Angeliq 1 mg/2 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Angeliq 1 mg / 2 mg film-coated tablets

estradiol / drospirenone

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you. Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist. This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, since it may harm them. If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet

1. What Angeliq is and what it is used for 1
2. What you need to know before taking Angeliq 1
3. How to take Angeliq 6
4. Possible side effects 7
5. How to store Angeliq 9
6. Contents of the pack and other information 9

1. What Angeliq is and what it is used for

Angeliq is indicated as hormone replacement therapy (HRT). It contains two types of female hormones, an oestrogen and a progestogen. Angeliq is used in postmenopausal women who had their last natural menstrual period more than 1 year ago.

Angeliq is used for:

Relief of symptoms occurring after menopause

During menopause, the amount of oestrogen produced by a woman's body decreases. This may cause symptoms such as warmth in the face, neck and chest ("hot flushes"). Angeliq relieves these postmenopausal symptoms. Your doctor will prescribe Angeliq to you if your symptoms seriously impair your daily life.

Prevention of osteoporosis

After menopause, women may develop brittle bones (osteoporosis). Please consult your doctor about all available treatment options.

If you have an increased risk of fractures due to osteoporosis and other medications are not suitable for you, Angeliq may be used to prevent postmenopausal osteoporosis.

2. What you need to know before starting Angeliq

Medical history and regular check-ups

The use of HRT carries risks that must be considered when deciding whether to start or continue treatment.

Experience with treating women with premature menopause (due to ovarian insufficiency or surgical intervention) is limited. If you have premature menopause, the risks of using HRT may differ. Consult your doctor.

Before starting (or resuming) HRT, your doctor will ask about your personal and family medical history. Your doctor may decide to perform a physical examination. This may include a breast examination and/or an internal examination, if necessary.

Once you have started treatment with Angeliq, you should visit your doctor for regular check-ups (at least once a year). During these visits, discuss with your doctor the benefits and risks of continuing Angeliq.

Regular breast examinations should be performed as recommended by your doctor.

Do not take Angeliq

if any of the following apply to you. If you are unsure about any of the following points, consult your doctor before taking Angeliq.

• If you have or have had breast cancer or suspect you may have it.
• If you have a cancer dependent on estrogen action, such as cancer of the inner lining of the uterus (endometrium), or if you suspect you may have it.
• If you have abnormal vaginal bleeding.
• If you have excessive thickening of the inner lining of the uterus (endometrial hyperplasia).
• If you have or have had formation of a blood clot in a vein (venous thrombosis), e.g., in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism).
• If you have a blood clotting disorder (such as protein C, protein S or antithrombin deficiency).
• If you have or have recently had a disease caused by blood clots in the arteries, such as heart attack, stroke or angina pectoris.
• If you have or have had a liver disease and your liver function tests have not returned to normal.
• If you have a rare inherited blood disorder called "porphyria".
• If you have severe kidney insufficiency or acute kidney failure.
• If you are allergic (hypersensitive) to estrogens, progestogens or any of the other components of Angeliq (listed in section 6).

?If any of these conditions occurs for the first time while you are taking Angeliq, stop treatment immediately and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Angeliq. Before starting treatment, inform your doctor if you have ever had any of the following conditions, as they may recur or worsen during treatment with Angeliq. If so, you should visit your doctor more frequently for check-ups:

• fibroids within the uterus
• growth of the inner lining of the uterus outside the uterus (endometriosis) or history of excessive growth of the inner lining of the uterus (endometrial hyperplasia)
• increased risk of developing blood clots (see “Blood clots in a vein (thrombosis)”)
• increased risk of developing an estrogen-dependent cancer (e.g., having a mother, sister or grandmother who had breast cancer)
• high blood pressure
• liver disorder, such as a benign liver tumor
• diabetes
• gallstones
• migraines or severe headaches
• an autoimmune disease affecting multiple organs (systemic lupus erythematosus, SLE)
• epilepsy
• asthma
• a disease affecting the eardrum and ear (otosclerosis)
• very high levels of fats in the blood (triglycerides)
• fluid retention due to heart or kidney problems
• hereditary and acquired angioedema

Stop taking Angeliq and seek immediate medical attention

If you experience any of the following conditions while taking HRT:

• any of the conditions listed in the section “Do not take Angeliq”
• yellowing of the skin or whites of the eyes (jaundice). This may be a sign of liver disease
• swelling of the face, tongue or throat and difficulty swallowing or hives accompanied by breathing difficulty, suggesting angioedema
• a significant increase in blood pressure (symptoms may include headache, fatigue, dizziness)
• first occurrence of migraine-type headaches
• if you become pregnant
• if you notice signs of a blood clot, such as
  • painful swelling and redness in the legs
  • sudden chest pain
  • difficulty breathing

For more information, see “Blood clots in a 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 old, you may still need to use an additional contraceptive method to prevent pregnancy. Seek advice from your doctor.

HRT and cancer

Excessive thickening of the inner lining of the uterus (endometrial hyperplasia) and cancer of the inner lining of the uterus (endometrial cancer)

Taking HRT with estrogens alone increases the risk of excessive thickening of the inner lining of the uterus (endometrial hyperplasia) and cancer of the inner lining of the uterus (endometrial cancer). The progestogen in Angeliq protects against this additional risk.

Irregular bleeding

You may experience irregular bleeding or spotting during the first 3–6 months of taking Angeliq. However, if irregular bleeding:

• continues beyond the first 6 months
• starts after having taken Angeliq for more than 6 months
• continues after stopping treatment with Angeliq

consult your doctor as soon as possible.

Breast cancer

Available data show that the use of combined estrogen-progestogen hormone replacement therapy (HRT) or estrogen-only HRT increases the risk of breast cancer. The additional risk depends on how long you use HRT. The additional risk becomes apparent after 3 years of use. After stopping HRT, the additional risk will decrease over time, but the risk may persist for 10 years or more if you have used HRT for more than 5 years.

Comparison

In women aged 50 to 54 years who are not using HRT, an average of 13 to 17 out of 1,000 will be diagnosed with breast cancer over a 5-year period.

In women aged 50 who start estrogen-only HRT for 5 years, there will be 16 to 17 cases per 1,000 women (i.e., 0 to 3 additional cases).

In women aged 50 who start combined estrogen-progestogen HRT for 5 years, there will be 21 cases per 1,000 women (i.e., 4–8 additional cases).

In women aged 50 to 59 years who are not taking HRT, an average of 27 cases of breast cancer per 1,000 women will be diagnosed over a 10-year period.

In women aged 50 who start estrogen-only HRT for more than 10 years, there will be 34 cases per 1,000 women (i.e., 7 additional cases).

In women aged 50 who start combined estrogen-progestogen HRT for 10 years, there will be 48 cases per 1,000 women (i.e., 21 additional cases).

?You should have regular breast examinations. Consult your doctor if you notice any changes such as:

• dimpling of the skin
• changes in the nipple
• any lump you can see or feel

In addition, you are advised to join screening mammography programs when offered. For screening mammograms, it is important that you inform the nurse/healthcare professional performing the X-ray that you are using HRT, as these medications can increase breast density, which may affect the mammogram result. When breast density is increased, a mammogram may not detect all lumps.

Ovarian cancer

Ovarian cancer occurs less frequently than breast cancer. The use of estrogen-only or combined estrogen-progestogen HRT has been associated with a slightly increased risk of ovarian cancer.

The risk of ovarian cancer varies with age. For example, in women aged 50 to 54 years who are not on HRT, about 2 cases of ovarian cancer per 2,000 women are observed over a 5-year period. In women on HRT for 5 years, about 3 cases per 2,000 patients are observed (i.e., about 1 additional case).

Effects of HRT on the heart and circulation

Blood clots in a vein (thrombosis)

The risk of venous blood clots is approximately 1.3 to 3 times higher in HRT users compared to non-users, especially during the first year of use.

Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathing difficulties, fainting, or even death.

Your risk of developing a venous blood clot increases with age and if any of the following apply to you. Inform your doctor if any of these situations affect you:

• you are unable to walk for a prolonged period due to major surgery, injury, or illness (see also section 3, If you need to undergo surgery)
• you have severe obesity (BMI > 30 kg/m²)
• you have a blood clotting disorder requiring long-term treatment with a medication used to prevent blood clots
• a close relative has ever had a blood clot in the leg, lung, or another organ
• you have systemic lupus erythematosus (SLE)
• you have cancer.

For symptoms of a blood clot, see “Stop taking Angeliq and seek immediate medical attention”.

Comparison

In women in their fifties not taking HRT, an average of 4 to 7 out of 1,000 are expected to have a venous blood clot over a 5-year period.

In women in their fifties who have been taking combined estrogen-progestogen HRT, there will be 9 to 12 cases per 1,000 users (i.e., 5 additional cases) over a 5-year period.

Coronary heart disease (heart attack)

There is no evidence that HRT prevents heart attacks.

Women over 60 years of age using combined estrogen-progestogen HRT are slightly more likely to develop heart disease than those not taking any HRT.

Stroke

The risk of stroke is approximately 1.5 times higher in HRT users compared to non-users. The number of additional stroke cases due to HRT use will increase with age.

Comparison

In women in their fifties not taking HRT, an average of 8 out of 1,000 are expected to have a stroke over a 5-year period. For women in their fifties taking HRT, there will be 11 cases per 1,000 users over a 5-year period (i.e., 3 additional cases).

Other diseases

• HRT does not prevent memory loss. There is some evidence of greater memory loss in women who start using HRT after age 65. Consult your doctor.

• If you have kidney disorder and elevated serum potassium levels, particularly if you are taking other medications that increase serum potassium, your doctor should monitor your serum potassium levels during the first month of treatment.

• If you have high blood pressure, you may experience a decrease in blood pressure during treatment with Angeliq. Angeliq should not be used for the treatment of hypertension.

• If you are prone to developing discoloration patches (melasma) on your face, avoid exposure to sunlight or ultraviolet radiation while taking Angeliq.

Use of Angeliq with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Some medicines may interfere with the effect of Angeliq, which may lead to irregular bleeding. These medicines include:

• medicines for epilepsy (such as barbiturates, phenytoin, primidone, carbamazepine, oxcarbazepine, topiramate and felbamate)
• medicines for tuberculosis (such as rifampicin and rifabutin)
• medicines for HIV infection and hepatitis C virus infection (called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as nevirapine, efavirenz, nelfinavir and ritonavir)
• herbal preparations containing St. John's wort (Hypericum perforatum)
• 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 conditions, high blood pressure (such as verapamil, diltiazem)
• grapefruit juice

HRT may affect the function of other medicines:

• An antiepileptic medicine (lamotrigine), as it could increase the frequency of seizures.
• medicines for hepatitis C virus (HCV) (e.g., HCV combination regimens ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin; glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir) may cause elevations in blood liver function tests (increase in liver enzyme ALT) in women using HRT containing ethinylestradiol. Angeliq contains estradiol instead of ethinylestradiol. It is unknown whether an increase in liver enzyme ALT may occur when Angeliq is used with these HCV combination regimens.

The following medicines may cause small increases in serum potassium:

• medicines used in the treatment of:
• inflammation or pain (e.g., aspirin, ibuprofen)
• certain types of coronary heart disease or hypertension (e.g., diuretics (water tablets), ACE inhibitors (e.g., enalapril), angiotensin II receptor antagonists (e.g., losartan)). If you are being treated for high blood pressure and take Angeliq, you may experience an additional drop in blood pressure.

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription, herbal remedies, and other natural products.

Your doctor will advise you accordingly.

Laboratory tests

If you need a blood test, inform your doctor or laboratory staff that you are taking Angeliq, as this medicine may affect the results of certain tests.

Pregnancy and breastfeeding

Angeliq is indicated for postmenopausal women.

If you become pregnant while taking Angeliq, you must stop treatment immediately and contact your doctor.

Driving and use of machines

There are no data suggesting that Angeliq affects the ability to drive or operate machinery.

Angeliq contains lactose

Angeliq contains lactose (a type of sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Angeliq

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. Your doctor will decide the duration of treatment.

Take one tablet once daily, preferably at the same time each day. Swallow the tablet whole with water. You may take Angeliq with or between meals. Start the next calendar pack the day after finishing the current one.

Do not make a break between packs.

If you have been treated with other HRT medicines: Continue your current treatment until you have finished the current pack and taken all the tablets for this month. Take your first Angeliq tablet the following day. Do not make a break between your previous tablets and Angeliq tablets.

If this is your first HRT treatment: You may start treatment with Angeliq on any day.

If you take more Angeliq than you should

An overdose may cause nausea and vomiting and irregular bleeding. Specific treatment is not required, but consult your doctor if you are concerned.

If you have taken more Angeliq than you should, contact your doctor or pharmacist immediately, or call the Poison Information Service (Tel: 91 562 04 20), indicating the medicine and amount taken.

If you forget to take Angeliq

If you have forgotten to take your tablet at the usual time and less than 24 hours have passed, you should take it as soon as possible. Take the next tablet at your usual time.

If more than 24 hours have passed, leave the missed tablet in the pack. Continue taking the remaining tablets at your usual time each day. Do not take a double dose to make up for missed doses.

If you miss taking tablets for several days, irregular bleeding may occur.

If you stop taking Angeliq

You may start to experience menopausal symptoms again, such as hot flushes, sleep disturbances, nervousness, dizziness, or vaginal dryness. You will also begin to lose bone mass when you stop taking Angeliq. Consult your doctor or pharmacist if you wish to discontinue treatment with Angeliq. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

If you need surgery

If you are undergoing surgery, inform your surgeon that you are taking Angeliq. You may need to stop taking Angeliq for 4 to 6 weeks before surgery to reduce the risk of blood clots (see also section 2 "Blood clots in a vein"). Ask your doctor when you can resume treatment with Angeliq.

4. Possible adverse effects

Like all medicines, Angeliq can cause adverse effects, although not everyone will experience them.

The following diseases occur more frequently in women using HRT compared to women who do not take HRT:

• breast cancer
• abnormal growth or cancer of the inner lining of the uterus (endometrial hyperplasia or cancer)
• ovarian cancer
• blood clots in the veins of the legs or lungs (venous thromboembolism)
• coronary heart disease
• stroke
• possible memory loss if HRT is started after the age of 65.

For more information about these adverse effects, see section 2.

Like all medicines, Angeliq can cause adverse effects, although not everyone will experience them.

The following list of adverse effects has been associated with the use of Angeliq:

Very common adverse effects (affect more than 1 in 10 patients):

• unexpected bleeding similar to menstrual periods (see also section 2 “HRT and cancer”)
• breast tenderness
• breast pain

During the first months of treatment with Angeliq, unexpected bleeding similar to menstrual periods may occur. This is usually temporary and typically resolves with continued treatment. If it does not, consult your doctor.

Common adverse effects (affect between 1 and 10 in 100 patients):

• depression, mood changes, nervousness
• headache
• abdominal pain, nausea, abdominal swelling
• breast lumps (benign breast neoplasm), breast enlargement
• increase in size of uterine fibroids
• non-cancerous growth of cells in the cervix (cervical benign neoplasia)
• menstrual disorders
• vaginal discharge
• loss of energy, localized fluid retention

Uncommon adverse effects (affect between 1 and 10 in 1,000 patients):

• weight gain or loss, loss or increase in appetite, increased blood fats
• sleep disorders, anxiety, decreased sexual desire
• prickling or sensation of heat, reduced ability to concentrate, dizziness
• eye disorders (e.g. red eyes), visual disturbances (e.g. blurred vision)
• palpitations
• blood clots, venous thrombosis (see also section 2 “Blood clots in a vein (thrombosis)”), hypertension, migraine, inflammation of veins, varicose veins
• difficulty breathing
• gastrointestinal disorders, diarrhea, constipation, vomiting, dry mouth, flatulence, altered taste
• changes in liver enzymes (detected in blood tests)
• skin problems, acne, hair loss, skin itching, excessive hair growth
• back pain, joint pain, limb pain, muscle cramps
• urinary tract disorders and infections
• breast cancer, endometrial hypertrophy, unusual benign growth in the uterus, mouth ulcers, vaginal dryness and itching
• breast lumps (fibrocystic breasts), ovarian, cervical and uterine disorders, pelvic pain
• generalized fluid retention, chest pain, general malaise, increased sweating

Rare adverse effects (affect between 1 and 10 in 10,000 patients):

• anemia
• dizziness
• tinnitus (ringing in the ears)
• gallstones
• muscle pain
• inflammation of the Fallopian tubes
• milk secretion from the nipples
• chills

The following adverse effects were observed in clinical studies conducted in women with high blood pressure:

• increased blood potassium concentration (hyperkalemia), which may sometimes cause muscle cramps, diarrhea, nausea, dizziness, or headache
• heart failure, enlargement of the heart, palpitations, effects on heart rhythm
• increased blood aldosterone concentration.

The following adverse effects have been reported with other HRT medicines:

• gallbladder disease

• various skin disorders:

• skin discoloration, especially on the face or neck, known as “pregnancy mask” (chloasma)

• painful red nodules on the skin (erythema nodosum)

• skin rash with target-like redness or sores (erythema multiforme)

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Angeliq

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the blister after “EXP”. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Angeliq

The active substances are estradiol (as estradiol hemihydrate) and drospirenone; each tablet contains 1 mg of estradiol and 2 mg of drospirenone.

The other components are lactose monohydrate, corn starch, pregelatinized corn starch, povidone, and magnesium stearate (E470b). The coating components are hypromellose (E464), macrogol 6000, talc (E553b), titanium dioxide (E171), and iron oxide red (E172).

Appearance of the product and contents of the pack

Angeliq coated tablets are red, round, and convex. One side is marked with the letters DL inside a regular hexagon.

Each pack contains a blister with 28 tablets, with the days of the week printed on the blister. Packs containing one or three blisters are available.

Marketing Authorization Holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3 - 5

08970 Sant Joan Despí – Barcelona

Spain

Manufacturer

Bayer AG

Müllerstrasse 178

13353 Berlin

or

Bayer Weimar GmbH und Co. KG, Weimar

Döbereinerstraße 20

99427 Weimar

Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Angeliq – Belgium, Croatia, Czech Republic, Estonia, Germany, Finland, Ireland, Italy, Lithuania, Latvia, Luxembourg, Malta, Netherlands, Poland, Portugal, Slovenia, Spain.

Date of the most recent revision of this leaflet:

September 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es.