Ginette Side Effects

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Answer side-effect and tolerability questions around ginette, including expected changes, warning signs and safe escalation guidance.

What is Ginette?

Ginette contains the active ingredient Ethinylestradiol, cyproterone acetate.

• Active ingredient — Ethinylestradiol, cyproterone acetate
• Registration number — 33/21.8.2/0185
• Registration holder — Cipla Medpro (Pty) Ltd

It is approved for:

• Oral contraception in women who require anti-androgen therapy (Blocks the effects of the hormone testosterone in the body)
• Control of abnormal hair growth of unknown cause, on the body and face of women
• Treatment of severe acne that is accompanied by excessive discharge, inflammation or formation of nodes (pimples)

Interactions and medicines to check

The approved leaflet names these interactions.

• Antiretroviral medicines used to treat HIV/AIDS such as ritonavir, nelfinavir and nevirapine
• Anticonvulsants (medicines used to treat epilepsy) such as barbiturates (including phenobarbitone), primidone, phenytoin, carbamazepine, oxycarbazepine and topiramate
• Antibiotics/antifungals such as griseofulvin, rifampicin, aminopenicillins (e.g., ampicillin, amoxicillin) and tetracyclines
• Herbal medicines such as St John’s wort (Hypericum perforatum)
• The use of a large supplement of vitamin C may affect the effects of GINETTE and if vitamin C is stopped breakthrough bleeding may occur
• GINETTE may reduce the effectiveness of anticoagulants (blood thinners), anti- depressants, anti-diabetics, anti-hypertensives, beta-blockers and diuretics (water tablets) and increase concentrations of medicines such as ciclosporin and theophylline
• Some laboratory tests may be changed, especially hormone tests, blood thickening, thyroid function, glucose tolerance, liver function and serum triglyceride tests

Who should take extra care

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• If you are hypersensitive (allergic) to cyproterone acetate, ethinylestradiol or any of the other ingredients of GINETTE (listed in section 6)
• If you are pregnant or suspected of being pregnant
• If you are lactating
• If you have undergone a procedure to remove a hydatiform mole (abnormal fertilized egg) until the gonadotropin (hormone) levels in the blood and urine have returned to normal)
• If you have known or suspected cancer
• If you are using another hormonal contraceptive
• If you have liver disease
• If you have a history of arterial or venous blood clotting disorders
• If you have severe chronic depression
• If you have depression, which is not well controlled with treatment
• If you have had depression with previous use of hormonal contraceptives
• If you have sickle cell anaemia
• If you have an oestrogen dependent cancer, functional ovarian cysts, Dubin- Johnson or Rotor syndromes
• If you have disorders of lipid (fat) metabolism, poor liver function, cerebrovascular insufficiency, coronary artery disease, thrombophlebitis (inflammation of veins associated with blood clots)
• If you have deteriorating otosclerosis (calcification of the labyrinth of the inner ear)
• If you have a history pruritus (itching) during previous pregnancy
• If you have undiagnosed vaginal bleeding
• If you have herpes, repeated cholestatic jaundice or porphyria
• If you suffer with classical migraines

Use with care, and tell your doctor, if

• If you smoke as there is an increased risk of a heart attack
• If you suffer from any of the following conditions you should notify your doctor:
• Diabetes mellitus with mild vascular disease or mild kidney, eye or nerve disease
• High blood pressure that is adequately controlled
• Porphyria
• Clinical depression
• Obesity
• Migraine
• Cardiovascular (heart) disease
• Chloasma (formation of large brown patches on the skin)
• Tell your doctor before using GINETTE:
• That you are on treatment for depression
• That you have had depression with previous use of hormonal contraceptives
• That you have a substance abuse problem
• You have underlying psychiatric disorder such as post-traumatic disorder or bipolar disorder
• That you have a family history of mental disorders
• That you have a history of physical or sexual abuse Depressed mood and depression are well-known undesirable effects of hormonal contraceptive use. Depression can be serious and is a well- known risk factor for suicidal behaviour and suicide. Women should be advised to contact their medical practitioner in case of mood changes and depressive symptoms, including shortly after initiating the treatment
• When taking medicines like GINETTE the risk of heart and circulatory diseases are higher. Stroke and blood clots are more likely in woman aged over 35, especially if they have been using contraceptives for more than 5 years or are cigarette smokers. It is also more common in women who are overweight or have high blood pressure
• The incidence of heart disease is also higher in women who suffer from diabetes and high cholesterol. Blood clots may be more common in women with Type A, B or AB blood groups
• The risk of blood clot sis increased when using GINETTE
• The risk for heart attacks and mini strokes are increased when using GINETTE
• If you experience symptoms such as severe chest pain, sudden breathlessness or coughing, any headache that is severe, unusual or present for a long time, double vision or sudden partial or total loss of vision, inability to use of understand language, slurred speech, fainting without seizure, weakness or sudden numbness affecting one side of your body and disturbance of movement, you should contact your doctor immediately
• The risk for blood clots increases with age, smoking, family history of blood clots, being overweight, high blood pressure, migraines, irregular heartbeat and extended period of immobility, which includes major surgery
• Tell your doctor if you have these conditions as they have been associated with negative circulatory events:
• Diabetes mellitus
• Systemic lupus erythematosus
• Haemolytic uraemic syndrome
• Chronic inflammatory bowel disease (e.g., Crohn’s disease or ulcerative colitis)
• Sickle cell anaemia
• The risk for breast, cervical and liver cancer is increased when using GINETTE
• Certain conditions like hyperlipidaemias (increased quantity of fat in the blood) and high blood pressure may worsen while taking GINETTE
• Tell your doctor if any of the following occurs while taking GINETTE:
• Jaundice (yellowing of the skin or white part of the eye as a result of liver disease)
• Gallstones
• Systemic lupus erythematosus
• Herpes gestationis
• Otosclerosis-related hearing loss
• Sickle cell anaemia
• Kidney disease
• Swelling of the deeper layers of the skin
• Epilepsy
• If chloasma occurs (brown patches on the skin), avoid ultraviolet radiation and exposure to the sun while taking GINETTE
• If you experience menstrual changes. Either a reduction of menstrual flow (this is normal), missed menstruation (You may be pregnant) or intermenstrual bleeding (If it continues after 3 cycles consult your doctor
• Do not stop taking GINETTE without having discussed an alternative contraception with your doctor
• GINETTE contains lactose. Patients with rare hereditary conditions of lactose intolerance should not take GINETTE

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine
• GINETTE is contraindicated during pregnancy
• If you become pregnant while on treatment with GINETTE, treatment must be stopped and you should contact your doctor
• GINETTE should not be taken if you are breastfeeding your child as it leads to a reduction in the volume of milk produced and small amounts of the medicine are excreted in the milk which may affect your child, particularly in the first 6 weeks after giving birth
• GINETTE should not be taken until your child has been weaned off breast milk

Common side effects of Ginette

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Frequent side effects

• Depressed mood or altered mood
• Headache
• Nausea
• Abdominal pain
• Weight increase

Less frequent side effects

• Vaginal candidiasis (fungal infection of the vagina)
• Anaemia
• Increased or decreased libido (sex drive)
• Migraine
• Dizziness
• Intolerance to contact lenses has been reported and vision may deteriorate in myopic patients (short-sighted patients)
• Vomiting
• Diarrhoea
• Bloating
• Gastrointestinal irritation
• Chloasma (brown patches on the skin), skin pigmentation and skin reactions
• Alteration in hair pattern
• Changes in menstrual flow (spotting, breakthrough bleeding, absence of menstrual bleeding) and intermenstrual bleeding
• Weight decrease

Bleeding, cycle and hormonal changes

Changes to bleeding and to the menstrual cycle are among the most commonly reported experiences with hormonal contraception, and they are one of the main reasons people stop a method. Knowing what pattern to expect with Ginette makes it easier to tell an expected change from one worth checking.

Bleeding patterns can include lighter or shorter periods, irregular spotting between periods, or periods stopping altogether. Which of these is expected depends on the method, and on how long it has been used.

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

What happens after stopping or changing the method?

What happens after stopping or changing Ginette depends on the method. Some methods stop working as soon as they are removed or discontinued; others take longer to clear. This matters both for side effects and for whether you are still protected against pregnancy.

Contraceptive cover

If you are changing method, there is often a window where you need additional protection. Getting that timing right is the single most important part of switching — ask a pharmacist, nurse or doctor to confirm it for your specific change rather than working it out from a general description.

Side effects and cycle after stopping

Side effects linked to a hormonal method usually ease once the hormone clears, though the time this takes varies by method. Cycles may take several months to settle into their own pattern, and that pattern may not be the same as before the method was started.

When to contact a healthcare professional urgently

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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