Instructions Set Deep Relief Gel 5% in a 100 g tube + Argette Pain Relief Patch 10 cm? 12 cm No. 5
Composition
active ingredients: ibuprofen, levomenthol;
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. ATX 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.
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
Deep Relief 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 non-steroidal anti-inflammatory drugs (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 non-steroidal anti-inflammatory drugs;
- 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 drugs from the group of non-steroidal anti-inflammatory drugs, the risk of side effects increases. Non-steroidal anti-inflammatory drugs may interact with drugs intended to lower blood pressure, may reduce the diuretic effect of furosemide and may 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 first use, it is necessary to check the patient's sensitivity to Deep Relief on a small area of skin.
Oral ibuprofen is known to worsen 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 nonsteroidal anti-inflammatory drugs should consult a doctor before using the drug.
The gel should not be applied to or near mucous membranes, lips, nostrils, areas near the eyes, genitals, or anus, or to damaged, inflamed, or irritated skin. If the gel gets on the above areas, rinse 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 and consult a doctor.
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, 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 appropriate to discontinue Deep Relief.
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 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.
It is necessary to ensure that children do not touch the areas of skin on which the drug has been applied.
Areas of skin to which the drug is applied should not be exposed to prolonged sunlight to avoid photosensitivity of the skin.
Use during pregnancy or breastfeeding
Pregnancy
Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/foetal development. Epidemiological data suggest an increased risk of miscarriage, cardiac malformations and gastroschisis after the use of prostaglandin synthesis inhibitors in early pregnancy. The absolute risk of cardiovascular malformation has increased from less than 1% to approximately 1.5%. The risk is thought to increase with increasing dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals treated with a prostaglandin synthesis inhibitor during the organogenetic period. Ibuprofen should not be administered during the first and second trimesters of pregnancy unless clearly necessary. If ibuprofen is used by a woman trying to conceive, or in the first and second trimesters of pregnancy, the dose should be as low as possible and the duration of treatment as short as possible.
The use of any prostaglandin synthesis inhibitor during the third trimester of pregnancy may result in the fetus having:
- cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
- renal impairment, which may progress to renal failure with oligohydramnios;
in the mother and newborn at the end of pregnancy:
- possible prolongation of bleeding time, anti-aggregation effect, which may occur even when using very low doses;
- suppression of uterine contractions, leading to delayed or prolonged labor.
Therefore, ibuprofen is contraindicated in the third trimester of pregnancy.
Breast-feeding
Ibuprofen is excreted in breast milk in minimal amounts and is not expected to affect the breastfed infant. Topical ibuprofen as a monotherapy can be used during breast-feeding. However, there is insufficient information on the excretion of levomenthol and its metabolites into breast milk. In the absence of sufficient data, use during breast-feeding is not recommended.
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 a strip of gel 1-4 cm 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, 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, you should consult a doctor.
A bandage should not be applied to the area where the gel was applied.
Children.
Deep Relief 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, 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.
Side effects
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. The most common skin disorders are: rash, urticaria, itching, dry skin, burning sensation, contact dermatitis. Photosensitivity reaction - frequency unknown.
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 nonsteroidal anti-inflammatory drugs depend on the amount of gel applied, the area of application, the integrity of the skin, the duration of treatment, and the use of an occlusive dressing.
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.
Vacation category
Without a prescription.
Producer
The Mentholatum Company Limited.
Address
1 Redwood Avenue, Peel Park Campus, East Kilbride, G74 5PE, United Kingdom.
2. Argette pain relief patch 10 cm x 12 cm No. 5
Composition
Methyl salicylate 5.7%, levomenthol 5.7%, camphor 1.2%, tocopherol acetate 2.0%.
Auxiliary components: acrylic saturated hydrocarbon resin, liquid paraffin, polyisobutylene, potisobutylene 1200000, block copolymers of butadiene and styrene, synthetic aluminum sitcat, fabric backing and protective paper.
Recommendations for use
For the symptomatic relief of acute and chronic pain associated with inflammation of tendons, ligaments, muscles and joints of traumatic origin, with sprains of ligaments and tendons, dislocations, bruises, pain in the joints, back, neck and lower back in adults and children over 12 years of age.
Method of application
For external use only.
Clean and dry the affected area and apply the patch, having previously removed the protective paper.
The duration of use of one patch is usually 8-12 hours. During the day, no more than 2 patches can be applied to the painful area.
If necessary, you can cut the patch and use a part that corresponds to the size of the affected area.
Application scheme
- Bend the patch in the middle and release part of the surface from the protective paper.
- Apply the patch to the painful area of skin and pull out part of the protective paper from under the patch.
- Smooth out.
Contraindication
Hypersensitivity to the active ingredients of the patch, to nonsteroidal anti-inflammatory drugs (NSAIDs), allergy to aspirin or salicylates.
The active ingredients do not enter the systemic bloodstream, but it is not recommended for use in cases of gastric or duodenal ulcer, gastrointestinal bleeding, a history of bronchial asthma, heart failure, severe forms of liver and kidney failure, pregnant and lactating women, children and adolescents under 12 years of age.
Do not allow the surface of the patch to come into contact with the eyes or mucous membranes.
Also, do not use on open wounds or areas of skin with pathological changes, such as eczema, acne, dermatitis, inflammation or infections of various origins.
Reservation
The product is not intended for internal use.
Consult a doctor before use.
Do not use simultaneously with a heating pad.
In case of accidental ingestion, seek medical attention immediately.
Stop using the patch and see a doctor if:
- in case of worsening skin condition (rash, itching or severe skin irritation).
- if pain symptoms persist for 3 days or symptoms recur after a short-term improvement.
Storage conditions
Store in the original packaging at a temperature not exceeding 25°C, protected from light and out of the reach of children.
Do not use after the expiration date indicated on the packaging.
After first opening the sachet, use within one month.
Shelf life 3 years.
Release form
1, 2, 5 or 10 patches measuring 10 cm (cm) x 12 cm (cm), in a sachet, 1, 2 or 5 sachets in a cardboard box.
