Description
Description
Transdermal patch 15 mg / day (70 cm2), rectangular with rounded edges, consisting of a beige polyester base with a uniformly applied adhesive layer from colorless to pale yellow with a slight aromatic odor
adhesive transparent protective film made of polyethylene with two transverse cuts, one of which has a wavy line on a transparent protective film, a drawing is shown showing how to remove the film from the surface of the patch the size of the patch is 70 100 mm.
Pharmacological action of
NSAIDs for external use.
Voltaren ® in the form of a transdermal patch is a base with an applied adhesive layer containing diclofenac, which has pronounced analgesic and anti-inflammatory properties.
The basis of the mechanisms of action of diclofenac is inhibition of prostaglandin synthesis.
Voltaren ® patch provides an anti-inflammatory and analgesic effect at the site of application, eliminating pain and reducing swelling associated with the inflammatory process.
Indications
Back pain with inflammatory and degenerative diseases of the spine (sciatica, osteoarthritis, lumbago, sciatica)
joint pain (including finger joints, knee joints) with rheumatoid arthritis, osteoarthritis due to sard sprains, overstrain, bruises, injuries) inflammation and swelling of soft tissues and joints due to injuries and rheumatic diseases (tendovaginitis, bursitis, damage to periarticular tissues).
Contraindications
Tendency to occur asthma attacks, skin rashes or acute rhinitis when using acetylsalicylic acid or other NSAIDs III trimester of pregnancy breastfeeding children under 15 years of age violation of the integrity of the skin at the site of the alleged gluing of the drug patch.
Precautions: hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe impaired liver and kidney function, chronic heart failure, bronchial asthma, advanced age.
Special instructions
The Voltaren ® patch should only be applied to intact skin, avoiding contact with open wounds.
Avoid contact with eyes and mucous membranes.
When using the Voltaren ® patch for too long, the possibility of developing systemic adverse reactions cannot be ruled out.
With the additional use of other dosage forms of diclofenac, its quantitative content in the patch should be taken into account so as not to exceed the maximum daily dose of diclofenac (150 mg / day).
Preclinical studies have shown the safety of the drug.
Effect on the ability to drive vehicles and mechanisms
The drug does not affect the speed of psychomotor reactions when driving and working with mechanisms.
Composition 1
patch:
diclofenac sodium (1%)
Excipients:
levomenthol – 22.5 mg,
methylpyrrolidone – 60 mg,
propylene glycol fatty acid esters – 30 mg,
citric acid – 6 mg,
isoprene-1 polystyrene polyprenolol 53 mg,
ester gum – 300 mg,
mercaptobenzimidazole – 3.7 mg,
butylhydroxytoluene – 3.7 mg,
liquid paraffin – up to 1500 mg,
base made of polyester fibers (50 den) 70 cm2, srdlp plastic film 70 cm2.
Dosage and administration
Applied externally in the form of applications on the skin.
For adults and adolescents over 15 years of age, the Voltaren ® patch is applied to the skin over the painful area for 24 hours. Only 1 patch is allowed per day.
In the treatment of soft tissue injuries, the Voltaren ® patch is used for no more than 14 days, and in the treatment of diseases of muscles and joints – no more than 21 days, unless there are special doctor recommendations.
If there is no improvement after 7 days and if you feel worse, you should consult your doctor.
In elderly patients, they are used similarly to the method of administration and doses for adults.
Side effects
Adverse reactions are mainly characterized by mild and passing skin manifestations at the site of application of the patch.
Local reactions: often (? 1/100, <1/10) - erythema, dermatitis, including contact dermatitis (symptoms: erythema, itching, swelling of the treated area of the skin, rash, papules, vesicles, peeling), eczema rarely (? 1/10 000, 1/1000) - bullous dermatitis is very rare (<1/10 000) - pustular rashes. Systemic reactions: very rarely (<1/10 000) - generalized skin rash, allergic reactions (urticaria, hypersensitivity: angioedema, asthma attacks, bronchospastic reactions), photosensitivity reactions. Drug Interactions Voltaren ® patch can enhance the effects of photosensitizing medications. No clinically significant interaction with other drugs has been described. Overdose Extremely low systemic absorption of active components and the dosage form of the drug when used externally makes overdose almost impossible. Storage conditions The product should be stored out of the reach of children, in the original package, at a temperature not exceeding 25 ° C. Shelf life 2 years. Deystvuyushtee substance Diclofenac Terms and conditions without prescription System A dosage form transdermal system Possible product names VOLTAREN 0,015 / SUT N2 TRANSTERM PLASTER VOLTAREN 0, 015 / ¡ £ ¢ N5 TRANSDRERM PLASTER Voltaren plast td 15mg / day x 2 Voltaren plast td 15mg / day x 5 Voltaren plast 15mg / 24hr No. 2
