Bupropion Modified-Release Tablets

• BUPROPION 300 ACCORD contains the active substance bupropion hydrochloride.

• BUPROPION 300 ACCORD is a medicine prescribed by your doctor to treat your depression. It’s thought to interact with chemicals in the brain called noradrenaline and dopamine, which are linked to depression.

• It may take a while before you start feeling better. It takes time for the medicine to have its full effect, sometimes weeks or months. When you do start feeling better, your doctor may advise you to keep taking BUPROPION 300 ACCORD to prevent your depression coming back.

• Your doctor has chosen this medicine to suit you and your condition. Don’t pass it on to others. Before deciding on treatment with BUPROPION 300 ACCORD, you and your doctor will probably have discussed the risks of harm and the benefits that it is likely to have for you. This leaflet will help you to take BUPROPION 300 ACCORD safely.

Do not take BUPROPION 300 ACCORD:

• If you are hypersensitive (allergic) to bupropion hydrochloride or any of the other ingredients of BUPROPION 300 ACCORD (listed in section 6)
• If you are less than 18 years of age. There is an increased risk of suicidal thoughts and behaviour when children under 18 years of age are treated with antidepressants.
• If you have been diagnosed with epilepsy or you have a history of epilepsy
• If you are taking any other medicines which contain bupropion.
• If you have a brain tumour
• If you are usually a heavy drinker who has just stopped or are about to stop drinking
• If you recently stopped taking tranquillisers or sedatives, or if you are going to stop them while you are taking bupropion hydrochloride.
• If you have an eating disorder, or used to (for example, bulimia or anorexia nervosa)
• If you have been taking other medicines for depression called monoamine oxidase inhibitors (MAOIs) in the last 14 days
• If you have moderate to severe liver disease.
• If you have an illness called bipolar disorder which causes unusual shifts in your mood, energy levels or concentration. BUPROPION 300 ACCORD might increase your symptoms.

If any of these apply to you, talk to your doctor immediately, without taking BUPROPION 300 ACCORD.

Warnings and precautions

Take special care with BUPROPION 300 ACCORD:

• If you have ever had fits or seizures in the past
• if you have previously had head trauma
• if you have a brain tumour
• if you regularly drink a lot of alcohol
• if you have diabetes for which you use insulin or tablets
• If you experience any allergic reactions (e.g. rash, difficulty breathing, swollen eyelids, lips or tongue)
• If you have had any mental illness other than depression
• If you are over 65 years of age
• If you suffer from high blood pressure
• If you have kidney disease.
• If you have heart disease.

Thoughts of suicide or worsening of your condition: If you are depressed you can sometimes have thoughts of harming or killing yourself. These thoughts may be increased when first starting antidepressants. These medicines all take time to work – usually about 2 weeks, but sometimes longer. You may be more likely to think like this:

• If you have previously had thoughts about killing or harming yourself
• If you are under 25 years old

If you have thoughts of harming or killing yourself at any time: Get medical advice as soon as possible (from a doctor or at a hospital).

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

• Always take BUPROPION 300 ACCORD exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• The usual dose is 300 mg once a day.

• Take your dose early in the morning to prevent difficulty sleeping at bedtime.

• Swallow the tablets whole. Do not chew, crush or split them. If you do the medicine will be released into your body too quickly and you are more likely to get side effects like seizures.

• This medicine is only for oral use. Do not inhale or inject this medicine as this is very dangerous and can lead to overdose, seizures and death.

• Your doctor will tell you how long to take BUPROPION 300 ACCORD for. It may take a few weeks or months before you notice any improvement. Even once you see an improvement your doctor may advise you to continue with the medicine to prevent the depression coming back. Do not stop taking BUPROPION 300 ACCORD without first discussing it with your doctor.

• If you have the impression that the effect of BUPROPION 300 ACCORD is too strong or too weak, tell your doctor or pharmacist.

If you take more BUPROPION 300 ACCORD than you should

In the event of overdose consult your doctor or pharmacist. If neither is available, contact your nearest hospital or poison centre. You may experience seizures, drowsiness, loss of consciousness and changes in your heart rhythm.

If you forget to take BUPROPION 300 ACCORD

If you forget to take BUPROPION 300 ACCORD, wait and take the next tablet at the usual time. Do not take a double dose to make up for forgotten individual doses.

BUPROPION 300 ACCORD can have side effects. Not all side effects reported for BUPROPION 300 ACCORD are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking BUPROPION 300 ACCORD, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop taking BUPROPION 300 ACCORD and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Difficulty breathing
• Severe skin rash or itching
• Swollen tongue or lips
• Muscle or joint pain

These are all very serious side effects. If you have them, you may have had a serious reaction to BUPROPION 300 ACCORD. 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:

• Seizures or fits
• Thoughts of harming or killing yourself

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 sleeping, feeling agitated, or anxious
• Tremors, headache, dizziness, alteration of taste
• Dry mouth, nausea, vomiting, stomach pain, constipation
• Rash, itchy skin or sweating
• Fever
• Changes to vision
• Ringing in ears
• High blood pressure
• Chest pain, weakness or lack of energy

• Less frequent side effects

• Loss of weight, changes in blood sugar level (you may experience fatigue, anxiety, sweating)
• Irritability, hallucinations, unusual dreams and nightmares, feeling restless and aggressive, depression
• Difficulty concentrating
• Muscle twitching, slurred speech, difficulty in coordination, fainting, memory impairment
• Heart rate increases
• Flushing, feeling faint when you wake up from a sitting position
• Yellowing of eyes, dark urine (could indicate jaundice)
• Change in frequency of urination

Depending on the side effects you experience, your doctor may conduct blood tests to check your blood counts, blood sugar levels or to check your liver and kidney function.

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 Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on the SAHPRA website. By reporting side effects, you can help provide more information on the safety of BUPROPION 300 ACCORD.

• Store all medicines out of reach of children.

• Store at or below 25 °C.