Instructions Fanigan Fast gel tube 30 g
Composition
active ingredients: 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.
Dosage form
Gel.
Main physicochemical properties: homogeneous white gel with a characteristic odor.
Pharmacotherapeutic group
Topical agents for joint and muscle pain. Nonsteroidal anti-inflammatory drugs for topical use. Diclofenac.
ATX code M02A A.
Pharmacological properties
Pharmacodynamics
The effect of FaniganÒ Fast gel is due to the components that make up its composition.
Diclofenac is a nonsteroidal anti-inflammatory drug with pronounced antirheumatic, analgesic, anti-inflammatory and antipyretic effects. The main mechanism of action is the inhibition of prostaglandin biosynthesis.
In inflammation caused by injuries or rheumatic diseases, the use of diclofenac leads to a reduction in pain, tissue swelling, and a reduction in the period of restoration of functions of damaged joints, ligaments, tendons, and muscles.
Menthol causes irritation of cold receptors. This is accompanied by narrowing and decreased permeability of capillaries at the site of its application, a feeling of coolness. Menthol causes a local distracting and moderately pronounced analgesic effect.
Methyl salicylate is a derivative of salicylic acid and causes a local irritant effect. By irritating skin receptors, methyl salicylate leads to the creation and release into the blood of a large number of biologically active substances that regulate pain sensitivity. Substance P is released from neurons. Reducing the accumulation of substance P in nerve endings leads to a decrease in pain. In addition, methyl salicylate, which belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs), inhibits the synthesis of prostaglandins due to the inhibition of cyclooxygenases, which reduces swelling and infiltration of inflamed tissues.
Flaxseed oil, the main component of which is a-linolenic acid (ethyl ester of unsaturated fatty acid), has an anti-inflammatory effect, antioxidant properties, and improves blood circulation at the site of application.
Pharmacokinetics
The effect of FaniganÒ Fast gel begins a few minutes after application to the skin. After 20-30 minutes, the effect of the gel reaches its maximum. The disappearance of the main clinical symptoms is usually observed within the first days of treatment.
When applied topically, less than 5% of the dose is absorbed, so the systemic effect of the drug is minimal.
Indication
Local treatment of myositis, fibrositis, sciatica, muscle and tendon strains, traumatic injuries of the musculoskeletal system, pain in muscles and joints during heavy physical exertion, inflammatory and degenerative joint diseases (osteoarthritis of peripheral joints and spine), rheumatic lesions of the musculoskeletal system (bursitis, arthritis, tendosynovitis, tendonitis).
Contraindication
- Hypersensitivity to diclofenac or to other components of the drug.
- History of attacks of bronchial asthma, urticaria or acute rhinitis caused by taking acetylsalicylic acid or other NSAIDs.
- Damage to the epidermis, open wounds in the area of application.
- Last trimester of pregnancy.
Interaction with other medicinal products and other types of interactions
Since systemic absorption following topical administration is very low, the likelihood of interactions is very low. However, the possible interactions known for oral forms of diclofenac should be taken into account.
Application features
Use with caution concomitantly with oral nonsteroidal anti-inflammatory drugs.
The likelihood of developing systemic side effects with topical application of diclofenac is insignificant compared to the use of its oral forms, but it cannot be ruled out when the drug is used on relatively large areas of skin for a long time.
Do not use FaniganÒ Fast Gel with other products containing diclofenac.
The drug should be used with caution in cases of peptic ulcer of the stomach and duodenum in the acute stage and in a history of it, impaired liver/kidney function, impaired hematopoiesis, polyposis of the nasal mucosa.
FaniganÒ Fast Gel is recommended to be applied only to intact skin, avoiding contact with inflamed, injured or infected skin. Avoid contact with eyes and mucous membranes. Do not swallow the product.
FaniganÒ Fast Gel contains propylene glycol, which may cause mild localized skin irritation in some patients.
If any skin rash appears, treatment with the drug should be discontinued. FaniganÒ Fast Gel should not be used under an airtight occlusive dressing. In case of ligament sprain, the affected area can be bandaged.
Use during pregnancy or breastfeeding
Clinical experience in pregnant women is limited, therefore, the use of this drug is not recommended during pregnancy or breastfeeding. FaniganÒ Fast Gel is contraindicated during the third trimester of pregnancy due to the possibility of developing weakness of labor and/or premature closure of the ductus arteriosus.
If there are good reasons to use FaniganÒ Fast Gel during breastfeeding, when the expected benefit of the drug in the opinion of the doctor outweighs the potential risk, the drug should not be applied to the mammary glands or large areas of skin and should not be used for a long time (more than 1 week).
Ability to influence reaction speed when driving vehicles or other mechanisms
It doesn't pour.
Method of administration and doses
Adults and children over 14 years of age: apply 2-4 g of gel (a strip of 4-8 cm) in a thin layer to the skin and rub in gently 2-3 times a day. The average daily dose is 10 g of gel, which corresponds to 100 mg of diclofenac sodium. The drug should be applied to intact skin, avoiding contact with eyes and mucous membranes. The gel should not be applied to open wounds.
After applying the drug, hands should be washed, except when this is the area to be treated.
The duration of treatment is determined by the doctor depending on the nature and course of the disease, and the effectiveness of the treatment.
The gel should not be used for more than 14 days for soft tissue injuries and rheumatism or for more than 21 days for arthritis pain, unless otherwise recommended by a doctor.
Elderly patients do not require dose adjustment.
Children
Contraindicated in children under 14 years of age. When using the drug in children over 14 years of age for more than 7 days or if the symptoms of the disease worsen, you should seek medical advice.
Overdose
Overdose is unlikely due to the low absorption of diclofenac into the systemic bloodstream when applied topically.
In case of accidental ingestion, it should be noted that 1 tube of the drug of 100 g contains the equivalent of 1 g of diclofenac sodium; in this case, the development of systemic adverse reactions is possible.
In case of accidental ingestion, the stomach should be emptied immediately and an adsorbent should be taken. Symptomatic treatment is indicated using therapeutic measures used for the treatment of poisoning with nonsteroidal anti-inflammatory drugs.
Adverse reactions
FaniganÒ Fast Gel is generally well tolerated. Adverse reactions include mild, transient skin reactions at the application site.
Immune system disorders: hypersensitivity reactions (including urticaria), angioedema.
From the respiratory system: bronchial asthma, bronchospasm, shortness of breath.
Skin and connective tissue disorders: irritation, rash (including pustular), eczema, erythema, dermatitis (including contact, bullous), itching, photosensitivity reactions, burning or tingling sensation of the skin, dry skin.
Expiration date
2 years.
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging. Do not freeze. Keep out of the reach of children.
Packaging
30 or 100 g in a tube and in a cardboard box.
Vacation category
Without a prescription.
Producer
KUSUM HEALTHCARE PVT. LTD.
Location of the manufacturer and its business address
SP 289 (A), RIICO Indl. Area, Chopanki, Bhiwadi (Raj.), India
