Instructions Voltaren Emulgel for external use 1% container 100 ml
Composition
active ingredient: diclofenac;
1 g of emulgel contains 11.6 mg of diclofenac diethylamine, which corresponds to 10 mg of diclofenac sodium;
excipients: carbomer, polyethylene glycol cetostearyl ether, cocoyl caprylocaprate, diethylamine, isopropyl alcohol, mineral oil, flavor 45 (containing benzyl benzoate), propylene glycol, purified water.
Dosage form
Emulgel for external use.
Main physicochemical properties: soft homogeneous creamy gel from white to yellowish color.
Pharmacotherapeutic group
Topical agents for joint and muscle pain. Nonsteroidal anti-inflammatory drugs for topical use. Diclofenac.
ATX code M02A A15.
Pharmacological properties
Pharmacodynamics
Diclofenac is a highly effective nonsteroidal anti-inflammatory drug with pronounced antirheumatic, analgesic, anti-inflammatory and antipyretic effects. The main mechanism of therapeutic action of diclofenac is the inhibition of prostaglandin biosynthesis by cyclooxygenase-2 (COX-2).
Thanks to its water-alcohol base, the drug also has a local anesthetic and cooling effect.
Clinical trial data.
In inflammation and pain of traumatic or rheumatic origin, Voltaren Emulgel reduces the period of restoration of movement of the affected joints, ligaments, tendons and muscles. Clinical data have shown that Voltaren Emulgel reduces acute pain as early as 1 hour after initial application. The drug reduces pain on movement by 75% within two days. 94% of patients responded to Voltaren Emulgel after 2 days of treatment compared to 8% who responded to placebo. Treatment of pain and restoration of joint movement was achieved after 4 days of treatment with Voltaren Emulgel.
Pharmacokinetics
The amount of diclofenac absorbed through the skin is proportional to the area of application and depends on both the total dose of the drug applied and the degree of skin hydration. After topical application of 2.5 g of Voltaren Emulgel to a skin surface area of 500 cm2, the degree of absorption of diclofenac is approximately 6%. The use of an occlusive dressing for 10 hours leads to a threefold increase in the absorption of diclofenac.
After application of Voltaren Emulgel to the skin of the hand and knee joints, 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. The protein binding of diclofenac is 99.7%.
Diclofenac accumulates in the skin, which serves as a reservoir from which the substance is gradually released into the surrounding tissues. From there, diclofenac mainly enters deeper inflamed tissues, such as joints, rather than into the blood plasma. There it continues to act and is detected in concentrations up to 20 times higher than in the blood plasma.
Diclofenac is metabolized mainly by single- or multi-step hydroxylation and subsequent glucuronidation or glucuronidation of the entire molecule.
Diclofenac and its metabolites are excreted mainly in the urine. The total systemic plasma clearance of diclofenac is 263 ± 56 ml/min and the terminal plasma half-life is 1-2 hours. Four metabolites, including two active ones, have a short half-life of 1-3 hours, and one has a slightly longer half-life, but is practically inactive.
In renal or hepatic insufficiency, the metabolism and excretion of diclofenac are not altered.
Indication
Local treatment of pain and inflammation of joints, muscles, ligaments and tendons of rheumatic or traumatic origin.
Contraindication
Hypersensitivity to diclofenac or to any of the other ingredients of the drug. History of attacks of bronchial asthma, angioedema, urticaria or acute rhinitis caused by taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs; last trimester of pregnancy.
Interaction with other medicinal products and other types of interactions
Since the systemic absorption of diclofenac following topical application is very low, the likelihood of interactions is very low.
Application features
Use with caution with oral nonsteroidal anti-inflammatory drugs.
The possibility of systemic side effects (which occur with systemic forms of diclofenac) should be considered when using the drug on larger areas of skin or for a longer period than recommended. In such cases, the drug should be used with caution in patients with hepatic, renal or cardiac insufficiency, as well as peptic ulcer disease in the active stage.
If any skin rash appears, treatment with the drug should be discontinued. Voltaren Emulgel should not be used under an airtight occlusive dressing, but it may be used under a non-occlusive dressing.
Voltaren Emulgel contains propylene glycol and benzyl benzoate, which may cause mild localized skin irritation.
Due to the possibility of photosensitivity, direct sunlight and visits to the solarium should be avoided during treatment and for 2 weeks after discontinuation of treatment.
Ability to influence reaction speed when driving vehicles or other mechanisms
The effect of diclofenac is absent when applied externally.
Use during pregnancy or breastfeeding
Clinical experience in pregnant women is limited. Like other nonsteroidal anti-inflammatory drugs, Voltaren Emulgel is contraindicated during the third trimester of pregnancy due to the possibility of developing labor weakness, fetal renal dysfunction with subsequent oligohydramnios and/or cardiopulmonary toxicity with premature closure of the ductus arteriosus and pulmonary hypertension. The use of the drug during the first two trimesters of pregnancy is allowed only if the expected benefit outweighs the potential risk to the fetus. In this case, women planning pregnancy and during the first two trimesters of pregnancy are recommended to reduce the dosage to the lowest possible level and shorten the duration of treatment.
It is not known whether diclofenac is excreted in breast milk when applied externally, therefore the use of Voltaren Emulgel during breastfeeding is allowed only if the expected benefit outweighs the potential risk to the infant. If there are good reasons for using the drug during breastfeeding, the drug should not be applied to the mammary glands or large areas of skin and should not be used in larger amounts or for longer periods than recommended.
There are no data on the effect of diclofenac on human fertility when applied topically.
Method of administration and doses
The drug is intended for external use only.
Before first use:
Aluminum tubes: Before first use, pierce the protective membrane using the piercing device on the outside of the cap. Aluminum laminated tubes: unscrew the cap, fit its reverse side onto the protected spout of the tube and turn so that the tube protection is removed. Tube with applicator cap: remove the transparent protective cap, unscrew the applicator. To remove the tube protection, use the star-shaped recess on the applicator cap. Before further application of the drug, the applicator should be screwed on.
Adults and children over 14 years of age should apply Voltaren Emulgel 3-4 times a day, gently rubbing into the skin at the site of pain. The amount of the drug used depends on the size of the affected area (for example, 2-4 g, which is the size of a cherry or walnut, is enough to apply to an area of 400-800 cm2).
When using the tube with applicator cap: To open the tube, simply pull the white part of the applicator. Gently press the tube to squeeze the desired amount of gel onto the surface of the applicator, then use the tube with applicator cap as if they were your fingers, gently and slowly rubbing the gel into the areas of pain and/or swelling. Do not press hard on the applicator cap. The applicator cap will automatically close as you rub the gel in. After use, wipe the applicator dry with a cotton towel or cloth.
After applying the drug, hands should be washed, except when this is the area to be treated.
The duration of therapy depends on the nature of the disease and the effectiveness of the treatment.
The drug should not be used for longer than 14 consecutive days for soft tissue injuries or rheumatism and 21 days for pain of arthritic origin, unless otherwise recommended by a doctor.
You should seek medical advice if the symptoms of the disease do not improve or worsen after 7 days of treatment.
Elderly patients can use the usual adult doses of the drug.
Children
Voltaren Emulgel is not recommended for use in children under 14 years of age. When using the drug in children over 14 years of age for more than 7 days or if the symptoms of the disease worsen, you should seek medical advice.
Overdose
Overdose is unlikely due to the low absorption of diclofenac into the systemic circulation when applied topically. However, side effects similar to those that occur with an overdose of tablets containing diclofenac are possible if the drug is accidentally swallowed. In this case, it should be borne in mind that 1 tube of the drug of 100 g contains the equivalent of 1 g of diclofenac sodium.
In case of accidental ingestion, the stomach should be emptied immediately and an adsorbent should be taken. Symptomatic treatment is indicated using therapeutic measures used for the treatment of poisoning with nonsteroidal anti-inflammatory drugs.
Adverse reactions
Infections and infestations
Rare (<1/10,000): pustular eruptions.
On the part of the immune system
Rare (<1/10,000): hypersensitivity reactions (including urticaria), angioedema.
From the respiratory system
Rare (<1/10,000): bronchial asthma.
Skin and connective tissue disorders
Common (≥1/100; <1/10): rash, pruritus, eczema, erythema, dermatitis, including contact dermatitis.
Uncommon (≥1/10,000; <1/1,000): bullous dermatitis.
Rare (<1/10,000): photosensitivity reactions.
If adverse reactions occur, treatment should be discontinued and a doctor should be consulted.
Expiration date
3 years.
Storage conditions
Store out of the reach of children at a temperature not exceeding 30 °C.
Packaging
100 g of the drug in aluminum laminated or aluminum with membrane tubes, sealed with screw-on polymer caps of white or blue color, round or triangular shape, or equipped with polymer massage caps-applicators. 1 tube in a cardboard box.
Vacation category
Without a prescription.
Producer
GSK Consumer Helsker S.A./GSK Consumer Healthcare SA
Location of the manufacturer and its business address
Route de l'Etraz, 1260 Nyon, Switzerland.
