Testaf Eme 1 % Cream

TestaFeme is used to treat hypoactive sexual desire dysfunction (HSDD) in postmenopausal women.
It contains the active ingredient testosterone. Testosterone belongs to a group of medicines called androgens and this form of testosterone is identical to the testosterone produced by the ovaries of women and the testes of men. HSDD is characterised by absence or marked reduction in desire or motivation to engage in sexual activity and is associated with distress. Testosterone has been shown to increase sexual motivation including sexual desire, pleasure, orgasm, responsiveness, and self-image, and reduce sexual concerns and distress in postmenopausal women. The skin readily absorbs testosterone and TestaFeme is a simple and effective means of getting testosterone into the bloodstream.
Ask your doctor if you have any questions about why TestaFeme has been prescribed for you. Your doctor may have prescribed it for another reason.

Do not take TestaFeme:
• If you are hypersensitive (allergic) to testosterone, tree nuts (almond oil) or any of the other ingredients of TestaFeme (listed in section 6). Some of the symptoms of an allergic reaction may include:
o shortness of breath,
o wheezing or difficulty breathing,
o swelling of the face, lips, tongue or other parts of the body,
o rash, itching or hives on the skin.
• If you have breast cancer.
• If you have any other cancer which your doctor has described as being caused or stimulated by androgen.
• If you have kidney disease known as nephrotic syndrome.
• If you have blockage of a blood vessel by a blood clot (thromboembolism).
• If you have high calcium levels in the blood (hypercalcaemia).
• If you are pregnant or breastfeeding
Do not take this medicine if you still have menstrual periods. TestaFeme should only be used by women who have no longer have their menstrual periods, either naturally or because they have had a total hysterectomy. Do not give TestaFeme to children. TestaFeme is for use by postmenopausal women with HSSD only. It should not be used in children.
Warnings and precautions
Tell your doctor if you have or have had any of the following medical conditions:
• Heart disease or high blood pressure.
• Liver disease.
• Kidney disease.
Tell your doctor if you had any of the following. Your doctor might monitor you more closely:
• A condition that affects blood flow to your brain (cerebrovascular disease), e.g., a stroke, bleeding in your brain.
• A heart attack (myocardial infarction) or pain in your chest (angina)
• High blood pressure that was difficult to control
• High blood levels of low-density lipoprotein (LDL) cholesterol, and fats called triglycerides, or both.
High level athletes need to be aware of the rules governing testosterone (an androgen) use if prescribed TestaFeme cream as testosterone may enhance athletic performance.
Other medicines and TestaFeme
Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Some medicines and TestaFeme may interfere with each other. These include:
• Oral oestrogens, medicines contained in oral contraceptives and hormone replacement therapy.
• Tibolone, a medicine used for hormone replacement.
• Oral anticoagulants, medicines used 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.
These medicines may be affected by TestaFeme or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Woman taking medicines for depression called SSRI/SNRI: In women who have low libido as a result of taking SSRI or SNRI antidepressant medications your interest in sex and/or ability to reach orgasm may increase when using TestaFeme. It is important that you continue the antidepression treatment to assist your mood, general well-being and/or depression unless advised otherwise by your doctor.

Do not share medicines prescribed for you with any other person. Ask your doctor or pharmacist if you are unsure of the correct dose for you. They will tell you exactly how much to take. Follow the instructions they give you. If you take the wrong dose, TestaFeme may not work as well, and your problem may not improve.
How much to use
The usual starting dose is 0,5 ml (5 mg) of cream by measured applicator per day. You should not use more than 1,0 ml (10 mg testosterone) of cream per day unless directed to do so by your doctor. You will need to return to your doctor three to six weeks after starting treatment so that the dose can be checked via a blood test and adjusted if required. It is recommended that women should ideally attend the same laboratory for baseline testosterone biochemistry prior to and during treatment.
It may take 1 - 2 months for you to notice an improvement. If symptoms do not improve after 6 months, you should discuss an alternative treatment with your doctor.
How to use it
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 TestaFeme box. The applicator is marked with 0,5 ml graduations for dosing accuracy. To measure the correct dose of cream, gently squeeze the base of the TestaFeme tube until cream reaches the open nozzle of the tube. Insert the tip of the applicator into the open nozzle of TestaFeme 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 TestaFeme tube and at the same time slowly withdraw the red 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 0,5 ml dose of TestaFeme (5 mg testosterone) needs the flat part of the plunger level with the 0,5 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. Remove the applicator from the nozzle of the tube and replace the cap firmly on the tube.
Where to apply TestaFeme cream
Always apply TestaFeme directly onto clean, dry, healthy skin of either the lower abdomen, the upper outer thigh or buttock. Massage the cream into the area until absorbed. Typically, this takes about 30 seconds. No perfume, deodorant or moisturising creams/gels should be used on the area because this may interfere with TestaFeme being absorbed. Cover the application area with clothing once applied. Never apply the cream to broken or damaged skin. Do not use TestaFeme on the genital or other areas. Wash your hands thoroughly with soap and water after applying the cream. Rinse the applicator in hot water after use and replace in the box with the TestaFeme cream.
When to use it
Apply TestaFeme once per day at approximately the same time each day. Applying the cream at the same time each day will have the best effect. It will also help you remember when to apply it. It is recommended that patients do not swim or shower until at least four hours after application of TestaFeme cream.
How long to use TestaFeme
Continue using TestaFeme for as long as your doctor tells you. TestaFeme is usually used for a minimum of 3 months to see if the medicine works for you. Your doctor will also check testosterone levels in the blood at regular intervals. If your symptoms do not improve after 6 months, your doctor may discontinue TestaFeme and discuss an alternative treatment with you.
There is currently limited safety information on the use of TestaFeme beyond two years. Your doctor will discuss the benefits and risks of longer use with you.
Use in children
Do not use TestaFeme in children as the safety and effectiveness in children have not been established.
If you use more TestaFeme than you should
Wash the skin with soap and water. In the event of accidental overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.
If you missed a dose of TestaFeme
Use your dose as soon as you remember and continue to apply it as you would normally. If it is almost time for your next dose, skip the dose you missed and apply your next dose when you are meant to. Do not apply a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.

TestaFeme can have side effects. Not all side effects reported for TestaFeme are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using TestaFeme, please consult your health care provider for advice.
If any of the following happens, stop using TestaFeme and tell your doctor immediately or go to the casualty department at your nearest hospital:
• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.
These are all very serious side effects. If you have them, you may have had a serious reaction to TestaFeme. You may need urgent medical attention or hospitalisation.
Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
Less frequent:
• nausea and vomiting,
• yellowing of the skin and/or eyes, also called jaundice,
• swelling of the ankles,
• weight gain,
• persistent headaches,
• deepening of the voice,
• changes in tissue of the breast,
• vaginal bleeding,
• ovulation and menstrual periods may stop in premenopausal women,
• enlargement of the clitoris.
These are all serious side effects. You may need urgent medical attention.
Tell your doctor if you notice any of the following:
Frequent:
• acne and oily skin,
• increased body hair particularly on the face,
• loss of head hair (male pattern baldness) or thinning,
• headache,
• abdominal bloating,
• constipation.
Other side effects not listed above may also occur in some people. Some of these side effects such as electrolyte disturbances and increased red blood cells can only be found when your doctor does tests from time to time to check your progress.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Reporting of side effects
If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reactions & Quality Problem Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 . By reporting side effects, you can help provide more information on the safety of TestaFeme.

Store all medicines out of reach of children.
• Store at or below 25 °C. Do not freeze.
• Keep your medicine in the original container.
• If you take it out of its original container it may not keep well.
• Once opened, the contents of the tube should be used within 125 days.
• Do not store TestaFeme in the bathroom or near a sink.
• Do not use after the expiry date stated on the label/ carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).