Sandrena is intended for use in women during or after the menopause.

Each sachet contains 0.5 mg or 1.0 mg of the active ingredient called oestradiol.

Sandrena foil sachets are marked Organon with the product name and pack size. Expiry date and batch number are also marked on each sachet.

Sandrena is used to replace the body's natural sex hormone oestradiol which is reduced after the menopause.

When applied to the skin the gel quickly evaporates and oestradiol is absorbed through the skin into the circulation.

What Sandrena is used for

During and after the menopause the production of sex hormones 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 relieve 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 cyclic progestin. This would be for about 10 to 14 days per month.

Before you use Sandrena

Sandrena may not be suitable for you if you suffer from certain medical conditions. Before you start to use Sandrena make sure you tell your doctor if you answer YES to any of the following questions:

• are you pregnant or do you think you may be pregnant?
• do you have a tumour (e.g. a breast tumour or a tumour in your womb)?
• do you have or have you ever had heart disease or blood vessel problems?
• do you have or have you ever had thrombosis (blood clots)?
• have you recently had unexpected vaginal bleeding?
• do you have or have you ever had liver disease?
• have you pre-existing uterine leiomyoma. Careful examinations should be performed at regular intervals during therapy, by your doctor.
• have you had heart failure, kidney problems or severe hypertension.

Caution: Before using Sandrena it is also important to tell your doctor if you have or have ever had too much cholesterol or other fatty substances in the blood.

Also tell your doctor if you have been treated with other sex hormones recently.

Tell your doctor if you are or think you are allergic to any of the components of the gel.

Your doctor will conduct a complete gynaecological examination before commencement with Sandrena.

During long-term treatment with Sandrena yearly medical checks are recommended.

Drug Interactions

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:

• barbiturates, carbamazepine and hydantoins (medicines for epilepsy or sleeplessness)
• rifampicin (medicine for bacterial infections)
• meprobamate and phenylbutazone

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.

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.

Directions

How and when to apply Sandrena

Rub the contents of one to two sachets daily on your 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. Most patients can start with a 1.0 mg oestradiol dose daily.

If you have not had a hysterectomy, your doctor will probably prescribe a progestin for cyclical use, to help prevent overgrowth of the tissues lining your womb.

Usually, a withdrawal bleeding resembling normal menstruation will occur after the progestin treatment. Unexpected or prolonged uterine bleeding during therapy should be reported to your doctor and its cause clarified.

What to do if you miss a dose

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.

Side Effects of Sandrena

Side effects are most common in the first months of the treatment. They are usually mild leading only seldom to discontinuation of the treatment.

Common side effects reported include:

• tension in the breasts
• headache
• nervousness
• fatigue
• nausea
• palpitations
• oedema
• weight increase
• unscheduled or breakthrough bleedings

Sporadically reported side effects include:

• migraine
• skeletal pain
• changes in libido and mood
• changes in liver enzyme levels in blood
• increase in blood pressure
• vomiting and stomach cramps

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.

You should stop using Sandrena if you experience any signs of thrombosis (headache or pain elsewhere in your body, dizziness, fainting, disturbances in vision, swollen ankles), or jaundice (yellowing of the eyes or skin).

Pregnancy

If you are pregnant or breast-feeding, or think you may be pregnant, do not use Sandrena. Overdose

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 and in females vaginal bleeding may occur after a few days.

Storage

Keep your Sandrena gel in the original container in a safe place out of the reach of children. Check if there are special storage conditions given on the box. The expiry date (sometimes written as "exp") is also printed on the strip of sachets - do not use after this date.

New packs have a shelf life of 3 years.

Disposal

Return any unused medicine to your pharmacist.

Ingredients

Sandrena consists of 0.1% oestradiol. Each sachet contains 0.5 mg or 1.0 mg of oestradiol.

Sandrena also contains the following inactive ingredients: carbomer 934, sodium hydroxide, propylene glycol, ethanol and water.