Femodette Tablets

What is Femodette?

Femodette is a combined oral contraceptive pill containing two synthetic female hormones: gestodene (a progestogen) and ethinylestradiol (an oestrogen). It belongs to the pharmacological class of combined hormonal contraceptives (CHCs).

Mechanism of Action

Femodette prevents pregnancy through three primary mechanisms:

1. Ovulation suppression: Inhibits the release of eggs from the ovaries
2. Cervical mucus thickening: Creates a barrier that sperm cannot easily penetrate
3. Endometrial changes: Prevents thickening of the uterine lining, making implantation less likely

Biological Pathway: The synthetic hormones mimic natural progesterone and estrogen, providing negative feedback to the hypothalamus and pituitary gland. This suppresses gonadotropin-releasing hormone (GnRH), follicle-stimulating hormone (FSH), and luteinizing hormone (LH), preventing the mid-cycle LH surge necessary for ovulation.

For detailed pharmacological information, refer to the official Femodette Summary of Product Characteristics.

What is Femodette Used For?

Femodette is indicated for:

• Contraception: Prevention of pregnancy in women of reproductive age
• Menstrual regulation: May help regulate menstrual cycles, reduce bleeding, and alleviate dysmenorrhea

Target Patient Populations

Before Using Femodette

Medical History Assessment Checklist

Before prescribing Femodette, clinicians assess:

• Personal or family history of blood clots (venous thromboembolism)
• Cardiovascular conditions (hypertension, heart disease)
• Migraine history (particularly with aura)
• Liver disorders or jaundice history
• Breast cancer or other hormone-sensitive cancers
• Diabetes with vascular complications
• Obesity (BMI calculation)
• Smoking status
• Current medications and supplements

Required Baseline Tests

• Blood pressure measurement (essential)
• BMI calculation
• Pregnancy exclusion if indicated
• Liver function tests if clinically indicated
• Cervical screening up-to-date status

Femodette Contraindications

Absolute Contraindications

• Current or history of venous thromboembolism (DVT, PE)
• Arterial thromboembolism (stroke, myocardial infarction)
• Known thrombophilia disorders
• Migraine with aura (current or history)
• Current or past breast cancer
• Severe liver disease or liver tumors
• Undiagnosed vaginal bleeding
• Pregnancy or suspected pregnancy
• Hypersensitivity to any ingredient

Relative Contraindications (Require Risk-Benefit Assessment)

Special Population Considerations

Elderly Patients

• Not indicated for postmenopausal women
• Risk of blood clots increases with age, particularly over 35 years

Adolescents

• May be prescribed after menarche with careful risk assessment
• Requires parental consent if under 16 (Gillick competence considered)

Renal Impairment

• No dose adjustment needed for mild-moderate impairment
• Use with caution in severe renal impairment

Hepatic Impairment

• Contraindicated in acute or severe liver disease
• Mild impairment requires careful monitoring

Femodette and Other Medicines

Significant interactions requiring monitoring:

High-Risk Interactions

• Enzyme-inducing medications: Carbamazepine, phenytoin, rifampicin, St. John's Wort - reduce contraceptive efficacy
• HIV/hepatitis C protease inhibitors: Ombitasvir/paritaprevir/ritonavir, dasabuvir - contraindicated
• Antibiotics: Rifampicin, rifabutin - significant interaction
• Anticoagulants: May alter warfarin effects

Timing Recommendations

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

1. Use additional barrier contraception during treatment
2. Continue barrier method for 7 days after stopping interacting medication
3. Consider extended hormone intake (skip pill-free interval) if on long-term enzyme inducers

Check the Drug Monitoring Database for comprehensive interaction information.

Pregnancy & Breastfeeding

Breastfeeding

• Not recommended during breastfeeding
• Small amounts of hormones pass into breast milk
• Alternative progestogen-only contraceptives preferred if breastfeeding

Contraception Requirements

• No additional contraception required if Femodette taken correctly
• Efficacy reduced with vomiting/diarrhoea or interacting medications

Driving & Machine Operation

No known effects on driving ability or machine operation. However, if experiencing:

• Migraine with visual disturbances
• Dizziness or lightheadedness
• Severe headache

Avoid driving or operating machinery until symptoms resolve and medical advice obtained.

Femodette Ingredients

Active Ingredients per Tablet

• Gestodene: 75 micrograms (progestogen)
• Ethinylestradiol: 20 micrograms (oestrogen)

Excipients (Inactive Ingredients)

Allergen Warnings

• Contains lactose and sucrose
• Not suitable for patients with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, or hereditary fructose intolerance

How to Use Femodette

Step-by-Step Administration

1. Choose consistent time: Take at same time daily
2. Swallow whole: With water if needed. Do not chew
3. Follow strip arrows: Take in direction indicated
4. 21 active days: Take one tablet daily for 21 consecutive days
5. 7 pill-free days: No tablets for next 7 days
6. Start new strip: Begin next strip after 7 pill-free days

First-Time Users

Femodette Dosage Guidelines

Standard Dosage

• One tablet daily for 21 consecutive days
• Followed by 7 tablet-free days
• Withdrawal bleed typically occurs during pill-free days

Titration Schedule

No titration required. Fixed-dose combination.

Special Administration Considerations

• Vomiting/diarrhoea: If within 4 hours of taking pill, consider as missed dose
• Extended cycle: Can be used to delay periods by omitting pill-free interval
• Surgery: Discontinue 4 weeks before elective surgery requiring immobilization

Administration Instructions

Detailed technique:

Detailed Technique

1. Check strip to ensure correct orientation (arrows indicate direction)
2. Press tablet through blister foil
3. Place tablet in mouth
4. Swallow with water (do not chew or crush)
5. Take at consistent time each day (e.g., with breakfast or before bed)

Missed Pill Scenarios

Missed Dose Management

Pill missed in Week 1 (Days 1-7):

1. Take most recent missed pill as soon as remembered
2. Take next pill at usual time (may mean two pills in one day)
3. Use additional contraception (condoms) for next 7 days
4. If had unprotected sex in previous 7 days, consider emergency contraception

Pill missed in Week 2 or 3 (Days 8-21):

1. Take missed pill immediately
2. Continue taking remaining pills at usual time
3. No additional contraception needed (if pills taken correctly for 7 days before missed pill)
4. Start next strip on time after 7 pill-free days

If vomiting/diarrhoea occurs:

If within 4 hours of taking pill, follow missed pill instructions above.

Overdose Information

Symptoms

• Nausea and vomiting
• Vaginal bleeding (even in pre-menarchal girls)
• No serious acute toxicity expected

Management

1. No specific antidote available
2. Symptomatic treatment if needed
3. Medical attention not usually required for single extra dose
4. Contact healthcare provider if large quantity ingested or symptoms severe

Possible Side Effects

Frequency-Based Categorisation

Very Common (>1/10)

• Headache
• Nausea
• Breast pain/tenderness
• Mood changes

Common (1/10 to 1/100)

• Weight changes
• Acne
• Libido changes
• Spotting/breakthrough bleeding (especially first 3 months)

Uncommon (1/100 to 1/1,000)

• Vomiting
• Fluid retention
• Contact lens intolerance
• Migraine

Rare (1/1,000 to 1/10,000)

• Blood clots (increased risk vs non-users)
• Hypertension
• Gallbladder disease
• Liver tumors (benign)

Blood Clot Risk Comparison

Source: Femodette PIL, February 2023

For complete side effect information, refer to the official Patient Information Leaflet.

How to Store Femodette

Storage Conditions

• Temperature: Below 25°C
• Light: Protect from direct light
• Moisture: Keep in original blister pack until use
• Children: Store out of sight and reach

Expiry

• Do not use after expiry date printed on strip

Disposal

• Do not flush or throw in household waste
• Return unused medication to pharmacy for safe disposal

Pack Information

Available Pack Sizes

• 1 x 21 tablet strip
• 3 x 21 tablet strips
• 6 x 21 tablet strips

Manufacturer Details

• Marketing Authorisation Holder: Bayer plc, 400 South Oak Way, Reading, RG2 6AD, UK
• Manufacturer: Bayer AG, Mullerstrasse 178, 13353 Berlin, Germany

Product Licence Number

• PL 00010/0322

Where Can I Buy Femodette Online in the UK