Visanne Side Effects

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

What is Visanne?

Visanne contains the active ingredient Dienogest.

• Active ingredient — Dienogest
• Registration number — 550034
• Registration holder — ADCOCK INGRAM LIMITED

It is approved for:

• VISAFEM contains a hormone, the progestogen dienogest
• VISAFEM is a preparation for the treatment of endometriosis (painful symptoms in which the lining of the womb grows outside the womb)

Common side effects of Visanne

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.

Less frequent side effects

• dizziness
• weight loss, increased appetite
• feeling anxious, mood swings
• sweating abnormalities, which could alternate between sweating too much and not sweating enough
• high activity level with a short attention span
• dry eyes, tinnitus (ringing in the ears)
• low blood pressure (feeling lightheaded)
• diarrhoea (loose stool), constipation
• swollen, puffy, dark red, sensitive gums
• dry, itchy skin
• abnormal growth of hair on a woman’s face and body
• nail disorders (loosening or separation of a fingernail or toenail from its nail bed)
• dandruff (small pieces of dead skin in your hair)
• red, swollen and sore skin sometimes with small blisters
• abnormal hair growth
• patchy loss of skin colour, which usually first appears on the hands and face
• pain and heaviness in the arms and legs, involuntary contractions of a muscle, pain in your bones
• itching, irritation or sore in or around the vagina, vaginal discharge
• swelling of all or part of the breast(s), breast lumps

Frequent side effects

• weight gain
• feeling depressed and/or nervous, sleeping problems
• changes in your mood, loss of sex drive
• headache, migraine (throbbing headache usually on one side of your head with sensitivity to light and sound, nausea and vomiting)
• nausea (feeling sick), stomach pain, flatulence (passing wind), bloating and swelling inn the belly area, vomiting (being sick)
• acne, hair loss (temporarily)
• back pain
• breast tenderness, pelvic and lower back pain, hot flushes, menstrual bleeding between your periods (spotting)
• chronic tiredness, irritability

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 hypersensitive (allergic) to dienogest or any of the other ingredients of VISAFEM (listed in section 6)
• if you are pregnant or suspect pregnancy
• if you are breastfeeding your baby
• if you are suffering from a blood clot (thromboembolic disorder) in your veins. This may occur, for example, in the blood vessels of the legs (deep vein thrombosis) or the lungs (pulmonary embolism). See also “VISAFEM and venous blood clots” below
• if you have or have ever had a severe arterial disease, including cardiovascular disease, such as a heart attack, stroke or heart disease which causes a reduced blood supply (angina pectoris). See also “VISAFEM and arterial blood clots” below
• if you have diabetes with blood vessel damage
• if you have or have ever had severe liver disease (and your liver function values have not returned to normal). Symptoms of liver disease may be yellowing of the skin and/or itching of the whole body
• if you have or have ever had a benign or malignant liver tumour
• if you suffer or have ever suffered, or if it is suspected that you suffer from a malignant sex-hormone dependent tumour such as cancer of the breast or the genital organs
• if you have any unexplained vaginal bleeding

Use with care, and tell your doctor, if

• if you have conditions of the uterus, these conditions may cause your menstrual bleeding (period) to be heavier than usual and continue for longer than usual
• if you have ever had a blood clot (venous thromboembolism) or anyone in your immediate family has had a blood clot at a relatively early age
• if you are overweight
• if you become immobile due to any reason, the use of VISAFEM should be stopped. Talk to your doctor about this before you stop taking VISAFEM
• if you have to go for surgery, treatment with VISAFEM should be stopped 4 weeks before surgery. Your doctor will tell you when you can start taking VISAFEM again
• if you experience symptoms such as pain and swelling in one leg, chest pain or numbness on one side of your body talk to your doctor immediately. These symptoms may be an indication of a blood clot and treatment with VISAFEM should be stopped immediately
• it is important to self-examine your breasts on a regularly basis for possible lumps or swelling. If you feeling anything unusual during your self-examination please contact your doctor immediately
• if you experience upper stomach pain, yellowing of the whites of the eyes and skin, nausea (being sick), vomiting (feeling sick), chest pain, shortness of breath, blood in your urine, contact your doctor immediately
• if you have a family history or if you have been diagnosed with osteoporosis (a condition in which the bones become brittle and fragile from loss of tissue, typically as a result of hormonal changes or deficiency of calcium or vitamin D)
• if you have ever suffered from depression
• if you have high blood pressure or develop high blood pressure while taking VISAFEM
• if you develop a liver disease while taking VISAFEM. Symptoms may include yellowing of the skin or eyes or itching all over your body
• if you have diabetes or had diabetes temporarily during previous pregnancy
• if you have ever had chloasma (golden-brown patches on the skin, particularly of the face); if so, avoid too much exposure to the sun or ultraviolet radiation while taking VISAFEM
• if you become pregnant while taking VISAFEM, consult your doctor immediately
• if you suffer from pain in your lower abdomen, breast tenderness, changes in your menstrual cycle (period) while taking VISAFEM, these may be symptoms of ovarian cysts (a solid or fluid-filled sac or pocket (cyst) within or on the surface of an ovary

Pregnancy and breastfeeding

• 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 VISAFEM
• Do not take VISAFEM if you are pregnant or when breastfeeding your baby
• Women of childbearing potential / Contraception in males and females If contraception is required a non-hormonal method should be used (e.g
• Your menstrual cycle (period) will return to normal within 2 months after stopping treatment with VISAFEM
• Fertility Based on available data, ovulation is inhibited in the majority of patients during treatment

Interactions and medicines to check

The approved leaflet names these interactions.

• epilepsy (e.g. phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate)
• tuberculosis (e.g. rifampicin)
• HIV and Hepatitis C Virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)
• the herbal remedy St. John’s wort
• fungal infections (griseofulvin, ketoconazole) Laboratory tests If you need a blood test, tell your doctor or the laboratory staff that you are taking VISAFEM, because VISAFEM can affect the results of some tests. VISAFEM with food and drink A high fat meal did not affect VISAFEM bioavailability. VISAFEM can be taken with or without a meal

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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