Instructions Voltaren Emulgel for external use 1% tube 50 g
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 nonsteroidal anti-inflammatory drug with pronounced antirheumatic, analgesic, anti-inflammatory and antipyretic effects. The main mechanism of action is the inhibition of prostaglandin biosynthesis.
In inflammation caused by trauma or rheumatic diseases, Voltaren® Emulgel reduces pain, tissue swelling and shortens the recovery period of damaged joints, ligaments, tendons and muscles. Clinical data have shown that Voltaren® Emulgel reduces acute pain within 1 hour of initial application. 94% of patients responded to Voltaren® Emulgel after 2 days of treatment compared to 8% who responded to placebo. Relief of pain and functional impairment was achieved after 4 days of treatment with Voltaren® Emulgel. Due to its water-alcohol base, the drug also has a local anesthetic and cooling effect.
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, 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 excreted mainly in the urine. The total systemic plasma clearance of diclofenac is 263 ± 56 ml/min and the terminal half-life is on average 1-3 hours.
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, urticaria or acute rhinitis caused by taking acetylsalicylic acid or other nonsteroidal 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 following topical application is very low, the likelihood of interactions is very low.
Application features
Use with caution concomitantly with oral nonsteroidal anti-inflammatory drugs.
The likelihood of developing systemic side effects with topical application of diclofenac is insignificant compared to the use of its oral forms, but it cannot be ruled out when the drug is used on relatively large areas of skin for a long time.
Voltaren® Emulgel should only be applied to intact skin, avoiding contact with inflamed, injured or infected skin. Avoid contact with eyes and mucous membranes. Do not swallow.
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. In the case of a sprain, the affected area can be bandaged.
Voltaren® Emulgel contains propylene glycol and benzyl benzoate, which may cause mild localized skin irritation.
Use during pregnancy or breastfeeding
Clinical experience in pregnant women is limited, therefore, the use of this drug is not recommended during pregnancy or breastfeeding. Voltaren® Emulgel is contraindicated during the third trimester of pregnancy due to the possibility of developing labor weakness and/or premature closure of the ductus arteriosus.
Animal studies have not revealed any harmful effects of the drug on pregnancy or embryonic development, childbirth or postnatal development of the child. If there are compelling reasons for the use of Voltaren® Emulgel during breastfeeding, when the expected benefit of the drug in the opinion of the doctor outweighs the potential risk, the drug should not be applied to the mammary glands or large areas of skin and should not be used for a long time.
The ability to influence the reaction speed when driving or working with other mechanisms
No effect.
Method of administration and doses
Adults and children over 14 years of age should apply Voltaren® Emulgel 3-4 times a day, rubbing lightly into the skin. 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).
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.
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, a doctor should be consulted.
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 noted that 1 tube of the drug of 100 g contains the equivalent of 1 g of diclofenac sodium; in this case, the development of systemic adverse reactions is possible.
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
Voltaren® Emulgel is generally well tolerated. Adverse reactions include mild, transient skin reactions at the application site. In rare cases, allergic reactions may occur.
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, burning sensation of the skin.
Expiration date
3 years.
Storage conditions
Store out of the reach of children at a temperature not exceeding 30 °C.
Packaging
20 g or 50 g or 100 g of the drug in aluminum laminated tubes or aluminum with a membrane, sealed with screw-on polymer caps of white or blue color, round or triangular shape. 1 tube in a cardboard box.
Vacation category
Without a prescription.
Producer
Novartis Pharma Produktions GmbH.
Novartis Consumer Health SA.
Location of the manufacturer and its business address
Öflinger Str. 44, 79664 Wehr, Baden-Württemberg, Germany/Öflinger Str. 44, 79664 Wehr, Baden-Württemberg, Germany.
Route de l'Etraz, 1260 Nyon, Switzerland.
