DICLAC 25 Milligram Tablets Gastro-Resistant

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DICLOFENAC SODIUM

Available from:

Rowex Ltd

ATC code:

M01AB05

INN (International Name):

DICLOFENAC SODIUM

Dosage:

25 Milligram

Pharmaceutical form:

Tablets Gastro-Resistant

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Acetic acid derivatives and related substances

Authorization status:

Authorised

Authorization date:

2004-10-29

Patient Information leaflet

 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

DICLAC 25MG & 50MG GASTRO-RESISTANT TABLETS  
DICLOFENAC SODIUM 

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 or nurse. This includes any possible 
side effects not listed in this leaflet. See section 4.  

 WHAT IS IN THIS LEAFLET  
1. What Diclac is and what it is used for  
2. What you need to know before you take Diclac  
3. How to take Diclac  
4. Possible side effects  
5. How to store Diclac  
6. Contents of the pack and other information  

1 WHAT DICLAC IS AND WHAT IT IS USED FOR  
Diclac belongs to a group of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs), which 
are used to treat pain and inflammation. Diclac relieves
symptoms of inflammation, such as swelling 
and pain and also reduces fever. It has no effect on the
cause of inflammation or fever. Diclac can be 
used to treat the following conditions:  
• inflammatory conditions such as rheumatoid arthritis,
osteoarthritis  
• acute musculoskeletal disorders such as frozen
shoulder or tendinitis  
• other painful conditions such as fractures, low back pain,
sprains, strains, dislocations, orthopaedic 
or dental surgery  


pain and swelling after surgery  
• painful menstrual periods  
• attacks of gout  


painful ear, nose and throat infections.  

2
 WHAT YOU NEED TO KNOW BEFORE YOU TAKE DICLAC  
DO NOT TAKE DICLAC IF:  
- you are allergic to diclofenac sodium or any of
t

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diclac 25 mg Gastro-resistant Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Diclofenac Sodium 25 mg.
Excipients: Each tablet contains lactose monohydrate 15mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablets.
Yellow-brown, round film coated gastro resistant tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Relief of all grades of pain and inflammation in a wide range of
conditions.
Treatment of:
Inflammatory and degenerative forms of rheumatism: rheumatoid
arthritis, juvenile rheumatoid arthritis,
ankylosing spondylitis, osteoarthritis and spondylarthritis.
Acute attacks of gout.
Post-traumatic and post-operative pain, inflammation, and swelling,
e.g. following dental or orthopaedic surgery.
Painful and/or inflammatory conditions in gynaecology, e.g. primary
dysmenorrhoea or adnexitis and associated
menorrhagia.
As an adjuvant in severe painful inflammatory infections of the ear,
nose, or throat, e.g. pharyngotonsillitis,
otitis.
In keeping with general therapeutic principles, the underlying disease
should be treated with basic therapy, as
appropriate. Fever alone is not an indication.
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).
The tablets should be swallowed whole with liquid, preferably before
meals, and must not be divided or chewed.
ADULTS:
DICLAC 25 mg: 75-150mg daily in two or three divided doses. The
tablets should be swallowed whole with liquid.
The recommended maximum daily dose of DICLAC is 150 mg. This may be
administered using a combination of
dosage forms, e.g. tablets and suppositories.
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