Fanigan Day

Diclofenac sodium.

Each gram of gel contains: Diclofenac sodium BP 50 mg (5% w/w).
Excipients/Inactive Ingredients: Hydroxy propyl methyl cellulose, Galaxy PEG-7 glycerol cocoate, isopropyl alcohol and purified water.

Pharmacotherapeutic group: Anti-inflammatory preparations, non-steroids for topical use. ATC code: M02AA15.
Pharmacology: Pharmacodynamics: Diclofenac sodium is a non-steroidal anti-inflammatory drug (NSAID) which has also analgesic properties. The inhibition of prostaglandin synthesis is considered to be an essential part of its mode of action.
Pharmacokinetics: The achieved systemic concentrations of diclofenac are about 50 times lower than those achieved following oral administration of equivalent amounts of diclofenac. Systemic plasma levels are not supposed to contribute to the efficacy of Diclofenac gel. Diclofenac is extensively bound to plasma proteins (about 99 %). Diclofenac and its metabolites are excreted mainly in the urine.

For the local symptomatic relief of mild to moderate pain and inflammation following acute blunt trauma of small and medium-sized joints and periarticular structures.

Dosage: Adults and adolescents aged 14 years and over: Sufficient amount of Fanigan Day gel is applied onto the skin of the affected site or affected body parts. Depending on the size to be treated (0.8-1.0 g of gel containing 40-50 mg of diclofenac sodium) should be applied 3 times a day at regular intervals. The maximum single dose of 1.0 g of the gel should not be exceeded. The maximum daily dose is up to 3.0 g gel containing 150 mg of diclofenac sodium.
The Fanigan Day gel is massaged gently into the skin. After this the hands should be washed unless they are the site to be treated. The treatment may be discontinued when the symptoms (pain and swelling) have subsided.
Treatment should not be continued beyond 7 days without review. The patient is requested to consult the doctor, if no improvement is seen after 3 days.
Children and adolescents: There are insufficient data on efficacy and safety available for children and adolescents below 14 years. In adolescents aged 14 years and over, if this product is required for more than 7 days for pain relief or if the symptoms worsen the patient/parents of the adolescent is/are advised to consult a doctor.
Elderly: The posology is the same as for adults.
Route of administration: Topical.

The low systemic absorption of topical diclofenac renders overdose very unlikely. However undesirable effects similar to those observed following an overdose of diclofenac tablets can be expected if Diclofenac gel is inadvertently ingested.
In the event of accidental ingestion resulting in significant systemic adverse effects, general therapeutic measures normally adopted to treat poisoning with non-steroidal anti-inflammatory medicines should be used. Gastric decontamination and the use of activated charcoal should be considered, especially within a short time of ingestion.

Hypersensitivity to diclofenac, or to any of the excipients used in this formulation.
Hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs).
During the third trimester of pregnancy.
Application to the breast area of breast-feeding mothers.
Use in children and adolescents less than 14 years is contraindicated.

Diclofenac gel can be used with non-occlusive bandages but should not be used with an airtight occlusive dressing.
Patients should be warned against excessive exposure to sunlight in order to reduce the incidence of photosensitivity. It may cause allergic reactions (possibly delayed). Discontinue the treatment if a skin rash develops after applying the product.
The concomitant use of Diclofenac gel with oral NSAIDs should be cautioned as the incidence of systemic undesirable effects may increase.
Diclofenac gel should only be used with caution in patients with a history of peptic ulcer, hepatic or renal insufficiency or bleeding diathesis or inflammatory bowel disease, as isolated cases with topical diclofenac have been reported.
The gel should not come into contact with or be applied to the mucosa or the eyes.
Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergenic disease or allergy to acetylsalicylic acid or other NSAID. The gel should be used with caution in patients with or without chronic asthma in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other nonsteroidal anti-inflammatory agents.
Effects on Ability to Drive and Use Machines: Patients who experienced dizziness or other central nervous disturbances while taking NSAIDs should refrain from driving or operating machinery but this would be very unlikely using topical preparations such as Diclofenac gel.

Pregnancy: The systemic concentration of diclofenac is lower after topical administration, compared to oral formulations. Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development.
Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. During the first and second trimester of pregnancy, diclofenac should not be given unless clearly necessary. If Diclofenac gel is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.
Lactation: Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at therapeutic doses of Diclofenac gel shows no effects on the suckling child are anticipated. Because of a lack of controlled studies in lactating women, the product should only be used during lactation under advice from a healthcare professional. Under this circumstance, Diclofenac gel should not be applied on the breasts of nursing mothers, nor to elsewhere on large areas of skin or for a prolonged period of time.

Skin disorders are commonly reported. Adverse reactions are ranked under heading of frequency, the most frequent first, using the following convention: very common (1/10); common (1/100 to < 1/10); uncommon (1/1,000 to < 1/100); rare (1/10,000 to < 1/1,000); very rare (< 1/10,000), unknown (can not to be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Immune system disorders: Very rare: Hypersensitivity (including urticaria), angioneurotic oedema.
Infections and Infestations: Very rare: Rash pustular.
Respiratory, thoracic and mediastinal disorders: Very rare: Asthma.
Skin and subcutaneous tissue disorders: Common: Rash, eczema, erythema, dermatitis (including dermatitis contact), pruritus.
Rare: Dermatitis bullous.
Very rare: Photosensitivity reaction.
Not known: Application site reaction, dry skin, burning sensation.
Undesirable effects may be reduced by using the minimum effective dose for the shortest possible duration.
The total single dose of product should not exceed 1.0 g of Diclofenac gel.
Nevertheless during long term treatment (> three weeks) and/or when treating large areas (i.e. more than 600 square centimeter of the body surface) there is a possibility of systemic adverse reactions. Reactions like abdominal pain, dyspepsia, gastric and renal disorders may occur.

Since systemic absorption of diclofenac from a topical application of gel is very low such interactions are very unlikely.
Concurrent acetylsalicylic acid or other NSAIDs may result in an increased incidence of adverse reactions.

Store below 30°C in cool place.
Protect from direct sunlight. Do not freeze.
Shelf-Life: 24 months.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M02AA15 - diclofenac ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.

OTC

Topical gel 5% (transparent, colorless to slightly yellow with alcoholic smell) x 30 g x 1's.