Masidemen 50mg/200microgram gastro-resistant tablets

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Diclofenac sodium; Misoprostol

Saatavilla:

Actavis UK Ltd

ATC-koodi:

M01AB55

INN (Kansainvälinen yleisnimi):

Diclofenac sodium; Misoprostol

Annos:

50mg ; 200microgram

Lääkemuoto:

Gastro-resistant tablet

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 10010100; GTIN: 5012617024589

Pakkausseloste

_Continued top of next column _
AAAG4136
Diclofenac Misoprostol 50mg/200mcg tablet leaflet - UK
item no:
print proof no:
origination date:
originated by:
revision date:
revised by:
dimensions:
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
4.
5.
6.
1.
2.
3.
date sent:
supplier:
technically app. date:
min pt size:
TECHNICAL APPROVAL
AAAG4136
5
03.01.14
jh
03.02.14
jh
Cipla
190 x 450
9, 10, 11
03.01.14
07.01.14
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 Masidemen is and what it is used for
2
What you need to know before you take
Masidemen
3
How to take Masidemen
4
Possible side effects
5
How to store Masidemen
6
Contents of the pack and other information
1
WHAT MASIDEMEN IS AND WHAT IT IS USED FOR
Masidemen 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.
Masidemen 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. Masidemen 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
MASIDEMEN
DO NOT TAKE MASIDEMEN IF YOU:
•
ARE PR

Valmisteyhteenveto

OBJECT 1
MASIDEMEN 50MG/200MICROGRAM MODIFIED-
RELEASE TABLETS
Summary of Product Characteristics Updated 04-Feb-2015 | Accord-UK Ltd
1. Name of the medicinal product
Masidemen 50mg/200microgram Modified-release Tablets
2. Qualitative and quantitative composition
Each Masidemen50 mg/200 microgram modified-release tablet contains 50
mg diclofenac sodium and
200 microgram misoprostol.
Excipient with known effect:
Each Masidemen 50 mg/200 microgram modified-release tablet contains 20
mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Modified-release tablet.
White, circular, biconvex uncoated tablets, 11.5 mm in diameter and
6.2 mm in thickness, plain on one
side and embossed “DM2“ on the other side.
4. Clinical particulars
4.1 Therapeutic indications
The diclofenac component of Masidemen is indicated for the symptomatic
treatment of osteoarthritis and
rheumatoid arthritis. The misoprostol component of Masidemen is
indicated for patients with a special
need for the prophylaxis of NSAID-induced gastric and duodenal
ulceration.
4.2 Posology and method of administration
Adults
One tablet to be taken with food, two or three times daily. Tablets
should be swallowed whole, not
chewed.
Elderly and patients with renal, cardiac or hepatic impairment
No adjustment of dosage is necessary in the elderly or in patients
with hepatic impairment or mild to
moderate renal impairment as pharmacokinetics are not altered to any
clinically relevant extent.
Nevertheless, elderly patients and patients with renal, cardiac or
hepatic impairment should be closely
monitored (see section 4.4 and section 4.8).
Children (under 18 years)
The safety and efficacy of diclofenac/misoprostol in children has not
been established.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
4.3 Contraindications
- Hypersensitivity to the active substances or to any of the
excipients listed in section 6.1
- Established con