Concerta  18 mg Tablets

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

Do not take CONCERTA:

• If you are hypersensitive (allergic) to methylphenidate or any of the other ingredients in CONCERTA (see What CONCERTA Contains).
• 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.

Warnings and precautions

Take special care with CONCERTA if you Talk to your doctor before or while taking CONCERTA if you:

• 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 CONCERTA, tell your doctor immediately.

Sport

The active ingredient in CONCERTA may show up as a drug if drug testing is performed.

Other medicines and CONCERTA

Always tell your healthcare professional if you are taking any other medicine. (This includes complimentary or traditional medicines).

• You should not use CONCERTA if you are treated or have been treated with (currently or within the previous 2 weeks) MAO inhibitors (see Do Not Take CONCERTA).
• CONCERTA should be used cautiously with vasopressor agents, a type of medicine that is used to increase your blood pressure.
• Tell your doctor if you 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).

CONCERTA with food, drink and alcohol

CONCERTA may be taken with or without food.

Pregnancy and breastfeeding

You should not take CONCERTA 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 CONCERTA.

Driving and using machines

CONCERTA may cause dizziness and could affect your ability to drive. You are therefore advised to use caution when driving, operating machinery, or doing activities that may be hazardous. It is not always possible to predict to what extent CONCERTA may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which CONCERTA affects them.

CONCERTA contains lactose

CONCERTA contains lactose (a type of sugar) which may have an effect on the control of your blood sugar if you have diabetes mellitus. Patients with the rare hereditary conditions of lactose or galactose intolerance should not take CONCERTA.

Do not share medicines prescribed for you with any other person Always take CONCERTA exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will tell you how long your treatment with CONCERTA will last. Do not stop treatment early because your symptoms may reappear. If you have the impression that the effect of CONCERTA is too strong or too weak, tell your doctor or pharmacist.

Take CONCERTA once each day in the morning. CONCERTA may be taken before or after eating. Swallow CONCERTA tablets whole with water or other liquids. Do not chew, crush or break the tablets. Take the dose prescribed by your doctor. The doctor may adjust the amount of medicine you take until it is right for you.

If you take more CONCERTA than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control center.

If you forget to take CONCERTA

Do not take a double dose to make up for forgotten individual doses. Consult a health care professional if you have questions.

If you stop taking CONCERTA

Do not stop taking CONCERTA early without your doctor’s advice because symptoms may reappear.

Not all side-effects reported for this medicine are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking CONCERTA, please consult your doctor, pharmacist or other healthcare professional for advice. Some side-effects could be serious. If you or your child has any of the side effects below, see a doctor straight away:

Frequent side effects:

• Uneven heartbeat (palpitations)
• Mood changes or mood swings or changes in personality

Less frequent side effects:

• Thinking about or feeling like killing yourself
• Seeing, feeling or hearing things that are not real, these are signs of psychosis
• Uncontrolled speech and body movements (Tourette’s)
• Signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing
• Feeling unusually excited, over-active and un-inhibited (mania)
• Heart attack
• Sudden death
• Suicidal attempt
• Fits (seizures, convulsion, epilepsy)
• Skin peeling or purplish red patches
• Inflammation or blocked arteries in the brain
• Muscle spasms which you cannot control affecting your eyes, head, neck, body and nervous system due to a temporary lack of blood supply to the brain
• Decrease in number of blood cells (red cells, white cells and platelets) which can make you more likely to get infections, and make you bleed and bruise more easily
• A sudden increase in body temperature, very high blood pressure and severe convulsions (Neuroleptic Malignant Syndrome). It is not certain that this side effect is caused by CONCERTA or other medicines that may be taken in combination with CONCERTA
• Unwanted thoughts that keep coming back
• Unexplained fainting, chest pain, shortness of breath (these can be signs of heart problems)
• Paralysis or problems with movement and vision, difficulties in speech (these can be signs of problems with blood vessels in your brain)

If you or your child has any of the side effects above, see a doctor straight away. Other side effects include the following, if they get serious, please tell your doctor or pharmacist:

Frequent:

• 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

Less frequent

• Dry eye
• Constipation
• Chest discomfort
• Blood in the urine
• Listlessness
• Shaking or trembling
• Increased need to pass urine

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 . By reporting side effects, you can help provide more information on the safety of CONCERTA.

Store at or below 25 °C. Do not use the tablets after the expiry date printed on the label. The desiccant in the pack (one or two pouches), used to keep the tablets dry, should not be eaten. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). Store all medicines out of reach of children.