BIJUVE

What is BIJUVE?

BIJUVE is a combined Hormone Replacement Therapy (HRT) containing two types of female hormones: an oestrogen (estradiol) and a progestogen (progesterone). It comes as soft gelatin capsules for oral administration and is specifically formulated for postmenopausal women who have experienced at least 12 months since their last natural menstrual period.

Mechanism of Action

BIJUVE works through a dual-action mechanism:

• Hormone replacement: Supplements declining oestrogen and progesterone levels during menopause
• Symptom relief: Alleviates vasomotor symptoms (hot flushes, night sweats)
• Endometrial protection: Progesterone component protects against uterine lining thickening

Imagine your hormonal system as a complex thermostat - BIJUVE helps recalibrate this system to restore hormonal balance when natural levels decline during menopause.

What is BIJUVE Used For?

BIJUVE is indicated for relief of symptoms occurring after menopause as an adjunct to lifestyle measures.

Approved Patient Groups

Before Using BIJUVE

Essential considerations before initiating treatment:

Medical History Assessment

• Breast cancer history (personal or family)
• Thromboembolic disorders history
• Liver disease or abnormal liver function
• Cardiovascular disease
• Endometrial hyperplasia or cancer

Required Baseline Tests

1. Blood pressure measurement
2. Clinical breast examination
3. Assessment of menopausal status
4. Review of personal/family cancer history
5. Thrombosis risk evaluation

BIJUVE Contraindications

Absolute contraindications where BIJUVE must not be used:

Absolute Contraindications

• Known or suspected pregnancy
• Breast cancer or history of breast cancer
• Known or suspected oestrogen-dependent malignant tumours
• Undiagnosed vaginal bleeding
• Untreated endometrial hyperplasia
• Active or history of venous thromboembolism
• Active or recent arterial thromboembolic disease
• Acute or chronic liver disease
• Porphyria
• Hypersensitivity to ingredients

Special Warnings

Special Population Considerations

Elderly Patients (≥65 years)

• Limited data on use in women over 65
• Increased risk of dementia when initiated after age 65
• Generally not recommended for initiation in this age group

Renal Impairment

• Mild-moderate impairment: No dose adjustment
• Severe impairment: Use with caution (potential fluid retention)

Hepatic Impairment

• Contraindicated in acute or chronic liver disease
• Impaired liver function increases hormone levels

BIJUVE and Other Medicines

Significant interactions requiring monitoring:

High-Risk Combinations

• Enzyme-inducing drugs: May reduce BIJUVE effectiveness
  • Antiepileptics: phenobarbital, phenytoin, carbamazepine
  • Antituberculosis: rifampicin, rifabutin
  • HIV medications: nevirapine, efavirenz
  • St John's Wort (herbal remedy)
• Drugs that increase hormone levels:
  • Some antifungal agents (ketoconazole)
  • Certain antibiotics
  • Grapefruit juice

Timing Recommendations

If taking enzyme-inducing medications:

• Discuss timing with your doctor
• Increased monitoring may be needed
• Dose adjustment may be required

Pregnancy & Breastfeeding

Pregnancy

• Contraindicated during pregnancy
• Discontinue immediately if pregnancy occurs
• Not a contraceptive - additional contraception may be needed

Breastfeeding

• Contraindicated during breastfeeding
• Hormones pass into breast milk
• Discuss alternatives with your doctor

Driving & Machine Operation

• May cause dizziness, drowsiness, or fatigue
• Especially common when starting treatment or after dose changes
• Do not drive or operate machinery if experiencing these symptoms
• Be cautious until you know how BIJUVE affects you

BIJUVE Ingredients

Active Substances

• Estradiol (as estradiol hemihydrate) 1mg
• Progesterone 100mg

Excipients

How to Use BIJUVE

Preparation Steps

1. Remove capsule from blister pack just before taking
2. Take with a glass of water during a meal or shortly after eating
3. Swallow capsule whole - do not chew, crush, or dissolve
4. Continue daily administration without breaks between packs

Administration Technique

• Timing: Take at approximately the same time each day
• With food: Always take with food for better absorption
• Continuity: Continue daily without breaks (continuous combined regimen)
• If difficulty swallowing: Capsule can be taken with yogurt or applesauce

Treatment Duration Protocol

1. Use the lowest effective dose
2. Use for the shortest duration necessary
3. Annual reassessment required
4. Regular breast screening as recommended

BIJUVE Dosage Guidelines

Standard Administration Schedule

Dose Adjustment Criteria

• Only one strength available (1mg/100mg)
• No titration schedule needed - standard dose from start
• If switching from other HRT: Follow doctor's instructions
• If symptoms not controlled: Consult doctor - do not increase dose

Administration Instructions

Step-by-step administration guide:

Daily Routine

1. Take capsule at same time each day (helps maintain stable levels)
2. Always take with food (enhances progesterone absorption)
3. Swallow whole with water (do not chew or crush)
4. Continue daily without breaks between packs

Special Situations

• Difficulty swallowing: Take with yogurt or applesauce
• With other medications: Take oral medications 1 hour before BIJUVE if possible
• Grapefruit juice: Avoid (may affect metabolism)
• Alcohol: Moderate consumption acceptable, but may worsen hot flushes

Missed Dose Management

General Principles

• Do NOT take double dose to make up for missed dose
• Missing doses may increase likelihood of breakthrough bleeding

Time-Based Guidance

Prevention Tips

• Set daily reminder on phone
• Use pill organizer
• Take at same time as another daily activity (e.g., breakfast)

Overdose Information

Symptoms

• Nausea and vomiting
• Drowsiness and dizziness
• Fatigue
• Withdrawal bleeding

Management

1. Seek immediate medical attention
2. Contact Poison Control Centre or go to nearest hospital
3. Take medicine pack with you to show medical staff
4. No specific antidote - treatment is symptomatic and supportive

Prevention

• Always take exactly as prescribed
• Use pill organizer if needed
• Keep out of reach of children

Possible Side Effects

Very Common (more than 1 in 10 people)

• Breast tenderness/pain

Common (1 in 10 to 1 in 100 people)

• Headache, dizziness
• Mood changes
• Fatigue
• Abdominal pain, indigestion
• Back/pelvic pain
• Weight gain
• Acne, dry skin
• Nausea
• Vaginal discharge
• Breakthrough bleeding/spotting (especially first 3-6 months)

Serious Side Effects

Reporting Side Effects: If you experience any side effects, report them via the UK Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

How to Store BIJUVE

Storage Conditions

• Store in original blister pack inside outer carton
• Protect from light and moisture
• Store at room temperature (15-25°C)
• Keep out of sight and reach of children

Expiry and Disposal

• Do not use after expiry date printed on carton
• Do not use if capsules show visible signs of deterioration
• Dispose of unused medicine via pharmacy
• Do not flush or throw in household waste

Expiry Date

Refers to last day of month shown on packaging.

Pack Information

Pack Sizes

• Blister packs of 28 capsules (1 month supply)
• Blister packs of 84 capsules (3 month supply)

Appearance

• Oval, opaque soft capsules
• Light pink on one side, dark pink on other side
• Imprinted '1C1' in white ink
• Clear, soft gelatin capsule shell

Manufacturing Details

• Marketing Authorisation Holder: Theramex Ireland Limited, Dublin, Ireland
• Manufacturer: Millmount Healthcare Ltd, County Meath, Ireland
• For detailed information on estradiol with progesterone formulations, see BNF medicinal forms.

Where Can I Buy BIJUVE Online in the UK