АНДЖЕЛИК 1 мг/2 мг Film-coated tablets

Содержание инструкции

1. What Angeliq is and what it is used for
2. What you need to know before taking Angeliq
3. How to take Angeliq
4. Possible side effects
5. How to store Angeliq
6. Package Contents and Other Information

A1 mg / 2 mg film-coated tablets
Estradiol / Drospirenone

Read this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Angeliq is and what it is used for
• 2. What you need to know before you take Angeliq
• Medical examination and regular check-ups
• Do not take Angeliq
• Warnings and precautions
• VTE and cancer
• Effects of HRT on the heart and circulation
• Other conditions
• Other medicines and Angeliq
• Laboratory tests
• Pregnancy and breastfeeding
• Driving and using machines
• Angeliq contains lactose
• 3. How to take Angeliq
• If you take more Angeliq than you should
• If you forget to take Angeliq
• If you stop taking Angeliq
• If you are going to have surgery
• 4. Possible side effects
• 5. How to store Angeliq
• 6. Contents of the pack and other information _________________________________________ Note: this index applies only to the “booklet” format of Angeliq, whereas in the sheet format the index contains only the main headings from 1 to 6:
• 1. What Angeliq is and what it is used for
• 2. What you need to know before you take Angeliq
• 3. How to take Angeliq
• 4. Possible side effects

• 5. How to store Angeliq
• 6. Contents of the pack and other information

1. What Angeliq is and what it is used for

Angeliq is a Hormone Replacement Therapy (HRT). It contains two types of female hormones, an
estrogen and a progestin. Angeliq is used in postmenopausal women for whom at least 1 year has
passed since their last natural menstruation.

Angeliq is used for:
Relief of symptoms that occur after menopause
During menopause, the amount of estrogen produced by a woman's body decreases. This
can cause symptoms such as hot flushes on the face, neck and chest (“hot flashes”). Angeliq relieves these
symptoms after menopause. Angeliq will be prescribed if your symptoms seriously compromise
daily life.

Prevention of osteoporosis
After menopause, some women may develop fragile bones (osteoporosis). You should
discuss all available options with your doctor.
If you are at high risk of fractures due to osteoporosis and cannot take other medicines, you may
use Angeliq for the prevention of osteoporosis after menopause.

2. What you need to know before taking Angeliq

Medical examination and regular check-ups
The use of HRT involves risks that must be considered when deciding whether to start or continue therapy.
Treatment experience of women with early menopause (due to cessation of ovulation or surgery) is limited. If you have early menopause, the risks associated with HRT use may be different. Consult your doctor.
Before starting (or restarting) HRT, your doctor will ask you some questions about your personal health history and that of your family. Your doctor may decide to perform some tests. These may include a breast exam and/or an internal examination if necessary.
Once you have started treatment with Angeliq, you will need to see your doctor for regular check-ups (at least once a year). During these check-ups, you will discuss with your doctor the benefits and risks associated with continuing treatment with Angeliq.

Have regular breast exams, as recommended by your doctor.
Do not take Angeliq
if any of the following conditions are present. If you are unsure about the conditions described below, consult your doctorbefore taking Angeliq.
Do not take Angeliq

• If you have or have ever had breast cancer, or if you suspect you have it
• If you have a cancer that is sensitive to estrogensuch as uterine lining cancer (endometrium), or if you suspect you have it
• If you have any unexplained vaginal bleeding
• If you have an excessive thickening of the uterine lining(endometrial hyperplasia)
• If you have or have ever had a blood clot in a vein(venous thrombosis), such as in the legs (deep vein thrombosis) or in the lungs(pulmonary embolism)
• If you have disorders related to blood clots(such as protein C, protein S or antithrombin deficiency)
• If you have or have recently had a condition caused by blood clots in the arteries, such as heart attack, stroke or angina
• If you have or have ever had liver diseaseand your liver function tests have not returned to normal
• If you have a rare inherited disease called "porphyria"
• If you have severe kidney disease or acute kidney failure
• If you are allergic(hypersensitive) to estrogens, progestogens or any of the excipients of Angeliq (listed in section 6). If any of the above conditions appear for the first time while you are taking Angeliq, stop treatment immediately and consult your doctor immediately.

Warnings and precautions

• Consult your doctor or pharmacist before taking Angeliq. Inform your doctor if you have ever had any of the following conditions before starting treatment, as these may recur or worsen during treatment with Angeliq. In such cases, you should visit your doctor more often for check-ups:
• fibroids inside the uterus
• growth of uterine mucosa in other locations (endometriosis) or a history of excessive growth of the uterine mucosa (endometrial hyperplasia)
• increased risk of developing blood clots (see “Blood clots in a vein(thrombosis)”)
• increased risk of estrogen-sensitive breast cancer (mother, sister or grandmother who have had breast cancer)
• high blood pressure
• liver disease such as a benign liver tumor
• diabetes
• gallstones
• migraine or severe headaches
• an autoimmune disease affecting many organs of the body (systemic lupus erythematosus (SLE))
• epilepsy
• asthma
• a condition affecting the eardrum and hearing (otosclerosis)
• very high levels of fats in the blood (triglycerides)
• fluid retention due to heart or kidney problems
• hereditary and acquired angioedema. Stop treatment with Angeliq and consult your doctor immediately

If you notice any of the following conditions while taking TOS:

• any condition described in the section “Do not take Angeliq”
• yellowing of the skin or whites of the eyes (jaundice). These may be signs of a liver disease
• swelling of the face, tongue and/or throat and/or difficulty swallowing or hives with difficulty breathing, which are indicative of angioedema
• marked increase in blood pressure (symptoms may include headache, fatigue, dizziness)
• new-onset migraine-type headache
• pregnancy
• if you notice signs of a blood clot, such as
• painful and swollen redness of the legs
• sudden chest pain
• difficulty breathing For more information see section “Blood clots in the vein (thrombosis)” Note: Angeliq is not a contraceptive. If less than 12 months have passed since your last menstrual period or if you are under 50 years of age, you may still need to use additional contraceptive measures to prevent pregnancy. Ask your doctor for advice. TOS and cancerExcessive thickening of the uterine mucosa (endometrial hyperplasia) and cancer of the uterine mucosa (endometrial carcinoma)Taking TOS based on estrogen alone increases the risk of thickening of the uterine mucosa (endometrial hyperplasia) and cancer of the uterine mucosa (endometrial carcinoma). The presence of a progestin in Angeliq protects you from this additional risk. Irregular bleedingIt may happen that you experience irregular bleeding or spotting during the first 3-6 months of taking Angeliq. However, if irregular bleeding:
• continues beyond the first 6 months
• occurs after you have been taking Angeliq for more than 6 months
• continues after stopping Angeliq see your doctor as soon as possible.Breast cancerEvidence shows that taking hormone replacement therapy (HRT) based on combined estrogens and progestins or estrogen alone increases the risk of breast cancer. The additional risk depends on the duration of use of HRT. This additional risk manifests within 3 years of use. After stopping HRT, the additional risk will decrease over time, but this risk may persist for 10 years or more if TOS is used for more than 5 years. ComparisonIn women aged between 50 and 54 who are not taking HRT, breast cancer will be diagnosed on average in about 13-17 women out of 1000 over a period of 5 years. In women aged 50 who start taking HRT based on estrogen alone for a period of 5 years, 16-17 cases will occur per 1000 users (i.e. 0-3 additional cases). In women aged 50 who start taking HRT based on combined estrogens and progestins for 5 years, there will be 21 cases per 1000 women treated (i.e. 4 to 8 additional cases).
  In women aged 50 to 59 who are not taking HRT, breast cancer will be diagnosed on average in 27 women out of 1000 over a period of 10 years.
  In women aged 50 who start taking HRT based on estrogen alone for 10 years, 34 cases will occur per 1000 users (i.e. 7 additional cases).
  In women aged 50 who start taking HRT based on combined estrogens and progestins for 10 years, 48 cases will occur per 1000 users (i.e. 21 additional cases).

• Check your breasts regularly. Make an appointment with your doctor if you notice anychanges such as:
• orange peel skin or depressions in the skin;
• changes in the nipples;
• any visible or palpable lump. You are also advised to participate in mammography screening programs when they are offered to you. For mammography screening, it is important that you inform the nurse/healthcare professional performing the X-ray that you are using HRT, as this treatment may increase breast density, which may alter the mammography result. When breast density is increased, mammography may not detect all nodules. Ovarian cancerOvarian cancer is rare - much rarer than breast cancer. The use of estrogen-only or estrogen-progestin therapy has been associated with a slight increase in the risk of ovarian cancer. The risk of ovarian cancer varies with age. For example, in women aged between 50 and 54 who are not taking HRT, about 2 women out of
• 2,000 will receive a diagnosis of ovarian cancer within 5 years. For women who are taking HRT for 5 years, there will be about 3 cases per 2,000 women treated (i.e., about 1 additional case). Effects of HRT on the heart and circulationBlood clots in a vein (thrombosis)HRT can increase the risk of blood clots in the veinsby 1.3 to 3 times, especially during the first year of use. Blood clots can be dangerous, and if they reach the lungs, they can cause chest pain, sudden shortness of breath, collapse or even death. The risk of having a blood clot in the veins increases with age and if any of the following conditions apply to you. Tell your doctor if any of the following conditions apply to you:
• you are unable to walk for a long time due to major surgery, accident or illness (see also section 4, “If you are going to have surgery”)
• you are severely overweight (BMI > 30 kg/m)
• you have any blood clotting problem that requires long-term treatment with a medicine that prevents blood clots
• if a close relative of yours has had a blood clot in the leg, lung or another organ
• you have systemic lupus erythematosus (SLE)
• you have cancer For possible signs of a blood clot, see “Stop using Angeliq and contact your doctor immediately” Comparison For women around the age of 50 who are not taking HRT, on average, over a period of 5 years, 4-7 cases per 1000 are expected to have a blood clot in a vein. For women around the age of 50 who are taking estro/progestinic HRT for more than 5 years, there will be 9-12 cases per 1000 users (i.e. an increase of 5 cases). Heart disease (heart attack)There is no evidence that HRT prevents heart disease. Women over the age of 60 who use estro-progestinic HRT have a slightly higher chance of developing heart disease than women who do not take HRT. StrokeThe risk of having a stroke is about 1.5 times higher in users of HRT than in non-users. The number of additional cases of stroke due to the use of HRT will increase with age. Comparison For women around the age of 50 who are not taking HRT, on average, over a period of 5 years, 8 cases per 1000 have the possibility of having a stroke. For women around the age of 50 who are taking estro/progestinic HRT for more than 5 years, there will be 11 cases per 1000 users (i.e. an increase of 3 cases). Other conditions
• HRT does not prevent memory loss. The risk of memory loss may be higher in women who start using HRT after the age of 65. Ask your doctor for advice.
• If you have a kidney diseaseand have high levels of serum potassium, in particular if you are taking other medicines that increase serum potassium, your doctor may check your blood potassium levels during the first month of treatment.
• If you have high blood pressure, treatment with Angeliq may lower it. Angeliq should not be used to treat high blood pressure.
• If you have a tendency to develop discoloration spots(chloasma) on the face, you should avoid exposure to the sun or ultraviolet light while taking Angeliq. Other medicines and AngeliqTell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines can interfere with the effects of Angeliq and cause irregular bleeding. This concerns the following medicines:
• medicines for epilepsy(e.g. barbiturates, phenytoin, primidone, carbamazepine, oxcarbazepine, topiramate and felbamate)
• medicines for tuberculosis(e.g. rifampicin and rifabutin)
• medicines for HIV and hepatitis C virus infections(so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as nevirapine, efavirenz, nelfinavir and ritonavir)
• the herbal remedy St. John's wort(Hypericum perforatum)
• medicines against hepatitis C virus (HCV) (such as regimens combining ombitasvir/paritaprevir/ritonavir with or without dasabuvir, as well as those based on glecaprevir/pibrentasvir) can cause increases in blood test results concerning liver function (increased liver enzyme ALT) in women using COCs containing ethinylestradiol. Angeliq contains estradiol instead of ethinylestradiol. It is not known whether an increase in liver enzyme ALT can occur when using Angeliq with these HCV regimens. Your doctor will give you the necessary instructions
• medicines for the treatment of fungal infections(such as griseofulvin, itraconazole, ketoconazole, voriconazole, fluconazole)
• medicines for the treatment of bacterial infections(such as clarithromycin, erythromycin)
• medicines for the treatment of certain heart diseases or high blood pressure(such as verapamil, diltiazem)
• Grapefruit juice The following medicines can cause slight increases in serum potassium:
• medicines used for the treatment of:
• inflammationor pain(e.g. aspirin, ibuprofen);
• some types of heart diseaseor hypertension(e.g. diuretics, ACE inhibitors (e.g. enalapril), angiotensin II receptor antagonists (e.g. losartan). If you are being treated for hypertension and take Angeliq, your blood pressure may decrease further. Tell your doctor or pharmacist if you are taking or have recently taken other medicines, including over-the-counter medicines, herbal remedies or other natural products. Laboratory testsIf you need a blood test, tell your doctor or the laboratory staff that you are taking Angeliq, because this medicine can affect the results of some tests.

Pregnancy and breastfeeding
Angeliq is intended for use in postmenopausal women.
If you become pregnant, stop taking Angeliq immediately and contact your doctor.

Driving and using machines
There is no reason to believe that the use of Angeliq will affect your ability to drive vehicles or use
machinery.

Angeliq contains lactose
Angeliq contains lactose (a type of sugar) If your doctor has diagnosed you with intolerance to
some sugars, contact him before taking this medicine

3. How to take Angeliq

Take this medicine exactly as your doctor has told you. If you have any doubts
consult your doctor or pharmacist. Your doctor will decide how long you should take Angeliq.
Take one tablet a day, preferably at the same time. Swallow the tablet whole
with a little water. You can take Angeliq with or without food. Start the next pack of
tablets the day after you have finished the current pack.
Do not interrupt the intake between the two packs.

If you are taking other TOS preparations: continue until you have finished your current pack
and have taken all the tablets for that month. Take the first Angeliq tablet the day after.
Do not leave an interval between the old tablets and the Angeliq tablets.

If this is your first treatment with TOS: you can start with the Angeliq tablets on
any day.

If you take more Angeliq than you should
Overdosage can cause nausea, vomiting and irregular bleeding. No specific
treatment is necessary, but if you are concerned, consult your doctor.

If you forget to take Angeliq
If you forget to take a tablet at the usual time, and less than 24 hours have passed, take
the tablet as soon as possible. Take the next tablet at the usual time.
If more than 24 hours have passed, leave the forgotten tablet in the pack. Continue to
take the rest of the tablets at the usual time each day. Do not take a double dose to
make up for the forgotten tablet.
If you forget to take the tablet for several days, irregular bleeding may occur.

If you stop taking Angeliq
You may start to experience again the typical symptoms of menopause, which may include hot
flushes, sleep disturbances, nervousness, dizziness or vaginal dryness. Stopping
taking Angeliq will also cause you to lose bone mass. If you want to stop treatment
with Angeliq, consult your doctor or pharmacist. If you have any doubts about the use of this
medicine, consult your doctor or pharmacist.

If you are going to have surgery
If you have scheduled surgery, tell the surgeon that you are taking Angeliq. It may
be necessary to stop taking Angeliq about 4-6 weeks before the operation
to reduce the risk of thrombosis (see also section 2 “ Blood clots in a vein”).
Ask your doctor when you can start taking Angeliq again.

4. Possible side effects

Like all medicines, Angeliq can cause side effects, although not everybody gets them.
Women who use HRT have a slightly higher risk of developing the following
diseases compared to those who do not use it:

• breast cancer
• excessive growth or cancer of the uterine lining (hyperplasia or endometrial cancer)
• ovarian cancer
• blood clots in the veins of the legs or lungs (venous thromboembolism)
• heart disease
• stroke
• possible memory loss if HRT is started after the age of 65. For more information about these side effects, see section 2. Like all medicines, Angeliq can cause side effects, although not everybody gets them. The following side effects have been associated with the use of Angeliq. More common side effects(affecting more than 1 in 10 people):
• unexpected bleeding similar to menstruation (see also section 2 “HRT and cancer”)
• breast tenderness
• breast pain. Unexpected bleeding similar to menstruationoccurs during the first few months of treatment with Angeliq. It is usually temporary and normally disappears with continued treatment. If this is not the case, contact your doctor. Common side effects(affecting 1-10 in 100 people):
• depression, mood swings, nervousness
• headache
• stomach pain, nausea, bloating
• breast nodules (benign breast neoplasm), breast swelling
• increase in the size of uterine fibroids
• non-cancerous growth of cells on the cervix (benign cervical growth)
• irregular vaginal bleeding
• vaginal discharge
• loss of energy, localized fluid retention. Uncommon side effects(affecting 1-10 in 1000 people):
• weight gain or loss, loss or increase of appetite, increased blood fats
• sleep disorders, anxiety, decreased sexual interest
• burning or tingling sensation, decreased concentration, dizziness
• eye problems (e.g. red eyes), vision disorders (e.g. blurred vision)
• palpitations
• thrombosis, venous thrombosis (see also section 2 “Blood clots in a vein (thrombosis)”), high blood pressure, migraine, inflammation of the veins, varicose veins
• shortness of breath
• stomach upset, diarrhea, constipation, vomiting, dry mouth, flatulence, altered taste
• altered liver enzymes (visible in blood tests)
• skin problems, acne, hair loss, skin itching, hirsutism
• back pain, joint pain, limb pain, muscle cramps
• urinary tract disorders and infections
• breast cancer, thickening of the uterine lining, unusual benign growth in the uterus, thrush, vaginal dryness and itching
• breast nodules (fibrocystic breast disease), ovarian, cervical and uterine pathologies, pelvic pain
• generalized fluid retention, chest pain, feeling unwell, increased sweating. Rare side effects(affecting 1-10 in 10000 people):
• anemia
• vertigo
• ringing in the ears
• gallstones
• muscle pain
• inflammation of the fallopian tubes
• nipple discharge
• chills. The following side effects have occurred in clinical studies in women with high blood pressure:
• high potassium levels (hyperkalemia) sometimes causing muscle cramps, diarrhea, nausea, dizziness or headache
• heart failure, heart enlargement, rapid heartbeat, effects on heart rhythm
• increased aldosterone in the blood. The following side effects have been reported with other HRT:
• gallbladder disease
• a variety of skin conditions:
• skin discoloration, especially of the face or neck, known as “chloasma” (pregnancy mask)
• painful, reddish skin nodules (erythema nodosum)
• skin rash with target-like lesions or ulcers (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 through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of this medicine.

5. 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 stated on the packaging and blister
after “EXP”. The expiry date refers to the last day of that month.
Angeliq does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Angeliq contains
The active ingredientsare estradiol (as estradiol hemihydrate) and drospirenone; each tablet
contains 1 mg of estradiol and 2 mg of drospirenone.
The excipientsare lactose monohydrate, corn starch, pregelatinized corn starch, povidone and
magnesium stearate (E470b). The excipients of the tablet coating are hypromellose
(E464), macrogol 6000, talc (E553b), titanium dioxide (E171) and iron oxide (E172).

Description of the appearance of Angeliq and contents of the pack
Angeliq tablets are film-coated, red, round, convex tablets. One side is
marked with the letters “DL” in a regular hexagon.
They are available in blisters of 28 tablets with the days of the week printed on the blister.
Angeliq is available in packs of 1 and 3 blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Bayer S.p.A. - Viale Certosa, 130 - 20156, Milan (MI)

Manufacturer
Bayer AG, Muellerstrasse 178 – 13353 Berlin - Germany.

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Angeliq –Belgium, Croatia, Czech Republic, Estonia, Germany, Finland, France, Ireland, Italy,
Lithuania, Latvia, Luxembourg, Malta, Netherlands, Poland, Portugal, Slovenia, Spain
Angemin – Sweden

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