Triphasil Side Effects

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

What is Triphasil?

Triphasil contains the active ingredient Levonorgestrel, ethinyl estradiol.

• Active ingredient — Levonorgestrel, ethinyl estradiol
• Registration number — N/18.8/0040
• Registration holder — PHARMACARE LIMITED

It is approved for:

• TRIPHASIL belongs to a group of medicines called combined oral contraceptives (COCs) and is one of a group of medicines often referred to as the Pill
• TRIPHASIL contains two types of hormones: an oestrogen, ethinylestradiol, and a progestogen, levonorgestrel
• It is a triphasic contraceptive
• This means that there are three levels of hormones in each pack which reflect the changing levels in your normal menstrual cycle

Interactions and medicines to check

The approved leaflet names these interactions.

• antibiotics (such as ampicillin, tetracycline, and rifampicin)
• medicines used to treat epilepsy or other illnesses, such as primidone, carbamazepine, oxcarbazepine, topiramate, lamotrigine, felbamate, hydantoins or barbiturates (such as phenobarbitone)
• griseofulvin (a medicine used to treat fungal infections)
• certain medicines used to treat depression (tricyclic antidepressants)
• ciclosporin (a suppressor of the immune system used e.g. during transplantation)
• the herbal remedy commonly known as St John’s Wort (hypericum perforatum)
• antiviral medicines such as nervirapine or ritonavir, that are used in HIV treatment. You may have to use another method of contraception as well, such as a condom, while you are taking these medicines and up to 28 days afterwards. Your doctor may advise you to use these extra precautions for even longer. If you are taking antibiotics, always ask your doctor’s advice about extra precautions. Always mention if you are on the combined pill if you are prescribed any medicines. TRIPHASIL with alcohol Increasing use of alcohol can affect you when taking TRIPHASIL

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 ethinyl oestradiol or levonorgestrel or to any of the other ingredients of TRIPHASIL (listed in section 6)
• if you or your close family have ever had problems with blood clotting or if you have the inherited disease called porphyria
• if you are taking ritonavir (a medicine used to treat HIV infections)
• if you have (or have ever had) a blood clot in a blood vessel of your legs (deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs
• if you know you have a disorder affecting your blood clotting – for instance, protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies
• if you need an operation or if you are off your feet for a long time
• if you have ever had a heart attack or stroke
• if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or transient ischaemic attack (TIA – temporary stroke symptoms)
• if you have any of the following diseases that may increase your risk of a clot in the arteries:
• severe diabetes with blood vessel damage
• high blood pressure
• a high level of fat in the blood (cholesterol or triglycerides)
• a condition known as hyperhomocysteinaemia
• if you have (or have ever had) a type of migraine called ‘migraine with aura’
• if you have or have ever had breast cancer
• if you have ever had a severe liver disease, and you have been told by your doctor that your liver function test results are not yet back to normal
• if you have ever had liver tumours
• if you become or think you may have become pregnant
• if you have undiagnosed vaginal bleeding
• if you have a condition called Dubin-Johnson or Rotor syndromes (condition that affects the liver)
• if you have depression, which is not well controlled with treatment
• if you have had depression with previous use of hormonal contraceptives. Tell your doctor or family planning nurse if you have any medical problems or illnesses

Use with care, and tell your doctor, if

• if you suffer from severe kidney impairment. You will need to consult with your healthcare professional
• if you have a history of liver disease or consume large quantities of alcohol. Seek urgent medical attention if you notice possible signs of a blood clot. This could mean that you are possibly suffering from a blood clot in the leg (i.e. deep vein thrombosis), a blood clot in the lung (i.e. pulmonary embolism) and a heart attack or stroke. What to do if you have a stomach upset? If you have been sick or had diarrhoea, the pill may not work. Continue to take it, but you may not be protected from the first day of vomiting or diarrhoea. Use another method, such as a condom, for any intercourse during the stomach upset and for the next seven days. What to do if you want to delay or to shift your period? If you want to delay or to shift your period, you should contact your doctor for advice. General notes Before you start taking TRIPHASIL you should read the information on blood clots. It is particularly important to read the symptoms of a blood clot. It is important that you understand the benefits and risks of taking TRIPHASIL before you start taking it, or when deciding whether to carry on taking it. Although TRIPHASIL is suitable for most healthy women it isn’t suitable for everyone. Tell your doctor if you have any of the illnesses or risk factors mentioned in this leaflet. CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR SIDE- EFFECTS FROM THE USE OF ORAL CONTRACEPTIVES.THE RISK INCREASES WITH AGE AND WITH HEAVY SMOKING (15 OR MORE CIGARETTES PER DAY) AND IS QUITE MARKED IN WOMEN OVER 35 YEARS OF AGE. YOU ARE THEREFORE ADVISED TO STOP SMOKING IF YOU ARE TAKING TRIPHASIL. Your doctor will ask about you and your family’s medical problems, check your blood pressure and exclude the likelihood of you being pregnant. Tell your doctor or family planning nurse if you have any medical problems or illnesses. Tell your doctor if any of the following conditions apply to you: If the condition develops, or gets worse while you are taking TRIPHASIL, you should also tell your doctor
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease)
• if you have systemic lupus erythematosus (SLE – a disease affecting your natural defence system)
• 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 haemolytic uraemic syndrome (HUS – a disorder of blood clotting causing failure of the kidneys)
• if you have sickle cell anaemia (an inherited disease of the red blood cells)
• if you have inflammation of the pancreas (pancreatitis)
• if you have elevated levels of fat in the blood (hypertriglyceridaemia) or a positive family history for this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas)
• if you need an operation, or you are off your feet for a long time
• if you have just given birth you are at an increased risk of blood clots. You should ask your doctor how soon after delivery you can start taking TRIPHASIL
• if you have an inflammation in the veins under the skin (superficial thrombophlebitis)
• if you have varicose veins
• if you have diabetes
• if you or your close family have ever had problems with your heart, or circulation such as high blood pressure
• if you are overweight (obese)
• if you have migraine headaches
• if you have any illness that worsened during pregnancy or previous use of TRIPHASIL or other oral contraceptives. Hormonal contraceptives including TRIPHASIL, 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, that may occur shortly after you start taking TRIPHASIL, contact your doctor for advice. You may also need other checks, such as a breast examination, but only if these examinations are necessary for you, or if you have any special concerns. While you’re on TRIPHASIL You will need regular check-ups with your doctor or family planning nurse, usually when you need another prescription of TRIPHASIL. You should go for regular cervical smear tests. Check your breasts and nipples every month for changes – tell your doctor if you can see or feel anything odd, such as lumps or dimpling of the skin. If you need a blood test tell your doctor that you are taking TRIPHASIL, because TRIPHASIL can affect the results of some tests. If you’re going to have an operation, make sure your doctor knows about it
• You may need to stop taking TRIPHASIL at least 6 weeks before the operation. This is to reduce the risk of a blood clot. Your doctor will tell you when you can start taking TRIPHASIL again. Blood clots Using a combined hormonal contraceptive such as TRIPHASIL increases your risk of developing a blood clot compared with not using one. In rare cases a blood clot can block vessels and cause serious problems. Blood clots can develop:
• in veins (referred to as a ‘venous thrombosis’, ‘venous thromboembolism’ or VTE)
• in the arteries (referred to as an ‘arterial thrombosis’, ‘arterial thromboembolism’ or ATE). Recovery from blood clots is not always complete. Rarely, there may be serious lasting effects or, very rarely, they may be fatal. It is important to remember that the overall risk of having a harmful blood clot due to TRIPHASIL is small. HOW TO RECOGNISE A BLOOD CLOT Seek urgent medical attention if you notice any of the following signs or symptoms. Are you experiencing any of these signs? What are you possibly suffering from? Swelling of one leg or along a vein in the leg or foot especially when accompanied by:
• pain or tenderness in the leg which may be felt only when standing or walking
• increased warmth in the affected leg
• change in colour of the skin on the leg e.g. turning pale, red or blue Deep vein thrombosis
• sudden unexplained breathlessness or rapid breathing
• sudden cough without an obvious cause, which may bring up blood
• sharp chest pain which may increase with deep breathing
• severe light headedness or dizziness
• rapid or irregular heartbeat
• severe pain in your stomach If you are unsure, talk to a doctor as some of these symptoms such as coughing or being short of breath may be mistaken for a milder condition such as a respiratory tract infection (e.g. a ‘common cold’). Pulmonary embolism Symptoms most commonly occur in one eye:
• immediate loss of vision or
• painless blurring of vision which can progress to loss of vision Retinal vein thrombosis (blood clot in the eye)
• chest pain, discomfort, pressure, heaviness
• sensation of squeezing or fullness in the chest, arm or below the breastbone
• fullness, indigestion or choking feeling
• upper body discomfort radiating to the back, jaw, throat, arm and stomach
• sweating, nausea, vomiting or dizziness
• extreme weakness, anxiety, or shortness of breath
• rapid or irregular heartbeats Heart attack
• sudden weakness or numbness of the face, arm or leg, especially on one side of the body
• sudden confusion, trouble speaking or understanding
• sudden trouble seeing in one or both eyes
• sudden trouble walking, dizziness, loss of balance or coordination
• sudden, severe or prolonged headache with no known cause
• loss of consciousness or fainting with or without seizure Sometimes the symptoms of stroke can be brief with an almost immediate and full recovery, but you should still seek urgent medical attention as you may be at risk of another stroke. Stroke
• swelling and slight blue discolouration of an extremity
• severe pain in your stomach (acute abdomen) Blood clots blocking other blood vessels See a doctor as soon as possible. Do not take any more TRIPHASIL until your doctor says you can. Use another method of contraception, such as condoms, in the meantime. Blood clots in a vein What can happen if a blood clot forms in a vein?
• The use of combined oral contraceptives such as TRIPHASIL have been connected with an increase in the risk of blood clots in the vein (venous thrombosis). However, these side effects are rare. Most frequently, they occur in the first year of use of a combined oral contraceptive
• If a blood clot forms in a vein in the leg or foot it can cause a deep vein thrombosis (DVT)
• If a blood clot travels from the leg and lodges in the lung it can cause a pulmonary embolism
• A clot may form in a vein in another organ such as the eye (retinal vein thrombosis). When is the risk of developing a blood clot in a vein highest? The risk of developing a blood clot in a vein is highest during the first year of taking TRIPHASIL for the first time. The risk may also be higher if you restart taking TRIPHASIL (the same product or a different product) after a break of 4 weeks or more. After the first year, the risk gets smaller but is always higher than if you were not using TRIPHASIL. When you stop TRIPHASIL your risk of a blood clot returns to normal within a few weeks. What is the risk of developing a blood clot? The risk of having a blood clot will vary according to your personal medical history. Factors that increase your risk of a blood clot in a vein Some conditions will increase the risk. Your risk is higher:
• if you are very overweight (body mass index or BMI over 30 kg/m2)
• if one of your immediate family members has had a blood clot in the leg, lung or other organ at a young age (e.g. below the age of about 50). In this case you could have a hereditary blood clotting disorder
• if you need to have an operation, or if you are off your feet for a long time because of an injury or illness, or you have your leg in a cast. The use of TRIPHASIL may need to be stopped at least 6 weeks before surgery or while you are less mobile. If you need to stop TRIPHASIL ask your doctor when you can start using it again
• as you get older (particularly above about 35 years)
• if you gave birth recently (approximately 1 month). The risk of developing a blood clot increases the more conditions you have. Air travel (>4 hours) may temporarily increase your risk of a blood clot, particularly if you have some of the other factors listed. It is important to tell your doctor if any of these conditions apply to you, even if you are unsure. Your doctor may decide that TRIPHASIL needs to be stopped. If any of the above conditions change while you are taking TRIPHASIL, for example, you start smoking or a close family member experiences a thrombosis for no known reason, or you gain a lot of weight, tell your doctor. Blood clots in an artery What can happen if a blood clot forms in an artery? Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke. Factors that increase your risk of a blood clot in an artery The risk of a heart attack or stroke from using TRIPHASIL is small but can increase:
• with increasing age (beyond about 35 years)
• if you smoke. When taking a combined hormonal contraceptive like TRIPHASIL, you are advised to stop smoking. If you are unable to stop smoking and are older than 35 your doctor may advise you to use a different type of contraceptive
• if you are overweight
• if you have high blood pressure
• if a member of your immediate family has had a heart attack or stroke at a young age (less than about 50). In this case you could also have a higher risk of having a heart attack or stroke
• if you, or someone in your immediate family, have a high level of fat in the blood (cholesterol or triglycerides)
• if you get migraines, especially migraines with aura
• if you have a problem with your heart (valve disorder, disturbance of the rhythm called atrial fibrillation)
• if you have diabetes. If you have more than one of these conditions or if any of them are particularly severe the risk of developing a blood clot may be increased even more. If any of the above conditions change while you are taking TRIPHASIL, for example you start smoking, a close family member experiences a thrombosis for no known reason, or you gain a lot of weight, tell your doctor. TRIPHASIL and cancer Oral contraceptives, such as TRIPHASIL increase your risk of cancer of the womb and breast. All women should have regular smear tests. If you have breast cancer, or have had it in the past, you should not take TRIPHASIL. Oral contraceptives, such as TRIPHASIL increase your risk of breast cancer. This risk goes up the longer you’re on the Pill but returns to normal within about 10 years of stopping it. Your risk of breast cancer is higher:
• if you have a close relative (mother, sister or grandmother) who has had breast cancer
• if you are seriously overweight. See a doctor as soon as possible if you notice any changes in your breasts, such as dimpling of the skin, changes in the nipple or any lumps you can see or feel. TRIPHASIL has also been linked to liver diseases, such as jaundice and non-cancer liver tumours, oral contraceptives have also been linked with some forms of liver cancer in women who have taken them for a long time. See a doctor as soon as possible if you get severe pain in your stomach, or yellow skin or eyes (jaundice)
• You may need to stop taking TRIPHASIL

Pregnancy and breastfeeding

• You should not take TRIPHASIL it you are pregnant or think that you may be pregnant or breastfeeding your baby
• TRIPHASIL is contraindicated in confirmed or suspected pregnancy If pregnancy occurs during medication with TRIPHASIL, treatment should be stopped immediately
• 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 healthcare provider for advice before taking this medicine

Common side effects of Triphasil

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

• Tender breasts, breast gets bigger or something secreted from it
• depressive moods
• headaches
• feeling sick (nausea)
• gall stone disease
• skin disorders such as acne
• brown patches on the face and body like those that occur in pregnancy
• irregular bleeding or missed bleeds
• bleeding or spotting between your periods
• excess water collecting in the body
• increase or decrease in body weight
• tummy pain

Less frequent side effects

• Changes in interest in sex
• nervousness
• high blood pressure
• presence of excess lipids in the blood called hyperlipidaemia
• changes in appetite
• impaired hearing (otosclerosis)
• stomach cramps, bloatedness, being sick, bloody diarrhoea (ulcerative colitis)
• hair loss, loss of scalp hair
• inflammation of the bladder
• diminution or loss of sensation or consciousness
• dizziness, slurred speech
• a movement disorder called Sydenham’s chorea
• visual disturbance (such as temporal loss of vision, blurred vision or double vision)
• intolerance to contact lenses
• exacerbation of hereditary angioedema
• fluid retention
• exacerbation of chorea (movement disorder)
• skin pigmentation
• breast hypertrophy
• vaginal discharge
• breast secretion
• post pill amenorrhoea
• vaginal candidiasis
• vaginitis
• precipitation of acute attack of porphyria
• haemolytic uremic syndrome
• haemorrhagic eruption. Side effects with an unknown frequency:
• Hirsutism, excessive hair growth anywhere on the body in either males or females
• cystitis like syndrome (chronic condition causing bladder pressure, bladder pain and sometimes pelvic pain)
• cervical erosion or secretion
• inflammation of walls of veins that can cause pain, swelling and tenderness
• sensation of heaviness
• an abnormal absence or infrequent menstrual periods, skipping of a women’s cycle, breast disorders, oligomenorrhoea

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 Triphasil 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 Triphasil 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.

Related pages

• Nordette side effects

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