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POTABA 3G POWDER SACHETS

Active substance(s): AMINOBENZOATE POTASSIUM

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stand (datum): 10.09.2015 [09:05 uhr] (5)
format: 148 x 330 mm
farben: 1/1-farbig schwarz
mat.-nr.: 9000815/12
schriftgröße: 9,3 pt

PACKAGE LEAFLET: INFORMATION FOR THE USER
Potaba 3 g Powder Sachets
Potassium para-aminobenzoate

(Referred to as Potaba Powder in the remainder of the 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. 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. The drug acts by increasing oxygen uptake at the tissue
level.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE POTABA POWDER
Potaba is not recommended for children
Do not take Potaba Powder if you:
• are allergic to potassium para-aminobenzoate
• are taking sulfonamides or fixed combinations of sulfonamides with other antibiotics,
e.g. sulfamethoxazole, sulfadimidine or co-trimoxazole
• have severe liver damage.
Warnings and precautions
Talk to your doctor or pharmacist before taking Potaba Powder if you:






have problems with your kidney function. Your condition will need to be carefully
monitored by your doctor to ensure you do not become over-sensitive to the
medication, in which case treatment with Potaba will be stopped. Symptoms of
this include fever, rash and tiredness
have a known liver disorder or disease.

Information for patients with liver problems
If you have a liver disorder or disease your doctor may want to carry out regular tests
on your liver function.
Other medicines and Potaba Powder
Please check with your doctor if you are taking any of the following medicines before
taking Potaba Powder as it can stop them from working:
• medicines known as sulfonamides, e.g. co-trimoxazole or sulfadimidine.
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those obtained without a prescription.
Potaba Powder with food and drink
Always take Potaba Powder with food, dissolving the powder in fruit juice. If you do
not, there is a risk that you may feel slightly sick.
If, for any reason, you are not eating, or are just eating very small amounts, it is advisable that you interrupt treatment with Potaba Powder until you start eating normally
again. It is possible that if you do not interrupt treatment the levels of sugar in your
blood may become too low and you may feel unwell.
In the elderly, the hypoglycaemia that may occur during periods of low food intake may
be more difficult to recognise and may cause more neurological symptoms.
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Potaba Powder should not affect your ability to drive or operate machinery.
However, if you feel confused, sleepy or weak whilst taking your medicine do not drive
or operate machinery until these symptoms have gone.

3. HOW TO TAKE POTABA POWDER
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
• The powder should be dissolved in fruit juice, to make it more pleasant to take, and
drunk during meal times.
• The recommended dose is 12 g a day. This is the equivalent of 4 sachets a day.
• The dosage should be spread throughout the day as evenly as possible, to maintain
the level of medicine in your system, making sure you swallow the medicine with
food.
• Potaba Powder should be taken for as long as your doctor has recommended.
Use in children
Not recommended for use in children.
If you take more Potaba Powder than you should
If you take too much Potaba Powder, or somebody else accidentally swallows Potaba
Powder, contact your doctor or the nearest hospital casualty department immediately.
Treatment for overdose will depend on the symptoms that are shown.
If you forget to take Potaba Powder
If you miss a dose, wait until the next time you should take Potaba Powder and take
this dose as normal. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines Potaba Powder can cause side effects, although not everybody gets
them.
Low levels of blood sugar (hypoglycemia) can occur if treatment with Potaba is
continued during periods of low food intake.
Symptoms include hunger, shaking, feeling nervous, anxious or confused, sweating,
dizziness or feeling light-headed, sleepiness, difficulty speaking or weakness.
Rarely people taking Potaba Powder have experienced changes in the way the liver
works, shown by blood tests.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information of the safety of this
medicine.
5. HOW TO STORE POTABA POWDER
Keep this medicine out of the sight and reach of children
• Do not use this medicine after the expiry date which is stated on the carton. The
expiry date refers to the last day of that month.
• Do not store above 25 °C.
• Store in the original packaging.
Do not throw away any medicines via waste water or household waste. Ask your
pharmacist how to throw away of medicines you no longer use. These measures will
help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Potaba Powder contains
The active substance in Potaba Powder is potassium para-aminobenzoate. Each
sachet contains 3 g of the active ingredient.
There are no other ingredients contained in the sachet.
What Potaba Powder looks like and contents of the pack
Potaba Powder is a powder contained within a foil laminate sachet.
Each pack contains 40 sachets.
Marketing Authorisation Holder and Manufacturer
CHEPLAPHARM Arzneimittel GmbH, Bahnhofstr. 1a,
17498 Mesekenhagen, Germany
For information about this medicine, contact the medical information department on
0800 145 5034 or email: cheplapharm@redlinepv.co.uk.
Product Licence Number: PL 27041/0005
This leaflet was last revised in August 2015.

9000815/12

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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