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POTABA 500MG CAPSULES

Active substance(s): AMINOBENZOATE POTASSIUM

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stand (datum): 10.09.2015 [09:00 uhr] (6)
format: 148 x 330 mm
farben: 1/1-farbig schwarz
mat.-nr.: 9000812/12
schriftgröße: 9,3 pt

PACKAGE LEAFLET: INFORMATION FOR THE USER
Potaba 500 mg Capsules
Potassium para-aminobenzoate

(Referred to as Potaba Capsules 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 Capsules are and what they are used for
2. What you need to know before you take Potaba Capsules
3. How to take Potaba Capsules
4. Possible side effects
5. How to store Potaba Capsules
6. Contents of the pack and other information
1. WHAT POTABA CAPSULES ARE AND WHAT THEY ARE USED FOR
The active ingredient in Potaba Capsules 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 CAPSULES
Potaba is not recommended for children
Do not take Potaba Capsules if you:
• are allergic to potassium para-aminobenzoate or to any of the other ingredients in
this medicine (listed in section 6)
• 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 Capsules 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 Capsules
Please check with your doctor if you are taking any of the following medicines before
taking Potaba Capsules as it can stop them from working:
• medicines known as sulfonamides, e.g. co-trimaxole 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 Capsules with food and drink
Always take Potaba Capsules with food. 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 Capsules 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 Capsules 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 CAPSULES
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
• The recommended dose is six capsules, four times a day, the first dose being
straight after breakfast.
• 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 Capsules 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 Capsules than you should
If you take too many Potaba Capsules, or somebody else accidentally swallows Potaba
Capsules, 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 Capsules
If you miss a dose, wait until the next time you should take Potaba Capsules 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 Capsules 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 Capsules 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 CAPSULES
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 Capsules contain
The active substance in Potaba Capsules is potassium para-aminobenzoate.
Each capsule contains 500 mg of the active ingredient.
The other ingredients are:
Capsule contents: none
Capsule shell: gelatin (E441), titanium dioxide (E171), black printing ink S-1-17720
What Potaba Capsules look like and contents of the pack
Potaba Capsules are white gelatin capsules marked "POTABA-51".
Each pack contains 240 capsules.
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 27041/0004
This leaflet was last revised in August 2015.
9000812/12

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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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