GESTOP 28 Tab.

Gestop 28 Tablet (Ethinylestradiol 0.03mg + Gestodene 0.075mg)

Manufacturer: Incepta Pharmaceuticals Ltd.
Generic Name: Ethinylestradiol 0.03mg + Gestodene 0.075mg
Therapeutic Class: Combined Oral Contraceptive Pill (COCP) / Hormonal Contraceptive
Pack: 28 tablets per blister strip (21 active + 7 placebo)
Price: ৳133.00 per 28-tablet pack

Indications

Gestop 28 is indicated for oral contraception (prevention of pregnancy) in women of reproductive age. It provides reliable hormonal contraception when taken correctly and consistently. It may also be used for the management of dysmenorrhoea (painful periods) and menstrual cycle regulation when prescribed by a physician.

Composition

Each active tablet contains:

• Ethinylestradiol 30 mcg (0.03mg)
• Gestodene 75 mcg (0.075mg)

The 28-day pack contains 21 active hormone tablets followed by 7 inert (placebo) tablets to maintain the habit of daily pill-taking.

Mechanism of Action

Gestop 28 acts through three complementary mechanisms:

• Ovulation suppression: Ethinylestradiol (synthetic oestrogen) and gestodene (a third-generation progestogen) suppress the hypothalamic-pituitary-ovarian axis, inhibiting the mid-cycle LH and FSH surges required for ovulation.
• Cervical mucus thickening: Gestodene thickens cervical mucus, impeding sperm penetration.
• Endometrial atrophy: The combination renders the endometrium less receptive to implantation.

When taken correctly, the Pearl Index for combined oral contraceptives is approximately 0.1–0.9 per 100 woman-years, making it one of the most effective reversible contraceptive methods.

Dosage and Administration

One tablet daily for 28 consecutive days, taken at the same time each day, preferably in the evening or at bedtime to minimise nausea.

Days 1–21: Active hormone tablets (yellow/coloured tablets).

Days 22–28: Inert placebo tablets (white tablets) — a withdrawal bleed typically occurs during this week.

Starting the first pack:

• Day 1 start: Begin on Day 1 of the menstrual cycle — immediate contraceptive protection.
• Day 5 start: Begin by Day 5 of the cycle — use additional contraception (barrier method) for the first 7 days.

Missed pill: If a pill is missed by <12 hours, take it immediately; no additional contraception needed. If >12 hours late (especially in the first or third week), take the last missed pill and use barrier contraception for the next 7 days. See the package insert for detailed missed-pill guidance.

Contraindications

• Active or history of arterial thrombosis (myocardial infarction, stroke) or venous thromboembolism (DVT, pulmonary embolism)
• Migraine with aura (focal neurological symptoms)
• Diabetes mellitus with vascular complications
• Severe or multiple risk factors for cardiovascular disease (smoking age >35, hypertension, dyslipidaemia)
• Known or suspected oestrogen-dependent malignancies (breast cancer, endometrial cancer)
• Undiagnosed abnormal vaginal bleeding
• Severe hepatic disease or hepatic tumours
• Pregnancy or suspected pregnancy
• Hypersensitivity to ethinylestradiol, gestodene, or any excipient

Warnings and Precautions

• Venous Thromboembolism (VTE): Third-generation progestogens (including gestodene) are associated with a marginally higher risk of VTE compared to levonorgestrel-containing pills. Absolute risk remains low (9–12 per 10,000 women-years vs. 5–7 for non-users). Discontinue immediately if symptoms of thrombosis occur (leg pain/swelling, sudden chest pain, breathlessness, or neurological symptoms).
• Blood Pressure: Monitor blood pressure periodically. Discontinue if sustained hypertension develops.
• Smoking: Strongly advise women not to smoke — smoking significantly increases cardiovascular risk, especially in women aged >35.
• Breast Cancer: Slight increase in risk during use and for up to 10 years after stopping; discuss with women with a family history of breast cancer.
• Cervical Cancer: Long-term use (≥5 years) associated with a slight increase in cervical cancer risk; regular cervical smear screening is recommended.
• Liver disease: Discontinue if jaundice, hepatitis, or significant liver function abnormalities develop.
• Efficacy: May be reduced by hepatic enzyme-inducing drugs or severe GI illness (vomiting/diarrhoea).

Side Effects

Common (≥1/100 to <1/10): Nausea, headache, breast tenderness/enlargement, breakthrough bleeding or spotting (especially in the first 3 months), mood changes, reduced libido, weight change.

Uncommon: Fluid retention, contact lens intolerance (due to changes in corneal curvature), depression, vaginal discharge.

Rare but serious: VTE, arterial thromboembolism, hypertension, liver disorders, cholelithiasis, erythema nodosum.

Drug Interactions

• Hepatic enzyme inducers (rifampicin, phenytoin, carbamazepine, barbiturates, St. John's Wort): Reduce contraceptive efficacy — use additional barrier contraception during co-administration and for 4 weeks after stopping the inducer.
• Some antibiotics (particularly rifampicin): Reduce contraceptive efficacy.
• Antiretrovirals (ritonavir, lopinavir): May significantly alter hormone levels.
• Cyclosporin, theophylline: COCP may increase plasma levels of these drugs.

Use in Pregnancy and Lactation

Pregnancy: Absolutely contraindicated. If pregnancy is discovered during use, discontinue immediately. Accidental exposure in early pregnancy does not appear to cause foetal abnormalities, but the drug is not indicated in pregnancy.

Lactation: Not recommended during breastfeeding — combined oral contraceptives reduce milk production and small amounts of hormones are excreted in breast milk. A progestogen-only pill is preferred post-partum for breastfeeding women.

Storage

Store below 25°C in a dry place, protected from light and moisture. Keep out of reach of children. Do not use after the expiry date printed on the pack.

Pricing

Gestop 28 Tablet (21 active + 7 placebo): ৳133.00 per 28-tablet pack

Disclaimer: This product information is for reference purposes only and does not substitute professional medical advice, diagnosis, or treatment. Always consult a registered physician or qualified healthcare professional before taking any medication.