Amfexa 5 mg Tablets

What Amfexa is

Amfexa contains the active substance dexamfetamine sulfate. Amfexa is a psychostimulant. It improves activity in parts of the brain. This medicine can help to improve attention span, concentration, and reduce impulsive behaviour.

What it is used for

Amfexa is used to treat attention-deficit/hyperactivity disorder (ADHD).

• It is used in children and adolescents aged 6-17 years.
• It is not indicated in all children with ADHD.
• It is used only after when another medicine called methylphenidate was not sufficiently effective.
• It should be used as part of a treatment programme which typically includes psychological, educational and social measures.

Amfexa treatment must only be initiated by and used under the supervision of a specialist in childhood or adolescent behavioural disorders. You must talk to a doctor if your child does not feel better or if they feel worse after a month. The doctor may decide that a different treatment is needed.

Do not use Amfexa if your child:

• is allergic (hypersensitive) to dexamfetamine or other amfetamine compounds or any of the other ingredients of Amfexa (listed in section 6)
• has a thyroid problem
• has increased pressure in the eyes (glaucoma)
• has a tumour of the adrenal gland (phaeochromocytoma)
• has an eating problem, does not feel hungry or does not want to eat (e.g. anorexia nervosa)
• has very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and legs
• has advanced thickening and hardening of the arteries (arteriosclerosis)
• has ever had heart problems - such as a heart attack, uneven heartbeat, pain and discomfort in the chest, heart failure, heart disease, or was born with a heart problem
• has had a problem with the blood vessels in the 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)
• has mental health problems such as:
• a psychopathic or borderline personality disorder
• abnormal thoughts or visions or schizophrenia
• signs of a severe mood disorder like:
• suicidal feelings
• severe depression
• mania
• is currently taking or has taken within the last 14 days an antidepressant (known as a monoamine oxidase inhibitor) – see the ‘Other medicines and Amfexa’ section below
• has ever abused alcohol, prescription medicines, or street drugs
• or anyone in your family has Tourette’s syndrome or other motor or verbal tics
• has hard-to-control, repeated twitching of any parts of the body or repeats sounds and words
• has porphyria
• pregnant or breastfeeding

Do not use this medicine if any of the above applies to your child. If you are not sure, talk to your doctor or pharmacist before you use Amfexa. This is because this medicine can make these problems worse.

Warnings and precautions

Talk to your doctor or pharmacist before taking Amfexa if your child:

• has a disease of the blood or liver, or kidney problems
• is hyperexcitable or has an unstable personality
• has had fits (seizures, convulsions, epilepsy) or any abnormal brain scans (EEGs)
• is female and has started having periods (see the ‘Pregnancy and breast-feeding’ section below)
• has high blood pressure
• has a heart problem which is not in the ‘Do not use’ section above
• has a mental health problem which is not in the ‘Do not use’ section above. This may include mood swings, unusual aggression, hallucinations, delusions, paranoia, agitation and anxiety, feelings of guilt or depression.

Tell your doctor or pharmacist if any of the above applies to your child before starting treatment. This is because this medicine can make these problems worse. Your doctor will want to monitor how the medicine affects your child.

How much to take

Always use this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The normal recommended dose is between 5 mg and 20 mg.

• Your doctor will usually start treatment with a low dose of one tablet Amfexa. This will be increased gradually by one tablet Amfexa at weekly intervals, as required.
• The maximum daily dose is 20 mg (in rare cases, 40 mg may be needed).

How to take

The medicine is intended for oral use. Your child should take Amfexa tablets with a drink of water, preferably with or immediately after meals. Amfexa tablets should be taken at the same time in relation to the meals. The last dose should, in general, not be given too late after lunch in order to prevent disturbances in falling asleep.

The tablets have a score line and can be divided, if needed. The score line is only there to help you break the tablet if there is difficulty swallowing it whole. To split it, place the tablet onto a hard surface with the cross-scored, smooth side downwards and then push carefully with your index finger at the centre of its top side. The tablet then breaks into four parts.

If your child does not feel better, tell your doctor. They may decide a different treatment is needed.

Long-term treatment

Your doctor will decide how long the treatment is given. If your child takes this medicine for more than a year, your doctor should stop treatment for a short time, e.g., during a school holiday. This will show if the medicine is still needed.

Not using Amfexa properly

If Amfexa is not used properly, it may cause abnormal behaviour. It may also mean that your child starts to depend on the medicine. Tell your doctor if your child has ever abused or been dependent on alcohol, prescription medicines or street drugs. This medicine is only for your child. Do not give this medicine to anyone else, even if their symptoms seem similar.

If your child takes more Amfexa than they should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Signs of overdose may include: excitement, hallucinations, convulsions leading to coma, irregular and rapid heartbeat, and reduced breathing.

If your child forgets to take Amfexa

Do not use a double dose to make up for a forgotten dose. If your child forgets a dose, wait until it is time for the next dose.

If your child stops taking Amfexa

If your child suddenly stops taking this medicine, this can lead to extreme tiredness, depression, mood disorders, agitation, sleep disturbances, increased appetite, or involuntary movements. Your doctor may want to gradually reduce the amount of medicine taken each day, before stopping it completely. Talk to your doctor before stopping Amfexa.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

This medicine can have side effects. Not all side effects reported for Amfexa are included in this leaflet. Should your child’s general health worsen or if he/she experience any untoward effects while taking Amfexa, please consult your health care provider for advice. Your doctor will talk to you about these side effects.

Frequent:

• decreased appetite, reduced weight gain and weight loss during prolonged use in children
• difficulty in sleeping
• nervousness
• irregular or increased heartbeat, a more noticeable heartbeat
• abdominal pain and/or cramps, nausea, vomiting, dry mouth
• These effects usually occur at the beginning of treatment and may be alleviated by taking the medicine with meals.
• changes in blood pressure and heart rate (usually increases)
• joint pain
• A feeling of dizziness or “spinning”, jerky or involuntary movements, headache, hyperactivity
• abnormal behaviour, aggression, excitation, anorexia, anxiety, depression, irritability

Less Frequent:

• angina pectoris
• difficulties in visual sharpening and focus, blurred vision, dilation of the pupils.
• reduced height increase during prolonged use in children
• fatigue
• rash, hives
• reduction in red blood cells which can make the skin pale and cause weakness or breathlessness, changes in blood cell counts (leukopenia, thrombocytopenia, thrombocytopenic purpura)
• cardiac arrest
• Tourette’s syndrome
• abnormal liver function ranging from hepatic enzyme elevations to hepatic coma
• muscle cramps
• convulsions, involuntary movements (choreoathetoid movements), bleeding inside the skull (intracranial haemorrhage)
• hallucinations, psychosis/psychotic reactions, suicidal behaviour or suicide, tics, worsening of pre-existing tics
• itchy red skin lesions (erythema multiforme) or scaly skin patches (exfoliative dermatitis), recurring rash, which happens in the same place each time the medicine is taken (fixed drug eruption)
• inflammation of the blood vessels of the spinal cord and brain (cerebral vasculitis) and/or occlusion

Not known: frequency cannot be estimated from the available data

• heart muscle disease (cardiomyopathy), heart attack
• inflammation of parts of the large intestine when the blow flow is reduced (ischaemic colitis), diarrhoea
• chest pain, growth retardation during prolonged use, increased body temperature, allergic reactions including serious allergic reaction which causes swelling of the face or throat (angioedema) and serious allergic reaction which causes difficulty in breathing or dizziness (anaphylaxis), sudden death
• disturbance of the acid-base balance of the body (acidosis)
• abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis)
• difficulty in controlling movements (ataxia), dizziness, abnormal or impaired sense of taste, concentration difficulties, hyperreflexia, stroke, shaking (tremor)
• confusion, dependence, dysphoria, emotional instability, euphoria, impaired cognitive test performance, altered libido, night terrors, obsessive-compulsive behaviour, panic states, paranoia, restlessness
• renal damage
• impotence
• sweating, hair loss
• circulatory failure
• fingers and toes feeling numb, tingling and changing colour (from white to blue, then red) when cold (Raynaud’s phenomenon).

Reporting of side effects

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. Additionally, suspected adverse reactions can be reported to the Holder of Certificate of Registration via [email protected].

Store all medicines out of reach of children.

Do not use this medicine after the expiry date which is stated on the blister and the box after “EXP”. The expiry date refers to the last day of that month.

Store at or below 25 °C.

Store in the original package in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.