Dolgit® cream

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT DOLGIT® CREAM

Composition:

Active substance: ibuprofen;

1 g of cream contains 50 mg of ibuprofen;

Excipients: medium-chain triglycerides, glycerol monostearate (E 471), macrogol stearate 1500, macrogol stearate 5000, propylene glycol (E 1520), sodium methylparahydroxybenzoate (E 219), xanthan gum (E 415), lavender oil, neroli oil, purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: homogeneous, soft cream ranging from white to creamy color, with a lavender-citrus odor.

Pharmacotherapeutic group. Topical preparations for joint and muscular pain. ATC code M02A A13.

Pharmacological properties.

Pharmacodynamics.

"Dolgit® cream" is a non-steroidal anti-inflammatory and analgesic agent for topical use in joint and muscular pain. Ibuprofen – the active ingredient of "Dolgit® cream" – exerts pronounced anti-inflammatory, analgesic, and moderate antipyretic effects, reduces swelling associated with inflammation caused by injuries or rheumatic diseases, and improves joint mobility. The pharmacological activity of the drug is due to its ability to inhibit prostaglandin synthesis.

When applied topically, ibuprofen is rapidly absorbed through the skin and penetrates into the site of inflammation. Penetration to the site of action may vary depending on the extent and type of injury, as well as the application site and target area.

Therapeutic concentrations are maintained in joint tissues for several hours, while only negligible amounts of the active substance are present in blood serum; therefore, systemic effects are practically absent.

Pharmacokinetics.

Biological transformation of ibuprofen occurs in the liver. Pharmacologically inactive metabolites are excreted by the kidneys (90%) and also with bile. Ibuprofen is 99% bound to plasma proteins. The elimination half-life ranges from 1.8 to 3.5 hours.

Clinical characteristics.

Indications.

For local treatment of degenerative joint diseases with pain syndrome (arthrosis), inflammatory rheumatic diseases of joints and spine, swelling or inflammation of soft tissues around joints (e.g., bursitis, tendinitis, tenosynovitis, ligament and joint capsule injuries), restricted mobility in the shoulder area, low back pain, lumbago, myalgia, as well as sports and other injuries such as contusions, muscle strain, ligament and tendon sprains.

Contraindications.

"Dolgit® cream" is contraindicated:

• in case of hypersensitivity to the active ingredient ibuprofen, to any of the excipients of the medicinal product, or to other analgesics and anti-rheumatic agents;
• for application on open wounds, inflammatory and infectious skin diseases such as eczema, as well as for application on mucous membranes;
• during the third trimester of pregnancy.

Interaction with other medicinal products and other types of interactions.

When applied topically according to recommendations, no interactions with other medicinal products have been observed.

Patients should inform their physician if they are currently receiving treatment with other medicinal products or have recently undergone therapy.

Special precautions for use.

Patients with asthma, hay fever, nasal mucosal swelling (so-called nasal polyps), chronic obstructive respiratory diseases, or chronic respiratory infections (particularly with symptoms resembling hay fever), as well as patients with hypersensitivity to analgesics and anti-rheumatic drugs of various types, have an increased risk of developing asthma attacks (analgesic intolerance/analgesic-induced asthma), local skin and mucous membrane swelling (angioedema, Quincke's edema), or urticaria.

The use of this medicinal product in such patients should be carried out under special conditions and under direct medical supervision. The product should be used with caution in patients with hypersensitivity (allergy) to other substances causing skin irritation, itching, or urticaria. If a skin rash develops, application of the cream should be discontinued immediately.

Severe skin adverse reactions have been reported with ibuprofen use, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis, which may be life-threatening or result in fatal outcomes (see section "Adverse reactions"). Most of these reactions occurred within the first month of treatment.

If signs or symptoms suggesting these reactions appear, ibuprofen should be discontinued immediately and alternative treatment options should be considered (if necessary).

Avoid contact of the product with the eyes.

Care should be taken to ensure that children do not touch areas of skin to which the product has been applied.

If discomfort persists for more than 3 days during treatment, a physician should be consulted.

Due to the possible occurrence of increased photosensitivity, patients should avoid intense exposure to sunlight or UV radiation during treatment with this product.

The medicinal product contains 50 mg of propylene glycol per 1 g. Propylene glycol may cause skin irritation.

Sodium methyl parahydroxybenzoate may cause hypersensitivity reactions (possibly delayed).

This medicinal product contains fragrances (lavender oil and neroli oil) with benzyl alcohol, benzyl benzoate, citral, citronellol, coumarin, eugenol, farnesol, geraniol, limonene/d-limonene, and linalool, which may cause allergic reactions.

Use during pregnancy or breastfeeding.

Pregnancy

There are no clinical data on the topical use of "Dolgit® cream" during pregnancy. Although systemic exposure is lower compared to oral administration, it is unknown whether systemic exposure to "Dolgit® cream" achieved after topical application could be harmful to the embryo/fetus. "Dolgit® cream" should not be used during the first and second trimesters of pregnancy unless clearly necessary. If used, the dose should be as low as possible and the duration of treatment as short as possible.

Systemic use of prostaglandin synthetase inhibitors, including "Dolgit® cream", during the third trimester of pregnancy may cause cardiopulmonary and renal toxicity in the fetus. Prolonged bleeding may occur in both mother and child near the end of pregnancy, and labor may be delayed. Therefore, "Dolgit® cream" is contraindicated during the last trimester of pregnancy (see section "Contraindications").

Breastfeeding

Only a minimal amount of ibuprofen metabolites and its breakdown products pass into breast milk. Currently, there is no evidence of negative effects on the newborn; therefore, breastfeeding does not need to be interrupted for short-term treatment. However, the daily dose should not exceed the amount delivered by 3–4 applications of a 4–10 cm cream strip, and breastfeeding should be interrupted during prolonged treatment.

Breastfeeding women should not apply this medicinal product to the breast area to avoid exposure of the infant to the drug.

Effect on ability to drive and use machines.

There are no data on the effects of ibuprofen in cream form on the ability to drive vehicles or operate potentially hazardous machinery.

Method of Administration and Dosage

For external use only. Apply the medicinal product 3–4 times daily. Depending on the size of the affected area, apply a thin layer of cream to the skin at the site of inflammation/pain using strips 4–10 cm long, corresponding to 2–5 g of cream (100–250 mg of ibuprofen), followed by gentle rubbing in. The maximum daily dose is 20 g of cream (equivalent to 1,000 mg of ibuprofen).

In the case of large hematomas and edema, during initial treatment the cream may be applied under an occlusive dressing.

The duration of treatment should be determined by a physician. In most cases, treatment lasts 2–3 weeks. There are no data on therapeutic benefit from using the medicinal product for longer periods.

Penetration of the active ingredient can be enhanced by iontophoresis (a special form of electrotherapy). In such cases, apply the preparation under the cathode (negative electrode), with a current intensity of 0.1–0.5 mA per 5 cm² of electrode surface area, and a procedure duration of up to 10 minutes.

After applying the cream to the skin, hands should be wiped with a paper towel and then washed, unless the hands themselves are the treatment site. The paper towel should be disposed of together with waste.

Before taking a shower or bath, the patient should wait until the active substance has been absorbed.

Children

Do not use in children under 14 years of age.

Overdose

If more cream is applied than recommended, remove any excess and wash the skin with water. In case of application of a very large amount or accidental ingestion of the cream, medical advice must be sought immediately. There is no specific antidote known.

Adverse reactions.

Classification of adverse reactions by frequency of occurrence: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,000), very rare (< 1/10,000), frequency not known.

Immune system disorders

Uncommon: hypersensitivity reactions such as local allergic reactions (contact dermatitis).

Respiratory, thoracic and mediastinal disorders

Rare: bronchospastic reactions.

Skin and subcutaneous tissue disorders

Common: local reactions such as skin redness, itching, burning sensation, exanthema, including formation of pustules and vesicles.

Rare: severe skin adverse reactions (including erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis).

Frequency not known: photosensitivity reactions; drug reaction with eosinophilia and systemic symptoms (DRESS syndrome); acute generalized exanthematous pustulosis.

When applying "Dolgit® cream" to large areas of skin and for prolonged periods, adverse reactions affecting specific organs or the body as a whole, which are possible with systemic use of medicinal products containing ibuprofen, cannot be excluded.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after marketing authorization is highly important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and pharmacists, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years. Shelf life after first opening – 12 months.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging. 20 g, 50 g, 100 g, or 150 g in a tube; 1 tube per cardboard box.

Supply classification. Over-the-counter.

Manufacturer.

Dolorgiet GmbH & Co. KG.

Manufacturer's address and place of business.

Otto-von-Guericke-Str. 1, 53757 Sankt Augustin, Germany.