COMPOSITION :

Each sachet contains : Diclofenac potassium 50 mg.

DESCRIPTION :

Diclosan fast (Diclofenac Potassium) is a non-steroidal anti-inflammatory drug with antirheumatic,

analgesic, and antipyretic properties. It acts mainly by inhibiting prostaglandin biosynthesis, which plays a

major role in inflammation, pain and fever. Diclofenac is absorbed rapidly and completely, the absorption

begins immediately after administration, it has rapid onset of action. Diclofenac is 99.7% bound to plasma

proteins. The elimination half - life is 1 - 2 hours. About 60% of the dose is excreted in the urine and the rest

of the dose is eliminated in the bile as metabolites.

INDICATIONS :

Diclosan fast is indicated in the following cases:

- Relieves pain and inflammation associated with orthopaedic ,dental and other minor surgery .

- Relieves pain and inflammation and reduces inflammatory swelling and wound edema after trauma such

as sprains, strains, soft tissue injuries.

- Relieves pain of the vertebral column and non-articular rheumatism.

- Used as an adjunct in severe infection of ear, nose, throat.

- Relieves pain in migraine attack and it relieves the symptoms accompanying it such as headache, nausea

and vomiting.

- Relieves pain in primary dysmenorrhea.

DOSAGE:

The lowest effective dose of Diclosan fast should be given for the shortest period of time (maximum 3

days).

- Adults: one sachet 2-3 times (100 – 150 mg) per day.

- Children over 14 years : one sachet 1-2 times per day ( 50 – 100 mg) .

- Primary dysmenorrhea : one sachet 1-3 times per day (50 – 150 mg).

- Migraine attack : An initial dose of 50 mg at the first sign of attack .A further 50 mg can be taken if the

symptoms persist for 2 hours after ingestion of the first dose . Additional doses of 50 mg can be taken if

necessary at intervals of 6 - 8 hours , the maximum dose is 150 mg per day.

ADMINISTRATION :

One sachet of Diclosan fast to be dissolved in a glass of water, then drink preferably before meals .

RESTRICTIONS ON USE :

Contraindications

- Patients with known hypersensitivity to Diclofenac or other NSAIDs.

- Patients with ulcer , bleeding or perforation in the stomach or intestine or ulcerative colitis .

- Severe hepatic and severe renal dysfunction (Creatinine clearance ˂ 30 ml/min.).

- Severe heart failure .

- Pregnant women in the third trimester of pregnancy .

- Children below 14 years of age.

Precautions

- Caution should be taken in patients with gastrointestinal disturbances , patients with a history of bleeding

or ulcer , patients who are taking concomitant drugs that may increase the risk of bleeding or ulcer or

patients with hepatic impairment , it should be given the lowest effective dose in these cases and it is

recommended to take protective agents .

- Caution should be taken in patients with coronary heart disease , cerebrovascular disorders, peripheral

arterial occlusive disease or in the presence of other factors (such as hypertension , hyperlipidemia ,

diabetes mellitus, smoking), it should be given the lowest effective dose for the shortest possible period .

- Caution should be taken in patients with impaired cardiac and renal function , hypertension , elderly

patients and patients who are taking diuretics ,because the effect of Diclofenac that may lead to fluid

retention or arterial hypertension, it is recommended to take the lowest effective dose.

- Caution should be taken in patients with asthma, seasonal allergic rhinitis or chronic obstructive

pulmonary diseases.

Effect on the ability of driving vehicles and use machines

Caution should be taken during driving or using machines ,because Diclofenac may cause visual

disturbances, dizziness or drowsiness.

Use in Pregnancy and lactation

There are studies indicate that Diclofenac increase the risk of abortion in pregnant women and cardiac

malformation in fetus , so it is not recommended for pregnant women during the first and second trimesters

of pregnancy unless if necessary for the lowest effective dose and shortest possible period. Diclofenac

may excrete into breast milk , so it is not recommended for lactating women .

DRUG INTERACTIONS :

- Concomitant use of Diclofenac with lithium, digoxin or phenytoin may increase their plasma

concentrations, so it is recommended to monitor their plasma levels .

- Concomitant use of Diclofenac may reduce the antihypertensive effects of antihypertensive agents

(such as beta blockers , ACEI) or diuretics , so attention should be paid to monitor blood pressure and

renal function continuously .

- Concomitant use of Diclofenac with NSAIDs or corticosteroids lead to increase the frequency of

gastrointestinal effects such as ulcer and bleeding .

- Concomitant use of Diclofenac with anticoagulant and antiplatelets agents increase the risk of bleeding.

- Concomitant use of Diclofenac with selective serotonin reuptake inhibitors increase the risk of

gastrointestinal tract bleeding .

- Hypoglycemia or hyperglycemia may occur after administration of antidiabetic agents with Diclofenac, so

blood glucose levels should be monitored.

- Diclofenac should be taken 24 hours before or after treatment with methotrexate to avoid increasing

blood level of methotrexate .

- Diclofenac must be taken at the lowest dose to avoid nephrotoxicity of cyclosporine when taken

concomitantly .

ADVERSE EFFECTS:

The side effects after administration of Diclosan fast are well tolerated. The reported adverse effects

include gastrointestinal disturbances such as nausea, vomiting, diarrhea, dyspepsia, abdominal pain,

flatulence and loss of appetite. Rarely effects such as hypersensitivity, drowsiness, gastritis, ulcer,

jaundice, urticaria.

OVERDOSAGE :

Symptoms : vomiting , gastrointestinal bleeding , diarrhea , tinnitus or convulsions. Sever intoxication may

lead to renal failure or liver damage.

Overdosage management : Symptomatic treatment should be given. In case of intoxication, charcoal can

be given or gastric lavage should be considered.

STORAGE INSTRUCTIONS :

Store below 30oC, in a dry place.

PRESENTATIONS :

Diclosan fast Powder : Pack of 30 sachets.

012-06-165 05/18

Diclosan fast