Scheduling Status
SYNAPAUSE VAGINAL CREAM is an S2 medicine.
Proprietary Name and Dosage Form
SYNAPAUSE VAGINAL CREAM
What SYNAPAUSE VAGINAL CREAM Contains
Each gram of SYNAPAUSE VAGINAL CREAM contains estriol 1 mg as the active ingredient.
The inactive ingredients include cetyl alcohol, cetyl palmitate, chlorhexidine dihydrochloride, glycerol, lactic acid, octyldodecanol, polysorbate 60, sodium hydroxide, sorbitan stearate and stearyl alcohol.
The preservative is chlorhexidine hydrochloride 0,01 % m/m.
SYNAPAUSE VAGINAL CREAM contains sugar in the form of glycerol, which is a sugar alcohol. It also contains alcohol in the form of glycerol, cetyl alcohol and stearyl alcohol.
What SYNAPAUSE VAGINAL CREAM Is Used For
SYNAPAUSE VAGINAL CREAM is used to help restore the mucosal layer of the vaginal wall.
Before You Apply SYNAPAUSE VAGINAL CREAM
SYNAPAUSE VAGINAL CREAM may not be suitable if any of the following apply:
| Do not use SYNAPAUSE VAGINAL CREAM if | Details |
|---|---|
| You are pregnant or think you may be pregnant | SYNAPAUSE VAGINAL CREAM should not be used during pregnancy |
| You are breastfeeding | SYNAPAUSE VAGINAL CREAM should not be used while breastfeeding |
| You have a tumour | This includes a breast tumour or tumour in the womb |
| You have recently had unexpected vaginal bleeding | This should be assessed by a doctor |
| You have had an allergic reaction to any ingredient | This may include the active or inactive ingredients |
| You have had abnormal growth of the lining of the womb | Also known as endometrial hyperplasia |
| You have or have had a blood circulation disorder | This includes blood clots in the veins of the legs or lungs |
| You have had a blood clotting disorder | This includes thrombophilic disorders such as protein C, protein S or anti-thrombin deficiency |
| You have or have had a disease caused by blood clots in the arteries | This includes angina pectoris, stroke or heart attack |
| You have or have had liver disease and liver function has not returned to normal | SYNAPAUSE VAGINAL CREAM may not be suitable |
| You have porphyria | SYNAPAUSE VAGINAL CREAM may not be suitable |
Take Special Care With SYNAPAUSE VAGINAL CREAM
Before starting SYNAPAUSE VAGINAL CREAM, your doctor should ask about your own and your family’s medical history. Your doctor may examine your breasts and/or abdomen and may perform an internal examination.
Periodic check-ups are needed, especially breast examinations. Your doctor will advise how often these should be performed.
After starting SYNAPAUSE VAGINAL CREAM, regular check-ups should take place at least once a year. During these visits, your doctor may discuss the benefits and risks of continuing treatment.
Tell your doctor if you have or have had any of the following conditions, or if they became worse during pregnancy or previous hormone use:
| Condition |
|---|
| Uterine fibroids |
| Endometriosis |
| Blood clots in the blood vessels, including thrombosis, deep vein thrombosis or lung embolism |
| Increased risk of developing blood clots |
| Family history of oestrogen-dependent cancer, such as breast cancer in a close relative |
| High blood pressure |
| Heart disease |
| Liver disorders |
| Kidney disorders |
| Diabetes |
| Gallstones |
| Migraine or severe headache |
| Systemic lupus erythematosus |
| Thickening of the womb layer |
| Epilepsy |
| Asthma |
| Otosclerosis, also known as inherited deafness |
Tell your doctor if you notice any change in your condition while using SYNAPAUSE VAGINAL CREAM.
Reasons for Immediately Stopping SYNAPAUSE VAGINAL CREAM
Stop using SYNAPAUSE VAGINAL CREAM and contact your doctor if any of the following occur:
| Reason to stop | What it may indicate |
|---|---|
| Yellowing of the skin | Jaundice or reduced liver function |
| Sudden increase in blood pressure | Possible cardiovascular concern |
| First-time migraine or severe headaches | Possible neurological or vascular concern |
| Pregnancy | SYNAPAUSE VAGINAL CREAM should not be used during pregnancy |
| Breastfeeding | SYNAPAUSE VAGINAL CREAM should not be used while breastfeeding |
Effects on Your Risk of Developing Cancer
Endometrial Cancer
Endometrial cancer is cancer of the lining of the womb. Women using hormone replacement therapy, such as SYNAPAUSE VAGINAL CREAM, may have a risk of endometrial cancer.
To help prevent endometrial stimulation, the maximum dose should not be exceeded and should not be used for longer than several weeks. In long-term treatment, your doctor may want to examine the uterus or prescribe a progestogen.
Breakthrough bleeding or spotting may occur during the first few months of treatment.
Contact your doctor if bleeding or spotting:
| Bleeding or spotting concern |
|---|
| Continues for more than the first few months |
| Starts after hormone replacement therapy has been used for some time |
| Continues after SYNAPAUSE VAGINAL CREAM has been stopped |
This may be a sign that the lining of the womb has become thicker.
Breast Cancer
Women who have breast cancer or have had breast cancer in the past should not use SYNAPAUSE VAGINAL CREAM.
Hormone replacement therapy may increase the risk of breast cancer. The risk increases with the duration of hormone replacement therapy use and returns to normal within about five years after stopping treatment.
It is not known whether SYNAPAUSE VAGINAL CREAM carries the same higher risk of breast cancer as other hormone replacement therapies. If concerned, discuss the benefits and risks with your doctor.
Regularly check your breasts for changes, including:
| Breast changes to look for |
|---|
| Dimpling of the skin |
| Changes in the nipple |
| Lumps that can be seen or felt |
Ovarian Cancer
Ovarian cancer is rare but serious. It can be difficult to diagnose because there are often no obvious signs.
Long-term use of oestrogen-only hormone replacement therapy, including treatment for at least five to ten years, is thought to carry a slight risk of ovarian cancer.
Effects on Your Heart or Circulation
Coronary Artery Disease
SYNAPAUSE VAGINAL CREAM is not recommended for women who have heart disease or have recently had heart disease.
If you have ever had heart disease, speak to your doctor before using SYNAPAUSE VAGINAL CREAM.
If symptoms of heart disease occur, such as chest pain spreading to the arm or neck, see a doctor as soon as possible. Do not use more hormone replacement therapy until your doctor says you can.
Stroke
Hormone replacement therapy may increase the risk of stroke.
If symptoms suggestive of stroke occur, such as unexplained migraine-type headaches with or without disturbed vision, see a doctor as soon as possible. Stop using SYNAPAUSE VAGINAL CREAM until your doctor says you can continue.
Blood Clots
Hormone replacement therapy may increase the risk of blood clots in the veins. These clots are also called deep vein thrombosis or DVT. A clot may travel to the lungs and cause chest pain, breathlessness, collapse or death. This is called pulmonary embolism or PE.
DVT and PE are examples of venous thromboembolism or VTE.
You may be more likely to get a blood clot if:
| Risk factor |
|---|
| You are older |
| You are pregnant or have recently had a baby |
| You have had one or more miscarriages |
| You use oestrogens such as SYNAPAUSE VAGINAL CREAM |
| You are seriously overweight |
| You have had a blood clot before in the leg, lung or another organ |
| A close family member has had blood clots |
| You have a blood clotting problem requiring medicine such as warfarin |
| You are off your feet for a long time due to major surgery, injury or illness |
| You have systemic lupus erythematosus |
| You have cancer |
If symptoms of a blood clot occur, such as painful swelling in the leg, sudden chest pain or difficulty breathing, see a doctor as soon as possible. Stop using SYNAPAUSE VAGINAL CREAM until your doctor says you can continue.
If surgery is planned, tell your doctor. You may need to stop using SYNAPAUSE VAGINAL CREAM about four to six weeks before the operation to reduce the risk of a blood clot. Your doctor will advise when treatment can be restarted.
Other Effects
Hormone replacement therapy will not prevent memory loss. The risk of memory loss may be somewhat higher in women who start hormone replacement therapy after the age of 65.
Pregnancy and Breastfeeding
If you are pregnant or breastfeeding while using SYNAPAUSE VAGINAL CREAM, consult your doctor, pharmacist or healthcare professional.
Do not use SYNAPAUSE VAGINAL CREAM if you are pregnant or think you may be pregnant.
Do not breastfeed while using SYNAPAUSE VAGINAL CREAM.
Driving and Using Machinery
As far as is known, SYNAPAUSE VAGINAL CREAM has no influence on alertness or concentration.
Important Information About Some of the Ingredients of SYNAPAUSE VAGINAL CREAM
SYNAPAUSE VAGINAL CREAM contains cetyl alcohol and stearyl alcohol. These ingredients may cause local skin reactions such as contact dermatitis.
Taking Other Medicines With SYNAPAUSE VAGINAL CREAM
Always tell your healthcare professional if you are taking any other medicine, including complementary or traditional medicines.
Especially tell your doctor if you take or are to receive:
| Medicine or medicine group |
|---|
| Corticosteroid hormones |
| Oral anticoagulants, which are medicines used to stop blood clots |
| Succinylcholine, used for muscle relaxation during anaesthesia |
| Theophyllines, used for asthma |
| Medicines for epilepsy or sleeplessness |
| Medicines for fungal, bacterial or viral infections |
How to Use SYNAPAUSE VAGINAL CREAM
SYNAPAUSE VAGINAL CREAM should be used as directed by your healthcare professional. Read the instructions on the medicine label. Ask your doctor or pharmacist if you are unsure how to use it.
For vaginal complaints, the usual dosage is one application daily during the first two to three weeks. Later, the dose is gradually decreased, for example to one application twice a week.
Use the applicator to apply the cream into the vagina. It is a good idea to use it before going to bed at night.
One application, with the applicator filled to the ring mark, contains 0,5 g of SYNAPAUSE VAGINAL CREAM, which provides 0,5 mg estriol.
Instructions for Use
- Remove the cap from the tube, invert it, and use the sharp point to open the tube.
- Screw the end of the applicator onto the tube. Make sure the plunger is fully inserted into the barrel.
- Squeeze the tube to fill the applicator with cream until the plunger stops at the red ring.
- Unscrew the applicator from the tube and replace the cap on the tube.
- To apply the cream, lie down, insert the end of the applicator deep into the vagina and slowly push the plunger all the way in until the applicator is empty.
After use, pull the plunger out of the barrel and wash both parts 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 reassembled by fully inserting the plunger into the barrel beyond the point where resistance is felt.
Discard the applicator once the tube is empty.
If You Use More SYNAPAUSE VAGINAL CREAM Than You Should
If some cream has been swallowed, consult a doctor.
Possible symptoms may include:
| Possible overdose symptoms |
|---|
| Nausea |
| Vomiting |
| Vaginal bleeding in females after a few days |
If You Forget to Use SYNAPAUSE VAGINAL CREAM
If you forget to use a dose, use it as soon as you remember, unless you notice the missed dose on the day of your next dose.
If you notice the missed dose on the day of your next dose, do not use the missed dose. Continue with the next dose as normal.
Never use two doses on the same day.
Possible Side Effects
SYNAPAUSE VAGINAL CREAM can have side effects.
Side Effects Table
| Side-effect category | Side effects / symptoms | Recommended action |
|---|---|---|
| General side effects | Local irritation, itching or excessive cervical mucous production | Consult your doctor if troublesome |
| General side effects | Swelling and increased tenderness of the breasts, sometimes painful | Consult your doctor if troublesome |
| Unexpected symptoms | Unexpected vaginal bleeding | Consult your doctor at once |
| Other possible side effects | Benign and malignant hormone-dependent tumours such as endometrial cancer | Seek medical advice |
| Other possible side effects | Heart attack and stroke | Seek urgent medical attention |
| Other possible side effects | Gall bladder disease | Consult your doctor |
| Skin or subcutaneous disorders | Brownish pigmentation of the skin, also known as chloasma | Consult your doctor |
| Skin or subcutaneous disorders | Skin diseases with blisters and nodules, or bleeding into the skin, including erythema multiforme, erythema nodosum and vascular purpura | Consult your doctor |
| Blood clot-related side effects | Venous thromboembolism, including deep leg or pelvic vein blood clots that may pass to the lungs | Seek urgent medical attention |
| Long-term risk | Using SYNAPAUSE VAGINAL CREAM for several years increases the risk of breast cancer | Discuss ongoing treatment and risk with your doctor |
| Side effects not listed | Any unusual, unexpected or untoward effects | Consult your doctor, pharmacist or other healthcare professional |
Not all side effects reported for SYNAPAUSE VAGINAL CREAM are included in the patient information. If your general health worsens or you experience unexpected effects while using SYNAPAUSE VAGINAL CREAM, consult your doctor, pharmacist or healthcare professional.
Storage and Disposing of SYNAPAUSE VAGINAL CREAM
Keep the 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.
Presentation of SYNAPAUSE VAGINAL CREAM
SYNAPAUSE VAGINAL CREAM is filled in collapsible aluminium tubes containing 15 g of cream.
The tubes are provided with a polyethylene screw cap.
The applicator consists of a polystyrene barrel and a polyethylene plunger.
Each tube is packed together with an applicator in a carton.
Identification of SYNAPAUSE VAGINAL CREAM
SYNAPAUSE VAGINAL CREAM is a white to almost white, smooth, homogenous cream mass.
Registration Number
V/18.6/201
Name, Business Address and Telephone Number of the Holder of the Certificate of Registration
PHARMACARE LIMITED
Healthcare Park
Woodlands Drive
Woodmead 2191
Date of Publication
06 June 2014
Medical Disclaimer
This article is intended as patient information based on the approved leaflet structure. It does not replace advice from a doctor, pharmacist or other healthcare professional. For regulated medical product use, follow the approved patient information leaflet and healthcare professional guidance.
