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DAPSONE Tablet (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

DAPSONE TABLETS BP 50mg.

Qualitative and quantitative composition

Each tablet contains 50mg Dapsone PhEur.

Pharmaceutical form

White uncoated tablets. White, circular, biconvex uncoated tablets impressed C on one face and the identifying letters DP on either side of a central division line on the reverse.

Therapeutic indications

As part of a multi-drug regimen in the treatment of all forms of leprosy. Treatment of dermatitis herpetiformis and other dermatoses. Prophylaxis of malaria in combination with pyrimethamine. Prophylaxis ...

Posology and method of administration

Posology Adults and children over 12 years Multibacillary leprosy (3-drug regimen): 100mg daily for at least two years. Paucibacillary leprosy (2-drug regimen): 100mg daily for at least six months. Malaria ...

Contraindications

Known hypersensitivity to sulfonamides, sulfones, or any of the excipients; severe anaemia; porphyria; severe glucose-6-phosphate dehydrogenase deficiency. Dapsone contains lactose. Patients with rare ...

Special warnings and precautions for use

Dapsone should be used with caution in patients with cardiac or pulmonary disease. It is recommended that regular blood counts be performed during treatment with dapsone. Patients deficient in glucose-6-phosphate ...

Interaction with other medicinal products and other forms of interaction

Excretion of dapsone is reduced and plasma concentrations are increased by concurrent administration of probenecid. Rifampicin has been reported to increase the plasma clearance of dapsone. Increased dapsone ...

Pregnancy and lactation

It is now generally considered that the benefits of dapsone in the treatment of leprosy outweigh any potential risk to the pregnant patient. Some leprologists recommend 5mg folic acid daily for leprosy ...

Effects on ability to drive and use machines

None known.

Undesirable effects

Dapsone should be discontinued or reduced in dosage if severe lepra reactions affecting the eyes or nerve trunks occur. Varying degrees of dose-related haemolysis and methaemoglobinaemia are the most frequently ...

Overdose

Symptoms are hypoxia, methaemoglobinaemia and haemolytic anaemia. In severe overdosage the stomach should be emptied by gastric lavage. Administration of activated charcoal by mouth has been shown to enhance ...

Pharmacodynamic properties

Dapsone is a sulfone active against a wide range of bacteria. Dapsones mechanism of action is probably similar to that of the sulfonamides which involves inhibition of folic acid synthesis in susceptible ...

Pharmacokinetic properties

Dapsone is almost completely absorbed from the GI tract with peak plasma concentrations occurring about 2-8 hours after a dose. Steady-state concentrations are not obtained until after at least 8 days ...

Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

List of excipients

Also contains: Lactose Magnesium stearate Maize starch Sodium lauryl sulfate

Incompatibilities

None known.

Shelf life

PVC Blister Packs: Three years. All other packs: Eighteen months.

Special precautions for storage

Store below 25°C in a dry place.

Nature and contents of container

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers with polyfoam wad or polyethylene ullage filler and snap-on polyethylene lids; in case ...

Special precautions for disposal and other handling

Not applicable.

Marketing authorization holder

Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Marketing authorization number(s)

PL 0142/6609 R

Date of first authorization / renewal of the authorization

November 1988; November 1993 Renewed: 17.11.93, 28.1.99

Date of revision of the text

30/08/2019

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