-v:v

koepcke.publishing

stand (datum): 29.01.2014 format: 100 x 265 mm farben: 1/1-farbig schwarz mat.-nr.: 9000812/11 schriftgroBe: 8,24 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.

-    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 symptoms are the same as yours.

-    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Potaba Capsules are and what they are used for

2.    Before you take Potaba Capsules

3.    How to take Potaba Capsules

4.    Possible side effects

5.    How to store Potaba Capsules

6.    Further 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.    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 (See section 6. Further information)

•    are taking sulphonamides, e.g. trimethoprim, trimoxazole or sulphadimidine

•    have severe liver damage.

Take special care with 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.

If any of the above points apply to you, speak to your doctor or pharmacist before taking Potaba Capsules.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Please check with your doctor if you are taking any of the following before taking Potaba Capsules as it can stop them from working:

•    medicines known as sulphonamides, e.g. trimethoprim, trimoxazole or sulphadimidine.

Taking Potaba 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

You should not take Potaba Capsules if you are pregnant or trying to become pregnant without first discussing this with your doctor.

Do not take Potaba Capsules if you are breast feeding without talking to your doctor first.

Ask your doctor or pharmacist for advice before taking any 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 Potaba Capsules exactly as your doctor has told you. Ask your doctor or pharmacist if you are not sure.

Not recommended for use in children.

•    The usual dosage 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.

Information for patients with liver problems

If you have liver disorder or disease your doctor may want to carry out regular tests on your liver function.

If you take more Potaba Capsules than you should

If you take too much 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 product, 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 Capsules 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 in speaking or weakness.

Rarely people have experienced changes in the way the liver works, shown by blood tests.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    HOW TO STORE POTABA CAPSULES

Keep out of the reach and sight of children

•    Do not use Potaba Capsules 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.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION

What Potaba Capsules contain

The active ingredient in Potaba Capsules is potassium para-aminobenzoate.

The capsules contain gelatine (E441). There are no other ingredients contained within Potaba Capsules.

What Potaba Capsules look like and the contents of the pack

Potaba Capsules are white gelatine capsules marked ”POTABA-51 “. Each pack contains 240 capsules.

Marketing Authorisation Holder and Manufacturer

CHEPLAPHARM Arzneimittel GmbH, Bahnhofstr. 1a,

17498 Mesekenhagen, Germany.

Product License Number: PL 27041/0004 The leaflet was last revised in January 2014.