Yaz Plus Side Effects

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

What is Yaz Plus?

Yaz-Plus contains the active ingredient Levomefolate calcium.

• Active ingredient — Levomefolate calcium
• Registration number — 45/21.8.2/0534
• Registration holder — Bayer (Pty) Ltd

It is approved for:

• YAZ PLUS is used to prevent pregnancy and to improve the folate status in women who decide to 29 use oral contraception. 30
• YAZ PLUS is used for the treatment of moderate acne vulgaris in women seeking oral 31 contraception. 32
• YAZ PLUS is also used for the treatment of symptoms of premenstrual dysphoric disorder 33 (PMDD) in women who have chosen oral contraceptive as their method of birth control. The 34 efficacy of YAZ PLUS for PMDD was not assessed beyond 3 cycles. 35 36 Each of the 24 pink film-coated tablets contains a small amount of the female hormones 37 ethinylestradiol and drospirenone and the vitamin levomefolate calcium (which is also contained 38 in the 4 light orange hormone-free film-coated tablets). 39 40 Contraceptive pills that contain two hormones are called ‘combined pills’ or ‘combined oral 41 contraceptives’. 42 43

Interactions and medicines to check

The approved leaflet names these interactions.

• medicines used for the treatment of: 264
• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, 265 topiramate, felbamate); 266
• tuberculosis (e.g. rifampicin); 267
• HIV and Hepatitis C Virus infections (so called protease inhibitors and non-nucleoside 268 reverse transcriptase inhibitors) (e.g. ritonavir, nevirapine); 269
• fungal infections (griseofulvin, azole antifungals, e.g. itraconazole, voriconazole, 270 fluconazole, ketoconazole); 271
• bacterial infections (macrolide antibiotics, e.g. clarithromycin, erythromycin); 272
• certain heart diseases, high blood pressure (calcium channel blockers, e.g. verapamil, 273 diltiazem; 274
• arthritis, arthrosis (etoricoxib) 275
• the herbal remedy St. John’s wort 276
• grapefruit juice 277 278 The efficacy of levomefolate calcium in YAZ PLUS can be diminished by: 279
• medicines containing methotrexate, trimethoprim, sulphasalazine, triamterene, cholestyramine, 280 or by antiepileptics such as carbamazepine, phenytoin, phenobarbital, primidone or valproic 281 acid. 282 283 YAZ PLUS may influence the effect of other medicines, e.g. 284
• anti-epileptics such as lamotrigine and phenytoin; 285
• ciclosporin; 286
• melatonin 287
• midazolam 288
• theophylline 289
• tizanidine 290
• methotrexate or pyrimethamine. 291 292 In theory your potassium levels may increase if you are taking YAZ PLUS with other medicines that 293 can also increase potassium levels. 294 295 Laboratory tests 296 297 If you need a blood test or other laboratory tests tell your doctor or the laboratory staff that you are 298 taking the Pill because oral contraceptives can affect the results of some tests. 299 300

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 65 of the other ingredients in YAZ PLUS (listed in section 6). This may cause, for example, itching, 66 rash or swelling 67
• if you have (or have ever had) a blood clot in a blood vessel of the leg (thrombosis), of the lung 68 (pulmonary embolism) or other parts of the body 69
• if you have (or have ever had) a heart attack or stroke (caused by a blood clot or a rupture of a 70 blood vessel in the brain) 71
• if you have (or have ever had) a disease that can be an indicator (i) of a future heart attack (for 72 example, angina pectoris which causes severe chest pain which may spread to the left arm) or (ii) 73 of a stroke (for example, a minor stroke with no residual effects, a so-called transient ischaemic 74 attack) 75
• if you have a high risk of venous or arterial blood clots 77
• if you have (or have ever had) a certain kind of migraine accompanied by e.g. visual symptoms, 78 speech disability, or weakness or numbness in any part of your body 79
• if you have diabetes mellitus with damaged blood vessels 80
• if you have (or have ever had) liver disease (symptoms of which may be yellowing of the skin or 81 itching over the whole body) and your liver is still not working normally 82
• if you are taking any antiviral medicines which contain ombitasvir, paritaprevir, or dasabuvir, and 83 combinations of these. These antiviral medicines are used to treat chronic (long-term) hepatitis C 84 (an infectious disease that affects the liver, caused by the hepatatis C virus). 85
• if you have (or have ever had) a cancer that may grow under the influence of sex hormones (e.g. of 86 the breast or the genital organs) 87
• if you have a severe kidney insufficiency or acute kidney failure 88
• if you have (or have ever had) a benign or malignant tumour of the liver 89
• if you have any unexplained bleeding from the vagina 90
• if you are pregnant or think you might be pregnant 91

Use with care, and tell your doctor, if

• if you smoke 99
• if you have diabetes 100
• if you are overweight 101
• if you have high blood pressure 102
• if you have a heart valve disorder or a certain heart rhythm disorder 103
• if you have an inflammation of your veins (superficial phlebitis) 104
• if you have varicose veins 105
• if anyone in your immediate family has ever had a blood clot (thrombosis in the leg, lung 106 ‘pulmonary embolism’, or elsewhere), a heart attack or a stroke at a young age 107
• if you suffer from migraine 108
• if you have epilepsy 109
• if you have an increased potassium blood level (e.g. due to problems with your kidneys) and also 110 use diuretics that may increase the potassium in your blood (ask your doctor if you’re not sure) 111
• if you or someone in your immediate family has ever had high blood levels of cholesterol or 112 triglycerides (fatty substances) 113
• if a close relative has or has ever had breast cancer 114
• if you have a disease of the liver or gall bladder 115
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease) 116
• if you have systemic lupus erythematosus (or SLE, a disease of the immune system) 117
• if you have haemolytic uremic syndrome (or ‘HUS’, a disorder of blood coagulation causing 118 failure of the kidneys) 119
• if you have sickle cell disease 120
• if you have a condition that occurred for the first time or worsened during pregnancy or previous 121 use of sex hormones (e.g. hearing loss, a metabolic disease called porphyria, a skin disease called 122 herpes gestationis, or a neurological disease called Sydenham’s chorea) 123
• if you have (or have ever had) golden brown pigment patches so-called ‘pregnancy patches’ 124 especially on the face (chloasma). If this is the case, avoid direct exposure to sunlight or 125 ultraviolet light 126
• if you suffer from vitamin B12 deficiency (for example due to a reduced B12 diet such as a strict 127 vegetarian diet, due to a history of gastrointestinal surgery or certain types of gastritis) tell your 128 doctor that you use YAZ PLUS because folates may hide vitamin B12 deficiency 129
• if you have hereditary angioedema. Consult your doctor immediately if you experience symptoms 130 of angioedema such as swollen face, tongue or throat, and/or difficulty swallowing, or hives, 131 together with difficulty breathing. Products containing estrogens may induce or worsen symptoms 132 of angioedema 133 134 If any of the above conditions appear for the first time, recur or worsen while using YAZ PLUS, 135 contact your doctor. 136 137 YAZ PLUS and depression 138 Some women using hormonal contraceptives including YAZ PLUS have reported depression or 139 depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If you 140 experience mood changes and depressive symptoms contact your doctor for further medical advice as 141 soon as possible. 142 143 YAZ PLUS and blood clots (thrombosis) 144 145 A thrombosis is the formation of a blood clot which may block a blood vessel. 146 147 A thrombosis sometimes occurs in the deep veins of the legs (deep venous thrombosis). If a blood clot 148 breaks away from the vein where it has formed, it may reach and block the arteries of the lungs, 149 causing a so-called ‘pulmonary embolism’. Blood clots can also occur very rarely in the blood vessels 150 of the heart (causing a heart attack). Blood clots or a ruptured blood vessel in the brain may cause a 151 stroke. 152 153 The risk of venous thromboembolism is highest during the first year of use. This increased risk is 154 present after initially starting the combined pill or restarting (following a 4 week or greater pill free 155 interval) the same or a different combined pill. Data from a large study suggest that this increased risk 156 is mainly present during the first 3 months. 157 158 Overall the risk for venous thromboembolism in users of low estrogen dose pills is two to threefold 159 higher than for non-users of combined oral contraceptives (COCs) who are not pregnant. Venous or 160 arterial thromboembolic events may cause serious permanent disabilities, may be life-threatening, or 161 may even be fatal. Blood clots can occur in other parts of the body including the liver, gut, kidney, 162 brain or eye. 163 164 Stop taking the pill and contact a doctor immediately if you notice signs of: 165 166 Deep venous thrombosis, such as: swelling of one leg or along a vein in the leg, pain or tenderness in 167 the leg which may be felt only when standing or walking, increased warmth in the affected leg, red or 168 discoloured skin on the leg. 169 170 Pulmonary embolism, such as: sudden onset of unexplained shortness of breath or rapid breathing, 171 sudden coughing which may bring up blood, sharp chest pain which may increase with deep breathing, 172 sense of anxiety, severe light-headedness or dizziness, rapid or irregular heartbeat. Some of these 173 symptoms (e.g. “shortness of breath”, “coughing”) are non-specific and be misinterpreted as more 174 common or less severe events (e.g. respiratory tract infection). 175 176 Arterial thromboembolism (arterial blood vessels blocked by blood clots and such blood clots 177 which have broken away) 178
• Stroke such as: sudden numbness or weakness of the face, arm or leg, especially on one side of 179 the body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or 180 both eyes; sudden trouble walking, dizziness, loss of balance or coordination; sudden, severe or 181 prolonged headache with no known cause; loss of consciousness or fainting with or without 182 seizure. 183
• Blood clots blocking other arterial blood vessels, such as: sudden pain, swelling and slight blue 184 discolouration of an extremity, “acute” abdomen. 185
• Heart attack such as pain, discomfort, pressure, heaviness, sensation of squeezing or fullness in 186 the chest, arm, or below the breastbone; discomfort radiating to the back, jaw, throat, arm, 187 stomach, fullness, indigestion or choking feeling; sweating, nausea, vomiting or dizziness; extreme 188 weakness, anxiety, or shortness of breath; rapid or irregular heartbeats. 189 190 Your doctor will check, e.g. whether you have a higher risk of getting a thrombosis due to a 191 combination of risk factors or perhaps one very strong risk factor. In the case of a combination of 192 factors the risk may be higher than simply adding two individual risks. If the risk is too high, your 193 doctor will not prescribe the Pill.. 194 195 The risk of venous or arterial blood clots (e.g. deep venous thrombosis, pulmonary embolism, heart 196 attack) or stroke increases: 197 198
• with older age 199
• if you are overweight 200
• if anyone in your immediate family has ever had a blood clot (thrombosis in the leg, lung 201 ‘pulmonary embolism’, or elsewhere), a heart attack or a stroke at a young age, or if you or any of 202 your relatives are known or suspected of having a hereditary blood clotting disorder increasing 203 your risk for developing blood clots 204
• with prolonged immobilisation (for example, when you have your leg or legs in plaster or splints), 205 major surgery, any surgery to the legs, or major trauma. In these situations it is better to stop 206 taking the YAZ PLUS (if the surgery is planned you should stop at least four weeks beforehand) 207 and not to start again until two weeks after you are fully on your feet again 208
• if you smoke (the risk increases the more you smoke and the older you get, especially in women 209 over 35 years of age). When using YAZ PLUS you should stop smoking, especially if you are 210 older than about 35 years of age. 211
• if you or someone in your immediate family has or has ever had high blood levels of cholesterol or 212 triglycerides (fatty substances) 213
• if you have high blood pressure . If you develop high blood pressure while using YAZ PLUS, 214 you may be told to stop using it. 215
• if you suffer from migraine 216
• if you have a heart valve disorder or a certain heart rhythm disorder 217 218 Directly after giving birth, women are at an increased risk of blood clots so you should ask your doctor 219 how soon after delivery you can start taking YAZ PLUS. 220 221 YAZ PLUS and cancer 222 223 Breast cancer has been observed slightly more often in women using combined contraceptive pills. 224 The risk of breast tumours becomes gradually less after stopping the combined hormonal 225 contraceptive. It is important to regularly check your breasts and you should contact your doctor if 226 you feel any lump. 227 228 Benign liver tumours, and malignant liver tumours have been reported. These tumours have led to 229 life-threatening internal bleeding. Contact your doctor if you have unusually severe abdominal pain. 230 231 The most important risk factor for cervical cancer is persistent Human Papilloma Virus (HPV) 232 infection. Studies suggest that long-term use of the pill increases a woman’s risk of developing 233 cervical cancer. 234 235 The afore mentioned tumours may be life-threatening or may have a fatal outcome. 236 237 Bleeding between periods 238 239 For the first few months, you can have irregular vaginal bleeding (spotting or breakthrough bleeding) 240 between your periods. Continue to take your tablets as normal. Irregular vaginal bleeding usually 241 stops once your body has adjusted to YAZ PLUS (usually after about 3 tablet-taking cycles). If it 242 continues, becomes heavy or starts again, tell your doctor. 243 244 What to do if no bleeding occurs 245 246 If you have taken all the tablets correctly, have not had any vomiting or severe diarrhoea and you have 247 not taken any other medicines, it is highly unlikely that you are pregnant. Continue to take YAZ PLUS 248 as usual. 249 250 If you have taken the tablets incorrectly, or, if you have taken the tablets correctly but the expected 251 bleeding does not happen twice in a row, you may be pregnant. Contact your doctor immediately. Do 252 not start the next pack until you are sure that you are not pregnant. 253 254

Pregnancy and breastfeeding

• 301 302 Do not take YAZ PLUS if you are pregnant, or, if you think you may be pregnant
• If you become 303 pregnant while taking YAZ PLUS, stop taking it immediately and contact your doctor
• If you want to 304 become pregnant, you can stop taking YAZ PLUS at any time
• If you stop YAZ PLUS in order to become pregnant you should consider to continue to take 306 folate supplements
• 307 308 YAZ PLUS should not be used during breastfeeding or before the breastfeeding mother has 309 completely weaned her child
• 310 311 If you are pregnant or breastfeeding, think you may be pregnant or planning to have a baby, please 312 consult your doctor, pharmacist or other health care provider for advice before taking this medicine

Common side effects of Yaz Plus

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

• Emotional lability (mood swings), depression/depressive mood
• Migraine
• Nausea
• Breast pain, unscheduled uterine bleeding (bleeding between periods), genital tract bleeding (vaginal bleeding) not further specified

Less frequent side effects

• Decrease and loss of libido (reduced or loss of sex drive)
• 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 Side effects that have been reported with the use of the Pill, without knowing their precise frequency: 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 characterised by tender red nodules)
• women with hypertriglyceridaemia (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 uraemic 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 YAZ 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 YAZ PLUS’. If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

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 Yaz Plus 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 Yaz Plus 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

• Triphasil side effects

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