Angemin 1 mg/2 mg Estradiol/Drospirenone Film Coated Tablets
1. What Angemin Is And What Angemin Used For?
Angemin is a preparation used for hormonal substitution therapy ( HormoneReplacement Therapy , HRT ). It contains two female sex hormones; an estrogen and a progestogen . Angemin is used in women whose menstruation has stopped ( menopause ) at least 1 year after their last natural menstruation.
Angemin used for
Relieve symptoms during and after menopause When menopause ceases ( menopause ), a woman’s estrogen drops . It can cause problems such as sweating and hot flashes. Angemin relieves these symptoms after menopause . Angemin should only be used if the problems cause problems in daily life
Preventing osteoporosis
after menopause suffer some women with osteoporosis ( osteoporosis ). Discuss all possible options with your doctor.
If you have an increased risk of fractures (bone fractures) and other medicines that are not suitable for you, you can use Angemin to prevent osteoporosis after menopause .
Angemin is a preparation used for hormonal substitution therapy ( HormoneReplacement Therapy , HRT ). It contains two female sex hormones; estrogen and a progestogen. Angemin is used in women whose menstruation has stopped ( menopause ) at least 1 year after their last natural menstruation.
2. What You Need To Know Before You Use Angemin?
Do Not Use Angemin:
Medical background and regular check-ups
The use of HRT involves risks that must be considered when deciding to start or continue an ongoing treatment.
Experience is limited for treating women whose menstruation has stopped prematurely (when the ovaries have stopped working or the uterus has been removed). If you belong to that group, the risks of HRT may be different. Talk to your doctor.
Before starting treatment (or resuming treatment), your doctor will ask about your and your family’s medical background. Your doctor may do a general medical and gynecological examination, including examination of your breasts.
Once you have started treatment with Angemin, you should have regular medical check-ups (at least once a year). During these checks, you should discuss with your doctor the benefits and risks of continuing treatment with Angemin.
Perform regular breast examinations according to your doctor’s recommendations.
Do not take Angemin
if any of the following apply to you. If you are not sure, talk to your doctor before taking Angemin.
- If you have or have had breast cancer or if there is a suspicion that you may have it.
- If you have an estrogen-dependent tumor, e.g., cancer of the uterine lining (endometrium) or if there is a suspicion of such cancer.
- If you have unexplained bleeding from the abdomen,
- If you have severe thickening of the uterine lining ( endometrial hyperplasia ).
- If you have or have had a blood clot in a vein (venous thromboembolism ), for example, in the legs (deep vein thrombosis ) or the lungs ( pulmonary embolism ).
- If you have a coagulation disorder , a condition with an increased risk of blood clots (lack of protein C, protein S or antithrombin).
- If you have or have had a disease caused by blood clots in the arteries, are as heart attack, stroke (stroke), or angina.
- If you have had any liver disease and still have abnormal liver function values.
- If you have porphyria, a rare, inherited blood disorder.
- If you have severe kidney disease or acute kidney failure .
- If you are allergic (hypersensitive) to estrogen , progestogens or any of the other ingredients of Angemin (these are listed in section 6).
If any of the above conditions affect you the first time you use Angemin, stop taking Angemin immediately and contact a doctor immediately.
Warnings And Cautions:
Talk to your doctor or pharmacist before taking Angemin. Talk to your doctor if you have ever had any of the following problems before starting treatment. They may recur or worsen during treatment with Angemin. Should this occur, have more frequent check-ups with a doctor.
- Benign tissue nodule in the uterus
- Growth of the uterine lining outside the uterus ( endometriosis ) or abnormal growth of the uterine lining ( endometrial hyperplasia )
- Increased risk of blood clots (see “Blood clots in a vein ( thrombosis )”)
- Increased risk of developing an estrogen-dependent tumor (for example, if you have a mother, sister or grandmother who has had breast cancer)
- High blood pressure
- Liver disease, e.g., benign liver tumor
- Ddiabetes
- Gallstone
- Migraine or severe headache
- A disease of the immune system that affects many of the body’s organs (systemic lupus erythematosus, SLE )
- Epilepsy
- Asthma
- A disease affecting the middle ear and hearing (otosclerosis)
- Very high levels of fat in the blood ( triglycerides )
- Fluid retention due to heart or kidney problems
Stop taking Angemin and see a doctor immediately. If you notice any of the following when using HRT:
- Any of the things mentioned in the section “Do not take Angemin.”
- If skin or whites of the eyes turn yellow (jaundice). It may be a sign of liver disease
- If your blood pressure rises sharply (symptoms may include headache, fatigue, dizziness)
- If you are experiencing migraine-like headaches for the first time
- If you become pregnant
- If you get symptoms of a blood clot, such as:
- Painful swelling and redness of the legs
- Sudden pain in the chest
- Breathing difficulties
For more information, see “Blood clot in a vein ( thrombosis ).”
Note: Angemin is not a contraceptive. If it is less than 12 months since your last period, or if you are younger than 50 years, you may need to use contraception to prevent pregnancy. Ask your doctor for advice.
HRT and cancer
Severe thickening of the uterine lining ( endometrial hyperplasia ) and cancer of the uterine lining (endometrial cancer)
Using HRT with estrogen alone increases the risk of severe thickening of the lining of the uterus ( endometrial hyperplasia ) and cancer of the uterine lining (endometrial cancer). The progestogen in Angemin protects you against this additional risk.
Irregular bleeding
You may experience irregular spotting during the first 3 – 6 months of taking Angemin. About the irregular bleeding:
- Lasts for longer than the first 6 months
- Starts after taking Angemin for more than 6 months
- Continues after you stop taking Angemin
you should see a doctor as soon as possible.
Breast cancer
Data show that hormone replacement therapy ( HRT ) with a combination of estrogen-progestogen or with estrogen alone increases the risk of breast cancer. The increased risk depends on how long you use HRT . The increased risk is seen within 3 years. When the treatment is stopped, the increased risk decreases over time, but it can persist for 10 years or more if you have used HRT for more than 5 years.
Comparison:
- Of 1,000 women aged 50 – 54 who do not take HRT , an average of 13 to 17 will be diagnosed with breast cancer over 5 years.
- In women who are 50 years old and start taking HRT with estrogen alone for 5 years, 16-17 cases per 1000 users (ie, 0-3 extra cases) will occur.
- In women who are 50 years old and start taking HRT with estrogen-progestogen for 5 years, there will be 21 cases per 1000 users (i.e., 4 – 8 different cases).
- Among women aged 50-59 who use HRT , an average of 27 out of 1,000 will be diagnosed with breast cancer over 10 years.
- In women who are 50 years old and start taking HRT with estrogen alone for 10 years, 34 cases per 1000 users (i.e., 7 extra cases) will occur.
- In women 50 years old and start taking HRT with estrogen-progestogen for 10 years, 48 cases per 1000 users (i.e., 21 extra cases) will occur.
Check your breasts regularly. Contact a doctor if you notice changes such as:
- Pits in the skin
- Changes of the nipple
- Nodules you can see or feel
You should also participate in a mammography examination when you are called to do so. At the mammogram, you must tell the nurse / healthcare professional who examines that you are using HRT, as this medicine may increase the density of the breasts. An increased breast density can make detecting lumps on the mammography images more difficult.
Ovarian cancer ( ovarian cancer )
Ovarian cancer is rare – much more rare than breast cancer. Use of HRT with estrogen alone or combined estrogen-progestogen has been associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer varies with age. For example, ovarian cancer diagnosis will be made on about 2 women out of 2000 aged 50 to 54 who do not take HRT for a 5-year period. For women who have taken HRT for 5 years, there will be about 3 cases per 2000 users (i.e., about 1 extra case).
How HRT affects the heart and circulation?
Blood clots in a vein ( thrombosis )
The risk of blood clots in a vein is about 1.3 – 3 times higher for women who take HRT than those who do not, especially during the first year of treatment.
Blood clots can be serious. A blood clot in the lungs can cause chest pain, shortness of breath, fainting or even death.
The risk of a blood clot in a vein increases with age and if any of the things mentioned below apply to you. Tell your doctor if any of the following apply to you:
- You can not walk for a long time due to a major operation, injury or illness (see also section 3, If you are going to have an operation)
- You are severely overweight ( BMI > 30 kg / m2)
- You have a coagulation disorder that requires long-term treatment with drugs that prevent blood clots.
- If a close relative has ever had a blood clot in a bone, lung or other organ
- You have systemic lupus erythematosus ( SLE )
- You have cancer
The symptoms of a blood clot are described in the section “Stop taking Angemin and see a doctor immediately.”
Comparison:
For women in their 50s who do not take HRT , an average of 4 – 7 out of 1000 people are expected to have a blood clot in a vein over 5 years.
Of women in their 50s who take HRT with estrogen-progestogen for more than 5 years, 9 – 12 out of 1000 users are expected to be affected (i.e., 5 cases).
Heart disease (heart attack):
There is no evidence that HRT prevents heart attack. Women over 60 who take HRT with estrogen – progestogens have a slightly higher risk of developing heart disease than those who do not.
Stroke (stroke):
The risk of stroke is about 1.5 times higher for those taking HRT than those who do not. The increase in the number of stroke cases due to the use of HRT increases with age.
Comparison:
Of women in their 50s who do not use HRT , 8 out of 1000 can be expected to suffer a stroke over 5 years. Of women in their 50s who use HRT , 11 out of 1,000 are expected to be affected (i.e., 3 cases).
Other conditions:
HRT does not prevent memory deterioration. There is some evidence that women who start using HRT after the age of 65 have an increased risk of impaired memory. Consult your doctor.
- Suppose you have kidney disease and has high potassium levels, mainly if you use other drugs that increase the levels of serum – potassium. In that case, your doctor may need to measure blood potassium levels during the first month of treatment.
- If you have high blood pressure , treatment with Angemin may lower it. Angemin should not be used to treat high blood pressure.
- If you are predisposed to develop pigmentation (chloasma) on the face, you should avoid exposing yourself to sunlight or ultraviolet light when taking Angemin.
Other Medicines And Angemin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines may affect the way Angemin works. This can lead to irregular bleeding. This applies to the following medicines:
- Medicines for epilepsy (eg barbiturates , phenytoin , primidone, carbamazepine, oxcarbazepine, topiramate and felbamate)
- Drugs for tuberculosis (e.g., rifampin and rifabutin)
- Drugs for HIV – and Hepatitis C infection s (called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as nevirapine, efavirenz, nelfinavir and ritonavir)
- (Traditional) herbal medicines containing St. John’s wort ( Hypericum perforatum)
- Medicines for fungal infections (e.g., griseofulvin, itraconazole, ketoconazole, voriconazole, fluconazole ), drugs for bacterial infection s (e.g., clarithromycin, erythromycin)
- Medicines for certain heart conditions, high blood pressure (e.g., verapamil, diltiazem )
- Grapefruit juice
The following may lead to small increases in serum potassium:
Medicinal products used to treat:
- Inflammation or pain (eg acetylsalicylic acid , ibuprofen )
- Certain types of heart disease or high blood pressure (e.g., diuretics (diuretics), ACE inhibitors (e.g., enalapril ), angiotensin II antagonists (e.g., losartan ). If treated for high blood pressure and can take Angemin, blood pressure is lowered further.
Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, herbal medicines or other natural products.
Results from blood test tests:
If you need to take a blood sample, tell your doctor, or the person taking the blood sample, that you are taking Angemin, as it may affect the results of some tests.
Pregnancy, Breastfeeding, And Fertility:
Angemin is intended for women whose menstruation has stopped. If you become pregnant, stop taking Angemin immediately and contact a doctor.
Driving And Using Machines:
Angemin does not affect your ability to drive or use machines.
Angemin Contains Lactose:
Angemin contains lactose (a kind of sugar). If your doctor has told you that you are intolerant to some sugars, contact your doctor before taking this medicine.
3. How To Use Angemin?
- Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. It is your doctor who decides how long to take Angemin.
- Take one tablet a day, preferably at the same time. Swallow the tablet whole with a bit of water. Angemin can be taken with or without food. After taking the last tablet in a tablet chart, start a new tablet chart the next day.
- Do not pause between the maps.
- If you have taken other HRT preparations: continue until you have taken the last tablet in a tablet chart and all the tablets for that month. Take your first Angemin tablet the next day. Do not pause between the old tablets and the Angemin tablets.
- If this is your first HRT treatment: you can start taking Angemin tablets at any time of the day.
- Always take Angemin precisely as your doctor has told you. Ask your doctor or pharmacist if you are unsure. It is your doctor who decides how long to take Angemin.
- Take one tablet a day, preferably at the same time. Swallow the tablet whole with some liquid. Angemin can be taken with or without food. After taking the last tablet in a tablet chart, start a new tablet chart the next day.
- Do not pause between the maps.
If You Take More Angemin Than You Should:
If you accidentally ingest too much Angemin, you may experience nausea, vomiting, or menstrual-like bleeding. No special treatment is necessary, but you should talk to your doctor or pharmacist if you are worried.
If You Forget To Use Angemin
If you forget to take a tablet at the usual time and if less than 24 hours have passed, you should take it as soon as possible.
If it has been more than 24 hours since you should have taken your tablet, then leave the forgotten tablet in the pack. Then continue to take the next tablet at the same time as usual.
Do not take a double dose to make up for a forgotten tablet. If you forget to take your tablet for several days, you may experience irregular bleeding.
If You Stop Taking Angemin:
You can feel the typical menopausal symptoms again, such as:
- Hot flashes
- Sleep problems
- Nervousness
- Dizziness
- Vaginal dryness
You will also start losing bone mass when you stop using Angemin. Talk to your doctor or pharmacist if you want to stop taking Angemin. Ask your doctor or pharmacist if you have any further questions about using this product.
If you need to have an operation
If you are going to have an operation, tell your surgeon that you are taking Angemin. You may need to stop taking Angemin for 4 to 6 weeks before surgery to avoid the risk of blood clots (see also section 2, “Blood clots in a vein ( thrombosis )”). Ask your doctor when you can start retaking Angemin.
4. Possible Angemin Side Effects:
Like all medicines, Angemin can cause side effects, although not everybody gets them. The following diseases are more common in women who take HRT than those who do not:
- Breast cancer
- Severe thickening of the uterine lining ( endometrial hyperplasia ) or cancer of the uterine lining (endometrial cancer)
- Ovarian cancer
- Blood clots in veins in bones or lungs (venous thromboembolism )
- Heart disease
- Stroke (stroke)
- Probable memory impairment if treatment with HRT begins after age 65
For more information on these side effects , see section 2.
Like all medicines, Angemin cause side effect is, although not everybody suffers. Below is a list of side effects is that has been linked to the use of Angemin,
The most common side effect are (occurring in more than 1 in 10):
- Unexpected menstrual-like bleeding (see also section 2, “HRT and cancer/cancer of the uterine lining”)
- Sore breasts
- Chest pain
Unexpected menstrual bleeding occurs during the first months of treatment with Angemin. It is usually transient and disappears after the treatment has been going on for some time. If symptoms persist, consult your doctor.
Common adverse s (occurring in 1 to 10 of 100 patients)
- Depression
- Mood swings
- Nervousness
- Headache
- Abdominal pain
- Nausea
- Abdominal enlargement
- Breast lumps (benign breast neoplasia)
- Swollen breasts
- Growth of fibroids (muscle knots in the uterus)
- Non-carcinogenic growth of cervical cells (benign cervical tumor )
- Bleeding disorders
- Relocations
- Weakness
- Local fluid retention
Less common side effect is (are present in 1 to 10 1 000 patients):
- Weight gain or weight loss
- Decreased or increased appetite
- Increase in blood fats
- Sleep problems, anxiety, decreased sex drive
- Burning or stinging sensation
- Decreased ability to concentrate
- Dizziness
- Eye problems (eg, red eyes)
- Visual disturbances (eg, blurred vision)
- Palpitation
- A blood clot
- Venous thrombosis (see also section 2 “Blood clot in a vein ( thrombosis )”),
- High blood pressure, migraine, vasculitis, varicose veins
- Shortness of breath
- Stomach problems
- Diarrhea
- Constipation
- Vomiting
- Dry mouth
- Flatulence
- Taste changes
- Altered liver enzymes (seen on blood tests)
- Skin problems, acne , hair loss, itching , increased hair growth
- Back pain
- Joint pain
- Pain in arms and legs
- Muscle cramps
- Urinary tract problems and urinary tract infections
- Breast cancer
- Thickening of the uterine lining
- Benign tumor of the uterus
- Fungal infection of the abdomen
- Dry vagina and itching in the vagina
- Thoracic nodules (fibrocystic breast changes)
- Effects on the ovaries
- Cervix and uterus
- Pain in the pelvis
- Accumulation of fluid in the body
- Chest pain
- General malaise, increased sweating
Rare side effects are (is present in 1 to 10 in 10 000 patients):
- Anemia ( anemia )
- Dizziness
- Earring ( tinnitus )
- Gallstone
- Muscle aches
- Fallopian tube inflammation
- Milk production without breastfeeding
- Overindulge
The following adverse reactions have been reported from clinical trials in women with high blood pressure:
- High levels of potassium in the blood ( hyperkalaemia ), which can sometimes:
- Lead to muscle cramps
- Diarrhea
- Nausea
- Dizzines
- Headache
- Heart failure , heart enlargement, heart flutter, effects on heart rhythm
- Increase in hormone et al. aldosterone in the blood
The following side effects have been reported for other HRTs:
- Diseases of the gallbladder
- Various skin diseases
- Pigment changes significantly on the face and neck, so-called “pregnancy spots” (chloasma)
- Sore red bumps on the skin (erythema nodosum)
- Red annular rash, sometimes with blisters in the middle (erythema multiforme)
If any of the side effects get serious or notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
Talk to your doctor, pharmacist, or nurse if you get any side effects. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How To Store Angemin?
- Keep this medicine out of sight and reach of children.
- Do not use this medicine after the expiry date stated on the carton, and blister after “EXP.” The expiration date is the last day of the specified month.
- No special storage instructions are required for Angemin.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
6. Contents Of The Packaging And Other Information:
What Angemin Contains?
- The active substances are estradiol (as estradiol hemihydrate) and drospirenone; each tablet contains 1 mg estradiol and 2 mg drospirenone.
- The other ingredients are lactose monohydrate , maize starch, pregelatinised maize starch, povidone and magnesium stearate (E470b). Ingredients in the film coating of the tablet are hypromellose (E464), macrogol 6000, talc (E553b), titanium dioxide (E171) and red iron oxide (E172)
What The Medicine Looks Like And Contents Of The Pack?
- Angemin are film-coated tablets. The tablets are red, round and have convex sides. The letters DL are inside a regular hexagon on one side
- Angemin is available in blister packs containing 28 tablets with the name of the week printed on the blister. There are packs of one or three blister cards.
Marketing Authorisation Holder
Bayer AB
Box 606
SE-169 26 Solna
Manufacturer
Bayer AG
Müllerstrasse 178
13353 Berlin
Germany
This medicinal product is authorized under the European Economic Area under the names:
Angeliq
- Austria, Belgium, Cyprus, Czech Republic, Estonia, Germany, Greece, Finland, France, Ireland, Italy, Croatia, Lithuania, Latvia, Luxembourg, Malta, Netherlands, Poland, Portugal, Slovenia, Slovakia, Spain