Angeliq tablets contain two active ingredients, estradiol and drospirenone. These are forms of the main female sex hormones, oestrogen and progesterone. Estradiol is a naturally occuring form of oestrogen and drospirenone is a synthetic form of progesterone.
What is Angeliq used for?
- Hormone replacement therapy to relieve symptoms of the menopause.
- Second-line option for preventing osteoporosis in postmenopausal women who are at high risk of fractures and cannot take other medicines licensed for preventing osteoporosis.
How does Angeliq work?
- Angeliq tablets contain two active ingredients, estradiol and drospirenone. These are forms of the main female sex hormones, oestrogen and progesterone.
How do I take Angeliq tablets?
- One Angeliq tablet should be taken once a day on a continuous basis with no breaks between packs. Your need for continued HRT should be reviewed with your doctor at least once a year.
- The tablets should be swallowed whole with a drink. They can be taken either with or without food.
- Your tablet should be taken at around the same time each day; this will help you remember to take it.
- If you forget to take a dose at your usual time you should take it as soon as you remember, unless it is nearly time for your next dose. In this case you should just leave out the forgotten dose and take your next dose as usual at your usual time. Don't take a double dose to make up for a missed dose.
Important information about Angeliq
- This medicine will not usually cause a monthly menstrual bleed. However, you may experience spotting or breakthrough bleeding during the first few months of treatment. Forgetting or missing a dose may increase the likelihood of breakthrough bleeding. If any bleeding continues after a few months of taking the medicine, or after stopping treatment, you should consult your doctor.
- Women taking any form of HRT should have regular medical and gynaecological check-ups. Your need for continued HRT should be reviewed with your doctor at least once a year.
- It is important to be aware that all women using HRT have an increased risk of being diagnosed with breast cancer compared with women who don't use HRT. This risk needs to be weighed against the personal benefits to you of taking HRT. Women on HRT should have regular breast examinations and mammograms and should examine their own breasts regularly. Report any changes in your breasts to your doctor or nurse.
- It is important to be aware that women using HRT have a slightly increased risk of stroke and of blood clots forming in the veins (eg deep vein thrombosis/pulmonary embolism) compared with women who don't use HRT. The risk is higher if you have existing risk factors (eg personal or family history of blood clots, smoking, obesity, certain blood disorders) and needs to be weighed against the personal benefits to you of taking HRT. Discuss these with your doctor before starting treatment.
- The risk of blood clots forming in the veins (thromboembolism) while taking HRT may be temporarily increased if you experience major trauma, have surgery, or are immobile for prolonged periods of time (this includes travelling for over three hours). For this reason, your doctor may recommend that you stop taking HRT for a period of time (usually four to six weeks) prior to any planned surgery, particularly abdominal surgery or orthopaedic surgery on the lower limbs, or if you are to be immobile for long periods. The risk of blood clots during long journeys may be reduced by appropriate exercise during the journey and possibly by wearing elastic hosiery. Discuss this with your doctor.
Stop taking this medicine and inform your doctor immediately if you experience any of the following symptoms: stabbing pains or swelling in one leg; pain on breathing or coughing; coughing up blood; breathlessness; sudden chest pain; sudden numbness affecting one side or part of the body; fainting; worsening of epilepsy; migraine or severe headaches; visual disturbances; severe abdominal complaints; increased blood pressure; itching of the whole body; yellowing of the skin or eyes (jaundice); or severe depression.
A woman is considered fertile for two years after her last menstrual period if she is under 50, or for one year if over 50. HRT does not provide contraception for women who fall within this group. If a potentially fertile women is taking HRT but also requires contraception, a non-hormonal method (eg condoms or contraceptive foam) should be used.
Angeliq should be used with caution by
- Women with a risk of developing cancers that are stimulated by oestrogen, for example women whose mother or sister has had breast cancer.
- Women with a history of benign breast lumps (fibrocystic breast disease).
- Women with fibroids in the womb.
- Women with a history of endometriosis.
- Women with a history of overgrowth of the lining of the womb (endometrial hyperplasia).
- Women with a personal or family history of blood clots in the veins (venous thromboembolism, eg deep vein thrombosis or pulmonary embolism).
- Women taking medicines to prevent blood clots (anticoagulants), eg warfarin.
- Women who are very overweight or obese.
- Women with severe varicose veins.
- Women with high blood pressure.
- Women with heart failure.
- Women with kidney problems.
- Women with diabetes.
- Women with raised levels of fats such as cholesterol or triglycerides in their blood.
- Women with high levels of potassium in their blood.
- Women with a history of gallbladder disease.
- Women with a long-term condition called systemic lupus erythematosus (SLE).
- Women who suffer from migraines or severe headaches.
- Women with epilepsy.
- Women with a history of asthma.
- Women with a history of depression.
- Women with a history of irregular brown patches appearing on the skin, usually of the face, during pregnancy or previous use of hormone preparations such as contraceptive pills (chloasma). Women with a tendency to this condition should minimise their exposure to the sun or UV light while taking HRT.
Angeliq should not be used by
- Women with known, suspected, or a past history of breast cancer.
- Women with known or suspected cancer in which growth of the cancer is stimulated by oestrogen, eg cancer of the lining of the womb (endometrial cancer).
- Women with untreated overgrowth of the lining of the womb (endometrial hyperplasia).
- Women with vaginal bleeding where the cause is not known.
- Women with blood disorders that increase the risk of blood clots in the veins, eg antiphospholipid syndrome, factor V Leiden, protein C deficiency, protein S deficiency or antithrombin deficiency.
- Women with a blood clot in a vein of the leg (deep vein thrombosis) or in the lungs (pulmonary embolism).
- Women with inflammation of a vein caused by a blood clot (thrombophlebitis).
- Women who have recently had a stroke caused by a blood clot.
- Women who have recently had a heart attack.
- Women with angina pectoris.
- Women with active liver disease, eg hepatitis, liver cancer, or a history of liver disease when liver function has not returned to normal.
- Women with severely decreased kidney function or kidney failure.
- Women with inherited blood disorders called porphyrias.
- Women who are pregnant or breastfeeding.
Women with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption (Angeliq tablets contain lactose).
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
- This medicine should not be used by women who are pregnant or breastfeeding. You should stop taking this medicine and consult your doctor immediately if you think you could be pregnant during treatment.
- A woman is considered fertile for two years after her last menstrual period if she is under 50, or for one year if over 50. HRT does not provide contraception for women who fall within this group. If you could get pregnant while taking this HRT, you should use a non-hormonal method of contraception (eg condoms or contraceptive foam). Seek further medical advice from your doctor.
Possible side effects of Angeliq
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. See also the important information section above. Just because a side effect is stated here, it does not mean that all women using this medicine will experience that or any side effect.
- Breast pain, tenderness or enlargement.
- Gut disturbances, such as nausea and vomiting, abdominal pain, bloating, flatulence, indigestion.
- Menstrual bleeding or spotting.
- Headache or migraine.
- Vaginal thrush.
- Increase in the size of uterine fibroids.
- Fluid retention, causing swelling (oedema).
- Premenstrual-like symptoms.
- Depression, anxiety, irritability or mood changes.
- Changes in sex drive.
- Weight changes.
- Leg cramps.
- Rise in blood pressure.
- Steepening of corneal curvature, which may make contact lenses uncomfortable.
- Skin reactions such as rash and itching.
- Irregular brown patches on the skin, usually of the face (chloasma).
- Disturbance in liver function and jaundice.
- Gallbladder disease.
- Inflammation of the pancreas (pancreatitis).
- Blood clots in the blood vessels.
- Riased level of potassium in the blood.
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
If you think you have experienced a side effect from a medicine or vaccine you should check the patient information leaflet. This lists the known side effects and what to do if you get them. You can also get advice from your doctor, nurse or pharmacist. If they think it's necessary they'll report it for you.
How can Angeliq affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.
The following medicines may potentially reduce the blood level and effect of this medicine, which could cause irregular menstrual bleeding or your symptoms to come back:
- the herbal remedy St John's wort (Hypericum perforatum)
Some women with diabetes may need small adjustments in their dose of insulin or antidiabetic tablets while taking this medicine. You should monitor your blood sugar and seek advice from your doctor or pharmacist if your blood sugar control seems to be altered after starting this medicine.
Estradiol may oppose and drospirenone may increase the effect of medicines used to lower high blood pressure. Your blood pressure will usually be checked periodically while you are taking HRT, but this is particularly important if you are also taking medicines for high blood pressure.
Estradiol may oppose and drospirenone may increase the fluid-losing effect of diuretic medicines.
This medicine may decrease the amount of the antiepileptic medicine lamotrigine in the blood. As this could increase the risk of seizures coming back or getting worse, the medicine may not be recommended for women who take lamotrigine on its own for epilepsy.
This medicine may increase the blood levels of the following medicines and this could possibly increase the risk of their side effects:
In some people (usually those with kidney problems or diabetes) drospirenone may cause an increase in the amount of potassium in your blood. There may be an increased risk of this if Angeliq is taken in combination with any of the following, which can also cause a rise in blood potassium levels:
- ACE inhibitors, eg enalapril, captopril, lisinopril
- angiotensin II antagonists, eg losartan, valsartan
- non-steroidal anti-inflammatory drugs (NSAIDs), eg ibuprofen, indometacin, diclofenac
- potassium salts, eg potassium citrate for cystitis
- potassium-containing salt substitutes, eg Lo-Salt
- potassium-sparing diuretics, eg amiloride, spironolactone, triamterene
- potassium supplements.
If you are taking any of the above, you should have a blood test during your first month of treatment with Angeliq to check your blood potassium level has not risen, particularly if you also have any kidney problems.