTIPHARM is and what it is used for

2.    What you need to know before you take RUPATADINE SUBSTIPHARM

3.    How to take RUPATADINE SUBSTIPHARM

4.    Possible side effects

5.    How to store RUPATADINE SUBSTIPHARM

6.    Contents of the pack and other information

1.    WHAT RUPATADINE SUBSTIPHARM IS AND WHAT IT IS USED FOR

Rupatadine, , the active substance in <RUPATADINE SUBSTIPHARM>, is an antihistamine.

RUPATADINE SUBSTIPHARM relieves the symptoms of allergic rhinitis such as sneezing, runny nose, itching in the eyes and nose.

RUPATADINE SUBSTIPHARM is also used to relieve the symptoms associated with urticaria (an allergic skin rash) such as itching and hives (localised skin redness and swelling).

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE RUPATADINE SUBSTIPHARM Do not take RUPATADINE SUBSTIPHARM

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

Talk to your doctor or pharmacist before taking this medicine

If you suffer from kidney or liver insufficiency, ask your doctor for advice. The use of RUPATADINE SUBSTIPHARM 1 0 mg tablets is at p resent not reco mmended in patients with impaired kidney or liver functions.

If you hav e low bl ood levels of p otassium and/or if you have a certain a bnormal pattern to your heartbeat (known prolongation of th e QTc interval on the ECG) which can occur in some forms of heart disease, ask your doctor for advice.

If you are older than 65, ask your doctor or your pharmacist.

Children and adolescent

RUPATADINE SUBSTIPHARM is not for use in children under 12 years of age.

Other medicines and RUPATADINE SUBSTIPHARM

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.

If you are taking RUPATADINE SUBSTIPHARM do not take medicines containing ketoconazole or erythromycin.

If you are taking central nervous system depressant medicines or statin medicines, ask your doctor for advice before taking Rupatidine Substipharm.

RUPATADINE SUBSTIPHARM with food and drink

RUPATADINE SUBSTIPHARM should not be taken in combination with grapefruit juice, as this may increase the level of RUPATADINE SUBSTIPHARM in your body.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take RUPATADINE SUBSTIPHARM during pregnancy and breastfeeding, unless clearly indicated by your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

At the recommended dosage, RUPATADINE SUBSTIPHARM is not expected to influence your ability to drive or use machinery. However, when you first start taking RUPATADINE SUBSTIPHARM you should take care to see how the treatment affects you before driving or using machines.

RUPATADINE SUBSTIPHARM contains lactose

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product..

3. HOW TO TAKE RUPATADINE SUBSTIPHARM

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

RUPATADINE SUBSTIPHARM is for adolescents (from 12 years and older) and adults. The usual dose is one tablet (10 mg of rupatadine) once daily with or without food. Swallow the tablet with a sufficient quantity of liquid (e. g. one glass of water).

Your doctor will tell you how long your treatment with RUPATADINE SUBSTIPHARM will last.

If you take more RUPATADINE SUBSTIPHARM than you should

If you have accidentally taken a high dose of your medicine, talk to your doctor or pharmacist immediately.

If you forget to take RUPATADINE SUBSTIPHARM

Take your dose as soon as possible and then continue with your tablets at the usual times. Do not take a double dose to make up for a forgotten doses.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to1 in 10 people) are:

Sleepiness, headache, dizziness, dry mouth, sensation of weakness and fatigue.

Uncommon side effects (may affect up to1 in 100 people) are:

Increased appetite, irritability, difficulty concentrating, nosebleed, nasal dryness, sore throat, cough, dry throat, rhinitis, nausea, abdominal pain, diarrhoea, indigestion, vomiting, constipation, rash, back pain, joint pain, muscle pain, thirst, general discomfort, fever, abnormal liver function test and increased weight.

Rare side effects (may affect up to 1 in 1,000 people): are palpitations, increased heart rate and hypersensitivity reactions (including anaphylactic reactions, angioedema, and urticarial).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard.By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE RUPATADINE SUBSTIPHARM

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and the carton.

No special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION What RUPATADINE SUBSTIPHARM contains

The active substance is rupatadine. Each tablet contains 10 mg of rupatadine (as fumarate).

The other ingredients are lactose monohydrate, microcrystalline cellulose PH 102, pregelatinized starch, iron oxide red, iron oxide yellow and magnesium stearate.

RUPATADINE SUBSTIPHARM are round, light salmon coloured tablets packed in unit blister doses of 20, 30, 50 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

SUBSTIPHARM DEVELOPPEMENT 24 RUE ERLANGER 75016 PARIS FRANCE

This medicinal product is authorised in the Member States of the EEA under the following names:

Portugal: RUPATADINA SUBSTIPHARM Italy: RUPATADINE SUBSTIPHARM 10 mg, compresse Spain: RUPATADINE SUBSTIPHARM 10 mg, comprimidos EFG Belgium: RUPATADINE SUBSTIPHARM 10 mg, comprimes The Netherlands: RUPATADINE SUBSTIPHARM 10 mg tabletten United Kingdom: RUPATADINE SUBSTIPHARM 10 mg tablet Austria: RUPATADINE SUBSTIPHARM 10 mg Tabletten

This leaflet was last revised in 01/2016.

D 205 - January 2016 Mod 1.3.1.4 page 4