Voltaren - instructions for use, dose, side effects, contraindications

Excipients: levomenthol 22.5 mg, methylpyrrolidone 60.0 mg, propylene glycol fatty acid esters 30.0 mg, citric acid 6.0 mg, isoprene terene copolymer 536.1 mg, polyisobutylene 30.0 mg, esterified 300.0 mg, mercaptobenzimidazole 3 , 7 mg, butyl hydroxytoluene 3.7 mg, paraffin liquid up to 1500.00 mg; polyester fiber base (50 den) 70 cm²; protective film of polyester (thickness 75 microns) 70 cm².

Description:

Plasters are rectangular with rounded edges, consisting of a polyester beige base with a uniformly applied adhesive layer from colorless to pale yellow with a weak aromatic odor. Adhesive surface is covered with a transparent protective film of polyethylene with two transverse notches, one of which has a wavy line. A pattern is shown on the transparent protective film showing how to remove the film from the surface of the patch.The size of the plaster is 70 x 100 mm.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID)

ATX: & nbsp

S.01.B.C.03 Diclofenac

M.01.A.B.05 Diclofenac

Pharmacodynamics:

Voltaren® in the form of a transdermal patch is the basis with an applied adhesive layer containing diclofenac, which has pronounced analgesic and anti-inflammatory properties. The mechanisms of diclofenac action are based on the inhibition of prostaglandin synthesis. Plaster Voltaren® provides anti-inflammatory and analgesic action at the site of application, eliminating pain syndrome and reducing swelling associated with the inflammatory process.

Pharmacokinetics:

Absorption and distribution in the body: The amount of diclofenac absorbed systemically from the Voltaren® patch within 24 hours is similar to that of an equivalent amount of Voltaren® Emulgel® (external gel 1%). 99.7% of diclofenac binds to serum proteins, mainly - to albumin (99.4%).

Elimination: The total systemic clearance of diclofenac from plasma is 263 ± 56 ml / min.The final half-life in blood plasma is 1-2 hours. Four metabolites, including two active metabolites, also have a short half-life of 1-3 hours. One metabolite is 3'-hydroxy-4'-methoxydiclofenac, has a longer half-life, however, is inactive. Diclofenac and its metabolites are excreted mainly with urine.

In patients with impaired renal function, there is no accumulation of diclofenac and its metabolites.

In patients with chronic hepatitis or undi-compensated cirrhosis, the kinetics and metabolism of diclofenac follow the same pattern as in patients who do not have liver disease.

Preclinical studies have shown the safety of the drug.

Indications:

Pain in the back with inflammatory and degenerative diseases of the spine (radiculitis, osteoarthritis, lumbago, sciatica).

Pain in the joints (joints of the fingers, knees, etc.) with osteoarthritis.

Pain in the muscles (due to stretching, overstrain, bruises, injuries).

Inflammation and swelling of soft tissues and joints due to injuries and rheumatic diseases (tendovaginitis, bursitis, lesions of periarticular tissues).

Contraindications:

Hypersensitivity to diclofenac or other components of the drug; propensity to occurrence of attacks of a bronchial asthma, skin rashes or sharp rhinitis at application of an acetylsalicylic acid or other NSAIDs; pregnancy (III trimester); breast-feeding; children's age (up to 15 years); violation of the integrity of the skin in the place of the alleged gluing of the patch.

Carefully:

Hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe violations of the liver and kidney function, chronic heart failure, bronchial asthma, elderly age.

Pregnancy and lactation:

The use of the drug in pregnant women has not been studied, therefore, the Voltaren® patch should not be used during pregnancy, especially in the third trimester because of the possibility of lowering the tone of the uterus and / or premature closure of the arterial duct of the fetus.

Studies in animals have not revealed any direct or indirect adverse effects on pregnancy, childbirth, embryonic and postembryonic development.

There is no data on the penetration of the drug into breast milk,therefore, the patch of Voltaren® is not recommended for breastfeeding.

Dosing and Administration:

Outer in the form of applications on the skin.

Adults and teens over 15 years of age:

Plaster Voltaren® is glued on the skin over the painful area for 24 hours. During the day, only 1 patch is allowed.

In the treatment of soft tissue injuries, the patch Voltaren^® apply no more than 14 days, and in the treatment of diseases of the muscles and joints - no more than 21 days, unless there are special recommendations of the doctor.

If there is no improvement in the condition after 7 days and with a deterioration of well-being, it is necessary to consult a doctor.

Children:

It is not recommended to use the Voltaren® patch in children under the age of 15 years.

Elderly:

Similar to the method of administration and doses for adults.

Side effects:

Undesirable reactions are mainly characterized by moderately expressed and passing skin manifestations at the place of patch application.

Very rare manifestations (<1/10000):

Local reactions: pustular eruptions.

Systemic reactions: generalized skin rash; allergic reactions (hives, hypersensitivity: angioedema, attacks of suffocation,bronchospastic reactions), photosensitivity reactions.

Rare (≥ 1/10000, 1/1000):

Local reactions: bullous dermatitis.

Frequent symptoms (≥ 1/100, <1/10):

Local reactions: erythema, dermatitis, incl. contact dermatitis (symptoms: erythema, pruritus, edema of the treated area of the skin, rash, papules, vesicles, peeling), eczema.

Overdose:Extremely low systemic absorption of active ingredients and dosage form of the drug with external application makes an overdose almost impossible.

Interaction:

The patch of Voltaren® can enhance the effect of drugs that cause photosensitivity.

Clinically significant interaction with other drugs is not described.

Special instructions:

Plaster Voltaren^® It should be applied only to intact skin, avoiding getting on open wounds. Do not allow the product to get into the eyes and mucous membranes.

When using the patch Voltaren^® For too long, it is impossible to exclude the possibility of developing systemic adverse reactions.

With the additional use of other dosage forms of diclofenac, one should take into account its quantitative content in the plaster,so as not to exceed the maximum daily dose of diclofenac (150 mg / day).

Effect on the ability to drive transp. cf. and fur:

The drug does not affect the speed of psychomotor reactions when driving and working with mechanisms.

Form release / dosage:

Transdermal patch, 15 mg / day (area 70 cm²).

Packaging:

By 2, 5, 7 or 10 patches in a package of aluminum foil. Directly on a package put the text or paste a label.

The package together with the instruction for use is placed in a cardboard pack.

Storage conditions:

Store at a temperature of no higher than 25 ° C, in the original packaging.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-001089

Date of registration:03.11.2011 / 05.12.2016

Expiration Date:Unlimited

The owner of the registration certificate:GlaxoSmithKline Helsker, ZAO GlaxoSmithKline Helsker, ZAO Russia

Manufacturer: & nbsp

Dojin Iyaku-Kako Co. Ltd Japan

Representation: & nbspGlaxoSmithKline Helsker GlaxoSmithKline Helsker United Kingdom

Information update date: & nbsp25.03.2017

Illustrated instructions

Instructions

Voltaren® (Voltaren®)