Restandol®
40 mg capsule
Testosterone undecanoate


What you should know about this medicine

This leaflet has been written to help you take your medicine.
If you have any questions or worries, ask your doctor or a pharmacist.
At the end of the leaflet you will find a list of things to remember about your medicine.
Please keep this leaflet until you have finished your medicine. You may want to read it again.

What is Restandol?

Each Restandol capsule contains 40 mg testosterone undecanoate as the active ingredient, dissolved in oleic acid. The capsule shell also contains glycerol, sorbitol concentrate, titanium dioxide (E171), iron oxide red (E172), gelatin and the preservatives sodium ethylhydroxybenzoate (E215) and sodium propylhydroxybenzoate (E217).

The brown soft gelatin capsules are printed with Org and D3V and are supplied in packs of 28 and 56.

Your body turns testosterone undecanoate into testosterone. Testosterone is a natural male hormone known as an androgen which controls normal sexual development in men.

The Product Licence is held by:

Organon Laboratories Ltd
Cambridge Science Park
Milton Road
Cambridge, CB4 OFL

Restandol is made by:

RP Scherer GmBH
Ederbach
Baden, Germany

What Is Restandol Used For?

Restandol is used in testosterone replacement therapy for male sexual problems for example:

• impotence caused by hormonal disorders
• after castration or a similar problem called eunuchoidism
• decreased sex drive and decreased mental and physical activity
• infertility caused by low sperm count
• bone loss caused by low hormone levels.

Before You Take This Medicine

Do you have cancer of the prostate or breast?
Do you suffer from heart disease?
Do you have hypercalcaemia or hypercalciuria (too much calcium in the blood or urine)?
Do you have kidney disease?

If the answer to any of these questions is YES:

• Did you tell your doctor at the last visit or an earlier visit?
• If you did NOT then you should do so as soon as possible and before taking these capsules.

However your doctor may still want you to take them.

What do I need to know before taking my medicine?

Extra supervision may be necessary in some cases, particularly the elderly. Tell your doctor if you have ever had:

• heart disease
• kidney disease
• liver disease
• high blood pressure
• epilepsy
• migraine
• cancer of the lungs, kidney, breast or bones

Blood tests may be affected.
Liver tumours have been seen rarely with testosterone treatment.
Extra supervision by the doctor is necessary in the treatment of young boys since male hormones may cause early sexual development and delay growth.

What Other Medicines Are You Taking?

Other medicines may affect how Restandol works or Restandol may affect how they work.
The following medicines may decrease the effect of Restandol: antibiotics such as rifampicin, and anti-epileptic drugs such as barbiturates, carbamazepine, dichloralphenazone, phenylbutazone, phenytoin and primidone.
If you are taking these or any other medicines, tell your doctor before taking Restandol.

What about allergies?

This medicine contains sorbitol concentrate.

How Should I Take Restandol?

It is important to take this medicine only as directed by your doctor or pharmacist.

How much.

Adults:

The usual dose is 3-4 capsules each day for the first 2-3 weeks. After a few weeks the dose is gradually reduced to 1-3 capsules each day.

Smaller, less frequent doses may be given to the elderly.

Children:

Restandol capsules should not be given to children.

How to take the capsules.

Swallow the capsules whole after meals.

Do not chew.

Take half of the daily dose in the morning and the other half in the evening.

If the daily dose is an uneven number of capsules, take the bigger number in the morning.

Take with some water or other drink if necessary.

What to do if you miss a dose.

Don’t worry. Take the missed dose as soon as you remember.

If you miss the morning dose and it is more than 2 hours after breakfast, wait until lunchtime and then take the dose.

What to do if someone accidentally takes too much.

If this happens contact your nearest hospital casualty department or tell your doctor immediately.

What About Side-Effects?

Restandol sometimes causes side effects in some people.

If you have any of the following side effects, tell your doctor. He or she may decide to stop your treatment for a while.

• prolonged painful erection
• increased sexual desire
• decreased amounts of ejaculation fluid
• low sperm count
• water retention
• in young boys, early sexual development, erections occurring more often than normal, enlarged penis, delayed growth
• hoarseness of the voice

Tell your doctor if you have any other side effects which are serious or troublesome, and if side effects continue.

How Should You Store Restandol?

Patient

Use this medicine within 3 months. The capsules should be kept in a dry place, away from light. Store the capsules at room temperature (up to 30°C). Do not store in the fridge.
Keep the capsules in the original bottle, in a place where children cannot see or reach them.

Pharmacist

When stored by the pharmacist the capsules should be dispensed before the “expiry” date on the pack. Store between 2-8°C and protect from light and moisture.

This information was written in May 1998

General things to remember about medicines.

1. Only use this medicine for your current medical problems. Do not use this medicine for other medical problems.
2. Do not allow other people to use your medicines and do not use medicines meant for other people.
3. Tell any doctor treating you what medicines you are taking. Always carry a medical information card showing which medicines you are using. This can also be very
   important if you are involved in an accident.
4. Return any medicines you have not used to the pharmacy; they will get rid of them safely.
5. Make sure that the people you live with or who look after you read this information.

PL: 0065/0059
UP3REST.doc