Arthrotec 75 modified-release tablets

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Misoprostol; DICLOFENAC SODIUM

Beschikbaar vanaf:

LTT Pharma Limited

ATC-code:

M01AB; M01AB55

INN (Algemene Internationale Benaming):

Misoprostol; DICLOFENAC SODIUM

Dosering:

75/0.2 milligram(s)

farmaceutische vorm:

Modified-release tablet

Prescription-type:

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

Therapeutisch gebied:

Acetic acid derivatives and related substances; diclofenac, combinations

Autorisatie-status:

Authorised

Autorisatie datum:

2017-03-01

Bijsluiter

ARTHROTEC 75 MODIFIED-RELEASE TABLETS
(diclofenac sodium/misoprostol)
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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
What Arthrotec is and what it is used for
What you need to know before you take Arthrotec
How to take Arthrotec
Possible side effects
How to store Arthrotec
Contents of the pack and other information
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.
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 aspirin (acetylsalicylic acid),
misoprostol or another prostaglandin medicine, or any of the other
ingredients in Arthrotec (see section 6)
*
currently have an ulcer or perforation (hole) in you

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Arthrotec 75 modified-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet consists of a gastro-resistant core containing 75 mg
diclofenac sodium surrounded by an outer mantle
containing 200 micrograms misoprostol.
Excipient(s) with known effect: lactose monohydrate
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 'SEARLE'
over ‘1421’ on one side, and four times ‘A’ around the
circumference with ‘75’ in the centre on the reverse side.
4 CLINICAL PARTICULARS
As per PA0822/112/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0822/112/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
Microcrystalline cellulose
Maize starch
Povidone K-30
Magnesium stearate
Copolymer, methylacrylic acid, ethyl acrylate (1:1) (EUDRAGIT L
100-55)
Sodium hydroxide
Talc
Triethyl citrate
Hypromellose
Crospovidone
Silica colloidal anhydrous
Hydrogenated castor oil
6.2 INCOMPATIBILITIES
Not applicable.
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6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR