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

Excipients: carbomer 940 (carbopol 980) 2.5 g, methyl parahydroxybenzoate (nipagin) 0.1 g, trometamol 1.7 g, lavender oil 0.1 g, polyester PE 240 5.0 g, ethyl alcohol 95% (ethanol) 40.0 g, water Purified 48.1 g.

Description:

Colorless or yellowish tinge, almost transparent gel with a specific odor. Opalescence is allowed.

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

ATX: & nbsp

M.02.A.A.10 Ketoprofen

Pharmacodynamics:

The mechanism of action of the drug is associated with the inhibition of the synthesis of prostaglandins.

Has a local anti-inflammatory, antiexudative and analgesic effect in the treatment of joints, tendons, ligaments, muscles, skin, veins, lymphatic vessels and lymph nodes. With articular syndrome, weakening of pain in rest and movement, decrease in morning stiffness and swelling of the joints.

Pharmacokinetics:With topical application in the form of a gel, it is absorbed extremely slowly and practically does not accumulate in the body.Bioavailability of the gel - about 5%. After application in a dose of 50-150 mg concentration in the blood plasma after 5-8 hours reaches 0.08-0.15 μg / ml.

Indications:

- Diseases of the musculoskeletal system (articular syndrome with exacerbation of gout, rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, osteochondrosis with radicular syndrome, sciatica, inflammatory lesions of ligaments, tendons, lumbago, bursitis, sciatica, psoriatic arthritis);

- muscular pain of rheumatic and non-rheumatic origin;

- injuries of the musculoskeletal system (including sports), post-traumatic inflammation of soft tissues.

Contraindications:

- Hypersensitivity to ketoprofen, acetylsalicylic acid or other NSAIDs (indication in the anamnesis of bronchospasm, urticaria, rhinitis caused by acetylsalicylic acid intake);

- wetting dermatoses, eczema, infected abrasions, wounds;

- children's age (up to 6 years);

- pregnancy III trimester, lactation.

Carefully:

Erosive-ulcerative lesions of the gastrointestinal tract, pronounced violations of kidney and liver function, hepatic porphyria; chronic heart failure, bronchial asthma, pregnancy I-II term, children's age.

Dosing and Administration:

Outwardly.

A small amount of gel (3-5 cm) is applied 2-3 times a day with a thin layer and lightly rubbed.

Children from 6 to 12 years - up to 3 cm not more than 2 times a day.

The duration of the course of treatment without consulting a doctor should not exceed 14 days.

Side effects:

Local Reactions: allergic dermatitis, skin hyperemia, photodermatitis, skin exanthema, bullous dermatitis, purpura, eczema.

Systemic reactions: urticaria, edema, generalized skin rash, photosensitivity, stomatitis.

Overdose:Low systemic absorption of the active component of the drug with external application makes an overdose almost impossible.

In case of accidental ingestion of large amounts of gel (more than 20 g), systemic undesirable reactions characteristic of NSAIDs are possible. It is necessary to wash the stomach, taking activated charcoal.

Interaction:

With external application of ketoprofen in the form of gel, drug interactions are not established.

However, if you are using other medications, you should consult your doctor before using the gel.

Special instructions:

It is necessary to avoid getting the gel on the mucous membranes, in the eyes, open wounds and inflamed skin.

After working with the gel, you should immediately wash your hands.

Do not use with occlusive (airtight) dressings.

With prolonged use of large amounts of the drug, it is impossible to exclude the occurrence of systemic side effects, characteristic for NSAIDs.

Effect on the ability to drive transp. cf. and fur:There is no data on the impact on the ability to drive a car and work with machinery.

Form release / dosage:

Gel for external use 2.5%.

Packaging:

By 30 grams, or 50 grams in an aluminum tube.

Tubu together with instructions for use are placed in a pack of cardboard.

Storage conditions:

In a dry, dark place at a temperature of 15 to 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-000476

Date of registration:01.03.2011 / 16.09.2016

Expiration Date:Unlimited

The owner of the registration certificate:TATHIMFARMPREPARATY, JSC TATHIMFARMPREPARATY, JSC Russia

Manufacturer: & nbsp

TATHIMFARMPREPARATY, JSC Russia

Representation: & nbspTATHIMFARM PREPARATIONS OJSC TATHIMFARM PREPARATIONS OJSC Russia

Information update date: & nbsp05.01.2018

Illustrated instructions

Instructions

Spazgel® (Spazgel®)