Instructions for Deep Relief gel tube 50 g
Composition
active ingredients: 1 g of gel contains ibuprofen 50 mg, levomenthol 30 mg;
excipients: propylene glycol, carbomer, diisopropanolamine, ethanol 96%, purified water.
Dosage form
Gel.
Main physicochemical properties: transparent gel without foreign particles with a menthol odor.
Pharmacotherapeutic group
Topical agents used for joint and muscle pain. ATC code M02A X10.
Pharmacological properties
Pharmacodynamics
Deep Relief 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 nonsteroidal anti-inflammatory drugs, 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, irritating effect and relieves pain.
Pharmacokinetics
Ibuprofen is well and rapidly absorbed through the skin when applied topically. It enters the systemic circulation in very small amounts. 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.
Indication
Deep Relief is recommended for pain relief and inflammation reduction in rheumatic, muscle and joint pain, back pain, as well as pain and swelling from injuries, sprains, and sports injuries.
Contraindication
The drug is contraindicated:
with hypersensitivity to ibuprofen, levomenthol, acetylsalicylic acid or any component of the drug or other non-steroidal anti-inflammatory drugs (including oral administration); with asthma and a history of attacks of bronchial asthma, urticaria or acute rhinitis caused by taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs; for use on damaged or bare (without epithelium) skin; for simultaneous use on the same area with other topical drugs; in the presence of local infection.
Interaction with other medicinal products and other types of interactions
When used together with acetylsalicylic acid or other drugs from the group of non-steroidal anti-inflammatory drugs, the risk of side effects increases. Non-steroidal anti-inflammatory drugs can interact with drugs intended to lower blood pressure and can enhance the effect of anticoagulants, although this probability is very low for topical drugs.
Application features
The drug contains propylene glycol, which can cause skin irritation, so before use, it is necessary to check the patient's sensitivity to Deep Relief on a small area of skin.
Patients with impaired renal function and active gastric and duodenal ulcers should consult a doctor before using the drug.
Do not apply the gel near mucous membranes, on the lips, nostrils, areas near the eyes, genitals and anus, as well as on damaged or irritated skin. In case of contact with the gel on the above areas, the drug must be washed off immediately with plenty of clean water.
After applying Deep Relief gel, you should always wash your hands unless they are the object of treatment.
If the drug is swallowed, the patient should immediately consult a doctor or 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.
Adverse reactions can be reduced by using the lowest effective dose for the shortest possible period.
If any undesirable effects occur, as well as if there is no improvement or if the condition worsens, the patient should consult a doctor.
The use of Deep Relief, as with other drugs that inhibit cyclooxygenase/prostaglandin synthesis, may impair fertility. Women who are unable to conceive or who are undergoing fertility studies should avoid the use of Deep Relief.
Use during pregnancy or breastfeeding
The drug is not recommended for use during 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 there is a risk of delayed labor, premature closure of the ductus arteriosus, increased likelihood of bleeding in the mother and child and increased risk of edema in the mother.
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 1-4 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
Deep Relief is contraindicated for use in children under 12 years of age.
Overdose
Overdose is unlikely with topical application. Symptoms caused by ibuprofen: nausea, headache, drowsiness, hypotension, vomiting.
Correction of electrolyte balance is indicated.
Adverse reactions
The following adverse reactions may occur as local adverse reactions: skin irritation, rash, itching, redness, dry skin, burning sensation, contact dermatitis and urticaria.
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, and renal failure in patients with a history of kidney disease.
The following hypersensitivity reactions have been reported with ibuprofen treatment:
a) nonspecific allergic reactions and anaphylaxis;
b) reactions of increased airway reactivity, including asthma, aggravated asthma, bronchospasm and dyspnea, can be expected in patients who have had or currently have bronchial asthma or allergic diseases;
c) rash, pruritus, urticaria, purpura, angioedema and rarely bullous dermatosis (including epidermal necrolysis and erythema multiforme).
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25°C out of the reach of children.
Incompatibility.
Do not use with other topical medications.
Packaging
15 g or 50 g or 100 g of gel in a tube; one tube in a cardboard box with instructions for medical use.
Vacation category
Without a prescription.
Producer
The Mentholatum Company Limited.
Location of the manufacturer and its business address
1 Redwood Avenue, Peel Park Campus, East Kilbride, G74 5PE, United Kingdom/1 Redwood Avenue, Peel Park Campus, East Kilbride, G74 5PE, United Kingdom.
