Menograine Side Effects

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

Part of otc pharmacy medicine side effects side effects.

What is Menograine?

Menograine contains the active ingredient Clonidine hydrochloride.

• Active ingredient — Clonidine hydrochloride
• Registration number — M/7.3/41
• Registration holder — PHARMACARE LIMITED

It is approved for:

• MENOGRAINE belongs to a group of medicines called anti-migraine preparations, used for the prevention of migraine

Common side effects of Menograine

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

• Feeling abnormally sad or down
• disturbances in your sleep
• drowsiness, dizziness, headache
• feeling sleepy and having trouble focusing and staying awake
• slight orthostatic hypotension (a form of low blood pressure that happens when you stand up from sitting or lying down)
• dry mouth
• constipation
• feeling sick, queasiness, feeling that one is about to vomit
• vomiting
• a sore or painful lump under the tongue, pain or swelling below the jaw or ears
• tiredness

Less frequent side effects

• Gynaecomastia (enlargement of a man’s breasts)
• numbness, tingling, pins and needles, cold, warmth, tingling pressure of the skin
• seeing or hearing things that are not really there (hallucinations)
• cramps
• Raynaud’s syndrome (a condition in which some areas of the body e.g. fingers and toes feel numb and cold in response to cold temperatures or stress)
• abnormalities in liver function tests for a short period of time
• large doses have been associated with initial increases in blood pressure and high blood sugar levels that may be experienced only for a short time. Side effects with an unknown frequency:
• Anxiety
• anorexia (loss of appetite)
• parotid pain (swelling happens in parotid glands on both sides of the face, giving the appearance of “chipmunk cheeks”)
• vivid dreams
• loss of male sexual ability (impotence) and loss of sex drive (libido), difficulty in achieving and maintaining erection in males
• confusional state, being unable to tell what is real and what is not
• urinary retention (the inability to empty the bladder completely) or incontinence (lack of voluntary control over urination)
• dry, itching, or burning sensations in the eye, difficulty focusing especially near, decrease in production of tears
• nasal dryness
• fluid retention usually for a short time
• vague feeling of bodily discomfort; a general feeling of being unwell

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 clonidine or any of the other ingredients of MENOGRAINE (listed in section 6)
• If you have porphyria (a group of disorders that can cause nerve or skin problems)
• If you suffer from a slower-than-expected heart rate, generally beating fewer than 60 beats per minute (bradydysrhythmia) which has been caused by conditions such as sick-sinus syndrome or AV block of 2nd or 3rd degree

Use with care, and tell your doctor, if

• If you are using methylphenidate, a medication to treat attention deficit hyperactivity disorder (ADHD)
• If you have a previous history of depression
• If you have cerebrovascular disease (a condition that affects blood supply to the brain)
• If you have problems with your heart or previously had a heart attack
• If you have problems with your kidneys
• If you have Raynaud’s syndrome (a condition in which some areas of the body e.g. fingers and toes feel numb and cold in response to cold temperatures or stress)
• If you have damage to your nerves that relay information between your brain and the rest of your body (peripheral nerves)
• If you have difficulty passing stools (constipation)
• Do not stop taking MENOGRAINE suddenly as it may cause rebound hypertension (high blood pressure), irritability, restlessness, sweating, increased heart rate, headache and nausea, discontinuation should be done over a period of 2 to 4 days
• If MENOGRAINE is given concurrently with a beta blocking medicine (medicines used to lower blood pressure), MENOGRAINE should not be discontinued until several days after stopping the beta-blocker
• If you are going to have anaesthesia, MENOGRAINE should not be stopped, but should be given intravenously during the operation to avoid the risk of rebound hypertension (high blood pressure)
• Intravenous injection of clonidine as contained in MENOGRAINE should be given slowly to avoid a possible increase in your blood pressure especially in patients already receiving other antihypertensive medicines (medicines used to lower your blood pressure) such as guanethidine or reserpine
• If you wear contact lenses. Children and adolescent There is no experience with MENOGRAINE in children younger than 18 years

Pregnancy and breastfeeding

• You should not take MENOGRAINE if you are pregnant or breastfeeding your baby
• 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 MENOGRAINE

Interactions and medicines to check

The approved leaflet names these interactions.

• If you take medicines used to treat depression (such as tricyclic antidepressants)
• If you take water tablets (diuretics)
• If you take medicines used to lower blood pressure (antihypertensives, such as guanethidine or reserpine)
• If you take medicines which are often used to slow the heart rate or lower the blood pressure (beta-blockers)
• If you are taking medicines for heart conditions (cardiac glycosides)
• If you take alcohol or other medicines that slow down the functioning of the brain. MENOGRAINE with food and alcohol Do not take MENOGRAINE with alcohol as it may aggravate the possible side effect of drowsiness and impaired concentration

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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