What is ACTIVELLE
ACTIVELLE is a hormone replacement therapy (HRT) designed for postmenopausal women who are experiencing symptoms related to estrogen deficiency. Each film-coated tablet contains a combination of two active ingredients: Estradiol (as hemihydrate), a naturally occurring estrogen, and Norethisterone acetate, a synthetic progestogen. The product is packaged in a 28-tablet calendar dial pack to support daily and consistent use.
- Estradiol: Replaces the estrogen that naturally declines during menopause, helping alleviate symptoms such as hot flashes, night sweats, and vaginal dryness.
- Norethisterone: Prevents estrogen-induced endometrial hyperplasia, which could develop into cancer in women with an intact uterus if unopposed by a progestogen.
- Indicated for:
- Relief of moderate to severe vasomotor symptoms of menopause.
- Prevention of postmenopausal osteoporosis in high-risk women who are not candidates for other medications.
- Continuous combined regimen: Taken daily without interruption, allowing for a steady hormone level and avoiding withdrawal bleeding in most users.
ACTIVELLE is a well-established option for managing menopause-related hormonal imbalances and protecting long-term bone health when used appropriately under medical supervision.
How to use ACTIVELLE
ACTIVELLE should be used exactly as prescribed by a healthcare provider. It follows a continuous combined regimen with no breaks between packs.
- Dosage form: One film-coated tablet per day, taken orally at the same time each day.
- Calendar dial pack: The 28-day blister pack is labeled with the days of the week, which helps ensure consistent daily intake and adherence to the therapy.
- With or without food: Tablets can be taken with or without meals, but taking it with food may reduce the chance of gastrointestinal upset.
- Missed dose: If a dose is missed, it should be taken as soon as remembered. If more than 12 hours have passed, skip the missed dose and continue with the next tablet. Do not take two tablets at once.
- Start timing: For women transitioning from another HRT, the switch can be made directly. For first-time users, therapy should start based on the doctor’s advice, preferably shortly after the last natural menstruation.
- Follow-up: Periodic re-evaluation by the prescribing physician is essential to assess the need for continued therapy.
Adherence to the prescribed regimen ensures optimal control of menopausal symptoms and protection of the endometrium.
Mode of Action ACTIVELLE
ACTIVELLE combines two hormones to replicate the physiological hormonal environment of premenopausal women, aiming to relieve menopausal symptoms and reduce long-term risks of estrogen deficiency.
- Estradiol (as hemihydrate):
- A form of 17β-estradiol, the principal endogenous estrogen.
- Acts by binding to estrogen receptors (ERα and ERβ) in various tissues such as the brain, bone, and urogenital tract.
- Reduces vasomotor symptoms (e.g., hot flashes), maintains bone density, and improves vaginal tissue health.
- Norethisterone acetate:
- A synthetic progestin that converts to norethisterone in the body.
- Acts by opposing the proliferative effects of estradiol on the endometrium, thereby reducing the risk of endometrial hyperplasia and carcinoma in women with a uterus.
- Modulates estrogen receptor activity and regulates menstrual-like bleeding.
- Combined effect: Maintains hormonal balance by restoring estrogen levels while preventing estrogen-induced endometrial complications.
Through this dual mechanism, ACTIVELLE provides comprehensive symptom relief and endometrial protection for postmenopausal women.
ACTIVELLE Interactions ACTIVELLE
Several drugs may interact with ACTIVELLE, altering its effects or increasing the risk of side effects. It is crucial to inform your doctor about all medications being used.
- Enzyme-inducing drugs:
- Rifampicin, rifabutin (antibiotics)
- Carbamazepine, phenytoin, phenobarbital (antiepileptics)
- St. John’s Wort (herbal remedy)
- These can lower estradiol and norethisterone levels by increasing hepatic metabolism, reducing efficacy.
- Protease inhibitors and antifungals:
- Ritonavir, ketoconazole, itraconazole may inhibit hormone metabolism and increase blood levels of ACTIVELLE.
- Anticoagulants:
- Estrogens may reduce the efficacy of anticoagulants like warfarin; monitoring is advised.
- Thyroid medications:
- ACTIVELLE may alter the need for thyroid hormone replacement (e.g., levothyroxine) due to protein binding interactions.
- Glucose-lowering agents:
- May affect insulin sensitivity, potentially impacting diabetes control.
Patients should not start, stop, or change dosages of any medication without consulting their healthcare provider while on ACTIVELLE.
Dosage of ACTIVELLE
The standard dosage of ACTIVELLE is one tablet daily, which contains:
- Estradiol (as hemihydrate): 1 mg
- Norethisterone acetate: 0.5 mg
This fixed-dose combination is intended for continuous use without breaks between cycles, providing a steady hormone level.
- Administration: One tablet is taken orally at the same time each day.
- Calendar pack: The 28-day pack is designed for convenience and to enhance compliance, with each tablet marked by day of the week.
- Special populations:
- Not recommended in children or adolescents.
- In elderly women, treatment should be individualized and closely monitored.
- Missed dose: If a tablet is missed and more than 12 hours have passed, the missed dose should be skipped to avoid doubling up.
- Starting treatment: Should begin under medical guidance, often initiated immediately after menopause or transitioning from another HRT.
Dosing must be reassessed periodically by a healthcare provider to ensure continued need and adjust therapy based on individual response.
Possible side effects of ACTIVELLE
As with any hormone-based therapy, ACTIVELLE may cause side effects. While not everyone experiences them, some effects can be serious and warrant immediate attention.
- Common side effects:
- Breast tenderness or pain
- Headache or migraine
- Nausea
- Vaginal bleeding or spotting
- Abdominal pain or bloating
- Less common or rare side effects:
- Weight changes (gain or loss)
- Mood swings or depression
- Skin rash or itching
- Increased blood pressure
- Serious side effects (seek immediate medical help):
- Signs of a blood clot: sudden leg pain, swelling, chest pain, or difficulty breathing
- Unusual vaginal bleeding
- Yellowing of the skin or eyes (jaundice)
- Vision or speech changes
Side effects should be discussed with a doctor, and therapy should be adjusted or discontinued if risks outweigh benefits.
ACTIVELLE Contraindications ACTIVELLE
ACTIVELLE should not be used in certain medical conditions due to the increased risk of severe complications.
- Absolute contraindications:
- Known, suspected, or history of breast cancer
- Estrogen- or progestogen-dependent malignancies
- Undiagnosed vaginal bleeding
- Active or history of venous thromboembolism (e.g., DVT, pulmonary embolism)
- Arterial thromboembolic disorders (e.g., stroke, myocardial infarction)
- Severe liver disease or liver tumors
- Known hypersensitivity to estradiol, norethisterone, or any excipients
- Relative contraindications (use with caution):
- History of endometriosis or fibroids
- Hypertension
- Diabetes with vascular involvement
- Gallbladder disease
Before initiating ACTIVELLE, a thorough medical history and physical examination are essential to rule out contraindications.
Storage of ACTIVELLE
Proper storage of ACTIVELLE is essential to maintain its potency and safety:
- Temperature: Store below 25°C (77°F).
- Humidity: Keep tablets in the original blister pack to protect from moisture and light.
- Location: Store in a dry place out of reach of children and pets.
- Do not refrigerate or freeze.
- Expiration: Do not use after the expiry date printed on the pack. Safely discard any unused medicine as directed by your pharmacist.
Adhering to these storage conditions helps ensure that ACTIVELLE remains effective and safe throughout its shelf life.
ACTIVELLE features an exceptional active ingredient renowned for its potent effects, comprising Estradiol (as hemihydrate), Norethisterone (acetate). This powerful formulation provides a superior solution for addressing diverse health concerns. With 1mg, 0.5mg/Tablet concentration and an easily manageable Tablets/Film-coated, it remains a preferred option for countless individuals seeking effective treatment.
Introduction
All you need to know about ACTIVELLE .
Welcome to Dwaey, specifically on ACTIVELLE page.
This medicine contains an important and useful components, as it consists of Estradiol (as hemihydrate), Norethisterone (acetate).
ACTIVELLE is available in the market in concentration 1mg, 0.5mg/Tablet and in the form of Tablets/Film-coated.
NOVO NORDISK A/S is the producer of ACTIVELLE and it is imported from DENMARK,
The most popular alternatives of ACTIVELLE are listed downward .
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Active Substance
Estradiol (as hemihydrate), Norethisterone (acetate)
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Size
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Indications
- No indications available.
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Type
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Company
Frequently Asked Questions
ACTIVELLE should be stored according to the instructions provided by NOVO NORDISK A/S.
In general, it is recommended to store ACTIVELLE in a cool, dry place, away from direct sunlight
and out of the reach of children.
The duration of treatment with ACTIVELLE may vary depending on the condition being treated
and the guidance of your healthcare provider. It is important to follow the prescribed treatment
plan and continue taking ACTIVELLE for the recommended duration, even if your symptoms improve.
If you have any concerns or questions about the duration of treatment, consult your healthcare provider.
It is important to check with your healthcare provider or read the medication label for specific
instructions regarding alcohol consumption while taking ACTIVELLE. Some medications, including
ACTIVELLE, may have interactions with alcohol that can reduce effectiveness, increase side
effects, or pose other risks to your health. It is best to follow the guidance provided by your
healthcare professional.
If you miss a dose of ACTIVELLE, take it as soon as you remember. However, if it is close
to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing
schedule. Do not take a double dose to make up for a missed one unless advised by your healthcare provider.
No, do not stop taking ACTIVELLE without consulting your healthcare provider, even if your
symptoms improve. It is important to complete the full course of treatment as prescribed. Stopping
the medication prematurely may lead to a relapse or incomplete resolution of the condition. If you
have concerns about the duration of treatment, consult your healthcare provider for guidance.
It is important to consult your healthcare provider before taking ACTIVELLE if you are
pregnant or breastfeeding. They will be able to assess the potential risks and benefits based on your
specific situation. Please note that the safety and suitability of ACTIVELLE during pregnancy
or breastfeeding may depend on the active substance [Active Substance], concentration 1mg, 0.5mg/Tablet,
and the specific recommendations of NOVO NORDISK A/S.
The effects of ACTIVELLE on your ability to drive or operate machinery can vary depending on
the active substance [Active Substance], concentration 1mg, 0.5mg/Tablet, and individual factors.
Some medications may cause drowsiness, dizziness, or other side effects that can impair your judgment
or coordination. It is important to read the medication label or consult your healthcare provider to
understand any potential effects on your ability to perform tasks that require alertness.
The instructions for taking ACTIVELLE with or without food may vary depending on the medication
and the recommendations of NOVO NORDISK A/S. Some medications may be more effective when taken with
food to enhance absorption or reduce stomach irritation, while others may need to be taken on an empty
stomach for optimal absorption. Read the medication label or consult your healthcare provider for specific instructions.
The use of ACTIVELLE in children or elderly individuals may depend on various factors, including
the specific medication, type Tablets/Film-coated, and the recommendations of NOVO NORDISK A/S. Some
medications may have specific dosing instructions or precautions for these age groups. Consult your
healthcare provider or read the medication label for information regarding the safe and appropriate use
of ACTIVELLE in children or elderly individuals.
Dwaey
All medical information published on the Dwaey website aims to increase medical awareness and health education among users. However, it is not a substitute for professional medical advice. Always consult with a specialist doctor. We strongly advise against using any information or medicine found on the site without referring to your healthcare provider.
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