Name:
Dicloran plus.
Description:
Soft gel from white to light yellow in color with a characteristic odor of methyl salicylate. The main active ingredient is Diclofenac diethylamine, Methyl salicylate, Levomenthol, Flax seed oil. Release formGel for external use. Dosage 30 g. Special instructions Dicloran® Plus should be applied only to intact skin, avoiding contact with open wounds. After application, an occlusive dressing should not be applied. Do not allow the drug to come into contact with the eyes and mucous membranes. In case of accidental ingestion of the drug, immediately seek medical help. If symptoms persist or worsen, or new symptoms appear, stop using the drug and contact your doctor. If the medicinal product has become unusable or the expiration date has expired, do not throw it into wastewater or into the street! Place the medicine in a bag and put it in a trash can. These measures will help protect the environment! Pharmacological group Means for topical use for pain in the joints and muscles. Non-steroidal anti-inflammatory drugs for topical use. ATX code: M02AA Pharmacodynamics Dicloran® Plus has a local analgesic, anti-inflammatory and anti-edematous effect. The pharmacological action of Dicloran® Plus is due to the components that make up its composition. Diclofenac and methyl salicylate are non-steroidal anti-inflammatory drugs (NSAIDs), whose anti-inflammatory action is based on the ability to suppress the synthesis of prostaglandins and thus reduce the manifestation of symptoms of inflammation. The main component of linseed oil is alpha-linolenic acid (unsaturated fatty acid ethyl ester), which has an anti-inflammatory effect. Menthol irritates the nerve endings and thus has a local distracting and mild analgesic effect. Pharmacokinetics The degree of absorption of diclofenac is insignificant and is not more than 6% of the equivalent dosage of diclofenac taken orally. When applied as a gel, diclofenac and methyl salicylate are slowly absorbed into the skin, penetrating into the subcutaneous tissue, muscle tissue, joint capsule and joint cavity. With prolonged treatment or when applied to large areas of damage, the components of the drug gradually penetrate into the subcutaneous tissues, synovial fluid, and plasma. The maximum plasma concentration of diclofenac is about 100 times lower than its concentration after oral administration at an equivalent dosage. Diclofenac is metabolized in the liver by conjugation with glucuronic acid. Excreted with urine 65%, with feces – 35%. Indications for use – For the treatment of pain, inflammation and swelling in: injuries of tendons, ligaments, muscles and joints – for example, torn ligaments, bruises, sprains and back pain after sports or as a result of accidents; localized forms of rheumatic diseases of soft tissues – for example, tendovaginitis, bursitis, shoulder-hand syndrome, periartopathy. – For the symptomatic treatment of arthrosis of joints of small and medium size – for example, the joints of the fingers or knees. Dosage and administration Externally. Adults: Depending on the size of the painful area, 2-4 g of the drug (which is comparable in volume, respectively, to the size of a cherry or walnut and is sufficient to treat a body surface area of 400-800 cm2) is applied to the affected skin area 3-4 times a day and lightly rubbed. The duration of treatment depends on the indications and the observed effect. If there is no improvement after 14 days, it is recommended to re-evaluate the effectiveness of treatment. Dicloran® Plus should not be used for more than 14 days. After applying the preparation, the hands must be washed if they are not the area of treatment (for example, with arthrosis of the joints of the fingers). Do not exceed the total daily dose of the drug 16 g per day. Use the lowest effective dose for the shortest period. Children: Not for use in children. Elderly (over 65 years of age): Elderly patients do not require dose adjustment. Use during pregnancy and lactation The drug is contraindicated during pregnancy and lactation. Influence on the ability to drive vehicles and other mechanisms The drug does not affect the ability to drive a car and maintain moving mechanical equipment. Precautions With caution, the drug should be prescribed for hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe violations of the liver and kidneys, chronic heart failure, bronchial asthma, in old age, in violation of hematopoiesis, polyposis of the nasal mucosa, elderly patients. Use only as an external agent. The drug must not be swallowed. The drug can cause a serious allergic reaction, especially in patients allergic to aspirin. Symptoms may include hives, facial swelling, asthma (wheezing), shock, skin redness, rash, or blisters. If any of these symptoms occur, patients should stop use and seek medical advice. Use with caution with oral non-steroidal anti-inflammatory drugs. Dicloran® Plus should not be used concomitantly with other medicinal products containing diclofenac. NSAIDs can cause gastrointestinal bleeding. The risk may increase with increasing dose and duration of use, and may be higher in elderly patients with a history of gastric ulcer, patients with coagulopathy taking anticoagulants, glucocorticoids, or other NSAIDs, and when drinking alcohol. NSAIDs may increase the risk of serious cardiovascular thrombosis, myocardial infarction and stroke. This risk may increase with increasing dose and duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. NSAIDs should be used with caution in patients with asthma, gastrointestinal disease, renal failure, liver disease, hypertension, fluid retention, cardiovascular disease, or in patients taking diuretics or coumarin anticoagulants. The use of salicylates can provoke Reye’s syndrome. If excessive skin irritation occurs, stop using the drug. Minimize or avoid exposure to natural or artificial sunlight on treated areas. When applying the drug to large areas of the skin and / or with its long-term use, the possibility of developing systemic side effects cannot be completely excluded. During therapy with diclofenac, an increase in the activity of liver enzymes may be observed. Diclofenac should be discontinued immediately if elevated liver enzymes persist or increase. Dicloran® Plus contains propylene glycol which may cause mild localized skin irritation in some patients. If any skin rash appears, treatment should be discontinued. In case of sprain, the affected area can be bandaged with a bandage. When taking the drug inside, isolated cases of gastrointestinal bleeding were noted. Interaction with other drugs If you are currently or have recently taken other drugs, tell your doctor. Diclofenac may enhance the effect of drugs that cause photosensitivity. Clinically significant interactions with other drugs have not been described. Methyl salicylate enhances the effect of anticoagulants, methotrexate during absorption, which should be taken into account when using large doses of the drug for a long time. It should be borne in mind that diclofenac sodium can potentiate specific effects, in particular the ulcerogenic effect of corticosteroids, increase the concentration of lithium in the blood, weaken the effect of diuretics and saluretics of the thiazide and furosemide groups. With simultaneous use with anticoagulants, the state of the blood coagulation system should be monitored. Caution should be exercised while using the gel with oral NSAIDs, as there is a risk of mutual potentiation of toxic effects, especially systemic side effects. Contraindications Hypersensitivity to diclofenac, methyl salicylate or other components that make up the drug; complete or incomplete combination of bronchial asthma, recurrent polyposis of the nasal mucosa and paranasal sinuses and intolerance to acetylsalicylic acid, ibuprofen or other non-steroidal anti-inflammatory drugs (including history); pregnancy and lactation period; children’s age (up to 18 years); violation of the integrity of the skin; use before or after cardiac surgery. Composition Per 1 g of gel Active substances: Diclofenac diethylamine 11.61 mg, which is equivalent to sodium diclofenac 10.0 mg Methyl salicylate 100.0 mg Levomenthol 50.0 mg Flax seed oil 30.0 mg Excipients: Butylhydroxyanisole (E 320) 0.20 mg Butylhydroxytoluene (E 321) 2.0 mg Benzyl alcohol (E 1519) 10.0 µl Disodium edetate 1.0 mg Diethylamine 7.1 µl Carbomer 980 10.8 mg Citric acid monohydrate (E 330) 1.0 mg Macrogol glyceryl hydroxystearate ( Cremophor RH-40) 35.0 mg Propylene glycol (E 1520) 100.0 mg Water Sc. req. up to 1.0 g Overdose The extremely low systemic absorption of the active components of the drug when applied externally makes an overdose almost impossible. In case of accidental ingestion, treatment is the same as for NSAID poisoning. The patient should see a doctor. Symptomatic treatment is carried out when signs of complications appear, such as high blood pressure, renal failure, convulsions, respiratory depression, and complications from the digestive tract. Ingestion treatment: gastric lavage, induction of vomiting, activated charcoal, forced diuresis, symptomatic therapy. Dialysis is ineffective due to the high degree of binding of diclofenac to plasma proteins (about 99%). Side effects The likelihood of systemic adverse reactions after topical application of diclofenac is small compared to the frequency of adverse reactions during oral administration of diclofenac, however, if the gel is applied to large areas of the skin for a long time, the possibility of systemic adverse reactions cannot be ruled out. In this case, you should be guided by the information set out in the instructions for use for other forms of release of diclofenac. If any side effects or other unusual reactions occur, stop using the drug and consult a doctor. Adverse reactions are ranked by frequency, using the following frequency assessment criteria: often (1/100 <1/10); infrequently (1/1,000 <1/100); rarely (1/10,000 <1/1,000); very rare (<1/10,000), including isolated reports. Infections and infestations: Very rare: pustular rash. On the part of the immune system: Very rarely: hypersensitivity, allergic reactions (urticaria, angioedema, bronchospastic reactions). On the part of the respiratory system, chest and mediastinum: Very rarely: asthma, dyspnea. On the part of the skin and subcutaneous tissue: Often: rash, eczema, erythema, dermatitis (including contact dermatitis). Rare: bullous dermatitis. Very rare: vesicles, papules, paresthesias, burns, pain, irritation, peeling, redness, itching at the site of application, swelling of the treated area, photosensitivity reactions (patients should be warned against excessive exposure to sunlight in order to reduce the likelihood of developing photosensitivity reactions). If any side effects or other unusual reactions occur, stop using the drug and consult a doctor. This applies to all possible side effects, including those that are not described in this leaflet. Storage conditions At a temperature not higher than 30 °C. Keep out of the reach of children. Buy Dicloran plus gel 30g No. 1 Price for Dicloran plus gel 30g No. 1
INN | DICLOFENAC+METHYLSALICYLATE+MENTHOL |
---|---|
The code | 31 472 |
Barcode | 8 901 086 040 770 |
Dosage | 30g |
Active substance | Diclofenac, methyl salicylate, menthol, linseed oil |
Manufacturer | Unique Pharmaceutical Laboratories (Division of JB Chemicals and Pharmaceuticals Ltd), India |
Importer | IOOO Interfarmaks 223028 Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Star, 19a-5, room. 5-2 |
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