Radd 18 mg Tablets

RADD contains methylphenidate hydrochloride, one of a group of medicines called centrally acting sympathomimetics. RADD is used:

• in children over the age of 6 years and adults in the treatment of Attention Deficit Hyperactivity Disorder (ADHD)
• only after trying treatments which do not involve medicines, such as counselling and behavioural therapy.

RADD 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.

Do not take RADD:

• if you are hypersensitive (allergic) to methylphenidate hydrochloride or any of the other ingredients of RADD (see section 6)
• if you currently suffer from anxiety, tension and agitation as RADD may make these symptoms worse
• if you have poorly controlled open-angle or angle-closure glaucoma (increased pressure in your eye)
• 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) - (see Other medicines)
• if you or anyone in your family has been diagnosed with Tourette’s syndrome (sudden, brief, intermittent movements or sounds that you have no control over)
• if you have a thyroid problem
• if you have an eating problem where you do not feel hungry or want to eat - such as anorexia nervosa
• if 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 such as feeling like killing yourself, severe depression, where you feel very sad, worthless and hopeless or mania, where you feel unusually excitable, over-active, and uninhibited
• if you have been diagnosed with Bipolar disorder and the symptoms are not properly controlled
• 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 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)
• if you are pregnant or breastfeeding your baby.

Warnings and precautions

RADD treatment is not indicated in all children with ADHD. Your doctor will decide if your child should use this medicine, based on a very thorough assessment of the severity and how long your child has been experiencing these symptoms in relation to their age.

RADD is not for use in children under 6 years of age and in elderly patients (over 65 years)

RADD does not have to be taken forever. Treatment will generally stop after puberty

Take special care with RADD:

• if you have high blood pressure as RADD could worsen this condition
• if you have a heart problem as RADD could worsen the condition and result in unwanted side effects
• if you are at risk of any condition that may affect the blood vessels of the brain (stroke or mini-stroke, are taking medicine to increase your blood pressure) your doctor will request to see you on a frequent basis for a check-up
• if you have hard-to-control, repeated twitching of any parts of the body or you repeat sounds and words as RADD may make these conditions worse
• if you currently suffer from depression or fatigue (extreme tiredness/weakness) as RADD may worsen these conditions
• if you have a mental health problem as RADD may increase the symptoms

Do not share medicines prescribed for you with any other person. Always take RADD exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. RADD should not be used in children under the age of 6 years. RADD, being a prolonged-release tablet, is taken once daily, in the morning, with or without food.

RADD must be swallowed whole with adequate liquid and must not be chewed, divided or crushed. Your doctor will prescribe a dose suitable to you, starting you on the lowest dose and increasing the dose slowly (once a week) should this be required. The maximum daily dosage of RADD is 54 mg in children aged 6 - 13 years; 72 mg in adolescents aged 13 - 18 years and 108 mg in adults.

The usual dose is Patients new to RADD: The recommended starting dose of RADD for patients who are not currently taking RADD is 18 mg once daily for children, and adolescents, and 18 or 36 mg once daily for adults. Patients currently taking another medicine containing Methylphenidate hydrochloride, twice or three times daily: If you are changing from your current ADHD medicine (that you take two or three times a day) to RADD, your doctor will prescribe a starting dose suitable to you and gradually increase the dose if required.

Long-term treatment: If you are undergoing long-term treatment (longer than 12 months), your doctor will discontinue your treatment from time to time to monitor your progress. Your doctor will tell you how long your treatment with RADD will last. Do not stop treatment early because the ADHD symptoms may come back or unwanted effects such as depression may appear.

If you have the impression that the effect of RADD is too strong or too weak, tell your doctor or pharmacist.

If you take more RADD than you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Symptoms of overdose may include: Vomiting, feeling agitated, shaking, increased uncontrolled movements, muscle twitching, fits (may be followed by coma), depression, confusion, seeing, feeling or hearing things that are not real (hallucinations), sweating, flushing, headache, high fever, changes in heart beat (slow, fast or uneven), high blood pressure, dilated pupils and dry nose and mouth.

If you forget to take RADD, take a dose as soon as you remember, then continue to take RADD at the usual times. Do not take a double dose to make up for forgotten individual doses.

If you stop taking RADD It is important that you continue the course of treatment even if you begin to feel better after a few days. If you suddenly stop taking this medicine, the ADHD symptoms may come back or unwanted effects such as depression may appear. Your doctor may want to gradually reduce the amount of RADD taken each day, before stopping it completely.

RADD can have side effects. Not all side effects reported for RADD are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using RADD, please consult your doctor, pharmacist or other healthcare professional for advice.

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

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• seizures

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to RADD. 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:

• uneven heartbeat (palpitations), increased, irregular or fast heartbeat (tachycardia), slower than normal heartbeat (bradycardia)
• mood changes or mood swings or changes in personality, confusion, depression, anxiety, aggression, delusions, abnormal behaviour, mood-swings
• thinking about or feeling like killing yourself
• hallucinations (hearing voices or seeing things which are not there), believing things that are not true or being suspicious
• uncontrolled speech and body movements (Tourette’s), seizures (fits), tremors
• feeling unusually excited, over-active and un-inhibited (mania)
• chest pain, swelling of the face, fluid accumulation in the lungs
• severe heart rhythm problems that may be life threatening (ventricular fibrillation)
• abnormal or deterioration of brain function, the occurrence of confusion, altered level of consciousness, coma
• 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
• sudden increase in body temperature, very high blood pressure and severe convulsions (Neuroleptic Malignant Syndrome)
• medicine dependence
• prolonged erections, sometimes painful or an increased number of erections
• Blood in the urine, passing more urine than is normal.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• lack of interest or concern, feeling nervous, sleep disturbances (insomnia)
• headache, dizziness, drowsiness
• joint pain, muscle tightness, muscle cramps
• vision disorder, loss of balance (vertigo)
• problems with sex drive, inability to develop or maintain an erection
• skin conditions ranging from a rash, hair loss, hives, itchy skin
• loss of appetite or decreased appetite, weight loss, anorexia
• feeling unusually sleepy or drowsy, feeling tired, tingling feeling, prickling, or numbness of the skin (pins and needles)
• cough, sore throat or nose and throat irritation, inflammation of sinuses
• high blood pressure
• feeling weak, movements which you cannot control, being unusually active, feeling aggressive, agitated, anxious, depressed, irritable, tense, jittery and abnormal behaviour, clenching or grinding your teeth, feeling of panic
• Upset stomach or indigestion, stomach pain, diarrhoea, nausea, stomach discomfort and vomiting, dry mouth, thirst.

Less frequent side effects:

• bruising, and slow blood clotting after injury, excessive bleeding
• anger, feeling restless or tearful, talking too much, excessive awareness of surroundings, repetitive actions
• blurred vision dry eye, vision changes, double vision
• chest pain and discomfort, hot flush
• difficulty breathing, cold
• constipation
• abnormal liver function (clay coloured stool, dark urine, itching, loss of appetite, yellow eyes or skin)
• skin conditions causing blisters and peeling
• muscle pain, muscle twitching, muscle cramps
• Enlarged breast tissue in males.

The following side effects have been reported but the frequency for them to occur is not known:

• dilation of the pupil of the eye
• cold and discoloured fingers and toes (Raynaud’s syndrome)
• high fever
• nosebleed
• migraine
• liver failure
• inability to control the excretion of urine (incontinence)
• A reduction in the desirable and beneficial effects of treatment.

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 RADD. You can also send an email directly to the company, [email protected], to ensure safety of the product.

Store all medicines out of reach of children.

Store at or below 30 °C in original container. Keep the container tightly closed. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).