Diclogen^® Plus (Gel) Instructions for Use

Marketing Authorization Holder

Agio Pharmaceuticals, Ltd. (India)

ATC Code

M02AX10 (Other drugs)

Active Substances

Methyl salicylate (Ph.Eur.)

Menthol (Ph.Eur.)

Diclofenac (Rec.INN)

Dosage Form

Diclogen® Plus

Gel for external use: tubes 30 g or 50 g

Dosage Form, Packaging, and Composition

Gel for external use from almost white to light yellow, homogeneous, with a characteristic odor.

Excipients: linseed oil (first cold pressed linseed oil) – 30 mg, carbomer 940 – 20 mg, trolamine – 30 mg, propylene glycol – 25 mg, isopropyl alcohol – 25 mg, benzyl alcohol – 10 mg, methylparaben – 2 mg, propylparaben – 2 mg, liquid paraffin (light liquid paraffin) – 20 mg, white soft paraffin – 20 mg, macrogol 40 glyceryl hydroxystearate (polyoxyl 40 hydrogenated castor oil) – 45 mg, purified water – up to 1 g.

30 g – aluminum tubes (1) – cardboard boxes.
50 g – aluminum tubes (1) – cardboard boxes.

Clinical-Pharmacological Group

NSAIDs for external use

Pharmacotherapeutic Group

Topical anti-inflammatory agent

Pharmacological Action

Combined anti-inflammatory drug.

Diclofenac and Methyl salicylate are non-steroidal anti-inflammatory drugs (NSAIDs). They exert local analgesic, anti-inflammatory, and anti-exudative effects. The mechanism of action is due to the suppression of prostaglandin synthesis. When applied topically, they reduce pain and inflammation in the joints, morning stiffness and joint swelling, and help increase the range of motion. Menthol (racemic menthol) causes irritation of nerve endings, exerts a local distracting and mild analgesic effect, and causes a feeling of coolness at the site of application.

Pharmacokinetics

When applied externally, diclofenac and Methyl salicylate are absorbed and penetrate into the subcutaneous tissue, muscle tissue, and joint capsule.

Indications

For the symptomatic therapy of musculoskeletal system diseases

• Rheumatoid arthritis;
• Psoriatic arthritis;
• Ankylosing spondylitis;
• Osteoarthritis of peripheral joints and spine;
• Rheumatic soft tissue lesions;
• Muscle pain of rheumatic and non-rheumatic origin;
• Traumatic soft tissue injuries.

ICD codes

Dosage Regimen

Externally.

Adults and children over 12 years apply the drug in a thin layer over the focus of inflammation 3-4 times a day and rub in gently. The required amount of the drug depends on the size of the painful area. A single dose of the drug is 2-4 g (comparable in volume to the size of a large cherry).

Children from 6 to 12 years use no more than 2 times a day, a single dose of the drug up to 2 g.

After applying the drug, hands must be washed.

The duration of treatment depends on the indications and the observed effect. After 2 weeks of using the drug, a doctor should be consulted.

Adverse Reactions

Local reactions eczema, photosensitivity, contact dermatitis (itching, redness, swelling of the treated skin area, papules, vesicles, peeling).

Systemic reactions generalized skin rash, urticaria, angioedema, bronchospastic reactions.

Contraindications

• History of bronchospasm, rhinitis, urticaria after taking acetylsalicylic acid or another NSAID;
• Pregnancy (III trimester);
• Lactation period;
• Children’s age (under 6 years);
• Violation of the integrity of the skin at the intended site of application;
• Hypersensitivity to diclofenac or other components of the drug, to acetylsalicylic acid or other NSAIDs.

With caution: hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe impairment of liver and kidney function, chronic heart failure, elderly age, bronchial asthma, pregnancy (I and II trimester).

Use in Pregnancy and Lactation

The drug is contraindicated in the third trimester of pregnancy. The issue of using the drug in the first and second trimesters of pregnancy is decided individually. Due to the lack of experience with the use of Diclogen Plus during lactation, the use of the drug during this period is not recommended.

Use in Hepatic Impairment

With caution: hepatic porphyria (exacerbation), severe liver dysfunction.

Use in Renal Impairment

With caution: severe renal impairment.

Pediatric Use

Contraindicated in children under 6 years of age.

Geriatric Use

With caution: elderly age.

Special Precautions

The drug should be applied only to intact skin, avoiding contact with open wounds. After application, an occlusive dressing should not be applied. Avoid getting the drug in the eyes and on mucous membranes.

Overdose

When applied externally in recommended doses, the extremely low systemic absorption of the active components of the drug makes overdose practically impossible.

Drug Interactions

Diclofenac may enhance the effect of drugs that cause photosensitivity. Clinically significant interaction with other drugs has not been described.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.