Livial Tablets

What is Livial?

Livial is a hormone replacement therapy (HRT) containing the active substance tibolone. Unlike conventional HRT which contains actual oestrogen and progestogen hormones, Livial contains tibolone, which is converted by your body into metabolites that have oestrogenic, progestogenic, and weak androgenic effects on different tissues.

Mechanism of Action

Livial works through a unique mechanism where tibolone is metabolised in the body into three different compounds that selectively act on various tissues:

• In bone and brain tissue: Tibolone metabolites have oestrogenic effects that help prevent bone loss and reduce menopausal symptoms like hot flushes
• In vaginal tissue: Oestrogenic effects improve vaginal dryness and discomfort
• In the endometrium (womb lining): Progestogenic effects prevent excessive thickening, reducing the need for cyclical progestogen addition

This selective tissue activity means Livial can provide the benefits of combined HRT (oestrogen and progestogen) in a single tablet, without stimulating the womb lining to the same extent as conventional oestrogen-only HRT.

Biological Pathway Explanation

After oral administration, tibolone is rapidly absorbed and metabolised in the liver and intestines. It is converted into three main metabolites:

1. 3α-OH-tibolone and 3β-OH-tibolone: These metabolites have oestrogen-like effects and are primarily responsible for relieving menopausal symptoms and preventing bone loss
2. Δ4-tibolone: This metabolite has progestogenic and weak androgenic activity, which helps protect the endometrium

The balanced activity of these metabolites on different tissues gives Livial its unique therapeutic profile among HRT options.

What is Livial Used For?

Livial is prescribed for postmenopausal women who are at least 12 months past their last natural menstrual period. It has two main approved uses as per official prescribing information:

Approved Indications

Target Patient Populations

Livial is specifically designed for:

• Postmenopausal women: At least 12 months since last natural period
• Women with intact uterus: Livial provides endometrial protection without the need for additional progestogen
• Women seeking symptom relief: Particularly those experiencing hot flushes, night sweats, vaginal dryness, or mood changes
• Women at risk of osteoporosis: Where other preventive treatments are not suitable

Before Using Livial

Before starting Livial, a comprehensive medical assessment is necessary to ensure it is safe and appropriate for you.

Medical History Assessment Checklist

Your doctor will review the following aspects of your medical history:

• Personal history: Any previous cancers (especially breast, uterine, or ovarian), blood clots, heart disease, stroke, liver disease, or migraine with aura
• Family history: Breast cancer in close relatives (mother, sister, daughter), blood clotting disorders, or cardiovascular disease
• Reproductive history: Age at menopause, surgical history (hysterectomy, oophorectomy), current menstrual status
• Lifestyle factors: Smoking status, alcohol consumption, physical activity levels
• Current symptoms: Nature and severity of menopausal symptoms, impact on daily life

Required Baseline Tests

Before prescribing Livial, your doctor may recommend or perform:

• Blood pressure measurement: HRT can affect blood pressure
• Breast examination: Clinical breast exam to check for abnormalities
• Mammogram: If you're due for routine screening or if there are any concerns
• Liver function tests: If there's any history or suspicion of liver problems
• Lipid profile: To assess cardiovascular risk factors
• Bone density scan: If assessing osteoporosis risk or prevention

Livial Contraindications

Livial must not be used in certain conditions due to potentially serious risks.

Absolute Contraindications (DO NOT USE)

• Known or suspected breast cancer
• Known or suspected oestrogen-dependent cancers (e.g., endometrial cancer)
• Unexplained vaginal bleeding
• Untreated endometrial hyperplasia (excessive thickening of womb lining)
• Active or history of venous thromboembolism (blood clots in veins)
• Active or recent arterial thromboembolic disease (e.g., heart attack, stroke, angina)
• Acute liver disease or severe liver impairment
• Porphyria (a rare inherited blood disorder)
• Pregnancy or breastfeeding
• Hypersensitivity to tibolone or any excipients

Relative Contraindications (Use with Extreme Caution)

In these situations, Livial should only be used after careful risk-benefit assessment:

• History of or risk factors for blood clots
• History of or risk factors for stroke or heart disease
• Migraine with aura or severe headaches
• Liver disorders (including benign liver tumours)
• Severe hypertension (high blood pressure)
• Diabetes with vascular complications
• Gallbladder disease or history of gallstones
• Systemic lupus erythematosus (SLE)
• Epilepsy
• Hypertriglyceridemia (very high blood fats)

Special Population Considerations

Elderly Patients

Women over 60 years old require special consideration when using Livial:

• The risk of blood clots, stroke, and breast cancer increases with age
• Regular monitoring of blood pressure and breast health is essential
• The lowest effective dose should be used for the shortest duration necessary
• Starting HRT after age 65 is generally not recommended due to increased risk of dementia

Renal Impairment

No specific dosage adjustment is needed for patients with renal impairment, but caution is advised in those with conditions causing fluid retention (like severe kidney disease).

Hepatic Impairment

Livial is contraindicated in acute or severe liver disease. In mild to moderate liver impairment, use with caution and monitor liver function regularly.

Premature Menopause

Women with premature menopause (before age 40) may have different risk-benefit considerations. Limited data exists for this population - discuss with a specialist.

Pediatric/Adolescent Use

Livial is not indicated for use in children or adolescents. It is specifically for postmenopausal women only.

Livial and Other Medicines

Livial can interact with other medications, which may affect its effectiveness or increase side effects.

High-Risk Medication Combinations

Pregnancy & Breastfeeding

Pregnancy

Livial is contraindicated in pregnancy. There is no therapeutic use for Livial during pregnancy, and it may cause harm to the developing fetus. If you have not reached menopause and could become pregnant, you must use effective non-hormonal contraception while taking Livial.

Breastfeeding

Livial is contraindicated during breastfeeding. Tibolone and its metabolites may pass into breast milk and could affect the nursing infant. Livial should not be used until you have completely stopped breastfeeding.

Driving & Machine Operation

Livial has no known effect on the ability to drive or operate machinery. However, individual responses may vary.

Impairment Potential Assessment

• Livial itself does not cause drowsiness or impair coordination
• Some women may experience dizziness, especially when starting treatment or if blood pressure changes occur
• If you experience dizziness, headaches, or visual disturbances, do not drive or operate machinery until symptoms resolve

Livial Ingredients

Active Ingredient

• Tibolone: 2.5mg per tablet - the therapeutic component

Excipients (Inactive Ingredients)

• Potato starch: Binder that helps hold the tablet together
• Lactose monohydrate: Filler/bulking agent
• Ascorbyl palmitate: Antioxidant that prevents degradation
• Magnesium stearate: Lubricant that aids tablet manufacturing

Allergen Warnings

How to Use Livial

Livial should be taken exactly as prescribed by your doctor. According to NHS guidelines for continuous combined HRT, follow these step-by-step instructions for proper use.

Step-by-Step Administration

1. Check the tablet: Ensure you have the correct medication - Livial tablets are white, marked "Organon*" on one side and "MK2" on the other
2. Remove from packaging: Press the tablet through the foil blister pack
3. Take with liquid: Swallow the tablet whole with a glass of water or other drink. Do not chew or crush the tablet
4. Timing: Take Livial at the same time each day to maintain consistent hormone levels
5. Follow the calendar strip: The strips are marked with days of the week. Start with the current day and follow the arrows
6. Continuous use: Take one tablet daily without breaks between strips or packs

Livial Dosage Guidelines

Standard Dosage

The recommended dose of Livial is one 2.5mg tablet taken once daily. This is the only available strength.

Treatment Duration Principles

• Use the lowest effective dose for the shortest duration necessary
• Re-evaluate the need for continued treatment at least annually with your doctor
• Regularly assess whether benefits still outweigh risks as you continue treatment
• Consider gradual discontinuation if appropriate, rather than abrupt stopping

Administration Instructions

Daily Routine

1. Choose a convenient time of day that you can remember consistently (e.g., with breakfast or before bed)
2. Take Livial with or without food - food does not affect absorption
3. If you have difficulty swallowing tablets, take with a full glass of water
4. Do not chew, crush, or break the tablet - swallow it whole

Using the Calendar Pack

• Livial comes in calendar strips marked with days of the week
• Start by taking the tablet marked with the current day
• Follow the arrows on the strip until all tablets are taken
• Start a new strip immediately after finishing the previous one - do not leave gaps between packs
• The calendar helps you track whether you've taken your daily dose

Missed Dose Management

Time-Based Guidance

What NOT to Do

• Do NOT take two tablets to make up for a missed dose
• Do NOT take extra tablets if you're unsure whether you took your dose
• If you frequently forget doses, consider setting a daily reminder or using a pill organiser

Overdose Information

Symptoms of Overdose

Accidental overdose with Livial is unlikely to cause serious harm, but may result in:

• Nausea and vomiting
• Vaginal bleeding or spotting
• Breast discomfort or tenderness

Management Protocol

1. If you take too much Livial: Do not take any more tablets until your next scheduled dose
2. Symptomatic treatment: Treat any nausea or discomfort symptomatically
3. Medical attention: Contact your doctor or pharmacist for advice, especially if you experience significant vaginal bleeding
4. Emergency care: In case of severe symptoms, seek immediate medical attention or call 111 (UK non-emergency number)

Livial Side Effects

Like all medicines, Livial can cause side effects, although not everyone experiences them. Side effects are categorised by frequency.

Frequency-Based Categorisation

Common (may affect up to 1 in 10 women)

• Breast pain or tenderness
• Abdominal or pelvic pain
• Unusual hair growth (hirsutism)
• Vaginal bleeding or spotting (especially in first 3-6 months)
• Vaginal problems: discharge, itching, irritation, thrush
• Weight gain

Uncommon (may affect up to 1 in 100 women)

• Swollen hands, ankles or feet (fluid retention)
• Stomach upset, indigestion
• Acne or skin problems
• Painful nipples or breast discomfort
• Vaginal infections

Rare (may affect up to 1 in 1,000 women)

• Itchy skin (pruritus)
• Depression, mood changes
• Dizziness, headache
• Joint or muscle pain
• Visual disturbances
• Changes in liver function tests

How to Store Livial

Storage Conditions

• Temperature: Store below 25°C. Do not refrigerate or freeze
• Packaging: Keep in the original blister pack inside the outer carton to protect from light and moisture
• Location: Store in a dry place, away from direct heat and sunlight
• Safety: Keep out of sight and reach of children and pets

Expiry Date

• Do not use Livial after the expiry date printed on the carton (after 'EXP')
• The expiry date refers to the last day of that month
• Do not use if the packaging is damaged or shows signs of tampering

Livial Pack Information

What's in the Pack

• Tablets: White, round tablets marked "Organon*" on one side and "MK2" on the other
• Pack sizes: Available in packs containing 1 strip of 28 tablets or 3 strips of 28 tablets (84 tablets total)
• Packaging: Tablets are in blister strips arranged in a calendar format with days of the week
• Each pack contains: The tablets in blister strips, outer carton, and patient information leaflet

Marketing Authorisation Holder

Organon Pharma (UK) Limited
Shotton Lane, Cramlington
United Kingdom, NE23 3JU

Manufacturer

NV Organon
PO Box 20, 5340 BH Oss
Netherlands

Where Can I Buy Livial Online in the UK