Arthrotec 50 modified-release tablets

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

DICLOFENAC SODIUM; Misoprostol

Disponível em:

Imbat Limited

Código ATC:

M01AB; M01AB55

DCI (Denominação Comum Internacional):

DICLOFENAC SODIUM; Misoprostol

Dosagem:

50/0.2 milligram(s)

Forma farmacêutica:

Modified-release tablet

Via de administração:

Oral use

Unidades em pacote:

60 tablets

Tipo de prescrição:

Product subject to prescription which may not be renewed (A)

Fabricado por:

Piramal Healthcare UK Limited

Grupo terapêutico:

Non-steroidal anti-inflammatory

Área terapêutica:

Acetic acid derivatives and related substances; diclofenac, combinations

Indicações terapêuticas:

It is indicated for the symptomatic treatment of osteoarthritis and rheumatoid arthritis

Status de autorização:

Authorised

Data de autorização:

2015-05-29

Folheto informativo - Bula

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ARTHROTEC
® 50 MODIFIED-RELEASE TABLETS
(diclofenac sodium/ misoprostol)
This medicine is available using the name Arthrotec 50
modified-release tablets but will be referred to as Arthrotec
throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

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 only. Do not
pass it on to others. It may harm them, even if their
signs of illness are the same as yours.

If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Arthrotec is and what it is used for
2.
What you need to know before you take Arthrotec
3.
How to take Arthrotec
4.
Possible side effects
5.
How to store Arthrotec
6.
Contents of the pack and other information
1.
WHAT ARTHROTEC IS AND WHAT IT IS USED FOR
Arthrotec helps to relieve the pain and swelling of
RHEUMATOID ARTHRITIS and OSTEOARTHRITIS, and may help to
protect patients at risk of irritation or ulceration of the
stomach or intestines.
Arthrotec contains diclofenac and misoprostol. Diclofenac
belongs to a group of medicinal products called Non-Steroidal
Anti-Inflammatory drugs (NSAIDs).
Although NSAIDs relieve the pain, they can reduce the
amount of natural protective substances called prostaglandins
in the stomach lining.
This means that NSAIDs can lead to stomach upsets or
stomach ulcers. Arthrotec also contains misoprostol which is
very similar to these prostaglandins and may help protect
your stomach.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ARTHROTEC
DO NOT TAKE ARTHROTEC
IF YOU:

have had an allergic reaction such as a skin rash,
swelling or itchiness of the skin, severe nasal
congestion, asthma or wheezing after taking diclofenac
or other NSAIDs such as as

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Arthrotec 50 modified-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg diclofenac sodium and 200 micrograms
misoprostol.
Excipient(s) with known effect
Lactose monohydrate and hydrogenated castor oil
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified-release tablet
_Product imported from France_
White, round, biconvex tablets, marked with 4 ‘A’s on one side,
and ‘SEARLE 1411’ on the other side.
4 CLINICAL PARTICULARS
As per PA0822/112/001
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Contains hydrogenated castor oil. May cause stomach upset and
diarrhoea.
5 PHARMACOLOGICAL PROPERTIES
As per PA0822/112/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
microcrystalline cellulose
maize starch
povidone K30
magnesium stearate
copolymer of methacrylic acid and ethyl acrylate (1:1) (EUDRAGIT L
100-55)
sodium hydroxide
talc
triethyl citrate
hypromellose
crospovidone
colloidal anhydrous silica
hydrogenated castor oil
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6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
blister strip and outer carton of the product as marked
in the country of origin.
6.4 SPECIAL PRECAUTIONS FO