Dicloran Plus, gel 30 g

Dicloran Plus – anti-inflammatory topical, analgesic.

Pharmacodynamics

NSAIDs for external use. It has topical analgesic, anti-inflammatory and anti-exudative effects. Diclofenac sodium and methyl salicylate are NSAIDs, whose mechanism of action is due to inhibition of GH synthesis. When applied topically, they reduce pain and inflammation in the joints, morning stiffness and joint swelling, and increase range of motion.

The main component of flax oil is α-linolenic acid which also has anti-inflammatory effects.

Levomenthol irritates the nerve endings, has a local distracting and mild analgesic effect, and causes a feeling of coolness in the area where it is applied.

Pharmacokinetics

When applied topically, diclofenac sodium, methyl salicylate and linseed oil are absorbed and penetrate into the subcutaneous tissue, muscle tissue and joint capsule.

Indications

diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis of peripheral joints and spine, osteochondrosis with radicular syndrome, radiculitis);
rheumatic lesions of soft tissues (tenosynovitis, bursitis);
muscle pain of rheumatic and non-rheumatic origin (including those caused by excessive physical exertion);
post-traumatic inflammation of soft tissues and joints (due to sprains, strains and bruises).

Pharmacological effect

Dicloran Plus is a local anti-inflammatory, analgesic.

Pharmacodynamics

NSAIDs for external use. It has a local analgesic, anti-inflammatory and anti-exudative effect. Diclofenac sodium and methyl salicylate are NSAIDs whose mechanism of action is due to the suppression of PG synthesis. When applied topically, they reduce pain and inflammation in the joints, morning stiffness and swelling of the joints, and help increase range of motion.

The main component of flaxseed oil is α-linolenic acid, which also has an anti-inflammatory effect.

Levomenthol causes irritation of nerve endings, has a local distracting and mild analgesic effect, and causes a feeling of coolness at the site of application of the drug.

Pharmacokinetics

When applied topically, diclofenac sodium, methyl salicylate and flaxseed oil are absorbed and penetrate into the subcutaneous tissue, muscle tissue and joint capsule.

Special instructions

The drug should be applied only to intact skin, avoiding contact with open wounds. Dicloran Plus should not be used under an occlusive dressing.

The drug should not come into contact with the eyes and mucous membranes.

Active ingredient

Diclofenac, Levomenthol, Methyl salicylate

Composition

Active ingredients:

diclofenac diethylamine 11.61 mg;

levomenthol 50 mg;

methyl salicylate 100 mg;

Excipients:

butylated hydroxyanisole – 0.2 mg;

butylated hydroxytoluene – 2 mg;

benzyl alcohol – 10 µl;

disodium edetate – 1 mg;

diethylamine – 7.1 µl;

carbomer 980 – 10.8 mg;

citric acid monohydrate – 1 mg;

macrogol glyceryl hydroxystearate (Cremophor RH-40) – 35 mg;

propylene glycol – 100 mg;

water – sk. required up to 1 g

Pregnancy

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 Dicloran® Plus during lactation, the use of the drug during this period is contraindicated.

Contraindications

Hypersensitivity to diclofenac, methyl salicylate or other components included in the drug; complete or incomplete combination of bronchial asthma, recurrent polyposis of the nasal mucosa and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including a history);
pregnancy (III trimester);
lactation period (breastfeeding);
children’s age (up to 6 years);
violation of the integrity of the skin.

With caution: the drug should be prescribed for severe impairment of liver and kidney function, bronchial asthma, in the first and second trimesters of pregnancy, and in elderly patients.

Side Effects

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

Systemic reactions: generalized skin rash, allergic reactions (urticaria, angioedema, bronchospastic reactions).

Interaction

Diclofenac may enhance the effect of drugs that cause photosensitivity.

Clinically significant interactions with other drugs have not been described.

Overdose

Symptoms: when used externally in recommended doses, the extremely low systemic absorption of the active components of the drug makes overdose almost impossible. In case of accidental ingestion, systemic side effects may develop.

Treatment if ingested: gastric lavage, induction of vomiting, administration of activated charcoal, forced diuresis, symptomatic therapy. Dialysis is ineffective due to the high degree of binding of diclofenac to plasma proteins (about 99%).

Storage conditions

At a temperature not exceeding 30 °C (do not freeze).

Shelf life

3 years

Manufacturer

Unique Pharmaceutical Laboratories, India