Estrace
(Estradiol Valerate)

What Estrace is and what it is used for

Zumenon is a Hormone Replacement Therapy (HRT). It contains the female hormone oestrogen. Zumenon is used in postmenopausal women with at least 6 months since their last natural period and women switching from standard (cyclic or sequential) HRT on the advice of their doctor. Zumenon is used for: Relief of symptoms occurring after menopause. During the menopause, the amount of the oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest (“hot flushes”). Zumenon alleviates these symptoms after menopause. You will only be prescribed Zumenon if your symptoms seriously hinder your daily life.

How to take Estrace

Always take Zumenon exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Take one tablet every day, without a break between packs. Swallow the tablet with water, with or without food. In women with a uterus, a progestagen should normally be added to Zumenon for 12
•14 days of each month. If you are having regular periods you should start taking Zumenon on day one of bleeding. If you are not having regular periods and are not taking any other HRT preparations, or you are switching from a combined continuous HRT product, you can start taking Zumenon on any convenient day. If you are currently using a ‘cyclic’ or ‘sequential’ HRT preparation (which involves taking an oestrogen tablet or patch for part of the month, followed by both oestrogen and progestagen tablet or patch for up to 14 days) start taking Zumenon the day after you finish the pack i.e. at the end of the progestagen phase. Your doctor will aim to prescribe the lowest dose to treat your symptom for as short as necessary. Speak to your doctor if you think this dose is too strong or not strong enough. You may experience some irregular bleeding or light bleeding (spotting) during your first few months of taking Zumenon. If the bleeding is troublesome, or continues beyond the first few months of treatment you should discuss this with your doctor. If you take more Zumenon than you should Nausea (feeling sick), vomiting, sleepiness, dizziness and withdrawal bleeding may occur. No treatment is necessary, but if you are worried contact your doctor for advice. If you forget to take Zumenon Take the missed tablet as soon as you remember. If it is more than 12 hours since you took the last one, take the next dose without taking the forgotten tablet. Do not take a double dose. Bleeding or spotting may occur if you miss a dose. If you need to have surgery If you are going to have surgery, tell the surgeon that you are taking Zumenon. You may need to stop taking Zumenon about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, Blood clots in a vein). Ask your doctor when you can start taking Zumenon again. If you stop taking Zumenon Do not stop taking Zumenon without first talking to your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following diseases are reported more often in women using HRT compared to women not using HRT:
• breast cancer
• abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer)
• ovarian cancer
• blood clots in the veins of the legs or lungs (venous thromboembolism)
• heart disease
• stroke
• probable memory loss over the age of 65 For more information about these side effects, see Section 2. The following serious side effects may occur during treatment with Zumenon:
•swelling of the skin around the face and neck. This may cause difficulty breathing.
•heart attack
•heavy, irregular or painful bleeds If any of these side effects occur you should stop treatment immediately and contact your doctor.

The following side effects may occur during treatment:

Common (in less than 1 in 10, but more than 1 in 100 patients treated):
•headache
•feeling sick
•leg cramps
•abdominal pain
•pelvic pain
•unscheduled bleeding or spotting
•wind
•feeling weak (asthenia)
•weight changes
•rash or itching

Uncommon (in less than 1 in 100, but more than 1 in 1,000 patients treated):
•hypersensitivity (allergic) reaction such as skin rash, itching, skin redness
•hives
•painful reddish skin nodules (erythema nodosum)
•feeling down
•vaginal thrush (a vaginal infection due to a fungus called Candida albicans)
•high blood pressure
•swelling of the ankles, feet or fingers (peripheral oedema)
•water retention (oedema)
•peripheral vascular disease
•varicose veins
•blood clots in the veins of the legs or lungs (venous thromboembolism)
•gall bladder disorder
•back pain
•indigestion
•nervousness
•dizziness
•problems with your sight
•faster heart beat (palpitations)
•breast pain or tenderness

Rare (in less than 1 in 1,000, but more than 1 in 10,000 patients treated):
•intolerance to contact lenses
•pre-menstrual tension (PMT)
•feeling anxious
•migraine
•vomiting
•feeling bloated
•excessive hair growth
•acne
•muscle cramps
•vaginal discharge
•feeling tired
•swelling of the breasts
•change in sex drive

Very rare (in less than 1 in 10,000 patients treated, not known (cannot be estimated from the available data)):
•reduction in red blood cells which can make the skin pale and cause weakness or breathlessness (anaemia) If unscheduled bleeding occurs after some time on HRT, you should contact your doctor. If unscheduled bleeding continues after stopping HRT, it may be necessary to perform tests to exclude disease of the endometrium (the lining of the uterus). Changes can occur in the levels of certain proteins and hormones in the blood. The action of the hormones in the body is not affected. You should tell your doctor that you are taking HRT if you are to have a blood test.

The following side effects have been reported in association with estradiol treatment (frequency unknown):
• fibroids get bigger (growths in the womb increase)
• chorea (muscle twitches)
• worsening of fits (epilepsy)
• blood clots in the arteries (arterial thromboembolism)
• inflammation of the pancreas (pancreatitis) in women with pre-existing high levels of certain blood fats (hypertriglyceridemia)
• a condition where gastric juices, containing acid, travel back from the stomach into the oesophagus (gastroesophageal reflux disease) symptoms include heartburn
• liver disorders, which may include jaundice (yellowing of the skin)
• discolouration of the skin especially of the face or neck known as ‘’pregnancy patches’’ (chloasma)
• rash with target shaped reddening or sores (erythema multiforme)
• skin discolouration (purpura)
• swelling of the skin around face and throat (angioedeme)
• urinary incontinence
• painful/lumpy breasts (fibrocystic breast disease)

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. 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 effects you can help provide more information on the safety of this medicine.

How to Store Estrace

Keep out of the reach and sight of children. This medicinal product does not require any special storage conditions. Do not use Zumenon after the “use before” date which is stated on the pack. The “use before” date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.