Migril Side Effects

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

What is Migril?

Migril contains the active ingredient Ergotamine tartrate, Cyclizine hydrochloride, Caffeine hydrate.

• Active ingredient — Ergotamine tartrate, Cyclizine hydrochloride, Caffeine hydrate
• Registration holder — iNova Pharmaceuticals (Pty) Ltd

It is approved for:

• S2 Migril is used in the treatment of migraines and to relief the symptoms and to stop the attack getting worse

Common side effects of Migril

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

• headache, dizziness, drowsiness
• diarrhoea, nausea and vomiting, stomach pain or bloating
• dryness of the mouth, nose and throat
• difficulty urinating

Less frequent side effects

• itching of skin

Frequency unknown side effects

• shortness of breath
• numbness and tremors
• anxiety, depression, confusion and hallucinations
• difficulty moving and thinking
• muscle cramps and joint pains
• sleep disturbances, including insomnia

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

• you are hypersensitive (allergic) to ergotamine tartrate, cyclizine hydrochloride, caffeine hydrate or any of the other ingredients of Migril (listed in section 6)
• if you are pregnant or breastfeeding
• if you have a disease of the blood vessels which includes coronary disease, obliterative vascular disease (narrowing of the arterial tree), chest pain, claudication (cramp-like pain and weakness in muscles), peripheral ischemia (deficiency of blood in legs, feet and hands)
• if you have Raynaud’s Syndrome
• if you have severe high blood pressure or heart problems
• if you recently had, or are planning to have angioplasty (surgical repair or unblocking of a vessel) or surgery to arteries and veins
• if you have porphyria
• if you have hyperthyroidism (overactive thyroid gland), sepsis (severe infections), kidney and liver disease, lack of proper nutrition and anaemia (deficiency of red cells in blood)
• if you have conditions such as glaucoma (increased pressure in the eye), bladder neck obstruction, inability to completely empty your bladder, enlarged prostate gland, and intestinal blockage
• if you suffer from anxiety disorders or sleeplessness
• if you have a peptic ulcer
• if you are HIV positive and are being treated with HIV-protease inhibitor medicine which are potent CYP 3A4 inhibitors, such as amprenavir, indinavir, nelfinavir, ritonavir
• Migril should not be given to children

Use with care, and tell your doctor, if

• If you are elderly, as you may be more susceptible to complications associated with sudden constriction of a blood vessel (vasospasm) and a dangerously low body temperature (hypothermia)
• if you are a heavy smoker, as it may increase your risk of peripheral ischemia (deficiency of blood in legs, feet and hands)
• if you have an acute infectious disease of the liver, as you may have an increased risk of precipitating peripheral ischaemia (deficiency of blood in legs, feet and hands)
• if you have problems of lactose intolerance, or glucose-galactose malabsorption

Pregnancy and breastfeeding

• Do not take Migril if you are pregnant, want to become pregnant or are breastfeeding

Interactions and medicines to check

The approved leaflet names these interactions.

• Always tell your health care provider if you are taking any other medicines
• (This includes all complementary or traditional medicines.) The following medicines can cause interactions with the Migril ingredient, ergotamine tartrate: Potent CYP3A4 inhibitors such as amprenavir, indinavir, nelfinavir and ritonavir (used in the treatment of HIV)
• Ergot alkaloids and beta-blocking agents (high blood pressure medicines) Antibiotics such as clarithromycin, erythromycin, tetracycline
• Vasoconstrictors (medicines that narrow blood vessels) and local anaesthetic solutions containing vasoconstrictors
• Nitroglycerine (used to widen blood vessels)
• Other antimigraine products such as methysergide, serotonin agonists, sumatriptan, almotriptan, rizatriptan and zolmitriptan
• Products called sympathomimetics
• It may cause severe elevation of blood pressure and narrowing of blood vessels
• The following medicines can cause interactions with the Migril ingredient, cyclizine hydrochloride: Alcohol and other central nervous system depressants, e.g
• hypnotics and tranquilisers

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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