50 g
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Diclofenac gel 5% (50 g)

Anti-inflammatory and analgesic drugs
Indication

Anti-inflammatory pain reliever

in the joints;

connection, tendon;

muscles

Features of application

Use with caution simultaneously with oral non-steroidal anti-inflammatory drugs

Application method

Adults

3-4 times a day, rubbing lightly into the skin

Duration of the course

Depending on the nature of the disease, but not longer than 14 days in a row

Contraindication

Pregnant and breastfeeding

Increased sensitivity to diclofenac

The product is certified

Due to its release in the form of a gel, “Diclofenac gel 5% (50 g)” quickly reaches the affected area, has a pronounced analgesic and anti-inflammatory effect.
It not only improves well-being, but also has a therapeutic effect – it reduces inflammation, eliminates swelling and accelerates the restoration of functions of the affected area.

Do you suffer from arthrosis, rheumatism, osteochondrosis? Can’t move freely and without pain? Try “Diclofenac” in the form of a gel.
It reduces the synthesis of prostaglandins, which provoke pain, eliminates swelling and inflammation.
Therefore, after 10-15 minutes you feel relief, and its effect lasts up to 8 hours.

The active substance accumulates in the skin, as if in a depot, from where it is gradually released and reaches deep tissues – muscles, blood vessels, joints.
That is why the effect of the drug lasts for a long time.

The tool is easy to use : a 4-8 cm strip of gel should be applied to the affected area and lightly rubbed. Apply 2-3 times a day.

Composition:
active ingredient: diclofenac sodium;
1 g of gel contains 10 mg of diclofenac sodium;
excipients: propylene glycol, ethanol 96%, macrogol 400, carbomer 980, purified water, methyl parahydroxybenzoate (E 218).

Medicinal form. Gel.
Main physicochemical properties: homogeneous, colorless, transparent or slightly opalescent gel.

Pharmacotherapeutic group. Means used locally for joint and muscle pain. Nonsteroidal anti-inflammatory drugs for local use. Diclofenac.
ATX code M02A A15.

Pharmacological properties.
Pharmacodynamics.
Diclofenac is a nonsteroidal anti-inflammatory agent with pronounced antirheumatic, analgesic, anti-inflammatory and antipyretic effects. The main mechanism of action is inhibition of prostaglandin biosynthesis.
In case of inflammation caused by injuries or rheumatic diseases, Diclofenac-Viola leads to reduction of pain, swelling of tissues and reduction of the period of recovery of functions of damaged joints, ligaments, tendons and muscles. Clinical data have proven that Diclofenac-Viola reduces acute pain already 1 hour after the initial application. 94% of patients had a response to Diclofenac-Viola after 2 days of treatment compared to 8% who had a response to placebo. Overcoming pain and functional disorders was achieved after 4 days of treatment with Diclofenac-Viola. Thanks to the water-alcohol base, the drug also has a local anesthetic and cooling effect.
Pharmacokinetics.
The amount of diclofenac that is absorbed through the skin is proportional to the area of its application and depends on both the total applied dose of the drug and the degree of hydration of the skin. After topical application of 2.5 g of Diclofenac-Viola to a skin surface of 500 cm2, the degree of absorption of diclofenac is approximately 6%. The use of an occlusive bandage for 10 hours leads to a threefold increase in the absorption of diclofenac.
After applying Diclofenac-Viola to the skin of the joints of the hand and knee, diclofenac is found in the blood plasma (where its maximum concentration is approximately 100 times lower than after oral administration), in the synovial membrane and synovial fluid. Binding of diclofenac to proteins is 99.7%.

Diclofenac accumulates in the skin, which serves as a reservoir, from where the substance is gradually released into the surrounding tissues. From there, diclofenac mainly enters deeper inflamed tissues, such as joints, where it continues to act and is detected in concentrations up to 20 times higher than in blood plasma.
Diclofenac is metabolized mainly by hydroxylation to form several phenolic derivatives, two of which are pharmacologically active, but to a much lesser extent than diclofenac.
Diclofenac and its metabolites are mainly excreted in the urine. The total systemic plasma clearance of diclofenac is 263 ± 56 ml/min, and the final elimination half-life is on average 1-3 hours.
In case of renal or hepatic insufficiency, the metabolism and elimination of diclofenac from the body do not change.

Clinical characteristics.
Indication. Local treatment of pain and inflammation of joints, muscles, ligaments and tendons of rheumatic or traumatic origin.

Contraindication. Hypersensitivity to diclofenac or other components of the drug. Presence in the anamnesis of attacks of bronchial asthma, urticaria or acute rhinitis caused by taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs; during the last trimester of pregnancy.

Interaction with other medicinal products and other types of interactions.
Since the systemic absorption of diclofenac due to local application of the drug is very low, the likelihood of interactions is very low.

Features of application.
Use with caution simultaneously with oral non-steroidal anti-inflammatory drugs.
The probability of developing systemic side effects with local application of diclofenac is insignificant compared to the use of its oral forms, but it is not excluded when the drug is used on relatively large areas of the skin for a long time.
Diclofenac-Viola is recommended to be applied only to intact areas of the skin, preventing contact with inflamed, injured or infected skin. Contact of the drug with eyes and mucous membranes should be avoided. The drug cannot be swallowed.
If any skin rashes appear, treatment with the drug should be stopped. Diclofenac-Viola should not be used under an airtight occlusive dressing, but it can be used under a non-occlusive dressing. In the case of sprained ligaments, the affected area can be bandaged.
Diclofenac-Viola contains propylene glycol, which may cause mild localized skin irritation.

Use during pregnancy or breastfeeding.
Clinical experience in pregnant women is limited, so it is not recommended to use this drug during pregnancy or breastfeeding. Diclofenac-Viola is contraindicated during the 3rd trimester of pregnancy due to the possibility of the development of labor weakness and/or premature closure of the ductus arteriosus.
In the course of research on animals, no manifestation of the harmful effect of the drug on pregnancy or embryonic development, childbirth or postnatal development of the child was found. If there are good reasons for using Diclofenac-Viola during breastfeeding, when the expected benefit of the drug in the opinion of the doctor exceeds the potential risk, the drug should not be applied to the mammary glands or large areas of the skin and should not be used for a long time.

The ability to influence the speed of reaction when driving a motor vehicle or working with other mechanisms. Does not affect.

Method of application and dosage.
Adults and children over 14 years of age should use Diclofenac-Viola 3-4 times a day, rubbing it lightly into the skin. The amount of drug used depends on the size of the affected area (so, 2-4 g, which corresponds to the size of a cherry or walnut, is enough to apply to an area of 400-800 cm2).
After applying the drug, hands should be washed, except for those cases when this area is to be treated.
The duration of therapy depends on the nature of the disease and the effectiveness of treatment.
The drug should not be used for longer than 14 days in a row.

Children. Diclofenac-Viola is not recommended for use in children under 14 years of age. When using the medicinal product for children over 14 years of age for more than 7 days or if the symptoms of the disease worsen, it is necessary to consult a doctor.

Overdose. Overdose is unlikely due to the low absorption of diclofenac into the systemic bloodstream when applied topically. In case of accidental ingestion, it should be taken into account that 1 tube of the drug of 40 g contains the equivalent of 0.4 g of diclofenac sodium; at the same time, the development of systemic adverse reactions is possible.
In case of accidental ingestion of the drug, the stomach should be emptied immediately and an adsorbent should be taken. Symptomatic treatment with the use of therapeutic measures used for the treatment of poisoning with non-steroidal anti-inflammatory drugs is indicated.

Adverse reactions.

Diclofenac-Viola is usually well tolerated. Adverse reactions include mild, temporary skin reactions at the application site. In rare cases, allergic reactions may occur.
Infections and infestations
Rare (< 1/10000): pustular rashes.
From the side of the immune system
Rare (< 1/10000): hypersensitivity reactions (including urticaria), angioedema.
From the respiratory system
Rare (< 1/10000): bronchial asthma.
From the skin and connective tissues
Common (≥1/100;< 1/10): rash, itching, eczema, erythema, dermatitis, including contact dermatitis.
Single (≥1/10000;< 1/1000): bullous dermatitis.
Rare (< 1/10000): photosensitivity reactions, burning sensation of the skin.

Expiration date. 2 years.

Storage conditions.
Store in the original packaging at a temperature not higher than 25 °C; freezing is not allowed. Keep out of the reach of children.

Packaging.
40 g in tubes; 1 tube in a pack or without a pack.

Leave category. Without a prescription.

Producer. PrJSC Pharmaceutical factory “Viola”.

The location of the manufacturer and its address of the place of business.
Ukraine, 69063, m. Zaporozhye, Akademika Amosova, 75.

The applicant PrJSC Pharmaceutical factory “Viola”.

Location of the applicant.
Ukraine, 69063, m. Zaporozhye, Akademika Amosova, 75.

Date last viewed. 04.04.2018

One response on “Diclofenac gel 5% (50 g)”

  1. I have not checked in here for some time since I thought it was getting boring, but the last several posts are great quality so I guess I’ll add you back to my everyday bloglist. You deserve it my friend 🙂

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