Voltaren Emulgel - instructions for use, dose, side effects, contraindications

Excipients: carbomers (carbopol 974 P) 1.20 g, macrogol cetostearate (cetomacrogol 1000) 2.00 g, cocoyl caprylcaprate (cetyl LC) 2.50 g, diethylamine 0.90 g, isopropanol 20.00 g, liquid paraffin 2.50 g, aromatic cream 45 (contains benzyl benzoate) 0.10 g, propylene glycol 5.00 g, water 64.64 g.

Description:Homogeneous, creamy gel, color from white to yellowish.

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

ATX: & nbsp

S.01.B.C.03 Diclofenac

M.01.A.B.05 Diclofenac

Pharmacodynamics:

Active component diclofenac non-steroidal anti-inflammatory drug possessing marked analgesic and anti-inflammatory properties. Indiscriminately inhibiting cyclooxygenase type 1 and 2, disrupts the metabolism of arachidonic acid.

Voltaren^® Emulgel® is used to eliminate the pain syndrome and reduce the swelling associated with the inflammatory process.

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

Pharmacokinetics:

With the recommended method of applying the drug, no more than 6% of diclofenac is absorbed. When applied to the area of the affected joint, the concentration in the synovial fluid is higher than in the plasma. Diclofenac mainly distributed and retained deeply in tissues susceptible to inflammation, such as joints, where its concentration is 20 times higher than in plasma.

Indications:

- Pain in the back with inflammatory and degenerative diseases of the spine (radiculitis, osteoarthritis, lumbago, sciatica);

- pain in the joints (joints of the fingers, knees, etc.) with osteoarthritis;

- pain in muscles (due to stretching, overstrain, bruises, injuries);

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

Contraindications:

Hypersensitivity to diclofenac or other components of the drug; propensity to occurrence of attacks of a bronchial asthma, skin rashes or sharp rhinitis at application of an acetylsalicylic acid or other NSAIDs; pregnancy (III trimester), 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 and ulcerative lesions of the gastrointestinal tract, severe violations of liver and kidney function, chronic heart failure, bronchial asthma, elderly age, pregnancy (I and II trimester).

Pregnancy and lactation:

Due to the lack of data on the use of Voltaren® Emulgel® in pregnant women, the use of the drug during the first and second trimester of pregnancy is recommended only for the doctor's prescription, comparing the benefits to the mother and the risk to the fetus.

The drug is contraindicated in the third trimester of pregnancy in connection with the possibility of lowering the tone of the uterus, impaired fetal kidney function with the subsequent development of low salinity and / or premature closure of the arterial duct of the fetus.

Due to the lack of data on the penetration of Voltaren® Emulgel® into breast milk, the drug is not recommended for use during breastfeeding. If nevertheless it is necessary to use the drug, it should not be applied to the mammary glands or to a large surface of the skin and not to be used for a long time.

Application data Voltaren^®Emulgel® and its effect on fertility in humans are absent.

Dosing and Administration:

Outwardly.

Adults and children over 12 years of age the drug is applied to the skin 3-4 times a day and lightly rubbed. 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 a cherry or walnut, respectively).

After applying the product, the hands should be washed.

The duration of treatment depends on the indications and the effect noted (to enhance the effect, the gel can be used together with other Voltaren® dosage forms). Consult a physician after 2 weeks if there is no therapeutic effect.

Laminated tubes: To remove the protective membrane, use a screw cap as a key (recess with protrusions on the outside of the cover). Align the recess on the outside of the lid with the tubular protective membrane and turn. The membrane must separate from the tube. Laminated tubes can have both a conventional lid (round shape) and an innovative lid (triangular shape), which is especially convenient for use with limited mobility of the joints of the hands due to osteoarthritis or other joint diseases or injuries.

Aluminum tubes: Before the first use, the protective membrane of the tube should be punctured with a special protrusion on the outside of the polypropylene screw cap.

Side effects:

Classification of incidence of adverse reactions: very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10000, <1/1000); very rarely (<1/10000), including individual messages.

Infectious and parasitic diseases:

Very rarely: pustular rash.

Immune system disorders:

Very rarely: hypersensitivity reactions (including urticaria), angioedema.

Disturbances from the respiratory system, chest and mediastinal organs:

Very rarely: asthma.

Disturbances from the skin and subcutaneous tissues:

Often: dermatitis (including contact dermatitis), rash, erythema, eczema, pruritus.

Rarely: bullous dermatitis.

Very rarely: photosensitization reactions.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

Extremely low systemic absorption of active components of the drug with external application makes an overdose almost impossible.However, with the occasional use of 100 g of gel equivalent to 1000 mg of diclofenac, undesirable reactions may occur, similar to adverse reactions.

The first help consists in washing the stomach, taking activated charcoal. If necessary, hospital treatment.

Interaction:

Voltaren® Emulgel® can enhance the effect of drugs that cause photosensitivity. Clinically significant interaction with other drugs is not described.

Special instructions:

Voltaren^® Emulgel^® Should be applied only to intact skin, avoiding contact with open wounds.

After applying, do not apply an occlusive dressing.

Do not allow the drug to enter the eyes and mucous membranes.

The preparation contains propylene glycol and benzyl benzoate, which in some cases can cause mild local skin irritation. It is necessary to stop treatment in case of development of a skin rash after application of a preparation.

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

Does not affect.

Form release / dosage:

Gel for external use, 1%.

Packaging:

10 grams, 20 grams, 30 grams, 50 grams, 60 grams, 75 grams, 100 grams, 120 grams, 150 grams or 180 grams in an aluminum tube equipped with an aluminum protective membrane with a screw-on plastic cover (white or blue) , having a protrusion for perforating the membrane from the outside. The tube together with the instruction for use is placed in a cardboard box.

10 g, 20 g, 30 g, 50 g, 60 g, 75 g, 100 g, 120 g, 150 g or 180 g in a laminated tube (low density polyethylene, aluminum, high density polyethylene) with a shoulder and a one-piece shaped protective a high-density polyethylene membrane and a polypropylene screw cap (white or blue), round or triangular in shape. The lid on the outside is provided with a key (a recess with projections) for opening the protective membrane of the tube. The tube together with the instruction for use is placed in a cardboard box.

75 ml or 100 ml in an aluminum vial (about 73 g and 97 g respectively) under pressure with a plastic pump dispenser on a polyethylene ring and a protective cap. The bottle together with the instruction for use is placed in a cardboard box.

Storage conditions:

At temperatures not higher than 30 ° C, out of reach of children.

Shelf life:

3 years.

The drug should not be used after the expiry date indicated on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N016030 / 01

Date of registration:09.09.2009 / 08.11.2016

Expiration Date:Unlimited

The owner of the registration certificate:GlaxoSmithKline Helsker, ZAO GlaxoSmithKline Helsker, ZAO Russia

Manufacturer: & nbsp

NOVARTIS CONSUMER HEALTH, S.A. Switzerland

NOVARTIS PHARMA PRODUCTIONS, GmbH Germany

Representation: & nbspGlaxoSmithKline Helsker GlaxoSmithKline Helsker United Kingdom

Information update date: & nbsp26.03.2017

Illustrated instructions

Instructions

Voltaren® Emulgel® (Voltaren® Emulgel®)