Nextt Aktivgel, gel 5% + 3% 50 g

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

ATX code: M02AA13

Pharmacological properties

Pharmacodynamics

NEXT ACTIVEGEL is a combination of two active substances – ibuprofen and levomenthol.

Ibuprofen is a non-steroidal anti-inflammatory agent, a derivative of propionic acid, non-selectively blocks cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2) enzymes, thus inhibiting the synthesis of prostaglandins – mediators of pain, inflammation and hyperthermia.

When used topically, ibuprofen has analgesic, anti-inflammatory and anti-edema effects (reduces exudation and edema due to inflammation).

Levomenthol has a local irritant effect, which explains the rapid development of the analgesic effect of the drug.

The combination of ibuprofen and levomenthol reduces pain and inflammation; it is effective for painful joints on movement and at rest and reduces morning joint stiffness.

Pharmacokinetics

After application to the skin, ibuprofen is detectable in the epidermis and dermis after 24 hours. It achieves high therapeutic concentration in the underlying soft tissues, joints and synovial fluid. There is practically no clinically significant systemic absorption.

The maximum concentration of ibuprofen in plasma during topical administration is 5% of the maximum concentration during oral administration of ibuprofen. Ibuprofen is metabolized in the liver. It is excreted by the kidneys (not more than 1% unchanged) and, to a lesser extent, with the bile through the intestine.

Indications

Active ingredient

Composition

Composition per 1 g of gel:

Active substances:

ibuprofen – 50.0 mg,

levomenthol – 30.0 mg

Excipients:

How to take, the dosage

The drug is intended for external use.

Adults and children from 14 years of age apply a small amount of gel (3-5 cm long strip) in a thin layer to the skin over the lesion and rub in gently.

Wash hands immediately after application if they are not to be treated.

Repeated use of the product is allowed up to 4 hours at the earliest. The product can be applied up to 4 times within 24 hours.

The duration of use of the drug without a doctor’s consultation is no more than 10 days. If longer use is necessary, consult a physician.

Interaction

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

Clinically significant interaction with other drugs has not been described.

In connection with the fact that even with local use of ibuprofen it is impossible to completely exclude the possibility of systemic action of the drug, caution should be exercised when using simultaneously with the following drugs: anticoagulants and thrombolytics, antihypertensive agents, acetylsalicylic acid, other NSAIDs. Theoretically, concomitant use with other NSAIDs may lead to increased side effects.

Special Instructions

Avoid getting the drug in the eyes, on the lips and other mucous membranes, damaged skin.

After application, no occlusive (sealed) dressing should be applied to the skin.

Avoid exposure to sunlight in the area where the product is applied.

There is a risk of systemic side effects if large amounts of the product are used over a long period of time.

You should consult your doctor before using the drug if you have kidney disease.

Impact on driving and operating machinery

The drug does not affect the ability to drive vehicles and operate machinery.

Contraindications

Side effects

The frequency of adverse reactions was evaluated 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 (< 1/10 000), frequency unknown (frequency cannot be determined based on available data).

– Immune system disorders

Frequency unknown: hypersensitivity reactions (non-specific allergic reactions and anaphylactic reactions), respiratory reactions (bronchial asthma, including its exacerbation, bronchospasm, dyspnea), skin reactions (itching, urticaria, purpura, exfoliative and bullous dermatoses, including toxic epidermal necrolysis (Lyell syndrome), Stevens-Johnson syndrome, erythema multiforme, eczema, photosensitization), Quincke’s edema.

– Gastrointestinal disorders

Prevalence unknown: abdominal pain, dyspepsia.

– Renal and urinary tract disorders

Prevalence unknown: impaired renal function.

With long-term use, development of systemic side effects of NSAIDs is possible.

If side effects occur, discontinue use of the drug and consult a physician.

Overdose

The phenomena of overdose when using the drug externally have not been described.

Pregnancy use

The use of the drug during pregnancy and breast-feeding is contraindicated.