Generic Name: dutasteride
Product Name: APO-Dutasteride soft capsules
Indication: What dutasteride is used for
This medicine belongs to a group of medicines called 5 alpha reductase enzyme inhibitors which are used in men who have a condition known as benign prostatic hyperplasia (BPH).
Dutasteride may also be taken in combination with another type of medicine called an alpha-blocker in order to treat symptoms of an enlarged prostate.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor’s prescription.
There is no evidence that this medicine is addictive.
This medicine should not be used in children.
Action: How dutasteride works
Prostate growth is caused by a hormone in the blood called dihydrotestosterone (DHT). Dutasteride lowers DHT production in the body, leading to shrinkage of the enlarged prostate in most men. Just as your prostate became large over a long period of time, reducing the size of your prostate and improving your symptoms may take time.
Each APO-Dutasteride soft capsule contains 500 micrograms of dutasteride as the active ingredient.
It also contains the following inactive ingredients mono- and di- glycerides, butylated hydroxytoluene, gelatin, glycerol, water – purified, iron oxide yellow CI77499, titanium dioxide, OPACODE monogramming ink S-1-15095 Red (PI#12470).
This medicine is gluten-free, lactosefree, sucrose-free, tartrazine-free and free of other azo dyes.
Dose advice: How to use dutasteride
Before you take this medicine
When you must not take it
Do not take this medicine if:
- You are a woman or child;
- You are hypersensitive to, or have had an allergic reaction to, dutasteride, other 5 alpha reductase enzyme inhibitors or any of the ingredients listed here. Symptoms of an allergic reaction may include cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting; or hay fever-like symptoms. If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital;
- The expiry date (EXP) printed on the pack has passed;
- The packaging is torn, shows signs of tampering or it does not look quite right.
Before you start to take it
Before you start taking this medicine, tell your doctor if:
- You have allergies to:
- Any other medicines;
- Any other substances, such as foods, preservatives or dyes;
- You suffer from liver disease and/or other medical conditions;
- You are planning to have surgery or an anaesthetic;
- You are currently receiving or are planning to receive dental treatment;
- You are taking or are planning to take any other medicines. This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.
Women (who are pregnant or may be pregnant) and children must avoid handling punctured or leaking capsules. Wash the affected area immediately with soap and water if there is any contact with the skin. If dutasteride is absorbed through the skin by a woman who is pregnant with a male baby, it may cause the male baby to be born with abnormalities of the genital organs.
Dutasteride has been found in the semen of men taking dutasteride. If your partner is or may be pregnant, you must avoid exposing her to your semen as dutasteride may affect the normal development of a male baby. You must use a condom during sex. You must not donate blood until 6 months after you’ve stopped taking dutasteride.
How to take this medicine
Follow carefully all directions given to you by your doctor. Their instructions may be different to the information here.
How much to take
Your doctor will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.
Do not stop taking your medicine or change your dosage without first checking with your doctor.
How to take it
Each capsule must be swallowed whole and not chewed or opened. Contact with the contents of the capsule may make your mouth or throat sore.
When to take it
Take this medicine at the same time each day. Taking it at the same time each day will have the best effect and will also help you remember when to take it.
It does not matter if you take it before, with or after food.
How long to take it for
Continue taking your medicine for as long as your doctor tells you.
Make sure you have enough to last over weekends and holidays.
If you forget to take it
If it is almost time to take your next dose, skip the missed dose and take your next dose at the usual time. Otherwise, take it as soon as you remember and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for missed doses. This may increase the chance of you experiencing side effects.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.
If you take too much (overdose)
If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively, go to the Accident and Emergency department at your nearest hospital. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
While you are taking this medicine
Things you must do
Tell your doctor that you are taking this medicine if:
- You are about to be started on any new medicine;
- You are about to have any blood tests;
- You are going to have surgery or an anaesthetic or are going to hospital.
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects. Go to your doctor regularly for a check-up.
Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.
Things you must not do
- Give this medicine to anyone else, even if their symptoms seem similar to yours;
- Take your medicine to treat any other condition unless your doctor tells you to;
- Stop taking your medicine, or change the dosage, without first checking with your doctor.
Storage and disposal
Keep your medicine in its original packaging until it is time to take it. If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 25°C.
Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a windowsill or in the car. Heat and dampness can destroy some medicines.
Keep this medicine where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.
Schedule of dutasteride
APO-Dutasteride is a Schedule 4 – prescription only medicine.
Side effects of dutasteride
Tell your doctor as soon as possible if you do not feel well while you are taking dutasteride or if you have any questions or concerns.
Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.
Tell your doctor if you notice any of the following:
- Impotence (inability to achieve or maintain an erection);
- Decrease in libido (sex drive);
- Difficulty with ejaculation;
- Breast swelling or tenderness;
- Dizziness when taken with an alpha-blocker;
- Hair loss (usually from the body) or hair growth;
- Depressed mood;
- Testicular pain and testicular swelling;
- A decrease in sperm count and semen volume.
Other side effects not listed above may occur in some patients.
If you think you are having an allergic reaction to dutasteride, do not take any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
Symptoms of an allergic reaction may include some or all of the following:
- Cough, shortness of breath, wheezing or difficulty breathing;
- Swelling of the face, lips, tongue, throat or other parts of the body;
- Rash, itching or hives on the skin;
- Hay fever-like symptoms.
For further information talk to your doctor.