ARTHROTEC 50/0.2 Milligram Modified-release Tablets

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

DICLOFENAC SODIUM MISOPROSTOL

Inapatikana kutoka:

B & S Healthcare

INN (Jina la Kimataifa):

DICLOFENAC SODIUM MISOPROSTOL

Kipimo:

50/0.2 Milligram

Dawa fomu:

Modified-release Tablets

Dawa ya aina:

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

Idhini hali ya:

Authorised

Idhini ya tarehe:

0000-00-00

Taarifa za kipeperushi

PATIENT INFORMATION LEAFLET 
ARTHROTEC
® 
50 MODIFIED-RELEASE TABLETS 
(diclofenac sodium 50mg, misoprostol 200micrograms) 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START 
TAKING THIS MEDICINE 
•  KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN. 
•  IF YOU HAVE ANY FURTHER QUESTIONS, PLEASE ASK YOUR 
DOCTOR OR PHARMACIST. 
•  THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. DO NOT 
PASS IT ON TO OTHERS. IT MAY HARM THEM, EVEN IF 
THEIR SYMPTOMS ARE THE SAME AS YOURS. 
•  IF ANY OF THE SIDE EFFECTS GETS SERIOUS OR IF YOU 
NOTICE ANY SIDE EFFECTS NOT LISTED IN THIS LEAFLET, 
PLEASE TELL YOUR DOCTOR OR PHARMACIST. 

IN THIS LEAFLET: 
1.  WHAT ARTHROTEC IS AND WHAT IT IS USED FOR 
2.  BEFORE YOU TAKE ARTHROTEC 
3.  HOW TO TAKE ARTHROTEC 
4.  POSSIBLE SIDE EFFECTS 
5.  HOW TO STORE ARTHROTEC 
6.  FURTHER 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. 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 an

Tabia za bidhaa

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(s):
Each tablet contains 13.0 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified-release Tablets
_Product imported from the UK:_
White, round, biconvex tablets marked '1141’ 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
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).
Children (under 18 years)
The safety and effica