Arthrotec 75 gastro-resistant tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Diclofenac sodium; Misoprostol

Available from:

Pfizer Ltd

ATC code:

M01AB55

INN (International Name):

Diclofenac sodium; Misoprostol

Dosage:

75mg ; 200microgram

Pharmaceutical form:

Gastro-resistant tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 5012882007607

Patient Information leaflet

Page 1 of 7
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 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:

have had an allergic reaction such as a skin rash, swelling or
itchiness of the skin, severe nasal
congestion, asthma or wheezing after taking diclofenac or other NSAIDs
such as aspirin
(acetylsalicylic acid), misoprostol or another prostaglandin medicine,
or any of the other
ingredients in Arthrotec (see section 6)

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Summary of Product characteristics

OBJECT 1
ARTHROTEC 75 TABLETS
Summary of Product Characteristics Updated 05-Apr-2017 | Pfizer
Limited
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 19.5 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Modified-release tablet.
White, round, biconvex tablets marked 'SEARLE' over '1421' on one
side, and four times 'A' around the
circumference with '75' in the centre on the reverse side.
4. Clinical particulars
4.1 Therapeutic indications
Arthrotec 75 is indicated for patients who require the non-steroidal
anti-inflammatory drug diclofenac
together with misoprostol.
The diclofenac component of Arthrotec 75 is indicated for the
symptomatic treatment of osteoarthritis and
rheumatoid arthritis. The misoprostol component of Arthrotec 75 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 Special warnings and
precautions for use).
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_
The safety and efficacy of Arthrotec 75 in children under 18 years has
not been established.
4.3 Contraind