Consumer Medicine Information
This leaflet answers some common questions about Sandrena®. It does not contain all the available information. It does not take the place to talking to your doctor or pharmacist.
Keep this information with the pack. You may wish to read it again.
A doctor's prescription is required to obtain this medicine.
During and after menopause the production of sex hormones produced by the body decreases. Women may then suffer from complaints such as hot flushes, night sweats, vaginal irritation, depression, and loss of sexual desire. Sandrena® can be used for the short-term relief of menopausal complaints.
It can also relieve these symptoms in women who have had their ovaries removed. Relief of symptoms usually starts within a few weeks, but optimal results are obtained after three months of treatment. Sandrena® is not intended for contraceptive use.
If you have not had a hysterectomy, your doctor will probably combine the Sandrena® treatment with another hormone product, a progestogen.
Sandrena® may not be suitable for you if you suffer from certain medical conditions.
Tell your doctor if you-
Also tell your doctor if:
Tell your doctor if you are or think you are allergic to any of the components of the gel. The ingredients are listed at the end of this leaflet. Note this product contains propylene glycol and may cause skin irritation.
Your doctor will conduct a complete gynaecological examination before commencement with Sandrena®.
Before starting with hormone replacement therapy (HT) you have to inform your doctor of your personal and family medical history. You will get a general and gynaecological examination. You will also get periodic check-ups, especially examinations of the breasts. Every woman is at risk of getting breast cancer, whether or not she takes HT. Breast cancer has been found slightly more often in women using HT than in women of the same age who have never used HT.
It is not known whether Sandrena® is associated with the same higher chance of having breast cancer diagnosed as other hormone replacement therapies.
Nevertheless, if you are concerned about the risk of breast cancer, discuss the risk compared to the benefits of treatment with your doctor.
There may be an increased risk of stroke when using this product.
There is an increased risk of ovarian cancer for women taking an oestrogen only product like Sandrena®.
Women who still have a uterus must take both oestrogen and progestogen as part of HT. This is because oestrogen stimulates the growth of the lining of the uterus (called the endometrium). Before menopause this lining is shed during your period through the action of a natural progestogen.
After menopause, taking oestrogen on its own as HT may lead to irregular bleeding and a disorder of the uterus lining called endometrial hyperplasia, which can become endometrial cancer. Progestogens help protect the lining of the uterus from developing this disorder.
Also, clinical studies on similar products showed a possible increased risk of cardiovascular problems in the first year of use and no benefit thereafter.
Thrombosis (blood clots)
All women have a very small chance of having a blood clot in the veins of the leg, lung or other parts of the body whether or not they take HT. Using some forms of HT may slightly increase this small chance. Whether or not Sandrena® may increase the chance of having a blood clot is not known.
You are more likely to have a blood clot (whether or not you use HT) if:
You should talk to your doctor about whether you should use Sandrena® if any of these apply to you.
If you get a blood clot while you are using Sandrena® you should stop taking it immediately and contact your doctor.
Warning signs to look out for are:
Other medicines may influence the effects of Sandrena®, or Sandrena® may affect other medicines.
You must tell your doctor or pharmacist if you are taking (or intend to take) other medicines such as:-
These drugs may reduce the effects of Sandrena®. Sandrena® may also reduce the effectiveness of other medicines such as some oral hypoglycaemics (medicines which lower blood sugar), antihypertensives (medicines which lower blood pressure) and some anticoagulants (medicines which "thin" the blood). Let your pharmacist or doctor know if you are a diabetic, or are being treated for blood clotting or high blood pressure.
Do not use Sandrena® if you are pregnant or breast-feeding, or think you may be pregnant.
Yearly medical checks are recommended. Additionally the doctor may check with you on how the treatment is progressing every six months or so.
Apply Sandrena® as directed by your doctor. You should also read the instructions on the label of your medicine. If you are not sure how to use Sandrena® ask your doctor or pharmacist.
The usual starting dose is one sachet per day. Your doctor or pharmacist will tell you exactly how much to use.
Open the sachet(s). Rub the contents daily on the skin of your lower abdomen or thighs. The application surface area should be one to two times the size of the hand.
Sandrena® should not be applied on the breasts, face or irritated skin.
Avoid contact with eyes, if Sandrena® does get into your eyes, wash out thoroughly with water. Wash hands thoroughly immediately after application.
In clinical trials the use of Sandrena® has infrequently caused irritation of the skin. The chance of skin reactions can be further decreased by changing the area of application daily (e.g. left and right side on alternate days). Sandrena® is used either cyclically or continuously, in individually adjusted doses.
If you have not had a hysterectomy, your doctor will probably prescribe a progestogen, to help prevent overgrowth of the tissues lining your womb.
If you forget to apply the gel do so as soon as you remember, unless you are more than twelve hours late. If you are more than twelve hours late, do not apply the missed dose and just carry on with the next dose as normal.
Ability to drive or operate machinery. As far as is known, Sandrena® has no effect on alertness and concentration.
Discuss with your doctor or pharmacist if you are unsure of any of the aspects of this product.
Side effects, which may or may not be related to Sandrena® are most common in the first months of the treatment. They are usually mild leading only seldom to discontinuation of the treatment.
Common (more than 1/100):
Uncommon (less than 1/100):
Tell your doctor if spotting occurs or if any side-effects become troublesome or continue.
It is also important to tell your doctor or pharmacist if you experience any other unusual or unexpected symptoms during treatment with Sandrena®.
Seek advice before using other medications to deal with any side effects you may have.
You should stop using Sandrena® and seek medical attention immediately if you experience any signs of-
If you are pregnant or breast-feeding, or think you may be pregnant, do not use Sandrena®.
If someone has taken or used several sachets at once, there is no need for great concern. However, you should consult a doctor. Symptoms that may arise are nausea and vomiting. Vaginal bleeding may occur after a few days.
Keep your Sandrena® gel in the original container in a safe place out of the reach of children.
Store below 25°C
The expiry date (sometimes written as "exp") is also printed on the strip of sachets - do not use after this date.
Return any unused medicine to your pharmacist.
Packs contain 28 loose foil sachets. The sachets are marked with the supplier's name and Sandrena® 0.1% with the pack size, batch number and expiry date.
Sandrena® consists of 0.1% oestradiol. Each sachet contains 1.0 mg of oestradiol.
Sandrena® also contains the following inactive ingredients:
Aspen Pharmacare Australia Pty Ltd
34 - 36 Chandos Street
St. Leonards NSW 2065
AUST R No. 93609 (1.0 g)
This leaflet was prepared in
Published by MIMS December 2013