Premarin

What Premarin is and what it is used for

Premarin is a Hormone Replacement Therapy (HRT). It contains the female hormone estrogen. Premarin is used to treat some of the symptoms and conditions associated with the menopause. Premarin 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"). Premarin alleviates these symptoms after menopause. You will only be prescribed Premarin if your symptoms seriously hinder your daily life. Prevention of osteoporosis After the menopause some women may be at risk of developing fragile bones (osteoporosis). You should discuss all available treatment options with your doctor. If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Premarin 0.625 mg or 1.25 mg Coated Tablets to prevent osteoporosis after menopause. Premarin is usually prescribed for women who have had their womb removed (hysterectomy). However, women who have not had this operation can still take Premarin and their doctor may prescribe a second type of tablet containing another hormone called a progestogen to be taken for 12-14 days per month as well as the Premarin tablets.

How to take Premarin

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is one tablet every day. Your doctor will aim to give you the lowest dose for the shortest time to treat your symptoms 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 already taking an HRT product or if you are taking an HRT product that does not give you a monthly bleed you may start your first pack of Premarin at any convenient time. If you are changing from an HRT product that gives you a monthly bleed, start Premarin the day after you finish the course of the previous product, unless instructed otherwise by your doctor. While you are taking Premarin you will have no tablet-free days. You should start your next pack the day after you finish the previous one. 3.2 The recommended dose For menopausal symptoms the usual dose is one tablet every day. Your doctor will prescribe the lowest dose that will control your symptoms. Premarin 0.3 mg is the lowest starting dose. If your symptoms are not adequately controlled higher doses of Premarin can be used. For the treatment of osteoporosis the usual dose is one 0.625 mg tablet every day but your doctor may advise you to use 1.25 mg each day. You and your doctor should review the need for treatment regularly. Do not try to take off the coating, divide or crush the tablets as this could affect the way Premarin works. Paediatric population Safety and effectiveness in paediatric patients have not been established. 3.3 While you are taking Premarin If you have had a hysterectomy you are not expected to have a period. If you have not had a hysterectomy, you may be taking an additional progestogen tablet for 12-14 days each month, and you will probably have a "period", or withdrawal bleed each month at about the time you finish the additional progestogen tablets. This is caused by the hormones in the HRT and is perfectly natural. Some women taking "combined HRT" (estrogen plus the additional progestogen) may experience a gradual reduction in withdrawal bleeding and it may eventually stop; this is quite normal. If you experience troublesome bleeding or it continues beyond the first 3 months of treatment discuss this with your doctor (see section 2.2 HRT and Cancer). 3.4 If you take more Premarin than you should If you take too many tablets don’t worry. You may feel some nausea (sickness), breast tenderness, dizziness, abdominal pain and drowsiness/fatigue. If you have not had a hysterectomy you may experience a short period of vaginal bleeding, but it is unlikely that serious problems will occur. If you are concerned, talk to your doctor or pharmacist. 3.5 If you forget to take Premarin 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. Do not take a double dose to make up for a forgotten tablet. Missed tablets may cause a short period of light bleeding in women who have not had a hysterectomy. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

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. In addition to those discussed in section 2, the following side effects have been reported in women taking HRT:
• abdominal uterine bleeding such as breakthrough bleeding or spotting, changes in menstrual flow, pelvic pain, vaginal inflammation and vaginal discharge
• a tendency to get thrush
• breast pain, breast tenderness, swollen breasts, discharge from the nipples and changes in breast tissue
• feeling or being sick, a feeling of being bloated, abdominal pain
• headache or migraine
• dizziness
• changes in mood including anxiety, depression and irritability
• joint pain, leg cramps
• changes in your interest in sex (increased or decreased libido)
• visible swelling of the face or ankles
• rash, itchiness, acne and dark or red patches on the skin
• changes in hair growth (loss or increase)
• minor changes to the eye, difficulty wearing contact lenses
• changes in weight (increase or decrease)
• changes in your triglyceride levels (fatty substances in the blood)
• an intolerance to glucose
• memory loss (dementia)
• a worsening of chorea (an existing neurological disorder characterised by involuntary spasmodic movements of the body)
• a worsening of asthma
• a worsening of hypocalcaemia (low blood levels of calcium)
• gallbladder disease or jaundice (e.g. gallstones or yellowing of the skin)
• growth of benign meningioma (a tumour of the membranes around the brain or spinal cord)
• inflammation of the colon (part of the intestine) which may present as lower left sided abdominal pain and/or bloody diarrhoea
• induce or exacerbate symptoms of angioedema, which consists of generalized swelling of parts of the body, most frequently around the face, mouth, tongue and neck areas, particularly in women with hereditary angioedema. These side effects are usually temporary and should get better over time. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard Malta ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal

How to Store Premarin

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