Inforin Activ (Gel) Instructions for Use

Marketing Authorization Holder

Spey Medical, Ltd (United Kingdom)

Manufactured By

Balkanpharma-Razgrad, AD (Bulgaria)

ATC Code

M02AA (Topical non-steroidal anti-inflammatory drugs)

Active Substances

Ibuprofen (Rec.INN registered by WHO)

Levomenthol (Rec.INN registered by WHO)

Dosage Form

Inforin Activ

Gel for external use 50 mg+30 mg/1 g: 40 g tube

Dosage Form, Packaging, and Composition

Gel for external use homogeneous, transparent, from colorless to light yellow.

Excipients: purified water – up to 1 g, ethanol 96% – 400 mg, propylene glycol – 50 mg, diisopropanolamine – 57 mg, carbomer interpolymer, type A – 20 mg.

40 g – lacquered aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

NSAIDs for external use

Pharmacotherapeutic Group

Nonsteroidal anti-inflammatory drug (NSAID)

Pharmacological Action

Ibuprofen non-selectively blocks the enzymes COX-1 and COX-2, thereby suppressing the synthesis of prostaglandins – mediators of pain, inflammation, and the hyperthermic reaction.

When applied topically, it has an analgesic and anti-inflammatory effect.

Levomenthol has a local irritant effect.

This combination reduces pain and inflammation, is effective for joint pain during movement and at rest, and reduces morning joint stiffness.

Pharmacokinetics

After application to the skin, Ibuprofen is detected in the epidermis and dermis within 24 hours.

It reaches a high therapeutic concentration in the underlying soft tissues, joints, and synovial fluid.

Clinically significant systemic absorption is practically absent.

C_max in plasma with topical application is 5% of the C_max level with oral administration.

Ibuprofen is metabolized in the liver.

It is excreted by the kidneys (unchanged no more than 1%) and, to a lesser extent, with bile through the intestines.

Indications

Muscle pain, back pain, arthritis, pain from ligament damage and sprains, sports injuries, and neuralgia.

ICD codes

Dosage Regimen

Apply externally only. Use on intact skin.

Apply a thin layer of gel to the affected area. Use an amount of gel corresponding to the size of the painful area; a strip of 4 to 10 cm is typically sufficient.

Gently massage the gel into the skin until fully absorbed.

Apply up to four times within 24 hours. Maintain intervals of at least 4 hours between applications.

The maximum duration of continuous use is 10 days.

Wash hands thoroughly with soap and water after each application, unless the hands are the treated area.

If symptoms persist after 10 days of use, or if they worsen, discontinue use and consult a physician.

Do not use an occlusive dressing over the application site.

Adverse Reactions

From the immune system hypersensitivity reactions (non-specific allergic reactions and anaphylactic reactions).

From the respiratory system: bronchial asthma, including its exacerbation, bronchospasm, shortness of breath, dyspnea.

From the skin: itching, urticaria, purpura, exfoliative and bullous dermatoses, including toxic epidermal necrolysis (Lyell’s syndrome), Stevens-Johnson syndrome, erythema multiforme, eczema, photosensitivity, angioedema.

From the gastrointestinal tract abdominal pain, dyspepsia.

From the kidneys and urinary tract impaired renal function.

Contraindications

Hypersensitivity to ibuprofen, acetylsalicylic acid and other NSAIDs, complete or incomplete combination of bronchial asthma, recurrent nasal and sinus polyposis and intolerance to acetylsalicylic acid or other NSAIDs, impaired skin integrity at the application site, children under 14 years of age, pregnancy, lactation period.

Use in Pregnancy and Lactation

Use is contraindicated during pregnancy and lactation.

Pediatric Use

Use is contraindicated in children under 14 years of age.

Special Precautions

Avoid contact with eyes, lips and other mucous membranes, and damaged skin areas.

After application to the skin, an occlusive dressing should not be applied.

Drug Interactions

This combination may enhance the effect of drugs that increase photosensitivity.

Since even with topical application of ibuprofen the possibility of systemic action cannot be completely excluded, caution should be exercised when used concomitantly with the following drugs: anticoagulants and thrombolytic drugs, antihypertensive agents, acetylsalicylic acid, other NSAIDs.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.