Primolut N Side Effects

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

What is Primolut N?

Primolut-N contains the active ingredient Norethisterone.

• Active ingredient — Norethisterone
• Registration number — G/21.8.2/3124
• Registration holder — Bayer (Pty) Ltd

It is approved for:

• PRIMOLUT N is a progestin, a synthetic hormonal product having properties in common with the natural female hormone progesterone
• PRIMOLUT N also has a residual androgenic (male sex hormone) effect
• PRIMOLUT N is used for timing of menstruation and to treat disturbances of the monthly bleeding (dysfunctional bleeding), absence of menstruation (primary and secondary amenorrhoea), and endometriosis (a disease leading to complaints caused by womb-lining tissue growing outside the womb)

Common side effects of Primolut N

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

• Uterine/Vaginal bleeding including Spotting*
• Weak periods (Hypomenorrhea)*
• Headache
• Nausea
• Absence of periods (Amenorrhea)*
• Generalised swelling (Oedema)

Less frequent side effects

• Migraine
• Hypersensitivity reactions
• Nettle rash (Urticaria)
• Rash
• Visual disturbances
• Shortness of breath (Dyspnoea)
• if taken for Endometriosis

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 norethisterone or any of the other ingredients of PRIMOLUT N (listed in section 6)
• If you are pregnant or think you might be pregnant
• If you are breastfeeding
• If you have (or have ever had) a heart attack or stroke (caused by a blood clot or a rupture of a blood vessel in the brain)
• If you have (or have ever had) a disease that can be an indicator (a) of a future heart attack (for example, angina pectoris which causes severe chest pain which may spread to the left arm) or (b) of a stroke (for example, a minor stroke with no residual effects, also called a transient ischaemic attack)
• If you have a severe or multiple risk factor(s) for blood clots
• If you have (or have ever had) a certain kind of migraine (with so-called focal neurological symptoms such as visual symptoms, speech disability, or weakness, or numbness in any part of your body)
• If you have diabetes with damaged blood vessels
• If you have or have had a severe liver disease and have been told by your doctor that your liver function values have not yet returned to normal. Symptoms of a liver disease may be, for instance, yellowing of the skin and/or itching of the whole body
• If you are taking any antiviral medicines which contain ombitasvir, paritaprevir, or dasabuvir, and 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 had a benign or malignant liver tumour
• If you have or have had a malignant sex hormone-dependent tumour such as cancer of the breast or the genital organs. If any of the above conditions appears for the first time while taking PRIMOLUT N, stop taking it at once and consult your doctor

Use with care, and tell your doctor, if

• if you smoke
• if you have diabetes (metabolic disease with elevated blood sugar levels)
• if you are seriously overweight
• if you have high blood pressure
• if you have a heart valve disorder or a certain heart rhythm disorder
• if you have had a thrombosis/embolism
• if anyone in your immediate family has had a thrombosis (venous thromboembolism in a sibling or a parent at a relatively early age), a heart attack or a stroke at a young age
• if you have an inflammation of your veins (superficial phlebitis)
• if you have varicose veins
• if anyone in your immediate family has had breast cancer
• if you have or have had chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face); if so, avoid too much exposure to the sun or ultraviolet radiation
• if you have a history of depression
• 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 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 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 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 appears for the first time, recurs or worsen while using PRIMOLUT N, you should contact your doctor. Primolut N and depression Some women using hormone-containing medicines including Primolut N 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. PRIMOLUT N and blood clots A thrombosis is the formation of a blood clot which may block a blood vessel. It has been concluded from epidemiological surveys that the use of oral estrogen/progestogen containing contraceptive pills increases a woman’s risk of developing a venous thrombosis compared with a woman who does not take any (contraceptive) pill. A thrombosis sometimes occurs in the deep veins of the legs (deep venous thrombosis). Venous thromboembolism (VTE) can develop whether or not you are taking the pill. It can also happen if you become pregnant. If a blood clot breaks away from the vein where it has formed, it may reach and block the arteries of the lungs, causing a so-called ‘pulmonary embolism’. Blood clots can also occur very rarely in the blood vessels of the heart (causing a heart attack). Blood clots or a ruptured blood vessel in the brain may cause a stroke. The risk of venous thromboembolism is highest during the first year of use. This increased risk is present after initially starting the combined pill or restarting (following a 4 week or greater pill free interval) the same or a different combined pill. Data from a large study suggest that this increased risk is mainly present during the first 3 months. Overall the risk for venous thromboembolism in users of low estrogen dose (< 50 μg ethinylestradiol) pills is two to threefold higher than for non-users of combined oral contraceptives who are not pregnant and remains lower than the risk associated with pregnancy and delivery. Venous thromboembolism, manifesting as deep venous thrombosis and/or pulmonary embolism, may occur during the use of all combined pills. Rarely blood clots can occur in other parts of the body including the liver, gut, kidney, brain or eye. The risk of thromboembolism is also increased shortly after childbirth. Blood clots can also occur seldomly in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke). WHEN SHOULD YOU CONTACT YOUR DOCTOR? Regular check-ups
• When you are using PRIMOLUT N, your doctor will tell you to return for regular check- ups. Contact your doctor as soon as possible if you:
• notice any changes in your health, especially involving any of the items mentioned in this leaflet
• feel a lump in your breast
• are going to use other medications
• will have a prolonged period of immobilisation or will have surgery (consult your doctor at least six weeks in advance)
• have unusual, heavy vaginal bleeding
• Stop taking PRIMOLUT N and see your doctor immediately if you notice possible signs of thrombosis such as:
• coughing for no apparent reason
• a feeling of pain and tightness in the chest which may reach the left arm
• breathlessness
• more frequent, unusually severe, or prolonged headache or a first migraine attack
• partial or complete loss of vision, or double vision
• slurring or speech disability
• sudden changes to your hearing, sense of smell, or taste
• dizziness or fainting
• weakness or numbness in any part of your body
• severe pain or swelling in either of your legs. Also stop taking PRIMOLUT N and see your doctor immediately if you notice:
• jaundice (yellowish skin, whites of the eyes; this may be a sign of hepatitis)
• generalised severe itching (pruritus)
• high blood pressure
• that you are pregnant The situation and symptoms mentioned above are described and explained in more detail elsewhere in this leaflet. The risk of venous or arterial blood clots (e.g. deep venous thrombosis, pulmonary embolism, heart attack) or stroke increases:
• with age
• if you are overweight
• 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, or if you or any of your relatives are known or suspected of having a hereditary blood clotting disorder increasing your risk for developing blood clots. In this case you should see a specialist before deciding about using any combined oral contraceptive. Certain blood factors that may suggest you have tendency for venous or arterial thrombosis include activated protein C (APC) resistance, hyperhomocysteinaemia, antithrombin-III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant)
• with prolonged immobilisation (e.g. when you have your leg or legs in plaster or splints), major surgery, any surgery to the legs, or major trauma. In this situation it is better to stop taking PRIMOLUT N (if the surgery is planned you should stop at least four weeks before hand) and not to start again until two weeks after you are fully on your feet again
• if you smoke (the risk increases the more you smoke and the older you get, especially in women over 35 years of age). When using PRIMOLUT N you should stop smoking, especially if you are older than about 35 years of age
• if you or someone in your immediate family has or has ever had high blood levels of cholesterol or triglycerides (fatty substances)
• if you have high blood pressure. If you develop high blood pressure while using PRIMOLUT N, you may be told to stop using it
• if you suffer from migraine
• if you have a heart valve disorder or a certain heart rhythm disorder Very occasionally thrombosis may cause serious permanent disabilities or may even be fatal. If you notice possible signs of a thrombosis, stop taking PRIMOLUT N and consult your doctor immediately. PRIMOLUT N 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 even more rarely, malignant liver tumours have been reported in users of hormonal substances such as the one contained in PRIMOLUT N. These tumours may lead to internal bleeding. 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 increase a woman’s risk of developing cervical cancer. However, it is not clear to what extent sexual behaviour or other factors such as Human Papilloma Virus increases this risk. The afore mentioned tumours may be life-threatening or may have fatal outcome. Contact your doctor immediately if you have severe pain in your abdomen

Pregnancy and breastfeeding

• You must not use PRIMOLUT N if you are pregnant or think you might be pregnant
• You must not use PRIMOLUT N during breastfeeding
• Driving or using machines There are no known effects
• PRIMOLUT N contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine

Interactions and medicines to check

The approved leaflet names these interactions.

• can have an influence on the blood levels of PRIMOLUT N
• can make it less effective
• can cause unexpected bleeding. These include:
• medicines used for the treatment of: o epilepsy (e.g. phenytoin, barbiturates, primidone, carbamazepine, oxcarbamazepine, topiramate, felbamate) o tuberculosis (e.g. rifampicin)
• HIV and Hepatitis C Virus infections (so-called protease inhibitors and nonnucleoside 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 (primarily used for the treatment of depressive moods)
• grapefruit juice. PRIMOLUT N may influence the effect of other medicines, e.g.: o ciclosporin o lamotrigine o midazolam o theophylline o melatonin o tizanidine Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Laboratory tests If you need a blood test, tell your doctor or the laboratory staff that you are taking PRIMOLUT N, because it can affect the results of some tests. PRIMOLUT N with food and drink The tablets are to be swallowed whole with some liquid

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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