Voltaren patch transdermal therapeutic system 15mg / day 2 pc

Description

Composition
Active substance:
Each transdermal patch is 15 mg / day (70 cm2) containing 15 mg diclofenac sodium (1%).
Excipients:
levomenthol 22.5 mg, 60.0 mg methylpyrrolidone, propylene glycol fatty acid esters 30.0 mg, 6.0 mg citric acid, copolymer izoprenstirol 536.1 mg, 30.0 mg polyisobutylene, gum efirizirovannaya 300.0 mg, mercaptobenzimidazole 3 , 7 mg, 3.7 mg BHT, liquid paraffin to 1500,00 mg; basis of polyester fibers (50 den) 70 cm2; protective polyester film (thickness 75 microns) 70 cm2.
Description:
The transdermal patch 15 mg / day (70 cm2), rectangular with rounded edges consisting of a base polyester with beige uniformly applied adhesive layer from colorless to pale yellow with a faint aromatic odor; the adhesive surface is covered with a transparent protective film of polyethylene with two transverse cuts, one of which has a wavy line; a transparent protective film deposited illustration showing how to remove the surface film from the patch; patch size of 70? 100 mm.
Product form:
2 patch in the package of aluminum foil. Directly on the package or paste is applied to the text label. Package together with instructions for use placed into cardboard pack.
Contraindications
The tendency to the emergence of attacks of bronchial asthma, skin rashes or acute rhinitis application of acetylsalicylic acid or other NSAIDs; III trimester of pregnancy; breast-feeding; Children up to age 15 years; violation of integrity of the skin at the site of the intended sticking plaster; hypersensitivity to the drug.
Dosage
15 mg
Indications
Back pain of inflammatory and degenerative diseases of the spine (sciatica, osteoarthritis, lumbago, sciatica); joint pain (including finger joints, knee joints) rheumatoid arthritis, osteoarthritis; muscle pain (due to stretching, overvoltage, bruises, injuries); inflammation and swelling of the soft tissues and joints due to injuries and rheumatic diseases (tendonitis, bursitis, lesions of periarticular tissues).
Interaction with other drugs
The patch may Voltaren® potentiate preparations inducing photosensitization. Clinically significant interactions with other drugs has not been described.
Overdose
Very low systemic absorption of active ingredients and dosage form of the drug when applied externally makes practically impossible overdose.
pharmachologic effect
Pharmacological group:
M02AA15
Pharmacodynamics:
NSAIDs for external application. Voltaren® a transdermal patch is a framework coated with an adhesive layer comprising diclofenac, which has a pronounced analgesic and anti-inflammatory properties. The diclofenac-based mechanisms of action is inhibition of prostaglandin synthesis. Plaster Voltaren® provides anti-inflammatory and analgesic effect at the site of application, eliminating pain and reducing swelling associated with the inflammation process.
Pharmacokinetics:
Absorption and distribution Number diclofenac is absorbed systemically from the patch Voltaren® for 24 hours, similar to that when using an equivalent quantity of drug Emulgel® Voltaren® (gel for topical application of 1%). diclofenac protein binding plaza is 99.7%, mainly – albumin (99.4%). Metabolism and excretion of total systemic clearance of diclofenac from plasma is 263 ± 56 mL / min. The final T1 / 2 in plasma is 1-2 hours metabolite 4, including two active also have shorter T1 / 2 – 1-3. One hour metabolite -. 3′-hydroxy-4′-metoksidiklofenak, has a longer T1 / 2, but it is inactive. Diclofenac and its metabolites are excreted primarily in the urine. Pharmacokinetics in specific clinical situations in patients with impaired renal function cumulation of diclofenac and its metabolites does not occur. Patients suffering from chronic hepatitis or cirrhosis nedekompensirovannym, kinetics and metabolism of diclofenac tested in the same manner as in patients without liver disease.
Pregnancy and breast-feeding
Use of the drug in pregnant women has not been studied, so Voltaren® patch should not be prescribed during pregnancy, particularly in the III trimester, due to the possibility of lowering the tone of the uterus and / or premature closure of the fetal blood flow. In experimental animal studies did not reveal any direct or indirect negative impacts on pregnancy, childbirth, and postembryonic embryonic development. No data on the drug’s ability to penetrate into breast milk, so the patch Voltaren® not recommended for use during breastfeeding.
Conditions of supply of pharmacies
Without recipe
side effects
Adverse reactions generally characterized by moderate and extending cutaneous manifestations in place of the patch application. Local reactions: often (> 1/100,
special instructions
Plaster Voltaren® should stick only to intact skin while avoiding contact with open wounds. Do not allow contact with the drug on the eyes and mucous membranes. When applying the patch Voltaren® for too long a time can not exclude the possibility of systemic adverse reactions. In a further application of other dosage forms of diclofenac, should take into account its quantitative content in the plaster so as not to exceed the maximum daily dose of diclofenac (150 mg / day). Preclinical studies have demonstrated the safety of the drug. The effect on the ability to drive vehicles and mechanisms drug has no effect on the rate of psychomotor reactions when driving and operating mechanisms.
Storage conditions
The drug should be stored in reach of children, in the original package, at a temperature not higher than 25 ° C.
Dosing and Administration
Apply externally in the form of applications to the skin. Adults and adolescents over 15 years Voltaren® plaster paste on the skin over the painful area for 24 hours. During the day is allowed to use only one patch. In the treatment of soft tissue injuries plaster Voltaren® use no more than 14 days, and in the treatment of diseases of the muscles and joints – no more than 21 days, if there are no special recommendations of the doctor. If no improvement status after 7 days and when you feel unwell, you should consult with your doctor. Elderly patients use a similar method of application and doses for adults.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist