Angeliq

(Estradiol/Drospirenone)

The active ingredients in Angeliq are estradiol (estrogen) and drospirenone (progestin). Your ovaries produce estrogen and progesterone, which are hormones that regulate your menstrual cycle. As you age and go through menopause, your ovaries produce fewer and fewer of these hormones. This can cause symptoms including hot flashes and nocturnal sweats. Angeliq is a hormone replacement medication (HRT) that restores the estrogen and progesterone hormones in postmenopausal women. Increasing estrogen with estradiol helps alleviate vasomotor symptoms (VMS) like hot flashes, vaginal dryness, and night sweats. Adding a progestin like drospirenone helps balance the influence of oestrogen on uterine lining growth.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Angeliq. However, the following is a synopsis of the general guidelines for the use of Angeliq:

• Do not chew, crush, break, or dissolve an Angeliq tablet. Swallow it fully.
• Take this medication at the same time every day.
• Angeliq may raise your risk of having a condition that can progress to uterine cancer. Your doctor may prescribe a progestin to reduce this risk. If you see any odd vaginal bleeding, report it right away.
• If you need significant surgery or will be on long-term bed rest, you may need to discontinue this medication for a brief period. Any doctor or surgeon who treats you should be aware that you are taking Angeliq. You may be at a high risk for some side effects of Angeliq if you do not move around normally for an extended period.
• You should regularly check your breasts for any changes and get breast scans (mammograms) done while on this medication.

The most common side effects of Angeliq seen in clinical trials as compared to placebo include:

• Breast pain.
• Fluid retention.
• Severe headaches.
• Abdominal pain.
• High cholesterol can lead to pancreatitis.

Some individuals may experience serious side effects while using Angeliq. These side effects may be life-threatening and require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Heart attack symptoms include chest pain, abdominal discomfort, perspiration, nausea, and dizziness.
• Stroke symptoms include sudden numbness or weakness in the arm, leg, or face, confusion, vision problems, headaches, and difficulty walking.
• Increased risk of deep vein thrombosis (blood clot in the leg), which can cause leg cramping, swelling, pain, and muscle tightness.
• Cough, chest pain, shortness of breath, and a racing heart are symptoms of a pulmonary embolism (a blood clot in the lungs).
• Liver or gallbladder disorders include yellowing of the skin or whites of the eyes (jaundice), fatigue, pain in the right upper stomach, and black urine.
• Abnormal vaginal bleeding, discharge, or pelvic pain.

These are not all of the possible side effects of Angeliq. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Angeliq, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Unusual vaginal bleeding that a doctor has not examined.
• A bleeding condition.
• Heart disease.
• A history of heart attack, stroke, or blood clots.
• Kidney disease.
• Liver disease.
• An adrenal gland disease.
• A history of hormone-related cancer, such as breast, uterine/cervical, or vaginal cancer.
• If you have undergone a hysterectomy
• High blood pressure.
• A thyroid condition.
• Gallbladder disease.
• High triglycerides (blood fat).

-Asthma.

-Epilepsy or another seizure disease.

• Endometriosis, or uterine fibroid tumours.
• High calcium or potassium levels in the blood, as well as low sodium levels.
• Hereditary angioedema.
• Porphyria (a genetic enzyme condition characterised by skin and neurological system symptoms).

Boxed Warnings

Estrogen therapies, whether alone or combined with progestins, are not recommended for preventing cardiovascular disease or dementia. Research from the Women’s Health Initiative (WHI) found that postmenopausal women taking estrogen plus progestin faced higher risks of heart attack, stroke, blood clots, breast cancer, and dementia compared to placebo. The dementia risk was particularly noted in women aged 65 and older. The WHI also confirmed an increased likelihood of invasive breast cancer with combined therapy, so treatment should be limited to the lowest dose and shortest duration possible. Additionally, unopposed estrogen use raises the risk of endometrial cancer in women with a uterus, though adding progestin can lower this risk. Any unexplained or persistent abnormal vaginal bleeding should be carefully investigated to rule out malignancy.

Abnormal vaginal bleeding that your gynaecologist is unaware of or that you have not reported to them.

• Currently have or have had breast cancer.
• Estrogen-dependent malignancies (such as endometrial cancer and ovarian cancer).
• High chance of forming a blood clot.
• A history of blood clots, strokes, or heart attacks.
• Kidney issues.
• Liver issues.
• Suffering from Addison's disease or another adrenal gland disorder.

The rate at which Angeliq (drospirenone/estradiol) acts varies from person to person, depending on the medical condition for which the prescription is prescribed. According to clinical research, those who used Angeliq (drospirenone/oestradiol) for hot flashes experienced a significant reduction in the quantity and severity of hot flashes by week 4 of treatment, compared to those who took a placebo.

When Angeliq is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Carbamazepine.
• Ketoconazole.
• Clarithromycin.
• Diltiazem.
• Erythromycin.
• St. John’s Wort.
• Grapefruit juice.

Angeliq tablets are available in two distinct strengths:

0.25 mg of drospirenone and 0.5 mg of oestradiol (for VSM symptoms exclusively).

0.5 mg drospirenone and 1 mg oestradiol (VSM and vaginal symptoms).

Your healthcare team will recommend a dose based on your medical condition.

Adults typically take one pill by mouth once daily.

Store at room temperature and keep out of reach of children.

Bayer is the pharmaceutical company that manufactures Angeliq.

There are no generic versions available of Angeliq.

Consult a healthcare expert before lowering or stopping your medication. In many cases, you can reduce the negative effects by gradually reducing your dose over time. It should only be done under the supervision of your doctor.

If you are pregnant, do not use Angeliq. If you become pregnant during treatment, contact your doctor right away.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.