Potaba 3g sachets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Potassium aminobenzoate

Available from:

Neon Healthcare Ltd

INN (International Name):

Potassium aminobenzoate

Dosage:

3gram

Pharmaceutical form:

Powder

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09060208; GTIN: 4260274650035

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
POTABA 3 G POWDER SACHETS
POTASSIUM PARA-AMINOBENZOATE
(referred to as 'Potaba Powder'
in the rest of this leaflet)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Potaba Powder is and what it is used for
2.
What you need to know before you take Potaba Powder
3.
How to take Potaba Powder
4.
Possible side effects
5.
How to store Potaba Powder
6.
Contents of the pack and other information
1. WHAT POTABA POWDER IS AND WHAT IT IS USED FOR
The active ingredient in Potaba Powder is potassium
para-aminobenzoate. It is used in the
treatment of Peyronie’s disease (the growth of fibrous plaques in
the soft tissue of the penis)
and scleroderma (excessive deposits of collagen in the skin or other
organs).
Potaba is an antifibrosis agent, which acts by increasing oxygen
uptake by the tissues.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE POTABA POWDER
DO NOT TAKE POTABA POWDER:

if you are allergic to potassium para-aminobenzoate or other
substances with similar
chemical structure (e.g. benzocaine, procaine, ethyl
parahydroxybenzoate) or any of the
other ingredients of this medicine (listed in section 6)

if you have kidney disease

if you have a raised level of potassium in your blood (each sachet
contains 669 mg
potassium)

if you are taking sulfonamides or combinations of sulfonamides with
other antibiotics (e.g.
sulfamethoxazole, sulfadimidine or co-trimoxazole)

if you have severe liver damage
WARNINGS AND PRECAUTIONS
You may need to stop taking Pota

Summary of Product characteristics

OBJECT 1
POTABA 3G POWDER SACHETS
Summary of Product Characteristics Updated 13-Mar-2017 | Cheplapharm
Arzneimittel GmbH
1. Name of the medicinal product
Potaba 3g 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 fruit juice and
taken orally with food.
4.3 Contraindications
Hypersensitivity to the active substance.
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 (eg, during
fasting, anorexia, nausea). This is to avoid the possible development
of hypoglycaemia. (See section 4.8
Undesirable effects).
Potaba 3 g powder should be given cautiously to patients with renal
impairment and treatment
discontinued if a hypersensitivity reaction occurs.
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 be inactivated by potassium para-aminobenzoate (See
section 4.3 Contraindications).
4.6 Fertility