Voltaren Emulgel for back, muscle and joint pain, gel 1%, 50 g

Briefly about the product

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:

diclofenac diethylamine 1.16 g, which corresponds to 1 g of diclofenac sodium;

Gel base: fat emulsion in an aqueous gel with the addition of isopropanol and propylene glycol.

Other ingredients:

diethylamine,

acrylic acid polymer,

cetomacrogol 1000,

caprylic/capric acid alcohol ether,

isopropyl alcohol,

propylene glycol,

liquid paraffin,

fragrance,

water.

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 administration 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. MetabolismMetabolism 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

• Back pain in inflammatory and degenerative diseases of the spine (sciatica, osteoarthritis, lumbago, sciatica);
• joint pain (including joints of fingers, knees) with rheumatoid arthritis, osteoarthritis;
• pain in muscles (due to sprain, strain, bruises, and injuries);
• inflammation and swelling of the soft tissues and joints due to injuries and rheumatic disease (tenosynovitis, bursitis, lesions of periarticular tissues, wrist syndrome).

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

Adverse reactions are mainly characterized by moderate and passing skin manifestations at the site of application of the gel. In very rare cases, allergic reactions may occur. Determination of the frequency of adverse reactions: very common (>10%), common (≥1%, but ≤10%), infrequent (≥0.1%, but ≤1%), rare (≥0.01%, but ≤0.1%); very rare (≤0.01%). Infectious and parasitic diseases: very rarely – pustular rashes. From the immune system: very rarely – generalized skin rash, allergic reactions (urticaria, hypersensitivity: angioedema). From the respiratory system: very rarely – attacks of suffocation, bronchospastic reactions. From the skin: often-erythema, dermatitis, including contact dermatitis (symptoms: eczema, itching, swelling of the treated skin area, rash, papules, vesicles, peeling); rarely-bullous dermatitis; very rarely-photosensitization reactions.

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 administration and dosage

The drug is used externally. For adults and children over 12 years of age, the drug is applied to the skin 3-4 times a day and lightly rubbed. The required amount of the drug depends on the size of the painful area. A single dose of the drug is 2-4 g (which is comparable in volume to the size of a cherry or walnut, respectively). After applying the drug, your hands should be washed. The duration of treatment depends on the indications and the observed effect (to enhance the effect, the gel can be used together with other dosage forms of Voltaren®). If there is no therapeutic effect after 2 weeks, you should consult your doctor. Laminated tubes: to remove the protective membrane, use the 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. Laminated tubes can have both a conventional cover (round shape) and an innovative cover (triangular shape), which is especially convenient for use with limited mobility of the joints of the hands due to osteoarthritis or other joint diseases or injuries, as well as an applicator cover. Aluminum tubes: before using the tube for the first time, the protective membrane of the tube should be punctured using a special protrusion on the outside of the polypropylene screw-on cover. It is not recommended to wash the applicator cover with water or use abrasive cleaning agents. After full use of the contents of the tube, it is recommended to dispose of the applicator cover together with the tube. Do not use the applicator cover with another tube.

Overdose

Due to the low systemic absorption when applying the gel, overdose is unlikely. Symptoms: accidental ingestion may cause systemic adverse reactions. 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 1% homogeneous, creamy, from white to yellowish 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. The ability to drive vehicles and mechanisms is not affected.

Form of production

Gel for external use

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

Pregnant women in the first and second trimester as prescribed by a doctor, Children over 14 years of age, For adults

Indications

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

Weight

Weight: 75 gr.