RUPAFIN 10MG TABLETS

Active substance: RUPATADINE

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Package Leaflet: Information for the user

Rupafin 10 mg Tablets
Rupatadine

Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or your 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 any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

In this leaflet
1. What Rupafin is and what it is used for
2. Before you take Rupafin
3. How to take Rupafin
4. Possible side effects
5. How to store Rupafin
6. Further information

1.

WHAT RUPAFIN IS AND WHAT IT IS USED FOR

Rupatadine is an antihistamine.
Rupafin relieves the symptoms of allergic rhinitis such as sneezing, runny nose, itching in the
eyes and nose.
Rupafin is also used to relieve the symptoms associated with urticaria (an allergic skin rush)
such as itching and hives (localised skin redness and swelling).
2.

BEFORE YOU TAKE RUPAFIN

Do not take Rupafin
- If you are allergic (hypersensitive) to rupatadine or any of the other ingredients of Rupafin.
Take special care with Rupafin
If you suffer from kidney or liver insufficiency, ask your doctor for advice. The use of Rupafin
10 mg tablets is at present not recommended in patients with impaired kidney or liver functions.
This medicine is not for use in children under 12 years of age.
If you are older than 65, ask your doctor or your pharmacist.
Using other medicines
Please tell your doctor or pharmacist if you are using or have recently used any other medicines,
including medicines obtained without a prescription.
If you are taking Rupafin do not take medicines containing ketoconazole or erythromycin.
Taking Rupafin with food and drink
Rupafin should not be taken in combination with grapefruit juice, as this may increase the
level of Rupafin in your body.
Pregnancy and breast-feeding
ES/H/0105/001/II/029

Do not take Rupafin during pregnancy and breast-feeding, 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, Rupafin is not expected to influence your ability to drive or use
machinery. However, when you first start taking Rupafin you should take care to see how the
treatment affects you before driving or using machines.
Important information about some of the ingredients of Rupafin
This medicinal product contains lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.

3.

HOW TO TAKE RUPAFIN

Always take Rupafin exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Rupafin 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 Rupafin will last.
If you take more Rupafin 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 Rupafin
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 forgotten individual doses.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, Rupafin can cause side effects, although not everybody gets them.
Common side effects (in less than 1 in 10, but more than 1 in 100 patients) are sleepiness,
headache, dizziness, dry mouth, sensation of weakness and fatigue. Uncommon side effects (in
less than 1 in 100, but more than 1 in 1000 patients) 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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5.

HOW TO STORE RUPAFIN

Keep out of the reach and sight of children.
Do not use Rupafin after the expiry date which is stated on the carton and blister. The expiry
date refers to the last day of that month.
ES/H/0105/001/II/029

Keep the blisters in the outer carton in order 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. These measures will help to protect the
environment.

6.

FURTHER INFORMATION

What Rupafin contains
The active substance is rupatadine. Each tablet contains 10 mg of rupatadine (as
fumarate).
The other ingredients are pregelatinised maize starch, microcrystalline cellulose, red iron
oxide (E-172), yellow iron oxide (E-172), lactose monohydrate and magnesium stearate.
What Rupafin looks like and contents of the pack
Rupafin are round, light salmon coloured tablets packed in unit blister doses of 30 tablets.
Marketing Authorisation Holder and Manufacturer:
J. Uriach & Cía., S.A.
Av. Camí Reial, 51-57
E-08184 Palau-solità i Plegamans (Barcelona - Spain)
Distributed by:
GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex UB11 1BT
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call free of
charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name:
Rupafin 10 mg tablets
Reference number:
11906/0007
This is a service provided by the Royal National Institute of Blind People.
This medicinal product is authorised in the Member Status of the EEA under the
following names:
Rupatall 10 mg Tablets Belgium, Luxembourg
Rinialer 10 mg Tablets
Portugal, Malta
Rupafin 10 mg Tablets
Austria, Cyprus, Estonia, Germany, Greece, Italy, Ireland,
Latvia, Lithuania, Netherlands, Poland, Slovenia, Slovak
Republic, Spain, United Kingdom
Wystamm 10 mg Tablets
France
Tamalis 10 mg Tablets
Hungary, Czech Republic
This leaflet was last approved in 22/12/2009

ES/H/0105/001/II/029

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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