Neucon Side Effects

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

What is Neucon?

Neucon contains the active ingredient Methylphenidate hydrochloride.

• Active ingredient — Methylphenidate hydrochloride
• Registration number — 46/1.2/0380; 46/1.2/0381; 46/1.2/0382; 46/1.2/0383
• Registration holder — JANSSEN PHARMACEUTICA (PTY) LTD

It is approved for:

• NEUCON is used for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents aged 6-17 and adults aged 18-65

Common side effects of Neucon

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
• Feeling nervous
• Not being able to sleep
• Joint pain
• Blurred vision
• Tension headache
• Dry mouth, thirst
• Trouble falling asleep
• High temperature (fever)
• Problems with sex drive
• Decreased interest in sex
• Unusual hair loss or thinning
• Muscle tightness, muscle cramps
• Loss of appetite or decreased appetite
• Inability to develop or maintain an erection
• Itching, rash or raised red itchy rashes (hives)
• Feeling unusually sleepy or drowsy, feeling tired
• Clenching or grinding your teeth, feeling of panic
• Tingling feeling, prickling or numbness of the skin
• Increased alanine aminotransferase (liver enzyme) level in your blood
• Cough, sore throat or nose and throat irritation, upper respiratory tract infection, sinus infection
• High blood pressure, fast heart beat (tachycardia)
• Dizziness (vertigo), feeling weak, movements which you cannot control, being unusually active
• Feeling aggressive, agitated, anxious, depressed, irritable, tense, jittery and abnormal behaviour
• Upset stomach or indigestion, stomach pain, diarrhoea, feeling sick, stomach discomfort and being sick

Less frequent side effects

• Dry eye
• Constipation
• Chest discomfort
• Blood in the urine
• Listlessness
• Shaking or trembling
• Increased need to pass urine
• Muscle pain, muscle twitching
• Persistent and painful erection of the penis
• Shortness of breath or chest pain
• Feeling hot
• Increased in liver test results (seen in a blood test)
• Anger, feeling restless or tearful, talking too much, excessive awareness of surroundings, problems sleeping
• Feeling disorientated or confused
• Trouble seeing or double vision
• Swelling of the breasts in men
• Excessive sweating, redness of the skin, red raised skin rash
• Muscle cramps
• Small red marks on the skin
• Abnormal liver function including liver failure and coma
• Changes in test results – including liver and blood tests
• Abnormal thinking, lack of feeling or emotion, doing things over and over again, being obsessed with one thing
• Fingers and toes feeling numb, tingling and changing colour (from white to blue, then red) when cold (Raynaud phenomenon)
• Liver damage
• Sudden liver failure
• Migraine
• Dilated pupils
• Very high fever
• Slow, fast or extra heart beats
• A major fit (grand mal convulsions)
• Believing things that are not true
• Severe stomach pain, often with feeling and being sick
• Nosebleeds If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet

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 methylphenidate or any of the other ingredients in NEUCON
• If you have glaucoma, an eye disease
• If you are being treated or have recently been treated with monoamine oxidase (MAO) inhibitor medicines
• If you have hereditary problems of galactose intolerance (Lapp lactase deficiency of glucose-galactose malabsorption)
• If you have hyperthyroidism (an overactive thyroid), severe angina (chest pain) or heart rhythm problems

Use with care, and tell your doctor, if

• Have a heart defect
• Have tics (movements or sounds that you cannot control) or Tourette’s syndrome, or if someone in your family has tics or Tourette’s syndrome
• Have eye problems, such as:
• Increased pressure in the eye
• A condition called “glaucoma”
• Far-sightedness (difficulty seeing near objects)
• Have serious mental health problems, such as:
• Believing things that are not true (delusions)
• Seeing, feeling, hearing, or smelling things that are not there (hallucinations)
• Being very over-active or over-excited
• Become aggressive, anxious or agitated or feel more aggressive, anxious or agitated than usual
• Problems with blood vessels in the brain (such as inflamed blood vessels, stroke caused by a burst blood vessel or blocked blood supply to the brain)
• Develop a persistent and painful erection of the penis
• Develop severe headaches, weakness, or paralysis of any body part, or develop problems with coordination, vision, speaking, finding words or with your memory
• have a history of drug dependence or alcoholism
• have a narrowing or blockage of the gut, foodpipe (or oesophagus), stomach, or intestines)
• Are not growing as expected for your age. Your doctor may carefully watch your height and weight
• have high blood pressure
• have kidney or liver problems
• have glaucoma, an eye disease. If you develop any of the above conditions or symptoms while taking NEUCON, tell your doctor immediately. Sport The active ingredient in NEUCON may show up as a drug if drug testing is performed

Pregnancy and breastfeeding

• You should not take NEUCON 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 health care provider for advice before taking

Interactions and medicines to check

The approved leaflet names these interactions.

• You should not use NEUCON if you are treated or have been treated (currently or within the previous 2 weeks) MAO inhibitors
• should be used cautiously with vasopressor agents, a type of medicine that is used to increase your blood pressure
• Tell your doctor if your take clonidine, a medicine used to treat high blood pressure
• Make sure your doctor knows if you take a type of medicine for depression or anxiety called a ‘serotonin reuptake inhibitor’ (SSRI) or a ‘serotonin and norepinephrine reuptake inhibitor’ (SNRI). NEUCON with food, drink and alcohol NEUCON may be taken with or without food

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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