Indomethacin Sopharma - instructions for use, dose, side effects, contraindications

Excipients: lanolin 17.50 g, petrolatum 52.45 g, dimethylsulfoxide 15.00 g, beeswax yellow 2.00 g, silicon dioxide colloid 3.00 g, lavender oil 0.05 g

Description:

Yellow homogeneous ointment with a specific odor.

Pharmacotherapeutic group:NSAIDs

ATX: & nbsp

C.01.E.B.03 Indomethacin

S.01.B.C.01 Indomethacin

M.02.A.A.23 Indomethacin

Pharmacodynamics:

Has anti-inflammatory, analgesic, decongesting effect associated with nonselective inhibition of cyclooxygenase-1 (COX1) and cyclooxygenase-2 (COX2), regulating the synthesis of anti-inflammatory prostaglandins. Eliminates pain, reduces swelling, erythema, morning stiffness and swelling of the joints, contributes to an increase in the volume of movements.

Pharmacokinetics:

Absorbed through the skin, accumulates in the underlying tissues, in joints and in synovial fluid in therapeutic concentrations.

It is excreted by the kidneys in the form of metabolites and in a small amount in unchanged form, and also partially through the gastrointestinal tract (GIT).

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, etc.) with osteoarthritis.

- 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, lesions of periarticular tissues, wrist syndrome).

- Inflammatory diseases of the musculoskeletal system. 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 indomethacin and other components of the drug, bronchial asthma, rhinitis, urticaria and angioedema, arising after the use of a nonsteroidal anti-inflammatory drug, pregnancy and lactation period, children under 14 years old, skin damage at the site of application.

Carefully:Allergic diseases and reactions, with a violation of the liver and kidneys (in case of application to large areas of the skin surface), erosive and ulcerative lesions of the gastrointestinal tract, impaired blood clotting (incl.hemophilia, prolonged bleeding time, bleeding tendency), concomitant use of NSAIDs, hepatic porphyria (exacerbation), complete or partial combination of asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including history) , elderly age.

Dosing and Administration:

Outwardly.

Ointment rubbed lightly, with a thin layer of skin on the painful area of the body of 4-5 cm 3-4 times a day (for adults) or 2-2.5 cm 2-3 times a day (for children older than 14 years).

The interval between application of the ointment should be at least 6 hours. The course of treatment is 7-10 days.

The total amount of ointment for adults per day should not exceed 15 cm, squeezed out of the tube, for children over 14 years - 7.5 cm.

Side effects:

Sometimes itching and hyperemia of the skin, burning, rashes, peeling, dry skin can occur.

Rarely develops local edema and vesicular rash, and in some cases - angioedema and dyspnea.

When applied to a large area of the skin may occur systemic reactions, mostly gastrointestinal disorders (anorexia, nausea, vomiting, diarrhea, abdominal pain,bleeding and ulcerations).

In isolated cases - exacerbation of psoriasis.

Dimethyl sulfoxide can be irritating to the skin.

Lanolin can cause local skin reactions (eg, contact dermatitis).

Overdose:

Overdose phenomena (mainly from the gastrointestinal tract) can be observed very rarely only with prolonged use on a large area of the skin surface.

If unintentional ingestion is observed burning in the mucous membrane of the mouth, salivation, nausea, vomiting.

Treatment for oral administration: washing of the mouth and stomach, if necessary, symptomatic treatment.

Interaction:

Not observed with topical application.

Special instructions:

The drug should be applied only to intact and uninfected areas of the skin.

Do not allow to enter eyes, mouth, mucous membranes or open wounds, in this case there is local irritation - lacrimation, redness, burning, pain (treatment - abundant washing of the affected area with running water or 0.9% solution of sodium chloride until the complaints decrease or disappear).

When rashes appear, treatment should be stopped immediately.

With prolonged treatment (more than 10 days) it is recommended to conduct a laboratory control of white blood cells and platelets.

The effectiveness and safety of the drug for children under 14 years is not established.

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

There is no evidence of impairment of the ability to drive a car and engage in other potentially hazardous activities requiring rapidity of psychomotor reactions and increased concentration of attention.

Form release / dosage:

Ointment for external use, 10%.

Packaging:

40 g of ointment in aluminum tubes.

Each tube together with the instruction for use is placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children!

Shelf life:

3 years.

Shelf life after first opening of tuba: 6 months.

Do not use after the expiry date printed on the package!

Terms of leave from pharmacies:Without recipe

Registration number:П N011473 / 01

Date of registration:27.01.2010 / 09.11.2016

Expiration Date:Unlimited

The owner of the registration certificate:Sopharma, AOSopharma, AO Bulgaria

Manufacturer: & nbsp

SOPHARMA, AD Bulgaria

Representation: & nbspSOFARMA SA SOFARMA SA Bulgaria

Information update date: & nbsp31.10.2017

Illustrated instructions

Instructions

Indomethacin Sopharma (Indometacin Sopharma)