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

Auxiliaries: menthol (levomenthol), cetostearyl alcohol (Lanette N, emulsifier), 2-octyldodecanol (Eutanol G), glycerol, ethanol, paraffin liquid, nipagine (p-methylhydroxybenzoate), nipase (p-propylhydroxybenzoate), purified water.

Description:Homogeneous mass from white to white with a yellowish tint of color, with a smell of menthol.

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

ATX: & nbsp

S.01.B.C.03 Diclofenac

M.01.A.B.05 Diclofenac

Pharmacodynamics:

Diclofenacol in a medicinal form cream for external use has a local anti-inflammatory and analgesic effect.

Active component diclofenac - a non-steroidal anti-inflammatory drug with pronounced analgesic and anti-inflammatory properties. Indiscriminately inhibiting cyclooxygenase 1 and 2 types, 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, reduce swelling and hyperemia associated with the inflammatory process. With the recommended method of applying the drug, no more than 6% of diclofenac is absorbed.

The menthol included in the preparation has a local "cooling" effect. With topical application, the drug causes weakening or disappearance of pain at the site of application, including joint pain at rest and during movement, reduces morning stiffness and swelling of the joints. Promotes an increase in the volume of movements.

Indications:

- Diseases of the musculoskeletal system: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis of peripheral joints and spine; rheumatic affections of soft tissues;

- Inflammatory swelling of soft tissues;

- Traumatic injuries of soft tissues - without compromising the integrity of the skin; bruises, sprains, ligaments, muscles and tendons;

- Muscle aches and pains in joints of rheumatic and non-rheumatic origin, including those caused by heavy physical exertion

Contraindications:Hypersensitivity to diclofenac and other components of the drug, acetylsalicylic acid or other NSAIDs; bronchial asthma in combination with polyposis of the nasal mucosa; peptic ulcer of stomach and duodenum in the phase of exacerbation; pregnancy (trimester) and the period of breastfeeding; in children up to 6 years; violation of the integrity of the skin.

Carefully:hepatic porphyria (exacerbation), erosive-ulcerative lesions of the gastrointestinal tract, severe violations of liver and kidney function, chronic heart failure, bronchial asthma, coagulation disorder; elderly age, children under 12 years, pregnancy I and II trimester.

Pregnancy and lactation:The drug should not be used in the III trimester of pregnancy. Experience in the use of diclofenac during lactation is not available. Use in I and II trimesters is possible only after consultation with a doctor.

Dosing and Administration:

OUTSIDE!

Adults and children from the age of 12: a small amount of cream - 2-4 g (4-8 cm) is applied a thin layer on the skin above the inflammation focus and is lightly rubbed to full suction 2-3 times a day. The required amount of the drug depends on the size of the painful area.

Children from 6 to 12 years: use up to 2 g of the drug not more than 2 times a day.The duration of the course of treatment should not exceed 14 days without consulting a doctor.

Side effects:The resulting side effects depend on individual sensitivity, the magnitude of the dose used and the duration of treatment. Local allergic reactions (rash, including Vesicular and papular, itching, burning, redness, contact dermatitis, eczema, photosensitivity, swelling the treated area of the skin, desquamation). With prolonged use of the cream and / or use of large amounts may cause systemic side effects of the respiratory system (bronchospasm, systemic anaphylactic reactions including shock), generalized skin rash, urticaria, angioedema, photosensitivity.

If there are any side effects, stop using the cream and consult a doctor.

Overdose:

Extremely low systemic absorption of active components of the drug with external application makes an overdose almost impossible. It does not exclude the possibility of an accidental overdose of oral route of large doses of the drug. Symptoms:

The clinical picture is determined by violations from the central nervous system (headache, dizziness, increased excitability, hyperventilation with increased convulsive readiness, in children-myoclonic cramps) and gastrointestinal disorders (abdominal pain, nausea, vomiting). There may be bleeding from the gastrointestinal tract and / or impaired liver and / or kidney function. Treatment: symptomatic.

Interaction:

You should consult your doctor before using Diclofenacol if you are under medical supervision or apply other NSAIDs.

Diclofenac can enhance the effect of drugs that cause photosensitivity. Clinically significant interaction with other drugs has not been described.

Special instructions:

Diclofenac should be applied only to intact skin, avoiding contact with open wounds. After applying, do not apply an occlusive dressing. Avoid contact with eyes and mucous membranes.

Before using Diclofenacol, you should consult your doctor if you:

■ peptic ulcer of stomach and duodenum in the anamnesis;

■ impaired liver and kidney function;

■ pronounced disturbances of the hematopoiesis system;

■ bronchial asthma, rhinitis, polyps of the nasal mucosa;

■ allergic reactions in the anamnesis.

Do not use the drug in children under 12 years old without consulting a doctor. Possible manifestation of systemic side effects with prolonged use and / or use of high doses of the drug.

Form release / dosage:

Cream for external use, 1%.

Packaging:

For 20 grams in an aluminum tube with a protective membrane, covered with a lacquer inside, sealed with a screwed plastic lid.

One tube together with instructions for use in a cardboard box.

Storage conditions:In dry, protected from light, out of reach of children at a temperature of 15 to 25 ° C. Do not freeze!

Shelf life:

3 years. Do not use the product after the expiry date indicated on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N012880 / 01

Date of registration:16.01.2009

The owner of the registration certificate:Hiperion S.A.Hiperion S.A. Romania

Manufacturer: & nbsp

HYPERION, S.A. Romania

Representation: & nbspРомфарма ОООРомфарма ООО

Information update date: & nbsp25.02.2016

Illustrated instructions

Instructions

Diclofenacol (Diclofenacol)