Dolgit 5% gel for external use 50 g

• injuries (sports, occupational, domestic, etc.) without skin integrity disruption (bruises, strains or tears of muscles and ligaments, sprains);
• muscle pain (due to strains, overexertion, bruises, injuries);
• painful degenerative diseases (arthrosis);
• inflammatory diseases of the joints and spine;
• swelling or inflammation of the periarticular soft tissues (e.g., bursitis, tendinitis, tenosynovitis);
• shoulder-scapular periarthritis, back pain, lumbago.
The product is intended for symptomatic therapy, reducing pain and inflammation at the time of use, and does not affect the progression of the disease.

For external use only. Do not take orally!
Dosage
Dolgite® gel is applied 3-4 times a day. Depending on the size of the affected area, a strip of gel measuring 4-10 cm is used, which corresponds to 2-5 g of gel (100-250 mg of ibuprofen). The maximum daily dose is 20 g of gel, which corresponds to 1000 mg of ibuprofen.
Method of application
Dolgite® gel is applied to the skin, gently rubbing it into the affected area. The penetration of the active substance through the skin may be enhanced by iontophoresis (a special type of electrotherapy). In this case, Dolgite® gel is applied under the area of the cathode (negative pole). The current strength should be 0.1 - 0.5 mA per 5 cm² of electrode surface, and the duration of the procedure is approximately 10 minutes.
The duration of treatment depends on the severity of the condition and the nature of the damage, averaging 1-2 weeks. The therapeutic effect of prolonged use of the product has not been proven. If there is no improvement after 3 days of treatment, or if symptoms worsen, or new symptoms appear, treatment should be discontinued and a doctor consulted for diagnosis clarification. The product should only be used according to the indications, method of application, and dosages specified in the instructions. Hands must be washed immediately after applying the product.

In 100 g of gel, there is:
active ingredient: ibuprofen 5.000 g;
excipients: isopropanol 16.500 g; dimethylhydroxymethyl-dioxolane (Solketal) 14.000 g; poloxamer a;b;c = 101;56;101 (Poloxamer 407, Pluronic F 127) 12.500 g; medium-chain triglycerides (Miglyol 812) 2.500 g; purified water 49.425 g; lavender oil 0.025 g; orange blossom oil (neroli oil) 0.050 g.

Transparent colorless gel with a characteristic odor.

• Increased sensitivity to ibuprofen and/or any of the components of the product;
• Increased sensitivity to other NSAIDs;
• Disruption of the integrity of the skin at the application site (including infected wounds and abrasions, weeping dermatitis, eczema);
• Use of an occlusive dressing at the application site;
• Pregnancy (third trimester);
• Age under 14 years.
With caution
In the presence of conditions listed in this section, it is necessary to consult a doctor before using the product.
Bronchial asthma, hay fever, nasal mucosa swelling (polypoid rhinosinusitis) or chronic obstructive pulmonary diseases (especially in combination with hay fever symptoms); increased sensitivity to analgesics and anti-inflammatory drugs; renal insufficiency; hepatic insufficiency; peptic ulcer disease, including history; first and second trimesters of pregnancy; breastfeeding period; when applied to large areas of skin and for prolonged periods (1-2 weeks).
Use during pregnancy and breastfeeding
Pregnancy
Data on the safety of ibuprofen use during pregnancy is lacking. Since the effect of inhibiting prostaglandin synthesis on pregnancy is unknown, the use of Dolgit® gel in the first and second trimesters of pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus. The maximum daily dose of the gel should not exceed 20 g, see "Method of use and dosage."
Dolgit® gel is contraindicated in the third trimester of pregnancy.
Considering the mechanism of action of the product, the following adverse effects may develop: prolonged pregnancy and weakened labor activity, manifestation of cardiovascular toxicity in the child (premature closure of the ductus arteriosus and pulmonary hypertension) and renal toxicity (oliguria, oligohydramnios), increased bleeding tendency in the mother and child, and increased propensity for edema in the mother.
Breastfeeding
Ibuprofen and its metabolites pass into breast milk in small amounts. Since no adverse effects on the child have been reported to date, there is usually no need to discontinue breastfeeding with short-term use of Dolgit® gel. However, the maximum daily dose should not exceed 3 applications of a strip of gel 4-10 cm long. If prolonged use of Dolgit® gel is necessary, breastfeeding should be discontinued. During breastfeeding, the woman should not apply Dolgit® gel to the breast area to avoid the product entering the child's body.

The Dolgit® gel is not recommended for use in children and adolescents under 14 years of age due to insufficient data on efficacy and safety in this age group (see "Contraindications").
Patients with bronchial asthma, hay fever, nasal mucosa edema (polypous rhinosinusitis), or chronic obstructive pulmonary diseases (especially when combined with hay fever symptoms), as well as patients with increased sensitivity to analgesics and anti-inflammatory drugs, have an increased risk of bronchial asthma attacks (in cases of intolerance to acetylsalicylic acid and other NSAIDs), angioedema (localized swelling of the skin and mucous membranes), or urticaria compared to other patients.
Dolgit® gel should be used in such patients with caution and under medical supervision. The same precautions should be taken for patients with a history of hypersensitivity reactions (allergic reactions) to other substances (e.g., skin reactions, itching, urticaria).
Avoid contact of the product with the eyes, lips, and other mucous membranes, as well as damaged areas of the skin. Exposure to sunlight in the area of application should be minimized.
Effect on the ability to drive vehicles and operate machinery
Dolgit® gel does not negatively affect the ability to drive vehicles and operate machinery when used once or for a short duration.

The frequency of side effects is presented according to the following classification: very common (≥ 1/10 cases); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10000, < 1/1000); very rare (< 1/10000) and unknown (frequency cannot be determined from the available data). The following adverse reactions have been observed with short-term use of ibuprofen at doses not exceeding 1000 mg/day. Common: skin reactions at the site of gel application (skin redness, itching, burning sensation, papular-vesicular rash); Uncommon: hypersensitivity reactions such as local allergic reactions (contact dermatitis); Very rare: bronchospasm. If Dolgit® gel is applied to large areas of skin and for an extended period, the development of systemic side effects characteristic of ibuprofen cannot be excluded. If any side effects listed in the instructions occur, as well as any other adverse effects not mentioned in the instructions, the use of the product should be discontinued and a doctor should be consulted.The probability of overdose with the external use of Dolgit® gel 5% is minimal. In case of exceeding the recommended dose during local application of the product, the gel can be removed from the skin surface, and the area of application should be washed with water. In the event of applying a very large amount of gel or accidental ingestion of Dolgit® gel, a doctor should be consulted. In children, symptoms of overdose from accidental ingestion may manifest as headache, vomiting, dizziness, and decreased blood pressure. In adults, the dose-dependent effect of overdose is less pronounced. The half-life of the drug in cases of overdose is 1.5-3 hours. Treatment: gastric lavage (only within one hour after ingestion), administration of activated charcoal, alkaline drinking, forced diuresis, symptomatic therapy. There is no specific antidote.The Dolgit® gel should be used with caution in conjunction with other medications, such as:• anticoagulants and thrombolytic agents;• antihypertensive agents;• acetylsalicylic acid;• other NSAIDs.It should be noted that even with external use of ibuprofen, its effect on the body as a whole cannot be completely excluded, and the simultaneous use of ibuprofen in the form of a "gel" with other NSAIDs may enhance side effects. Before starting the use of Dolgit® gel alongside other medications (including over-the-counter drugs), it is advisable to consult a doctor.

Ibuprofen belongs to non-steroidal anti-inflammatory/analgesic agents, exerting its effect by inhibiting prostaglandin synthesis based on animal studies. In humans, ibuprofen reduces the severity of pain, swelling, and fever caused by inflammation. Additionally, ibuprofen reversibly decreases platelet aggregation induced by ADP and collagen.

After oral administration, ibuprofen is partially absorbed in the stomach and then fully absorbed in the small intestine. During biotransformation in the liver (hydroxylation, carboxylation), pharmacologically inactive metabolites are formed, which are primarily excreted by the kidneys (90%) and also eliminated through the hepatobiliary system. The half-life in healthy individuals and in patients with liver and/or kidney diseases is 1.8-3.5 hours. Plasma protein binding is 99%.

After application to the skin, ibuprofen likely accumulates in the skin, from where it is gradually released into the surrounding tissues at a rate of about 5% (bioavailability) of the maximum concentration level observed with oral forms of ibuprofen.

The therapeutic effect observed in the application area is primarily explained by the achievement of therapeutic concentrations in the underlying tissues. The penetration of the gel into the action area varies depending on the degree and type of lesion, as well as the area of gel application and the site of action.

Dolgit 5% gel for external use is a medicinal product designed to relieve pain and reduce inflammatory reactions in musculoskeletal disorders such as rheumatoid arthritis, osteoarthritis, bursitis, and tendinitis. The gel contains the active ingredient ibuprofen, which has analgesic and anti-inflammatory properties. The gel is quickly absorbed into the skin, allowing for rapid and prolonged local effect. Dolgit 5% gel is convenient to use due to its user-friendly form of release.