Fenadol 100mg modified-release Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DICLOFENAC SODIUM

Available from:

Proge Farm S.r.l. Baluardo La Marmora, 4 - 28100 - Novara, Italy

ATC code:

M01AB05

INN (International Name):

DICLOFENAC SODIUM 100 mg

Pharmaceutical form:

MODIFIED-RELEASE TABLET

Composition:

DICLOFENAC SODIUM 100 mg

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Withdrawn

Authorization date:

2006-09-18

Patient Information leaflet

 
FENADOL 
D
ICLOFENAC

MODIFIED-RELEASE TABLETS - SUPPOSITORIES 

COMPOSITION:  
Each 100 mg modified-release tablet contains:  Active ingredient:
Diclofenac sodium 100 mg. 
Excipients: Microgranular cellulose, Lactose, Starch,
Polyvinylpyrrholidon, Magnesium stearate, 
Hydroxypropylcellulose, Diethylphtalate, Cellulose acetophthalate,
Titanium dioxide.  
Each 100 mg suppository contains: Active ingredient: Diclofenac
sodium 100 mg. Excipients: Solid 
semi- synthetic glyceride.  
PHARMACEUTICAL FORM – PACKAGING  
20 modified-release tablets 100 mg - 10 suppositories 100 mg  
PHARMACO-THERAPEUTICAL CLASS  
Non-steroidal anti-inflammatory product. 
MARKETING AUTHORISATION HOLDER 
PROGE FARM S.r.l. - Baluardo La Marmora, 4 - 28100 NOVARA 
MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
Modified-release tablets: Omicron Pharma S.r.l., Via Follereau 25,
24027 Nembro (BG) - Italy 
Suppositories: Fulton Medicinali S.p.A., Via Marconi 28/9, Arese (MI)
- Italy 
THERAPEUTIC INDICATIONS 
Inflammatory and degenerative rheumatic affections like: rheumatoid
arthritis and ankylosing 
spondylitis; arthrosis; extra-articular rheumatism. Pain caused
by extra – rheumatic or post-
traumatic inflammation. Symptomatic treatment of primary
dysmenorrhea (menstrual pain).  
CONTRAINDICATIONS 
Hypersensitivity to components or chemically-related substances.  
This product should not be used in case of gastric or duodenal ulcer,
serious gastroenteric disorders, 
serious kidney and/or hepatic insufficiency, during pregnancy
and nursing, during intense therapy 
with diuretics, in patients with ongoing haemorrhage and
haemorrhagic disposition, in case of 
haemopoiesis alterations and concomitant treatment with
anticoagulants since a synergetic action 
may occur.  
Diclofenac, like other non-steroidal anti-inflammatory substances,
is contraindicated in patients 
showing urticaria or acute rhinitis after intake
of acetylsalicylic acid or other drugs wh

Summary of Product characteristics

Page 1 of 6 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. NAME OF THE MEDICINAL SPECIALITY 

FENADOL 100 mg modified-release tablets  
FENADOL 100 mg suppositories 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
_ _
_Modified-release tablets 100 mg_: each tablet contains: active
ingredient: Diclofenac sodium 100 mg 
_Suppositories 100 mg_: each suppository contains: active ingredient:
Diclofenac sodium 100 mg 
For excipients, see 6.1. 

3. PHARMACEUTICAL FORM 

100 mg modified-release tablets – 20 tablets 
100 mg suppositories – 10 suppositories 

4. CLINICAL PARTICULARS 

4.1. THERAPEUTIC INDICATIONS 

Inflammatory and degenerative rheumatic affections:
rheumatoid arthritis, ankylosing spondylitis; 
arthroses; extra-articular rheumatism; painful conditions
from phlogosis with extra-rheumatic or 
post-traumatic origin; symptomatic treatment of primary
dysmenorrhea. 

4.2. POSOLOGY AND METHOD OF ADMINISTRATION 
_ _
_Modified- release tablets_:
one tablet daily. If the symptoms are more marked during the
night or in 
the morning, FENADOL should be preferably taken
in the evening. The tablets must be swallowed 
whole with water, preferably during the meals.  
The use of the product is limited to adults. 
In the treatment of aged patients the posology must be carefully
established by the physician, who 
will have to evaluate a possible reduction of the above
mentioned doses. 
_Suppositories:  _suppositories are particularly indicated to
eliminate or relieve the nightly pain and 
the morning rigidity. Posology is one suppository daily, given in the
evening before to go to bed. 
Administer only by rectal way. 

4.3. CONTRAINDICATIONS 

Hypersensitivity towards the components and
towards substances strictly related from the chemical 
point of view.  
The product should not be used in case of gastric or duodenal ulcer,
of severe gastroenteric 
disorders, of severe renal and/or hepatic insuffici