This information is intended for use by health professionals

1. Name of the medicinal product

Potaba 3 g Powder Sachets

2. Qualitative and quantitative composition

Each sachet contains 3 g potassium para-aminobenzoate.

3. Pharmaceutical form

Powder for oral solution

Each sachet contains 3 g white/off-white powder.

4. Clinical particulars
4.1 Therapeutic indications

Potaba 3 g powder is indicated for the treatment of Peyronie's disease and scleroderma in adults.

4.2 Posology and method of administration

Posology

One sachet containing 3 g Potaba powder should be taken orally, four times daily.

Paediatric population

The safety of Potaba 3 g powder in children aged 0 to 18 years has not been established. No data are available.

Method of administration

For oral use.

The contents of one sachet should be dissolved in cold water or fruit juice and taken orally with food.

4.3 Contraindications

- Hypersensitivity to the active substance potassium para-aminobenzoate or para-substituted aromatic amines (e. g. benzocaine, procaine, ethyl parahydroxybenzoate).

- Renal insufficiency (GFR < 45 ml/min).

- Hyperkalaemia (each sachet contains 669 mg potassium).

- Potaba 3 g powder should not be given to patients taking sulphonamides as these medicinal products will be inactivated by 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 3 g powder should be interrupted during periods of low food intake (e.g. during fasting, anorexia, nausea). This is to avoid the possible development of hypoglycaemia. (see section 4.8).

In patients with impaired renal function or other diseases that are often accompanied by hyperkalaemia, Potaba 3g powder should be used with caution because of the risk of hyperkalaemia.

Potaba 3g powder must be discontinued if a hypersensitivity reaction occurs.

Liver function tests should be performed monthly, (e. g. transaminases, GGT, ALP, LDH, bilirubin) and Potaba 3g powder discontinued immediately if elevated.

4.5 Interaction with other medicinal products and other forms of interaction

Sulfonamides will be inactivated by Potaba 3 g powder since aminobenzoate is preferentially taken up by bacteria.

Methotrexate is displaced from plasma protein binding by aminobenzoate. Subsequently, plasma levels of methotrexate may increase if administered together with Potaba 3 g powder.

The potassium in Potaba 3 g powder can reduce the effect of concomitant cardiac glycosides.

Aldosterone antagonists, potassium-sparing diuretics and ACE inhibitors may further increase potassium levels.

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 3 g powder is 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 3 g powder has 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 utilised 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)

Gastrointestinal disorders

Common: nausea, vomiting, anorexia, stomach discomfort, diarrhoea

Hepatobiliary disorders

Uncommon: elevated liver enzymes (e. g. transaminases, GGT, ALP, LDH)

Rare: hepatitis

Skin and subcutaneous tissue disorders

Uncommon: pruritus

General disorders and administration site conditions

Common: pyrexia, chills

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via www.mhra.gov.uk/yellowcard.

4.9 Overdose

No particular problems are expected following overdose with Potaba 3 g powder. Symptomatic and supportive therapy should be given as appropriate.

5. Pharmacological properties
5.1 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 dependent 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

Absorption

Aminobenzoate is well absorbed after oral administration.

Oral administration of 3 g Potaba to healthy volunteers resulted in maximum plasma levels of 29-74 μg/mL after 41-90 min. followed by rapid decrease to less than 10 μg/mL after 4 h.

Elimination

Potassium and conjugated aminobenzoate are eliminated by the kidney.

5.3 Preclinical safety data

In-vitro bacterial tests with para-aminobenzoate revealed no mutagenic potential. There are no long term tests for carcinogenic potential. Adequate reproductive toxicity tests are not available for potassium para-aminobenzoate. In limited studies in pregnant rats, oral administration of 50 mg/kg/day para-aminobenzoate reduced fetal weights. In animal experiments, para-aminobenzoate crosses the placenta.

6. Pharmaceutical particulars
6.1 List of excipients

None in this presentation.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

5 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

Cardboard outer containing 40 foil laminate sachets.

6.6 Special precautions for disposal and other handling

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

7. Marketing authorisation holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

8. Marketing authorisation number(s)

PL 27041/0005

9. Date of first authorisation/renewal of the authorisation

28/04/1981 / 16/01/2004

10. Date of revision of the text

01/06/2018