Next activegel gel for external application 5%+3%, tube 50g

Composition

Composition per 1 g of gel:

Active ingredients:

ibuprofen – 50.0 mg,

levomentol-30.0 mg

Auxiliary substances:

propylene glycol-100.0 mg, ethanol 95% – 300.0 mg, carbomer-20.0 mg, diisopropanolamine-55.0 mg, purified water – up to 1000.0 mg

Pharmacological action

Pharmacotherapy group: nonsteroidal anti-inflammatory drug (NSAID).

ATX code: M02AA13

Pharmacological properties

Pharmacodynamics

NEXT ACTIVGEL is a combination of two active substances – ibuprofen and levomentol.

Ibuprofen is a non-steroidal anti-inflammatory drug derived from propionic acid, selectively blocks the enzymes cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2), as a result of which it suppresses the synthesis of prostaglandins – mediators of pain, inflammation and hyperthermic reaction.

When applied topically, ibuprofen has analgesic, anti-inflammatory and anti-edematous effects (reduces exudation and swelling caused by inflammation).

Levomentol has a local irritating effect, which causes the rapid development of the analgesic effect of the drug.

The combination of ibuprofen and levomentol reduces pain and inflammation, is effective for joint pain when moving and at rest, and reduces morning joint stiffness.

Pharmacokinetics

After application to the skin, ibuprofen is detected in the epidermis and dermis after 24 hours. It reaches a high therapeutic concentration in the underlying soft tissues, joints and synovial fluid. Clinically significant systemic absorption practically does not occur. The maximum concentration of ibuprofen in blood plasma with topical application is 5% of the maximum concentration with oral use of ibuprofen. Ibuprofen is metabolized in the liver. It is excreted by the kidneys (no more than 1% unchanged) and, to a lesser extent, with bile through the intestines.

Indications

As a topical analgesic and anti-inflammatory agent for conditions such as muscle pain, back pain, arthritis, pain from ligament injuries and sprains, sports injuries, and neuralgia.

Use during pregnancy and lactation

The use of the drug during pregnancy and lactation is contraindicated.

If you need to use the drug during lactation, you should stop breastfeeding.

Contraindications

• Hypersensitivity to ibuprofen or other components of the drug;
• increased sensitivity to acetylsalicylic acid and other NSAIDs;
• complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance of acetylsalicylic acid or other NSAIDs (including in the anamnesis);
• violation of the integrity of the skin at the site of application of the drug (including infected wounds and abrasions, moist dermatitis, eczema);
• children up to age 14 years;
• pregnancy, lactation.

With caution, before using the drug, it is necessary to consult a doctor in the presence of concomitant diseases of the liver and kidneys, gastrointestinal tract, exacerbation of hepatic porphyria, with bronchial asthma, urticaria, rhinitis, nasal mucosal polyps, chronic heart failure, as well as elderly patients.

Side effects

The frequency of adverse reactions is estimated based on the following criteria: very common (≥1/10), common (≥1/100 to <1/10), infrequent (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (

– Violations of the immune system

Frequency not known: hypersensitivity reactions (non-specific allergic reactions and anaphylactic reactions), reactions of the respiratory tract (bronchial asthma, including the exacerbation, bronchospasm, dyspnea, dyspnea), skin reactions (pruritus, urticaria, purpura, exfoliative and bullous dermatoses, including toxic epidermal necrolysis (Lyell’s syndrome), and Stevens-Johnson syndrome, erythema multiforme, eczema, photosensitivity), angioedema.

– Disorders of the gastrointestinal tract

Frequency unknown: abdominal pain, dyspepsia.

– Renal and urinary tract

disorders Frequency unknown: impaired renal function.

With prolonged use, systemic side effects of NSAIDs may develop.

If side effects occur, you should stop using the drug and consult a doctor.

Interaction

The drug may enhance the effect of drugs that cause photosensitization.

No clinically significant interactions with other drugs have been described.

Due to the fact that even with topical application of ibuprofen, the possibility of systemic action of the drug cannot be completely excluded, caution should be exercised when used simultaneously with the following drugs: : anticoagulants and thrombolytics, antihypertensive agents, acetylsalicylic acid, and other NSAIDs. Theoretically, when used concomitantly with other NSAIDs, side effects may increase.

How to take, course of use and dosage

The drug is intended for external use.

For adults and children from 14 years of age, a small amount of gel (a strip 3-5 cm long) is applied in a thin layer to the skin above the lesion and rubbed in with light movements.

Immediately after applying the drug, you should wash your hands if they are not the object of treatment.

Repeated use of the drug is possible no earlier than in 4 hours. The drug can be applied up to 4 times within 24 hours.

The duration of using the drug without consulting a doctor is no more than 10 days. If longer-term use is necessary, consult your doctor.

Overdose

The phenomena of overdose with external use of the drug are not described.

If the drug is taken orally, headache, vomiting, drowsiness, and a decrease in blood pressure may occur. Gastric lavage is recommended (only within an hour after ingestion), taking activated charcoal, alkaline drinking, forced diuresis, and symptomatic therapy.

Special instructions

It is necessary to avoid contact with the drug in the eyes, lips and other mucous membranes, damaged skin areas.

After applying to the skin, do not apply an occlusal (sealed) dressing.

Avoid direct sunlight on the application area.

With prolonged use of a large amount of the drug, there is a risk of developing systemic side effects.

Before using the drug, you should consult your doctor if you have kidney disease.

Influence on the ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles and work with mechanisms.

Storage conditions

At a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

life is 2 years. Do not use after the expiration date indicated on the package.

Active ingredient

: Ibuprofen, Levomentol

Dosage form

gel for external use

Description

For adults, Children over 14 years of age

Indications

Sciatica, Rheumatoid Arthritis, Osteochondrosis, Bruises, Lumbago, Sciatica, Osteoarthritis