Conufen Prolonged-Release Tablets

CONUFEN contains the active substance methylphenidate and is used to treat:

• Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 and adults aged 18 to 65 who meet specific criteria for ADHD. ADHD is a medical condition where the child has difficulty concentrating, staying focused and sitting still.

How it works:

• CONUFEN 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 CONUFEN if:

• You are allergic to methylphenidate or any of the other ingredients of CONUFEN (listed in section 6).
• You have a thyroid problem.
• You have increased pressure in your eye (glaucoma).
• You have a tumour of your adrenal gland (pheochromocytoma).
• You have very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and legs.
• 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).
• You are currently taking or have taken within the last 14 days an antidepressant (known as a monoamine oxidase inhibitor) (see ‘Other medicines and CONUFEN’).
• You suffer from anxiety, tension or agitation.
• You or a family member suffers from Tourette’s syndrome (a condition characterised by uncontrolled speech and body movements).
• You are pregnant or breastfeeding.

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

Warnings and precautions

• CONUFEN 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’s symptoms are in relation to their age.
• CONUFEN is not for use in children under 6 years of age and in elderly patients.
• CONUFEN does not have to be taken forever. Treatment will generally stop after puberty.

Talk to your doctor before taking CONUFEN if:

• You have thoughts about killing or trying to kill yourself.
• You have problems with your heart (including heart defects) or an increased heartbeat. CONUFEN can increase your heart rate (pulse). Sudden death has been reported in patients with heart defects.
• You have high blood pressure. CONUFEN can increase blood pressure.
• You have low blood pressure. CONUFEN can cause dizziness or fainting in people with low blood pressure.
• You have problems with sudden changes in your blood pressure or your heart rate.
• You have cardiovascular disease or past medical history of stroke.
• You have liver problems. You may need a lower dose.
• You have psychotic symptoms including hallucinations (hearing voices or seeing things which are not there), believing things that are not true or being suspicious.
• You have mania (feeling elated or over-excited, which causes unusual behaviour) and agitation.
• You have aggressive feelings.
• You have unfriendly and angry (hostility) feelings.
• You have a history of epilepsy or have had seizures for any other reason. CONUFEN might lead to an increase in seizure frequency.
• You have different moods than usual (mood swings) or feel very unhappy.
• You have hard-to-control, repeated twitching of any parts of the body or you repeat sounds and words.
• You have kidney problems.
• You have a problem with swallowing or swallowing whole tablets.
• You have a narrowing or blockage of your gut or food-pipe.
• You have had any abnormal brain scans (EEGs).
• You have ever abused or been dependent on alcohol, prescription medicines or street drugs.
• You are a girl and have started your periods (see the pregnancy, breast-feeding and contraception section below).

Other mental health problems include:

• Feeling anxious or tense.
• Feeling depressed or guilty.

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

During treatment, boys and adolescents may unexpectedly experience prolonged erections. 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.

Children and adolescents:

• If your child is not growing or gaining height or weight as expected as CONUFEN treatment may need to be interrupted.
• If your child is on long-term treatment (longer than 12 months), your doctor will monitor their weight and height.

Do not share medicines prescribed for you with any other person. Your doctor will usually start treatment with a low dose and increase it gradually as required. You should take CONUFEN once each day in the morning with a glass of water. The tablet should be swallowed whole and not chewed, broken, or crushed. The tablet may be taken with or without food.

Always take CONUFEN exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how long your treatment with CONUFEN will last.

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

If you take more CONUFEN 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. Signs of overdose may include: being sick, feeling agitated, shaking, increased uncontrolled movements, muscle twitching, fits (may be followed by coma), feeling very happy, being confused, seeing, feeling or hearing things that are not real (hallucinations), sweating, flushing, headache, high fever, changes in heartbeat (slow, fast or uneven), high blood pressure, dilated pupils and dry nose and mouth, muscle spasms, fever, red-brown urine which could be possible signs of abnormal breakdown of muscles (rhabdomyolysis).

If you forget to take CONUFEN

Do not take a double dose to make up for a forgotten dose. If you forget a dose, wait until it is time for the next dose.

If you stop taking CONUFEN

If you suddenly stop taking CONUFEN, the ADHD symptoms may come back or unwanted effects such as depression may appear. Talk to your doctor before stopping CONUFEN.

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

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

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing. These are all very serious side effects. If you have them, you may have had a serious allergic reaction to CONUFEN. You may need urgent medical attention.

Some side effects could be serious. If you have any of the side effects below, see a doctor straight away:

Frequent:

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

Less frequent:

• Thinking about or feeling like hurting or killing yourself.
• Seeing, feeling or hearing things that are not real (these are signs of psychosis).
• Uncontrolled speech and body movements (Tourette’s syndrome).
• 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, overactive and uninhibited (mania).
• Heart attack.
• Sudden death.
• Suicidal attempt.
• Fits (seizures, convulsions epilepsy).
• Skin peeling or purplish red patches.
• Inflammation or blocked arteries in the brain.
• Temporary paralysis or problems with movement and vision, difficulties in speech (these can be signs of problems with the blood vessels in your brain).
• Muscle spasms which you cannot control affecting your eyes, head, neck, body and nervous system.
• 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 methylphenidate or other drugs that may be taken in combination with methylphenidate.

Frequency unknown:

• Unwanted thoughts that keep coming back.
• Unexplained fainting, chest pain, shortness of breath (these can be signs of heart problems).
• Prolonged erections, sometimes painful or an increased number of erections.

If you have 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.
• Unusual hair loss or thinning.
• Muscle tightness, muscle cramps.
• Loss of appetite or decreased appetite.
• Inability to develop or maintain an erection.
• Itching, rash or raised red itchy rashes (hives).
• Feeling unusually sleepy or drowsy, feeling tired.
• Excessive teeth grinding (bruxism).
• Feeling of panic.
• Tingling feeling, prickling, or numbness of the skin.
• Increased alanine aminotransferase (liver enzyme) level in your blood.
• Cough, sore throat or nose and throat irritation, upper respiratory tract infection, sinus infection.
• High blood pressure, fast heart beat (tachycardia).
• Dizziness (vertigo), feeling weak, movements which you cannot control, being unusually active.
• Feeling aggressive, agitated, anxious, depressed, irritable, tense, jittery and abnormal behaviour.
• Upset stomach or indigestion, stomach pain, diarrhoea, feeling sick, stomach discomfort and being sick.

Less Frequent:

• Dry eyes.
• Constipation.
• Chest discomfort.
• Blood in the urine.
• Listlessness.
• Shaking or trembling.
• Increased need to pass urine.
• Muscle pain, muscle twitching.
• Shortness of breath or chest pain.
• Feeling hot.
• Increases in liver test results (seen in a blood test).
• Anger, feeling restless or tearful, talking too much, excessive awareness of surroundings, problems sleeping.
• Feeling disorientated or confused.
• Trouble seeing or double vision.
• Swelling of the breasts in men.
• Excessive sweating, redness of the skin, red raised skin rash.
• Muscle cramps.
• Small red marks on the skin.
• Abnormal liver function including sudden liver failure and coma.
• Changes in test results – including liver and blood tests.
• Abnormal thinking, lack of feeling or emotion, doing things over and over again, being obsessed with one thing.
• Fingers and toes feeling numb, tingling and changing colour (from white to blue, then red) when cold (‘Raynaud’s phenomenon’).

Unknown frequency:

• Migraine.
• Dilated pupils.
• Very high fever.
• Slow, fast or extra heart beats.
• A major fit (‘grand mal convulsions’).
• Believing things that are not true.
• Severe stomach pain, often with feeling and being sick.
• Inability to control the excretion of urine (incontinence).
• Spasm of the jaw muscles that makes it difficult to open the mouth (Trismus).
• Stuttering.

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 or pharmacist. 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 CONUFEN. Suspected adverse reactions can also be reported directly to the HCR via [email protected].

• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.
• Store at or below 25 °C.
• Keep the container tightly closed.
• Do not use after the expiry date printed on the label / carton.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).