Lizinna Tablets

What is Lizinna?

Lizinna is a combined hormonal contraceptive pill containing two synthetic female sex hormones: norgestimate (250μg) and ethinylestradiol (35μg). It belongs to the drug class of combined oral contraceptives (COCs).

Mechanism of Action

Lizinna works through three primary mechanisms:

1. Ovulation suppression: The hormones prevent the release of eggs from the ovaries
2. Cervical mucus thickening: Makes the cervical mucus thicker, creating a barrier that sperm cannot easily penetrate
3. Endometrial changes: Alters the lining of the womb to make it less receptive to a fertilised egg

Think of Lizinna as a multi-layered defence system against pregnancy. Like a security system with multiple alarms, it prevents egg release (the first line), blocks sperm entry (the second line), and creates an unfavourable environment for implantation (the third line).

Biological Pathway

The synthetic hormones in Lizinna mimic natural oestrogen and progesterone. They act on the hypothalamus and pituitary gland in the brain to suppress the release of follicle-stimulating hormone (FSH) and luteinising hormone (LH). Without the LH surge that normally triggers ovulation, the ovaries don't release mature eggs. This hormonal feedback system is similar to how a thermostat regulates temperature - when synthetic hormones are detected, the body's natural hormone production is "turned down".

What is Lizinna Used For?

Lizinna is prescribed for:

• Contraception: Prevention of pregnancy in women of reproductive age
• Menstrual regulation: Making periods more regular, lighter and less painful
• Pre-menstrual symptom management: May help with symptoms like bloating, mood swings and breast tenderness

Target Patient Population

Lizinna is suitable for most healthy women of reproductive age who:

• Seek reliable, reversible contraception
• Have no contraindications to combined hormonal contraceptives
• Are non-smokers under 35 (or willing to stop smoking if over 35)
• Have normal blood pressure
• Have no personal or strong family history of blood clots

Before Using Lizinna

Before starting Lizinna, a comprehensive medical assessment is required:

Medical History Assessment Checklist

• Personal history of blood clots, heart attack, or stroke
• Family history of thrombosis or clotting disorders
• Current or past cancers (especially breast, liver, or cervical)
• Migraine history (particularly migraine with aura)
• Liver or gallbladder disease
• High blood pressure
• Diabetes (especially with vascular complications)
• Smoking status and age
• Body Mass Index (BMI) calculation
• Current medications and supplements

Required Baseline Tests

1. Blood pressure measurement - must be normal or controlled
2. Weight and BMI calculation - caution if BMI >30kg/m²
3. Breast examination - if clinically indicated or concerns
4. Cervical smear test - should be up-to-date
5. Pregnancy test - if there's any possibility of pregnancy

Pre-treatment Evaluations

Your clinician will assess your suitability based on:

• Thrombotic risk assessment: Evaluating personal and family history
• Cardiovascular risk factors: Age, smoking, blood pressure, lipids
• Liver function considerations: History of liver disease or elevated enzymes
• Drug interaction review: Current medications that may affect efficacy

Lizinna Contraindications

Absolute Contraindications (MUST NOT TAKE)

• Current or history of venous thromboembolism (DVT, PE)
• Current or history of arterial thromboembolism (stroke, MI)
• Known thrombophilic disorders (Factor V Leiden, protein deficiencies)
• Major surgery with prolonged immobilisation
• Migraine with aura (current or history)
• Current or past breast cancer
• Current or severe liver disease, liver tumours
• Uncontrolled hypertension (>160/100 mmHg)
• Diabetes with vascular complications
• Pregnancy or suspected pregnancy
• Hypersensitivity to any ingredients

Relative Contraindications (Use with Extreme Caution)

• Age ≥35 years with smoking
• BMI ≥30 kg/m²
• Controlled hypertension
• Diabetes without complications
• Migraine without aura
• Family history of thrombosis in first-degree relative <50 years
• Immobilisation (long flights, leg casts)
• Postpartum <21 days

Special Population Considerations

Elderly Patients

Combined contraceptives are generally contraindicated in women over 35 who smoke due to significantly increased cardiovascular risk. For non-smokers over 35, individual risk assessment is required.

Renal Impairment

No dosage adjustment needed for mild to moderate renal impairment. Severe renal impairment or acute renal failure requires careful monitoring.

Hepatic Impairment

Contraindicated in acute or severe liver disease. Mild hepatic impairment requires careful monitoring of liver function.

Paediatric/Adolescent

Can be used from menarche (first period). No specific paediatric dosing - same as adults. Ensure proper education on adherence.

Genetic Populations

Women with known hereditary angioedema may experience exacerbation of symptoms. Those with hereditary thrombophilias have absolute contraindication.

Lizinna and Other Medicines

Medications that REDUCE Lizinna Efficacy

• Enzyme inducers:
  • Antiepileptics: carbamazepine, phenytoin, topiramate, primidone
  • Antibiotics: rifampicin, rifabutin
  • Antiretrovirals: efavirenz, nevirapine
  • Herbal: St. John's Wort
• Other: bosentan, modafinil, griseofulvin

Medications AFFECTED by Lizinna

• Increased levels: ciclosporin, prednisolone, selegiline
• Decreased levels: lamotrigine (reduced seizure control)
• Altered metabolism: theophylline, tizanidine

High-Risk Combinations

Timing Recommendations

When taking short-term enzyme inducers (e.g., antibiotics):

1. Use additional barrier contraception during treatment
2. Continue additional contraception for 7 days after stopping the interacting drug
3. If these 7 days run into the pill-free interval, start next pack without break

Pregnancy & Breastfeeding

Pregnancy

Category X: Lizinna is contraindicated in pregnancy. If pregnancy occurs while taking Lizinna, stop immediately. No increased risk of birth defects from inadvertent use, but contraceptive benefits no longer apply.

Breastfeeding

Not recommended during first 6 weeks postpartum due to increased thrombosis risk. After 6 weeks, can be considered but may reduce milk supply. Progestogen-only pills are preferred for breastfeeding women.

Contraception Requirements

Women of childbearing potential must use effective contraception while taking Lizinna. No additional contraception needed if taken correctly. If enzyme-inducing drugs are used, additional barrier contraception required.

Driving & Machine Operation

Lizinna has no known effect on driving ability or machine operation. However, be aware that:

• Migraine or severe headache (possible side effect) may impair ability
• Dizziness (uncommon side effect) could affect coordination
• Visual disturbances (rare side effect) may impact driving safety

If you experience any symptoms that could impair your alertness, do not drive or operate machinery until symptoms resolve.

Lizinna Ingredients

Active Ingredients (per tablet)

• Norgestimate: 250 micrograms (progestogen)
• Ethinylestradiol: 35 micrograms (oestrogen)

Excipients (Inactive Ingredients)

• Lactose anhydrous & monohydrate: Fillers/binders
• Povidone K-25: Binder
• dl-a-tocopherol: Antioxidant
• Microcrystalline cellulose: Binder/filler
• Croscarmellose sodium: Disintegrant
• Starch Pregelatinised: Binder
• Magnesium stearate: Lubricant
• Indigo carmine aluminium lake (E132): Colourant

Allergen Warnings

• Contains lactose: Not suitable for lactose intolerance
• Contains colourant E132: Rarely may cause allergic reactions
• Sodium content: Essentially sodium-free (<1mmol per tablet)

How to Use Lizinna

Standard 21/7 Regimen

1. Take one tablet daily at approximately the same time
2. Continue for 21 consecutive days
3. Follow with 7 pill-free days
4. Start next pack on day 8 regardless of bleeding

Starting Instructions

Lizinna Dosage Guidelines

Lizinna comes in one strength only: 250μg norgestimate / 35μg ethinylestradiol.

Standard Dosage

• One tablet daily for 21 days
• Followed by 7 tablet-free days
• Cycle repeats continuously

No Titration Required

Unlike some medications, Lizinna does not require dose titration. The standard dose is appropriate for all indicated patients.

Missed Dose Protocol

See Section 13 for detailed missed dose management based on timing and number of missed pills.

Administration Instructions

Step-by-Step Administration

1. Choose consistent time: Select a convenient time (e.g., with breakfast or before bed)
2. Check pack orientation: Ensure you're following arrow direction on strip
3. Remove tablet: Push through foil from blister side
4. Swallow whole: Take with water if needed. Do not chew or crush
5. Record intake: Consider using pill reminder app or calendar

Tips for Adherence

• Link pill-taking to daily routine (e.g., brushing teeth)
• Set phone alarm or use pill reminder app
• Keep pack in visible location (e.g., bedside table)
• Always carry spare pack when travelling

Vomiting/Diarrhoea Protocol

1. If vomit within 2 hours of taking pill: take replacement from spare pack
2. If vomiting/diarrhoea continues >24 hours: follow missed pill rules
3. If gastrointestinal upset persists: consult doctor for alternative contraception

Missed Dose Management

Time-Based Guidance

• Less than 24 hours late: Take ASAP, next dose at usual time
• More than 24 hours late: Follow 2+ missed pills protocol
• Starting pack >1 day late: Use additional contraception for 7 days

Overdose Information

Symptoms of Overdose

• Nausea and vomiting
• Vaginal bleeding/spotting
• Breast tenderness
• Dizziness
• Fatigue

Management Protocol

1. No specific antidote exists for combined contraceptive overdose
2. Symptomatic treatment: Anti-emetics for nausea, rest for dizziness
3. Medical attention: Seek advice if large quantity ingested or severe symptoms
4. Monitoring: No specific laboratory monitoring required

Important Notes

• Overdose in children requires immediate medical attention
• Serious toxicity unlikely with accidental extra dose
• Keep out of reach of children - packaging not child-resistant

Lizinna Side Effects

Frequency-Based Categorisation

Very Common (≥1 in 10)

• Headache
• Nausea, vomiting, diarrhoea
• Breakthrough bleeding/spotting (first few months)
• Painful or unusual periods

Common (≥1 in 100 to <1 in 10)

• Migraine (or worsening)
• Depression, mood changes, nervousness
• Insomnia, dizziness
• Acne, rash
• Breast pain, tenderness
• Weight gain
• Vaginal infections, discharge
• Abdominal bloating, constipation

Uncommon (≥1 in 1000 to <1 in 100)

• Breast enlargement, nipple discharge
• Anxiety, tingling sensations
• Changes in skin pigmentation
• Alopecia or excessive hair growth
• Changes in libido
• Vaginal dryness
• Ovarian cysts

Rare (≥1 in 10,000 to <1 in 1000)

• Pancreatitis (severe abdominal/back pain)
• Gallbladder disease
• Hypertension exacerbation
• Liver tumours (very rare with long-term use)

Frequency Not Known

• Reduced breast milk production
• Contact lens intolerance
• Changes in blood lipid levels
• Angioedema (in predisposed individuals)

Managing Common Side Effects

Breakthrough bleeding: Usually settles in 2-3 cycles. If persists >3 months, consult doctor.

Nausea: Take pill with food or at bedtime. Usually improves after first pack.

Headache: Ensure adequate hydration. Consider pain relief if needed. If severe or migraine with aura, stop pill immediately.

How to Store Lizinna

Storage Conditions

• Temperature: Store below 25°C
• Container: Keep in original blister pack
• Protection: Protect from light and moisture
• Location: Keep out of sight and reach of children

Expiry Information

• Do not use after expiry date on pack
• Expiry refers to last day of month shown
• Return expired medication to pharmacy

Disposal Protocol

1. Do not dispose via wastewater or household waste
2. Return unused/expired tablets to pharmacy
3. Pharmacies provide safe disposal services
4. Proper disposal protects the environment

Lizinna Pack Information

Available Pack Sizes

• 21 tablets: 1 month supply (1 strip)
• 63 tablets: 3 month supply (3 strips)
• 126 tablets: 6 month supply (6 strips)

Tablet Description

• Colour: Blue
• Shape: Round, flat with bevelled edges
• Markings: "146" debossed on one side
• Diameter: 6.4mm
• Coating: Uncoated

Manufacturing Information

• Marketing Authorisation Holder: Morningside Healthcare Limited, Leicester, UK
• Manufacturer: Morningside Pharmaceuticals Ltd, Loughborough, UK
• Product Licence Number: PL 16180/0018
• Last Leaflet Revision: January 2023

Where Can I Buy Lizinna Online in the UK