Fanigan® fast
Ukraine
Table of Contents
- INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Fanigan® Fast (Fanigan® Fast)
- Composition:
- Pharmacological Properties
- Clinical characteristics.
- Special precautions for use
- Method of Administration and Dosage
- Adverse reactions.
- Composition:
- Pharmacological Properties
- Clinical characteristics.
- Special precautions for use.
- Method of Administration and Dosage
- Adverse reactions.
APPROVED |
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Fanigan® Fast (Fanigan® Fast)
Composition:
Active substances: diclofenac, menthol, methyl salicylate, linseed oil;
1 g of gel contains: 10 mg of diethylamine diclofenac, calculated as sodium diclofenac, 50 mg of menthol, 100 mg of methyl salicylate, 30 mg of linseed oil;
Excipients: propylene glycol, carbomer 940, disodium edetate, polysorbate 80, benzyl alcohol, sodium hydroxide, purified water.
Pharmaceutical form. Gel.
Main physicochemical properties: homogeneous white gel with a characteristic odor.
Pharmacotherapeutic group. Agents used locally for joint and muscular pain. Topical non-steroidal anti-inflammatory agents.
ATC code M02A A.
Pharmacological Properties
Pharmacodynamics
The action of Phanigan® Fast gel is due to its constituent components.
Diclofenac is a non-steroidal anti-inflammatory agent with pronounced anti-rheumatic, analgesic, anti-inflammatory, and antipyretic effects. Its main mechanism of action is the inhibition of prostaglandin biosynthesis.
In inflammation caused by injuries or rheumatic diseases, the use of diclofenac reduces pain, tissue swelling, and shortens the recovery period of functions in damaged joints, ligaments, tendons, and muscles.
Menthol stimulates cold receptors, resulting in vasoconstriction and reduced capillary permeability at the site of application, as well as a sensation of coolness. Menthol produces a local counterirritant and moderately expressed analgesic effect.
Methyl salicylate is a derivative of salicylic acid and exerts a local irritant effect. By stimulating skin receptors, methyl salicylate induces the formation and release into the bloodstream of a large number of biologically active substances that regulate pain sensitivity. This includes the release of substance P from neurons. Reduced accumulation of substance P in nerve endings leads to diminished pain sensation. In addition, methyl salicylate, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs), inhibits prostaglandin synthesis by suppressing cyclooxygenase, thereby reducing swelling and infiltration of inflamed tissues.
Flaxseed oil, whose main component is α-linolenic acid (ethyl ester of an unsaturated fatty acid), has anti-inflammatory and antioxidant properties and improves blood circulation at the site of application.
Pharmacokinetics
The effect of Phanigan® Fast gel begins within a few minutes after application to the skin. The maximum effect is reached within 20–30 minutes. With topical application, less than 5% of the dose is absorbed, so the systemic effect of the drug is minimal.
Clinical characteristics.
Indications.
Local treatment of myositis, fibrositis, sciatica, muscle and tendon strains, traumatic injuries of the musculoskeletal system, muscle and joint pain due to heavy physical exertion, inflammatory and degenerative joint diseases (osteoarthritis of peripheral joints and spine), rheumatic disorders of the musculoskeletal system (bursitis, arthritis, tenosynovitis, tendinitis).
Contraindications.
- Hypersensitivity to diclofenac or to any of the excipients of the product.
- History of asthma attacks, urticaria, or acute rhinitis induced by acetylsalicylic acid or other NSAIDs.
- Skin lesions, open wounds at the site of application.
- Third trimester of pregnancy.
- Age under 14 years.
Interaction with other medicinal products and other forms of interaction.
Since systemic absorption of the components of the medicinal product FaniGAN® Fast, gel, including diclofenac, after topical application is very low, the likelihood of interactions is extremely small. Nevertheless, possible interactions known for oral forms of diclofenac should be taken into account.
Although adequate controlled interaction studies have not been conducted, excessive use of topical salicylates may potentially enhance the effect of coumarin anticoagulants and antiplatelet agents. Therefore, caution should be exercised in patients receiving coumarin anticoagulants and antiplatelet agents, including aspirin.
Special precautions for use
Use with caution when used concomitantly with oral nonsteroidal anti-inflammatory drugs.
The likelihood of developing systemic adverse effects with topical application of diclofenac is low compared to oral formulations; however, such risk cannot be excluded when the drug is applied over relatively large skin areas for prolonged periods.
Do not use FaniGAN® Fast gel with other products containing diclofenac.
The drug should be used with caution in patients with active peptic ulcer of the stomach or duodenum, history of peptic ulcer, impaired liver or kidney function, disorders of blood formation, or nasal mucosal polyposis.
FaniGAN® Fast gel should be applied only to intact skin areas, avoiding contact with inflamed, damaged, or infected skin. Contact of the drug with eyes and mucous membranes should be avoided. The gel must not be ingested.
Due to the possibility of photosensitivity reactions, exposure to direct sunlight and use of tanning beds should be avoided during treatment and for 2 weeks after discontinuation of therapy.
The product contains salicylates, which are aspirin-like substances; therefore, the same precautions recommended for aspirin should be observed.
FaniGAN® Fast gel contains propylene glycol, which may cause skin irritation.
If any skin rash develops, treatment with the drug should be discontinued. Do not apply FaniGAN® Fast gel under airtight occlusive dressings. In case of ligament sprains, the affected area may be bandaged with a non-occlusive bandage.
Use during pregnancy or breastfeeding
Pregnancy. There are no clinical data on the use of FaniGAN® Fast gel during pregnancy. Although the systemic effect of diclofenac is lower with topical compared to oral administration, it is unknown whether the systemic exposure to diclofenac achieved after topical application of FaniGAN® Fast gel may be harmful to the embryo/fetus. During the first and second trimesters of pregnancy, FaniGAN® Fast gel should not be used unless clearly necessary. If required, the dose should be as low as possible and the duration of treatment as short as possible.
During the third trimester of pregnancy, systemic use of prostaglandin synthesis inhibitors, including diclofenac, may cause cardiovascular and renal toxicity in the fetus. At late stages of pregnancy, prolonged bleeding may occur in both mother and child, and labor may be delayed. Therefore, FaniGAN® Fast gel is contraindicated during the third trimester of pregnancy (see section "Contraindications").
Breastfeeding period. If there are strong medical reasons for using FaniGAN® Fast gel during breastfeeding, and the expected benefit outweighs the potential risk according to the physician’s judgment, the drug should not be applied to the breasts or large skin areas and should not be used for prolonged periods (more than 1 week).
Fertility. There are no data on the effect of topically applied diclofenac on human fertility.
Ability to affect reaction speed when driving or operating machinery
No effect.
Method of Administration and Dosage
For adults and children aged 14 years and older: apply 2–4 g of gel (a strip 4–8 cm long) as a thin layer to the skin and gently rub in 2–3 times daily. The average daily dose is 10 g of gel, corresponding to 100 mg of sodium diclofenac. The product should be applied to intact skin; avoid contact with eyes and mucous membranes. The gel must not be applied to open wounds.
After applying the product to the skin, hands should be wiped with a paper towel and then washed, unless the hands themselves are the area being treated. If an excessive amount of gel is accidentally applied, the excess should be wiped off with a paper towel, which should then be disposed of with household waste to prevent water contamination. After applying the gel, wait several minutes before applying a dressing.
The duration of treatment is determined by the physician depending on the nature and course of the disease and the treatment response.
Treatment with this medicinal product should be re-evaluated after 14 days when treating injuries and soft tissue rheumatism, and after 4 weeks when treating osteoarthritis.
Elderly patients do not require dose adjustment.
Children.
Contraindicated in children under 14 years of age. When using the medicinal product in children aged 14 years and older for longer than 7 days, or if disease symptoms worsen, medical advice should be sought.
Overdose.
Overdose is unlikely due to the low systemic absorption of diclofenac when applied topically. However, in case of accidental ingestion, note that one 100-g tube of the product contains the equivalent of 1 g of sodium diclofenac; systemic adverse reactions may occur.
In case of accidental ingestion, gastric lavage should be performed immediately and an adsorbent administered. Symptomatic treatment is indicated, using therapeutic measures appropriate for poisoning with nonsteroidal anti-inflammatory drugs.
Adverse reactions.
Immune system disorders: hypersensitivity reactions (including urticaria), angioedema.
Respiratory system disorders: bronchial asthma, bronchospasm, dyspnea.
Skin and subcutaneous tissue disorders: at the site of application, irritation, desquamation, skin swelling, rash (including pustular), eczema, erythema, dermatitis (including contact, bullous), pruritus, photosensitivity reactions, burning or stinging sensation, dryness of skin, skin discoloration.
If adverse reactions occur, treatment should be discontinued and medical advice should be sought.
Reporting suspected adverse reactions
Reporting of suspected adverse reactions after registration of the medicinal product is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.
Shelf life. 2 years.
Storage conditions.
Store at a temperature not exceeding 25 °C in the original packaging.
Do not freeze.
Keep out of reach and sight of children.
Packaging.
30 g or 100 g in a tube. 1 tube per cardboard pack.
Supply category.
Over-the-counter (without prescription).
Manufacturer.
Kusum Healthcare Pvt Ltd.
Manufacturer's address and place of business.
SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India.
INSTRUCTION
for medical use of the medicinal product
FanIgan® Fast
(Fanigan® Fast)
Composition:
Active substances: diclofenac, menthol, methyl salicylate, linseed oil;
1 g of gel contains: diethylamine diclofenac equivalent to 10 mg of sodium diclofenac, menthol 50 mg, methyl salicylate 100 mg, linseed oil 30 mg;
Excipients: propylene glycol, carbomer 940, disodium edetate, polysorbate 80, benzyl alcohol, sodium hydroxide, purified water.
Pharmaceutical form. Gel.
Main physicochemical characteristics: homogeneous white-colored gel with a characteristic odor.
Pharmacotherapeutic group. Topically applied agents for joint and muscular pain. Topical non-steroidal anti-inflammatory drugs.
ATC code M02A A.
Pharmacological Properties
Pharmacodynamics
The action of Phanigan® Fast gel is due to the components contained in its formulation.
Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) with pronounced anti-rheumatic, analgesic, anti-inflammatory, and antipyretic effects. Its main mechanism of action is the inhibition of prostaglandin biosynthesis.
In inflammation caused by injuries or rheumatic diseases, the use of diclofenac leads to reduced pain, tissue swelling, and shortened recovery time for impaired functions of joints, ligaments, tendons, and muscles.
Menthol stimulates cold receptors, resulting in vasoconstriction and reduced capillary permeability at the site of application, accompanied by a cooling sensation. Menthol produces a local counterirritant effect and moderate analgesic action.
Methyl salicylate is a derivative of salicylic acid and exerts a local irritant effect. By stimulating skin receptors, methyl salicylate induces the formation and release into the bloodstream of a large number of biologically active substances that regulate pain sensitivity. This process involves the release of substance P from neurons. Reduced accumulation of substance P in nerve endings leads to diminished pain perception. Furthermore, methyl salicylate, belonging to the group of nonsteroidal anti-inflammatory drugs (NSAIDs), inhibits prostaglandin synthesis by suppressing cyclooxygenase activity, thereby reducing edema and infiltration of inflamed tissues.
Flaxseed oil, whose main component is α-linolenic acid (ethyl ester of an unsaturated fatty acid), has anti-inflammatory and antioxidant properties and improves blood circulation at the site of application.
Pharmacokinetics
The effect of Phanigan® Fast gel begins within a few minutes after application to the skin. The maximum effect is reached within 20–30 minutes. With topical application, less than 5% of the dose is absorbed, so the systemic effect of the drug is minimal.
Clinical characteristics.
Indications.
Local treatment of myositis, fibrositis, sciatica, muscle and tendon strains, traumatic injuries of the musculoskeletal system, muscle and joint pain due to heavy physical exertion, inflammatory and degenerative joint diseases (osteoarthritis of peripheral joints and spine), rheumatic disorders of the musculoskeletal system (bursitis, arthritis, tenosynovitis, tendinitis).
Contraindications.
- Hypersensitivity to diclofenac or to any other components of the medicinal product.
- History of asthma attacks, urticaria, or acute rhinitis induced by acetylsalicylic acid or other NSAIDs.
- Skin barrier impairment, open wounds at the site of application.
- Third trimester of pregnancy.
- Age under 14 years.
Interaction with other medicinal products and other forms of interaction.
Since systemic absorption of the components of the medicinal product Fanigan® Fast, gel, including diclofenac, after topical application is very low, the likelihood of interactions is extremely small. Nevertheless, possible interactions known for oral forms of diclofenac should be considered.
Although adequate controlled interaction studies have not been conducted, excessive use of topical salicylates may potentially enhance the effect of coumarin anticoagulants and antiplatelet agents. Therefore, caution should be exercised in patients receiving coumarin anticoagulants and antiplatelet agents, including aspirin.
Special precautions for use.
Use with caution when used concomitantly with oral nonsteroidal anti-inflammatory drugs.
The likelihood of developing systemic adverse effects with topical application of diclofenac is low compared to oral forms of diclofenac, but it cannot be excluded when the drug is applied over relatively large areas of skin for prolonged periods.
Do not use FaniGAN® Fast gel with other products containing diclofenac.
The drug should be used with caution in patients with active peptic ulcer of the stomach or duodenum, history of peptic ulcer, impaired liver or kidney function, disorders of blood formation, or nasal mucosal polyposis.
FaniGAN® Fast gel should be applied only to intact skin areas, avoiding application on inflamed, damaged, or infected skin. Contact of the drug with eyes and mucous membranes should be avoided. The product must not be ingested.
Due to the possibility of photosensitivity reactions, exposure to direct sunlight and visits to solariums should be avoided during treatment and for 2 weeks after discontinuation of therapy.
The product contains salicylates, which are aspirin-like substances; therefore, the same precautions recommended for aspirin should be observed.
FaniGAN® Fast gel contains propylene glycol, which may cause skin irritation.
If any skin rash develops, treatment with the drug should be discontinued. Do not apply FaniGAN® Fast gel under airtight occlusive dressings. In case of ligament sprains, the affected area may be bandaged with a bandage.
Use during pregnancy or breastfeeding.
Pregnancy. There are no clinical data on the use of FaniGAN® Fast gel during pregnancy. Although the systemic effect of diclofenac is lower with topical application compared to oral administration, it is unknown whether the systemic exposure to diclofenac achieved after topical use of FaniGAN® Fast gel may be harmful to the embryo/fetus. FaniGAN® Fast gel should not be used during the first and second trimesters of pregnancy unless clearly necessary. If use is required, the dose should be as low as possible and the duration of treatment as short as possible.
During the third trimester of pregnancy, systemic use of prostaglandin synthesis inhibitors, including diclofenac, may cause cardiovascular and renal toxicity in the fetus. At late stages of pregnancy, prolonged bleeding may occur in both mother and child, and labor may be delayed. Therefore, FaniGAN® Fast gel is contraindicated during the third trimester of pregnancy (see section "Contraindications").
Breastfeeding period. If there are strong medical reasons for using FaniGAN® Fast gel during breastfeeding, and the expected benefit outweighs the potential risk, the product should not be applied to the breasts or large areas of skin, and should not be used for prolonged periods (more than 1 week).
Fertility. There are no data on the effect of topically applied diclofenac on human fertility.
Ability to influence reaction speed when driving or operating machinery.
No effect.
Method of Administration and Dosage
For adults and children aged 14 years and older, apply 2–4 g of gel (a 4–8 cm strip) as a thin layer to the skin and gently rub in 2–3 times daily. The average daily dose is 10 g of gel, corresponding to 100 mg of sodium diclofenac. The preparation should be applied to intact skin. Avoid contact with eyes and mucous membranes. Do not apply the gel to open wounds.
After applying the gel, hands should be wiped with a paper towel and then washed, unless the hands themselves are the treated area. If an excessive amount of gel has been applied accidentally, wipe off the excess with a paper towel, which should be disposed of with household waste to prevent water contamination. Wait several minutes after applying the gel before applying a dressing.
The duration of treatment should be determined by a physician according to the nature and course of the disease, as well as the treatment response.
Treatment with this medicinal product should be re-evaluated after 14 days in cases of injuries and soft tissue rheumatism, and after 4 weeks in cases of osteoarthritis.
Elderly patients do not require dose adjustment.
Children.
Contraindicated in children under 14 years of age. If the medicinal product is used in children aged 14 years and older for longer than 7 days, or if disease symptoms worsen, medical advice should be sought.
Overdose.
Overdose is unlikely due to the low systemic absorption of diclofenac following topical application. However, in case of accidental ingestion, note that one 100 g tube of the preparation contains the equivalent of 1 g of sodium diclofenac, which may lead to systemic adverse reactions.
In case of accidental ingestion, the stomach should be emptied immediately and an adsorbent agent administered. Symptomatic treatment should be provided, applying therapeutic measures used for poisoning with nonsteroidal anti-inflammatory drugs.
Adverse reactions.
Immune system disorders: hypersensitivity reactions (including urticaria), angioneurotic edema.
Respiratory system disorders: bronchial asthma, bronchospasm, dyspnea.
Skin and subcutaneous tissue disorders: at the application site, irritation, desquamation, skin swelling, rash (including pustular), eczema, erythema, dermatitis (including contact, bullous), pruritus, photosensitivity reactions, burning or stinging sensation, dryness of skin, skin discoloration.
If adverse reactions occur, treatment should be discontinued and medical advice should be sought.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.
Shelf life. 2 years.
Storage conditions.
Store at a temperature not exceeding 25 °C in the original packaging.
Do not freeze.
Keep out of reach and sight of children.
Packaging.
30 g or 100 g in a tube. One tube per cardboard pack.
Supply category.
Over-the-counter (without prescription).
Manufacturer.
LLC "GLEDFARM LTD".
Manufacturer's address and place of business.
54 Davydovskoho Hryhoriia Street, Sumy, Sumy Oblast, 40020, Ukraine.