Arthrotec 50 modified-release tablets

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Misoprostol; DICLOFENAC SODIUM

থেকে পাওয়া:

PCO Manufacturing Ltd.

এটিসি কোড:

M01AB; M01AB55

INN (আন্তর্জাতিক নাম):

Misoprostol; DICLOFENAC SODIUM

ডোজ:

50 mg/0.2 milligram(s)

ফার্মাসিউটিকাল ফর্ম:

Modified-release tablet

প্রেসক্রিপশন টাইপ:

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

থেরাপিউটিক এলাকা:

Acetic acid derivatives and related substances; diclofenac, combinations

অনুমোদন অবস্থা:

Authorised

অনুমোদন তারিখ:

2004-03-31

তথ্য লিফলেট

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ARTHROTEC
® 50 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 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:

think you may be allergic to diclofenac sodium, aspirin
(acetylsalicylic acid),
ibuprofen or any other NSAIDs, misoprostol or another prostaglandin
medicine, or
any of the other ingredients of Arthrotec (see section 6). Signs of a
hypersensitivity reaction include a skin rash, swelling or itchiness
of the skin,
swelling of the

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
08 June 2022
CRN00CZ1L
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Arthrotec 50 modified-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet consists of a gastro-resistant core containing 50
milligrams diclofenac sodium surrounded by an outer
mantlecontaining 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 tablet
_ _
_Product imported from Spain , Netherlands and France:_
White, round, biconvex tablets marked 'Searle' and '1411' on one side
and four 'A's on the other side.
4 CLINICAL PARTICULARS
As per PA0822/112/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0822/112/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose
Microcrystalline cellulose
Maize starch
Povidone
Cellulose acetate phthalate
Diethyl phthalate
Hypromellose
Crospovidone
Magnesium stearate
Hydrogenated castor oil
Colloidal anhydrous silica
The product imported from France contains the following excipients:
Lactose
Microcrystalline cellulose
Maize starch
Povidone
Magnesium stearate
Methacrylic acid copolymer type C
Sodium Hydroxide
Talc
Triethyl citrate
Crospovidone
Colloidal anhydrous silica
Health Products Regulatory Authority
08 June 2022
CRN00CZ1L
Page 2 of 3
Hydrogenated castor oil
The product imported from Netherlands contains the following
excipients:
Lactose monohydrate
Microcrystalline cellulose
Maize starch
Povidone K-30
Hypromellose
Crospovidone
Magnesium Stearate
Methylacrylic acid copolymer type-C
Sodium hydroxide
Talc
Triethyl citrate
Hydrogenated castor oil
Colloidal silicon dioxide
6.2 INCOMPATIBILITIES
Not applicable.
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.