Diclofenac 75 mg/Misoprostol 200 micrograms modified release tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Diclofenac sodium; Misoprostol

Tilgjengelig fra:

Morningside Healthcare Ltd

ATC-kode:

M01BA; M01BA55

INN (International Name):

Diclofenac sodium; Misoprostol

Dosering :

75 mg/200 microgram(s)

Legemiddelform:

Modified-release tablet

Resept typen:

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

Terapeutisk område:

Antiinflammatory/antirheumatic agents in combination with corticosteroids; Acetic acid derivatives and related substances

Autorisasjon status:

Not marketed

Autorisasjon dato:

2013-01-18

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
Diclofenac/Misoprostol
75mg/200 microgram 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 Diclofenac/Misoprostol Tablets are and what they
are used for
2.
What you need to know before you take Diclofenac/
Misoprostol Tablets
3.
How to take Diclofenac/Misoprostol Tablets
4.
Possible side effects
5.
How to store Diclofenac/Misoprostol Tablets
6.
Contents of the pack and other information
1.
What Diclofenac/Misoprostol Tablets are and
what they are used for
Diclofenac/Misoprostol Tablets help 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.
Diclofenac/Misoprostol Tablets contain 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. Diclofenac/Misoprostol Tablets
also contain misoprostol which is very similar to these
prostaglandins and may help protect your stomach.
2.
What you need to know before you take
Diclofenac/Misoprostol Tablets
Tell your doctor if you recently had or you are going to
have a surgery of the stomach or intestinal tract before
taking Diclofenac/Misoprostol Tablets, as Diclo

Preparatomtale

Health Products Regulatory Authority
06 January 2020
CRN009DHS
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diclofenac 75 mg/Misoprostol 200 micrograms 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):
Each tablet contains 30.0 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified Release Tablet
White circular, biconvex uncoated tablets plain on one side and
embossed with “DM1” on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Diclofenac/Misoprostol tablets are indicated for patients who require
the non-steroidal anti-inflammatory drug diclofenac
together with misoprostol.
The diclofenac component of Diclofenac/Misoprostol Tablets is
indicated for the symptomatic treatment of osteoarthritis and
rheumatoid arthritis. The misoprostol component of
Diclofenac/Misoprostol Tablets 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
Posology
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms (see section 4.4).
Adults
One tablet to be taken with food, two times daily. Tablets should be
swallowed whole, not chewed.
Elderly/Renal, Cardiac and 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).
Paediatric population (under 18 years)
The safety and efficacy of Diclofenac/Misoprostol Tablets in children
has not been established.
4.3 CONTRAINDICATIONS