Potaba Capsules

1. Name Of The Medicinal Product

Potaba®(Potassium para-aminobenzoate)

2. Qualitative And Quantitative Composition

Capsules: white/white gelatin capsule shell containing the active ingredient 500mg of potassium para-aminobenzoate powder.

3. Pharmaceutical Form

Capsules: White/white size zero gelatin capsules containing 500mg potassium para-aminobenzoate with Potaba 51 on the shell.

4. Clinical Particulars

4.1 Therapeutic Indications

Peyronie's Disease

Scleroderma

4.2 Posology And Method Of Administration

Potaba capsules should be taken orally; six capsules four times daily with food.

Children: not recommended.

4.3 Contraindications

Potaba should not be given to patients taking sulphonamides as it will inactivate this medication.

4.4 Special Warnings And Precautions For Use

Treatment with Potaba should be interrupted during periods of low food intake (egg, during fasting, anorexia, nausea). This is to avoid the possible development of hypoglycaemia.

Potaba treatment should be given cautiously to patients with renal impairment and treatment discontinued if a hypersensitivity reaction occurs.

Potaba should not be taken by patients on sulphonamides; Potaba may cause inactivation of this medication.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

With the exception of sulphonamides, no interactions with other medicaments have been established.

4.6 Pregnancy And Lactation

No information is available on this, therefore it is not recommended.

4.7 Effects On Ability To Drive And Use Machines

There is no evidence that Potaba has any effect on ability to drive or use machines.

4.8 Undesirable Effects

Treatment with Potaba should be interrupted during periods of low food intake,(e.g. during fasting, anorexia, nausea).This is to avoid the possible development of hypoglycaemia.

No serious adverse effects have been reported in patients treated with Potaba.

4.9 Overdose

No particular problems are expected following overdosage with Potaba. Symptomatic and supportive therapy should be given as appropriate.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

P.Aminobenzoate is considered a member of the Vitamin B complex. Small amounts are found in cereal, eggs, milk and meats. Detectable amounts are normally present in human blood, spinal fluid, urine and sweat. The pharmacological action of this chemical has not been clearly established, but it has been suggested that the antifibrosis activity of Potaba is brought about by the drug increasing oxygen uptake at the tissue level. Fibrosis is believed to occur from either too much serotonin or too little monoamine oxidase activity over a period of time. The activity of monoamine oxidase is dependant on an adequate oxygen supply. By increasing oxygen supply at tissue level Potaba enhances monoamine oxidase activity thereby preventing or bringing about regression of fibrosis.

5.2 Pharmacokinetic Properties

Potaba is rapidly absorbed and metabolised as food. Excretion is through renal function.

5.3 Preclinical Safety Data

N/A

6. Pharmaceutical Particulars

6.1 List Of Excipients

None

6.2 Incompatibilities

Sulphonamides.

6.3 Shelf Life

Capsules: three years from date of manufacture.

6.4 Special Precautions For Storage

Store below 25ºC.

6.5 Nature And Contents Of Container

.

White polypropylene tube with tamper-evident polyethylene cap. A filla may be inserted to reduce ullage.

Containers of 240 x 500mg capsules.

6.6 Special Precautions For Disposal And Other Handling

7. Marketing Authorisation Holder

Glenwood Laboratories Ltd. ,

Jenkins Dale,

Chatham

Kent ME4 5RD

8. Marketing Authorisation Number(S)

Potaba Capsules: 00245/5001R

9. Date Of First Authorisation/Renewal Of The Authorisation

March 1998

10. Date Of Revision Of The Text

June 2002