Instructions for Dolgit cream tube 100 g
Composition
active ingredient: ibuprofen;
1 g of cream contains ibuprofen 50 mg;
excipients: medium chain triglycerides, glycerol monostearate, polyoxyethylene-30-stearate, polyoxyethylene-100-stearate, propylene glycol, sodium methyl-4-hydroxybenzoate (E 219), xanthan gum (E 415), lavender oil, neroli oil, purified water.
Dosage form
Cream.
Main physicochemical properties: homogeneous, soft cream from white to cream color with a lavender-citrus odor.
Pharmacotherapeutic group
Topical agents for joint and muscle pain. ATX code M02A A13.
Pharmacological properties
Pharmacodynamics.
Dolgit cream is a nonsteroidal anti-inflammatory and analgesic for topical use for joint and muscle pain. Ibuprofen - the active ingredient of the drug Dolgit cream - has a pronounced anti-inflammatory, analgesic and moderate antipyretic effect, reduces swelling that occurs with inflammation caused by injuries or rheumatic diseases, improves joint mobility. The pharmacological activity of the drug is due to its ability to inhibit the synthesis of prostaglandins.
When applied topically, ibuprofen is rapidly absorbed through the skin and penetrates into the focus of inflammation. Penetration to the site of action may vary depending on the degree and type of lesion, as well as the site of application and the site of action.
In joint tissues, therapeutic concentrations are maintained for several hours, while in blood serum the active substance is present in only a small amount, so systemic action is practically absent.
Pharmacokinetics.
Biological transformation of ibuprofen occurs in the liver. Pharmacologically inactive metabolites are eliminated by the kidneys (90%) and with bile. Ibuprofen is 99% bound to plasma proteins. The half-life is 1.8-3.5 hours.
Indication
For local treatment of degenerative joint diseases with pain syndrome (arthrosis), inflammatory rheumatic diseases of the joints and spine, swelling or inflammation of soft tissues near the joints (e.g., bursitis, tendonitis, tendovaginitis, damage to ligaments and joint capsule), stiffness of movements in the shoulder area, lower back pain, lumbago, myalgia, sports and other injuries, such as bruises, muscle strains, sprains of ligaments and tendons.
Contraindication
Dolgit cream is contraindicated:
with increased individual sensitivity to the active substance ibuprofen, the preservative sodium methyl-4-hydroxybenzoate, propylene glycol, to any of the components of the drug or to other analgesics and antirheumatic drugs;
when applied to open wounds, inflammatory and infectious skin diseases such as eczema, as well as mucous membranes;
in the last trimester of pregnancy.
Interaction with other medicinal products and other types of interactions
When the drug is used externally according to the recommendations, no interactions with other drugs were observed.
It is necessary to inform the doctor about simultaneous treatment with other medications, if this occurs, or about recent therapy.
Application features
Patients with asthma, hay fever, swelling of the nasal mucosa (rhinopolyps), chronic obstructive airway diseases or chronic respiratory infections (especially with hay fever symptoms) and patients with hypersensitivity to analgesics and antirheumatic drugs of various types are at increased risk of developing asthma attacks (analgesic intolerance/analgesic asthma), local swelling of the skin and mucous membranes (Quincke's edema) or urticaria.
The use of the drug in such patients should be carried out under special conditions and under the direct supervision of a physician. The drug should be used with caution in patients with hypersensitivity (allergy) to other substances that cause skin irritation, itching, urticaria.
If a skin rash appears, stop using the cream immediately.
Do not allow the drug to get into the eyes.
Care should be taken to ensure that children do not touch the treated areas of skin. Hands should be washed thoroughly after each application of the product, unless they are the object of treatment.
If discomfort during treatment lasts longer than 3 days, you should consult a doctor.
Due to the possible occurrence of excessive photosensitivity, patients should avoid intense exposure to sunlight/UV rays while using the drug.
Propylene glycol may cause skin irritation.
Use during pregnancy or breastfeeding
There is insufficient data to assess the safety of ibuprofen during pregnancy.
Due to the suppression of labor, there is a risk of prolongation of pregnancy and delayed labor, the occurrence of cardiovascular problems (premature closure of the ductus arteriosus, pulmonary hypertension) and renal toxicity (oliguria, oligoamnios) in the fetus, an increased likelihood of bleeding in the mother and child, and an increased risk of edema in the mother.
Only a small amount of active ibuprofen derivatives and its breakdown products pass into breast milk. At the moment there is no data on the negative effect on the newborn, therefore in the case of short-term treatment there is no need to interrupt breastfeeding. However, the daily dose of 4-10 cm of a strip of cream with three applications should not be exceeded, and in the case of long-term treatment it is necessary to interrupt breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
There is no data on the effect of ibuprofen in cream form on the ability to drive and operate potentially dangerous machinery.
Method of administration and doses
For external use only. The drug should be used 3-4 times a day. Depending on the size of the affected area, apply a thin layer of cream to the skin in the area of inflammation/pain in strips 4-10 cm long, which corresponds to 2-5 g of cream (100-250 mg of ibuprofen) followed by gentle rubbing. The maximum daily dose is 20 g of cream (corresponding to 1 g of ibuprofen).
For large hematomas and edema, a cream can be used under an occlusive dressing at the beginning of treatment.
The duration of treatment is determined by the doctor. In most cases, the duration of treatment with the drug is 2-3 weeks. There is no data on the therapeutic benefit of using the drug for a longer period of time. The penetration of the active component can be enhanced by iontophoresis (a special form of electrotherapy). In this case, the drug is applied under the cathode (negative electrode), the current intensity is 0.1-0.5 mA per 5 cm2 of the electrode surface, the duration of the procedure is up to 10 minutes.
Children.
Do not use in children under 14 years of age.
Overdose
If more cream than recommended is applied, remove any remaining cream and rinse the skin with water. If a very large amount is applied or if the cream is accidentally taken internally, a doctor should be informed. 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 (≥ 1/1000, < 1/100), isolated (≥ 1/10000, < 1/1000), rare (< 1/10000), frequency unknown.
Local adverse reactions such as skin redness, itching, burning sensation, exanthema, including the formation of pustules and vesicles, are often observed; infrequently - hypersensitivity reactions and/or local allergic reactions (contact dermatitis); in rare cases, bronchospastic reactions may occur.
When using Dolgit cream on large areas of skin and for a long time, adverse reactions that affect certain organs or the body as a whole and are possible with systemic use of drugs containing ibuprofen cannot be excluded.
Sodium methyl-4-hydroxybenzoate may cause hypersensitivity reactions (possibly delayed).
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging: 20 g or 50 g or 100 g in a tube; 1 tube in a cardboard box.
Vacation category
Without a prescription.
Producer
Dolorgiet GmbH & Co. KG.
Location of the manufacturer and address of its place of business.
Otto von Guericke Str. 1, 53757 Sankt Augustin, Germany/Otto-von-Guericke-Str. 1, 53757 Sankt Augustin, Germany.
