Instruction for use: Diclogen plus

Dosage form

Gel for external use

Composition

1 g of gel contains:

Active substances:

Diclofenac diethylamine - 11.6 mg is equivalent to the content of diclofenac sodium - 10 mg.

Methylsalicylate - 100 mg.

Racetenthol 50 mg.

Excipients:

Flax seed seeds oil, carbomer 940, trolamine, propylene glycol, isopropanol, benzyl alcohol, butyl hydroxy anisole, butyl hydroxytoluene, polysorbate-60, hydrogenated castor oil, purified water.

Description of dosage form

Semi-transparent gel from almost white to pale yellow with a characteristic odor.

Pharmacological group

Anti-inflammatory for topical use.

pharmachologic effect

Combined anti-inflammatory drug.

Diclofenac and methyl salicylate are non-steroidal anti-inflammatory drugs (NSAIDs). They have a local analgesic, anti-inflammatory and anti-exsudative effect. The mechanism of action is due to the suppression of the synthesis of prostaglandins. With topical application

reduce pain and inflammation in the joints, morning stiffness and swelling of the joints, contribute to an increase in the volume of movements. Menthol (racementol) causes irritation of nerve endings, has a local distraction and easy analgesic effect, causes a feeling of coolness at the site of application of the drug.

Pharmacokinetics

With external use, diclofenac and methyl salicylate are absorbed and penetrate into the subcutaneous tissue, muscle tissue and the joint capsule.

Indications

For symptomatic therapy of diseases of the musculoskeletal system: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis of peripheral joints and spine, rheumatic soft tissue injuries, muscular pain of rheumatic and non-rheumatic origin, traumatic injuries of soft tissues.

Contraindications

Hypersensitivity to diclofenac or other components of the drug, to acetylsalicylic acid or other NSAIDs, anamnestic data on the attack of bronchial obstruction, rhinitis, urticaria after taking acetylsalicylic acid or other NSAIDs, pregnancy (III trimester), lactation period, children's age (up to 6 years), violation of the integrity of the skin at the site of the intended application.

Carefully

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

Application in pregnancy and lactation

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

Dosing and Administration

Outwardly.

For adults and children over 12 years old the drug is applied a thin layer over the inflammation focus 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 (by volume comparable to the size of a large cherry).

Children from 6 to 12 years of age should not be used more than 2 times a day, a single dose of the drug up to 2 g.

After applying the product, the hands should be washed.

The duration of treatment depends on the indications and the effect observed. After 2 weeks of use, consult a physician.

Side effects

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

Systemic reactions: generalized skin rash, hives, angioedema, bronchospastic reactions.

Overdose

At external application in recommended doses extremely low systemic absorption of active components of a preparation does an overdose practically impossible.

Interaction

Diclofenac can enhance the effect of drugs that cause photosensitivity.

Clinically significant interaction with other drugs has not been described.

special instructions

The drug should be applied only to intact skin, avoiding getting on open wounds.

After applying, do not apply an occlusive dressing.

Do not allow the drug to enter the eyes and mucous membranes.

Form of issue

Gel for external use.

30 g or 50 g of gel in an aluminum tube. 1 tube with instructions for use in a cardboard pack.

Storage conditions

In dry, the dark place at a temperature of no higher than 30 ° C.

Do not freeze.

Keep out of the reach of children.

Shelf life

3 years.

Do not use the product after the date shown on the package.

Conditions of leave from pharmacies

On prescription.