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Voltaren Gel 1% *100gr by Novartis

Ref. number: 1072

Diclofenac gel is a topical non-steroidal anti-inflammatory drug (NSAID) that demonstrates an anti-inflammatory effect useful to treat the pain and swelling caused by medical conditions such as arthritis. Diclofenac has also been shown to have antinociceptive and antipyretic effects. Diclofenac inhibits the enzyme, cyclooxygenase (COX), an early component of the arachidonic acid (AA) cascade. The AA cascade is a signaling pathway associated with the body's inflammatory response. COX inhibition results in the lowering of AA cascade components such as prostaglandins, thromboxanes and prostacylin. It is not completely understood how reduced synthesis of these components results in therapeutic efficacy


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Diclofenac gel is a topical non-steroidal anti-inflammatory drug (NSAID) that demonstrates an anti-inflammatory effect useful to treat the pain and swelling caused by medical conditions such as arthritis. Diclofenac has also been shown to have antinociceptive and antipyretic effects. Diclofenac inhibits the enzyme, cyclooxygenase (COX), an early component of the arachidonic acid (AA) cascade. The AA cascade is a signaling pathway associated with the body's inflammatory response. COX inhibition results in the lowering of AA cascade components such as prostaglandins, thromboxanes and prostacylin. It is not completely understood how reduced synthesis of these components results in therapeutic efficacy

It is suitable for the treatment of:
Adults and adolescents over 14 years:
Muscle and joint injuries (sprains, dislocations, strains, bruises, back pain, sports injuries);
Inflammation of the tendons (such as "tennis elbow").
Adults (over 18 years):
Mild forms of arthritis of the knees or toes


Contraindications
Aspirin allergy. Late pregnancy. Coronary artery bypass graft surgery.

Interactions
Avoid concomitant topical products and medications (eg, sunscreens, cosmetics, lotions, moisturizers, insect repellents). Increased risk of GI effects with aspirin, oral NSAIDs, corticosteroids, anticoagulants, alcohol, smoking. May antagonize diuretics, ACE-Inhibitors. Monitor for toxicity with lithium, methotrexate, cyclosporine.

Precautions
Advanced renal disease: not recommended. Do not apply to open wounds, infections, inflammations, exfoliative dermatitis. Avoid eyes, mucous membranes, external heat and/or occlusive dressings, sunlight. Peptic ulcer. GI bleed. Asthma. CHF. Edema. Hypertension; monitor BP. Monitor blood, hepatic, renal function in long-term use; discontinue if toxicity develops. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.

Common side effects (These may affect between 1 to 10 in every 100 people):
Skin rash, itching, redness or stinging of the skin.
Very rare side effects (These can affect less than 1 in 10,000 people):
The skin may be more sensitive when exposed to sunlight. Possible signs are sunburn with itching, swelling and blisters.
If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


Keep out of reach of children.


Manufacturer: Novartis


Adults: Use dosing card to apply gel. Lower extremities (eg, knees, ankles, feet): Apply 4g to the affected area 4 times daily; max: 16g/day. Upper extremities (eg, elbows, wrists, hands): Apply 2g to the affected area 4 times daily; max: 8g/day. Total max dose over all affected joints: 32g/day. Do not wash treated hands for at least 1hr after application. Wait at least 10 minutes after application before getting dressed. Use on spine, hip, or shoulder has not been evaluated.

The active substance is diclofenac diethylamine. Each gram of gel contains 11.6 mg diclofenac DEA.
The other ingredients (excipients) are: carbomer, macrogol tsitostearileter, kokoilkaprilokaprat, diethylamine, isopropyl alcohol, propylene glycol, purified water, liquid paraffin, perfume composition 45.