Trigestrel Side Effects

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Answer the side-effect intent for trigestrel without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Trigestrel?

Trigestrel contains the active ingredient Levonorgestrel.

• Active ingredient — Levonorgestrel
• Registration number — A40/18.8/0743
• Registration holder — Mylan (Pty) Ltd

It is approved for:

• TRIGESTREL is used for prevention of pregnancy
• If you use it as instructed you are very unlikely to become pregnant
• Oral contraceptives are also used for control of painful menstrual bleeding, and / or to control abnormal uterine bleeding
• It also benefits those who want to use oral contraceptive and have coincidental acne

Common side effects of Trigestrel

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

• Nausea and/or vomiting, bloating, abdominal cramps
• Water retention
• Breast tenderness and menstrual irregularities such as spotting, breakthrough bleeding or complete stopping of menstrual bleeding
• Acne

Less frequent side effects

• High blood pressure
• Intolerance to contact lenses has been reported and vision may deteriorate in some patients
• Headache, weight gain
• Impaired liver function
• Reduced glucose tolerance and changes in lipid metabolism
• Increased risk of cervical cancer, breast cancer, and liver tumours
• Rapid, involuntary movements
• Depression and other mental changes
• Changes in libido, vaginal infections
• Spots or patches on the skin, and other skin or hair changes, skin rashes, increased facial hair. Post marketing reported side effects:
• Suicidal thoughts/behaviour and suicide

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.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• If you have depression, which is not well controlled with treatment
• If you have had depression with previous use of hormonal contraceptives. Before you take TRIGESTREL tell your doctor if you have any of these:
• If you have blood clots in any part of the body or ever had these before
• If you ever had a heart attack or heart related disease
• Cancer of the breast or womb or have ever had either of these conditions or have family history for either of these conditions
• If you have (or history of) tumours in uterus
• Abnormal bleeding from vagina
• If you are pregnant or think you are pregnant
• If you had liver related disease or liver tumours
• If you suffer from migraine or frequent severe headache
• If you are allergic to any of the ingredients of TRIGESTREL. If you are taking medicines on a regular basis, concomitant use of the medicine may cause undesirable interactions. Please consult your doctor, pharmacist or other health care professional for advice. If you are pregnant or breastfeeding your baby while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice

Use with care, and tell your doctor, if

• If you have (or family history of) high blood pressure
• If you have (or history of) diabetes
• If you have (or history of) gall bladder disease
• Tell your doctor in charge that you are taking this medicine before any kind of surgery (including dental surgery) or emergency treatment
• If you are a porphyric patient
• If you have (or history of) epilepsy seizures
• If you have (or history of) asthma
• If you are mentally depressed
• 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 stress disorder or bipolar disorder
• That you have a family history of mental disorders
• That you have a history of physical or sexual abuse
• If you have vomiting or diarrhoea you need to take extra protection during and for 7 days after recovery
• Tell your doctor in case that you are taking this medicine before any laboratory test
• Tell your doctor if you have recently got evacuation of a hydatidiform mole. Hormonal contraceptives including TRIGESTREL, may cause mood changes and depression, which may be severe. Severe depression is associated with a higher risk of suicidal thoughts/behaviour (e.g. talking about suicide, withdrawing from social contact, having mood swings, being preoccupied with death or violence, feeling hopeless about a situation, increasing use of alcohol/drugs, doing self-destructive things, personality changes) and suicide. If you experience mood changes and depression contact your doctor for advice. Psychiatric disorders: Some women using hormonal contraceptives including TRIGESTREL have reported depression or depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If you experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible
• Stop taking TRIGESTREL, immediately consult your doctor if any of following occur:
• Sudden severe chest pain, sudden breathlessness, or severe pain/swelling in calf of one leg
• Unusual, severe prolonged headache, sudden disturbances of vision or hearing or other perceptual disorders, collapse, marked numbness or weakness affecting one side of the body or other signs or symptoms suggestive of cerebrovascular accident
• A first unexplained epileptic seizure
• Severe upper abdominal pain
• Onset of severe depression
• Significant rise in blood pressure (above 160 mm Hg systolic or 1000 mm/Hg diastolic)

Pregnancy and breastfeeding

• Pregnancy If you think you might be pregnant or if two or one menstrual cycle have been missed, stop taking TRIGESTREL and consult your doctor immediately
• Use another method of contraception until you see your doctor
• If you are taking oral contraceptive and wish to go start a family, you should discontinue TRIGESTREL and use non-hormonal method (like a condom or a spermicidal gel) of contraception for minimum 3 months before attempting to conceive
• 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
• Lactation You can start using TRIGESTREL after six months of breast- feeding or weaning whichever is earlier

Interactions and medicines to check

The approved leaflet names these interactions.

• Always tell your health care provider if you are taking any other medicine
• (This includes all complementary or traditional medicines.) Oral contraceptive may affect the action of antibacterials, antidepressant, antidiabetics, antifungals, antivirals, retinoid, stimulants, antiepileptics, analgesics, anticonvulsants, anticoagulants, antihypertensives, benzodiazepines, cyclosporins, clofibrate, corticosteroids, lidocaine, selegiline, levothyroxine and xanthines
• If you have diarrhoea, it may stop TRIGESTREL from working properly and make it less effective
• Carry on taking TRIGESTREL and also use another method of contraception, until 7 days after you have recovered from stomach upset
• If you are taking other medicines on a regular basis, including complementary or traditional medicine, the use of TRIGESTREL with these medicines may cause undesirable interactions
• Please consult your doctor, Pharmacist or other health care professional for advice
• TRIGESTREL with food and drink There are no known interactions between TRIGESTREL and food or drinks

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

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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