Prempro
(Estrogens, Conjugated/Medroxyprogesterone Acetate)

What Prempro is and what it is used for

Premique Low Dose is a Hormone Replacement Therapy (HRT). It contains two types of female hormones, an estrogen and a progestogen (medroxyprogesterone acetate). Premique Low Dose is used to treat some of the symptoms and conditions associated with the menopause. Premique Low Dose is a period-free HRT (an HRT product where you do not have a monthly bleed). Premique Low Dose is used for:Relief of symptoms occurring after menopause During the menopause, the amount of the estrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest ("hot flushes"). Premique Low Dose alleviates these symptoms after menopause. You will only be prescribed Premique Low Dose if your symptoms seriously hinder your daily life. You must talk to a doctor if you do not feel better or if you feel worse.

How to take Prempro

3.1 Instructions for proper use Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is one tablet every day. 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. Take your tablet at the same time each day as this will help to remind you to take your medicine. If you are not currently taking HRT or you are taking another period-free HRT, you may start your first pack of Premique Low Dose at any convenient time. If you are changing from an HRT product that gives you a monthly bleed, start Premique Low Dose the day after you finish the course of the previous product, unless instructed otherwise by your doctor. Begin your pack of Premique Low Dose by taking the first tablet marked for that day of the week. Continue to take one tablet each day following the arrows until all 28 tablets have been taken. While you are taking Premique Low Dose you will have no tablet-free days. You should start your next pack the day after you finish the previous one. Premique Low Dose does not cause periods. However, you may experience some irregular bleeding or light bleeding (spotting) during your first few months of taking Premique Low Dose. If the bleeding is troublesome, or continues beyond the first 3 months of treatment you should discuss this with your doctor (see section titled Irregular bleeding above). Do not try to take off the coating, divide or crush the tablets as this could affect the way Premique Low Dose works. 3.2 If you take more Premique Low Dose than you should If you take too many tablets don’t worry. You may feel some nausea (sickness), breast tenderness, dizziness, abdominal pain, drowsiness, fatigue or experience a short period of vaginal bleeding, but it is unlikely that serious problems will result. If you are concerned talk to your doctor or pharmacist. 3.3 If you forget to take Premique Low Dose If you forget to take a tablet don’t worry. Take it as soon as you remember and then carry on taking the remaining tablets at the usual time. If more than one tablet has been forgotten, do not take extra to try to make up for the forgotten tablets. Missed tablets may cause a short period of light bleeding in women who have not had a hysterectomy. 3.4 If you need to have surgery If you are going to have surgery make sure your doctor knows about it and/or tell the surgeon that you are taking Premique Low Dose. You may need to stop taking Premique Low Dose about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2.3
•Blood Clots in a vein (thrombosis). Ask your doctor when you can start taking Premique Low Dose again. If you have any further questions on the use of this medicine, 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 if HRT is started over the age of 65. For more information about these side effects, see section 2.

Other side effects

Very common: may affect more than 1 in 10 women
• breast pain

Common: may affect up to 1 in 10 women
• breakthrough bleeding or spotting, vaginal inflammation, period pain
• breast tenderness, swollen breasts, nipple discharge
• depression
• muscle and joint aches, leg cramps
• weight change (increase or decrease)
• changes in your triglyceride levels (fatty substances in the blood)

Uncommon: may affect up to 1 in 100 women
• changes in menstrual flow, vaginal discharge
• vaginal thrush
• nausea, bloating, abdominal pain
• headache, migraine
• blood clots in the veins
• dizziness
• changes in mood including anxiety
• changes in your interest in sex (increased or decreased libido)
• visible swelling of the face or ankles
• itchiness, acne
• difficulty wearing contact lenses
• gallbladder disease (e.g. gallstones)
• hair loss

Rare: may affect up to 1 in 1,000 women
• vomiting
• changes in breast tissue, milky secretion from the breasts
• irritability
• allergic reactions including swelling, rash or red patches on the skin
• increase in hair growth
• an intolerance to glucose
• a worsening of asthma
• increased size of fibroids
• ovarian cancer
• worsening of epilepsy
• heart attack, stroke
• inflammation of veins just under the skin
• inflammation of the pancreas

Very rare: may affect up to 1 in 10,000 women
• jaundice (e.g. yellowing of the skin)
• a worsening of chorea (an existing neurological disorder characterised by involuntary spasmodic movements of the body)
• a worsening of hypocalcaemia (low blood levels of calcium)
• blurred vision or loss of vision
• worsening of porphyria (a rare inherited metabolic disorder)
• growth of benign liver tumours
• increase in blood pressure. These side effects are usually temporary and should get better over time.

The following side effects have been reported with other HRTs:
• various skin disorders: o painful reddish skin nodules (erythema nodosum) o rash with target-shaped reddening or sores (erythema multiforme)
• memory loss (dementia).

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 website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How to Store Prempro

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that month. Do not store above 25°C. Keep the blister in the outer carton to protect from light. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.