Trisequens Tablets

What is Trisequens?

Trisequens is a sequential combined hormone replacement therapy (HRT) prescribed for postmenopausal women. It contains two active ingredients: estradiol (a natural oestrogen identical to that produced by the ovaries) and norethisterone acetate (a synthetic progestagen). The treatment comes in a calendar pack of 28 film-coated tablets designed to be taken daily without interruption.

Mechanism of Action

During menopause, the body's natural oestrogen production declines significantly. Trisequens supplements these hormone levels:

• Estradiol component: Directly replaces declining natural oestrogen, alleviating symptoms like hot flushes and preventing bone loss
• Norethisterone acetate (progestagen): Added to protect the lining of the womb (endometrium) from overgrowth, which can occur with oestrogen-only therapy and increase cancer risk

Estradiol binds to oestrogen receptors throughout the body, particularly in the brain (affecting temperature regulation), bones (maintaining density), and vaginal tissues. The progestagen component modifies the endometrial response to oestrogen, inducing a regular monthly shedding (withdrawal bleed) that mimics a natural menstrual cycle and prevents abnormal cell growth.

What is Trisequens Used For?

Trisequens is licensed for two primary purposes in postmenopausal women who still have their uterus:

1. Relief of menopausal symptoms: Specifically moderate to severe symptoms like hot flushes, night sweats, vaginal dryness, and sleep disturbances (prescribed only when symptoms significantly impact daily life)
2. Prevention of postmenopausal osteoporosis: To reduce bone loss and fracture risk in women at increased risk, when other osteoporosis treatments are not suitable

Before Using Trisequens

Before starting or restarting Trisequens, a comprehensive medical assessment is required:

Medical History Checklist

Your doctor will ask about:

• Personal or family history of breast cancer, endometrial cancer, or other hormone-sensitive cancers
• History of blood clots (deep vein thrombosis, pulmonary embolism) or clotting disorders
• Cardiovascular disease (heart attack, stroke, angina)
• Liver disease or abnormal liver function tests
• Migraines with or without aura
• Uterine conditions (fibroids, endometriosis, endometrial hyperplasia)
• High blood pressure, diabetes, gallbladder disease

Required Baseline Tests

• Physical examination: Including breast examination
• Blood pressure measurement
• Mammogram: As per national screening guidelines
• Liver function tests: If liver disease suspected

Trisequens Contraindications

Absolute Contraindications (Do NOT use):

• Known, suspected, or history of breast cancer
• Known or suspected oestrogen-dependent cancers
• Untreated endometrial hyperplasia
• Unexplained vaginal bleeding
• Active or history of venous thromboembolism
• Active or recent arterial thromboembolic disease
• Severe liver disease
• Porphyria
• Hypersensitivity to ingredients
• Pregnancy or breastfeeding

Relative Contraindications (Use with caution):

Special Population Considerations

Elderly Patients (over 65 years):

• Limited experience in this age group
• Increased risk of stroke, blood clots, and dementia with HRT initiation after age 65
• Generally not recommended to start HRT after this age unless for severe symptoms

Renal Impairment:

• No dosage adjustment needed
• Caution in severe renal impairment due to potential fluid retention

Hepatic Impairment:

• Contraindicated in acute or severe liver disease
• Use with caution in mild-moderate impairment with regular liver function monitoring

Trisequens and Other Medicines

Medicines that REDUCE Trisequens effectiveness:

• Enzyme-inducing antiepileptics: Phenobarbital, phenytoin, carbamazepine
• Antibiotics: Rifampicin, rifabutin
• HIV medications: Nevirapine, efavirenz, ritonavir
• Herbal remedies: St John's Wort

Medicines affected BY Trisequens:

• Lamotrigine: May increase seizure frequency
• Cyclosporine: May require dose monitoring

Always inform your doctor/pharmacist about ALL medicines you take, including prescriptions, over-the-counter products, and herbal supplements.

Pregnancy & Breastfeeding

Pregnancy:

• If you become pregnant while taking Trisequens, stop immediately
• The medication is not a contraceptive
• Women under 50 or within 12 months of their last period may still be fertile

Breastfeeding:

• Contraindicated
• Components may pass into breast milk and affect the infant

Driving & Machine Operation

• Trisequens has no known effect on the ability to drive or operate machinery
• If you experience dizziness, migraine, visual disturbances, or drowsiness (possible side effects), avoid driving or operating machinery until symptoms resolve
• Report these symptoms to your doctor

Trisequens Ingredients

Active Ingredients:

• Estradiol hemihydrate: 2mg (blue & white tablets) or 1mg (red tablets)
• Norethisterone acetate: 1mg (white tablets only)

Excipients (Inactive Ingredients):

Sodium Content:

• Less than 1 mmol sodium (23 mg) per tablet
• Essentially 'sodium-free'

How to Use Trisequens

Preparation Steps

1. Start on any convenient day if not switching from another HRT
2. If switching, follow your doctor's instructions
3. Take one tablet at approximately the same time each day with water

Calendar Pack Sequence

• Days 1-12: Take one blue tablet daily (estradiol 2mg)
• Days 13-22: Take one white tablet daily (estradiol 2mg + norethisterone acetate 1mg)
• Days 23-28: Take one red tablet daily (estradiol 1mg)

Post-Treatment Protocol

1. After finishing the pack, start a new pack immediately without a break
2. A withdrawal bleed (period-like bleeding) usually occurs during the red tablet days or when starting a new pack

Trisequens Dosage Guidelines

Standard Dosage Schedule

Treatment Duration

• Use the lowest effective dose for the shortest duration
• Re-evaluate need annually with your doctor
• If symptoms aren't relieved after 3 months, consult your doctor

Administration Instructions

General Guidelines

• With or without food: Can be taken with or without food
• Timing: Take at approximately the same time each day
• If swallowing difficulty: Tablets should be swallowed whole with water

Surgery Protocol

• Inform surgeons you are taking HRT
• May need to stop 4-6 weeks before major surgery to reduce blood clot risk
• Discuss with your doctor

Missed Dose Management

General Principles

• Do NOT take a double dose
• May increase likelihood of breakthrough bleeding or spotting

Time-Based Guidance

Overdose Information

Symptoms

• Nausea, vomiting
• Breast tenderness
• Abnormal vaginal bleeding

Management

1. Contact a doctor or pharmacist immediately
2. No specific antidote exists
3. Symptomatic treatment as needed
4. Consider stomach emptying if within 1 hour of ingestion (medical supervision only)

Emergency:

In case of severe symptoms, call 999 or go to A&E.

Trisequens Side Effects

Serious Side Effects (Stop taking and seek IMMEDIATE medical help):

• Signs of blood clot: painful/swollen leg, sudden chest pain, shortness of breath, coughing blood
• Signs of stroke: sudden numbness/weakness, confusion, trouble speaking, vision problems
• Signs of allergic reaction/angioedema: swelling of face/tongue/throat, difficulty breathing, hives
• Yellowing of skin/eyes (jaundice) - possible liver problem
• Unexpected vaginal bleeding

Frequency-Based Side Effects:

Reporting:

Report any side effects to your doctor or via the Yellow Card Scheme.

How to Store Trisequens

Storage Conditions

• Temperature: Store below 25°C
• Light protection: Keep in outer carton
• Moisture: Keep the container tightly closed
• Do not refrigerate

Safety & Disposal

• Keep away from children and pets
• Do not use after expiry date
• Do not dispose via wastewater or household waste
• Return unused medicines to pharmacy for proper disposal

Pack Information

Pack Sizes

• 1 x 28 film-coated tablets (calendar pack)
• 3 x 28 film-coated tablets (3 calendar packs)

Tablet Identification

• Blue tablets: 6mm round, engraved "NOVO 280"
• White tablets: 6mm round, engraved "NOVO 281"
• Red tablets: 6mm round, engraved "NOVO 282"

Manufacturer Details

• Marketing Authorisation Holder: Novo Nordisk Limited, Gatwick, West Sussex, RH6 0PA, UK
• Manufacturer: Novo Nordisk A/S, DK-2880 Bagsværd, Denmark
• PIL last revised: April 2025

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