Финалгон®
Producer: Boehringer Ingelheim Pharma (Beringer Ingelkhaym Pharma) Germany
Code of automatic telephone exchange: M02AX10
Release form: Soft dosage forms. Ointment.
General characteristics. Structure:
Active ingredients: 4 mg of a nonivamid (ваниллиламид nonyl acid) (PSVA), 25 mg of a nikoboksil (butoksietilovy ether of niacin) (NSBE) in 1 g of ointment.
Excipients: диизопропиладипинат (Krodamol), silicon dioxide colloid, vaseline (paraffin, soft white), sorbic acid, citronella grass oil, the water purified.
Pharmacological properties:
Pharmacodynamics. Nonivamid Yavlyaetsya a synthetic analog of capsaicine also has the anesthetizing properties which are shown as a result of gradual penetration of substance into peripheral nociceptive S-fibers and the A-delta nerve fibrils at repeated putting drug on skin.
Nikoboksil. Has direct vasodilating effect. The combined action. Nonivamid also nikoboksit have the vasodilating properties supplementing each other, cause a dermahemia, increase the speed of enzymatic reactions, activate a metabolism.
Emergence of reddening and temperature increase of skin within several minutes after drawing demonstrate bystry penetration of active components of drug into skin. Action of Finalgona® is shown locally.
Effect of drug develops during several min., maximum effect occurs in 20-30 min.
Indications to use:
Arthritis, rheumatic joint pain and muscles, sports injuries, bruises and damages of the copular device, the muscular pain caused by an excessive exercise stress, a lumbago, neuritis, an ischialgia, a bursitis and a tendovaginitis.
For preliminary "warming up" of muscles before physical exercises, sports competitions. As a part of complex vasodilating therapy at disturbances of peripheric circulation.
Route of administration and doses:
Interactions with other drugs used locally or systemically are not revealed. The column of drug no more than 0,5 cm in size, by means of the enclosed applicator, is applied on the respective site of skin of the size of a palm with the easy rubbing movements. For strengthening of medical action the site of skin on which drug is applied can be covered with woolen fabric.
For preliminary warming up of muscles before physical exercises, sports competitions it is recommended to rub approximately in 30 minutes prior to their beginning. At repeated use reaction to ointment can decrease that demands increase in a dose which is selected individually. Ointment is used by 2-3 times a day. In the absence of desirable effect within 10 days it is necessary to address the specialist. After putting drug on skin it is necessary to wash up carefully hands with soap.
Features of use:
Pregnancy and period of a lactation. There are no data on whether drug gets into breast milk. Not to use drug during pregnancy and breastfeeding.
Drug causes a dermahemia owing to what there is a reddening, a caumesthesia, an itch and burning in the place of use. These symptoms can be more expressed when causing excess amount of drug or in case of intensive grinding on the surface of skin. Use of excessive amounts of drug or intensive grinding on the surface of skin can lead to emergence of vesicles or pustules in an ointment site of application. After use of the drug Finalgon® it is necessary to wash up immediately hands with soap. It is necessary to be careful and avoid accidental hit of drug on other sites of skin or hit of drug on other person. To avoid accidental hit of drug on the person, in eyes, a nose or a mouth. It can lead to a temporary face edema, pain in a face, to an inflammation of a conjunctiva, a hyperemia of eyes, burning in eyes, to a vision disorder, discomfort in an oral cavity and to stomatitis.
To or after putting drug on skin it is not necessary to take a hot bath or a shower.
Release of sweat or application of heat to a site of application of drug can cause erubescence and an intensive caumesthesia even in several hours after drawing Finalgona®.
As a part of drug sorbic acid which can cause local irritation of skin contains (for example, contact dermatitis).
Influence on ability to drive the car or to work with mechanisms. Special clinical trials of influence of drug on ability to drive the car and mechanisms it was not carried out. However during use of drug during the driving and work with mechanisms it is necessary to show care.
Side effects:
During long experience of use of drug the following side effects were revealed:
From immune system: anaphylactic reactions, hypersensitivity.
From a nervous system: paresthesia, skin burning sensation.
From a respiratory organs: cough, short wind.
From skin and hypodermic fabrics: vesicles or pustules in a site of application, local skin reaction (for example, contact dermatitis), an itch, rash, a face edema, urticaria, feeling of heat in a site of application.
Interaction with other medicines:
Interactions with other drugs used locally or systemically are not revealed.
Contraindications:
• Hypersensitivity to a nikoboksil, a nonivamid or excipients of drug.
• It is not necessary to apply ointment on sensitive skin, open wounds, the inflamed sites of skin, sites of skin with a hyperpermeability: neck, stomach bottom, interior of hips.
• Children's age up to 12 years.
Overdose:
Symptoms. The effect of a dermahemia and weight of dozozavisimy side effects can be aggravated after use of excess amount of FINALGON® ointment.
Use of excessive amounts of drug can lead to emergence of vesicles or pustules in an ointment site of application.
The overdose by drug can cause system reactions (reddening of an upper body, fervescence, blood "inflows", a painful hyperemia, a lowering of arterial pressure) since ethers of niacin possess good tranedermalny absorption.
Treatment. When using excess amount of drug the effect can be reduced if to remove ointment from the surface of skin by means of vegetable oil or cosmetic cream on a fat basis, from a mucous membrane of an eye (at accidental hit) - by means of medical vaseline. If necessary, the symptomatic treatment has to be carried out.
Storage conditions:
Period of validity 4 years. Not to use after expiry date. At a temperature not above 25 °C, in the place, unavailable to children
Issue conditions:
Without recipe
Packaging:
Ointment for external use. On 20 g or 50 g in a tuba aluminum, closed by a cap from plastic with a punch for a membrane. Each tuba with the applicator and the application instruction is placed in a pack from a cardboard.