Voltaren gel for back, muscle and joint pain, 2%, 100g

Product description

Voltaren Emulgel-designed for pain in joints, back, muscles, as well as inflammation and swelling of soft tissues and joints. Voltaren Emulsifier has a triple effect!1: against pain 2: against inflammation*3: to speed up recovery**The Active ingredient diclofenac is a non-steroidal anti-inflammatory drug with pronounced analgesic and anti-inflammatory properties, penetrates deep into the skin, acting both on pain and on its cause – inflammation. ** Instructions for medical use, RU No. P N016030 / 01 from 09.09.2009** Limit. Musculoskeletal disorders. 2013,14: 250. Compared to using a placebo.

Composition

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of 100 g of gel contains:  

Active ingredients:  

Diclofenac diethylamine – 2.32 g, which corresponds to the content of diclofenac sodium 2 g.

Auxiliary substances:  

Carbomers* – 1.1-1.7 Cetostearomacrogol – 2 g; Cocoyl caprylocaprate-2.5 g; Diethylamine* – 0.89-1.37 Isopropanol – 17.5 g; Liquid paraffin-2.5 g; Oleyl alcohol-0.75 g; Eucalyptus flavor-0.1 g; Propylene glycol-5 g; Butylhydroxytoluene-0.02 g; Purified water* – 64.22-65.32 d

. * when using different production equipment and different batch sizes (1000 kg and 2500 kg), the amounts of carbomers, diethylenamine and purified water can be slightly adjusted within the specified figures.

Pharmacological action

of NSAIDs for external use. Diclofenac has a pronounced analgesic and anti-inflammatory and antipyretic effect. By indiscriminately inhibiting COX-1 and COX-2, it disrupts arachidonic acid metabolism. Voltaren® Emulgel® is used to eliminate pain and inflammation in joints, muscles and ligaments of traumatic or rheumatic origin, helping to reduce pain and swelling associated with the inflammatory process, increasing joint mobility. Thanks to its water-alcohol base Voltaren® Emulsifier® has a soothing and cooling effect.

Clinical pharmacology

Absorption The amount of diclofenac absorbed through the skin is proportional to the area of the treated surface and depends on both the total dose of the drug applied and the degree of hydration of the skin. After applying 400 cm2 Voltaren®to the skin surface Emulsifier®, gel for external use 2% (2 applications per day), the concentration of the Active ingredient in plasma corresponds to its concentration when using 1% diclofenac gel (4 applications per day). On day 7, the relative bioavailability of the drug (AUC ratio) is 4.5% (for an equivalent dose of diclofenac sodium salt). When wearing a moisture-permeable bandage, the absorption did not change. Distribution When the drug was applied to the affected joint area, the concentration of diclofenac in plasma, synovial membrane and synovial fluid was determined. Cmax in plasma was approximately 100 times lower than after oral use of the same amount of diclofenac. The binding of diclofenac to plasma proteins is 99.7%, mainly to albumins (99.4%). Diclofenac is predominantly distributed and retained deep in tissues prone to inflammation, such as joints, where its concentration is 20 times higher than in plasma. Metabolism Metabolism of diclofenac is carried out partly by glucuronidation of the unchanged molecule, but mainly by single and multiple hydroxylation, which leads to the formation of several phenolic metabolites, most of which are converted to glucuronide conjugates. Two phenolic metabolites are biologically active, but to a much lesser extent than diclofenac. Elimination The total systemic plasma clearance of diclofenac is 263±56 ml/min. The final T1 / 2 is 1-2 h. The T1 / 2 of metabolites, including two pharmacologically active ones, is also short-lived and is 1-3 h. One of the metabolites (3′ – hydroxy-4 ‘ – methoxydiclofenac) has a longer T1 / 2, but this metabolite is completely inactive. Most of diclofenac and its metabolites are excreted in the urine.

Indications

Use during pregnancy and lactation

Due to the lack of data on the use of Voltaren® Emulgel® during pregnancy, the use of the drug in the first and second trimesters of pregnancy is recommended only as prescribed by a doctor, comparing the benefit to the mother and the risk to the fetus. The drug is contraindicated in the third trimester of pregnancy due to the possibility of a decrease in uterine tone, impaired fetal kidney function, followed by the development of low water and/or premature closure of the fetal arterial duct. Due to the lack of data on the release of the Active ingredient of the drug Voltaren® Emulsifier® with breast milk, the drug is not recommended for use during breastfeeding. If it is still necessary to use the drug, then it should not be applied to the mammary glands or on a large surface of the skin and should not be used for a long time. There are no data on the effect of the drug on fertility.

Contraindications

Hypersensitivity to diclofenac or other components of the drug; a tendency to develop attacks of bronchial asthma, skin rashes or acute rhinitis when using acetylsalicylic acid or other NSAIDs; violation of the integrity of the skin at the intended site of application; III trimester of pregnancy; lactation (breastfeeding); children under 12 years of age. With caution, the drug should be prescribed for hepatic porphyria (in the acute phase), erosive and ulcerative lesions of the gastrointestinal tract, severe liver and kidney function disorders, chronic heart failure, bronchial asthma, as well as in the first and second trimesters of pregnancy and elderly patients.

Side effects

Determination of the frequency of adverse reactions: very common (≥1/10), common (≥1/100, <1/10), infrequent (≥1/1000, <1/100), rare (≥1/10 000, <1/1000), very rare (Infectious and parasitic diseases: very rare: pustular rash. From the immune system: very rarely – hypersensitivity reactions (including urticaria), angioedema. From the respiratory system: very rarely – asthma. From the skin and subcutaneous tissues: often-dermatitis (including contact dermatitis), rash, erythema, eczema, pruritus; rarely-bullous dermatitis; very rarely-photosensitization reactions. If any of the above side effects get worse, or the patient has noticed any other side effects, you should inform your doctor.

Interaction

Voltaren® Emulsifier® can enhance the effect of drugs that cause photosensitization. No clinically significant interactions with other drugs have been described.

How to take, course of use and dosage

The drug is used externally. For adults and children over 12 years of age, the drug is applied to the skin 2 times / day (every 12 hours: preferably in the morning and evening), lightly rubbing into the skin. The required amount of the drug depends on the size of the painful area. A single dose of the drug – 2-4 g (which is comparable in volume to the size of a cherry or walnut, respectively) – is enough to treat an area of 400-800 cm 2. If the hands are not a zone of pain localization, then after applying the drug they must be washed. The duration of treatment depends on the indications and the observed effect. The gel should not be used for more than 14 days for post-traumatic inflammation and rheumatic soft tissue diseases without a doctor’s recommendation. If after 7 days of use the therapeutic effect is not observed or the condition worsens, the patient should consult a doctor. To remove the protective membrane, use a screw-on cover as a key (a recess with protrusions on the outside of the cover). Align the recess on the outside of the lid with the shaped protective membrane of the tube and rotate. The membrane must separate from the tube. The tubes can have either a conventional cover (round shape) or an innovative cover (triangular shape), which is especially convenient for use in cases of limited mobility of the joints of the hands due to osteoarthritis or other joint diseases or injuries.

Overdose

Due to the low systemic absorption when applying the gel, overdose is unlikely. Symptoms:  if accidentally ingested, systemic adverse reactions may occur. Treatment of accidental oral overdose: gastric lavage, induction of vomiting, activated charcoal, symptomatic therapy. Dialysis and forced diuresis are not effective due to the high degree of binding of diclofenac to plasma proteins (about 99%).

Description

Gel for external use 2% homogeneous, creamy, from white to white with a yellowish tinge of color.

Special instructions

Voltaren® Emulsifier® should only be applied to undamaged skin, avoiding contact with open wounds. Do not allow the drug to get into the eyes and mucous membranes. After applying the gel for external use of 1%, do not apply an occlusive dressing. After applying the gel for external use of 2%, it is allowed to apply a bandage, but do not apply airtight occlusive dressings. If a skin rash develops after applying the drug, its use should be discontinued. The drug contains propylene glycol, which can cause mild local irritation in some people.It also contains butylhydroxytoluene, which can cause local skin reactions (for example, contact dermatitis) or irritation of the eyes and mucous membranes.

Product form

100 g-laminated tubes (1) – cardboard packs.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 30°C.

Shelf life

3 years

Active ingredient

Diclofenac

Dosage form

gel for external use

Purpose

For adults, Children over 12 years of age, Pregnant women in the first and second trimester as prescribed by a doctor

Indications

Gout, Sciatica, Tendon Inflammation, Rheumatoid Arthritis, Swelling after Injuries and operations, Lumbago, Osteoarthritis, Periarthritis, Adnexitis, Bursitis, Osteoarthritis and Arthritis