Ginette 35 Tablet

GINETTE 35 TABLET is a hormonal medication primarily used for the treatment of androgen-dependent conditions in women. It is manufactured by Cipla Health Ltd.

Name

• Common Name: Ginette 35 Tablet
• Brand Names: Ginet, Ginette, Cyproterone Acetate and Ethinylestradiol tablets

Composition

GINETTE 35 TABLET contains a combination of two active ingredients:

• Cyproterone Acetate: 2 mg
• Ethinylestradiol: 0.035 mg

Uses

GINETTE 35 TABLET is prescribed for various medical conditions, including:

• Androgen-dependent diseases: Treatment of moderate to severe acne, very oily skin, and excessive hair growth (hirsutism) in women of reproductive age. It is also used for androgenic alopecia (male pattern hair loss).
• Polycystic Ovary Syndrome (PCOS) management: Helps alleviate symptoms such as irregular periods, excessive hair growth, and acne associated with PCOS.
• Contraception: It also functions as an oral contraceptive, and patients using Ginette 35 should not use additional hormonal contraceptives.

Dosage and Administration

• Take one tablet daily for 21 days, followed by a 7-day tablet-free interval.
• It should be taken at the same time every day, with or without food.
• The first tablet of a course is typically taken on the first day of menstruation.
• Swallow the tablet whole; do not chew, crush, or break it.
• Adherence to the prescribed dose and duration is crucial.

Side Effects

Common side effects may include:

• Nausea, stomach pain
• Headache
• Weight gain
• Breast pain or tenderness
• Mood changes

Serious side effects, though less common, can include:

• Increased risk of blood clots (in legs, lungs, or other organs), stroke, or heart attack. Seek immediate medical attention if you experience symptoms like unexplained swelling/pain in limbs, shortness of breath, chest pain, vision changes, or a severe, unusual headache.

Precautions

• Contraindications: GINETTE 35 TABLET is unsafe during pregnancy and likely unsafe while breastfeeding. It should not be used by individuals with a history of blood clotting disorders, heart attack, stroke, breast cancer, severe liver disease or liver tumors, uncontrolled high blood pressure, undiagnosed vaginal bleeding, or allergies to its components.
• Warnings: Smoking increases the risk of serious cardiovascular events. Caution is advised with alcohol consumption. Inform your doctor if you have conditions like diabetes, high cholesterol, migraines, depression, or liver/kidney disease.
• Drug Interactions: It may interact with certain antiepileptic drugs, antifungals, antiretrovirals, and antibiotics. Etoricoxib can increase its levels, and Ginette 35 can affect the levels of cyclosporin and lamotrigine.
• Not recommended for children under 18 years of age.

Storage

Store GINETTE 35 TABLET below 30°C, in a cool, dry place, away from direct sunlight and moisture. Keep it out of sight and reach of children.

Here are the most frequently asked questions about GINETTE 35 TABLET:

What is GINETTE 35 TABLET used for?

GINETTE 35 TABLET is primarily used to treat androgen-dependent conditions in women of reproductive age, such as moderate to severe acne, very oily skin, and excessive hair growth (hirsutism). It is often prescribed for symptoms associated with Polycystic Ovary Syndrome (PCOS), including irregular periods. Due to its contraceptive properties, it also functions as an oral contraceptive. It should only be prescribed if other anti-acne treatments have not been effective.

How does GINETTE 35 TABLET work?

GINETTE 35 TABLET contains two hormonal medicines: cyproterone acetate and ethinylestradiol. Cyproterone acetate is an anti-androgen that works by blocking the effects of male hormones (androgens) in the body and reducing their overproduction in the ovaries. Ethinylestradiol, a synthetic estrogen, enhances the effect of cyproterone by further reducing androgen levels in the blood. Together, they help to regulate hormonal imbalances, reduce acne and unwanted hair growth, and normalize menstrual cycles. It also inhibits ovulation, thereby preventing conception.

What is the usual dosage for GINETTE 35 TABLET?

The usual dosage is one tablet daily for 21 consecutive days, followed by a 7-day tablet-free interval. It should be taken at the same time each day, with or without food, to maintain consistent medicine levels in your body.

What are the possible side effects of GINETTE 35 TABLET?

Common side effects include nausea, stomach pain, headache, weight gain, breast pain, and mood changes. More serious, though less common, risks include blood clots (thrombosis), heart attack, and stroke. If you experience severe or persistent side effects, or symptoms like unexplained swelling/pain in limbs, shortness of breath, chest pain, or vision changes, you should consult your doctor immediately.

Is GINETTE 35 TABLET safe during pregnancy or breastfeeding?

GINETTE 35 TABLET is considered highly unsafe and is contraindicated during pregnancy. If you become pregnant while taking this medicine, treatment must be stopped. It is also likely unsafe to use during breastfeeding as it can reduce milk volume and small amounts of the medicine may be excreted in breast milk, potentially affecting the baby.

Can GINETTE 35 TABLET be taken with other medications?

GINETTE 35 TABLET can interact with certain medications, which may reduce its effectiveness or alter how it works. These include some antiretroviral agents (e.g., ritonavir, nelfinavir), anticonvulsants (e.g., phenytoin, carbamazepine, phenobarbitone), and antibiotics (e.g., rifampicin, griseofulvin). It can also affect the metabolism of other drugs like cyclosporin. Always inform your doctor about all other medicines, supplements, or herbal remedies you are taking.

What precautions should be taken while using GINETTE 35 TABLET?

Do not use GINETTE 35 TABLET if you are already using another hormonal contraceptive, as this will expose you to excessive hormones. There is an increased risk of blood clots, especially if you are over 35 and smoke, are overweight, have high blood pressure, diabetes, or a history of blood clots. Inform your doctor if you have liver or kidney disease, a history of breast cancer, migraine, or depression. If you are scheduled for surgery, your doctor may advise you to stop taking GINETTE 35 TABLET several weeks beforehand to reduce the risk of blood clots. This medicine contains lactose.

What happens if a dose of GINETTE 35 TABLET is missed?

If you miss a tablet by less than 12 hours, take it as soon as you remember and continue with your regular schedule. If you are more than 12 hours late, skip the missed dose and continue with your usual dosing schedule. In this case, use an additional non-hormonal birth control method (like condoms) for the next 7 days to prevent pregnancy. If tablets are missed during the last 7 days of a pack, you should start the next pack immediately after finishing the current one, without a tablet-free break.

How should GINETTE 35 TABLET be stored?

GINETTE 35 TABLET should be stored in a cool, dry place at a temperature not exceeding 25°C or 30°C. Keep it away from direct sunlight and moisture, and ensure it is out of the sight and reach of children and pets.