Arthrotec 75 modified-release tablets

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Misoprostol; DICLOFENAC SODIUM

Commercializzato da:

Imbat Limited

Codice ATC:

M01AB; M01AB55

INN (Nome Internazionale):

Misoprostol; DICLOFENAC SODIUM

Dosaggio:

75/0.2 milligram(s)

Forma farmaceutica:

Modified-release tablet

Via di somministrazione:

Oral use

Confezione:

60 tablets

Tipo di ricetta:

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

Prodotto da:

Piramal Healthcare UK Limited

Gruppo terapeutico:

Non-steroidal anti-inflammatory

Area terapeutica:

Acetic acid derivatives and related substances; diclofenac, combinations

Indicazioni terapeutiche:

It helps to relieve the pain and swelling of rheumatoid arthritis and osteoarthritis

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2015-05-29

Foglio illustrativo

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ARTHROTEC
® 75 MODIFIED-RELEASE TABLETS
(diclofenac sodium/ misoprostol)
This medicine is available using the name Arthrotec 75
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

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Arthrotec 75 modified-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 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 around ‘75’
on one side, and ‘SEARLE’ on ‘1421’ on the other
side.
4 CLINICAL PARTICULARS
As per PA0822/112/002
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Contains hydrogenated castor oil. May cause stomach upset and
diarrhoea.
5 PHARMACOLOGICAL PROPERTIES
As per PA0822/112/002
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.