Valestra Tablet

Estradiol Valerate is indicated for Hormone Replacement Therapy in:

• Ovulation Induction
• Intrauterine Insemination
• In vitro fertilization

Estradiol valerate is an estrogen medication. In women, it is used in hormone therapy for menopausal symptoms.

Drugs for menopausal symptoms: Hormone replacement therapy, Female Sex hormones

Ovulation Induction:

• Estradiol valerate: 2 mg twice daily for 5 days (from 8th day to 12th day of cycle)
• Letrozole: 2.5 mg twice daily for 5 days (from 3rd day till 7th day of cycle)
• Duration: 3 cycles

Intrauterine Insemination:

• Estradiol Valerate: 6 or 8 mg daily in 3 or 4 divided doses (from 8th day till 12th day of cycle)
• Duration: 3 cycles

In vitro fertilization:

• Estradiol Valerate: 6 mg in 3 divided doses daily. From 1st to 28th day of the cycle 600 mg progesterone in 3 divided doses daily from 14th to 28th day of the cycles
• Duration: 8 weeks of the cycle

Substances increasing the clearance of sex hormones (diminished efficacy by enzyme-induction), e.g.: The metabolism of oestrogens may be increased by concomitant use of substances known to induce drug- metabolising enzymes, specifically cytochrome P450 enzymes, such as anticonvulsants (e.g. barbiturates, phenytoin, primidone, carbamazepine) and anti-infectives (e.g. rifampicin, rifabutin, nevirapine, efavirenz) and possibly also felbamate, griseofulvin, oxcarbazepine, topiramate and products containing the herbal remedy St. John's Wort (Hypericum perforatum). Clinically, an increased metabolism of oestrogens and progestogens may lead to decreased effect and changes in the uterine bleeding profile. Enzyme induction can already be observed after a few days of treatment. Maximal enzyme induction is generally seen within a few weeks. After cessation of drug therapy enzyme induction may be sustained for about 4 weeks.

Substances decreasing the clearance of sex hormones (enzyme inhibitors): Strong and moderate CYP3A4 inhibitors such as azole antifungals (e.g. fluconazole, itraconazole, ketoconazole, voriconazole), verapamil, macrolides (e.g. clarithromycin, erythromycin), diltiazem and grapefruit juice can increase plasma concentrations of the oestrogen.

The following diseases are reported more often in women using HRT compared to women not using HRT:

• breast cancer
• abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer)
• ovarian cancer
• blood clots in the veins of the legs or lungs (venous thromboembolism)
• heart disease
• stroke
• probable memory loss if HRT is started over the age of 65 Other side effects that have been linked to the use of Estradiol Valerate and other oral hormone replacement therapies
• During the first few months of treatment you may experience some vaginal bleeding at unexpected times (breakthrough bleeding and spotting). These symptoms normally lessen with continued treatment. If they don’t, contact your doctor (see section 2 HRT and cancer/Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)’ for more information)
• breast pain, tenderness or enlargement, breast discharge
• painful periods, changes in vaginal secretions, pre-menstrual symptoms, increased size of fibroids in the womb, thrush, changes to the neck of the womb
• indigestion, a feeling of being bloated, passing wind, feeling or being sick, abdominal pain, gall bladder disease
• skin rashes or discolouration, itching, eczema, acne, unusual hair loss or hair growth, increased skin pigment especially on the face (chloasma other conditions for more information), some rare skin problems
• headache, migraine, dizziness, anxiety or depressive symptoms, fatigue
• fast or irregular heartbeat (palpitations), high blood pressure, inflammation of veins usually in the legs
• fluid retention leading to swelling of parts of the body
• changes in body weight and sex drive, increased appetite
• muscle cramps, leg pains
• nose bleeds, visual disturbances (such as blurred vision), discomfort with contact lenses, allergic-type reactions, a worsening of glucose tolerance, bladder inflammation, rare disorders (porphyria, chorea).

Conditions that need supervision:  If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised. It should be taken into account that these conditions may recur or be aggravated during treatment with It, in particular:

• Leiomyoma (uterine fibroids) or endometriosis
• Risk factors for, thromboembolic disorders » Risk factors for oestrogen dependent tumours, e.g. 1st degree heredity for breast cancer
• Hypertension
• Liver disorders (e.g. liver adenoma)
• Diabetes mellitus with or without vascular involvement
• Cholelithiasis
• Migraine or (severe) headache
• Systemic lupus erythematosus
• A history of endometrial hyperplasia
• Epilepsy
• Asthma
• Otosclerosis
• Hereditary angioedema.

If you forget to take Estradiol Valerate: If the woman forgets to take a tablet at the usual time, she may take it within the following 12 hours. If the woman is more than 12 hours late the forgotten tablet should not be taken and the remaining tablets taken at the usual time on the right days. A missed dose may lead to breakthrough bleeding or spotting.

Store below 30°C and dry place. Keep away from light. Keep out of the reach of children.