Arthrotec 50 modified-release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DICLOFENAC SODIUM; Misoprostol

Available from:

Imbat Limited

ATC code:

M01AB; M01AB55

INN (International Name):

DICLOFENAC SODIUM; Misoprostol

Dosage:

50/0.2 milligram(s)

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral use

Units in package:

60 tablets

Prescription type:

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

Manufactured by:

Piramal Healthcare UK Limited

Therapeutic group:

Non-steroidal anti-inflammatory

Therapeutic area:

Acetic acid derivatives and related substances; diclofenac, combinations

Therapeutic indications:

It is indicated for the symptomatic treatment of osteoarthritis and rheumatoid arthritis

Authorization status:

Authorised

Authorization date:

2015-05-29

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ARTHROTEC
® 50 MODIFIED-RELEASE TABLETS
(diclofenac sodium/ misoprostol)
This medicine is available using the name Arthrotec 50
modified-release tablets but will be referred to as Arthrotec
throughout this leaflet.
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 as

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Arthrotec 50 modified-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg diclofenac sodium and 200 micrograms
misoprostol.
Excipient(s) with known effect
Lactose monohydrate and hydrogenated castor oil
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified-release tablet
_Product imported from France_
White, round, biconvex tablets, marked with 4 ‘A’s on one side,
and ‘SEARLE 1411’ on the other side.
4 CLINICAL PARTICULARS
As per PA0822/112/001
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Contains hydrogenated castor oil. May cause stomach upset and
diarrhoea.
5 PHARMACOLOGICAL PROPERTIES
As per PA0822/112/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
microcrystalline cellulose
maize starch
povidone K30
magnesium stearate
copolymer of methacrylic acid and ethyl acrylate (1:1) (EUDRAGIT L
100-55)
sodium hydroxide
talc
triethyl citrate
hypromellose
crospovidone
colloidal anhydrous silica
hydrogenated castor oil
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_1_
_8_
_/_
_0_
_6_
_/_
_2_
_0_
_1_
_8_
_C_
_R_
_N_
_ _
_2_
_2_
_0_
_6_
_3_
_4_
_7_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
blister strip and outer carton of the product as marked
in the country of origin.
6.4 SPECIAL PRECAUTIONS FO