Ibalgin (Cream) Instructions for Use

Marketing Authorization Holder

Zentiva, a.s. (Czech Republic)

ATC Code

M02AA13 (Ibuprofen)

Active Substance

Ibuprofen (Rec.INN registered by WHO)

Dosage Form

Ibalgin

Cream for external use 5%: 30 g or 50 g tubes

Dosage Form, Packaging, and Composition

Cream for external use 5% of emulsion type, white or almost white in color.

Excipients: witepsol (hydrogenated fat), medium saturated triacetyl glycerides (miglyol 812), cetylstearyl alcohol, ethoxylated C12-C16 alcohols (sovvasol 2430), monoglycerides of saturated higher fatty acids (polinol A), carbomer 940, trolamine, methylparaben, propylparaben, propylene glycol, purified water.

30 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

NSAIDs for external use

Pharmacotherapeutic Group

NSAID

Pharmacological Action

The drug has a local analgesic and anti-inflammatory effect and eliminates inflammatory edema. The key element in the mechanism of the specific action of ibuprofen is the inhibition of prostaglandin synthesis due to the inhibition of cyclooxygenases type 1 and 2.

Pharmacokinetics

After application of the cream to the skin, Ibuprofen penetrates well into the subcutaneous tissue. The C_max of ibuprofen in plasma after topical application of 5 g of cream (corresponding to 250 mg of ibuprofen) is about 100 ng/ml, which is about 0.5% of that after oral administration of a similar dose.

Indications

• Diseases of the musculoskeletal system: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis of peripheral joints and spine, low back pain;
• Muscle pain of rheumatic and non-rheumatic origin;
• Traumatic soft tissue injury.

ICD codes

Dosage Regimen

For external use only. Apply a 4-10 cm strip of cream onto the skin over the affected area.

Rub in gently with light movements until fully absorbed.

Apply the cream 2-3 times per day at regular intervals.

For severe pain or extensive hematomas, you may cover the treated area with a protective, air-permeable bandage.

Wash hands thoroughly after each application, unless the hands are the treated area.

Avoid contact with eyes, mucous membranes, and open or damaged skin.

Do not dilute or mix this cream with other topical products.

The duration of treatment must not exceed 5-7 days without medical consultation.

Discontinue use and consult a physician if symptoms persist or worsen.

Do not apply under occlusive dressings unless specifically directed by a doctor.

Adverse Reactions

Possible allergic reactions to the components of the drug in the form of redness, itching of the skin, swelling, burning sensation, skin rash.

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

If signs of allergic reactions appear, the use of the drug should be discontinued.

Contraindications

• History of bronchial asthma attacks and other allergic manifestations associated with the use of acetylsalicylic acid or other NSAIDs;
• Weeping dermatoses;
• Eczema;
• Infected abrasions and wounds;
• Children under 12 years of age;
• Pregnancy, lactation period;
• Hypersensitivity to the main active substance or to other components of the drug.

The drug should not be applied to an open wound surface or damaged skin surface. Avoid getting the cream into the eyes and mucous membranes.

Use in Pregnancy and Lactation

Contraindication: pregnancy, lactation period.

Pediatric Use

Contraindication: children under 12 years of age.

Special Precautions

It is not recommended to dilute or mix Ibalgin cream with other topical products.

Overdose

Cases of overdose have not been described.

In case of accidental ingestion of the drug or application to damaged skin, nausea and vomiting may occur; it is necessary to perform gastric lavage and consult a doctor; if necessary, symptomatic treatment is carried out.

Storage Conditions

At a temperature of 10-25°C (-13°F) in a dry place out of the reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.