INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
PANAMOR - 25 TABLETS
PANAMOR AT - 50 TABLETS
PANAMOR - 75 SR TABLETS
PANAMOR - 100 SR TABLETS
PANAMOR - 75 INJECTION
PANAMOR SUPPOSITORIES - 12,5
PANAMOR SUPPOSITORIES - 25
PANAMOR SUPPOSITORIES - 100

SCHEDULING STATUS:
S3 S2        (See indications below)

PROPRIETARY NAME
(and dosage form):

PANAMOR - 25 TABLETS
PANAMOR AT - 50 TABLETS
PANAMOR - 75 SR TABLETS
PANAMOR - 100 SR TABLETS
PANAMOR - 75 INJECTION
PANAMOR SUPPOSITORIES - 12,5
PANAMOR SUPPOSITORIES - 25
PANAMOR SUPPOSITORIES - 100

COMPOSITION:
Film-coated tablets (which are also enteric coated) containing 25 mg or 50 mg diclofenac sodium, and film-coated tablets containing 75 mg or 100 mg diclofenac sodium tablets in a sustained-release form. These are also enteric-coated.
Each 3 mL ampoule contains 25 mg/mL diclofenac sodium with 4% v/v benzyl alcohol as preservative.
Each suppository contains 12,5 mg, 25 mg or 100 mg diclofenac sodium.

PHARMACOLOGICAL CLASSIFICATION:
A 3.1: Anti-rheumatics (anti-inflammatory agents).

PHARMACOLOGICAL ACTION:
Diclofenac sodium is a non-steroidal anti-inflammatory compound with analgesic, anti-inflammatory, antirheumatic and antipyretic properties.
Plasma concentrations show a linear relationship to the size of the dose. Peak levels are attained in 1 to 4 hours with the tablets, and in the case of the suppositories, less than 1 hour. The peak-plasma concentration of Panamor - 75 SR and 100 - SR tablets, though comparable to that reached after a single coated tablet of 25 mg, is maintained over a longer period due to the larger quantity of active substance.
Diclofenac sodium is eliminated principally by metabolism and subsequent urinary and biliary excretion of glucuronide and sulphate conjugates of the metabolites. The principal metabolite in man is the 4-hydroxy derivative of diclofenac sodium. The amount excreted in urine accounts for 20 - 30% of the dose, and that in bile for 10 - 20%. The mean terminal elimination half-life is 1,2 to 1,8 hours.

INDICATIONS:
Tablets S3:
Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis. Treatment of post traumatic pain and inflammation. Symptomatic treatment of primary dysmenorrhoea.
Tablets S2:
Emergency treatment of acute gout attacks. Treatment of post-traumatic conditions such as pain, swelling and inflammation for a maximum period of 5 days.
Injection S3:
For use as initial therapy for inflammatory and degenerative rheumatic diseases. Painful conditions due to inflammation of non-rheumatic origin and acute attacks of gout.
Suppositories S3:
Rheumatoid arthritis, osteoarthritis-arthritis and ankylosing spondylitis. Treatment of post traumatic pain and inflammation. For use as initial therapy for inflammatory and degenerative rheumatic diseases.

CONTRA-INDICATIONS:
Patients with porphyria.
Children under the age of 2 years.
Patients with a history of active gastro-intestinal bleeding or peptic ulceration.
Severe hepatic or renal impairment.
Contra-indicated in aspirin-sensitive patients, patients sensitive to any other non-steroidal anti-inflammatory agent, and in patients hypersensitive to any of the ingredients in these products.
Safety during pregnancy and lactation has not been established.
The use of the suppositories is contra-indicated in proctitis.

WARNINGS:
Serious interactions have been reported after the use of high dose methotrexate with diclofenac.

DOSAGE AND DIRECTIONS FOR USE:
The tablets should be swallowed whole with a glass of water.
Panamor-25 and AT-50 tablets:
The initial dosage is 100 mg to 150 mg. In milder cases, as well as for long-term therapy, 75 mg to 100 mg daily is sufficient. The maximum daily dosage is 150 mg. The daily dose should be prescribed in two or three fractional doses. The dose in children is 2 - 3 mg per kg body mass in two to three fractional doses.
In primary dysmenorrhoea the daily dosage, which should be individually adapted, is 50 mg to 150 mg. Treatment should be started upon first appearance of symptoms, and, depending on their intensity continued for a few days.
Panamor-75 SR and -100 SR tablets:
As a rule, the initial daily dosage is 100 mg to 150 mg administered as one tablet of Panamor-100 SR as a single dose, or two tablets of Panamor-75 SR tablets taken in two divided doses. In milder cases, as well as for long-term therapy one tablet of Panamor-75 SR is usually sufficient. These tablets should be neither broken nor chewed and should preferably be taken at meal times. Where the symptoms are most pronounced during the night or in the morning Panamor-100 SR tablets should be taken in the evening.
Injection:
75 mg by deep intragluteal injection once daily, or two times daily, in severe or hospitalised cases. Each injection must be given at a different site. Not to be given by intravenous injection. Each injection should be separated by an interval of a few hours. Parenteral administration should not be given for more than a few days, if necessary; treatment can be continued with oral therapy.
Suppositories:
Suppositories should never be divided for administration as the active substance may be distributed unevenly.
12,5 mg and 25 mg Suppositories:
Children aged 2 years or more should be given 2 to 3 mg per kg body mass daily, in two or three fractional doses.
100 mg Suppositories:
The average dose is 100 mg each evening.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal disorders, including epigastric pain, eructation, nausea and vomiting may occur. Peptic ulceration and gastro-intestinal bleeding have been reported. Other side-effects include vertigo, headache, skin rashes, pruritis, tinnitus, depression, drowsiness, nervousness, insomnia, irritability, agitation, minor hearing disorders, oedema, palpitations, blurred vision and other ocular reactions. Sensitivity reactions, abnormalities of liver function tests, impairment of renal function, agranulocytosis and thrombocytopenia have been observed. Dizziness, eczema and haemolytic anaemia may also occur.
It is advisable to perform blood counts in patients undergoing prolonged treatment.
Panamor should be given with care to patients with cardiovascular disease, bleeding disorders, in those who are receiving coumarin anticoagulants, and in patients with impaired hepatic or renal function.
Allergic reactions which include angio-oedema, bronchospasm, urticaria and anaphylactic reactions have occurred. Because of the possibility of cross-sensitivity due to structural relationships which exist among non-steroidal anti-intlammatory medicines, acute allergic reactions may be more likely to occur in patients who have exhibited allergic reactions to these compounds.
Plasma concentrations are significantly decreased by the concomitant administration of therapeutic doses of aspirin.
When given together with preparations containing lithium or digoxin, diclofenac sodium may raise their plasma concentrations.
Concomitant administration of glucocorticoids or other non-steroidal anti-inflammatory agents may aggravate gastro-intestinal side-effects.
Concurrent administration with two or more non-steroidal anti-inflammatory agents may promote the occurrence of side-effects.
Should be used, with caution in patients with asthma or bronchoconstriction.
Use carefully in elderly patients.
Decreased platelet aggregation with increased bleeding time may occur.
May increase the half-life of probenecid.
Use with care together with other protein-bound medicines e.g. tolbutamide, coumarin and hydantoin.
In view of the product's inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and Special Precautions". Treatment is symptomatic and supportive.

IDENTIFICATION:

25 mg tablets:	Yellowish-mustard, film-coated, shallow biconvex tablets, which are also enteric-coated.
50 mg tablets:	Light brown, film-coated, shallow biconvex tablets, which are also enteric-coated.
75 mg SR tablets:	Pink. film-coated, triangular tablets, which are also enteric-coated.
100 mg SR tablets:	Pale red, film-coated, round biconvex tablets, which are also enteric-coated.
75 mg/3 mL injection.	Clear, colourless to slightly straw-coloured solution in amber ampoules.
12,5 mg suppositories:	White torpedo-shaped suppositories.
25 mg suppositories:	White torpedo-shaped suppositories.
100 mg suppositories:	Large, white, torpedo-shaped suppositories.

PRESENTATION:

25 mg tablets:	Blister packs of 30 and 100 tablets.
50 mg tablets:	Blister packs of 15, 21 and 105 tablets.
75 mg SR tablets:	Blister packs of 30 tablets
100 mg SR tablets:	Blister packs of 28 tablets
75 mg/3 mL injections:	Amber glass ampoules in packs of 5 and 50.
12,5 mg suppositories:	Packs of 5 suppositories.
25 mg suppositories:	Packs of 5 suppositories.
100 mg suppositories:	Packs of 5 suppositories.

STORAGE INSTRUCTIONS:
Protect from moisture.
Protect ampoules from heat and light.
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER

25 mg tablets:	R/3.1/49
50 mg tablets:	R/3.1/50
75 mg SR tablets:	29/3.1/0121
100 mg SR tablets:	29/3.1/0122
75 mg/3 mL injections:	W/3.1/52
12,5 mg suppositories:	27/3.1/0121
25 mg suppositories:	Z/3.1/172
100 mg suppositories:	Y/3.1/395

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited, 7 Fairclough Road, Korsten
PORT ELIZABETH 6020

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
9 August 1994

        G751J
KOHLER C&P P.E

Updated on this site: June 2003
Current: March 2005
Source: Hospital Pharmacy
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