Thrombocid Forte 5mg/g Ointment 100G

Thrombocid Forte (5 Mg / G Ointment 1 Tube 100 G)

ACTION AND MECHANISM

Pentosan polysulfate sodium is a low molecular weight semisynthetic heparinoid of plant origin. It is precisely its low molecular weight that facilitates its absorption through the skin.

Cutaneously, it presents thrombolytic activity, by preventing the formation of thrombi and favoring the regression of those of small size already formed. In turn, it improves blood supply, especially in the capillaries. Likewise, also through the skin, it shows an anti-ecchymotic activity in models of experimental bruises and bruises, by causing an increase in the rate of their disappearance and reabsorption.

Like other heparinoids, it has anticoagulant activity (much weaker than that of heparin), of interest from a clinical point of view in preparations for systemic administration, but without special relevance for the percutaneous route.

INDICATIONS

- Local symptomatic treatment of superficial venous disorders such as heaviness and tightness in the legs with [VARICES] in adults and superficial [HEMATOMA] produced by blows, in adults and children older than 1 year.

POSOLOGY

Topical route:

- Adults and children> 1 year: apply a thin layer 3-4 times a day. If symptoms persist after 5 days of treatment or irritation or worsening occurs, the clinical situation of the patient should be evaluated.

- Children <1 year: not recommended.

DOSAGE IN KIDNEY INSUFFICIENCY

No specific dosage recommendations have been made.

DOSAGE IN LIVER INSUFFICIENCY

No specific dosage recommendations have been made.

RULES FOR CORRECT ADMINISTRATION

Apply a thin layer to the affected area, distributing it with a gentle massage. A bandage is not normally necessary, but it can be covered with a gauze or pad if necessary.

Never apply on mucous membranes, ulcers or open or infected wounds.

CONTRAINDICATIONS

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

- Patients with bleeding or severe coagulation disorders.

PRECAUTIONS

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

ADVICE TO THE PATIENT

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

- Avoid prolonged use or in large areas of the skin, as well as contact with eyes, mucous membranes or skin wounds.

PREGNANCY

Safety in animals : it does not present teratogenic effects.

Safety in humans : There are no adequate and well-controlled studies in humans. Its administration is only accepted if there are no safer therapeutic alternatives, and the benefits outweigh the possible risks.

Effects on Fertility : No specific studies have been performed in humans.

LACTATION

Animal safety: no data available.

Safety in humans: it is not known if it is excreted with milk, and the consequences it could have for the infant. It is recommended to avoid its administration, unless the benefits to the mother outweigh the risks to the infant.

KIDS

Pentosan polysulfate sodium is authorized for the treatment of bruises in children older than 1 year. Its safety and efficacy have not been evaluated in <1 year, so it is advisable to avoid its use.

ELDERLY

No specific problems have been described in the elderly that require a dosage adjustment.

EFFECTS ON DRIVING

It does not present significant effects.

ADVERSE REACTIONS

Adverse reactions are described according to each frequency range, being considered very common (> 10%), common (1-10%), uncommon (0.1-1%), rare (0.01-0.1%) , very rare (<0.01%) or of unknown frequency (cannot be estimated from the available data).

- Immune system disorders: very rare [HYPERSENSITIVITY REACTIONS].

ADVERSE REACTIONS RELATING TO EXCIPIENTS

- This medicine contains propylene glycol, so it can cause [SKIN IRRITATION].

- Because it contains methyl parahydroxybenzoate, it can cause [HYPERSENSITIVITY REACTIONS] (possibly delayed).

- Because it contains ethyl parahydroxybenzoate, it can cause [HYPERSENSITIVITY REACTIONS] (possibly delayed).

- Containing cetostearyl alcohol can cause local skin reactions, such as [CONTACT DERMATITIS].

OVERDOSE

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

Thrombocid Forte 5mg / g Ointment 100G Leaflet