Misoprostol vaginal Side Effects

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

What is misoprostol vaginal?

Misoprostol-Vaginal contains the active ingredient Misoprostol.

• Active ingredient — Misoprostol
• Registration number — 55/11.10/0503
• Registration holder — Ruby Pharmaceuticals (Pty) Ltd

It is approved for:

• ACEMISO tablets contain misoprostol which is similar to a chemical substance called ‘prostaglandin’ which your body produces naturally
• Prostaglandins are produced in the stomach and intestine and help to protect the lining
• ACEMISO belongs to a group of medicines known as ‘anti-ulcer medicines’
• The ACEMISO tablets may help prevent you getting ulcers in your stomach or the part it empties into, called the duodenum

Common side effects of misoprostol vaginal

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

• skin rashes
• diarrhoea
• dizziness
• headache
• stomach pain
• constipation
• wind
• indigestion
• feeling or being sick
• Birth defects (foetal malformations)

Less frequent side effects

• fever
• irregular periods
• periods problems
• severe uterine pain
• some older women may have vaginal bleeding even though they have gone through the menopause
• cramping
• Tearing of the womb (uterine rupture) Unknown frequency
• allergic reactions, including swelling of the hands and feet, face, lips, tongue or throat and which may cause great difficulty in breathing
• prolonged heavy or painful bleeding
• chills
• high temperature
• abnormal contractions of the womb
• bleeding from the womb
• placenta remaining in the womb after birth, termination or miscarriage
• amniotic fluid (the fluid which surrounds the baby when pregnant) entering the mother’s bloodstream causing an allergic reaction
• incomplete miscarriage and premature birth
• foetal death

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 to misoprostol or any of the other ingredients of ACEMISO (listed in section 6), or other prostaglandin medicines
• If you are a woman of childbearing age and you are not using an effective contraceptive method to avoid becoming pregnant
• if you are pregnant or trying to become pregnant or do not have a negative pregnancy test because it may cause a miscarriage, premature birth or birth defects
• if you are breastfeeding (as this may give your baby diarrhoea)
• If you have kidney disease or impaired renal function

Use with care, and tell your doctor, if

• if you are pregnant or plan to become pregnant. Due to the risk for the foetus, your treatment with ACEMISO must be discontinued immediately
• if you are a woman of childbearing age. Due to the risk for the foetus, it is important to use effective contraception while you are taking ACEMISO
• heart disease
• low or high blood pressure, or any disease of the blood vessels
• inflammatory bowel disease
• prone to dehydration. If you are a younger woman who has not yet gone through the menopause, your doctor will have only prescribed ACEMISO if he is satisfied you are at high risk of developing ulcers from your NSAID medicine. Children: Do not give ACEMISO to children under the age of 18 years because it is unlikely to be safe

Pregnancy and breastfeeding

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine Pregnancy Do not take ACEMISO if you are pregnant or plan to become pregnant
• Your doctor will make you aware of the risks if you do become pregnant as ACEMISO may cause a miscarriage, premature birth or birth defects
• If you are a younger woman who has not yet gone through the menopause, your doctor will have only prescribed ACEMISO if he is satisfied you are at high risk of developing ulcers from your NSAID medicine
• ACEMISO can cause a miscarriage or damage to your womb, so it is very important to use reliable contraception while taking this medicine
• If you want to try for a baby, tell your doctor as you will have to stop taking ACEMISO and use a different treatment
• Do not breastfeed while taking ACEMISO

Interactions and medicines to check

The approved leaflet names these interactions.

• Always tell your health care provider if you are taking any other medicine
• (This includes all complementary or traditional medicines.) If you use an antacid (something to reduce acid in the stomach) you should avoid antacids with magnesium in them as these may make diarrhoea worse
• If you are taking any medicines for a heart condition, please consult your doctor
• Use with NSAIDs in rare cases can result in swelling of feet or hands and an increase in liver enzymes
• Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription

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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