Diane Side Effects

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

What is diane?

Diane contains the active ingredient Cyproterone acetate, ethinylestradiol.

• Active ingredient — Cyproterone acetate, ethinylestradiol
• Registration number — V/21.8.2/300
• Registration holder — Bayer (Pty) Ltd

It is approved for:

• 2 What you need to know before you take DIANE-35 3 How to take DIANE-35 4 Possible side effects 5 How to store DIANE-35 6 Contents of the pack and other information 1
• What DIANE-35 is and what it is used for DIANE-35 is used to treat skin conditions such as acne, very oily skin and excessive hair growth in women of reproductive age
• These include patients with polycystic ovary syndrome, who require treatment for these symptoms
• DIANE-35 is a hormonal contraceptive (the “Pill”)

Common side effects of diane

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Frequent side effects

• nausea
• abdominal pain
• weight gain
• headache
• depressed or altered mood
• breast pain including breast tenderness

Less frequent side effects

• vomiting
• diarrhoea
• fluid retention
• migraine
• reduced interest in sex or increased interest in sex
• breast enlargement
• vaginal discharge
• breast discharge
• rash
• urticaria (hives)
• erythema nodosum or multiforme (skin disorders)
• venous blood clot
• contact lens intolerance
• allergic reactions (hypersensitivity)
• weight loss

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• if you are allergic (hypersensitive) to ethinylestradiol, cyproterone acetate or any of the other ingredients in DIANE-35. This may cause, for example, itching, rash or swelling
• if you have (or have ever had) a blood clot in your leg (thrombosis), lung (pulmonary embolism) or other part of your body
• if you have (or have ever had) a heart attack or stroke
• if you have (or have ever had) a disease that may be an indicator of a heart attack in the future (e.g angina pectoris which cases severe pain in the chest) or ‘mini-stroke’ (transient ischaemic attack)
• if you have (or have ever had) a migraine, with visual disturbances, speech disability or weakness or numbness in part of your body
• if you have a condition that may increase the risk of a blood clot in your arteries. This applies to the following conditions: o diabetes affecting your blood vessels. o very high blood pressure. o a very high level of fat in your blood (cholesterol or triglycerides)
• if you have problems with blood clotting (e.g. protein C deficiency)
• if you have (or have ever had) 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, or any 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 (or have ever had) a benign or malignant tumour of the liver
• if you have any unexplained bleeding from the vagina
• if you are using another hormonal contraceptive
• if you are pregnant or think you might be pregnant
• if you are breast-feeding If any of these conditions appear for the first time while using DIANE-35, stop taking it at once and consult your doctor. In the meantime, use non-hormonal contraceptive measures. See also ‘General notes’. DIANE-35 is not for use in men

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 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 a polycystic ovary syndrome (a disorder of your ovaries that may cause infertility, sometimes combined with androgenetic symptoms and an increased risk of thrombosis)
• 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 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 DIANE-35, contact your doctor
• Stop taking tablets and contact your doctor immediately if you notice possible signs of a blood clot. The symptoms are described in section ‘DIANE-35 and blood clots’. If you suffer from hirsutism and it has only recently appeared or has lately intensified to a considerable extent the doctor must be expressly informed of this because of the necessity to clarify the cause. DIANE-35 also works as an oral contraceptive. You and your doctor must consider all the factors that are important for the safe use of oral hormonal contraceptives. The experience with estrogen/progestogen combinations like DIANE-35 is predominantly based on combined oral contraceptives (“the Pill”). Therefore, the following warnings related to the use of “the Pill” apply also for DIANE-35. DIANE-35 and depression Some women using hormonal contraceptives including DIANE-35 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. DIANE-35 and blood clots Blood clots (thrombosis) When taking DIANE-35, the risk of a blood clot (also called a thrombosis) may be slightly increased. The likelihood of a blood clot is only slightly increased when taking DIANE-35 compared with women not taking DIANE-35 or any other birth control pill. A full recovery does not always happen and in 1-2 % of cases may be fatal. Blood clots in a vein A blood clot in a vein (also called a ‘venous thrombosis’) can block the vein. This may occur in the veins of the legs, lungs (pulmonary embolism), or any other organ. When using a combined pill, a woman’s risk of developing such clots is increased compared to a woman not taking a combined pill. The risk of developing a blood clot in a vein is highest in the first year of pill use. The risk is not as high as that of getting a blood clot during pregnancy. The risk of blood clots in a vein among users of a combined pill rises further:
• with increasing age
• if you smoke. If you take a hormonal contraceptive such as DIANE-35, you are strongly advised to stop smoking, especially if you are over 35 years of age
• if a close relative has had a blood clot in the leg, lung or other organ at a an early age
• if you are overweight
• if you need to undergo surgery, or if you have been bedridden over a prolonged period due to an injury or illness, or you have your leg in a cast. If this applies to you, it is important to tell your doctor you are using DIANE-35, as treatment may have to be discontinued in some cases. Your doctor may tell you to stop using DIANE-35 for several weeks before surgery or if you have only limited mobility. Your doctor will also tell you when you can start using DIANE-35 again, once you are back on your feet. Blood clots in an artery A blood clot in an artery can cause serious problems. For example, a blood clot in one of the arteries in the heart can cause a heart attack, or in one of the arteries in the brain, a stroke. The use of a combined pill has been associated with an increased risk of clots in the arteries. This risk increases further:
• with increasing age
• if you smoke. If you take a hormonal contraceptive such as DIANE-35, you are strongly advised to stop smoking, especially if you are over 35 years of age
• if you are overweight
• if you have high blood pressure
• if a close relative has had a heart attack or stroke at a young age
• if you have high fat levels (cholesterol or triglycerides)
• if you get migraines
• if you have a heart problem (heart valve defect, heart rhythm disorders). Symptoms of blood clots Stop taking the tablets at once and consult your doctor immediately if you notice possible signs of a blood clot, such as:
• sudden cough of unclear cause
• severe chest pain, which may radiate into the left arm
• shortness of breath and/or rapid or irregular heartbeats
• unusual, severe, or prolonged headaches or worsening of migraine
• partial or complete loss of vision, or double vision
• slurred speech or problems in speaking
• sudden changes in the sense of hearing, smell, or taste
• dizziness or fainting fits
• weakness or numbness in any part of the body
• severe abdominal pain
• severe pain or swelling in a leg. A full recovery does not always happen after a blood clot. Rarely, serious permanent disabilities may occur or the blood clot may be fatal. Immediately after childbirth, women are at increased risk of blood clots, which is why you should ask your doctor how soon after giving birth you can start taking DIANE-35. Your doctor will check 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.. DIANE-35 and cancer Breast cancer has been observed slightly more often in women using combined pills, but it is not known whether this is caused by the treatment itself. For example, it may be that more tumours are detected in women on combined pills because they are examined by their doctor more often. 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. In rare cases, benign liver tumours, and in even fewer cases malignant liver tumours have been reported in contraceptive pill users. In isolated cases, 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. However, it is not clear to what extent sexual behaviour or other factors such as HPV infection increases this risk. The above-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 requiring the use of sanitary protection. Continue to take your tablets as normal. Irregular vaginal bleeding usually stops once your body has adjusted to DIANE-35 (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 for one cycle, have not had any vomiting or severe diarrhoea and you have not taken any other medicines, it is unlikely that you are pregnant. Continue to take DIANE-35 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. In the meantime, use non-hormonal contraceptive measures. See also ‘General notes’

Pregnancy and breastfeeding

• Do not take DIANE-35 if you are pregnant, or, if you think you may be pregnant
• If you become pregnant while taking DIANE-35, stop taking it immediately and contact your doctor
• If you want to become pregnant, you can stop taking DIANE-35 at any time
• DIANE-35 must not be used during breast-feeding

Interactions and medicines to check

The approved leaflet names these interactions.

• HIV and Hepatitis C Virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors) o fungal infections (griseofulvin, azole antifungals, e.g. itraconazole, voriconazole, fluconazole) o bacterial infections (macrolide antibiotics, e.g. clarithromycin, erythromycin) o certain heart diseases, high blood pressure (calcium channel blockers, e.g. verapamil, diltiazem) o arthritis, arthrosis (etoricoxib) − the herbal remedy St. John’s wort − grapefruit juice DIANE-35 may influence the effect of other medicines, e.g. − lamotrigine − cyclosporine − melatonin − midazolam − theophylline − tizianidine Laboratory tests If you need a blood test or other laboratory tests tell your doctor or the laboratory staff that you are taking DIANE-35 because oral contraceptives can affect the results of some tests

What to do if you experience side effects

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

If the symptom is severe or frightening

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

If the symptom is mild but bothering you

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

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

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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