Bupropion XR 150 mg Tablets

BUPROPION XR 150 ADCO contains bupropion hydrochloride which belongs to a class of medicines called antidepressants. It’s thought to interact with chemicals in the brain called noradrenaline and dopamine, which are linked with depression (mood disorder that causes a persistent feeling of sadness and loss of interest).

BUPROPION XR 150 ADCO is used for the treatment of depression and preventing a relapse and recurrence of further depressive episodes.

Do not take BUPROPION XR 150 ADCO:

• if you are 18 years or younger.
• if you are hypersensitive (allergic) to bupropion or any of the other ingredients of BUPROPION XR 150 ADCO listed in section 6.
• if you have a condition that causes fits (seizures), such as epilepsy, or if you have a history of fits.
• if you are being treated with other medicines containing bupropion as this may induce fits.
• if you have a brain tumour.
• if you are undergoing abrupt discontinuation of alcohol, sedatives (medicines used for sleeping), or medicines to treat anxiety (especially benzodiazepines or similar medicines) or if you are going to stop them while you are taking BUPROPION XR 150 ADCO.
• if you have an existing condition or history of eating disorders [such as anorexia (a mental condition, characterised by an obsessive desire to lose weight, by refusing to eat and cause loss of appetite) or bulimia (an emotional disorder characterised by an obsessive desire to lose weight, in which bouts of extreme overeating are followed by fasting or self-induced vomiting or purging)].
• if you are taking medicines for depression or Parkinson’s disease called monoamine oxidase inhibitors (MAOIs) or have taken them in the last 14 days.
• if you have moderate to severe liver disease including cirrhosis.

Warnings and precautions

Take special care with BUPROPION XR 150 ADCO

BUPROPION XR 150 ADCO has been shown to cause fits (seizures). This side effect is more likely to occur:

• if you have had a serious head injury or a history of head trauma
• if you ever had any fits or seizures in the past
• if you have a brain tumour
• if you are taking certain medicines that can cause fits (see “Other medicines and BUPROPION XR 150 ADCO” below)
• if you regularly drink a lot of alcohol
• if you take medicines used for sleeping (sedatives)
• if you have diabetes for which you use insulin or diabetes treatment tablets
• if you are using any stimulants or medicine to help you lose weight.

If you have a fit during treatment you should stop taking BUPROPION XR 150 ADCO and see your doctor.

If you are depressed, you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting BUPROPION XR 150 ADCO, since it takes time to work, usually about two weeks but sometimes longer. You are more likely to think like this if you have previously had thoughts about killing yourself or if you are a young adult.

If you experience worsening of your depression and/or have thoughts of harming or killing yourself, whether or not you are taking antidepressant medicines contact your doctor or go to the hospital immediately.

Tell your doctor before you take BUPROPION XR 150 ADCO:

• if you have a bipolar disorder (extreme mood swings) or a family history of suicide, bipolar disorder or depression; BUPROPION XR 150 ADCO could bring on an episode of this illness
• if you have a recent history of heart attack (myocardial infarction) or diagnosed with unstable heart disease
• if you have high blood pressure or are using nicotine patches to stop smoking; your doctor may need to monitor your blood pressure
• if you have glaucoma (increased pressure in the eyeball), are over 60, have had an eye injury, or have high blood pressure; you may be at risk of developing angle-closure glaucoma
• if you have kidney or liver disease as you may be more likely to get side effects; your doctor may need to start your treatment at a low dose and then gradually increase your dose
• if you are older than 65 years as you might be at a higher risk to experience side effects; your doctor may need to start your treatment at a low dose and then gradually increase your dose
• if you have a rare blood disorder called porphyria which is passed down in families (inherited); BUPROPION XR 150 ADCO may worsen your condition.
• if you have a condition called Brugada syndrome (a rare hereditary syndrome that affects the heart rhythm) or if cardiac arrest or sudden death occurred in your family.

If any of the above applies to you, talk to your doctor again before taking BUPROPION XR 150 ADCO. He or she may want to pay special attention to your care or recommend another treatment.

Stop taking BUPROPION XR 150 ADCO immediately if you have any signs of an allergic reaction (see “Possible side effects” below).

Children and adolescents

Do not give this medicine to children younger than 18 years because the safety of BUPROPION XR 150 ADCO has not been established in patients younger than 18 years old.

Do not share medicines prescribed for you with any other person.

Always take BUPROPION XR 150 ADCO exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

The usual dosage of BUPROPION XR 150 ADCO is one tablet (150 mg) taken daily in the morning. Your doctor may increase your dose to 300 mg (two tablets) once a day if your depression does not improve.

Do not take more than the prescribed dose of BUPROPION XR 150 ADCO. BUPROPION XR 150 ADCO must be swallowed whole. Do not chew, crush or split the tablets as this may lead to a higher risk of side effects including fits. You must wait for at least 24 hours before taking the next tablet.

Your doctor will tell you how long your treatment with BUPROPION XR 150 ADCO will last. Do not stop treatment early because it may take some time for BUPROPION XR 150 ADCO to have an effect on your depression. If you have the impression that the effect of BUPROPION XR 150 ADCO is too strong or too weak, tell your doctor or pharmacist.

BUPROPION XR 150 ADCO should not to be used by children aged less than 18 years.

Please tell your doctor if you are an elderly patient (older than 65 years), have liver or kidney disease as your dose of BUPROPION XR 150 ADCO may need to be adjusted.

If you take more BUPROPION XR 150 ADCO than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Take this leaflet and the rest of the remaining BUPROPION XR 150 ADCO with you so the doctor will know what you have taken.

Signs and symptoms of overdosage: If you take too many tablets you may experience fits, drowsiness, hallucinations (seeing or hearing things that are not real), paraesthesia (numbness or tingling sensation), nausea, vomiting, loss of consciousness and/or abnormal reading of the heart (seen on ECG, electric activity of your heart), irregular or fast heartbeat.

If you forget to take BUPROPION XR 150 ADCO

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

If you stop taking BUPROPION XR 150 ADCO

Do not stop taking BUPROPION XR 150 ADCO or reduce your dose without talking to your doctor first. Your doctor will lower the dose over a time period to avoid the returning of depression or other unwanted effects.

BUPROPION XR 150 ADCO can have side effects. Not all side effects reported for BUPROPION XR 150 ADCO are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking BUPROPION XR 150 ADCO, please consult your provider for advice.

If any of the following happens, stop taking BUPROPION XR 150 ADCO and tell you doctor immediately or go to the casualty department at your nearest hospital:

• allergic reactions presenting as red skin or rash (like nettle rash) with development of itchiness and wheals (urticaria).
• fits (seizures or convulsions), the chance of this happening is higher if you take too much BUPROPION XR 150 ADCO, if you take certain medicines, or if you are at higher than usual risk of fits; talk to your doctor if you are concerned
• allergic reactions presenting as blisters and peeling skin, unusual wheezing or difficulty in breathing, swollen eyelids, lips or tongue, pains in muscles or joints, collapse or blackout. These are all very serious side effects. If you have them, you may have had a serious reaction to BUPROPION XR 150 ADCO. 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:

• chest pain.
• changes in the way your heart beats, for example if you notice it beating faster or irregular.
• thoughts of harming or killing themselves while taking BUPROPION XR 150 ADCO or soon after stopping treatment (see “Take special care with BUPROPION XR 150 ADCO” in section 2).

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:

• difficulty in sleeping (make sure you take BUPROPION XR 150 ADCO in the morning)
• headache
• dry mouth, feeling sick, vomiting, tummy pain or other upsets (constipation)
• fever, dizziness, itching, sweating and skin rash (sometimes due to an allergic reaction)
• shakiness, tremor, weakness, tiredness
• feeling anxious or agitated
• changes in the taste of food, loss of appetite (anorexia)
• increase in blood pressure sometimes severe, flushing
• ringing in the ears, visual disturbances.

Less frequent side effects:

• feeling depressed (see “Take special care with BUPROPION XR 150 ADCO” in section 2).
• difficulty concentrating, feeling confused, restless, irritable, hostile, aggressive, strange dreams, tingling or numbness, loss of memory, fainting
• weight loss, changes in blood sugar levels
• twitching, muscle stiffness, uncontrolled movements, problems with walking or coordination
• yellowing of skin or the whites of your eyes (jaundice) which may be caused by raised liver enzymes, hepatitis
• urinating more or less than usual.
• worsening of psoriasis (thickened patches of red skin)
• feeling unreal or strange (depersonalisation), seeing or hearing things that are not there (hallucinations), sensing or believing things that are not true (delusions), severe suspiciousness (paranoia)
• feeling dizzy or fainting when getting up to quickly.

Side effects with unknown frequency:

• loss of contact with reality and unable to think or judge clearly (psychosis), other symptoms may include hallucinations and/or delusions.
• low sodium levels in the blood

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. This includes any possible side effects not listed in this leaflet. 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 BUPROPION XR 150 ADCO.

Store all medicines out of reach of children.

Store at or below 25 °C.

Store in the original packaging.

Store in a cool, dry place.

Protect from moisture and light.

Keep the container tightly closed.

Do not use after the expiry date stated on the bottle.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).