Yasmin Side Effects

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

What is Yasmin?

Yasmin contains the active ingredient Levomefolate calcium.

• Active ingredient — Levomefolate calcium
• Registration number — 45/18.8/0535
• Registration holder — Bayer (Pty) Ltd

It is approved for:

• YASMIN PLUS is a contraceptive pill and it is used to prevent pregnancy and to improve the folate status in women who decide to use oral contraception
• Each of the 21 orange film-coated tablets contains a small amount of the female hormones ethinylestradiol and drospirenone and levomefolate calcium (which is also contained in the 7 light orange hormone-free film-coated tablets)
• Contraceptive pills that contain two hormones are called “combined pills” or “combined oral contraceptives”

Interactions and medicines to check

The approved leaflet names these interactions.

• medicines used for the treatment of:
• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate)
• tuberculosis (e.g. rifampicin)
• HIV and Hepatitis C Virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors)
• fungal infections (griseofulvin, azole antifungals, e.g. itraconazole, voriconazole, fluconazole, fluconazole, ketoconazole)
• bacterial infections (macrolide antibiotics, e.g. clarithromycin, erythromycin)
• certain heart diseases, high blood pressure (calcium channel blockers, e.g. verapamil, diltiazem)
• arthritis, arthrosis (etoricoxib)
• the herbal remedy St. John’s wort (primarily used for the treatment of depressive moods)
• grapefruit juice The efficacy of levomefolate calcium in YASMIN PLUS can be diminished by:
• medicines containing methotrexate, trimethoprim, sulphasalazine, triamterene, cholestyramine, or by antiepileptics such as carbamazepine, phenytoin, phenobarbital, primidone or valproic acid. YASMIN PLUS may influence the effect of other medicines, e.g
• anti-epileptics such as lamotrigine and phenytoin
• ciclosporin
• melatonin
• midazolam
• theophylline
• tizanidine
• methotrexate or pyrimethamine. In theory your potassium levels may increase if you are taking YASMIN PLUS with other medicines that can also increase potassium levels. Laboratory tests If you need a blood test or other laboratory tests tell your doctor or the laboratory staff that you are taking the Pill because oral contraceptives can affect the results of some 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 allergic (hypersensitive) to ethinylestradiol, drospirenone, levomefolate calcium or any of the other ingredients in YASMIN PLUS (listed in section 6). This may cause, for example, itching, rash or swelling
• If you have (or have ever had) a blood clot in a blood vessel of the leg (thrombosis), of the lung (pulmonary embolism) or other parts of the body
• If you have (or have ever had) a heart attack or stroke (caused by a blood clot or a rupture of a blood vessel in the brain)
• If you have (or have ever had) a disease that can be an indicator (i) of a future heart attack (for example, angina pectoris which causes severe chest pain which may spread to the left arm) or (ii) of a stroke (for example, a minor stroke with no residual effects, a so-called transient ischaemic attack)
• If you have a high risk of venous or arterial blood clots
• If you have (or have ever had) a certain kind of migraine (with so-called focal neurological symptoms such as visual symptoms, speech disability, or weakness or numbness in any part of your body)
• If you have diabetes mellitus with damaged blood vessels
• If you have (or have ever had) a liver disease (symptoms of which may be yellowing of the skin or itching over the whole body) and your liver is still not working normally
• If you are taking any antiviral medicines which contain ombitasvir, paritaprevir, or dasabuvir, and combinations of these. These antiviral medicines are used to treat chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus)
• If you have (or have ever had) a cancer that may grow under the influence of sex hormones (e.g. of the breast or the genital organs)
• If you have a severe kidney insufficiency or acute kidney failure
• If you have (or have ever had) a benign or malignant tumour of the liver
• If you have any unexplained bleeding from the vagina
• If you are pregnant or think you might be pregnant; If any of these conditions appear for the first time while using YASMIN PLUS, stop taking it at once and consult your doctor. In the meantime, use non-hormonal contraceptive measures (e.g. condom)

Use with care, and tell your doctor, if

• if you smoke
• if you have diabetes
• if you are overweight
• if you have high blood pressure
• if you have a heart valve disorder or a certain heart rhythm disorder
• if you have an inflammation of your veins (superficial phlebitis)
• if you have varicose veins
• if anyone in your immediate family has ever had a blood clot (thrombosis in the leg, lung “pulmonary embolism”, or elsewhere), a heart attack or a stroke at a young age
• if you suffer from migraine
• if you have epilepsy
• if you have an increased potassium blood level (e.g. due to problems with your kidneys) and also use diuretics that may increase the potassium in your blood (ask your doctor if you’re not sure)
• if you or someone in your immediate family has ever had high blood levels of cholesterol or triglycerides (fatty substances)
• if a close relative has or has ever had breast cancer
• if you have a disease of the liver or gall bladder
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease)
• if you have systemic lupus erythematosus (or SLE, a disease of the immune system)
• if you have haemolytic uremic syndrome (or HUS, a disorder of blood coagulation causing failure of the kidneys)
• if you have sickle-cell disease
• if you have a condition that occurred for the first time or worsened during pregnancy or previous use of sex hormones (e.g. hearing loss, a metabolic disease called porphyria, a skin disease called herpes gestationis, or a neurological disease called Sydenham’s chorea)
• if you have or have ever had golden brown pigment patches so-called “pregnancy patches” especially on the face (chloasma). If this is the case, avoid direct exposure to sunlight or ultraviolet light
• if you suffer from vitamin B12 deficiency (for example due to a reduced B12 diet such as a strict vegetarian diet, due to a history of gastrointestinal surgery or certain types of gastritis) tell your doctor that you use YASMIN PLUS because folates may hide vitamin B12 deficiency
• if you have hereditary angioedema. Consult your doctor immediately if you experience symptoms of angioedema such as swollen face, tongue or throat, and/or difficulty swallowing, or hives, together with difficulty breathing. Products containing estrogens may induce or worsen symptoms of angioedema. If any of the above conditions appear for the first time, recur or worsen while using YASMIN PLUS, you should contact your doctor. YASMIN PLUS and depression Some women using hormonal contraceptives including YASMIN 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. YASMIN PLUS and blood clots (thrombosis) A thrombosis is the formation of a blood clot, which may block a blood vessel. A thrombosis sometimes occurs in the deep veins of the legs (deep venous thrombosis). If a blood clot breaks away from the vein where it has formed, it may reach and block the arteries of the lungs, causing a so-called “pulmonary embolism”. Blood clots can also occur very rarely in the blood vessels of the heart (causing a heart attack). Blood clots or a ruptured blood vessel in the brain may cause a stroke. The risk of venous thromboembolism is highest during the first year of use. This increased risk is present after initially starting the combined Pill or restarting (following a 4 week or greater pill-free interval) the same or a different combined Pill. Data from a large study suggest that this increased risk is mainly present during the first 3 months. Overall the risk for venous thromboembolism in users of low estrogen dose pills is two to threefold higher than for non-users of combined oral contraceptives who are not pregnant. Venous or arterial thromboembolic events may cause serious permanent disabilities or may even be fatal. Blood clots can occur in other parts of the body including the liver, gut, kidney, brain or eye
• Stop taking the pill and contact a doctor immediately if you notice signs of: Deep venous thrombosis, such as: swelling of one leg or along a vein in the leg, pain or tenderness in the leg which may be felt only when standing or walking, increased warmth in the affected leg, red or discoloured skin on the leg. Pulmonary embolism, such as: sudden onset of unexplained shortness of breath or rapid breathing, sudden coughing which may bring up blood, sharp chest pain which may increase with deep breathing, sense of anxiety, severe light-headedness or dizziness, rapid or irregular heartbeat. Some of these symptoms (e.g. “shortness of breath”, “coughing”) are non-specific and be misinterpreted as more common or less severe events (e.g. respiratory tract infection). Arterial thromboembolism (arterial blood vessels blocked by blood clots and such blood clots which have broken away)
• Stroke such as: sudden numbness or weakness 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
• Blood clots blocking other arterial blood vessels, such as: sudden pain, swelling and slight blue discolouration of an extremity, “acute” abdomen
• Heart attack such as pain, discomfort, pressure, heaviness, sensation of squeezing or fullness in the chest, arm, or below the breastbone; discomfort radiating to the back, jaw, throat, arm, stomach, fullness, indigestion or choking feeling; sweating, nausea, vomiting or dizziness; extreme weakness, anxiety, or shortness of breath; rapid or irregular heartbeats. Your doctor will check, e.g. whether you have a higher risk of getting a thrombosis due to a combination of risk factors or perhaps one very strong risk factor. In the case of a combination of factors the risk may be higher than simply adding two individual risks. If the risk is too high, your doctor will not prescribe the Pill.. The risk of venous or arterial blood clots (e.g. deep venous thrombosis, pulmonary embolism, heart attack) or stroke increases:
• With older age
• if you are overweight
• if anyone in your immediate family has ever had a blood clot (thrombosis in the leg, lung “pulmonary embolism”, or elsewhere), a heart attack or a stroke at a young age, or if you or any of your relatives are known or suspected of having a hereditary blood clotting disorder increasing your risk for developing blood clots. In this case you should see a specialist before deciding about using YASMIN PLUS. Certain blood factors that may suggest you have tendency for venous or arterial thrombosis include Activated Protein C (APC) resistance, hyperhomocysteinaemia, antithrombin-III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant)
• with prolonged immobilisation (for example, when you have your leg or legs in plaster or splints), major surgery, any surgery to the legs, or major trauma. In these situations it is better to stop taking YASMIN PLUS (if the surgery is planned you should stop at least four weeks beforehand) and not to start again until two weeks after you are fully on your feet again
• if you smoke (the risk increases the more you smoke and the older you get, especially in women over 35 years of age). When using the Pill you should stop smoking, especially if you are older than about 35 years of age
• if you or someone in your immediate family has or has ever had high blood levels of cholesterol or triglycerides (fatty substances)
• if you have high blood pressure. If you develop high blood pressure while using YASMIN PLUS, you may be told to stop using it
• if you suffer from migraine
• if you have a heart valve disorder or a certain heart rhythm disorder. Directly after giving birth, women are at an increased risk of blood clots so you should ask your doctor how soon after delivery you can start taking YASMIN PLUS. YASMIN PLUS and cancer Breast cancer has been observed slightly more often in women using combined pills. The risk of breast tumours becomes gradually less after stopping the combined hormonal contraceptive. It is important to regularly check your breasts and you should contact your doctor if you feel any lump. Benign liver tumours, and malignant liver tumours have been reported in contraceptive pill users. These tumours have led to life-threatening internal bleeding. Contact your doctor if you have unusually severe abdominal pain. The most important risk factor for cervical cancer is persistent Human Papilloma Virus (HPV) infection. Some studies suggest that long-term use of the Pill increases a woman’s risk of developing cervical cancer. The afore mentioned tumours may be life-threatening or may have a fatal outcome. Bleeding between periods For the first few months, you can have irregular vaginal bleeding (spotting or breakthrough bleeding) between your periods
• You may need to use sanitary protection, but continue to take your tablets as normal. Irregular vaginal bleeding usually stops once your body has adjusted to YASMIN PLUS (usually after about 3 tablet-taking cycles). If it continues, becomes heavy or starts again, tell your doctor. What to do if no bleeding occurs If you have taken all the tablets correctly, have not had any vomiting or severe diarrhoea and you have not taken any other medicines, it is highly unlikely that you are pregnant. Continue to take YASMIN PLUS as usual. If you have taken the tablets incorrectly, or, if you have taken the tablets correctly but the expected bleeding does not happen twice in a row, you may be pregnant. Contact your doctor immediately. Do not start the next pack until you are sure that you are not pregnant

Pregnancy and breastfeeding

• Do not take YASMIN PLUS if you are pregnant, or, if you think you may be pregnant
• If you become pregnant while taking YASMIN PLUS, stop taking it immediately and contact your doctor
• If you want to become pregnant, you can stop taking YASMIN PLUS at any time
• If you stop YASMIN PLUS in order to become pregnant you should consider to continue to take folate supplements
• YASMIN PLUS should not be used during breastfeeding or before the breastfeeding mother has completely weaned her child
• If you are pregnant or breastfeeding, think you may be pregnant or planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine

Common side effects of Yasmin

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.

Reported side effects

• emotional lability (mood swings), depression/ depressive mood
• decrease and loss of libido (reduced or loss of sex drive)
• migraine
• nausea
• breast pain, unscheduled uterine bleeding (bleeding between periods), genital tract bleeding (vaginal bleeding) not further specified Less frequent side effects
• venous and arterial thromboembolic events*
• Estimated frequency, from epidemiological studies encompassing a group of combined oral contraceptives. Frequency was borderline to Very Rare. The term venous and arterial thromboembolic events covers the following: any blockage or clot in a deep peripheral vein, clots which travel through the venous blood system (e.g. to the lung known as pulmonary embolism or as pulmonary infarction), heart attack caused by blood clots, stroke caused by blockage of the blood supply to or in the brain Other side effects that have been reported are: erythema multiforme (a skin condition characterised by itchy red blotches or swollen patches of skin). Description of selected side effects Side effects with very low frequency or with delayed onset of symptoms which are considered to be related to the group of combined oral contraceptives are listed below: Tumours
• The frequency of diagnosis of breast cancer is very slightly increased among users of oral contraceptives. As breast cancer is rare in women under 40 years of age the excess number is small in relation to the overall risk of breast cancer. It is not known whether there is a direct link to users of combined oral contraceptives
• liver tumours (benign and malignant) Other conditions
• erythema nodosum (a skin condition characterized by tender red nodules)
• women with hypertriglyceridemia (increased blood fats resulting in an increased risk of pancreatitis when using combined oral contraceptives)
• high blood pressure
• occurrence or worsening of conditions for which a link to combined oral contraceptives is not definite: jaundice and/or itching related to cholestasis (blocked bile flow); gallstone formation; a metabolic condition called porphyria; systemic lupus erythematosus (a chronic autoimmune disease); haemolytic uremic syndrome (a blood clotting disease); a neurological condition called Sydenham’s chorea; herpes gestationis (a type of skin condition that occurs during pregnancy); otosclerosis-related hearing loss
• In women with hereditary angioedema (characterised by sudden swelling of e.g. the lips, tongue, eyes, mouth, throat etc.) external estrogens may induce or worsen symptoms of angioedema
• disturbed liver function
• changes in glucose tolerance or effect on peripheral insulin resistance
• Crohn’s disease, ulcerative colitis
• chloasma
• hypersensitivity (including symptoms such as rash, urticaria) Interactions Unexpected bleeding and/or contraceptive failure may result from interactions of other medicines with YASMIN PLUS (e.g. the herbal remedy St. John’s wort, or medicines for epilepsy, tuberculosis, HIV and Hepatitis C Virus infections and other infections). See section ‘Other medicines and YASMIN PLUS’

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 Yasmin 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

The leaflet lists these as serious side effects needing immediate attention.

Frequent

• emotional lability (mood swings), depression/ depressive mood
• decrease and loss of libido (reduced or loss of sex drive)
• migraine
• nausea
• breast pain, unscheduled uterine bleeding (bleeding between periods), genital tract bleeding (vaginal bleeding) not further specified

Less frequent

• venous and arterial thromboembolic events*
• Estimated frequency, from epidemiological studies encompassing a group of combined oral contraceptives. Frequency was borderline to Very Rare. The term venous and arterial thromboembolic events covers the following: any blockage or clot in a deep peripheral vein, clots which travel through the venous blood system (e.g. to the lung known as pulmonary embolism or as pulmonary infarction), heart attack caused by blood clots, stroke caused by blockage of the blood supply to or in the brain

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 Yasmin 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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