Composition, form of production and packaging
? Gel for external use 1% white, homogeneous.
1 g
diclofenac diethylamine 11.6 mg,
diclofenac sodium 10 mg
Excipients: carbomer, macrogol, diethanolamine, isopropanol, propylene glycol, sodium sulfite anhydrous, cetomacrogol, decyloleate, vaseline oil, purified water.
60 g - aluminum tubes (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Naklofen gel is a non-steroidal anti-inflammatory drug (NSAID) for topical application, with pronounced analgesic and anti-inflammatory properties. Indiscriminately inhibiting cyclooxygenase 1 and 2 types, disrupts the metabolism of arachidonic acid, reduces the number of prostaglandins, including in the inflammatory focus.Naklofen gel is used to eliminate pain syndrome and reduce puffiness associated with the inflammatory process.
PHARMACOKINETICS
With the recommended method of using the drug, no more than 6-7% of diclofenac is absorbed into the systemic circulation. It is excreted by the kidneys. Diclofenac is rapidly absorbed, with the concentration in the synovial fluid higher than in the plasma.
INDICATIONS
The drug is used to relieve pain and inflammation according to the following indications:
- rheumatoid arthritis, osteoarthritis, rheumatic lesions of soft tissues (tendovaginitis, bursitis);
- bruises, damage to ligaments, muscles and tendons;
- inflammatory swelling of soft tissues, tenderness of muscles and joints, including those caused by heavy physical exertion.
DOSING MODE
Outwardly. Adults and adolescents over 12 years of age, a strip of gel 5-10 cm long is applied to the affected area and gently rubbed into the skin 2-3 times a day.Children aged 6 to 12 years are treated with a strip no more than 3 cm not more often than 2 times a day. When using the drug for more than 10 days should consult with your doctor.
SIDE EFFECT
Gel Naklofen rarely causes side effects.
On the part of the skin: redness, photosensitivity, contact dermatitis (itching, hyperemia, swelling of the treated skin, papular-vesicular rashes, peeling), burning sensation, erythematous skin rash, hives, eczema.
Systemic reactions: urticaria, bronchial asthma, angioedema, systemic anaphylactic reactions (including shock).
CONTRAINDICATIONS
- children under the age of 6;
- violation of the integrity of the skin;
- pregnancy (III trimester);
- Naklofen gel should not be used in case of hypersensitivity to diclofenac or auxiliary components of the drug or to other non-steroidal anti-inflammatory drugs (complete or incomplete acetylsalicylic acid intolerance syndrome - rhinosinusitis, urticaria, nasal polyps, bronchial asthma).
With caution: hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe violations of liver and kidney function, chronic heart failure, bronchial asthma, impaired blood clotting (including hemophilia, lengthening bleeding time, tendency to bleeding), elderly age, pregnancy I-II trimester and lactation period.
PREGNANCY AND LACTATION
The drug is not recommended for use in the third trimester of pregnancy. In I-II trimesters of pregnancy and during lactation, Naklofen gel is used in small amounts and for a short period of time. The lactating woman should not apply the drug to the mammary gland.
APPLICATION FOR FUNCTIONS OF THE LIVER
Use with caution in severe violations of kidney function.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Use with caution in severe violations of liver function, hepatic porphyria (exacerbation).
APPLICATION FOR CHILDREN
Contraindicated in children under 6 years.
APPLICATION IN ELDERLY PATIENTS
Use with caution in old age.
SPECIAL INSTRUCTIONS
Gel Naklofen should be applied only to undamaged skin. Avoid contact with eyes, mucous membranes or open wounds. Gel Naklofen should not be used under airtight (occlusive) bandages. Care should be taken when applying a large amount of gel to large surfaces of sensitive skin for an extended period of time. When used with other dosage forms of diclofenac, the total maximum daily dose should be taken into account.
During the period of application of the Naklofen gel, prolonged exposure to sunlight should be avoided.
After applying the gel on the skin, you should wash your hands thoroughly. The drug is intended for external use only.
Impact on the ability to drive vehicles and manage mechanisms
The drug does not affect the ability to drive and other mechanical means.
OVERDOSE
Extremely low systemic absorption of diclofenac with external application makes an overdose virtually impossible. With the occasional ingestion of a large amount of the drug, the development of nausea, vomiting and systemic side effects characteristic of NSAIDs is possible.
Symptoms: nausea and vomiting.
Treatment: gastric lavage, activated charcoal, forced diuresis, symptomatic therapy. Hemodialysis is ineffective.
DRUG INTERACTION
Caution should be exercised while taking oral forms of other non-steroidal anti-inflammatory drugs. Diclofenac gel can enhance the effect of drugs that cause photosensitivity. Clinically significant interaction with other drugs is not described.
TERMS OF RELEASE FROM PHARMACY
Without recipe.
TERMS AND CONDITIONS OF STORAGE
Store at a temperature not exceeding 30 В° C. Keep out of the reach of children. Shelf life - 4 years.
