Methycap 10 mg Capsules

METHYCAP LA 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. METHYCAP LA is used for Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 years and older and in adults with ADHD onset in childhood. ADHD is a medical condition where the child or adult has difficulty in paying attention and staying focused on most tasks given to them. They also tend to move around a lot and are very fidgety (making unnecessary fuss). METHYCAP LA is prescribed only by a specialist in behavioural disorders. This specialist will follow up your further treatment. A thorough examination is necessary. If you are an adult and have not been treated before, the specialist will carry out tests to confirm that you have had ADHD since childhood. Using treatment programmes as well as medicine helps to manage ADHD.

Do not take METHYCAP LA:

• if you are hypersensitive (allergic) to methylphenidate, or to any of the ingredients of METHYCAP LA (see section 6)
• if you suffer from anxiety, tension or agitation
• if you have uncontrolled speech and body movements (Tourette’s syndrome) or if any other family members suffer from Tourette’s syndrome
• if you have a thyroid problem
• 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 feeling like killing yourself, severe depression (where you feel very sad, worthless and hopeless), mania (where you feel excitable, over-active and uninhibited), anorexia
• if you have increased pressure in your eye (glaucoma)
• if you have a tumour of your adrenal gland (phaeochromocytoma)
• 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
• If you have very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and legs
• 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 taking a medicine called a ‘monoamine oxidase inhibitor’ (MOI) used for depression or have taken a MAOI in the last 2 weeks
• if you are pregnant or breastfeeding your baby.

Do not take METHYCAP LA if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before you take METHYCAP LA. This is because METHYCAP LA may make these problems worse.

Warnings and precautions

Take special care with METHYCAP LA if you or your child:

• unexpectedly experience prolonged erections during treatment, in both children and adults. This may be painful and can occur at any time. It is important to contact your doctor straight away if your erection lasts for longer than 2 hours, particularly if this is painful.
• experience a combination of the following symptoms: mental status changes (e.g. agitation, hallucinations, delirium, and coma) a dysfunction of the nerves that regulate non-voluntary body functions, such as heart rate, blood pressure and sweating (irregular heartbeat, temporary high blood pressure, dizziness, excessive sweating, flushing, overheating), muscular problems (e.g. tremor, rigidity, muscle jerks, overactive or overresponsive bodily reflexes, incoordination), seizures/fits and gastrointestinal problems (e.g. nausea, vomiting, diarrhoea) while taking METHYCAP LA with medicines that raise the level of serotonin in the body (serotonergic medicines, for example those used to treat depression like sertraline and venlafaxine), stop treatment with METHYCAP LA and medicines that raise the level of serotonin in the body and tell your doctor immediately
• have a history of drug or alcohol abuse
• have had fits, epilepsy, convulsions, seizures
• have high blood pressure (hypertension)
• have any heart defects (e.g. structural cardiac abnormality) or any other current or previous heart problems
• have or have had any disorder of the blood vessels in the brain e.g. weakening of blood aneurysm, stroke, inflammation of blood vessels (vasculitis) - symptoms of vasculitis include severe headache, numbness, weakness, paralysis, and impairment of coordination, vision, speech, language or memory
• have acute mental disorders that cause abnormal thinking and perceptions, psychosis or feeling unusually excited, over-active and uninhibited acute mania – your doctor will have told you if you have this
• if you have depression, anorexia nervosa/anorexic disorders (an eating disorder causing people to obsess about weight and what they eat), suicidal tendencies, psychotic symptoms, severe mood disorders, mania (extremely elevated and excitable mood), schizophrenia (a disorder that affects a person's ability to think, feel and behave clearly), psychopathic/borderline personality disorder (a mental disorder characterised by unstable moods, behaviour and relationships)
• experience psychotic symptoms such as seeing or feeling things that are not really there (hallucinations)
• already have, or start to experience aggressive behaviour
• experience any suicidal thoughts or behaviour
• already have or start to experience hard-to-control, repeated twitching of any parts of the body or you repeat sounds and words, or if any other family members suffer from tics
• have been diagnosed with any form of bipolar disorder (see Do not take METHYCAP LA)
• experience slower weight gain and slightly slower growth when using METHYCAP LA for a long time. There is evidence that patients with ADHD may become addicted to METHYCAP LA, especially in patients who have a history of drug or alcohol abuse. METHYCAP LA will be given to you or your child only under close medical supervision and after a proper diagnosis. METHYCAP LA is not indicated for use in children under the age of 6 years.

Do not share medicines prescribed for you with any other person. Always use METHYCAP LA exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure.

Adults

Your doctor will tell you how many capsules to take. The usual starting dose in patients taking METHYCAP LA for the first time is 20 mg daily. If you have previously been treated with an immediate-release medicine containing methylphenidate for ADHD, your doctor will inform you of the relevant dosage to take. Your doctor will monitor your progress and may increase your dose at weekly intervals in 20 mg increments. The highest recommended daily dose in adults is 80 mg.

Children and adolescents (6 years and older):

The doctor will tell you how many capsules of METHYCAP LA to give your child. The usual starting dose is 20 mg once daily, gradually increased until an improvement is noticed. A lower dose starting at 10 mg may be recommended by your doctor. The highest recommended total daily dose is 60 mg.

When and how to take METHYCAP LA

Take METHYCAP LA once daily in the morning, with or without food. Swallow the capsule as a whole with water. Do not crush, chew or divide the capsule or the contents. If you or your child are unable to swallow a METHYCAP LA capsule, you can sprinkle the contents on a small amount of food, as follows:

• carefully open the capsule and sprinkle the beads over a small amount of soft food (e.g. apple-sauce)
• the food should not be warm because this could affect the special properties of the beads
• immediately swallow all of the medicine/food mixture.
• this soft food mixture should not be chewed; it must be swallowed only
• do not store any medicine/food mixture for future use.

If you do not feel better, tell your doctor. They may decide you need a different treatment. Your doctor will tell you how long your treatment with METHYCAP LA will last. Do not stop treatment early because stopping treatment immediately can cause unwanted side effects. If used inappropriately, this medicine may become addictive. Treatment for ADHD varies in length from patient to patient. The doctor may discontinue METHYCAP LA periodically to see whether it is still needed. If you have the impression that the effect of METHYCAP LA is too strong or too weak, tell your doctor or pharmacist.

If you take more METHYCAP LA 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, agitation, tremors, hyperreflexia (overactive or overresponsive bodily reflexes), muscle twitching, convulsions (may be followed by coma), euphoria (a feeling or state of intense excitement and happiness), confusion, hallucinations, delirium (a serious change in mental abilities), sweating, flushing, headache, fever, irregular heartbeats, high blood pressure, mydriasis (diluted pupils), dryness of mucous membranes and red-brown urine which could be possible signs of abnormal breakdown of muscles (rhabdomyolysis).

If you forget to take METHYCAP LA

METHYCAP LA capsules should not be taken too late in the morning as it may cause disturbances in sleep. If you miss your morning dose, take your normal dose the next day. Do not take a double dose to make up for forgotten individual doses.

If you stop taking METHYCAP LA

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 medicine taken each day, before stopping it completely. Talk to your doctor before stopping METHYCAP LA.

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

If any of the following happens, stop using METHYCAP LA 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
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to METHYCAP LA. 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)
• changes in personality, anxiety, restlessness, depression, disorientation, abnormal thinking
• excessive teeth grinding (bruxism)
• thinking about or feeling like killing yourself
• feeling, or hearing things that are not real, these are signs of psychosis or hallucinations
• uncontrolled speech and body movements (Tourette’s), fits (seizures, convulsions epilepsy), fast heartbeat, chest pain, uncontrollable twitching and jerking (sign of dyskinesia)
• mood changes/mood swings, feeling unusually excited, over-active and un-inhibited (mania), disorientation, hypervigilance, confusion, dependence, delusions, thought disturbances, excessive and often incoherent talkativeness or wordiness
• tightness or pain in the chest, neck, back or arms, as well as fatigue, lightheadedness, abnormal heartbeat and anxiety (symptoms of a heart attack)
• severe headache or confusion, weakness or paralysis of limbs or face, difficulty speaking (signs of disorders of blood vessels 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
• skin peeling or purplish red patches (sign of erythema multiforme)
• skin blisters or itching (sign of exfoliative dermatitis)
• prolonged erection, causing discomfort of the penis (sign of priapism)
• 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 (thrombocytopenia)
• fatigue, weakness, dizziness, trouble breathing, fast heartbeat, fever, pale skin, purple or red spots on the skin, rash, easy bruising, and abnormal bleeding (pancytopenia).

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:

• sore throat and runny nose
• decreased appetite
• nervousness, insomnia (sleeplessness), uncontrollable outburst of laughter or crying, aggression, irritability, abnormal behaviour, lower sex drive, panic attack, stress, anxiety, restlessness, sleep disorder, agitation
• uncontrolled, involuntary muscle movement. tremors, headache, drowsiness, dizziness, restlessness or an inability to sit still, sleepiness
• high blood pressure, coldness of hands and feet
• cough, pain in your throat, difficulty breathing
• nausea, dry mouth, stomach pain and discomfort, diarrhoea, vomiting, indigestion, toothache
• rash, itching, hives, fever, hair loss, excessive sweating
• joint pain, swelling and stiffness
• feeling jittery, fever, thirst, growth retardation, fatigue
• weight loss, blood pressure and heart rate changes (increased).

Less frequent side effects:

• stomach flu
• anaemia, easy bruising, bleeding and pinpoint-sized reddish-purple spots on the lower legs, abnormal blood test results, a problem with the blood-forming stem cells in the bone marrow (symptoms include fatigue, weakness, dizziness, trouble breathing, fast heartbeat, fever, pale skin, purple or red spots on the skin, rash, easy bruising, and abnormal bleeding)(leucopenia)
• anorexia (no appetite), reduced weight and height gain during prolonged use in children
• hyperactivity, anger, tearfulness, mood swings, apathy, tension, disorientation, repetitive behaviour, over-focusing, sex drive disorder, abuse, and dependence
• temporary muscle weakness, sedation, movement disorder, speech impediment, loss of skin sensation or other functions of the body due to a temporary lack of blood supply to the brain (reversible ischaemic neurological deficit)
• blurred vision, difficulties in visual accommodation, dilated pupils, visual disturbances
• chest pain
• inflammation and/or blocking of central nervous system arteries, cold hands and feet, fingers and toes feeling numb, tingling and changing colour (from white to blue, then red) when cold (Raynaud’s phenomenon)
• constipation
• abnormal liver function including liver coma
• easy bruising, bleeding and pinpoint-sized reddish-purple spots on the lower legs, painless swelling under the skin, itchy, hive-like welts or fluid-filled blisters, peeling skin, skin rash with red bumps on a flat, red patch of skin
• muscle cramps, muscle tightness, muscle twitching, muscle pain
• blood in urine
• breast enlargement in males
• decrease in number of blood cells (red cells, white cells and platelets), blood test for alkaline phosphatase increased, heart murmur, liver enzyme increased (as per blood test).

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

• nosebleeds
• delusions, thought disturbances, lack of feeling or emotion
• migraine, convulsions/fits, inflammation and/or blocking of central nervous system arteries
• double vision
• abnormal heartbeats
• swelling of face and throat, redness of the skin, large red blotches on the skin appearing within a few hours of taking the medicine
• lockjaw
• incontinence (loss of bladder control)
• erectile dysfunction
• chest discomfort, extreme fever.

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

Store all medicines out of reach of children. Store at or below 30 °C and protect from moisture. Keep blisters in carton until required for use. 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).