Instructions Neofen Belupo plus gel for external use 50 mg/g tube 50 g
Composition
active ingredient: ibuprofen;
1 g of gel contains 50 mg of ibuprofen;
Excipients: levomenthol, ethanol 96%, propylene glycol, carbomer 940, diisopropanolamine, purified water.
Dosage form
Gel.
Main physical and chemical properties: transparent gel with a menthol odor. Upon contact with air, the upper layer becomes cloudy and white.
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory drugs for topical use. ATC code M02A A13.
Pharmacological properties
Pharmacodynamics
The gel is intended for external use. Contains the active substance ibuprofen, a product of phenylpropionic acid. Ibuprofen has a pronounced anti-inflammatory and analgesic effect by inhibiting prostaglandin synthesis, which occurs directly in the focus of inflammation. Since the drug is a volatile water-alcohol gel, it has a soothing and cooling effect at the site of application.
Pharmacokinetics
When applied externally, ibuprofen is rapidly and extensively absorbed through the skin (about 22% of the total dose taken within 48 hours) and reaches the site of inflammation, reaching high therapeutic concentrations in soft tissues, joints and synovial fluid. The concentration of the active substance in blood plasma remains insignificant. Therefore, undesirable systemic effects, except for rare cases of hypersensitivity to ibuprofen, are practically absent.
There are no significant differences in the biotransformation and elimination of ibuprofen when administered orally or topically.
Indication
Rheumatic pain, muscle pain, back pain, pain and swelling from sprains, strains and other sports injuries, as well as neuralgia.
Contraindication
Hypersensitivity to ibuprofen or to any of the components of the gel; hypersensitivity reactions (e.g. bronchial asthma, rhinitis, angioedema or urticaria) after the use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs; ulcerative lesions of the gastrointestinal tract; dermatoses; wet eczema.
Pregnancy and breastfeeding. Children under 12 years of age.
Do not apply the medicine to damaged skin or open wounds.
Do not use under occlusive dressings.
Interaction with other medicinal products and other types of interactions
Nonsteroidal anti-inflammatory drugs may interact with blood pressure lowering drugs and may potentiate the effects of anticoagulants, although the likelihood of such events with topical application of the drug is low. Concomitant use of acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs may lead to an increase in the frequency of adverse reactions.
The drug may reduce the diuretic effect of furosemide.
Application features
Contact of the gel with eyes, mucous membranes and damaged skin should be avoided. If this happens, the affected area should be washed with plenty of clean water. If skin rashes occur, the use of the drug should be stopped immediately and consult a doctor.
After applying the gel, wash your hands thoroughly. If the drug is swallowed, the patient should immediately consult a doctor or the nearest emergency room. The gel should not be used under occlusive dressings.
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, mucosal edema, or urticaria than other patients. Systemic absorption of ibuprofen with topical application is less than with oral administration, so the listed complications may occur in rare cases. The use of the drug in these patients should be carried out under the supervision of a physician.
The physician should assess the appropriateness of using this medicinal product in patients with peptic ulcer disease, as well as in patients with impaired renal function, a history of asthma, and patients receiving treatment with oral nonsteroidal anti-inflammatory drugs.
Areas of skin to which the drug is applied should not be exposed to prolonged sunlight to avoid photosensitivity of the skin.
The excipient propylene glycol may in rare cases cause skin irritation.
Ability to influence reaction speed when driving vehicles or other mechanisms
There is no data on the effect of ibuprofen in gel form on the ability to drive or operate potentially dangerous machinery.
Use during pregnancy or breastfeeding
There is no experience with the use of the gel during pregnancy or breastfeeding, so it should not be used in this category of patients.
Fertility
No effect on fertility was observed during use of the gel.
Method of administration and doses
For external use in adults and children over 12 years of age. Apply a thin layer of the gel to the skin in the area of inflammation in strips 4–10 cm long (corresponding to 50–125 mg of ibuprofen) and rub in gently until completely absorbed into the skin. The drug should be used 3–4 times a day with intervals of at least 4 hours. Wash hands after each application of the gel. The recommended dosage must be followed. Do not apply under an occlusive dressing.
The duration of treatment depends on the extent and nature of the lesion and is determined by the doctor based on the clinical picture. After 7 days of use, the appropriateness of treatment should be assessed, especially in the event of recurrence or worsening of symptoms.
Children
Not recommended 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, dizziness; arterial hypotension). If symptoms of overdose appear, you should stop using the drug and consult a doctor.
If the recommended dose is exceeded, the gel should be washed off with water. Specific antidote is unknown. Correction of electrolyte balance is indicated.
Adverse reactions
Skin and subcutaneous tissue disorders: hypersensitivity reactions, which may manifest as skin rashes, urticaria, pruritus, purpura, angioedema, bullous dermatoses (including epidermal necrolysis and erythema multiforme); skin redness, skin irritation, burning sensation, contact dermatitis.
On the part of the respiratory system, thoracic organs and mediastinum: hypersensitivity reactions in the form of attacks of bronchial asthma or worsening of its course, shortness of breath, bronchospasm and dyspnea.
Gastrointestinal: abdominal pain, dyspepsia.
Renal and urinary disorders: renal dysfunction in patients with a history of kidney disease.
Immune system disorders: Hypersensitivity reactions, including anaphylactic shock, angioedema and non-specific allergic reactions.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
50 g in tubes, 1 tube in a cardboard pack.
Vacation category
Without a prescription.
Producer
Belupo, medicines and cosmetics, etc.
Location of the manufacturer and its business address
Danica Street 5, 48000 Koprivnica, Croatia.
