Cream containing 10% w/v (100mg/mL) Progesterone B.P (Prog-4-ene-3,20-dione)
Consumer Medicine Information
What is in this leaflet?
This leaflet answers some of the common questions about PROFEME®. 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 PROFEME® against the benefits it can have for you.
If you have any concerns about using PROFEME® talk to your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again.
What PROFEME® is used for?
PROFEME® contains the active ingredient progesterone. This form of progesterone is identical to the progesterone produced by the ovaries of women.
Progesterone plays an important role in the menstrual cycle, reproduction, hormone production, mood, fluid balance, metabolism, energy levels and well-being in women.
When women suffer from a deficiency of progesterone one or more of these areas may be affected. PROFEME® provides progesterone to address this deficiency. The skin readily absorbs progesterone and PROFEME® is a clean, simple and effective means of getting progesterone into the body.
Prior to using PROFEME®
PROFEME® cream should not be used if you are allergic to progesterone, or any of the ingredients contained within PROFEME®. These are listed at the end of this leaflet. This product contains almond oil and macadamia nut oil. Do not use PROFEME® if you have kidney disease, liver disease, unexplained abnormal vaginal bleeding or blisters during pregnancy (pemphigoid gestationis). Check with your doctor or pharmacist if you are unsure about whether you have any of these conditions before using PROFEME®. If you are taking other medications check with your doctor or pharmacist before using PROFEME®. PROFEME® is best applied to the inner forearm or upper thigh. The area should be clean and dry. No perfume, deodorant or moisturising creams or gels should be used on the area because this may interfere with PROFEME® from being absorbed.
Do not use PROFEME® after the expiry date printed on the base (crimp) of the tube.
Do not use PROFEME® if the foil seal at the top of the tube is damaged or broken.
PROFEME® is not indicated for use in children.
How to use PROFEME®
Your doctor or pharmacist will explain how to apply PROFEME®. Follow all directions exactly as they are explained. If you are unclear clarify with your doctor or pharmacist prior to use.
The dose of PROFEME® will be determined for you by your doctor. This dose will be specific to your condition and should not be varied unless directed to do so by your doctor. If you do not understand the instructions on the label, ask your doctor or pharmacist for help.
Opening the tube
To open the tube remove the cap and peel off the foil seal. Dispose of the foil seal and replace the cap firmly after using the cream.
Measuring the correct dose of PROFEME® Cream
To measure the correct dose of cream, gently squeeze the base of the the tip of the PROFEME® 10 tube until cream reaches the open nozzle of the tube. Insert the tip of the applicator into the open nozzle of PROFEME® 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 PROFEME® 10 tube and at the same time slowly withdraw the red plunger. The cream will flow into the barrel of the applicator.
Do not try to squeeze the cream into the syringe.
Fill to the required dose. For example: a 0.3mL dose of PROFEME® 10 (30mg of progesterone) needs the flat part of the plunger level with the 0.3mL mark. If there are any air bubbles in the measured dose fill slightly past the required dose mark then depress the plunger so the excess cream flows back into the tube. Stop at the required dose mark. Remove the applicator from the nozzle and replace the cap firmly on the tube.
Where to apply PROFEME® cream
Always apply PROFEME® cream to clean dry areas of skin. The best area to use PROFEME® is the inner arms or the upper thighs. Never apply the cream to broken or damaged skin. PROFEME® cream should be applied at approximately the same time each day.
How often to apply PROFEME® cream
Because each woman has a different progesterone requirement there is not a single “correct” dose of PROFEME®. Should you be unsure of the dose or frequency of dose, contact your doctor. A dosage guide follows.
Usual dose of PROFEME®
Perimenopausal women (including moderate heavy bleeding, uterine fibroids and mild endometriosis).
Apply 0.3mL of PROFEME® 10% cream via measured applicator (30mg progesterone) daily or in divided doses from day 12-26 of each menstrual cycle. If a menstrual period starts prior to day 26, cease using PROFEME® and consider the first day of bleeding as Day 1 of the new cycle. This is a common occurrence when initiating treatment in perimenopausal women and should be considered a sign the treatment is having a positive effect. Symptoms usually abate in the 2nd or 3rd month of use. Where symptoms are more severe or unresponsive your doctor may need to increase the dose to 100-200mg (1-2mL daily).
Premenstrual syndrome (PMS).
Apply 0.3mL of PROFEME® 10% cream via measured applicator (30mg progesterone) daily or in divided doses from day 12-26 of each menstrual cycle. Significant alterations to this dosage may be made to achieve a crescendo effect 4-5 days prior to menses. Symptoms generally abate in the 2nd or 3rd month of use.
Premenstrual dysphoric disorder (PMDD).
Apply 0.5-1mL of PROFEME® 10% cream via measured applicator (50-100mg progesterone) daily or in divided doses from day 12-26 of each menstrual cycle. Significant alterations to this dosage may be made to achieve a crescendo effect 4-5 days prior to menses. Symptoms generally abate in the 2nd or 3rd month of use.
Severe endometriosis, severe menstrual bleeding/flooding and postpartum depression.
Apply 1.0 – 2.0mL of PROFEME® 10% cream via measured applicator (100-200mg progesterone) daily or in divided doses depending upon the severity of the condition. In reproductive, cyclical women initiate treatment on a day 12-26 basis. This may need to be increased to three weeks use in every four if symptoms/pain emerge upon withdrawal.
Infertility/Repeated First-term Miscarriage Luteal phase and first trimester corpus luteal support.
Apply 1 mL of PROFEME® 10% cream (100mg progesterone) daily or in divided doses via measured applicator from day 12-26 of each cycle until pregnancy is confirmed and then 1-2mL daily on a continuous basis until at least week 13 or until full term.
Before conceiving, a woman prone to miscarriage should use 0.3mL of PROFEME® 10% cream (30mg progesterone) from days 12-26 of the cycle until the pregnancy is confirmed. If spotting occurs at week 6 or 7 of pregnancy, use a high dose of 100-200mg progesterone cream (PROFEME® 10%) twice or three times daily. PROFEME® can be used until the baby is full term (40 weeks of gestation).
Note: Amount and duration of application for all conditions must be tailored to individual requirements.
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 nine hours of your usual time of application. Otherwise do not apply the cream until the next application is due. Missing a dose will not create a significant disruption to your treatment.
If you use too much (overdose)
Because of the way PROFEME® is used, an unintentional overdose is unlikely.
If you think that you or anyone else may have used too much PROFEME®, immediately telephone your doctor or your local hospital.
During PROFEME® use
Inform your doctor or pharmacist that you are using PROFEME® 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 PROFEME®.
Do not give PROFEME® 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 using PROFEME® until you know how PROFEME® affects you. There is no evidence that PROFEME® will affect your ability to drive or to operate machinery. It is recommended that patients do not swim or shower until at least four hours after application of PROFEME® cream.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using PROFEME®. All medicines can have side effects in some people. Some side effects may need medical attention.
Tell your doctor if you notice any of the following that are 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.
- Breast tenderness
- Light headedness
These effects are occasionally reported and usually disappear with adjustment of dose.
Tell your doctor if you observe any other side effects not listed above.
After using PROFEME®
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.
Keep medicines out of reach of children.
If your doctor tells you to stop using PROFEME® return your tube to your pharmacy to be correctly disposed of.
PROFEME® 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 and in the box is a consumer information sheet and a graduated measuring applicator.
Each 50mL tube of PROFEME® 10% contains 5000 milligrams (5000mg) of progesterone. Each 1mL dose via measured applicator delivers 100mg of progesterone. Other ingredients in the cream include cetomacrogol 1000, cetostearyl alcohol, almond oil, macadamia nut oil, dl-α-tocpherol acetate (Vitamin E acetate), butylated hydroxytoluene, anhydrous citric acid, triethanolamine, Carbomer 940, B&J Phenonip® and purified water.
PROFEME® 10% is supplied in a 50mL sealed laminated tube.
Name and Address of Supplier
Lawley Pharmaceuticals Pty Ltd
Unit 2/15A Harrogate Street,
West Leederville, 6007
Western Australia, AUSTRALIA
P.O Box 1146, West Leederville, 6901
Western Australia, AUSTRALIA
Telephone : +61 8 9388 0096
Toll-Free phone (Australia): 1800 627 506
Fax: +61 8 9388 0098
USA & Canada
Toll-Free phone: 1800-961-7813
Toll-Free fax: 188-961-7650
Date of Preparation: December 2016.
PROFEME® is a registered trademark.
Published by MIMS December 2020