Femodene Tablets

What is Femodene?

Femodene is a combined oral contraceptive (COC) pill, belonging to the pharmacological class of hormonal contraceptives. It contains two active synthetic hormones:

• Gestodene (75 micrograms): A third-generation progestogen.
• Ethinylestradiol (30 micrograms): An oestrogen.

Mechanism of Action

Femodene works through a combined action of its two hormones to prevent pregnancy in three primary ways:

1. Inhibition of Ovulation: The primary mechanism. The hormones suppress the release of gonadotropin-releasing hormone (GnRH) from the hypothalamus, which in turn prevents the pituitary gland from releasing follicle-stimulating hormone (FSH) and luteinising hormone (LH). Without the LH surge, the ovary does not release an egg (ovulate).
2. Thickening of Cervical Mucus: The progestogen (gestodene) causes the mucus in the cervix (the entrance to the womb) to become thicker and stickier. This forms a barrier that is difficult for sperm to penetrate, preventing them from reaching and fertilising an egg.
3. Thinning of the Endometrium: The hormones alter the lining of the womb (endometrium), making it less receptive to a fertilised egg, thereby preventing implantation.

What is Femodene Used For?

Approved Indication:
Femodene is indicated for contraception (prevention of pregnancy) in women of reproductive age.

Target Patient Population:
Women seeking a reliable, reversible form of hormonal contraception who have no contraindications to combined hormonal contraceptives. It may be particularly suitable for those who benefit from its additional non-contraceptive benefits.

Before Using Femodene

A thorough medical assessment is essential before starting any combined contraceptive pill. Your clinician will:

• Take a full personal and family medical history, focusing on risk factors for blood clots, cardiovascular disease, and cancer.
• Measure your blood pressure.
• Exclude the possibility of an existing pregnancy.
• Consider the need for examinations like a breast check or cervical smear based on your age and medical history.

Required Baseline Considerations: Assess personal risk factors from sections 2.1, 2.2, and 2.3 of the official PIL.

Femodene Contraindications

Absolute Contraindications (Do NOT use):

• Present or past history of venous or arterial thrombosis (e.g., DVT, PE, heart attack, stroke).
• Known hereditary or acquired predisposition to thrombosis (e.g., Factor V Leiden, protein deficiencies, antiphospholipid antibodies).
• Major surgery with prolonged immobilisation (stop at least 4 weeks prior).
• Migraine with aura (now or in the past).
• Present or past breast cancer or other oestrogen-dependent cancers.
• Present or past severe liver disease, liver tumours, or abnormal liver function.
• Untreated severe hypertension.
• Diabetes with vascular complications.
• Pancreatitis with severe hypertriglyceridaemia.
• Pregnancy or suspected pregnancy.
• Hypersensitivity to any ingredient.

Relative Contraindications/Risk Factors Requiring Careful Assessment:

• Obesity (BMI ≥30 kg/m²).
• Smoking, especially aged over 35.
• Controlled hypertension.
• Migraine without aura (new onset or worsening).
• Family history of thrombosis, heart attack, or stroke at young age.
• Conditions like SLE, Crohn's disease, ulcerative colitis, sickle cell disease, HUS, porphyria.
• Current or history of severe depression.

Special Population Considerations

Elderly: Not applicable, as contraception is not intended for post-menopausal women.

Adolescents: Femodene can be used after menarche (first period). No specific dose adjustment.

Renal Impairment: No specific studies, but no known additional risks. Caution in diseases affecting renal circulation (e.g., HUS).

Hepatic Impairment: Contraindicated in acute or severe liver disease. Discontinue if jaundice develops.

Femodene and Other Medicines

Some medicines can reduce the effectiveness of Femodene or be affected by it. Always inform any doctor or pharmacist that you are taking Femodene.

Medicines that may reduce Femodene's efficacy (require additional contraception):

• Enzyme-inducing drugs: Certain anti-epileptics (e.g., phenytoin, carbamazepine, topiramate), barbiturates, rifampicin, griseofulvin, St. John's Wort.
• Some HIV/HCV medicines: Protease inhibitors, NNRTIs.
• Broad-spectrum antibiotics (e.g., rifampicin, rifabutin – others like amoxicillin are debated; use caution).

Femodene may affect levels of other medicines: e.g., ciclosporin, lamotrigine, theophylline. Your doctor may need to adjust doses.

Pregnancy & Breastfeeding

Pregnancy: NOT SUITABLE. Femodene is contraindicated during pregnancy. If you become pregnant, stop taking Femodene immediately and consult your doctor.

Breastfeeding: Not generally recommended. Combined hormones can pass into breast milk and may reduce milk production. Progestogen-only pills (mini-pills) are usually preferred while breastfeeding. Consult your doctor.

Contraception Requirement: Femodene itself is a contraceptive. No additional method is needed if taken correctly, except when interacting medicines are used (see section 6).

Driving & Machinery Operation

Femodene has no known influence on the ability to drive or operate machinery. However, if you experience side effects such as dizziness, migraine, or visual disturbances, you should not drive or use machines until you feel well.

Femodene Ingredients

Active Ingredients (per tablet):

• Gestodene: 75 micrograms
• Ethinylestradiol: 30 micrograms

Excipients (Inactive Ingredients):

• Lactose (milk sugar) – Allergen warning for those with lactose intolerance.
• Sucrose – Consideration for those with rare hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
• Maize starch, povidone, magnesium stearate (E572), sodium calcium edetate, macrogol 6000, calcium carbonate (E170), talc, montan glycol wax.

Sodium content: Less than 1 mmol (23 mg) per tablet, essentially 'sodium-free'.

How to Use Femodene

Femodene must be taken correctly to ensure maximum contraceptive efficacy.

1. Dosage Regimen: One white tablet taken orally at the same time each day for 21 consecutive days.
2. Pill-Free Interval: After 21 days, stop taking pills for 7 days. During these 7 days, a withdrawal bleed (like a period) usually occurs.
3. Next Strip: Start the next strip of 21 pills on the 8th day, even if the withdrawal bleed has not finished.

This creates a 28-day cycle (21 days on + 7 days off).

Femodene Dosage Guidelines & 12. Administration Instructions

Standard Dosage: One tablet daily, as per the 21/7 regimen. There is no titration or strength variation.

Step-by-Step Administration:

1. Choose a convenient time of day (e.g., with breakfast or at bedtime).
2. Start your first pack: Take the first pill from the blister marked with the correct day of the week.
3. Follow the direction of the arrows on the strip. Take one pill each day.
4. Swallow the tablet whole with water. Do not chew.
5. After the last pill of the strip, have 7 pill-free days.
6. Start your next new strip on the 8th day after finishing the previous one.

Missed Dose Management

What to do depends on how many pills are missed and when.

• One pill, less than 12 hours late: Take it immediately, then next pill at usual time. Protection is maintained.
• One pill, more than 12 hours late, OR more than one pill missed:
  1. Take the most recent missed pill now (even if two at once).
  2. Continue taking pills daily at the usual time.
  3. Use extra contraception (e.g., condoms) for the next 7 days.
  4. If missed pills were in Week 1 (pills 1-7) and you had unprotected sex in that week, consider emergency contraception.
  5. If you finish the strip within these 7 days, start the next strip the next day without a pill-free break.

If no withdrawal bleed occurs in the pill-free week after missing pills, perform a pregnancy test before starting a new pack.

Overdose Information

Serious effects from taking several pills at once are unlikely. Possible symptoms may include nausea, vomiting, and vaginal bleeding in young girls. There is no specific antidote. Treat symptomatically. Contact a doctor or poison control centre for advice if a large overdose is taken.

Femodene Side Effects

Like all medicines, Femodene can cause side effects. The most serious risk is of blood clots (VTE/ATE). Frequency categories from the official PIL:

Common (≥1/100 to <1/10):

• Nausea, abdominal pain
• Headache, migraine
• Breast pain, tenderness, enlargement
• Mood swings, depression
• Weight increase

Uncommon (≥1/1,000 to <1/100):

• Vomiting, diarrhoea
• Fluid retention
• Libido decreased
• Rash, urticaria

Rare (≥1/10,000 to <1/1,000):

• Contact lens intolerance
• Libido increased
• Vaginal discharge
• Chloasma (skin discolouration)

Serious Side Effects – Seek IMMEDIATE medical help:

• Signs of blood clots: See PIL section 2.3.
• Signs of severe allergic reaction/angioedema: Swelling of face/tongue/throat, difficulty breathing/swallowing, hives.
• Signs of breast cancer: New lumps, skin dimpling, nipple changes.
• Signs of severe liver problems: Severe upper abdominal pain, jaundice (yellow skin/eyes).
• Signs of cervical cancer: Unusual vaginal bleeding/discharge, pelvic pain.

Reporting: You can report suspected side effects via the Yellow Card Scheme at yellowcard.mhra.gov.uk.

How to Store Femodene

• Keep out of sight and reach of children.
• Do not use after the expiry date printed on the strip/carton.
• Store below 25°C. Protect from light.
• Do not dispose of medicines via wastewater or household waste. Return unused tablets to your pharmacy for safe disposal.

Femodene Pack Information

• Pack Sizes Available: Strips of 21 tablets. Packs containing 1, 3, or 6 strips.
• Marketing Authorisation Holder: Bayer plc, 400 South Oak Way, Reading, RG2 6AD, UK.
• Manufacturer: Bayer AG, Berlin, Germany or Bayer Weimar GmbH & Co KG, Weimar, Germany.
• Legal Category: POM (Prescription Only Medicine).
• PL Number: 00010/0323 (check specific pack).

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