Diclofenac - instructions for use, dose, side effects, contraindications

Excipients: isopropanol 45.00 g, macrogol 7 glyceryl cocoate 6.00 g, hypromellose 4tys (in terms of dry matter) 3.00 g, pine needles, oil 0.15 g, lavender oil 0.05 g, water - up to 100.00 g.

Description:

Colorless or with a weak yellowish tinge transparent gel with a characteristic odor.

Pharmacotherapeutic group:NSAIDs

ATX: & nbsp

S.01.B.C.03 Diclofenac

M.01.A.B.05 Diclofenac

Pharmacodynamics:

Active component - diclofenac - non-steroidal anti-inflammatory drug, which has pronounced analgesic and anti-inflammatory properties. Indiscriminately inhibiting cyclooxygenase type 1 and 2, disrupts the metabolism of arachidonic acid and the synthesis of prostaglandins, which are the main link in the development of inflammation.

With rheumatic diseases reduces swelling, flushing and pain in rest and motion, morning stiffness and swelling of the joints, improving their functional capacity.

With postoperative and traumatic injuries quickly suppresses pain and inflammation in the area of application, promotes resorption of post-traumatic hematoma.

Pharmacokinetics:

With external application diclofenac well penetrates through the skin, mainly concentrating in the focus of inflammation and synovial fluid. The amount of diclofenac that is absorbed through the skin, in proportion to the time of contact of the gel with the skin and the area of application, depends on the total dose of the drug and on the degree of hydration of the skin. With the recommended method of applying the drug, no more than 6% of diclofenac is absorbed. The use of an occlusive dressing for 10 hours leads to a 3-fold increase in the resorption of diclofenac.

Indications:

- Inflammatory diseases of the musculoskeletal system;

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

- degenerative diseases of the musculoskeletal system (deforming osteoarthritis, osteochondrosis);

- post-traumatic inflammation of tendons, ligaments, muscles and joints (as a result of damage, with strain and bruises);

- pain syndrome and puffiness associated with diseases of muscles and joints (lumbago, sciatica, neuralgia, myalgia, tendonitis).

It is intended for symptomatic therapy, reducing pain and inflammation at the time of use, the progression of the disease is not affected.

Contraindications:

Hypersensitivity to diclofenac and other components of the drug.

Complete or incomplete combination of bronchial asthma, angioedema or urticaria, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including in the anamnesis).

Pregnancy (III trimester), the period of breastfeeding, children's age (up to 12 years).

Violation of the integrity of the skin in the intended site of application.

Carefully:

Hepatic porphyria (exacerbation), erosive-ulcerative lesions gastrointestinal tract in the anamnesis (including peptic ulcer and duodenal ulcers), severe violations of the liver and kidney function, chronic heart failure, blood clotting disorders (incl.haemophilia, prolonged bleeding time, a tendency to bleed), bronchial asthma, elderly age, pregnancy I and II trimester.

Pregnancy and lactation:

The drug should not be used in the III trimester of pregnancy. Experience with the drug during breastfeeding is not available. Use in I and II trimesters is possible only after consulting a doctor if the expected benefit to the mother exceeds the potential risk to the fetus.

Dosing and Administration:

Outwardly.

Adults and children over 12 years of age The drug is applied to the skin 2-3 times a day, at a dose of 2 g (about 4 cm with the tube open completely open). Apply a thin layer on the skin above the focus of inflammation and lightly rub.

Single dose of the drug - 2 g.

The maximum daily dose of the gel should not exceed 6 g.

The course of treatment is no more than 14 days. The need for a longer use of the drug is determined by the doctor.

If the hands are not a zone of pain localization, then after applying the gel, they must be washed.

Apply in minimally effective doses a minimally short course.

Side effects:

The adverse events presented below are listed according to anatomophysiological classification and frequency of occurrence.

The frequency of occurrence is determined by WHO and has the following gradation: very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10000, <1/1000); very rarely (<1/10000); not installed.

Local Reactions: infrequently - multiforme exudative erythema (including Stevens-Johnson syndrome), eczema; rarely bullous dermatitis; very rarely - contact dermatitis (itching, hyperemia, swelling of the treated area of the skin, papular-vesicular rashes, peeling).

When applying the gel on large surfaces of the skin, during a long period of time, it is possible to develop systemic side effects of diclofenac.

Systemic reactions: rarely - generalized skin rash, allergic reactions (hives, angioedema, bronchospastic reactions), rarely photosensitization, very rarely anaphylactic reactions (including shock).

If you experience any side effects, including those not listed in the instructions, you should stop using the drug and consult a doctor.

Overdose:

Due to low systemic absorption when applying gel, an overdose is unlikely. With accidental ingestion, it is possible to develop systemic adverse reactions.

Symptoms: nausea and vomiting.

Treatment: gastric lavage, induction of vomiting, Activated carbon, symptomatic therapy.

Hemodialysis and forced diuresis are ineffective due to the high degree of binding to diclofenac proteins (about 99%).

Interaction:

It is not recommended to use the drug with other nonsteroidal anti-inflammatory drugs.

Diclofenac can enhance the effect of drugs that cause photosensitivity.

Clinically significant interaction with other drugs has not been described.

Special instructions:

Apply only externally.

The gel can only be applied to undamaged skin. After applying the gel, do not apply an occlusive bandage.

Before use, patients with gastric ulcer and duodenal ulcer, liver, kidney, or hematopoiesis, as well as other non-steroidal anti-inflammatory drugs, should consult with a physician.

When using the drug in conjunction with other dosage forms of diclofenac should take into account the maximum daily dose.

With prolonged use and / or application on extensive surfaces, it is possible to develop systemic side effects due to resorptive action.

Avoid contact with eyes, mucous membranes or open wounds. If you accidentally get the gel in the eyes, on the mucous membranes or sensitive areas of the skin, wash them with plenty of water.

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

The drug has no effect on the ability to carry out potentially dangerous activities requiring increased concentration of attention and speed of psychomotor reactions (vehicle management, work with moving mechanisms, dispatcher, operator).

Form release / dosage:Gel for external use, 5%.

Packaging:

By 25, 30, 40, 50, 60 g in the tubes are aluminum.

Each tube, together with the instruction for use, is placed in a cardboard package (bundle).

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-003967

Date of registration:16.11.2016

Expiration Date:16.11.2021

The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia

Manufacturer: & nbsp

OZONE, LLC Russia

Representation: & nbspOZONE LLC OZONE LLC Russia

Information update date: & nbsp13.12.2016

Illustrated instructions

Instructions

Diclofenac (Diclofenac)