COMPOSITION:

Active substances:

1 g of gel contains Diclofenac diethylamine equivalent to Diclofenac sodium 10 mg, Menthol 50 mg, Methyl salicylate 100 mg, Linseed oil 30 mg;

Excipients:

Propylene glycol, Carbomer 940, Disodium Edetate, Polysorbate 80, Benzyl alcohol, ammonia solution, Purified water.

INDICATIONS:

The local treatment of myositis, fibrositis, ischias, muscles stretching and strain, traumatic injuries of the musculoskeletal system, myalgia and arthralgia in acute exercise, inflammatory and degenerative diseases of the joints (osteoarthritis of peripheral joints and spine), rheumatic damage of the musculoskeletal system (bursitis, arthritis, tendosynovitis, tendinitis).

DOSAGE:

In adults and children over 12 years of age apply a thin layer of 2-4 g of gel (4-8cm) on the skin and slightly rub in 2-3 times per day. The average daily dose is 10 g of gel, which corresponds to 100 mg of Diclofenac sodium. The drug should be applied on intact skin, avoiding contact with eyes and mucous tunics. Do not apply the gel on open wounds.

After application of the drug, wash your hands thoroughly, unless this area was subject to treatment.

The duration of treatment is determined by the physician depending on the character and course of the disease and efficacy of treatment.

The gel should not be applied longer than 14 days in case of damage or rheumatism of soft tissues, or 21 day in case of arthritis, unless otherwise recommended by the physician.

Elderly patients can apply usual doses.

ADVERSE REACTIONS:

As usual, Fanigan® Fast gel is well-tolerated. Skin redness, itching, burning, prickling sensation, dryness are possible at the site of application.

In very rare cases there are hypersensitivity reactions such as skin rashes, including generalized, urticaria, erythema, pustular eruptions, eczema, itching sensation, blistering, scales, edema, papules, dermatitis (including contact and bullous dermatitis) angioneurotic edema, photosensitivity.

In case of idiosyncrasy to any component of the drug, the development of asthma, bronchospasm and dyspnea is possible.

The likelihood of systemic adverse effects after topical application of Diclofenac is insignificant compared to the frequency of adverse reactions during oral Diclofenac treatment, however if the gel is applied to large areas of skin for a long time, the possibility of systemic adverse reactions should not be excluded. In this case, follow the information provided in the instructions for medical use for other pharmaceutical forms of Diclofenac.

Drug interactions:

As systemic absorption after topical application of the drug is very low, the likelihood of interactions is insignificant.

In case of large doses of Fanigan® Fast gel, it should be taken into account that Diclofenac may amplify the effect of anticoagulants, corticosteroids, Lithium, and suppress the effect of furosemide and thiazide diuretics.

When concomitant topical application of several drugs containing NSAIDs, local irritation, such as urticaria, redness, desquamation, may develop.

Pregnancy and lactation:

During the first and second trimesters of pregnancy, Fanigan® Fast gel should be applied only in case of extreme necessity on small areas for a short time.

The drug is contraindicated during the third trimester due to the effect of Diclofenac or other inhibitors of prostaglandins on the possibility of premature closure of the arterial duct or uterine inertia.

If the use of drug is necessary during the period of lactation, it cannot be applied on breasts and large areas of skin for a long time (more than 1 week).

Children:

Contraindicated in children under 12 years of age.

PRECAUTIONS:

Caution should be exercised when using concomitantly with oral NSAIDs.

As the possibility of the development of systemic side effects when topical application of Diclofenac is not excluded when applying large doses of Fanigan® Fast gel on large skin surfaces for a long period, caution should be exercised when using the drug in case of active peptic ulcer disease of stomach and duodenum or history of peptic ulcer disease, impaired hepatic/renal function, hemodyscrasia, polyposis of the nasal mucosa.

It is recommended to apply the drug only to intact skin surfaces, preventing its contact with inflamed, wounded or infected skin.

Avoid contact with eyes and other mucous tunics. Do not swallow the drug.

Fanigan® Fast gel contains Propylene glycol, which may cause mild localized skin irritation in some patients.

In case of any skin rash, the drug therapy should be stopped. Do not apply the drug under airtight occlusive dressing. In case of tension of ligaments, the affected area can be bandaged.

Drug interactions:

As systemic absorption after topical application of the drug is very low, the likelihood of interactions is insignificant.

In case of large doses of Fanigan® Fast gel, it should be taken into account that Diclofenac may amplify the effect of anticoagulants, corticosteroids, Lithium, and suppress the effect of furosemide and thiazide diuretics.

When concomitant topical application of several drugs containing NSAIDs, local irritation, such as urticaria, redness, desquamation, may develop.

Overdose:

The overdose is unlikely due to insignificant systemic absorption of Diclofenac in case of topical application. In case of accidental ingestion, the treatment is the same as in case of poisoning by nonsteroidal anti-inflammatory drugs. The patient should seek medical attention.

Symptomatic treatment is performed in case of emergence of signs of complications, such as high blood pressure, renal failure, seizures, respiratory depression, gastrointestinal disorders.

Ability to influence reaction velocity while driving or operating any other mechanisms.

Has no effect.

CONTRAINDICATIONS:

Hypersensitivity to Diclofenac and other components of the drug, acetylsalicylic acid or other NSAIDs. A history of bronchial asthma attacks, urticaria or acute rhinitis caused by acetylsalicylic acid or other NSAIDs administration. Epidermis injury, open wounds at the site of application.

PHARMACOLOGICAL PROPERTIES:

Nonsteroidal anti-inflammatory agents for local application. Code ATC М02А А.

When applied locally, provides pain-relieving, anti-inflammatory and antiedemic effect. Eliminates pain and arthritis, reduces morning stiffness and arthrophyma, increases the range of motions in joints.

Effect of the Fanigan® Fast gel responds to the components in its composition.

Diclofenac sodium belongs to a group of nonsteroidal anti-inflammatory agents. Inhibits cyclooxygenase, inhibits the biosynthesis of prostaglandin – endogenic substances that play an important role in the genesis of fever, inflammation and pain. Diclofenac eliminates pain and inflammation.

Menthol irritates cold receptors. This is accompanied by constriction of capillary tubes and decrease in their permeability at the site of application, a sense of coolness. Menthol induces local revulsive and mild pain-relieving effects.

Methyl salicylate is a derivative of salicylic acid and causes local irritating effect. Causing the irritation of the skin receptors, Methyl salicylate provokes production and ejection into blood of a large amount of biologically active substances that regulate pain sensitivity. The substance P is released from neurons. Reduction of the substance P accumulation in effectors leads to a reduction of pain sensation. Furthermore, Methyl salicylate, which belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs), inhibits the synthesis of prostaglandins due to inhibition of cyclooxygenases, which reduces swelling and infiltration of the inflamed tissues.

Linseed oil, the main component of which is α-linolenic acid (eicosanoic acid ethyl ester), has anti-inflammatory effect, antioxidant properties, improves blood circulation at the site of application.

The effect of Fanigan® Fast gel is observed already within several minutes since the moment of application on skin. Within 20-30 minutes the gel effect reaches its maximum. The main symptoms usually disappear within the first days of treatment.

When applied locally, less than 5% of the dose is absorbed, thus, the systemic exposure to the drug is minimal.

PHARMACEUTICAL CHARACTERISTICS:

General physic-chemical properties:

Uniform white gel with characteristic odor.

Shelf-life:

2 years.

Storage:

Store at the temperature not more than 25°С the original package. Do not freeze. Keep out of reach of children.

Package:

30 or 100 g in tube in a carton.

Conditions of supply:

Without prescription.