Like all medicines, methylphenidate can cause side effects, but not everybody gets them. While most people find that this medicine helps them, headache, feeling nervous and not being able to sleep are very common side effects, affecting more than 1 in 10 people. Please read the Patient Information Leaflet inside the methylphenidate oral solution packaging for full information on all of the possible side effects of this medicine.

Side effects are the unwanted things that can happen when you take a medicine. If any of the following happen or if you have any concerns about other possible side effects tell an adult you trust straight away. They can then talk to your doctor.

The main things that could affect you are:

• Feeling or being sick, having tummy pains or having a dry mouth. These may only happen when you first start taking the medicine. It is best to take the medicine with food
• Feeling worried or nervous
• Feeling shaky, trembling or being unusually active
• Feeling dizzy, or getting headaches
• Being very depressed and unhappy or wanting to hurt yourself
• Being very sweaty
• Having different moods than usual, not being able to get to sleep
• Skin rashes, bruising easily, getting out of breath or chest pains
• The medicine can also make you feel sleepy. If you feel sleepy, it is important not to do outdoor sports like riding a horse or bike, swimming or climbing trees. You could hurt yourself and others.
• Your heart beating faster than usual.
• Mood changes or mood swings or changes in personality.
• Excessive teeth grinding (bruxism).

Other common side effects include:

• joint pain
• dry mouth
• high temperature (fever)
• unusual hair loss or thinning
• feeling unusually sleepy or drowsy
• loss of appetite or decreased appetite
• decreased weight
• itching, rash or raised red itchy rashes (hives)
• cough, sore throat or nose and throat irritation
• high blood pressure, fast heartbeat (tachycardia)
• feeling dizzy, movements which you cannot control, being unusually active
• feeling aggressive, agitated, anxious, depressed, irritable and abnormal behaviour
• stomach pain, diarrhoea, feeling sick, stomach discomfort and being sick.

These usually occur at the beginning of the treatment and may be reduced by taking the medicine with food.

If your child has side effects
If your child experiences any side effects while taking methylphenidate oral solution, tell a healthcare professional. This includes any possible side effects not listed in the Patient Information Leaflet found inside methylphenidate oral solution packaging. You can also report side effects directly to the Medicines and Healthcare products Regulatory Agency (MHRA) via the Yellow Card Scheme at https://yellowcard.mhra.gov.uk/. By reporting side effects, you can help provide more information on the safety of this medicine.

Seek advice from a healthcare professional straightaway if you notice changes in your child’s mood or any problems with their heart while on methylphenidate therapy.

Do not take Methylphenidate if:

• • you are allergic to methylphenidate or any of the other ingredients of this medicine (listed in Section 6)
  • you have a thyroid problem
  • you have increased pressure in your eye (glaucoma)
  • you have a tumour of your adrenal gland (phaeochromocytoma)
  • you have an eating problem when you do not feel hungry or want to eat – such as ‘anorexia nervosa’
  • you have very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and legs
  • you have ever had heart problems – such as a heart attack, uneven heartbeat, pain and discomfort in the chest, heart failure, heart disease or were
    born with a heart problem
  • you have had a problem with the blood vessels in your brain – such as a stroke, swelling and weakening of part of a blood vessel (aneurysm), narrow or blocked blood vessels, or inflammation of the blood vessels (vasculitis)
  • you have mental health problems such as:
    – a ‘psychopathic’ or ‘borderline personality’ problem
    – abnormal thoughts or visions or an illness called ‘schizophrenia’
  • signs of a severe mood problem like:
    – severe depression, where you feel very sad, worthless and hopeless
    – mania, where you feel unusually excitable, over-active, and un-inhibited.

Do not take Methylphenidate if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before you take Methylphenidate.

This is because methylphenidate can make these problems worse.