Scheduling Status
TRIPHASIL is an S3 medicine.
Product Name
TRIPHASIL 50 µg/30 µg; 75 µg/40 µg; 125 µg/30 µg sugar-coated tablets
Active Ingredients
TRIPHASIL contains the active substances ethinyl oestradiol and levonorgestrel.
Contains Sugar
TRIPHASIL contains lactose monohydrate and sucrose.
| Tablet colour | Sugar content |
|---|---|
| Brown tablets | Lactose monohydrate and sucrose |
| White tablets | Lactose monohydrate and sucrose |
| Yellow tablets | Lactose monohydrate and sucrose |
| Red placebo tablets | Lactose monohydrate and sucrose |
Read Before Taking TRIPHASIL
Read the patient information carefully before starting TRIPHASIL. Keep the leaflet because it may be needed again. Patients should ask a doctor, pharmacist, nurse, or healthcare provider if they have further questions.
TRIPHASIL is prescribed personally and should not be shared with other people, even if their symptoms or needs appear similar.
What Is in This Article
- What TRIPHASIL is and what it is used for
- What you need to know before you take TRIPHASIL
- How to take TRIPHASIL
- Possible side effects
- How to store TRIPHASIL
- Contents of the pack and other information
1. What TRIPHASIL Is and What It Is Used For
TRIPHASIL belongs to a group of medicines called combined oral contraceptives, also known as COCs or the Pill.
It contains two hormones:
| Hormone type | Active ingredient |
|---|---|
| Oestrogen | Ethinyl oestradiol |
| Progestogen | Levonorgestrel |
TRIPHASIL is a triphasic contraceptive, meaning the pack contains three different levels of hormones. These levels are designed to reflect the changing hormone levels during the normal menstrual cycle.
TRIPHASIL works by helping to prevent pregnancy in several ways. It prevents the ovary from releasing an egg, thickens the mucus at the neck of the womb so sperm find it harder to reach the egg, and changes the lining of the womb so that it is less likely to accept a fertilised egg.
TRIPHASIL is used to prevent pregnancy. It may also help control irregularities in the frequency and flow of the menstrual cycle and assist with menstrual cramps and pain. During contraceptive use, it may also provide benefit for acne.
2. What You Need to Know Before You Take TRIPHASIL
Do Not Take TRIPHASIL
Do not take TRIPHASIL if any of the following apply:
| Do not take TRIPHASIL if | Details |
|---|---|
| You are allergic to ethinyl oestradiol, levonorgestrel, or any ingredient in TRIPHASIL | This may cause a serious allergic reaction |
| You or your close family have had blood clotting problems | This includes inherited clotting conditions |
| You have porphyria | TRIPHASIL may not be suitable |
| You are taking ritonavir | Ritonavir is used to treat HIV infections |
| You have or have ever had a blood clot | This includes clots in the legs, lungs, or other organs |
| You have a blood clotting disorder | Examples include protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden, or antiphospholipid antibodies |
| You need an operation or will be off your feet for a long time | This may increase the risk of blood clots |
| You have ever had a heart attack or stroke | TRIPHASIL may increase cardiovascular risk |
| You have or have had angina or transient ischaemic attack | These may be warning signs of serious cardiovascular disease |
| You have severe diabetes with blood vessel damage | This can increase clotting risk |
| You have high blood pressure | This may increase cardiovascular risk |
| You have high cholesterol or triglycerides | This may increase cardiovascular risk |
| You have hyperhomocysteinaemia | This may increase clotting risk |
| You have migraine with aura | This increases the risk of stroke |
| You have or have had breast cancer | TRIPHASIL should not be used |
| You have had severe liver disease | TRIPHASIL should not be used until liver function is normal |
| You have or have had liver tumours | TRIPHASIL should not be used |
| You are pregnant or think you may be pregnant | TRIPHASIL is not used during pregnancy |
| You have undiagnosed vaginal bleeding | This must be assessed by a healthcare provider |
| You have Dubin-Johnson or Rotor syndrome | These conditions affect the liver |
| You have depression that is not well controlled | Medical review is needed |
| You previously had depression with hormonal contraceptives | Medical review is needed |
Warnings and Precautions
Take special care with TRIPHASIL if you have severe kidney impairment, a history of liver disease, or consume large quantities of alcohol.
Seek urgent medical attention if you notice possible signs of a blood clot. These may include symptoms of deep vein thrombosis, pulmonary embolism, heart attack, or stroke.
Before starting TRIPHASIL, it is important to understand the benefits and risks. TRIPHASIL is suitable for many healthy women, but it is not suitable for everyone.
Cigarette Smoking Warning
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptives. The risk increases with age and with heavy smoking, especially in women over 35 years of age.
Women taking TRIPHASIL are advised to stop smoking.
Medical Checks Before and During Use
Before TRIPHASIL is started, a doctor may ask about personal and family medical history, check blood pressure, and exclude pregnancy.
During treatment, regular check-ups may be needed, usually when another prescription is required. Regular cervical smear tests should be continued. Patients should check their breasts and nipples monthly and report changes such as lumps or dimpling of the skin.
If a blood test is needed, the doctor should be told that TRIPHASIL is being taken because it can affect some test results.
Conditions to Tell Your Doctor About
Tell your doctor if any of the following apply or develop while taking TRIPHASIL:
| Condition or risk factor |
|---|
| Crohn’s disease or ulcerative colitis |
| Systemic lupus erythematosus |
| Treatment for depression |
| Previous depression with hormonal contraceptives |
| Substance abuse problem |
| Psychiatric disorder such as post-traumatic stress disorder or bipolar disorder |
| Family history of mental disorders |
| History of physical or sexual abuse |
| Haemolytic uraemic syndrome |
| Sickle cell anaemia |
| Pancreatitis |
| High triglycerides |
| Need for surgery |
| Long-term immobility |
| Recent childbirth |
| Superficial thrombophlebitis |
| Varicose veins |
| Diabetes |
| Family history of heart or circulation problems |
| High blood pressure |
| Obesity |
| Migraine headaches |
| Any illness that worsened during pregnancy or previous oral contraceptive use |
Mood Changes and Depression
Hormonal contraceptives, including TRIPHASIL, may cause mood changes and depression. Depression may be severe and may be associated with suicidal thoughts or behaviour.
If mood changes or depression occur, especially soon after starting TRIPHASIL, contact a doctor for advice.
Blood Clots
Using a combined hormonal contraceptive such as TRIPHASIL increases the risk of developing a blood clot compared with not using one. In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can occur in veins or arteries.
| Type of clot | Medical term |
|---|---|
| Clot in a vein | Venous thrombosis or venous thromboembolism |
| Clot in an artery | Arterial thrombosis or arterial thromboembolism |
Recovery from blood clots is not always complete. In rare cases, blood clots may cause serious lasting effects or may be fatal.
How to Recognise a Blood Clot
Seek urgent medical attention if any symptoms of a blood clot occur.
| Signs or symptoms | Possible condition |
|---|---|
| Swelling of one leg or along a vein in the leg or foot, pain or tenderness, increased warmth, pale/red/blue skin colour change | Deep vein thrombosis |
| Sudden unexplained breathlessness, rapid breathing, sudden cough, coughing blood, sharp chest pain, dizziness, rapid or irregular heartbeat, severe stomach pain | Pulmonary embolism |
| Immediate loss of vision or painless blurred vision that may progress to loss of vision | Retinal vein thrombosis |
| Chest pain, pressure, heaviness, squeezing sensation, indigestion or choking feeling, pain radiating to back/jaw/throat/arm/stomach, sweating, nausea, vomiting, dizziness, extreme weakness, anxiety, shortness of breath, rapid or irregular heartbeat | Heart attack |
| Sudden weakness or numbness of face/arm/leg, sudden confusion, trouble speaking, trouble seeing, trouble walking, dizziness, loss of balance, severe headache, fainting or seizure | Stroke |
| Swelling with blue discolouration of an extremity, severe stomach pain | Blood clots blocking other blood vessels |
Do not take more TRIPHASIL until a doctor says it is safe. Use another contraceptive method, such as condoms, in the meantime.
Blood Clots in a Vein
Combined oral contraceptives such as TRIPHASIL have been associated with an increased risk of venous blood clots. These side effects are rare and most often occur in the first year of use.
A clot in the leg or foot can cause deep vein thrombosis. A clot that travels to the lung can cause pulmonary embolism. A clot may also occur in another organ, such as the eye.
The risk of developing a blood clot is highest during the first year of taking TRIPHASIL for the first time. The risk may also be higher when restarting TRIPHASIL after a break of four weeks or more.
Factors That Increase the Risk of Blood Clots in a Vein
The risk of a blood clot in a vein may be increased by:
| Risk factor |
|---|
| Being very overweight |
| Family history of blood clots at a young age |
| Surgery |
| Long-term immobility |
| Leg in a cast |
| Increasing age, especially above about 35 years |
| Recent childbirth |
| Air travel lasting more than four hours, especially with other risk factors |
Blood Clots in an Artery
A blood clot in an artery may cause serious problems such as a heart attack or stroke.
The risk of heart attack or stroke from using TRIPHASIL is small but may increase with certain risk factors.
Factors That Increase the Risk of Blood Clots in an Artery
| Risk factor |
|---|
| Increasing age |
| Smoking |
| Being overweight |
| High blood pressure |
| Family history of heart attack or stroke at a young age |
| High blood fat levels |
| Migraine |
| Heart problems |
| Diabetes |
What to Do If You Have a Stomach Upset
If vomiting or diarrhoea occurs, the pill may not work properly.
Continue taking TRIPHASIL, but additional contraception, such as condoms, should be used during the stomach upset and for the next seven days.
What to Do If You Want to Delay or Shift Your Period
If you want to delay or shift your period, contact your doctor for advice.
Other Medicines and TRIPHASIL
Always tell your doctor, pharmacist, nurse, or healthcare provider if you are taking, have recently taken, or may take any other medicines.
Some medicines may affect how TRIPHASIL works or may increase the chance of side effects.
| Medicine or medicine group | Use or relevance |
|---|---|
| Ritonavir | Used for HIV infections |
| Medicines used for epilepsy | May reduce contraceptive protection |
| Medicines used for tuberculosis | May reduce contraceptive protection |
| Certain antibiotics or antifungals | May affect TRIPHASIL |
| Herbal products such as St John’s wort | May reduce contraceptive protection |
A doctor or pharmacist should advise whether extra contraceptive protection is needed.
Pregnancy and Breastfeeding
TRIPHASIL should not be used if you are pregnant or think you may be pregnant.
If pregnancy occurs while taking TRIPHASIL, stop taking it and contact a doctor.
TRIPHASIL is not recommended during breastfeeding because combined oral contraceptives may reduce milk flow.
Driving and Using Machines
TRIPHASIL is not usually expected to affect the ability to drive or use machines. However, patients should be aware of how they respond to the medicine.
TRIPHASIL Contains Lactose and Sucrose
TRIPHASIL contains lactose and sucrose. Patients who have been told by a doctor that they have an intolerance to some sugars should consult a doctor before taking this medicine.
3. How to Take TRIPHASIL
TRIPHASIL should be taken exactly as directed by a doctor or pharmacist.
Starting the First Pack
The first pill should be taken on the first day of the period. This is day one of the cycle.
If TRIPHASIL is started on days 2 to 5 of the period, another contraceptive method, such as condoms, should be used for the first seven pill-taking days.
The pill should be taken at about the same time each day. It may be easiest to take it last thing at night or first thing in the morning.
Take one pill every day in the order shown until all 21 active pills have been taken. After the 21 active pills, there are seven placebo days. Bleeding usually starts after about two to three days and may continue for several days.
The Next Pack
After the seven placebo days, the next pack should be started whether or not bleeding has stopped. A new pack will always start on the same day of the week.
Changing to TRIPHASIL From Another Combined Hormonal Contraceptive
When changing from another combined pill, vaginal ring, or transdermal patch, TRIPHASIL should usually be started after the last active pill, or after removing the ring or patch.
The next pack should not be started later than the day after the usual pill-free, placebo, patch-free, or ring-free interval.
Changing From a Progestogen-Only Pill
A progestogen-only pill can be stopped at any time, and TRIPHASIL can be started the next day at the same time. Additional contraception, such as condoms or spermicides, should be used for the first seven days.
Changing From a Contraceptive Injection or Implant
If changing from an injection or implant, TRIPHASIL can be started when the next injection is due or when the implant is removed. Additional contraception should be used during the first seven days.
Starting After Childbirth, Miscarriage, or Abortion
After childbirth, miscarriage, or abortion, a doctor should advise when TRIPHASIL may be started.
After miscarriage or abortion during the first three months of pregnancy, TRIPHASIL may be started immediately, and additional contraception is not usually needed.
After delivery or abortion during the second trimester, TRIPHASIL may be started 21 to 28 days later. If started later, additional contraception should be used for the first seven days.
If unprotected sex has occurred, TRIPHASIL should not be started until pregnancy is excluded or until the next period starts.
If You Forget to Take TRIPHASIL
If One Pill Is 12 Hours Late or Less
Contraceptive protection should not be affected. Take the late pill immediately and take the next pill at the usual time. This may mean taking two pills in one day.
If More Than 12 Hours Late or More Than One Pill Is Missed
Contraceptive protection may be reduced. Extra protection should be used. The more pills missed, the greater the risk that protection is reduced.
Missed Pill During the First Week
Take the last missed pill as soon as remembered, even if this means taking two pills at the same time. Continue taking pills at the usual time. Use a barrier method, such as a condom, for the next seven days.
If intercourse occurred in the previous seven days, pregnancy should be considered.
Missed Pill During the Second Week
Take the last missed pill as soon as remembered, even if this means taking two pills at the same time. Continue taking the pills at the usual time.
If the pills were taken correctly during the seven days before the missed pill, additional contraception may not be needed. If this was not the case, or if more than one pill was missed, another contraceptive method should be used for seven days.
Missed Pill During the Third Week
Take the last missed pill as soon as remembered, even if this means taking two pills at the same time. Continue taking the pills at the usual time.
Then start the next pack immediately after taking the last active pill in the current pack, without the usual seven-day placebo interval.
Alternatively, stop taking active pills from the current pack and have a pill-free period of up to seven days, including the days when pills were forgotten, then continue with the next pack.
If pills were missed and there is no withdrawal bleed during the first normal placebo interval, pregnancy should be considered.
If You Take More TRIPHASIL Than You Should
In case of overdose, consult a doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.
Taking too much TRIPHASIL is not likely to cause serious harm, but nausea, vomiting, or vaginal bleeding may occur. A doctor can advise what action is needed.
4. Possible Side Effects
TRIPHASIL can have side effects. Not all side effects are listed here. If general health worsens or any unexpected effects occur while taking TRIPHASIL, consult a healthcare provider.
Side Effects Table
| Side-effect category | Side effects / symptoms | Recommended action |
|---|---|---|
| Very serious allergic reactions | Swelling of hands, feet, ankles, face, lips, mouth, or throat; difficulty swallowing or breathing; rash; itching | Stop taking TRIPHASIL and seek urgent medical attention immediately |
| Serious side effects requiring urgent care | New or worsening migraine; breast cancer symptoms such as lump, nipple discharge, breast rash, or breast pain; liver tumour symptoms such as loss of appetite, stomach pain, vomiting, or weakness; symptoms of blood clot formation; stroke-like symptoms; heart attack; vertigo; dizziness; fainting; fits; sudden weakness or numbness; motor disturbances; severe abdominal pain; need for surgery or immobilisation; suicidal thoughts or behaviour; suicide attempts; Crohn’s disease; cholestatic jaundice; pancreatitis; systemic lupus erythematosus | Tell a doctor immediately or go to the nearest casualty department |
| Blood clot warning symptoms | Unusual pain or swelling in the legs; sudden sharp chest pain; sudden shortness of breath; sudden cough; severe or long-lasting headache; sudden eyesight changes; slurred speech; weakness or numbness on one side of the body; severe abdominal pain | Do not take more pills until a doctor advises; use another contraceptive method meanwhile |
| Frequent side effects | Tender breasts; enlarged breasts; breast secretion; depressive moods; headaches; nausea; gall stone disease; acne or skin disorders; brown patches on face or body; irregular bleeding; missed bleeds; bleeding or spotting between periods; water retention; weight increase or decrease; tummy pain | Tell a doctor if troublesome or persistent |
| Less frequent side effects | Changes in interest in sex; nervousness; high blood pressure; hyperlipidaemia; appetite changes; impaired hearing; stomach cramps; bloatedness; vomiting; bloody diarrhoea; hair loss; bladder inflammation; reduced sensation or consciousness; dizziness; slurred speech; Sydenham’s chorea; visual disturbance; contact lens intolerance; worsening hereditary angioedema; fluid retention; worsening chorea; skin pigmentation; breast hypertrophy; vaginal discharge; breast secretion; post-pill amenorrhoea; vaginal candidiasis; vaginitis; acute porphyria attack; haemolytic uraemic syndrome; haemorrhagic eruption | Tell a doctor |
| Frequency unknown side effects | Excessive hair growth; cystitis-like syndrome; cervical erosion or secretion; inflammation of vein walls; sensation of heaviness; absence or infrequent menstrual periods; breast disorders; oligomenorrhoea | Tell a doctor or pharmacist |
| Side effects not listed | Any side effect not mentioned or any unexpected health change | Inform a doctor or pharmacist |
Reporting of Side Effects
If side effects occur, talk to a doctor, pharmacist, or nurse. Reporting side effects helps provide more information about the safety of TRIPHASIL.
5. How to Store TRIPHASIL
Store all medicines out of reach of children.
TRIPHASIL should be stored at or below 25 °C and kept in the original packaging until required for use.
Do not store TRIPHASIL in a bathroom. Do not use it after the expiry date on the label. Unused medicine should be returned to a pharmacist. Unused medicine should not be disposed of in drains or sewerage systems, including toilets.
6. Contents of the Pack and Other Information
What TRIPHASIL Contains
TRIPHASIL contains:
| Tablet type | Quantity in pack | Active ingredients |
|---|---|---|
| Brown active sugar-coated tablets | 6 | Levonorgestrel and ethinyl estradiol |
| White active sugar-coated tablets | 5 | Levonorgestrel and ethinyl estradiol |
| Yellow active sugar-coated tablets | 10 | Levonorgestrel and ethinyl estradiol |
| Red placebo sugar-coated tablets | 7 | No active contraceptive hormone |
Active Tablets
| Tablet colour | Levonorgestrel content | Ethinyl estradiol content |
|---|---|---|
| Brown active tablet | 50 µg | 30 µg |
| White active tablet | 75 µg | 40 µg |
| Yellow active tablet | 125 µg | 30 µg |
Other Ingredients
The active tablets contain ingredients such as calcium carbonate light, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, sucrose, starch maize, purified talc, titanium dioxide, and Waradur XE. Some tablets also contain colourants and preservatives.
The red placebo tablets contain lactose monohydrate, sucrose, colourants, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium benzoate, purified talc, and Waradur XE.
What TRIPHASIL Looks Like and Contents of the Pack
| Tablet colour | Description |
|---|---|
| Brown active tablet | Pale brown, lustrous, round, biconvex sugar-coated tablet |
| White active tablet | White, lustrous, round, biconvex sugar-coated tablet |
| Yellow active tablet | Yellow, lustrous, round, biconvex sugar-coated tablet |
| Red placebo tablet | Red, biconvex sugar-coated tablet |
Each pack contains 28 sugar-coated tablets in a blister strip. The blister strip is packed in an outer cardboard carton together with a leaflet.
Holder of Certificate of Registration
PHARMACARE LIMITED
Healthcare Park
Woodlands Drive
Woodmead 2191
Hotline
0800 122 912
Leaflet Revision Date
10 February 2023
Registration Number
N/18.8/0040
Additional Registration Information
| Country | Registration information |
|---|---|
| Botswana | B9320080 S2 |
| Namibia | NS2 90/18.8/001250 |
Medical Disclaimer
This article is intended as patient information based on the approved leaflet structure. It does not replace advice from a doctor, pharmacist, nurse, or healthcare provider. For regulated medical product use, follow the approved patient information leaflet and healthcare professional guidance.
