Tibopause (2.5mg) 30 Tablets

Tibopause (2.5mg) 30 Tablets

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  • Manufacturer ZAFA PHARMACEUTICALS (PVT.) LTD.
  • Generic Name Tibolone

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Product Information

  • Description
  • Ingredients
  • Drug Class
  • Dosage Form
  • Uses
  • In case of Overdose
  • Missed Dose
  • How To Use
  • When Not to Use
  • Side Effects
  • Precautions & Warnings
  • Drug Interactions
  • Food Interactions
  • Storage/Disposal
  • Quick Tips, if any
  • Description

    Tibolone is a synthetic steroid with tissue-specific estrogenic, progestogenic, and androgenic activities. It acts as a prodrug, with its active metabolites 3α-hydroxytibolone, 3β-hydroxytibolone, and Δ^4-isomerized derivatives exerting the primary effects. These metabolites bind to estrogen, progesterone, and androgen receptors, selectively activating or inhibiting their activity in different tissues. In the brain, tibolone and its metabolites can bind to serotonin and sigma-1 receptors, which may contribute to their positive effects on mood and cognition. Tibolone and its metabolites also influence the synthesis and metabolism of neurotransmitters like serotonin, norepinephrine, and dopamine, potentially affecting cognitive function and mood regulation.

  • Ingredients

    Tibolone
  • Drug Class

    Estrogen modulator.

  • Dosage Form

    Tablet

  • Uses

    The following are the uses of Tibolone 2.5mg Tablet:

    • Used for treating menopausal symptoms such as hot flashes and vaginal dryness.
    • Used to prevent osteoporosis in postmenopausal women.
    • Used to alleviate mood swings and depressive symptoms associated with menopause.
    • Helps restore vaginal health and reduce discomfort during sexual intercourse.
    • Manages night sweats and sleep disturbances caused by hormonal changes.
    • Can improve skin elasticity and reduce the occurrence of wrinkles.
    • Used to enhance overall well-being and energy levels during menopause.
    • Provides relief from joint pain and stiffness sometimes experienced during this transitional period.
  • In case of Overdose

    In the case of an overdose of Tibolone 2.5mg Tablet, it is important to recognize the potential symptoms and take appropriate action. Overdose symptoms may include nausea, vomiting, dizziness, and in severe cases, it can lead to abdominal pain and increased blood pressure. If you suspect an overdose, seek medical advice immediately. Contact a healthcare professional or a poison control center for guidance on the necessary steps to address the situation effectively. Prompt action can help manage any adverse effects and ensure the best possible outcome.

  • Missed Dose

    In the case of a missed dose of Tibolone 2.5mg Tablet, it is important to take the medication as soon as you remember. If it is almost time for your next scheduled dose, skip the missed one and continue with your regular dosing schedule. Do not double the dose to make up for a missed one. If you have missed multiple doses, consult your healthcare professional for advice on how to resume your medication safely. It is generally recommended to take the missed dose as soon as possible, but if it is close to the time for your next dose, it's best to skip the missed one to avoid any potential side effects.

  • How To Use

    To take Tibolone 2.5mg Tablet, swallow the tablet whole with a glass of water, preferably at the same time each day, as directed by your healthcare provider, without crushing or chewing it.

  • When Not to Use

    Here are the circumstances when Tibolone 2.5mg Tablet should be avoided:

    • Must not be taken by individuals with a known allergy to Tibolone or any of its ingredients.
    • Not suitable for women who have had or are at risk of blood clots, such as deep vein thrombosis (DVT) or pulmonary embolism (PE).
    • Contraindicated in women with a history of stroke or mini-stroke (transient ischemic attack).
    • Should not be used if you have or have had breast cancer or other estrogen-dependent cancers.
    • Avoid if you have or are suspected of having a liver disorder or disease.
    • Not recommended for women with undiagnosed abnormal genital bleeding.
    • Do not take if you have a history of severe arterial disease, such as a heart attack or angina.
  • Side Effects

    The side effects of Tibolone 2.5mg Tablet may include:

    • Nausea and vomiting.
    • Abdominal pain or discomfort.
    • Breast tenderness or enlargement.
    • Changes in menstrual bleeding patterns (including spotting or irregular periods).
    • Hot flashes or night sweats.
    • Mood changes, including depression or irritability.
    • Skin reactions such as rash, itching, or hives.
    • Increased risk of blood clots (deep vein thrombosis or pulmonary embolism).
  • Precautions & Warnings

    Following are the precautions and warnings for Tibolone 2.5mg Tablet:

    • Not recommended for individuals with a history of or current blood clots, stroke, or heart attack.
    • Patients with a history of liver disease or liver tumors should exercise caution and undergo regular liver function tests.
    • Women with undiagnosed abnormal genital bleeding should not use this medication until the cause is determined.
    • Smoking increases the risk of blood clots, especially in women over 35; smoking cessation is advised.
    • May cause dizziness; patients should be cautious when driving or operating machinery.
    • Not recommended for individuals with a history of hormone-dependent cancers, such as breast or endometrial cancer.
    • Women with a history of migraine headaches may experience more frequent or severe migraines while taking this medication.
  • Drug Interactions

    Following are the drug interactions for Tibolone 2.5mg Tablet:

    • Concomitant use with enzyme-inducing drugs, such as rifampin, carbamazepine, or phenytoin, may reduce tibolone’s effectiveness by increasing its metabolism.
    • Use with anticoagulants, such as warfarin, may enhance their effects, increasing the risk of bleeding.
    • Concomitant use with other hormone replacement therapies (HRT) may lead to hormonal imbalances and an increased risk of side effects.
    • CYP3A4 inhibitors, such as ketoconazole or erythromycin, may increase tibolone levels in the blood, potentially leading to a higher risk of adverse effects.
    • Use with tamoxifen or aromatase inhibitors may reduce the effectiveness of these medications in hormone-sensitive conditions like breast cancer.
    • Herbal supplements like St. John’s Wort may reduce tibolone’s effectiveness by increasing its metabolism.
  • Food Interactions

    Following are the food interactions for Tibolone 2.5mg Tablet:

    • Consumption of grapefruit and grapefruit juice should be avoided as they can interfere with the metabolism of Tibolone, leading to increased drug levels in the body and potentially causing adverse effects.
    • Alcohol intake should be minimized or avoided as it may enhance the sedative effects of Tibolone, increasing the risk of dizziness and drowsiness.
    • High-fat meals can delay the absorption of Tibolone, resulting in a potential decrease in its effectiveness.
    • Caffeine-rich foods and beverages may interact with Tibolone, affecting its metabolism and potentially altering its effects.
    • Dairy products containing calcium may reduce the absorption of Tibolone, so it is advisable to separate the medication and dairy intake by a few hours.
    • Certain leafy green vegetables like spinach and kale, rich in vitamin K, might interfere with the action of Tibolone, particularly in individuals taking it for hormone replacement.
    • Spicy foods can sometimes exacerbate gastrointestinal side effects, such as heartburn or stomach discomfort, when taking Tibolone.
    • Avoid excessive salt intake, as Tibolone may impact sodium levels, and high salt consumption could lead to fluid retention and related issues.
  • Storage/Disposal

    Tibolone 2.5mg Tablets should be stored in a secure and dry location, preferably in a medicine cabinet or a designated storage area, away from direct sunlight, moisture, and heat sources. Keep the tablets in their original packaging or container, ensuring the lid is tightly sealed to maintain their integrity. It is crucial not to store them in the bathroom or kitchen, as these areas can expose the medication to temperature fluctuations and humidity. Regularly check the expiration date, and if the tablets are expired or no longer needed, proper disposal is essential. Avoid flushing them down the toilet or sink; instead, consult your pharmacist or local waste management guidelines for safe disposal methods. Always keep medications out of children's reach to prevent accidental consumption.

  • Quick Tips, if any

    Following are the quick tips for Tibolone 2.5mg Tablet:

    • Consult your doctor before taking this medication, especially if you have a history of blood clots, liver disease, or uterine/breast cancer.
    • Ensure you understand the benefits and risks associated with this medicine.
    • Take the tablet at the same time each day to maintain consistent levels.
    • It can be taken with or without food, but a consistent routine is recommended.
    • Avoid smoking and alcohol consumption while using this medication.
    • Regularly monitor your health and report any unusual symptoms to your doctor.
    • Store the tablets at room temperature, away from moisture and heat.

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