Orthofen - instructions for use, doses, side effects, contraindications

Excipients: propylene glycol 50.0 mg; ethanol 95% (ethyl alcohol 95%) - 300.0 mg; Hyethellosis (hydroxyethyl cellulose) 25.0 mg; purified water - up to 1.0 g.

Description:Colorless or with a yellowish tinge transparent gel with a characteristic smell of ethanol. Opalescence and air bubbles are allowed.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID)

ATX: & nbsp

S.01.B.C.03 Diclofenac

M.01.A.B.05 Diclofenac

Pharmacodynamics:

Non-steroidal anti-inflammatory drug for external use. Diclofenac has a pronounced analgesic and anti-inflammatory effect. Indiscriminately inhibiting cyclooxygenase types 1 and 2 (COX-1 and COX-2), disrupts the metabolism of arachidonic acid and the synthesis of prostaglandins, which are the main link in the development of inflammation.

Diclofenac is used to eliminate pain syndrome and reduce puffiness associated with the inflammatory process.

Pharmacokinetics:With external application of the drug, systemic absorption of diclofenac is not more than 6%. The connection with plasma proteins is 99.7%. It is excreted by the kidneys. Diclofenac predominantly distributed and retained deep in tissues prone to inflammation. When applying the drug on the affected joint, the concentration of diclofenac in the synovial fluid is higher than in the blood plasma.

Indications:- Pain in the back with inflammatory and degenerative diseases of the spine (radiculitis, osteoarthrosis, lumbago, sciatica);

- pain in the joints (joints of the fingers, knees and others) with rheumatoid arthritis, osteoarthrosis;

- pain in the muscles (due to stretching, overstrain, bruises, injuries);

- inflammation and puffiness of soft tissues and joints due to injuries and rheumatic diseases (tendovaginitis, bursitis, periarticular tissue lesions, wrist syndrome).

Contraindications:

- Hypersensitivity to diclofenac or other components of the drug, acetylsalicylic acid or other NSAIDs;

- propensity to occurrence of attacks of bronchial asthma, skin rashes or acute rhinitis with the use of acetylsalicylic acid or other NSAIDs;

- pregnancy (III trimester);

- the period of breastfeeding;

- children's age till 12 years;

- violation of the integrity of the skin in the intended site of application.

Carefully:Hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe impairment of liver and kidney function, chronic heart failure, blood clotting disorders (including hemophilia, prolonged bleeding time, a tendency to bleeding), advanced age, bronchial asthma, pregnancy (I and II trimester).

Pregnancy and lactation:

The use of the drug during the first and second trimester of pregnancy is recommended only for the appointment of a doctor, comparing the benefits to the mother and the risk to the fetus.

The drug is contraindicated in the third trimester of pregnancy in connection with the possibility of lowering the tone of the uterus and / or premature closure of the arterial duct of the fetus. Due to the lack of data on the penetration of diclofenac into breast milk, the drug is not recommended for use during breastfeeding. If nevertheless it is necessary to use the drug, it should not be applied to the mammary glands or to a large surface of the skin and not to be used for a long time.

Dosing and Administration:

For external use only.

Adults and children over the age of 12 lay the drug 2 times a day (every 12 hours, preferably in the morning and in the evening), lightly rubbing into the skin.

The required amount of the drug depends on the size of the painful area. A single dose of the drug - up to 2 g (about 4 cm with a fully open neck of the tube). If the hands are not a zone of pain localization, then after applying the drug, they must be washed.

The duration of treatment depends on the indications and the effect observed. The drug should not be used for more than 14 days with post-traumatic inflammations and rheumatic diseases of soft tissues without a doctor's recommendation. If after 7 days of application the therapeutic effect is not observed or the condition worsens, you should consult a doctor.

Side effects:

Classification of the incidence of adverse events according to the recommendations of the World Health Organization (WHO):

very often> 1/10;

often from> 1/100 to <1/10;

infrequently from> 1/1000 to <1/100;

rarely from> 1/10000 to <1/1000;

very rarely <1/10000, including individual messages;

the frequency is unknown - it is not possible to establish the frequency of occurrence from the available data.

From the immune system:

very rarely - generalized skin rash, allergic reactions (hives, hypersensitivity: angioedema).

From the respiratory and thoracic and mediastinal organs:

very rarely - attacks of suffocation, bronchospastic reactions.

From the skin:

often erythema, dermatitis, including contact dermatitis (symptoms: eczema, itching, swelling of the treated area of the skin, rash, papules, vesicles, peeling); rarely bullous dermatitis;

very rarely - the reaction of photosensitization, pustular eruptions.

Overdose:

Symptoms

Due to low systemic absorption in external applications, an overdose is unlikely. With accidental ingestion, it is possible to develop systemic adverse reactions.

Treatment

In case of accidental ingestion - gastric lavage (only within an hour after a random intake), induction of vomiting, reception of activated charcoal, symptomatic therapy. Dialysis and forced diuresis are not effective 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 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. Do not allow the drug to enter the horn, eyes and mucous membranes. After applying the drug, a bandage bandage is allowed, but no airtight occlusive dressings should be applied. Avoid excessive exposure to sunlight on the area of application. With prolonged use (more than 14 days) and / or application of the drug on large surfaces, it is possible to develop systemic side effects due to resorptive action.

If side effects occur, discontinue use and consult a doctor.

Effect on the ability to drive transp. cf. and fur:Does not affect.

Form release / dosage:

Gel for external use 5%.

Packaging:

30 g or 50 g in an aluminum tube.

One tube together with instructions for use in a pack of cardboard.

Storage conditions:Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Shelf life:

2 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002228

Date of registration:16.09.2013 / 17.08.2015

Expiration Date:16.09.2018

Date of cancellation:2018-09-16

The owner of the registration certificate:VERTEKS, AO VERTEKS, AO Russia

Manufacturer: & nbsp

VERTEKS, AO Russia

Information update date: & nbsp12.06.2017

Illustrated instructions

Instructions

Orthophene (Ortophen)