Brand Name Choices
No generic medication is available for Angeliq (Drospirenone/Estradiol)
What Angeliq is and what it is used for
Angeliq is a Hormone Replacement Therapy (HRT). It contains two types of female hormone, an oestrogen and a progestogen. Angeliq is used in postmenopausal women with at least 12 months (1 year) since their last natural period. What Angeliq 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”). Angeliq alleviates these symptoms after menopause. You will only be prescribed Angeliq if your symptoms seriously hinder your daily life. Prevention of osteoporosis After the menopause, some women may develop fragile bones (osteoporosis). You should discuss all availableoptions 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 Angeliq to prevent osteoporosis after menopause.
How to take Angeliq
Do not start taking Angeliq until at least 12 months after your last natural period. About the pack This pack is designed to help you remember to take your medicine. Each tablet is placed in a section marked with the day of the week on which it should be taken. The arrows between tablets show the order in which they must be taken. Your doctor may tell you when to start (see "when to start" for further information). On the day you start, take your first tablet from the top row of tablets marked with the correct day. For instance, if you start on a Tuesday, press out the tablet from the blister marked 'TUE'. Take one tablet each day, following the directions of the arrows, until you have finished all 28 tablets in the pack. When you have finished each memo strip, start the next memo strip on the following day. Do not leave a break between memo strips. V014_0 It is best to take your tablet at the same time each day. You can take Angeliq with or without food. The tablet should be swallowed whole with a glass of water or milk. When to start If you have been taking other HRT preparations: carry on until you have finished your current pack and have taken all the tablets for that month. Take your first Angeliq tablet the next day. Do not leave a break between your old tablets and the Angeliq tablets. If this is your first HRT treatment: you can start your Angeliq tablets any day. If you take more Angeliq than you should If you have taken too many Angeliq tablets by mistake, you may feel sick, vomit or have some menstruationlike bleeding. No specific treatment is necessary but you should consult your doctor or pharmacist if you are worried. If you forget to take Angeliq If you forget to take a tablet at your usual time and you are less than 24 hours late, take it as soon as possible. Take the next tablet at the usual time. If you are more than 24 hours late, leave the forgotten tablet in the pack. Continue to take the rest of the tablets at the usual time every day. If you forget to take your tablet for several days you may experience irregular bleeding. If you stop taking Angeliq You may begin to feel the usual symptoms of the menopause again, which may include hot flushes, trouble sleeping, nervousness, dizziness or vaginal dryness. Consult your doctor or pharmacist if you want to stop taking Angeliq tablets. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. If you need to have surgery If you are going to have surgery, tell the surgeon that you are taking Angeliq. You may need to stop taking Angeliq about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, “Blood clots in a vein (thrombosis)”). Ask your doctor when you can start taking Angeliq again.
Possible side effects
Like all medicines, Angeliq can cause side effects, although not everybody gets them.
If any of the side effects gets serious, or if you notice any side effects not listed in this booklet, please tell your
doctor or pharmacist.
The following diseases are reported more often in women using HRT compared to women not using
Serious side effects
• 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 leg or the lungs (venous thromboembolism)
• heart disease
• probable memory loss if HRT is started over the age of 65 V014_0 For more information about these side effects see Section 2. The following is a list of side effects that have been linked to the use of Angeliq: Most frequent side effects (affecting more than 1 patient in every 10 patients):
• breakthrough bleeding at unexpected times (see also section 2 "HRT and cancer”)
• breast tenderness
• breast pains These side effects occur during the first few months of treatment with Angeliq. They are usually temporary and normally disappear with continued treatment. If they do not, contact your doctor.
Common side effects (affecting between 1 and 10 in every 100 patients):
• depression, mood changes, nervousness
• stomach ache, nausea, stomach enlargement
• non-cancerous breast tumour (benign breast neoplasm), swollen breasts
• increase in size of uterine fibroids
• non-cancerous growth of cells at the neck of the womb (benign cervical growth)
• irregularities in your menstrual period
• vaginal discharge
• loss of energy, localised swelling.
Uncommon side effects (affecting between 1 and 10 in every 1000 patients):
• weight increase or decrease, loss or increase of appetite for food, increase blood fats
• sleep problems, anxiety, decrease in sex drive
• burning or pricking sensation, decreased concentration, dizziness
• eye problems, visual disturbances (such as dry eyes or blurred vision)
• blood clot, venous thrombosis (leg pain) (also see section 2 “Blood clots in a vein (thrombosis)”), high blood pressure, migraine, inflammation of the veins, varicose veins
• stomach disorder, diarrhoea, constipation, vomiting, dry mouth, wind, altered sense of taste
• altered liver enzymes (will show up in blood tests)
• skin problems, acne, hair loss, itchy skin, rash, excessive hair or hair problems
• backache, pains in hands and feet, joint pain, muscle cramps
• urinary tract disorders and infections
• thickening of the lining of the womb, thrush, vaginal dryness and itchiness or burning of the vagina.
• lumpy breast (fibrocystic breast), disorders of the ovaries, cervix and uterus, pelvic pain
• generalised fluid retention, chest pain, feeling generally unwell, increase in sweating
• non-cancerous tumour of the womb (benign uterine neoplasm)
Rare side effects (affecting between 1 and 10 in every 10,000 patients):
• giddiness (vertigo)
• ringing in the ears (tinnitus)
• gall stones (cholelithiasis)
• muscle pain (myalgia)
• inflammation of the fallopian tubes (salpingitis)
• milky discharge from the nipples (galactorrhoea)
The following side effects have occurred in clinical trials of women with high blood pressure:
• high potassium levels (hyperkalaemia)
• heart failure, enlargement of the heart, heart flutter, effects on heart rhythm
• increase in blood aldosterone V014_0
The following side effects have been reported with other HRTs:
• gall bladder disease
• various skin disorders:
• discoloration of the skin especially of the face or neck known as pregnancy patches (chloasma)
• painful reddish skin nodules (erythema nodosum)
• rash with target-shaped reddening or sores (erythema multiforme)
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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 Angeliq
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is printed on the label after "EXP". The expiry date refers to the last day of that month. 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 to protect the environment.
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