Arthrotec 75 modified-release tablets

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Diclofenac sodium; Misoprostol

Disponibbli minn:

IMED Healthcare Ltd.

Kodiċi ATC:

M01AB; M01AB55

INN (Isem Internazzjonali):

Diclofenac sodium; Misoprostol

Dożaġġ:

75/0.2 milligram(s)

Għamla farmaċewtika:

Modified-release tablet

Żona terapewtika:

Acetic acid derivatives and related substances; diclofenac, combinations

Data ta 'l-awtorizzazzjoni:

2021-04-23

Fuljett ta 'informazzjoni

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ARTHROTEC
®
75 MODIFIED-RELEASE TABLETS
diclofenac sodium, misoprostol
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 contains diclofenac and misoprostol. Diclofenac belongs to a
group of
medicinal products called Non-Steroidal Anti-Inflammatory drugs
(NSAIDs).
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.
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:
•
currently have an ulcer or perforation (hole) in your stomach or
intestines
•
currently suffer from bleeding in your stomach, intestines or brain
•
are pregnant, or trying to become pregnant, because it may cause a
miscarriage. Women
who have not reached the menopause should use reliable contraception
while they are
taking Arthro

Karatteristiċi tal-prodott

Health Products Regulatory Authority
10 July 2023
CRN00DNYW
Page 1 of 2
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:
Each tablet contains lactose monohydrate.
Each tablet contains hydrogenated castor oil.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified-release tablet.
Product imported from _Portugal_
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
_Core:_
Lactose monohydrate
Microcrystalline cellulose
Maize starch
Povidone K-30
Magnesium stearate
_Mantle/Coat:_
Methylacrylic acid copolymer type C
Sodium hydroxide
Talc
Triethylcitrate
Hypromellose
Crospovidone
Hydrogenated castor oil
Colloidal silicon dioxide
Microcrystalline cellulose
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
10 July 2023
CRN00DNYW
Page 2 of 2
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25 °C. Store in the original package.
6.5 NATURE AND CONTENTS OF CONTAINER
Arthrotec 75 is presented in cold-formed aluminium blisters in pack
sizes of 60 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 P