SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Potaba 500mg Capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains 500 mg potassium para-aminobenzoate. Excipients

For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Capsule

White gelatin capsules marked with Potaba 51 on the shell.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Potaba 500 mg capsules are indicated for the treatment of Peyronie's Disease and Scleroderma.

Potaba 500 mg capsules are indicated in adults.

4.2 Posology and method of administration

Posology

Six capsules should be taken orally, four times daily with food.

Paediatric population

The safety of Potaba 500 mg capsules in children aged 0 to 18 years has not been established. No data are available.

Method of administration For oral use.

Potaba 500 mg capsules should be taken with food.

Hypersensitivity to the active substance or to any of the excipients.

Potaba 500 mg capsules should not be given to patients taking sulphonamides as these medicinal products will inactivate potassium para-aminobenzoate (see section 4.5 Interaction with other medicinal products and other forms of interaction).

Severe liver damage.

4.4 Special warnings and precautions for use

Treatment with Potaba 500 mg capsules should be interrupted during periods of low food intake (eg, during fasting, anorexia, nausea). This is to avoid the possible development of hypoglycaemia. (see section 4.8 Undesirable effects).

Potaba 500 mg capsules should be given cautiously to patients with renal impairment and treatment should be 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, APL, LDH).

4.5 Interaction with other medicinal products and other forms of interaction

Sulphonamides will inactivate potassium para-aminobenzoate (see section 4.3 Contraindications).

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no or limited amount of data from the use of potassium para-aminobenzoate in pregnant women.

Potaba 500 mg capsules are not recommended during pregnancy. Breastfeeding

It is unknown whether potassium para-aminobenzoate/metabolites are excreted in human milk.

A risk to the newborns/infants cannot be excluded.

Fertility

There are no or limited amount of data on the effects of potassium para-aminobenzoate on fertility.

4.7 Effects on ability to drive and use machines

Potaba 500 mg capsules have no or negligible influence on the ability to drive and use machines. If patients experience confusion, lethargy or weakness they should not drive until such symptoms have fully reversed.

4.8 Undesirable effects

The following convention has been utilized for the classification of undesirable effects:-

Very common (>1/10), common (>1/100, <1/10), uncommon

(>1/1000, <1/100), rare (>1/10000, <1/1000), very rare (<1/10000), not known

(cannot be estimated from the available data).

Metabolism and nutrition disorders
Not known	Hypoglycaemia (See section 4.4 Special warning and precautions for use)
Hepatobiliary disorders
Rare	Elevated hepatic enzyme activity in some cases leading to hepatitis

4.9 Overdose

No particular problems are expected following over dose with Potaba 500 mg capsules. Symptomatic and supportive therapy should be given as appropriate.

5 PHARMACOLOGICAL PROPERTIES

Pharmacodynamic properties

Pharmacotherapeutic group: Antifibrosis agent Mechanism of action

Potassium para-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 potassium para-aminobenzoate 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 potassium para-aminobenzoate enhances monoamine oxidase activity thereby preventing or bringing about regression of fibrosis.

5.2    Pharmacokinetic properties

Potassium para-aminobenzoate is rapidly absorbed and metabolised as food. Excretion is through renal function.

5.3    Preclinical safety data

Not applicable.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Capsule shell:

Gelatin (E441)

Titanium dioxide (E171)

Black printing ink S-1-17720

6.2    Incompatibilities

Not applicable.

3 years.

6.4 Special precautions for storage

Do not store above 25°C.

Store in the original packaging.

6.5 Nature and contents of container

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

Pack size of 240 capsules.

6.6 Special precautions for disposal

Any unused product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Cheplapharm Arzneimittel GmbH Bahnhofstr. 1a 17498 Mesekenhagen Germany

8    MARKETING AUTHORISATION NUMBER(S)

PL 27041/0004

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION 28/04/1981 / 16/01/2004

10 DATE OF REVISION OF THE TEXT

01/06/2014