Flamidez phytplus

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FLAMIDASE PHYTOPLUS (FLAMIDASE PHYTOPLUS)

Composition:

Active substances: 1 g of ointment contains levomenthol 50 mg, camphor 100 mg, thymol 10 mg, methyl salicylate 50 mg, eucalyptus oil (Eucalyptus oil) 10 mg, turpentine oil (Turpentine oil) 30 mg;

Excipients: white wax, soft white paraffin.

Pharmaceutical form. Ointment.

Main physicochemical properties: soft mass of almost white color.

Pharmacotherapeutic group.

Topically used agents for joint and muscular pain. Other topically used agents for joint and muscular pain.

ATC Code M02A X10.

Pharmacological properties.

Pharmacodynamics.

Levomenthol.

Levomenthol exerts local irritant, analgesic, counterirritant, antipruritic, antiseptic, and soothing effects. The effect is mainly due to reflex reactions associated with stimulation of sensory nerve endings: stimulation of skin receptors promotes the formation and release of endogenous biologically active substances (enkephalins, endorphins, peptides, kinins), which participate in regulation of pain sensations, vascular permeability, and other processes providing analgesic, counterirritant, and antipruritic actions. The irritant (counterirritant) effect contributes to reduction of pain sensations. Local action is accompanied by vasoconstriction, a sensation of coldness, which then changes into a feeling of mild burning and tingling. Cutaneous-visceral reflexes improve tissue trophism (according to innervation zones). Levomenthol reflexively alters the tone of both superficial and deeply located vessels in tissues and internal organs.

Camphor.

Camphor exhibits antiseptic, locally irritant, analeptic, and antiaggregatory effects. It demonstrates peripheral pressor activity. It inhibits platelet aggregation. When applied locally, it shows counterirritant properties.

Thymol.

Thymol is an antiseptic and disinfectant. By destroying enzymes essential for microbial viability, it prevents the spread of putrefaction processes and arrests them if already initiated.

Methyl salicylate.

Methyl salicylate exerts anti-inflammatory and analgesic effects. It non-selectively inhibits cyclooxygenase, reducing prostaglandin synthesis. It normalizes increased capillary permeability, improves microcirculation, reduces edema and infiltration of inflamed tissues.

Eucalyptus oil and turpentine oil.

Eucalyptus oil exhibits antiseptic and anti-inflammatory effects and reduces sensitivity upon local application. Eucalyptus oil also stimulates cardiac activity. Turpentine oil is used locally as a counterirritant and warming agent.

Clinical characteristics.

Indications.

Use for muscle and joint pain.

Contraindications.

Hypersensitivity to the components of the medicinal product, acetylsalicylic acid, and other nonsteroidal anti-inflammatory agents; skin diseases and skin injuries at the site intended for application of the medicinal product, including burns, eczema, dermatitis, and pyoderma; bronchial asthma, whooping cough, pseudocroup; epilepsy, predisposition to seizures.

Interaction with other medicinal products and other forms of interaction.

Although adequate controlled interaction studies have not been conducted, excessive use of topical salicylates may potentially enhance the effect of coumarin anticoagulants and antiplatelet medicinal agents. Therefore, caution is advised in patients taking coumarin anticoagulants and antiplatelet agents, including aspirin.

Special precautions for use

FLAMIDES PHYTOPRO PLUS is intended for topical use only. Do not apply tight bandages, do not use simultaneously with individual heating devices, and do not apply heating dressings over the area where the ointment has been applied. Do not use on mucous membranes. Avoid contact of the medicinal product with eyes and mucous membranes. In case of accidental contact with eyes, rinse thoroughly with water and seek immediate medical advice. In case of accidental ingestion or overdose, seek immediate medical attention.

The medicinal product should be applied only to intact healthy skin; it must not be applied to open wounds. If local irritation occurs, discontinue use and initiate appropriate therapy. Hands should always be washed after applying the medicinal product.

Do not apply the medicinal product to large areas of skin.

Do not apply to children’s facial skin due to the risk of reflex bronchospasm.

Note that the medicinal product may leave stains on fabric it comes into contact with.

Use during pregnancy or breastfeeding

Do not use during pregnancy or breastfeeding.

Effect on ability to drive or operate machinery

No effect.

Dosage and Administration.

For muscle and joint pain, apply the ointment in a thick layer to the affected muscle or joint area and gently rub in.

For adults and children, apply the medicinal product up to 3 times daily. The duration of treatment is determined individually, depending on the severity of the condition and clinical response.

Children. The medicinal product is indicated for children aged 3 years and older.

Overdose.

Symptoms.

Possible intensification of adverse reaction symptoms, sensation of strong warmth and burning. In case of accidental oral ingestion, abdominal pain, nausea, vomiting, diarrhea, headache, symptoms of central nervous system depression, dizziness, ataxia, seizures, flushing, drowsiness, respiratory difficulty, and reflex respiratory arrest may occur.

The product generally does not exhibit systemic toxic effects when the recommended dose is exceeded; however, excessive topical application over large skin areas may potentially cause toxic symptoms such as nephrotoxicity and central nervous system disturbances (occurring directly after camphor application).

Accidental exposure of the product to the nose or face of infants and children may cause apnea due to laryngospasm—a condition requiring emergency medical intervention.

Treatment.

In case of local reactions following topical application, wash off the product with water and soap.

In case of accidental oral ingestion, seek immediate medical attention. Do not induce vomiting.

In the event of symptoms of camphor intoxication (after accidental ingestion of a large amount of the product), such as nausea, vomiting, abdominal pain, headache, dizziness, facial flushing or redness, warmth sensation, excitement, hallucinations, seizures, respiratory depression, or coma, hospitalization and inpatient monitoring are indicated. In cases of respiratory depression, intubation is strongly recommended, along with assisted mechanical ventilation and intensive care support as needed.

Patients presenting with severe gastrointestinal or neurological symptoms of poisoning require medical supervision and symptomatic treatment.

Side effects.

Immune system disorders: hypersensitivity reactions.

Skin and subcutaneous tissue disorders: hyperemia, mild local irritation, erythema, rash, urticaria, desquamation, pruritus, dermatitis, burns, blisters, temporary mild skin discoloration.

Respiratory system disorders: bronchospasm.

Nervous system disorders: headache, dizziness, excitation, seizures.

When the ointment is applied to large areas of skin over a prolonged period, systemic adverse reactions characteristic of methyl salicylate may occur (including tinnitus, visual disturbances, nausea, vomiting, diarrhea, epigastric pain).

Prolonged use may increase sensitivity to the medicinal product and reduce its clinical efficacy.

Reporting of adverse reactions after marketing authorization is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmacy professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the automated pharmacovigilance information system at: https://aisf.dec.gov.ua

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Do not freeze. Keep out of reach of children.

Packaging.

20 g or 40 g in a tube; 1 tube per cardboard pack.

20 g in a container; 1 container per pack.

Supply category. Over-the-counter.

Manufacturer.

Encube Ethicals Private Limited.

Manufacturer's address and location of operations:

Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post Mardol, Ponda, Goa – 403 404, India.