Potaba Sachets

1. Name Of The Medicinal Product

Potaba® (Potassium para-aminobenzoate)

2. Qualitative And Quantitative Composition

Envules: foil laminate sachets containing 3g of potassium para-aminobenzoate.

3. Pharmaceutical Form

Envule; contains 3g potassium para-aminobenzoate; white/off-white powder.

4. Clinical Particulars

4.1 Therapeutic Indications

Peyronie's Disease

Scleroderma

4.2 Posology And Method Of Administration

Potaba envules should be taken orally; four times daily with food; dissolve the powder in fruit juice.

Children: not recommended.

4.3 Contraindications

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

Severe liver damage.

4.4 Special Warnings And Precautions For Use

Treatment with Potaba should be interrupted during periods of low food intake (eg, 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.

In patients with known liver function disorders, eg hepatitis or toxic poisoning,(eg alcohol abuse), liver function tests should be performed regularly (transaminases, GGT, ALP, LDH).

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,(eg during fasting, anorexia, nausea.) This is to avoid the possible development of hypoglycaemia.

Rarely: increased liver enzyme activity up to hepatitis.

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 in this presentation.

6.2 Incompatibilities

Sulphonamides.

6.3 Shelf Life

Envules: five years from date of manufacture.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

Cardboard outer containing 40 x 3g foil laminate sachets.

6.6 Special Precautions For Disposal And Other Handling

Not applicable

7. Marketing Authorisation Holder

Glenwood Laboratories Ltd.

Jenkins Dale,

Chatham

Kent ME4 5RD

8. Marketing Authorisation Number(S)

Potaba Envules: 00245/5000R

9. Date Of First Authorisation/Renewal Of The Authorisation

March 2003

10. Date Of Revision Of The Text

Sept 05, April 02