Gynest 0.01% w/w Cream

• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
• If you get side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Gynest is and what it is used for
2. What you need to know before you use Gynest
3. How to use Gynest
4. Possible side effects
5. How to store Gynest
6. Contents of the pack and other information

Gynest is used for vaginal problems caused by a lack of the hormone oestrogen.

• Gynest replaces the hormone oestrogen in the vaginal area when your body is not producing enough
• This happens most often during or after the menopause (see ‘What is the menopause?’)

Women produce oestrogen hormones from their ovaries throughout their adult life. These hormones are important in sexual development and control of the menstrual cycle.

The menopause happens when the level of hormones produced by the ovaries goes down. This is a gradual process. During this time the levels of oestrogen can go up and down.

This can cause the following symptoms:

• Vaginal dryness or itching
• Uncomfortable or painful sexual intercourse

You may get the same symptoms if you have had your ovaries taken out in an operation. This is called a ‘surgical menopause’.

• Are allergic to soya or peanuts. Gynest contains peanut oil (arachis oil). See ‘Important information about some of the ingredients of Gynest’
• Are allergic to any of the other ingredients in Gynest (listed in section 6 below)
• Have ever had or think you may have breast cancer
• Have a cancer that is made worse by oestrogens such as cancer of the lining of the womb (endometrial cancer)
• Have ever had blood clots (thrombosis)
• Have an abnormality of your clotting system that makes you more prone to develop blood clots
• Have or have recently had blocked arteries (arterial thrombo-embolic disease) that gave you angina or a heart attack
• Have a blood problem called ‘porphyria’
• Have abnormal vaginal bleeding which has not been explained
• Have thickening of the lining of your womb (endometrial hyperplasia) which has not been treated
• Have acute liver disease or a history of liver disease which is not completely resolved
• Have or have ever had breast cancer, or if you are suspected of having it

Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Gynest.

Check with your doctor or pharmacist before using Gynest if:

• You are using a ‘barrier’ method of contraception. This includes condoms or diaphragms. This is because Gynest can damage the rubber and stop them working properly. Talk to your doctor about using another type of contraception while you are using this medicine.

Before taking HRT, your doctor should ask about you and your family’s medical history. Your doctor may decide to examine your breasts or your stomach and may do an internal examination. They will only do this if it is necessary for you or if you have any special concerns.

Once you have started on HRT, see your doctor for regular check-ups (every three months). At these check-ups, your doctor may discuss the benefits and risks of continuing to take HRT.

Make sure that you:

• Go for regular breast screening and cervical smear tests
• Regularly check your breasts for any changes such as dimpling of the skin, changes in the nipple or any lumps you can see or feel

Tell your doctor if you have ever had any of the following. You may need above checks more often.

• A problem caused by growth of the womb lining:
  • Inside the womb (fibroids)
  • Outside the womb (endometriosis)
• Increased risk of blood clots (see ‘Blood clots’)
• An increased risk of cancers related to oestrogens e.g. a family history of breast cancer (see ‘Breast cancer’ below)
• High blood pressure (hypertension)
• Liver problems
• Diabetes
• Gallstones
• Migraine or severe headaches
• Systemic lupus erythematosus (SLE). This is an allergic condition that causes joint pain, skin rashes and fever
• Epilepsy
• Asthma
• Bone formation in the ear (otosclerosis)
• Heart or kidney problems
• High levels of fats called 'triglycerides' in your blood (hypertriglyceridaemia)

Tell your doctor if you are going to have surgery. You may need to stop taking HRT about 4 to 6 weeks before the operation to reduce the risk of blood clot. Your doctor will tell you when you can start taking HRT again.

If you visit a hospital or your family doctor for a blood or urine test, tell them that you are using Gynest. This is because this medicine may affect the results of the test.

As well as benefits, HRT has some risks. Consider the following when deciding to take or continue HRT.

Studies have shown that there was no increase in heart disease in women without a womb using oestrogen-only HRT.

If you get a pain in your chest that spreads to your arm and neck

• See a doctor as soon as possible
• Do not use any more HRT until your doctor says you can

This pain may be a sign of heart disease.

The risk of having a stroke due to a blood clot is up to 1.5 times higher with HRT. Other things that can increase the risk of stroke include:

• Getting older
• High blood pressure
• Smoking
• Drinking too much alcohol
• An irregular heartbeat

If you are worried about any of these things or if you have had a stroke in the past, talk to your doctor to see if you should take HRT.

How likely is a stroke?

Looking at women in their 50s, on average, over 5 years:

• In women not taking HRT - 8 in 1000 would be expected to have a stroke
• In women taking HRT - 11 in 1000 would be expected to have a stroke (i.e.an extra 3 cases

If you get migraine-type headaches which you cannot explain

• See a doctor as soon as possible
• Do not use any more HRT until your doctor says you can

These headaches may be an early warning sign of a stroke.

Blood clots

HRT may increase the risk of blood clots in the veins (also called deep vein thrombosis or DVT), by up to 3 times, especially during the first year of taking it.

These blood clots are not always serious. However, if a clot travels to the lungs, it can cause chest pain, breathlessness, collapse or even death. This is called pulmonary embolism or PE.

The risk of a blood clot increases with age. In addition, you are more likely to get a blood clot if:

• You are very overweight
• You have had a blood clot before
• Any of your close family have had blood clots
• You are pregnant or just had a baby
• You have had one or more miscarriages
• You have any blood clotting problem that needs treatment with a medicine such as warfarin
• You are off your feet for a long time because of major surgery, injury or illness
• You have a rare illness called SLE
• You have cancer

If any of these things apply to you, talk to your doctor to see if you should take HRT.

How likely is a blood clot?

Looking at women in their 50s, on average, over 5 years:

• In women not taking HRT - 7 in 1000 would be expected to get a blood clot
• In women taking oestrogen-only HRT tablets - 8 in 1000 would be expected to get a blood clot (i.e. an extra 1 case)

If you get painful swelling in your leg, sudden chest pain or have difficulty breathing

• See a doctor as soon as possible
• Do not use any more HRT until your doctor says you can

These may be signs of a blood clot.

The following risks apply to hormone replacement therapy (HRT) medicines which circulate in the blood. However Gynest, is for local treatment in the vagina and the absorption into the blood is very low. It is less likely that the conditions mentioned below will get worse or come back during treatment with Gynest, but you should see your doctor if you are concerned.

Breast cancer

Women who have breast cancer or are suspected of having breast cancer or have had breast cancer in the past should not take HRT.

Evidence suggests that using Gynest does not increases the risk of breast cancer in women who had no breast cancer in the past. It is not known if Gynest can be safely used in women who had breast cancer in the past.

Your risk of breast cancer is also higher if:

• You have a close relative (mother, sister or grandmother) who has had breast cancer
• You are very overweight

How likely is breast cancer?

Looking at women between the ages of 50 and 65, on average, over 5 years:

• In women not taking HRT - 9-12 in 1000 will get breast cancer
• In women taking oestrogen-only HRT, there will be around an extra 1-2 cases per 1,000

If you notice any changes in your breast, such as:

• Dimpling of the skin
• Changes in the nipple
• Any lumps you can see or feel

Make an appointment to see your doctor as soon as possible

Endometrial cancer (cancer of the lining of the womb)

Taking oestrogen-only HRT tablets for a long time can increase the risk of cancer of the lining of the womb (the endometrium). It is possible there may be a similar risk with oestrogen cream used for repeated treatments or over a long time. You do not need to take a separate progestogen with Gynest.

If you get breakthrough bleeding or spotting, it is usually nothing to worry about, especially in the first few months of taking HRT. However, if it carries on for more than a few months, or starts after you have been using Gynest for a while, or carries on after you have stopped using Gynest, you should make an appointment to see your doctor. It could be a sign that your endometrium has become thicker.

How likely is endometrial cancer?

Looking at women who still have a uterus and who are not taking HRT - on average 5 in 1,000 will be diagnosed with endometrial cancer.

For women who take oestrogen-only HRT, the number will be 2-12 times higher, depending on the dose and how long they take it. Even after they stop taking oestrogen-only HRT, they will be at higher risk for at least 10 years.

Ovarian cancer

Ovarian cancer (cancer of the ovaries) is very rare, but it is serious. It can be difficult to diagnose. This is because there are often no obvious signs of the disease. Some studies have suggested that taking oestrogen-only HRT for more than 5 years may slightly increase the risk of ovarian cancer by 1 extra case per 2,500 women. It is not yet known whether Gynest increases the risk in the same way.

Tell your doctor if these illnesses return or get worse while you are using Gynest.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following:

• Medicines for epilepsy such as phenobarbital, phenytoin or carbamazepine
• Medicines for infections such as rifampicin, rifabutin, nevirapine or efavirenz
• Medicines for HIV infection called ritonavir and nelfinavir
• Bosentan - for high blood pressure in the blood vessels of the lungs
• St. John’s Wort - for depression

Taking these medicines with Gynest can stop Gynest from working as well as it should and may cause bleeding from your womb.

• A medicine for epilepsy called lamotrigine. Using Gynest with lamotrigine could affect control of your epilepsy.

Do not use this medicine if you are pregnant, think you may be pregnant or might become pregnant. This is because it may affect the baby. Do not use this medicine if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

There is no information about whether Gynest affects your ability to drive or use machines.

See how this medicine affects you before you drive or use any tools or machines.

• Gynest contains peanut oil (arachis oil). Do not use Gynest if you are allergic to peanuts or soya. See ‘Do not use Gynest if’ above
• Gynest also contains benzoic acid (E210). This can irritate your skin, eyes, eyelids, mouth and nostrils if it comes into contact with them.

1. Remove the cap from the tube. Use the top of the cap to pierce the metal seal on the tube
2. One end of the applicator has a plunger. Screw the other end of the applicator onto the tube
3. Squeeze the tube so that the applicator barrel is completely filled with cream. This will push the plunger out
4. Unscrew the filled applicator and replace the cap on the tube
5. Lie down with your knees bent and spread apart
6. Gently insert the open end of the applicator well into your vagina
7. Push the plunger firmly but gently. Empty the cream into your vagina by pushing the plunger as far as it will go
8. Keep the plunger firmly pressed down. Grip the applicator by the barrel and remove the empty applicator
9. Wash your hands afterwards
10. Use a sanitary towel to stop your clothes getting stained

After each use:

• Pull the plunger out of the barrel with a sharp tug
• Clean with mild soap and warm water (not boiling water)
• Rinse well

Putting the applicator back together

• Put the tip of the plunger back into the barrel. Push the plunger firmly

If you lose or break your applicator you can get a new one from a pharmacist. Ask for the Gynest Vaginal Applicator.

When to stop using Gynest

• See your doctor after 3 months to see if you need to continue treatment
• Gynest should be used at the lowest dose and for the shortest period of time for your symptoms

If a large amount of the cream is eaten or swallowed talk to a doctor or go the nearest hospital casualty department straight away.

Apply the missed dose when you remember. Do not use Gynest more than once on any one day.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Wash out the cream. Too much oestrogen therapy may cause breast pain or tenderness, nausea, spotting, abdominal cramps and/or bloating. If you are worried or have any unusual symptoms you should contact your doctor.

• Sudden swelling of the face or throat which may cause difficulty in swallowing or breathing. Hives (also known as nettle rash or urticaria), severe irritation, reddening or blistering of your skin. These may be signs of a severe allergic reaction. This only happens in a small number of people
• Blood clots (thrombosis), a heart attack or stroke (see section 2 'Before you use Gynest')
• New or unusual migraine-type headaches, with or without disturbed vision
• Yellowing of the skin or whites of the eyes (jaundice), or worsening of liver problems
• A significant increase in your blood pressure
• endometrial cancer or ovarian cancer (see section 2 'Before you use Gynest')
  Pregnancy
• If you start to have any of the conditions listed above under 'Do not use Gynest if:'.

In the reproductive and urinary system

• Break-through bleeding
• Vaginal discharge
• Needing to pass urine more often or pain on passing urine (cystitis)
• Pre-menstrual tension syndrome (PM1)

In the breasts

• Breast tenderness and pain

In the stomach

• Feeling sick (nausea), being sick (vomiting)
• Feeling bloated, stomach pain or stomach cramps
• Problems with a gland on the underside of the liver called the 'gallbladder'

In the skin

• Patches of darkened skin, small red marks on the skin, red painful swellings or bruising on the legs

In the nervous system and brain

• Migraine or severe headaches made worse
• Depression
• Dementia (loss of memory) over the age of 65

In other parts of the body

• Fast or irregular heart beats (palpitations)
• Leg pain

If any of the side effects gets serious, or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist

If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side affects you can help provide more information on the safety of this medicine.

The active substance in Gynest is estriol.

Gynest contains 0.01% estriol.

The other ingredients are benzoic acid (E210), glyceryl monostearate, arachis oil (peanut oil), glycerin, glutamic acid, purified water.

Gynest is a white to yellowish-white cream. It comes in tubes of 80g.

The product licence is held by:

Gynest is made by:

For information in large print, tape, CD or Braille, telephone 01279 406759.