Femoston 2/10 Tablet (28 Tab)

FEMOSTON 2/10 TABLET (28 TAB) by ABBOTT INDIA LIMITED

FEMOSTON 2/10 TABLET is a hormone replacement therapy (HRT) designed for women experiencing symptoms related to estrogen deficiency during and after menopause. It is a continuous sequential therapy.

Composition

FEMOSTON 2/10 TABLET comes in a 28-tablet combipack, containing two types of film-coated tablets:

• Estradiol tablets: 14 round, brick-red tablets, each containing 2 mg of estradiol (as hemihydrate).
• Estradiol and Dydrogesterone combination tablets: 14 round, yellow tablets, each containing 2 mg of estradiol (as hemihydrate) and 10 mg of dydrogesterone. The tablets also contain excipients, including lactose monohydrate.

Uses

FEMOSTON 2/10 TABLET is prescribed for postmenopausal women (at least 6 months since their last menstrual period) with an intact uterus for:

• Relief of estrogen deficiency symptoms: This includes common menopausal symptoms such as hot flushes, night sweats, vaginal dryness, irritation, and mood swings.
• Prevention of osteoporosis: It helps prevent bone density loss and fractures in postmenopausal women who are at an increased risk of osteoporosis and for whom other suitable medicines are not available.

Dosage and Administration

FEMOSTON 2/10 TABLET is taken continuously without a break between packs.

• For the first 14 days of a 28-day cycle, one brick-red tablet (2 mg estradiol) is taken daily.
• For the following 14 days, one yellow tablet (2 mg estradiol and 10 mg dydrogesterone) is taken daily. Tablets should be swallowed whole with water, with or without food, preferably at the same time each day to ensure consistent levels of medicine in the body.

Side Effects

Common Side Effects include:

• Nausea, vomiting, abdominal pain, bloating
• Headache, dizziness, drowsiness, fatigue
• Breast tenderness, pain, or enlargement
• Vaginal bleeding or spotting, mood changes, back pain

Serious Side Effects (seek immediate medical attention if experienced):

• Allergic reactions causing swelling of the face, tongue, throat, and/or difficulty breathing
• Signs of a blood clot (e.g., painful swelling and redness in legs, sudden chest pain, shortness of breath, changes in vision)
• Heart attack or stroke
• Jaundice (yellowing of skin or eyes)
• Significant rise in blood pressure or new migraine-like headaches
• Unexplained heavy, irregular, or painful genital bleeding.

HRT use is associated with an increased risk of certain conditions, including breast cancer, endometrial hyperplasia or cancer, ovarian cancer, venous thromboembolism (blood clots), heart disease, stroke, and probable memory loss if started over the age of 65.

Precautions

• Contraindications: Do not use if you have known, past, or suspected breast cancer; endometrial cancer; unexplained vaginal bleeding; untreated endometrial hyperplasia; blood clotting disorder; heart attack or angina; inherited porphyria; liver disease; or an allergy to any ingredients.
• Pregnancy and Breastfeeding: FEMOSTON 2/10 TABLET is highly unsafe during pregnancy and breastfeeding.
• Medical History: Inform your doctor about any history of kidney or liver issues, diabetes, stroke, or problems with blood circulation.
• Alcohol Consumption: Avoid alcohol as it may increase the risk of breast cancer.
• Surgery: Inform your doctor about any scheduled surgery, as FEMOSTON may need to be stopped at least 4 weeks prior to certain procedures.
• Regular Check-ups: Regular medical examinations, including breast checks, mammograms, uterine and cervical checks, and Pap smears, are recommended during therapy.
• Not for Children: This medicine is not recommended for children under 18 years of age.

Storage

Store FEMOSTON 2/10 TABLET in a cool, dry place below 30°C, protected from direct sunlight and moisture. Keep it out of the sight and reach of children. Do not use the medicine after the expiry date.

FEMOSTON 2/10 TABLET (28 TAB) by ABBOTT INDIA LIMITED is a Hormone Replacement Therapy (HRT) medication containing estradiol and dydrogesterone, used to alleviate menopausal symptoms and prevent osteoporosis.

What is FEMOSTON 2/10 TABLET used for?

FEMOSTON 2/10 TABLET is primarily used for Hormone Replacement Therapy (HRT) in postmenopausal women. It helps relieve symptoms associated with menopause, such as hot flashes, night sweats, vaginal dryness, irritation, and mood changes. It is also used to prevent osteoporosis (thinning of the bones) in postmenopausal women who are at high risk of fractures or cannot take other osteoporosis prevention medicines.

How does FEMOSTON 2/10 TABLET work?

This medicine contains two active ingredients: estradiol and dydrogesterone. Estradiol is a form of estrogen that replaces the natural estrogen levels which decrease during menopause, thereby easing menopausal symptoms and maintaining bone density. Dydrogesterone is a synthetic progestogen that protects the uterine lining from the excessive thickening that can be caused by unopposed estrogen, thus reducing the risk of endometrial hyperplasia and cancer.

What is the usual dosage for FEMOSTON 2/10 TABLET?

The usual dosage is one tablet daily, taken continuously without a break between packs. The 28-day pack typically consists of two types of tablets: 14 brick-red tablets containing only 2 mg of estradiol for the first 14 days, followed by 14 yellow tablets containing 2 mg of estradiol and 10 mg of dydrogesterone for the subsequent 14 days. It should be swallowed whole with water, preferably at the same time each day, with or without food.

What are the possible side effects of FEMOSTON 2/10 TABLET?

Common side effects include breast tenderness or enlargement, headache, nausea, abdominal pain, vaginal bleeding or spotting, and mood changes. More serious, though less common, side effects associated with HRT can include an increased risk of breast cancer, endometrial cancer, ovarian cancer, blood clots in the legs or lungs, heart disease, stroke, and probable memory loss if started over the age of 65. If you experience severe side effects or any signs of a blood clot (painful swelling or redness in legs, sudden chest pain, difficulty breathing), sudden severe headache, or yellowing of the skin or eyes, contact your doctor immediately.

Is FEMOSTON 2/10 TABLET safe during pregnancy or breastfeeding?

No, FEMOSTON 2/10 TABLET is not recommended for use during pregnancy as it is considered unsafe due to probable risks to the baby. It is also not advised for use in breastfeeding women. If you become pregnant while taking this medicine, stop immediately and contact your doctor.

Can FEMOSTON 2/10 TABLET be taken with other medications?

FEMOSTON 2/10 TABLET can interact with several other medications. These include certain medicines for epilepsy (e.g., phenytoin, phenobarbital, carbamazepine, lamotrigine), some antibiotics and antivirals (e.g., rifampicin, ritonavir), and herbal medicines containing St. John's wort. It may also interfere with medicines that have a narrow therapeutic index, such as tacrolimus, ciclosporin, fentanyl, and theophylline, potentially leading to increased plasma levels of these drugs. Always inform your doctor or pharmacist about all other medicines, including herbal remedies and over-the-counter drugs, you are taking.

What precautions should be taken while using FEMOSTON 2/10 TABLET?

Before starting treatment, your doctor will conduct a thorough medical check-up, including breast examinations and potentially a mammogram and Pap smear. Regular check-ups are recommended at least once a year. Inform your doctor about any history of blood clots, breast cancer, endometrial cancer, liver disease, or unexplained vaginal bleeding. You should check your breasts monthly and report any changes promptly to your doctor. It's advisable to avoid alcohol consumption while taking this medication. If you are scheduled for surgery, you may need to stop taking FEMOSTON at least 4 weeks beforehand to reduce the risk of blood clots.

What happens if a dose of FEMOSTON 2/10 TABLET is missed?

If you miss a dose, take it as soon as you remember. However, if it has been more than 12 hours since the missed dose, it is generally recommended to skip the forgotten tablet and continue with your regular dosing schedule, taking the next tablet at its usual time. Do not take a double dose to make up for a missed one. Missing a dose may increase the likelihood of breakthrough bleeding or spotting.

How should FEMOSTON 2/10 TABLET be stored?

FEMOSTON 2/10 TABLET should be kept in its original pack in a cool, dry place where the temperature stays below 30°C. Protect it from light and moisture, and ensure it is kept out of the sight and reach of children and pets. Do not use the medicine after the expiry date.