Modrenal

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER
Modrenal 60 mg and 120 mg capsules
(trilostane)

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 gets serious, or if you notice any side effects not listed in
  this leaflet, please tell your doctor.

In this leaflet:

1. What Modrenal Capsules are and what they are used for
2. Before you take Modrenal Capsules
3. How to take Modrenal Capsules
4. Possible side effects
5. How to store Modrenal Capsules
6. Further information
7. WHAT MODRENAL CAPSULES ARE AND WHAT THEY ARE USED FOR
   Modrenal Capsules contain the active ingredient trilostane which reversibly reduces the
   production of steroids (hormones). Modrenal Capsules are used to treat:

• an excessive production of steroids, also known as adrenal cortical hyperfunction.
  Cushing’s disease is one example of an excessive production of steroids.
• postmenopausal breast cancer in women who have been on other therapy.

1. BEFORE YOU TAKE MODRENAL CAPSULES
   Do NOT take Modrenal Capsules if you:

• are allergic to trilostane or any of the other ingredients in the product (see Section 6
  and end of Section 2)
• are pregnant.
  Modrenal Capsules must not be given to children.
  Take special care with Modrenal Capsules
  Speak to your doctor if you:
• become pregnant while taking Modrenal Capsules
• have severe liver or kidney problems
  Your doctor will carry out regular blood tests and may adjust your dose. Your doctor may
  prescribe additional drugs if you have:
• an abnormally low concentration of potassium ions in your blood (hyperkalaemia)
• a low concentration of sodium in your blood which results in low blood pressure
  (hyponatraemia)
• a low concentration of corticosteroids.
  Taking other medicines
  Please inform your doctor if you are taking or have recently taken any other medicines,
  including those obtained without a prescription.
  In particular, tell your doctor if you are taking any of the following:
• hormonal contraceptives – use other contraceptive methods during treatment
• thiazide diuretics – when taken together with Modrenal this can lead to dizziness due
  to low blood pressure and your doctor may need to add another medication
• high doses of “aspirin-like” drugs (called nonsteroidal anti-inflammatory drugs or
  NSAIDs) for pain.
  Taking Modrenal Capsules with food and drink
  Taking the capsules with food may help to reduce the side effects.
  Pregnancy and breast-feeding
  During treatment with Modrenal you must avoid becoming pregnant and if necessary you should
  use barrier or non-hormonal methods of contraception.
  Your doctor will advise you if you are breast-feeding.
  Ask your doctor for advice before taking any medicine.
  Driving and using machines
  Modrenal capsules are not expected to affect your ability to drive or operate machinery, but if
  you feel drowsy or tired, you should not perform any tasks requiring special attention until
  you know how the medicine affects you.
  Further information about some of the other ingredients in Modrenal Capsules
  Lactose is an ingredient in Modrenal Capsules. Tell your doctor if you know you have an
  intolerance to some sugars.

1. HOW TO TAKE MODRENAL CAPSULES
   Always take Modrenal Capsules exactly as your doctor has told you. You should check with
   your doctor or pharmacist if you are not sure.
   For oral use in adults only. These capsules should not be given to children.
   Modrenal Capsules must be swallowed whole with a drink of water. Taking them with food
   may help to reduce the side effects.
   Excessive production of steroids
   The initial dose is 240 mg/day (2 to 4 capsules) in divided doses for at least 3 days, then the
   dose will be adjusted by your doctor, following blood/urine tests.
   The usual dose is 120 – 480 mg/day but may be increased to 960 mg if your doctor considers
   this necessary.
   Postmenopausal breast cancer
   The initial dose is 240 mg/day (2 to 4 capsules) to be taken in divided doses. At the start of
   treatment, you will also be given 30 mg hydrocortisone daily, in divided doses.
   The dose of Modrenal will be increased every 3 days to 480 mg to 720 mg to 960 mg. The
   dose may be reduced to 720 mg if you cannot tolerate the higher dose.
   If you are admitted to hospital, please let the staff know that you are taking Modrenal
   Capsules.
   If you take more Modrenal Capsules than you should
   If you or someone else takes too many capsules, contact your doctor or nearest hospital
   casualty department immediately. Take this leaflet and any remaining capsules with you, if
   possible.
   If you forget to take Modrenal Capsules
   If you miss a dose, take your next dose at the correct time. Do not take a double dose to make
   up for the forgotten one.
   If you have any further questions on the use of this product, ask your doctor or pharmacist.
2. POSSIBLE SIDE EFFECTS
   Like all medicines, Modrenal Capsules can cause side effects, although not everybody gets
   them.
   The following side effects have been reported:

• flushing, tingling in mouth, swelling of the palate, runny nose, sickness, vomiting,
  diarrhoea, cramps and skin rash.
  These side effects are mild and reversible and tend to wear off as treatment goes on, but if they
  persist, or you are worried, tell your doctor. Your dose may need to be adjusted or you may
  require additional treatment to control the symptoms (e.g. antacids, anti-diarrhoeal medicines
  with a small dose of aspirin).
  Rarely, a stomach ulcer may bleed (you may vomit blood or pass tarry stools), but this is only
  likely if you are taking regular high doses of “aspirin-like” drugs for pain. If this occurs tell
  your doctor immediately.
  Very rarely, in cancer patients, a decrease in one type of a white blood cell (granulocytes) may
  occur. Your doctor will monitor your blood levels for this and may adjust your dose if
  necessary.
  If any of the side effects gets serious, or if you notice any side effects not listed in this
  leaflet, please tell your doctor.

1. HOW TO STORE MODRENAL CAPSULES
   Keep out of the reach and sight of children.
   Store below 25°C in the original package.
   Do not use Modrenal Capsules after the expiry date stated on the container.
   Medicines should not be disposed of via wastewater or household waste. Ask your Pharmacist
   how to dispose of medicines no longer required. These measures will help to protect the
   environment.
2. FURTHER INFORMATION
   What Modrenal Capsules contain
   The active substance is trilostane, 60mg or 120mg per capsule.
   The other ingredients are lactose, maize starch, magnesium stearate.
   The capsule shells contain gelatin, titanium dioxide (E171) and iron oxide red or iron oxide yellow
   (E172).
   What Modrenal Capsules look like and contents of the pack

• The 60 mg capsules are pink and black and marked with “60”
• The 120 mg capsules are pink and yellow and marked with “120”
  They are available in packs of 100 capsules in brown glass bottles with screw top lids.
  Marketing Authorisation Holder
  Bioenvision Limited
  Bassett House, 5 Southwell Park Road, Camberley, Surrey GU15 3PU, United Kingdom
  Manufacturer
  Almac Pharma Services Limited
  Almac House, 20 Seagoe Industrial Estate, Craigavon, Co. Armagh, BT63 5QD
  This leaflet was last approved in 11/2008