Cream containing 2% w/v (20 mg/mL) Testosterone B.P (17-β-hydroxyandrost-4-en-3-one)
Consumer Medicine Information
What is in this leaflet
This leaflet answers some of the common questions about ANDROFORTE® 2. 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 possible risks of you using ANDROFORTE® 2 against the benefits it can have for you.
If you have any concerns about using ANDROFORTE® 2 talk to your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again.
What ANDROFORTE® 2 is used for?
ANDROFORTE® 2 contains the active ingredient testosterone. This form of testosterone is identical to the testosterone produced by the testes of men and the ovaries of women. Testosterone plays an important role in physical and sexual development, sexual arousal, sexual response, libido, maintenance of bone, energy levels and wellbeing in men and women. When men suffer from a deficiency of testosterone one or more of these areas may be affected and ANDROFORTE® 2 provides testosterone to address this deficiency. The skin reasily absorbs testosterone and ANDROFORTE® 2 is a simple and effective means of getting testosterone into the bloodstream.
Prior to using ANDROFORTE® 2
ANDROFORTE® 2 cream is only for use in men. ANDROFEME® 1% testosterone cream is recommended for use in women. ANDROFORTE® 2 cream should not be used if you are allergic to testosterone or any of the ingredients contained within ANDROFORTE® 2. These are listed at the end of the leaflet. This product contains almond oil.
If you have used ANDROFORTE® 2 or any other testosterone preparation before and became unwell, tell your doctor or pharmacist before using the cream. Other testosterone containing preparations include Testogel®, (AndroGel® and Testim® USA only), Reandron®, Sustanon®, Andriol®, Primodian® depot and Primoteston® depot. Do not use ANDROFORTE® 2 if you have cancer especially prostatic cancer, breast cancer, kidney cancer or have high calcium levels in the blood. If you have heart disease, high blood pressure or liver disease make sure your doctor is aware of these conditions before using ANDROFORTE® 2 because it may not be appropriate for you. Check with your doctor or pharmacist if you are unsure about whether you have any of these conditions before starting ANDROFORTE® 2. If you are taking other medications check with your doctor or pharmacist before starting ANDROFORTE® 2. High level athletes need to be aware of the rules governing androgen use if prescribed ANDROFORTE® 2 cream. Do not use ANDROFORTE® 2 after the expiry date which is printed on the base (crimp) of the tube. If you use this medicine after the expiry date has passed, it may not work as well. Do not use ANDROFORTE® 2 if the foil seal at the top of the tube is damaged or broken.
ANDROFORTE® 2 is not indicated for use in children or women
How to use ANDROFORTE® 2
Your doctor or pharmacist will explain how to apply ANDROFORTE® 2. Follow all directions exactly as they are explained. If you are unclear talk to your doctor. The dose of ANDROFORTE® 2 will be determined for you by your doctor. This dose is specific to your condition and 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.
Opening the tube
To open the tube remove the cap and peel off the foil seal. Dispose of the foil seal and replace the camp firmly after using the cream.
Measuring the correct dose of ANDROFORTE® 2 cream
A measuring applicator (syringe style) in a sealed sleeve is enclosed in the ANDROFORTE® 2 box. The dose of ANDROFORTE® 2 is measured in milllilitres. The applicator is marked with 0.5 mL graduations for dosing accuracy. Your doctor will have determined with dose is appropriate for you. To measure the correct dose of cream insert the tip of the applicator into the open nozzle of ANDROFORTE® 2 cream so that the nozzle and the shoulder of the applicator are in contact. GENTLY squeeze the base of the ANDROFORTE® 2 tube until the cream reaches the open nozzle of the tube. At the same time slowly withdraw the plunger of the applicator. The cream will flow into the barrel of the applicator. Fill to the required dose. For example: a 1 mL dose of ANDROFORTE® 2 (20 mg testosterone) needs the flat part of the plunger level with the 1 mL mark. If there are any air bubbles in the measured does fill slightly past the required dose mark then depress the plunger so that the excess cream flows back into the tube. Depress the plunger of the applicator containing the dose of ANDROFORTE® 2 directly onto the scrotal area. Massage the cream into the scrotal area until absorbed. Rinse the applicator in warm water after use and replace in box with ANDROFORTE® 2 testosterone cream ready for the next day's application. Each 1 mL of ANDROFORTE® 2 contains 20 mg of testosterone.
Where to apply ANDROFORTE® 2 cream
Always apply ANDROFORTE® 2 cream to clean dry skin. The best area to use ANDROFORTE® 2 is the scrotum (the skin sack that holds the testicles). This is the recommended site of application because absorption is greatest from this part of the body. If a dose greater than 1.5 mL (30 mg testosterone) once daily is required it is recommended that ANDROFORTE® 5 testosterone cream be used. Many men experience a warming sensation of the scrotal skin for a few minutes after applying ANDROFORTE® 2 – this is normal and quickly subsides. No perfume, deodorant, or moisturizing creams or gels should be used on the area because this may interfere with ANDROFORTE® 2 from being absorbed.
Never apply the cream to broken or damaged skin. ANDROFORTE® 2 cream should be applied at approximately the same time every day. It is recommended that patients do not swim or shower until at least 1 hr after application of ANDROFORTE® 2 cream. Close skin contact with the area of application within an hour of application by a partner should be avoided. This may result in the partner absorbing some testosterone via skin contact.
If you miss a dose
If you forget to apply your cream, you should apply it as soon as you remember provided this is within 9 hours of your usual time of application. Otherwise do not apply the cream until the next application time. Missing a dose will not create an undue disruption to your treatment.
If you use too much (overdose)
Because of the way ANDROFORTE® 2 is used, an unintentional overdose is unlikely. If you think that you or anyone else may have used too much ANDROFORTE® 2, immediately telephone your doctor or your local Poisons Information Centre for advice or go to the Accident and Emergency Department at your nearest hospital. Do this even if there are no signs of discomfort or poisoning. If ANDROFORTE® 2 is accidently swallowed or eaten contact a doctor.
During ANDROFORTE® 2 use
Inform your doctor or pharmacist that you are using ANDROFORTE® 2 before starting any other prescribed medicine. Some medicines interact with other medications. Tell all doctors, dentists and pharmacists who are treating you that you are using ANDROFORTE® 2. Have your testosterone blood levels measured regularly by your doctor. This is especially important
in the first few weeks of starting ANDROFORTE® 2 to ensure that testosterone levels are within the normal levels for men.
Do not give ANDROFORTE® 2 to anyone else, even if they have the same symptoms or condition as you. Observe care when driving or operating machinery at the start of treatment using ANDROFORTE® 2 until you know how ANDROFORTE® 2 affects you. There is no evidence that ANDROFORTE® 2 will affect your ability to drive or operate heavy machinery.
Tell your doctor as soon as possible if you do not feel well while you are using ANDROFORTE® 2. All medicines can have side effects in some people. Sometimes they are serious, most of the time they are not. Some side effects may need medical treatment. Tell your doctor if you notice any of the following that troublesome or ongoing:
- skin irritation, for example rash or slight redness and itching of the skin where the cream has been applied. Any irritation will usually disappear within a few days. If it persists contact your doctor or pharmacist. Many men experience a warm sensation of the scrotal skin for a few minutes after applying ANDROFORTE® 2 – this is normal.
- Loss of head hair (male pattern baldness)
- Nausea, sickness
- Swelling of the ankles
- Yellowing of the skin
- Increased body hair
- Weight gain
- Deepening of the voice
- Frequent or persistent erections
Rarely reported events associated with testosterone supplementation include:
- Electrolyte imbalances in the blood
- A reduction in the number of sperm produced
Tell your doctor if you observe any other effects not listed about. Do not be alarmed by this list of possible side effect. You most likely will not experience any of them. ANDROFORTE® 2 has not been associated with these effects but because it contains testosterone there is a potential for side effects.
After using ANDROFORTE® 2
Keep the tube sealed until time for use.
Replace cap firmly on the tube once opened.
Do not transfer the cream out of the original tube into another container. Keep the tube in a cool dry place where the temperature stays below 25°C.
DO NOT FREEZE. Once opened, the contents of the tube should be used with 12 weeks. Keep medicines out of reach of children.
If your doctor tells you to stop using ANDROFORTE® 2 ask your pharmacist how to dispose of any cream that is left over.
ANDROFORTE® 2 cream is a white opaque odorless cream in a laminated tube. The crimp at the base of the tube has the batch number and expiry date imprinted on it.
The tube is boxed together with a consumer information sheet and graduated measuring applicator.
Each 50 mL tube contains 1000 milligram (1000 mg) of testosterone. Each 1 mL dose delivers 20 mg of testosterone. Other ingredients in the cream include cetomacrogol 1000, cetostearyl alcohol, almond oil, dl-a-tocopherol (vitamin E acetate), butylated hydroxtoluene, anhydrous citric acid, triethanolamine, Carbomer 940, B&J Phenonip® and purified water.
ANDROFORTE® 2 is available in a 50 mL sealed laminated tube
Name and Address of Supplier
Lawley Pharmaceuticals Pty Ltd for Lawley Pharmaceuticals
Unit 2/15A Harrogate St,
West Leederville, 6007
Western Australia, AUSTRALIA
P.O. Box 1146,
West Leederville, 6901
Western Australia, AUSTRALIA
International Telephone: +61 8 9388 0096
Fax: +61 8 9388 0098
Date of preparation: Sept 2011.
ANDROFORTE® 2 is a registered trademark.
Published by MIMS March 2013