📌 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; absorption begins immediately after administration, and it has a 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 oedema 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 the ear, nose and throat.
• Relieves pain in migraine attacks and relieves the symptoms accompanying it such as headache, nausea and vomiting.
• Relieves pain in primary dysmenorrhoea.

📌 DOSAGE

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

• 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 dysmenorrhoea: 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 is to be dissolved in a glass of water, then drunk, 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. The lowest effective dose should be given 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, hyperlipidaemia, diabetes mellitus, smoking). The lowest effective dose should be given 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 Diclofenac 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 to drive 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 indicating that Diclofenac increases the risk of abortion in pregnant women and cardiac malformation in the foetus, so it is not recommended for pregnant women during the first and second trimesters of pregnancy unless necessary, at the lowest effective dose and for the shortest possible period. Diclofenac may be excreted 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, ACE inhibitors) or diuretics, so attention should be paid to monitor blood pressure and renal function continuously.
• Concomitant use of Diclofenac with NSAIDs or corticosteroids leads to an increase in the frequency of gastrointestinal effects such as ulcer and bleeding.
• Concomitant use of Diclofenac with anticoagulant and antiplatelet agents increases the risk of bleeding.
• Concomitant use of Diclofenac with selective serotonin reuptake inhibitors increases the risk of gastrointestinal tract bleeding.
• Hypoglycaemia or hyperglycaemia 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 the 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, diarrhoea, dyspepsia, abdominal pain, flatulence and loss of appetite. Rare effects such as hypersensitivity, drowsiness, gastritis, ulcer, jaundice and urticaria.

📌 OVERDOSAGE

Symptoms: Vomiting, gastrointestinal bleeding, diarrhoea, tinnitus or convulsions. Severe 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 30°C in a dry place.

📌 PHARMACEUTICAL FORMS

• Diclosan fast Powder: Pack of 30 sachets.

012-06-165 05/18