Diclofenac (Diclofenac)

Description

Gel for external use 1% uniform, creamy, white to yellowish.

Release form

Gel for external use

Pharmacological action of

NSAIDs for external use. Diclofenac has a pronounced analgesic and anti-inflammatory and antipyretic effect. Indiscriminately inhibiting COX-1 and COX-2, disrupts the metabolism of arachidonic acid.

Voltaren® Emulgel® is used to eliminate pain and inflammation in joints, muscles and ligaments of a traumatic or rheumatic origin, helping to reduce pain and swelling associated with the inflammatory process, increasing joint mobility.

Thanks to its water-alcohol base, Voltaren® Emulgel® has a calming and cooling effect.

Indications

Back pain in inflammatory and degenerative diseases of the spine (sciatica, osteoarthrosis, lumbago, sciatica)

joint pain (including knee joints of the fingers, knee) with rheumatoid arthritis, osteoarthritis in the muscles (srdlp pain , overstrain, bruises, injuries)

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

Contraindications

Hypersensitivity to diclofenac or other components of the

drug, a tendency to occur attacks of bronchial asthma, skin rashes or acute rhinitis with the use of acetylsalicylic acid or other NSAIDs

violation of the integrity of the skin at the intended site of application

III trimester of pregnancy

lactation (breastfeeding)

children under 12 years of age.

Caution is advised to prescribe the drug for hepatic porphyria (in the acute phase), erosive and ulcerative lesions of the gastrointestinal tract, severe violations of the liver and kidneys, chronic heart failure, bronchial asthma, as well as in the first and second trimesters of pregnancy and elderly patients.

Use during pregnancy and lactation

Due to the lack of data on the use of the drug VoltarenВ® EmulgelВ® during pregnancy, use of the drug in the first and second trimesters of pregnancy is recommended only as directed by a doctor, comparing the benefits for the mother and the risk for the fetus.

The drug is contraindicated in the III trimester of pregnancy due to the possibility of lowering the tone of the uterus, impaired renal function of the fetus, followed by the development of oligohydramnios and / or premature closure of the arterial duct of the fetus.

Due to the lack of data on the release of the active substance of VoltarenВ® EmulgelВ® with breast milk, the drug is not recommended for use during breastfeeding. If you still need to use the drug, then it should not be applied to the mammary glands or to a large surface of the skin and should not be used for a long time.

There are no data on the effect of the drug on fertility.

Composition of

100 g of gel diethlamine contains: dildofl 1.16 g, which corresponds to 1 g of diclofenac sodium

Gel base:

fat emulsion in an aqueous gel with the addition of isopropanol and propylene glycol.

Other ingredients:

diethylamine,

polymer of acrylic acid,

cetacrylpric acid 1000,

cetrocrycrpol acid 1000 isopropyl alcohol,

propylene glycol, srd lkp liquid paraffin,

flavor,

water

Dosage and administration

The drug is used externally.

For adults and children over 12 years of age, the drug is applied to the skin 3-4 times / day and rubbed lightly. The required amount of the drug depends on the size of the painful area. A single dose of the drug is 2-4 g (which is comparable in volume to the size of cherries or walnuts, respectively).

Wash hands after application. The duration of treatment depends on the indications and the observed effect (to enhance the effect, the gel can be used together with other dosage forms of Voltaren®).

If there is no therapeutic effect, consult a doctor after 2 weeks.

Laminated tubes: to remove the protective membrane, use a screw cap as a key (recess with protrusions on the outside of the cap). Align the recess on the outside of the lid with the curly protective membrane of the tube and turn. The membrane should separate from the tube.

Laminated tubes can have either a regular cap (round shape) or an innovative cap (triangular shape), which is especially suitable for use with limited mobility of the joints of the hands due to osteoarthritis or other joint diseases or injuries, as well as an applicator cap.

Aluminum tubes: Before first use, pierce the tube’s protective membrane with a special protrusion on the outside of the polypropylene screw cap.

It is not recommended to wash the applicator cap with water or use abrasive cleaners. After full use of the contents of the tube, it is recommended to dispose of the applicator cap with the tube. Do not use the applicator cap with another tube.

Side effects

Adverse reactions are mainly characterized by mild and passing skin manifestations at the site of application of the gel. In very rare cases, the development of allergic reactions is possible.

Determination of the incidence of adverse reactions: very often (> 10%), often ( 1%, but 10%), infrequently ( 0.1%, but 1%), rarely ( 0.01%, but 0.1%) is very rare ( 0.01%).

Infectious and parasitic diseases: very rarely - pustular rashes.

On the part of the immune system: very rarely - generalized skin rash, allergic reactions (urticaria, hypersensitivity: angioedema).

From the respiratory system: very rarely - asthma attacks, 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 is very rare - photosensitivity reactions.

Drug Interaction

Voltaren® Emulgel® can enhance the effects of photosensitization drugs.

No clinically relevant interaction with other medicinal products has been reported.

Overdose

Due to low systemic absorption upon gel application, overdose is unlikely.

Symptoms: systemic adverse reactions may occur with accidental ingestion.

Treatment of overdose with accidental ingestion: gastric lavage, induction of vomiting, activated charcoal, symptomatic therapy. Dialysis and forced diuresis are not effective because of the high degree of binding of diclofenac to plasma proteins (about 99%).

Storage conditions

Keep out of the reach of children at a temperature not exceeding 30 ° C.

Expiration

3 years.

Deystvuyuschee substances

Diclofenac

Prescription terms from

pharmacies No prescription

Dosage form

Dosage form

gel for external use

Novartis Farm Stein AG, Switzerland



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