Arthrotec 50 modified-release tablets

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Diclofenac sodium; Misoprostol

זמין מ:

Pfizer Healthcare Ireland

קוד ATC:

M01AB; M01AB55

INN (שם בינלאומי):

Diclofenac sodium; Misoprostol

כמות:

50 mg/0.2 milligram(s)

טופס פרצבטיות:

Modified-release tablet

סוג מרשם:

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

איזור תרפויטי:

Acetic acid derivatives and related substances; diclofenac, combinations

מצב אישור:

Marketed

תאריך אישור:

1993-06-16

עלון מידע

Page 1 of 7
2019-0053632
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 ski

מאפייני מוצר

Health Products Regulatory Authority
26 June 2023
CRN00D6H8
Page 1 of 12
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
mantle
containing 200 micrograms misoprostol.
Excipient with known effect
Each tablet contains 13 mg lactose monohydrate.
Each tablet contains 1.3 mg hydrogenated castor oil.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified-release tablet.
White round biconvex tablet marked ‘1411’ and ‘Searle’ on one
side with four ‘A’s on the reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Arthrotec 50 is indicated for patients who require the non-steroidal
anti-inflammatory drug diclofenac together with
misoprostol.
The diclofenac component of Arthrotec 50 is indicated for the
symptomatic treatment of osteoarthritis and rheumatoid
arthritis. The misoprostol component of Arthrotec 50 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 or three 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 50 in children under 18 years has
not been established.
4.3 CONTRAINDICATIONS
Arthrotec 50 is