Diclofenac 50 mg/Misoprostol 200 micrograms modified release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DICLOFENAC SODIUM; Misoprostol

Available from:

Morningside Healthcare Ltd

ATC code:

M01AB; M01AB55

INN (International Name):

DICLOFENAC SODIUM; Misoprostol

Dosage:

50 mg/200 microgram(s)

Pharmaceutical form:

Modified-release tablet

Prescription type:

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

Therapeutic area:

Acetic acid derivatives and related substances; diclofenac, combinations

Authorization status:

Not marketed

Authorization date:

2013-01-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Diclofenac/Misoprostol
50mg/200microgram 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 Diclof

Summary of Product characteristics

Health Products Regulatory Authority
06 January 2020
CRN009DHS
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diclofenac 50 mg/Misoprostol 200 micrograms modified release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet consists of a gastro-resistant core containing 50 mg
diclofenac sodium surrounded by an outer mantle containing
200 micrograms misoprostol.
Excipient(s):
Each tablet contains 20.0 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 one side and embossed
with “DM2” 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
Adults
One tablet to be taken with food, two or three times daily. Tablets
should be swallowed whole, not chewed.
Elderly/Renal 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 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.
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
Hypersensiti