Arthrotec 75 modified-release tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Diclofenac sodium; Misoprostol

Saatavilla:

PCO Manufacturing Ltd.

ATC-koodi:

M01AB; M01AB55

INN (Kansainvälinen yleisnimi):

Diclofenac sodium; Misoprostol

Annos:

75/0.2 milligram(s)

Lääkemuoto:

Modified-release tablet

Prescription tyyppi:

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

Terapeuttinen alue:

Acetic acid derivatives and related substances; diclofenac, combinations

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2004-03-31

Pakkausseloste

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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 ar

Valmisteyhteenveto

Health Products Regulatory Authority
19 December 2022
CRN00D8LS
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
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Modified-release tablets
_Product imported from Italy (Misofenac & Arthrotec):_
White, round, biconvex tablets, plain on both sides or white, round,
biconvex tablets marked 'SEARLE' and '1421' on one side
with four 'A's and '75' on the other 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
Microcrystalline cellulose
Maize starch
Povidone K-30
Methacrylic Acid Copolymer Type C
Sodium Hydroxide
Triethyl Citrate
Hypromellose
Crospovidone
Magnesium stearate
Hydrogenated castor oil
Colloidal anhydrous silica.
Talc
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
19 December 2022
CRN00D8LS
Page 2 of 2
6.3 SHELF LIFE
The shelf-life expiry date of this product is 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 in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister pack containing 30 or 60 tablets.
Not all pack sizes may be marketed
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
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/114/002
9 DATE OF FIRST AUTHORISA