Contramyl XR 18 mg Prolonged-Release Tablets

• CONTRAMYL XR contains the active substance methylphenidate that improves the activity of certain parts of the brain, which are under-active. The medicine can help improve attention (attention span), concentration and reduce impulsive behaviour.

• CONTRAMYL XR is used to treat attention deficit hyperactivity disorder (ADHD).

Do not take CONTRAMYL XR:

• • if you are hypersensitive (allergic) to methylphenidate or any of the other ingredients of CONTRAMYL XR (listed in section 6);
• • if you have increased pressure in your eye (glaucoma);
• • if you have a tumour of your adrenal gland (phaeochromocytoma);
• • if you are currently taking or have taken within the last 14 days an antidepressant known as a monoamine oxidase inhibitor (MAOI) - see ‘Taking other medicines with CONTRAMYL XR’;
• • if you have thyroid disorders;
• • if you have an eating problem when you do not feel hungry or want to eat - such as ‘anorexia nervosa’ or other anorexic disorders, severe mood disorders, 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:
• o feeling like killing yourself;
• o severe depression, where you feel very sad, worthless and hopeless;
• • diagnosis or history of severe and episodic (Type I) bipolar (affective) disorder (that is not well controlled);
• • if you have or 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 disorder;
• • if you have very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and legs;
• • if 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);
• • family history or diagnosis of Tourette’s syndrome (uncontrolled speech and body movements);
• • if you have liver or kidney function disorders;
• • if you are pregnant or breastfeeding (see ‘Pregnancy and Breastfeeding’);
• • if you are not sure, talk to your doctor or pharmacist before taking CONTRAMYL XR.
• Do not give to a child of younger than 6 years old (see ‘Take special care with CONTRAMYL XR’).

Warnings and precautions

Take special care with CONTRAMYL XR:

• • If children are not growing or gaining weight as expected, their treatment must be stopped (see sub-header ‘Children and adolescents’ below). Suppression of growth has been reported with long-term use of medicines such as CONTRAMYL XR.
• • If you are an adult - the safety and efficacy have not been established for the initiation of treatment or the routine continuation of treatment beyond 18 years of age. Your doctor will review the need for further treatment on a regular basis.
• • If you are elderly - you should not receive CONTRAMYL XR as safety and efficacy has not been established in this age group.

Do not share medicines prescribed for you with any other person. Always take CONTRAMYL XR exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is:

• • You should take CONTRAMYL XR once each day in the morning with a glass of water and must not be chewed, divided or crushed.
• • Even though the tablets have a score line, it is not intended as a break line and the tablets should not be divided and taken at different intervals.
• • You may take CONTRAMYL XR with or without food.
• • Your doctor will usually start CONTRAMYL XR treatment with a low dose and increase it gradually as required.

Elderly: The use of CONTRAMYL XR in elderly patients over 65 years has not been studied.

If you take more CONTRAMYL XR than you should

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

If you forget to take a dose of CONTRAMYL XR

• • If you miss a dose, wait and take your next dose at the usual time.
• • Do not take a double dose to make up for forgotten individual doses.

If you stop taking CONTRAMYL XR

• • If you suddenly stop taking CONTRAMYL XR, the symptoms may come back or unwanted effects such as depression may appear.
• • Your doctor may want to gradually reduce the amount of medicine taken each day, before stopping it completely. Talk to your doctor before stopping CONTRAMYL XR.

If you have any further questions on the use of CONTRAMYL XR, ask your doctor.

CONTRAMYL XR can have side effects. Not all side effects reported for CONTRAMYL XR are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking CONTRAMYL XR, please consult your healthcare provider for advice.

If any of the following happens, stop taking CONTRAMYL XR and tell your doctor immediately or go to the casualty department at your nearest hospital:

• • Anaphylactic reactions - this is an immediate hypersensitivity reaction resulting in life-threatening breathing difficulty, usually followed by collapse of the arteries and veins and shock;
• • hypersensitivity reactions including pruritus and sudden swelling of the skin or mucous membranes (e.g. throat or tongue) with difficulty breathing;
• • flaking off of skin (skin peeling) itching of the skin; rashes and eruptions; or purplish red patches;
• • a sudden increase in body temperature, very high blood pressure and severe convulsions (‘Neuroleptic Malignant Syndrome’). These are all very serious side effects. If you have them, you may have had a serious reaction to CONTRAMYL XR. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• • disturbance in or loss of regular heart rhythm; fast heartbeat (tachycardia); awareness of one’s own heartbeat;
• • unexplained fainting, shortness of breath (these can be signs of heart problems), heart attack and sudden cardiac death, increase in heart rate, slowness of the heartbeat, as evidenced by slowness of the pulse rate, fast or extra heartbeats;
• • tics (hard-to-control, repeated twitching of any parts of the body or repeating sounds and words);
• • mania (feeling unusually excited, overactive and uninhibited); disorientation; confusion;
• • excessive drowsiness or sleepiness;
• • psychotic disorders (seeing, feeling, or hearing things that are not real and not there, these are signs of psychosis);
• • suicidal ideation - suicide attempt (including completed suicide); transient depressed mood; abnormal thinking; lack of feeling or emotion (apathy); repetitive behaviours; over-focussing; a belief or impression that is not in accordance with a generally accepted reality (delusion); thought disturbance;
• • abuse and dependence;
• • fits (seizures, convulsions, epilepsy, a major fit (Grand mal convulsion));
• • problems with the blood vessels in your brain (stroke);
• • cerebral arteritis and/or occlusion; peripheral coldness; fingers and toes feeling numb, tingling and changing colour (from white to blue, then red) when cold (Raynaud’s phenomenon);
• • liver enzyme elevations; abnormal liver function; including hepatic coma. These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

The following side effects have been reported frequently:

• • inflammation of the throat; upper respiratory tract infection; sinus infection;
• • anorexia; decreased appetite and weight loss; reduced height gain during prolonged use in children;
• • not being able to sleep; nervousness;
• • rapid changes in emotion; aggression; agitation; feeling anxious; depression; irritability; mood swings;
• • decreased interest in sex;
• • grinding of the teeth; panic attack;
• • dizziness;
• • difficulty of moving; sensation of movement;
• • unpleasant tingling feeling in arms or legs;
• • tension headache;
• • eye focus impairment;
• • high blood pressure;
• • cough, pain in mouth and throat;
• • stomach pain; diarrhoea; nausea; stomach discomfort; vomiting; dry mouth; upset stomach or indigestion;
• • loss of hair; itching of the skin; rash; smooth, slightly elevated area on the skin, which is redder and paler than the surrounding skin;
• • pain in a joint; muscle tightness; muscle spasms or cramps;
• • growth retardation during prolonged use in children;
• • fatigue;
• • feeling jittery; lack or loss of strength or energy; thirst;
• • increased alanine aminotransferase (this will be established by blood tests).

The following side effects have been reported less frequently:

• • anaemia (reduced numbers of red blood cells which can cause tiredness, headaches and shortness of breath);
• • leucopenia (reduction in the number of white blood cells);
• • thrombocytopenia (reduction in the number of blood platelets which are cells that help blood to clot);
• • swelling of the ear(s);
• • worsening of pre-existing tics (hard-to-control, repeated twitching of any parts of the body or repeating sounds and words);
• • excessive, rapid speech;
• • abnormally increased responsiveness;
• • sedation;
• • tremor;
• • blurred vision; dry eyes;
• • difficulties in visual focusing; visual disorders, seeing double;
• • hot flush;
• • constipation;
• • hyperhidrosis (excessive sweating); macular rash;
• • pain in a muscle or muscles; muscle twitching; muscle cramps;
• • blood in the urine; pollakiuria (frequent, abnormal urination during the day);
• • swelling of the breasts in men;
• • chest pain;
• • 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.

The following side effects have been reported but the frequency is unknown:

• • Pancytopenia (a decrease in all types of blood cells);
• • migraine;
• • abnormal dilation of the pupil (mydriasis);
• • restriction of motion of the jaws;
• • fever;
• • erectile dysfunction;
• • urinary frequency - inability to control the excretion of urine (incontinence);
• • liver failure.

Post-marketing possible side effect:

• Nosebleed.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of CONTRAMYL XR.

Store all medicines out of reach of children. Store at or below 25 oC. Keep the container tightly closed. Keep in the original container until required for use. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). Do not store in a bathroom.