Diane 35 Tablet (21 Tab)

DIANE 35 TABLET (21 TAB) by BAYER ZYDUS PHARMA PVT. LTD.

Diane 35 Tablet is a hormonal medication combining an anti-androgen and an estrogen, primarily used for managing androgen-related conditions in women of reproductive age. It also functions as a hormonal contraceptive.

Composition

Each coated tablet contains:

• Cyproterone Acetate: 2 mg
• Ethinylestradiol: 0.035 mg (35 mcg) The tablets also contain excipients like lactose monohydrate and sucrose.

Uses

Diane 35 Tablet is prescribed for:

• Treatment of moderate to severe acne related to androgen-sensitivity, with or without seborrhoea, when other treatments (topical therapy or systemic antibiotics) have failed.
• Management of excessive growth of facial or body hair (hirsutism) of a mild to moderate degree, where no underlying cause has been found.
• Symptoms of Polycystic Ovary Syndrome (PCOS), such as irregular periods, excessive hair growth, and acne.
• It also serves as an effective hormonal contraceptive, and should not be used in combination with other hormonal contraceptives.

Dosage and Administration

One tablet is to be taken daily for 21 consecutive days, preferably at about the same time each day with some liquid. This is followed by a 7-day tablet-free interval, during which a withdrawal bleed usually occurs. Each subsequent pack is started after this 7-day break. For new users or those switching from other contraceptives, specific instructions apply, often requiring additional barrier contraception for the initial days. Treatment for acne or hirsutism may require several months for noticeable improvement.

Side Effects

Common side effects include:

• Nausea, vomiting, and stomach pain/cramps.
• Headache.
• Weight gain or changes.
• Breast pain, tenderness, or swelling.
• Mood changes and irritability.
• Irregular vaginal bleeding (spotting or breakthrough bleeding), especially in the first few months.

Serious side effects, though rare, can include:

• Increased risk of blood clots (venous thromboembolism or VTE), especially during the first year of use or after restarting.
• Increased risk of breast cancer and cervical cancer.
• Increased risk of meningioma (a type of brain tumour) with higher doses of cyproterone acetate.
• High blood pressure.

Precautions

• Contraindications: Do not use if pregnant or suspected pregnancy, during lactation, or if you have a history of blood clots, severe liver disease, severe hypertension, severe dyslipoproteinaemia, known or suspected sex-steroid influenced malignancies, or undiagnosed vaginal bleeding.
• Smoking: Smoking significantly increases the risk of serious cardiovascular side effects, especially in women over 35. It is strongly advised to stop smoking.
• Other Hormonal Contraceptives: Do not use in combination with other hormonal contraceptives.
• Drug Interactions: Inform your doctor about all other medications you are taking, including antiviral medicines for Hepatitis C, as they can interact.
• Monitoring: Regular check-ups with your doctor are recommended to assess the need for continued treatment and monitor for potential side effects.
• Missed Tablets: If a tablet is missed by more than 12 hours, contraceptive protection may be reduced, and additional barrier methods may be needed.
• Surgery and Immobilization: Discontinue use at least four weeks before major surgery or periods of prolonged immobilization to reduce the risk of blood clots.
• Diabetes: Women with diabetes should be carefully monitored.

Storage

Store tablets in their blister pack in a cool, dry place where the temperature stays below 25°C or 30°C, protected from light and moisture. Keep out of reach of children and pets.

1. What is Diane 35 Tablet used for?

Diane 35 Tablet is a combination of two hormonal medicines, cyproterone and ethinyl estradiol. It is primarily used to treat symptoms of polycystic ovary syndrome (PCOS) in women of reproductive age, such as moderate to severe acne (when topical or antibiotic treatments have failed), excessive hair growth (hirsutism), and irregular periods. It also functions as a hormonal contraceptive, so no other hormonal birth control should be used concurrently.

2. How does Diane 35 Tablet work?

Diane 35 Tablet works by combining cyproterone acetate and ethinyl estradiol. Cyproterone acts as an anti-androgen, blocking the overproduction of male hormones (androgens) in the ovaries, which are responsible for symptoms like acne and unwanted hair growth. Ethinyl estradiol, a synthetic estrogen, enhances the effect of cyproterone by reducing androgen levels in the blood and helps regulate the menstrual cycle. This combination also prevents pregnancy by delaying or stopping ovulation, thickening cervical mucus, and thinning the uterine lining.

3. What is the usual dosage of Diane 35 Tablet?

Diane 35 Tablet is typically taken daily for 21 consecutive days, followed by a 7-day tablet-free interval, during which withdrawal bleeding usually occurs. Each tablet should be taken at about the same time each day with some liquid. It's crucial to take it regularly to achieve both therapeutic efficacy and contraceptive protection.

4. What are the possible side effects of Diane 35 Tablet?

Common side effects can include nausea, stomach pain, headache, weight gain, mood changes, and breast pain or tenderness. Other possible side effects include vomiting, bloating, spotting between periods, and changes in appetite. More serious, but rare, risks include blood clots (venous thromboembolism), which can be fatal. If you experience signs of blood clots (like unexplained swelling and pain in limbs, shortness of breath, chest pain, or vision changes), stop taking the tablet and consult your doctor immediately.

5. Is Diane 35 Tablet safe during pregnancy or breastfeeding?

Diane 35 Tablet is not indicated and is considered unsafe during pregnancy. If pregnancy occurs during treatment, further intake must be stopped. It is also contraindicated during breastfeeding, as cyproterone acetate and ethinyl estradiol can pass into breast milk and potentially affect the newborn.

6. Can Diane 35 Tablet be taken with other medications?

Interactions can occur with drugs that induce microsomal enzymes, such as phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and products containing St. John's wort, which can reduce the efficacy of Diane 35 Tablet and lead to breakthrough bleeding or contraceptive failure. Co-administration with direct-acting antiviral (DAA) medicines containing ombitasvir, paritaprevir, or dasabuvir is contraindicated due to the risk of increased ALT levels. Estrogen/progestogen combinations like Diane 35 Tablet may also affect the metabolism of other drugs, increasing or decreasing their plasma concentrations (e.g., cyclosporin, lamotrigine). It should not be used in combination with other hormonal contraceptives.

7. What precautions should be taken with Diane 35 Tablet?

Before starting Diane 35 Tablet, a complete medical history and physical examination should be conducted. Precautions include avoiding use if you are obese, over 50, smoke, on prolonged bed rest, or have a history of blood clots, as these increase the risk of serious adverse effects like heart attack or stroke. Women with a tendency to chloasma (skin discoloration) should avoid sun exposure and UV radiation while taking this medicine. Diabetic women should be carefully monitored, as Diane 35 Tablet may affect glucose tolerance.

8. What happens if a dose of Diane 35 Tablet is missed?

If you miss a dose but remember within 12 hours of the usual time, take the tablet as soon as you remember and continue with the next tablet at your usual time; contraceptive protection should not be reduced. If you are more than 12 hours late, contraceptive protection may be reduced. In this case, take the last missed tablet as soon as you remember (even if it means taking two tablets at once) and continue as usual. Additionally, a barrier method of contraception (like a condom) should be used for the next 7 days. If intercourse occurred in the preceding 7 days, consider the possibility of pregnancy.

9. How should Diane 35 Tablet be stored?

Diane 35 Tablet should be stored in a cool and dry place, at temperatures not exceeding 30°C (or below 25°C in some regions), and protected from light. Keep the tablets in their original blister pack until it's time to take them and out of sight and reach of children.