Pentalgin extra-Gel gel naruzhn.prim th 5% 50g tuba ind y

Description

Composition
Active substance:
1 g of gel contains: ketoprofen – 50.0 mg.
Excipients:
Cayenne pepper tincture fruits (capsicum pepper tincture) – 40.0 mg, dimethylsulfoxide (dimexide) – 30.0 mg, camphor – 30.0 mg, peppermint leaf oil (peppermint oil) – 9.0 mg hypromellose – 20 0 mg sodium hydroxide – 7.5 mg, 96% ethanol 350.0 mg purified water – up to 1000.0 mg.
Description:
Transparent or translucent uniform gel from yellowish to reddish brown color with a characteristic smell. Presence of opalescence and air bubbles.
Product form:
Gel for external use, 5%.
Gel 30 g, 50 g or 100 g in aluminum tubes with polymeric Bouchon
The tube together with instructions for use placed in a pile of cardboard.
Contraindications
Individual hypersensitivity to ketoprofen or other components of the formulation; hypersensitivity to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) (indicating a history of bronchospasm, urticaria and rhinitis caused by the intake of acetylsalicylic acid), tiaprofenic acid, and fenofibrate; complete or partial combination of asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including history); increased skin sensitivity to sunlight exposure (photosensitivity) history; skin allergy history on sunscreen or perfume; the impact of sunlight on the areas to be treated, including a solarium, during the course of the drug, and 2 weeks after; damage to the skin (moist dermatitis, eczema, infected abrasions, wounds) at the site of the intended application; pregnancy (III trimester), breast-feeding; Children up to age 18 years.
Carefully
Erosive and ulcerative lesions of the gastrointestinal tract, severe liver and renal function, hepatic porphyria, chronic heart failure, bronchial asthma, advanced age, pregnancy (I and II trimester).
If you have one of these diseases / conditions before taking this medication, you should consult with your doctor.
Dosage
5 %
Indications
Acute and chronic inflammatory diseases of the musculoskeletal system (inflammation of the tendons and ligaments, osteoarthrosis, osteochondrosis with radicular syndrome, sciatica, bursitis, sciatica, lumbago, joint syndrome, gout during exacerbation); muscular pain of rheumatic and rheumatic origin; post-traumatic inflammation of soft tissue and musculoskeletal system (damages and torn ligaments, bruises).
The drug is intended for the symptomatic therapy reduce pain and inflammation at the time of use, does not affect the progression of the disease.
Interaction with other drugs
The drug can increase the effects of drugs that cause photosensitization.
Although a lesser degree of absorption of ketoprofen through the skin, with frequent and prolonged use may appear symptoms interactions with other medications (same as for systemic use).
In a joint application with other NSAIDs, corticosteroids, ethanol, corticotropin, the formation of ulcers in the gastrointestinal tract and the development of gastrointestinal bleeding.
Patients taking coumarin anticoagulants, it is advisable to carry out regular monitoring of the international normalized ratio (INR).
When the joint application ketoprofen enhances the toxicity of methotrexate.
Part of the auxiliary substances dimethylsulfoxide enhances the penetration of drugs through the skin.
Overdose
In case of accidental use of the drug in doses exceeding recommended, the risk of developing symptoms of overdose is minimal due to the very low systemic absorption with topical ketoprofen.
When the local side effects of the drug should be discontinued and wash the application site.
Accidental ingestion of large quantities of the gel may cause systemic adverse reactions typical of NSAIDs. Necessary gastric lavage, administration of activated charcoal.
pharmachologic effect
Pharmacological group:
Non-steroidal anti-inflammatory agent for topical application.
Pharmacodynamics:
Ketoprofen – a non-steroidal antiinflammatory agent, by topical application has analgesic, anti-inflammatory and anti-edematous action. The mechanism of action is associated with the suppression of activity of the enzymes cyclooxygenase 1 and cyclooxygenase 2 regulating the synthesis of prostaglandins. When applying a gel provides local therapeutic effect in relation to the affected joints, tendons, ligaments, muscles. When the articular syndrome, reduces joint pain at rest and in motion, morning stiffness and swelling of joints. It does not have a damaging effect on articular cartilage.
Pharmacokinetics:
When applied topically, in a gel penetrates into the inflammatory focus through the skin and is absorbed from an inflammatory focus is extremely slow and practically accumulates in the body. Bioavailability of ketoprofen – about 5%. After external application in a dose of 50-150 mg of the plasma concentration after 5-8 hours – 0.08-0.15 g / ml.
Pregnancy and breast-feeding
Use of the drug is contraindicated in the III trimester of pregnancy. In I and II trimesters of pregnancy, the use of the drug is possible only after consultation with a physician, in the event that the anticipated benefits to the mother outweighs the potential risk to the fetus.
If necessary, use during lactation should stop breastfeeding.
Conditions of supply of pharmacies
Without recipe.
side effects
Adverse reactions listed with the frequency of occurrence in accordance with the WHO classifications: very often (with a frequency of 1/10), often (with a frequency not less than 1/100 but less than 1/10) infrequently (at a frequency of at least 1/1000 but less than 1/100), rare (with a frequency of not less than 1/10000, but less than 1/1000), very rarely (at a frequency of less than 1/10000, including single messages), the frequency is unknown (it can not be determined from the available data ).
For the skin: rare: erythema, itching, eczema; rarely, photosensitivity, bullous dermatitis, urticaria; very rarely, contact dermatitis, angioedema.
On the part of the gastrointestinal tract: Very rare: peptic ulcers, bleeding, diarrhea.
Immune system: very rare: anaphylactic reactions, hypersensitivity reactions.
From the urinary system: very rare: aggravation of current renal failure.
When these or other side effects you must stop using the product and seek medical advice.
special instructions
The gel should be applied only to undamaged skin, avoiding contact with open wounds, the eyes and mucous membranes.
After applying the drug to wash hands.
It allowed the formation of a transparent film on the skin at the site of gel application.
Do not use with occlusive dressings.
It can be used in phonophoresis.
Prolonged use of local tools can lead to increased sensitivity and appearance of symptoms of skin irritation at the site of application.
In order to avoid manifestations of photosensitivity, it is recommended to avoid exposure of the skin to direct sunlight during the course of treatment and after two weeks after the last treatment (including not visit a solarium).
With long-term use of the drug in large quantities in very rare cases may cause systemic side effects (hypersensitivity reactions, disorders of the gastrointestinal tract, worsening the flow of renal failure).
Patients with severe renal, cardiac or hepatic impairment caution should be exercised in the application of ketoprofen.
The risk of systemic side effects increases depending on the amount of gel applied, the area of ​​the treated skin area, skin condition, the duration.
It should stop using the product in the event of any skin reactions, including reactions with simultaneous deposition of sunscreen, or other cosmetic products containing organic sunscreen octocrylene.
Effect on the ability to drive mechanisms and
The drug does not affect the ability to drive and operate machinery.
Storage conditions
At a temperature of not higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
A preparation for external application.
The gel should be applied to clean and dry skin. A small amount of gel (3-5 cm) are thin layer, followed by gently rubbing into inflamed or painful areas of the body. The drug should be applied 2-3 times a day.
The duration of treatment should not exceed 14 days.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist