Description
Briefly about the product
Voltaren Emulgel – intended for pain in joints, back, muscles, as well as inflammation and swelling of soft tissues and joints.
Voltaren Emulgel has a triple effect!
1: against pain
2: against inflammation *
3: to accelerate recovery **
The active substance diclofenac, a non-steroidal anti-inflammatory drug with pronounced analgesic and anti-inflammatory properties, penetrates deep under the skin, acting on the pain and its cause – inflammation . *
* Instructions for medical use, RU No Ñ N016030 / 01 dated 09.09.2009
** Limit. Musculoskeletal disorders. 2013, 14: 250. Compared to using a placebo.
Description
Gel for external use 2% uniform, creamy, white to white with a yellowish tint.
Latin name
VOLTAREN EMULGEL
Production form
100 g – laminated tubes (1) – packs of cardboard.
Pharmacological Action increasing joint mobility.
Thanks to its water-alcohol base, Voltaren ® Emulgel ® has a calming and cooling effect.
Indications
Back pain with 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 asthma attacks, skin rashes or acute rhinitis with acetylsalicylic acid or other NSAIDs violation of the integrity of the skin at the proposed site of application of the third trimester of pregnancy lactation up to 12 years old.
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 Voltaren® Emulgel® during pregnancy, the use of the drug in the I and II trimesters of pregnancy is recommended only as prescribed by the doctor, comparing the benefits for the mother and the risk to 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 Voltaren® Emulgel® with breast milk, the drug is not recommended for use during breastfeeding. If you still need to use the drug, 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.
Special instructions
Voltaren ® Emulgel ® should only be applied to intact skin, avoiding contact with open wounds.
Avoid contact with eyes and mucous membranes.
After applying the gel for external use of 1%, do not apply an occlusive dressing.
After applying the gel for external use of 2%, a bandage dressing is allowed, but airtight occlusive dressings should not be applied.
If skin rash develops after application of the drug, its use must be discontinued.
The drug contains propylene glycol, which in some people can cause mild local irritation.
It also contains butyl hydroxytoluene, which can cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
Impact on ability to drive vehicles and mechanisms
Not affected.
Composition of
100 g of gel contains:
Active ingredients:
Diclofenac diethylamine – 2.32 g, which corresponds to the content of diclofenac sodium 2 g.
Excipients:
Carbomer * – 1.1-1.7 g
Cetostearomacrogol – 2 g
Cocoyl caprylocaprate – 2.5 g
Diethylamine * – 0.89-1.37 g
Isopropanol – 17.5 g
Liquid paraffin – 2.5 g srldgp 0.1 g
Propylene glycol – 5 g
Butylhydroxytoluene – 0.02 g
Purified water * – 64.22-65.32 g.
* using various production equipment and different batch sizes (1000 kg and 2500 kg), the number of carbomers, diethyleneamine and purified water can be slightly adjusted within numbers indicated.
Dosage and administration
The drug is used externally.
For adults and children over 12 years of age, the drug is applied to the skin 2 times / day (every 12 hours: preferably in the morning and evening), rubbing slightly into the skin.
The required amount of the drug depends on the size of the painful area. A single dose of the drug – 2-4 g (which is comparable in volume to the size of cherries or walnuts, respectively) – enough to treat an area of 400-800 cm2.
If the hands are not a localized area of pain, then after applying the drug, they must be washed.
The duration of treatment depends on the indications and the observed effect. The gel should not be used for more than 14 days with post-traumatic inflammation and rheumatic diseases of the soft tissues without the recommendation of a doctor. If after 7 days of use the therapeutic effect is not observed or the condition worsens, the patient should consult a doctor.
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 cap with the curly protective membrane of the tube and rotate. The membrane should separate from the tube.
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.
Side effects
Determination of frequency of adverse reactions: very common ( 1/10), often ( 1/100, <1/10), infrequent ( 1/1000, <1/100), rare ( 1 / 10,000, <1/1000), very rare (<1 / 10,000), including individual messages. Infectious and parasitic diseases: very rare: pustular rash. From the immune system: very rarely – hypersensitivity reactions (including urticaria), angioedema. From the respiratory system: very rarely – asthma. From the skin and subcutaneous tissues: often – dermatitis (including contact dermatitis), rash, erythema, eczema, itching rarely – bullous dermatitis very rarely – photosensitization reactions. If any of the above side effects are exacerbated, or the patient has noticed any other adverse reactions, you should tell your doctor. Drug Interaction Voltaren ® Emulgel ® may enhance the effects of photosensitization agents. No clinically relevant interaction with other medicinal products has been reported. Overdose Due to the low systemic absorption during application of the gel, an overdose is unlikely. Symptoms: with accidental ingestion, systemic adverse reactions may develop. Overdose treatment for accidental ingestion: gastric lavage, induction of vomiting, activated charcoal, symptomatic therapy. Dialysis and forced diuresis are not effective due to the high degree of binding of diclofenac to plasma proteins (about 99%). Storage conditions The product should be stored out of the reach of children at a temperature not exceeding 30 ° C. Expiration 3 years. active substance Diclofenac pharmacy leave terms srdlkrodpffpt pharmacy leave terms without pharmacy Over-the-counter Novartis Farma Stein AG, Switzerland
