Dicloran Plus gel for external use, 30g

Composition

Active ingredients:

diclofenac diethylamine 11.61 mg;

levomentol 50 mg;

methyl salicylate 100 mg;

Auxiliary substances:

butylhydroxyanisole — 0.2 mg;

the butylhydroxytoluene 2 mg;

benzyl alcohol 10 µl;

disodium edetate — 1 mg;

diethylamine is 7.1 µl;

karbomer 980 — 10.8 mg;

citric acid monohydrate 1 mg;

macrogol glycerylmonostearate (Cremophor RH-40) — 35 mg;

propylene glycol — 100 mg;

water — SK. req. up to 1 g

Pharmacological action

Dicloran Plus – local anti-inflammatory, analgesic.

Pharmacodynamics

of 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 joint pain and inflammation, morning stiffness and joint swelling, and increase the amount of movement.

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

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

Pharmacokinetics

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

Indications

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

Use during pregnancy and lactation

The drug is contraindicated in the third trimester of pregnancy. The question of using the drug in the first and second trimesters of pregnancy is decided individually.

Due to lack of experience with Dicloran® Plus, during lactation, the use of the drug during this period is contraindicated.

Contraindications

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

With caution:  the drug should be prescribed for severe liver and kidney disorders, bronchial asthma, in the first and second trimesters of pregnancy, and 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 increase the effect of drugs that cause photosensitization.

No clinically significant interactions with other medicinal products have been described.

How to take, course of use and dosage

Externally. For adults and children over 12 years of age, the drug is applied to the skin 3-4 times a day and lightly rubbed. The required amount of the drug depends on the size of the painful area. A single dose of the drug is 2-4 g (4-8 cm with the tube neck fully open). Children from 6 to 12 years of age should be used no more than 2 times a day, a single dose of the drug-up to 2 g.

The duration of treatment without consulting a doctor should not exceed 10 days.

The question of the possibility of longer-term use of the drug is decided by the doctor individually.

Overdose

Symptoms:  when used externally at the recommended doses, the extremely low systemic absorption of the active components of the drug makes overdose almost impossible. If accidentally ingested, systemic side effects may occur.

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

Special instructions

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

Do not allow the drug to get into the eyes and mucous membranes.

Product form

gel for external use

Storage conditions

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

Shelf life

3 years

Active ingredient

Diclofenac

Dosage form

gel for external use

Description

Children over 6 years of age, Pregnant women in the first and second trimester as prescribed by a doctor, For adults

Indications

Rheumatoid Arthritis, Arthritis, Swelling after injuries and operations, Osteoarthritis, Osteoarthritis