Answer side-effect and tolerability questions around norlevo, including expected changes, warning signs and safe escalation guidance.
Source
Clinical statements on this page are taken from the SAHPRA-approved patient information leaflet (approved 11/11/2022) and professional information (approved 11/11/2022) for this product: patient information leaflet, professional information. Retrieved 2026-09-03. Where this page and the approved leaflet differ, the leaflet is correct.
What is Norlevo?
Which leaflet this comes from
There is no approved leaflet for Norlevo in SAHPRA’s public repository. The information below is from the approved leaflet for HY-AN, another South African product containing Levonorgestrel. Products with the same active ingredient can still differ in strength, formulation and approved uses, so check the leaflet in your own pack.
Norlevo contains the active ingredient Levonorgestrel.
- Active ingredient — Levonorgestrel
- Registration number — A40/18.8/0747
- Registration holder — Mylan (Pty) Ltd
It is approved for:
- HY-AN is an oral contraceptive
- The active ingredient is levonorgestrel, which is a type progesterone. It works by thickening the fluid (mucus) at the neck of the womb (cervix) making it very difficult for the sperm to reach the egg, and it also alters the lining of the womb to make it less likely to accept a fertilised egg
Interactions and medicines to check
The approved leaflet names these interactions.
- Increased clearance of paracetamol and morphine
- Increased and decreased effects reported with the use of anticoagulants
- Reduced effectiveness but also increased toxicity reported with some antidepressants
- Antagonism of the effect of antidiabetics
- Increased or decreased clearance reported with benzodiazepines
- Increased toxicity reported with ciclosporin
- Increased clearance and antagonism of the effect of clofibrate
- Reduced clearance and enhanced effect of corticosteroids
- Decreased clearance of selegiline
- Reduced free fraction of thyroxine due to an increased binding globulin concentration
- Increased free fraction of lignocaine due to altered protein binding
- Decreased clearance of xanthines HY-AN with food and drink There are no known interactions between HY-AN and food or drinks
Bring the actual products to the conversation
A pharmacist can check for interactions much faster from the packaging than from remembered names.
Who should take extra care
The approved leaflet identifies the following cautions and factors.
Do not use it at all if
- If you have hypersensitivity to HY-AN or to any components of the formulation
- If you have liver disease or markedly impaired liver function
- If you suffer from hormone-dependent neoplasms, known or suspected
- Cerebrovascular disease or thromboembolic disease, active or past history thereof
- Undiagnosed genital bleeding
- Pregnancy
- If you have depression, which is not well controlled with treatment
- If you have had depression with previous use of hormonal contraceptives
Use with care, and tell your doctor, if
- heart disease
- malabsorption syndromes
- liver dysfunction, including recurrent cholestatic jaundice
- a history of jaundice in pregnancy
- functional ovarian cysts
- past ectopic pregnancy
- igraine (if focal)
- Hypertension
- Diabetes mellitus
- And thrombo-embolic disorders Tell your doctor before using HY-AN:
- That you are on treatment for depression
- That you have had depression with previous use of hormonal contraceptives
- That you have a substance abuse problem
- You have underlying psychiatric disorder such as post-traumatic stress disorder or bipolar disorder
- That you have a family history of mental disorders
- That you have a history of physical or sexual abuse Hormonal contraceptives including HY-AN, may cause mood changes and depression, which may be severe. Severe depression is associated with a higher risk of suicidal thoughts/behaviour (e.g. talking about suicide, withdrawing from social contact, having mood swings, being preoccupied with death or violence, feeling hopeless about a situation, increasing use of alcohol/drugs, doing self-destructive things, personality changes) and suicide. If you experience mood changes and depression contact your doctor for advice. Psychiatric disorders: Some women using hormonal contraceptives including HY-AN 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. Please note that
- Oral contraceptives may be used by women over the age of 35 years provided they do not smoke & have no other risk factors for cardiovascular disease. Oral contraceptive should be avoided over age of 50 years
- The Use of oral contraceptives should be stopped 4 to 6 weeks before major elective surgery
- The use of oral contraceptives may influence the results of certain laboratory tests including liver, thyroid adrenal, and renal function test, plasma concentrations of binding proteins and lipid/lipoprotein fractions and fibrinolysis and coagulation parameters
Pregnancy and breastfeeding
- Pregnancy Do not take HY-AN during pregnancy
- 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 health care provider for advice before taking this medicine
- Lactation Progesterone only contraceptives does not affect lactation, but should not be given until 3 weeks after birth to avoid an increased risk of breakthrough bleeding
Common side effects of Norlevo
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.
About these frequency terms
This leaflet groups effects as “Frequent” and “Less frequent” rather than the very common/common/uncommon scale used in some other markets.
Frequent side effects
- Hyperglycaemia, weight gain
- Mood changes
- Headache, fatigue
- Fluid retention
- Abdominal pain or cramping, diarrhoea, nausea
- Amenorrhoea, breakthrough bleeding, menorrhagia, spotting
Less frequent side effects
- Thromboembolism or thrombus formation
- Increases in hepatic enzyme levels, jaundice
- Melasma, acne, skin rash
- Breast pain or tenderness Post marketing reported side effects:
- Suicidal thoughts/behaviour and suicide
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 Norlevo 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.
Evidence required before publish — source the following for Norlevo from the SAHPRA-approved patient information leaflet or professional information, and cite what you actually used.
- The bleeding pattern the approved information for Norlevo describes as expected
- How long the source says an irregular pattern typically continues before settling
- What the source says about periods stopping, and whether that is described as harmless
- Bleeding that the source says should prompt medical review
Bleeding that needs checking
Very heavy bleeding that soaks through protection hourly, bleeding with severe pain or dizziness, or bleeding after sex that is new for you should be looked at by a healthcare professional rather than waited out.
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
Call for emergency help now if any of these happen
- Difficulty breathing, wheezing, or tightness in the throat or chest
- Swelling of the face, lips, tongue or throat
- A widespread rash with blistering or peeling skin, or sores in the mouth, eyes or genitals
- Fainting, collapse, or a sudden severe drop in alertness
- Chest pain, or sudden weakness or numbness on one side of the body
- A fit (seizure), or confusion that comes on suddenly
In South Africa call 10177 for an ambulance, or 112 from a mobile phone. Go to your nearest emergency department if it is faster. Do not wait to see whether the symptom settles.
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.
Evidence required before publish — source the following for Norlevo from the SAHPRA-approved patient information leaflet or professional information, and cite what you actually used.
- Anything the approved information for Norlevo says about how long specific effects last
- Whether the source describes any effect as usually temporary, or as needing review if it persists
- Whether any effect is described as continuing after the product is stopped
What happens after stopping or changing the method?
What happens after stopping or changing Norlevo 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.
Evidence required before publish — source the following for Norlevo from the SAHPRA-approved patient information leaflet or professional information, and cite what you actually used.
- What the approved information for Norlevo says about stopping or removal
- How long the source says it takes for the effect to wear off
- What the source says about return of fertility
- Any symptom the source says to expect after stopping, and any that needs review
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.
Call for emergency help now if any of these happen
- Difficulty breathing, wheezing, or tightness in the throat or chest
- Swelling of the face, lips, tongue or throat
- A widespread rash with blistering or peeling skin, or sores in the mouth, eyes or genitals
- Fainting, collapse, or a sudden severe drop in alertness
- Chest pain, or sudden weakness or numbness on one side of the body
- A fit (seizure), or confusion that comes on suddenly
In South Africa call 10177 for an ambulance, or 112 from a mobile phone. Go to your nearest emergency department if it is faster. Do not wait to see whether the symptom settles.
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
If you are having thoughts of harming yourself
Help is available in South Africa. The SADAG helpline is 0800 567 567, or you can go to your nearest emergency department. You do not have to wait until it feels like an emergency.
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
Reporting is not a substitute for medical care
If someone is unwell now, get medical help first and report afterwards. Urgent symptoms always take precedence over paperwork.
For a fuller walkthrough see how to report an adverse drug reaction.
Related pages
← Back to more contraception side effects.
Report a side effect
If you think you have had a side effect, you can report a suspected side effect in South Africa. Report a suspected side effect through the appropriate SAHPRA pathway where relevant.
Information only
This page gives general medicine-safety information for people in South Africa. It is not a diagnosis and not personalised medical advice. It cannot tell you whether a symptom you are having is caused by a particular product. Speak to a pharmacist or doctor about your own situation, and do not stop or change a prescribed treatment on the basis of a web page.
Editorial status: draft — not for publication
Brief SE-00404 · build rank 404 · Phase 2 · Tier 2. Every evidence slot on this page must be completed from the SAHPRA-approved source and the page signed off by a qualified clinical or pharmacy reviewer before it is published. Target length 1,300–2,000 words.