Thrombocid Forte 5mg/g Ointment 100 grams

Thrombocid Forte 5mg/g Ointment 100 grams

Pentosan polysulphate sodium is a low molecular weight semi-synthetic heparinoid of plant origin. It is precisely its low molecular weight that facilitates its absorption through the skin.

It has thrombolytic activity via the skin, preventing the formation of thrombi and promoting the regression of small thrombi already formed. It also improves blood flow, especially in capillaries. It also has anti-echemotic activity in experimental haematoma and ecchymosis models by increasing the rate of disappearance and reabsorption of haematomas and ecchymoses.

Like other heparinoids, it has anticoagulant activity (much weaker than that of heparin), which is of clinical interest in preparations for systemic administration, but not particularly relevant for percutaneous administration.

Indications

-VARICES]: Local symptomatic relief of superficial venous disorders such as heaviness and tightness in legs with varicose veins.

-HEMATOMA]: Local symptomatic relief of superficial haematomas caused by blows.

Posology

Topical use:

- Adults and children > 1 year: 3-4 applications/day for 5-6 days generally. If symptoms persist or irritation or worsening occurs, the clinical situation of the patient should be assessed.

- Children < 1 year: no studies on safety and efficacy have been performed, use is not recommended.

Guidelines for proper administration

Wash hands before and after application.

Apply a thin layer of ointment to the affected area, spreading it with a gentle massage.

A bandage is not normally necessary, but it can be covered with gauze or a compress if necessary.

Never apply to mucous membranes, ulcers and open or infected wounds.

Do not use for a prolonged period of time or on very large areas of skin.

Contraindications

- Hypersensitivity to pentosanopolysulphuric acid or to any other component of the ointment.

- HEMORRHAGE] and/or [COAGULATION ALTERATIONS].

Precautions

- THROMBOEMBOLISM]. Apply the product gently and without massage.

Warnings on excipients:

- Containing ethyl parahydroxybenzoate may cause allergic reactions (possibly delayed).

Warnings on excipients:

- Containing propyl parahydroxybenzoate may cause allergic reactions (possibly delayed).

Warnings about excipients:

- Containing methyl parahydroxybenzoate may cause allergic reactions (possibly delayed).

Warnings about excipients:

- This medicine contains propylene glycol and may cause skin irritation.

Excipient Warnings:

- Containing ketostearyl alcohol may cause local skin reactions such as contact dermatitis.

Advice to the patient

- If symptoms persist for more than 5 days or if irritation or worsening occurs, consult a doctor or pharmacist.

Special warnings

- Never apply to mucous membranes, ulcers and open or infected wounds. Avoid contact with eyes.

- Do not use for prolonged periods of time or on very large areas of skin.

- If symptoms persist for more than 5 days or if irritation or worsening occurs, assess the patient's clinical condition.

Pregnancy

FDA Category C. It is believed that this drug does not cross the placenta. However, there are no adequate and well-controlled studies, so the use of this drug is only acceptable in the absence of safer therapeutic alternatives.

Breast-feeding

It is not known whether this medicinal product is excreted in significant amounts in breast milk, and whether this could affect the child. However, with the use of the topical form it is unlikely that much of the drug will pass into the bloodstream. Not recommended for use.

Children

Safety and efficacy studies have not been performed in children < 1 year of age, so use is not recommended.

Approved for use in children > 1 year of age.

Elderly

No specific geriatric problems have been reported in this age group.

Adverse reactions

Occasionally, skin reactions related to [HYPERSENSITIVITY REACTIONS].

Overdose

In the case of accidental ingestion of the contents of the tube, it is recommended to drink a good quantity of water or other aqueous liquid and, if digestive disorders appear, to go to a hospital centre and apply symptomatic treatment.