Synapause Vaginal Cream

SYNAPAUSE VAGINAL CREAM is used to restore the mucosal layer of the vaginal wall.

SYNAPAUSE VAGINAL CREAM may NOT be suitable for you if the answer is YES to any of the following questions:

• Are you pregnant or do you think you may be pregnant?
• Are you breastfeeding your baby?
• Do you have a tumour (e.g. a breast tumour or a tumour in your womb)?
• Have you recently had unexpected vaginal bleeding?
• Have you ever had an allergic reaction to one of the ingredients of SYNAPAUSE VAGINAL CREAM?
• Have you had abnormal growth of the lining of your womb (endometrial hyperplasia)?
• Have you or have you had a blood circulation disorder such as blood clots (in the veins of the legs or the lungs)?
• Have you had a blood clotting disorder (thrombophilic disorder, such as protein C, protein S or anti-thrombin deficiency)?
• Have you or have you had a disease caused by blood clots in the arteries, such as angina pectoris, stroke or a heart attack?
• Have you or have you had liver disease where the function of the liver has not returned to normal?
• Do you have porphyria?

Take special care with SYNAPAUSE VAGINAL CREAM

Before you start using SYNAPAUSE VAGINAL CREAM, your doctor should enquire about your own and your family’s medical history. Your doctor may decide to examine your breasts and/or your abdomen, and may do an internal examination. You will also have to have periodic check-ups, especially examinations of the breasts. Your doctor will tell you how often these tests should be performed.

SYNAPAUSE VAGINAL CREAM should be used as directed by your health care professional. You should read the instructions on the label of your medicine. If you are not sure how to use SYNAPAUSE VAGINAL CREAM, ask your doctor or pharmacist.

For vaginal complaints the usual dosage is 1 application daily during the first 2 to 3 weeks; later on the dose is gradually decreased to, for instance, 1 application twice a week. Use the applicator to apply the cream in the vagina. It is good idea to do this before retiring at night. One application (applicator filled to the ring mark) contains 0,5 g of SYNAPAUSE VAGINAL CREAM, which has 0,5 mg estriol in it.

Instructions:

1. Remove cap from the tube, invert it, and use the sharp point to open the tube.
2. Screw the end of the applicator onto the tube. Make sure the plunger is fully inserted into the barrel.
3. Squeeze tube to fill the applicator with the cream until the plunger stops (at the red ring, see arrows in picture below).
4. Unscrew applicator from tube and replace cap on tube.
5. To apply the cream, lie down, insert the end of the applicator deep into the vagina and slowly push plunger all the way in until the applicator is empty. After use, pull plunger out of barrel and wash both in warm, soapy water.

Do not use detergents. Rinse well afterwards. DO NOT PUT THE APPLICATOR IN HOT OR BOILING WATER. The applicator can be re-assembled by fully inserting the plunger into the barrel beyond the point where resistance is felt. Discard the applicator once the tube is empty.

SYNAPAUSE VAGINAL CREAM can have side effects. In general SYNAPAUSE VAGINAL CREAM may cause side effects such as:

• Local irritation or itching or excessive cervical mucous production
• Swelling and increased tenderness (sometimes painful) of the breasts.

Consult your doctor at once if unexpected vaginal bleeding occurs, if side effects are troublesome, or if you notice any other unusual or unexpected symptoms during treatment with SYNAPAUSE VAGINAL CREAM.

Other side effects which may occur with SYNAPAUSE VAGINAL CREAM:

• Benign and malignant hormone-dependent tumours such as endometrial cancer
• Heart attack and stroke
• Gall bladder disease
• Skin- or subcutaneous disorders, such as brownish pigmentation of the skin (chloasma), various skin diseases with blisters and nodules or bleeding into the skin (erythema multiforme, erythema nodosum, vascular purpura)
• Venous thromboembolism i.e. deep leg or pelvic vein blood clots which may pass to your lungs (see BEFORE YOU APPLY SYNAPAUSE VAGINAL CREAM - Blood clots).

Using SYNAPAUSE VAGINAL CREAM for several years increases the risk of breast cancer. Not all side effects reported for SYNAPAUSE VAGINAL CREAM are included in this leaflet. If your general state of health worsens or if you experience any untoward effects while using SYNAPAUSE VAGINAL CREAM, please consult your doctor, pharmacist or other healthcare professional for advice.

Keep your tube of SYNAPAUSE VAGINAL CREAM in the original box in a safe place out of the reach of children. Store in a cool place at or below 25 °C. Do not freeze.