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Dosage form: & nbspgel for external use
Composition:

For 1 g of gel:

Active substances:


Diclofenac diethylamine

11.61 mg

which is equivalent to diclofenac sodium

10.0 mg

Flax seed oil

30.0 mg

Levomenthol


Methylsalicylate

100.0 mg

Excipients:


Butylhydroxyanisole

0.20 mg

Butylhydroxytoluene

2.0 mg

Benzyl alcohol

10.0 μl

Cyanatium Edetate

1.0 mg

Cytethylamine


Carbomer 980


Citric acid monohydrate

1.0 mg

Macrogol glycerol hydroxy stearate


(Cremophora RH-40)

35.0 mg

Lropilen glycol


Water

Sk. demand. up to 1.0 gr

Pharmacotherapeutic group:NSAIDs
ATX: & nbsp
  • Other drugs
  • Pharmacodynamics:

    Non-steroidal anti-inflammatory drug (NSAID) for external use. Has a local analgesic, anti-inflammatory and anti-exsudative action.

    Diclofenac sodium and methyl salicylate - NSAIDs, the mechanism of action of which 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.

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

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

    Pharmacokinetics:With topical application diclofenac sodium, methyl salicylate and linseed oil are absorbed and penetrate into the subcutaneous tissue, muscle tissue and articular capsule.
    Indications:

    - Diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis peripheral joints and spine, osteochondrosis with radicular syndrome, radiculitis);

    - rheumatic affections of soft tissues (tendovaginitis, bursitis);

    - muscular pain of rheumatic and non-rheumatic origin (caused, including excessive physical exertion);

    - posttraumatic inflammation of soft tissues and joints (due to stretching, overstrain and bruises).

    Contraindications:

    Hypersensitivity to diclofenac, methyl salicylate or other components included in the preparation, complete or incomplete combination of bronchial asthma, recurrent polyposis of the nasal mucosa and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including in the anamnesis), pregnancy (III trimester), lactation period (breastfeeding), children's age (up to 6 years), violation of the integrity of the skin.

    Carefully:

    With severe violations of the liver and kidney function, bronchial asthma, in the I and II trimester of pregnancy, elderly patients.

    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 DICLORANA® PLUS during lactation, the use of the drug in this period is not recommended.

    Dosing and Administration:

    Outwardly.

    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 - 2-4 g (4-8 cm with a fully open neck of the tube).

    Children from 6 to 12 years old apply not more than 2 times a day, a single dose of the drug to 2 g. The duration of treatment without consulting a doctor should not exceed 10 days.

    The doctor decides whether to prolong the use of the drug individually.

    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, allergic reactions (urticaria, 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. With accidental ingestion, it is possible to develop systemic side effects.

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

    Diclofenac can enhance the effect of drugs that cause photosensitivity, clinically meaningful interaction with other drugs is not described.

    Special instructions:

    For external use only.

    DIKLORAN® PLUS should only be applied to intact skin, avoiding contact with open wounds. After applying the gel, do not apply an occlusive bandage. With prolonged application to open surfaces, it is possible to develop systemic side effects due to resorptive action.Do not allow the drug to enter the eyes and mucous membranes.

    If the medicine has become unusable or the expiration date has expired, do not throw it into sewage or into the street! Place the drug in a bag and put it in the trash. These measures will help protect the environment.

    Effect on the ability to drive transp. cf. and fur:

    The drug does not affect the ability to drive and maintain moving mechanical equipment.

    Form release / dosage:Gel for external use.
    Packaging:
    • tubes, aluminum (1) / ~ / - packs, cardboard
    • plastic tubes (1) / ~ / - packs, cardboard
    Storage conditions:

    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 after the expiration date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N012077 / 01
    Date of registration:16.09.2011 / 14.01.2013
    The owner of the registration certificate:Johnson & Johnson, LLC Johnson & Johnson, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspJohnson & Johnson LLC Johnson & Johnson LLC Russia
    Information update date: & nbsp05.03.2016
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