WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about ANDROFORTE 5. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.
If you have any concerns about using this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
WHAT ANDROFORTE 5 IS USED FOR
ANDROFORTE 5 is used to replace the body’s natural hormone testosterone when not enough is made by the body.
Testosterone is a natural hormone, known as an androgen, which controls normal sexual development and function in men.
Testosterone is essential for the development and maintenance of the male reproductive organs as well as other male characteristics, such as facial and body hair growth, deep voice, sexual drive, muscle mass and body fat distribution.
ANDROFORTE 5 is a testosterone containing cream that is applied by the patient daily to the skin. The testosterone passes from the cream through the skin and into the bloodstream. Absorption can be variable between individuals.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.
BEFORE YOU USE ANDROFORTE 5
When you must not use it
Do not use ANDROFORTE 5 if you have an allergy to:
- testosterone, the active ingredient in ANDROFORTE 5
- any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
- shortness of breath
- wheezing or difficulty breathing
- swelling of the face, lips, tongue or other parts of the body
- rash, itching or hives on the skin.
Do not use ANDROFORTE 5 if you have or are suspected to have:
- prostate cancer
- breast cancer (a rare condition in men).
ANDROFORTE 5 must not be used by children. The safety of ANDROFORTE 5 in children under 18 years of age has not been established.
ANDROFORTE 5 must not be used by women, particularly if they are or anticipate becoming pregnant. ANDROFORTE 5 may cause harm to the unborn child when administered to pregnant women. ANDROFORTE 5 may cause serious reactions in nursing infants. Pregnant women must avoid any contact with the ANDROFORTE 5 treated skin.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start using this medicine, talk to your doctor.
Before you start to use it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have, or have had, any of the following medical conditions:
- high blood calcium levels associated with bone cancer and tumours (hypercalcaemia)
- high levels of calcium in the urine (hypercalciuria)
- high blood pressure or heart disease
- a tendency to retain fluid (signs may include swollen feet or ankles)
- liver or kidney disease
- epilepsy (fits)
- migraines
- diabetes
- difficulty in passing water (urinating) due to enlarged prostate gland
- abnormal pauses in breathing during sleep (sleep apnoea).
ANDROFORTE 5 may quicken the growth of existing prostatic tumours and benign prostatic hyperplasia (enlargement of the prostate gland). It may also increase the risk of breast cancer in males. Before treatment, your doctor should conduct tests to check that you do not have existing prostate or breast cancer. During treatment, your doctor may monitor the effects of this medicine.
Worsening of breathing problems during sleep has been reported during treatment with testosterone replacement in people prone to breathing problems during sleep. This is especially true if you are overweight or have lung problems.
If you use ANDROFORTE 5 over long periods of time, you may develop an abnormal increase in the number of red blood cells in the blood (polycythaemia). Your doctor may organise regular blood counts to monitor this.
If you have not told your doctor about any of the above, tell them before you start using ANDROFORTE 5.
Athletes should note that the active substance, testosterone, may produce a positive reaction in antidoping tests. Misuse of androgens to enhance your physical ability in sport carries serious health risks and is discouraged.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and ANDROFORTE 5 may interfere with each other. These include:
- oral anticoagulants, medicines used to thin blood and to treat or prevent blood clots
- corticosteroids or adrenocorticotropic hormone (ACTH), hormones used to control inflammation
- oxyphenbutazone, a medicine used to treat pain and inflammation
- insulin, a medicine used to control blood sugar levels
- bupropion, a medicine used to aid in smoking cessation
- ciclosporin, a medicine used to suppress the immune system
- some herbal products such as ancreamica dahurica, chapparal, comfrey, eucalyptus, germander tea, Jin Bu Huan, kava, penny royal oil, skullcap, and valerian.
These medicines may be affected by ANDROFORTE 5 or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine.
HOW TO USE ANDROFORTE 5
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
If you do not understand the instructions, ask your doctor or pharmacist for help.
How much to use
Your doctor or pharmacist will explain how and where on the body to apply ANDROFORTE 5.
It is very important to use the correct dose of cream on the correct part of the body because the two sites of application absorb testosterone very differently.
Application to the upper body
The usual starting dose is 2 mL of cream by measured applicator per day applied to the upper body (torso, abdomen and sides of the body). Your doctor or pharmacist will tell you exactly how much to use. You should not use more than 4 mL (200 mg testosterone) of cream per day. The dose should not be varied unless directed to do so by your doctor. You will need to return to your doctor at regular intervals so that the dose can be checked via a blood test.
Application to the scrotum
The usual starting dose is 0.5 mL of cream by measured applicator per day applied to the entire scrotum (the skin sack that holds the testicles). Your doctor or pharmacist will tell you exactly how much to use. You should not use more than 1 mL (50 mg testosterone) of cream per day. The dose should not be varied unless directed to do so by your doctor. You will need to return to your doctor at regular intervals so that the dose can be checked via a blood test.
How to use it
Follow these steps when applying ANDROFORTE 5:
To open the tube, remove the cap and peel off the foil seal. A measuring applicator (syringe style) in a sealed sleeve is enclosed in the ANDROFORTE 5 box. The applicator is marked with 0.25 mL graduations for dosing accuracy.
To measure the correct dose of cream, gently squeeze the base of the ANDROFORTE 5 tube until cream reaches the open nozzle of the tube. Insert the tip of the applicator into the open nozzle of ANDROFORTE 5 cream so that the nozzle and the shoulder of the applicator are in contact. Invert the tube and the applicator so the cream will flow with gravity when squeezed.
Carefully squeeze the base of the ANDROFORTE 5 tube and at the same time slowly withdraw the plunger of the applicator. The cream will flow into the barrel of the applicator.
Do not try to squeeze the cream into the syringe.
Fill the applicator to the required dose. For example: a 2 mL dose of ANDROFORTE 5 (100 mg testosterone) needs the flat part of the plunger level with the 2 mL mark. If there are any air bubbles in the measured dose fill slightly past the required dose mark then depress the plunger so that the excess cream flows back into the tube. Stop at the required dose mark.
To view a demonstration video of how to use the dose application see https://www.lawleypharm.com.au/patients.php
Remove the applicator from the nozzle of the tube and replace the cap firmly on the tube. Depress the plunger of the applicator containing the dose of ANDROFORTE 5 directly onto clean, dry and healthy skin on the part of the body as directed by your doctor:
- on the upper body including the torso, abdomen and the sides of the body from the waist to just below the arm pits. It is preferable to apply to areas on the upper body with minimal hair and body fat.
- on the scrotum (the skin sack that holds the testicles). The scrotum does not need to be shaved prior to application of the cream.
Massage the cream into the area until absorbed. Typically, this takes 30 seconds or so. Rinse the applicator in hot water after use and replace in box with ANDROFORTE 5 cream ready for the next day's application.
Wash your hands thoroughly with soap and water after applying the cream.
Cover the application area with clothing once applied.
Do not shower or swim for at least six (6) hours after applying the cream to the upper body or two (2) hours after applying the cream to the scrotum.
When to use it
Apply ANDROFORTE 5 once per day at approximately the same time each day, preferably in the morning. Using it at the same time each day helps maintain a steady level of testosterone in the blood. It will also help you remember when to apply it.
How long to use it
ANDROFORTE 5 helps control the symptoms of your condition, but does not cure it. Therefore you must use ANDROFORTE 5 every day.
When you have finished a tube, start the next tube on the following day. Never leave a break between tubes.
Continue using ANDROFORTE 5 for as long as your doctor tells you to.
If you forget to use it
If you forget to apply a dose, apply it as soon as you remember.
If you do not remember to apply the dose until the next dose is due, then just apply one dose.
Do not apply a double dose to make up for a forgotten individual dose.
Continue as normal the following day.
If you use too much (overdose)
Wash the skin with soap and water.
Immediately telephone your doctor or the Poisons Information Centre on 13 11 26 for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have used too much ANDROFORTE 5. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
WHILE YOU ARE USING ANDROFORTE 5
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using ANDROFORTE 5.
Tell any other doctors, dentists, and pharmacists who treat you that you are using this medicine.
Keep all of your doctor’s appointments so that your progress can be checked. Your doctor may monitor your blood pressure, examine your prostate and conduct other tests (including blood tests) from time to time, particularly if you are elderly. This is to make sure the medicine is working and to check for unwanted side effects.
The use of ANDROFORTE 5 may affect the results of certain laboratory tests. If you are about to have any tests, tell your doctor that you are using this medicine.
Things you must not do
Do not use ANDROFORTE 5 to treat any other complaints unless your doctor tells you to.
Do not give ANDROFORTE 5 to anyone else, even if they have the same condition as you.
Do not stop using ANDROFORTE 5, or change the dosage, without checking first with your doctor. If you stop using it suddenly, your condition may worsen or you may have unwanted side effects.
Things to be careful of
Testosterone may be transferred to another person during close and relatively prolonged skin contact with the cream application area. If contact occurs a number of times or for long periods of time this could cause the other person to show signs of increased testosterone such as more hair on the face and body and a deepened voice. In women, this may also cause changes in the menstrual cycle. Signs of increased testosterone in children include enlarged penis or clitoris, early development of pubic hair, increased erections or sex drive, aggressive behaviour.
Call your doctor right away if you see any signs in a child or a woman that may have occurred through accidental exposure to ANDROFORTE 5.
Unwanted transfer of testosterone to another person can be avoided by wearing clothes which cover the application area and/or by showering before contact. You need to ensure that your partner is not put at risk of receiving testosterone by accident.
You should leave a gap of 6 hours between applying ANDROFORTE 5 to the upper body and having intimate physical contact. You should also wear clothing such as a T-shirt to cover the application area and/or have a shower or bath beforehand.
If applying ANDROFORTE 5 to the scrotum leave a gap of at least 2 hours after application before intimate contact and/or have a shower or bath beforehand.
If your partner is pregnant, it is extra important that you take care to protect her from testosterone.
If a woman or child does come into contact with ANDROFORTE 5, thoroughly wash the area of skin exposed to the cream with soap and water immediately.
SIDE EFFECTS
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using ANDROFORTE 5.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Do not be alarmed by the list of possible side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
- skin reactions such as irritation, redness, dry or stinging skin, acne and/or hives, oily skin
- headaches or migraines
- prostatic disorders such as difficulty or pain while urinating, frequent urination
- changes in sexual drive
- painful, tender or enlarged breasts
- dizziness, difficulty in breathing or worsening of sleep apnoea
- increased feeling or sensitivity of skin
- memory loss
- changes in the sense of smell or taste
- mood changes, nervousness, anger
- increased or decreased blood pressure, flushing
- increased appetite
- hair loss, discoloured hair, excessive hairiness
- muscle cramps or pain
- unusual weakness, generally feeling unwell
- changes in the levels of blood glucose.
These are the possible side effects of ANDROFORTE 5.
Tell your doctor immediately, or go to Accident and Emergency department at your nearest hospital if you notice any yellowing of the skin and eyes, also called jaundice. This is a very serious side effect. You may need urgent medical attention or hospitalisation.
Your doctor may need to monitor your blood pressure and conduct blood tests, as ANDROFORTE 5 may increase your blood pressure and affect your liver function. You may not experience any specific symptoms.
Side effects associated with high doses or long-term treatment include:
- increased tendency to retain fluid (signs may include swollen feet or ankles) and changes in electrolytes
- decreased sperm count, which may affect fertility
- reduction in the size of the testicles
- unwanted, frequent or prolonged and painful erections.
Tell your doctor if you notice anything else that is making you feel unwell.
Other side effects not listed above may also occur in some patients. Some of these side effects can only be found when your doctor does tests from time to time to check your progress:
- increases in blood cholesterol, increased haematocrit (percentage of red blood cells in the blood), haemoglobin and red blood cell count
- increased creatinine
- increased Prostate Specific Antigen (PSA). PSA is a protein produced by the prostate which can be used to detect prostate disease.
AFTER USING ANDROFORTE 5
Storage
Keep ANDROFORTE 5 in a cool dry place where the temperature stays below 25°C.
Do not store it or any other medicine in the bathroom, near a sink, or on a window-sill.
Do not leave it in the car. Heat and dampness can destroy some medicines.
Keep it 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.
Disposal
If your doctor tells you to stop using this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over. Return any unused medicine to your pharmacist.
PRODUCT DESCRIPTION
What it looks like
ANDROFORTE 5 is a white, opaque cream presented in a boxed laminated tube together with a sealed syringe-style measuring applicator marked in 0.5 mL graduations.
ANDROFORTE 5 is supplied in a 50 mL sealed tube.
Ingredients
Active ingredient per tube:
- ANDROFORTE 5 – 50 mg testosterone per 1 mL of cream
Inactive ingredients:
- dl-α-tocopheryl acetate (Vitamin E acetate)
- almond oil
- cetomacrogol 1000
- cetostearyl alcohol
- carbomer 940
- trolamine
- butylated hydroxytoluene
- Phenonip (PI 10352) contains hydroxybenzoates
- citric acid
- purified water.
PRESENTATION AND STORAGE CONDITIONS
ANDROFORTE 5 is presented as single boxed tube with a graduated syringe-style measuring device.
ANDROFORTE 5 is supplied in a 50mL sealed tube and contains 50mg testosterone per 1mL of cream.
The tube should not be opened until immediately prior to application of the cream.
Store below 25°C. Do not freeze.
In-use storage: ANDROFORTE 5 should be used within 12 weeks of opening.
Shelf Life: ANDROFORTE 5 has a 36 month shelf-life from the date of manufacture.
For the expiry date and batch number please see the crimp of the tube.
Supplier
Made in Australia for:
Lawley Pharmaceuticals Pty Ltd
Unit 2/15A Harrogate Street
West Leederville WA 6007
ABN 12095973523
Australian Registration Numbers
ANDROFORTE 5 - AUST R 123764
This leaflet was revised in November 2020.
See TGA website (www.tga.gov.au) for latest Australian Consumer Medicine Information.
® Registered Trademark of Lawley Pharmaceuticals Pty Ltd
© Lawley Pharmaceuticals Pty Ltd
All rights reserved.
Published by MIMS February 2021
1 Iyer R, Mok SF, Savkovic S, et al. Pharmacokinetics of testosterone cream applied to scrotal skin. Andrology. 2017 Jul;5(4):725-731.
Chemical Formula: C19H28O2.