Instructions for Darfen gel tube 100 g
Composition
active ingredient: ibuprofen, levomenthol;
1 g of gel contains: ibuprofen 50 mg, levomenthol 30 mg;
excipients: ethanol 96%, propylene glycol, carbomer, diisopropanolamine, purified water.
Dosage form
Gel.
Main physicochemical properties: transparent homogeneous gel with a menthol odor.
Pharmacotherapeutic group
Topical agents used for joint and muscle pain.
ATX code M02A X10.
Pharmacological properties
Pharmacodynamics
Darfen® Gel is a combined preparation for external use containing ibuprofen with menthol of natural origin. Ibuprofen, a derivative of phenylpropionic acid, is a representative of the group of non-steroidal anti-inflammatory drugs (NSAIDs), has an analgesic, anti-inflammatory effect due to the inhibition of prostaglandin synthetase. The action of levomenthol, an optical isomer of menthol, is due to reflex reactions associated with irritation of sensitive nerve endings of the skin. Menthol stimulates skin nociceptors. As a result, peptides are released that have a vasodilating effect. The drug has a distracting and irritating effect, and also relieves pain.
Pharmacokinetics
Ibuprofen is well and rapidly absorbed through the skin when applied topically. It enters the systemic circulation in very small quantities. The maximum concentration of ibuprofen in the blood plasma is reached 2 hours after application of the drug and is 0.6 μg/ml. The absorption of ibuprofen when applied topically is approximately 5% of the absorption when taken orally.
Levomenthol absorbed through the skin is transported to the liver. Some phase I metabolism may occur in the skin, but the majority occurs in the liver. Menthol is hydroxylated and then conjugated with a glucuronide before circulating to the kidneys for excretion in the urine.
Indication
Darfen® Gel is recommended for pain relief and inflammation reduction in rheumatic, muscle and joint pain, back pain, as well as pain and swelling due to injuries, sprains and sports injuries.
Contraindication
The drug is contraindicated:
with hypersensitivity to ibuprofen, levomenthol, acetylsalicylic acid or to any component of the drug or other NSAIDs (including oral administration);
with asthma and a history of attacks of bronchial asthma, urticaria, angioedema or acute rhinitis caused by taking acetylsalicylic acid or other NSAIDs;
for use on damaged or bare (without epithelium) skin;
for use on open wounds, for inflammatory and infectious skin diseases such as wet eczema, as well as for use on mucous membranes;
for dermatoses;
in the presence of local infection;
for simultaneous use on the same area with other topical preparations;
with ulcerative lesions of the gastrointestinal tract.
Interaction with other medicinal products and other types of interactions
When used together with acetylsalicylic acid or other NSAIDs, the risk of side effects increases. NSAIDs can interact with drugs intended to lower blood pressure, can reduce the diuretic effect of furosemide and can enhance the effect of anticoagulants, although this probability is very low for topical drugs.
Application features
The medicine contains propylene glycol, which can cause skin irritation, therefore, before first use, it is necessary to check the patient's sensitivity to Darfen® Gel on a small area of skin.
Oral ibuprofen is known to aggravate renal failure or exacerbate active peptic ulcer disease. Patients with impaired renal function, asthma, a history of active gastric or duodenal ulcer disease, and patients receiving oral NSAIDs should consult a doctor before using the drug. The gel should not be applied to mucous membranes, near mucous membranes, lips, nostrils, areas near the eyes, genitals, and anus, or to damaged, inflamed, or irritated skin. If the gel gets on these areas, the drug should be washed off immediately with plenty of clean water.
After applying Darfen® Gel, hands should always be washed unless they are being treated.
If the medicine is swallowed, the patient should immediately consult a doctor or go to the nearest emergency room.
Do not apply an airtight bandage to the area where the gel was applied.
Discontinue use if rash or irritation occurs and consult a doctor.
Adverse reactions can be reduced by using the lowest effective dose for the shortest period of time.
The use of Darfen® Gel, as with other drugs that inhibit cyclooxygenase/prostaglandin synthesis, may impair fertility, although this is less likely for topical NSAIDs than for oral agents. In women who have difficulty conceiving or who are undergoing fertility studies, it may be advisable to discontinue use of Darfen® Gel.
Patients with bronchial asthma, hay fever, chronic lung disease, and patients with hypersensitivity to analgesics and antirheumatic drugs are at greater risk of developing asthma attacks, swelling of the mucous membrane (Quincke's edema) or urticaria than other patients. Systemic absorption of ibuprofen with topical application is less than with oral administration, so these complications may occur rarely. The use of the drug in such patients should be carried out under the supervision of a physician.
It is necessary to ensure that children do not touch the areas of skin on which the medicine has been applied.
Areas of skin to which the medicine is applied should not be exposed to prolonged sunlight to avoid photosensitivity of the skin.
Use during pregnancy or breastfeeding
The safety of ibuprofen during pregnancy in humans has not been adequately documented. Animal studies using the oral formulation have not shown teratogenic effects.
Ibuprofen and its metabolites pass into breast milk, so the use of this medicine during breastfeeding is not recommended.
The drug is not recommended for use in the first and second trimesters of pregnancy or during breastfeeding. The drug is contraindicated in the third trimester, since in case of sufficient systemic concentration, the risk of delayed labor, premature closure of the ductus arteriosus, bleeding in the mother and newborn, and edema in the mother increases.
Ability to influence reaction speed when driving vehicles or other mechanisms
Not installed.
Method of administration and doses
For external use only.
The sealed hole in the tube must be pierced with a spike located in the upper outer part of the cap.
For each application, use 1-7 cm of gel from a tube containing 50 g or 100 g of gel, and 4-10 cm from a tube containing 15 g of gel.
Apply the gel to the painful area and rub in gently until completely absorbed. If necessary, apply up to 3 times a day, but not more often than every 4 hours. If there is no improvement in the condition after two weeks, consult a doctor. Do not apply a bandage to the area where the gel was applied.
Children
The drug is contraindicated for use in children under 12 years of age.
Overdose
The probability of overdose when using ibuprofen in the form of a gel for external use is insignificant. However, in case of overdose, side effects are possible that are observed with systemic use of ibuprofen (dyspepsia: nausea, heartburn, vomiting, flatulence; allergic skin reactions; headache, drowsiness, dizziness; arterial hypotension). If symptoms of overdose appear, the drug should be discontinued and a doctor should be consulted. If the recommended dose is exceeded, the gel should be washed off with water. The specific antidote is unknown. Correction of electrolyte balance is indicated.
Adverse reactions
Skin and subcutaneous tissue disorders: hypersensitivity reactions, which may manifest as cutaneous purpura, angioedema, bullous dermatoses (including epidermal necrolysis and erythema multiforme); skin redness, skin irritation, photosensitivity reactions. The most common skin disorders are: rash, urticaria, itching, dry skin, burning sensation, contact dermatitis.
Respiratory, thoracic and mediastinal disorders: Hypersensitivity reactions in the form of asthma attacks or worsening of asthma, shortness of breath, dyspnoea and bronchospasm may occur in patients with a history of asthma attacks or allergic diseases.
From the gastrointestinal tract, depending on the amount of gel applied, the area of application, the integrity of the skin, the duration of treatment, and the presence of an occlusive dressing, the following are possible, although unlikely: abdominal pain, dyspepsia.
Renal and urinary disorders: renal dysfunction in patients with a history of renal disease.
Immune system disorders: Hypersensitivity reactions, including anaphylactic shock, angioedema and non-specific allergic reactions.
Other systemic adverse reactions to NSAIDs depend on the amount of gel applied, the area of application, skin integrity, duration of treatment, and use of an occlusive dressing.
Reporting of suspected adverse reactions.
Reporting suspected adverse reactions after the marketing authorisation of a medicinal product is an important procedure. It allows for continued monitoring of the benefit-risk balance of the medicinal product concerned. Healthcare professionals should report any suspected adverse reactions via the national reporting system.
Expiration date
3 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Incompatibility
Do not use with other topical medications.
Packaging
15 g or 50 g or 100 g in a tube; 1 tube in a pack.
Vacation category
Without a prescription.
Producer
PrJSC "Pharmaceutical Company "Darnitsa".
Location of the manufacturer and address of its place of business
Ukraine, 02093, Kyiv, Boryspilska St., 13.
