Progynova

Progynova contains only estradiol valerate, without a progestogen. It is suitable for women without a uterus (after a hysterectomy) who do not need an additional progestogen to protect the uterine lining.

Estradiol valerate is converted to estradiol in the body and replaces the body's own estrogen that is lacking.

Women with menopausal symptoms after removal of the uterus.

• 1 mg or 2 mg estradiol valerate
• One tablet daily for 3 weeks, followed by a break of at least 1 week

One tablet daily for 3 weeks, followed by a break of at least 1 week.

Progynova must not be used in case of:

• hypersensitivity to estradiol valerate or any of the other ingredients
• current or past breast cancer, or suspected breast cancer
• estrogen-dependent malignant tumor, or suspicion of one (especially endometrial cancer)
• unexplained bleeding in the genital area
• untreated thickening of the uterine lining (endometrial hyperplasia)
• past or current venous blood clots (especially deep vein thrombosis, pulmonary embolism)
• known clotting disorders with a tendency to thrombosis (e.g. protein C, protein S or antithrombin deficiency)
• current or recent arterial thromboembolic disease (especially angina pectoris, heart attack)
• acute liver disease or past liver disease, as long as liver values have not returned to normal
• porphyria
• past or current liver tumors (benign or malignant)
• severely elevated triglyceride levels (severe hypertriglyceridemia)

With an intact uterus: ONLY with an additional progestogen!

Common (1 to fewer than 10 in 100 users):

• Headache
• Nausea, abdominal pain
• Changes in body weight (gain or loss)
• Skin rash, itching
• Bleeding irregularities: bleeding from the uterus or vagina, heavier or lighter withdrawal bleeding, spotting or breakthrough bleeding (these usually no longer occur with continued treatment)

Uncommon (1 to fewer than 10 in 1,000 users):

• Breast tenderness, breast pain
• Hypersensitivity reactions
• Depressed mood
• Dizziness
• Visual disturbances
• Palpitations
• Indigestion (dyspepsia), increased appetite
• Pigment spots on the skin (chloasma), erythema multiforme, erythema nodosum, vascular purpura, hives (urticaria)
• Fluid retention (edema)

Rare (1 to fewer than 10 in 10,000 users):

• Anxiety, changes in libido
• Migraine
• Contact lens intolerance
• Flatulence, vomiting
• Increased body hair (hirsutism), acne, hair loss
• Muscle cramps
• Painful menstrual bleeding, vaginal discharge, symptoms similar to premenstrual syndrome, breast enlargement
• Tiredness

Further side effects have also been reported with estrogen-only treatment, e.g. high blood pressure, mood swings, liver function disorders or worsening of varicose veins.

Serious risks of hormone replacement therapy:

• Blood clots in the veins (especially deep vein thrombosis, pulmonary embolism): The risk is increased 1.3- to 3-fold. A blood clot is more likely in the first year of treatment than later.
• Stroke: The risk is increased up to 1.5-fold. The overall risk increases with age.
• Breast cancer: With estrogen-only treatment, the risk is slightly increased, but lower than with a combination with a progestogen. It depends on the duration of treatment.
• Ovarian cancer: slightly increased risk
• Endometrial cancer: If you have a uterus, longer treatment with estrogen alone increases the risk of thickening of the uterine lining and of endometrial cancer.
• In rare cases benign, and even more rarely malignant, liver tumors, which in isolated cases have led to life-threatening bleeding in the abdomen.
• Dementia: In women who are older than 65 years at the start of treatment, there are indications of an increased risk.
• In hereditary or acquired angioedema, estrogens can trigger or worsen the symptoms.

Contact a doctor immediately if you notice possible signs of a blood clot, especially a painful swelling of a leg, sudden chest pain or shortness of breath. Stop taking the tablets immediately and contact your doctor in case of jaundice or worsening liver function, a marked rise in blood pressure, new migraine-like headaches, acute visual disturbances or other functional deficits, and in case of pregnancy.

The effect of Progynova can be weakened by:

• medicines for epilepsy (e.g., barbiturates, phenytoin, primidone, carbamazepine; possibly also felbamate, oxcarbazepine, topiramate)
• medicines for infections (e.g., rifampicin, rifabutin, nevirapine, efavirenz; possibly also griseofulvin)
• possibly also herbal medicines containing St. John's wort
• activated charcoal
• antibiotics such as ampicillin or tetracycline

The estrogen level can be increased by, e.g., fluconazole, itraconazole, ketoconazole, voriconazole, clarithromycin, erythromycin, verapamil, diltiazem, grapefruit juice and paracetamol. Many combinations of HIV medicines, including combinations with hepatitis C medicines, can increase or decrease the estrogen level.

Progynova can affect other medicines:

• Lamotrigine: The control of seizures can weaken.
• Imipramine: Effects and side effects can be enhanced.
• Ciclosporin: The blood levels of ciclosporin, creatinine and liver enzymes (transaminases) can rise.
• Diabetes tablets and insulin: Whether they are needed, and at what dose, can change.

Caution is required when the hepatitis C medicines ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir are used at the same time. Progynova can affect the results of certain laboratory tests.