What do I need to know before I take Mysimba?

When do I not take Mysimba?

Allergic to naltrexone or bupropion
Do not take Mysimba if you are allergic to:

• naltrexone;
• bupropion; or
• any of the other ingredients of this medicine.

Abnormally high blood pressure
Do not take Mysimba if you have abnormally high blood pressure (hypertension) that is not controlled by using medicine.

Fits (seizures)
Do not take Mysimba if you have a condition that causes fits (seizures); or you have a history of fits.

Brain tumour
Do not take Mysimba if you have a brain tumour.

You drink a lot of alcohol
Do not take Mysimba if you are usually a heavy drinker and you have just stopped drinking alcohol, or are going to stop while you are taking Mysimba.

Sedatives or anxiety medicines
Do not take Mysimba if you have recently stopped taking sedatives or medicines to treat anxiety (especially benzodiazepines); or if you are going to stop them while you are taking Mysimba.

Bipolar disorder
Do not take Mysimba if you have a bipolar disorder (extreme mood swings).

Already taking bupropion or naltrexone
Do not take Mysimba if you are using any other medicines which contain bupropion or naltrexone (the two main active ingredients in Mysimba).

Eating disorders
Do not take Mysimba if you have an eating disorder or have had one in the past (for example, bulimia or anorexia nervosa).

Opiate agonists including methadone
Do not take Mysimba if you are currently dependent on chronic opiates or opiate agonists (for example methadone); or if you are going through acute withdrawal (‘cold turkey’).

Monoamine oxidase inhibitors (MAOIs)
Do not take Mysimba 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.

Liver disease
Do not take Mysimba if you have severe liver disease.

Kidney disease
Do not take Mysimba if you have end-stage kidney disease

Talk to your doctor or pharmacist

It is important to talk to your doctor or pharmacist before taking Mysimba because some pre-existing conditions make it more likely that you could have side effects.

Mental health problems

If you feel depressed, are contemplating suicide, have a history of attempting suicide or any other mental health problems, you should tell your doctor before taking Mysimba.

Fits (seizures)

Mysimba has been shown to cause fits (seizures) in up to 1 in 1,000 patients. You should tell your doctor before taking Mysimba if you:

• have had a serious head injury or head trauma;
• regularly drink alcohol;
• regularly use medicines to help you sleep (sedatives);
• are currently dependent on, or addicted to, cocaine or other stimulating products;
• have diabetes for which you use insulin or oral medicines that may cause low sugar levels in your blood (hypoglycaemia);
• are taking medicines that may increase the risk of fits; or
• have a fit (seizure), you should stop taking Mysimba and consult your doctor immediately.

Allergic reaction

You should stop taking Mysimba immediately and consult your doctor if you are experiencing any symptoms of an allergic reaction after taking this medicine, like:

• swelling of the throat, tongue, lips, or face;
• difficulty swallowing or breathing;
• dizziness;
• fever;
• rash;
• pain in the joints or in the muscles; or
• itching or hives.

You should talk to your doctor, especially if:
High blood pressure
If you have high blood pressure talk to your doctor before taking Mysimba, because it can get worse. Your doctor will measure your blood pressure and heart rate before you start taking Mysimba and while you are taking it. If your blood pressure or heart rate increases significantly, you may need to stop taking Mysimba.

Uncontrolled coronary artery disease
If you have uncontrolled coronary artery disease talk to your doctor before taking Mysimba. Coronary artery disease is heart disease caused by poor blood flow in the blood vessels of the heart. Symptoms may include angina (characterised by chest pain) or a recent heart attack.

Cerebrovascular disease
If you already have or have had a condition affecting the circulation of blood in the brain (cerebrovascular disease) – talk to your doctor before taking Mysimba.

Liver problems
If you have any liver problems talk to your doctor before taking Mysimba.

Kidney problems
If you have any kidney problems talk to your doctor before taking Mysimba.

Mania
If you have a history of mania (feeling elated or over-excited, which causes unusual behaviour), talk to your doctor before taking Mysimba.

Other medicines and Mysimba

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take Mysimba with the following

Monoamine oxidase inhibitors
These medicines are used to treat depression or Parkinson’s disease. They include:

• phenelzine,
• selegiline, and
• rasagiline.

You must stop taking these medicines for at least 14 days before starting Mysimba.

Opiates and opiate-containing medicines
If you are taking Mysimba do not take opiates or opiate-containing medicines, which can include:

• medicines to treat coughs and colds like mixtures containing dextromethorphan or codeine;
• methadone – can be taken by people addicted to opiates;
• pain medicines like morphine and codeine;
• diarrhoea medicines like paregoric.

You must have stopped taking any opiate medicines at least seven to 10 days before starting Mysimba. Your doctor may carry out a blood test to make sure that your body has cleared these medicines before starting your treatment.
One of the two main ingredients in Mysimba, naltrexone, blocks the effects of opiates. If you take higher doses of opiates to overcome the effects of naltrexone, you may suffer from an acute opiate intoxication which may be life threatening.
After you stop treatment with Mysimba, you may be more sensitive to low doses of opiates.

Tell your doctor if you are taking any of the following medicines

Tell your doctor if you are taking any of the following medicines, as your doctor will closely monitor you for side effects.

Some medicines increase risk of fits
Some medicines may, when used alone or in combination with naltrexone or bupropion (the main active ingredients in Mysimba), increase the risk of fits. These include:

• medicines for depression – and other mental health problems;
• steroids – except drops, creams, or lotions for eye and skin conditions or inhalers for breathing disorders such as asthma;
• malaria – medicines used to prevent malaria;
• quinolones – antibiotics such as ciprofloxacine to treat infections;
• tramadol – a painkiller which is a type of opiate; and
• theophylline – used to treat asthma.

If you are taking any of these medicines, tell your doctor.

Antihistamines
Antihistamines are used to treat allergic reactions. When you take an antihistamine that causes sleepiness, like chlorphenamine, it may also increase the risk of fits (seizures) when you take it alone or together with Mysimba. Antihistamines are used to treat:

• hay fever,
• itch, and
• other allergic reactions.

If you are taking any of these medicines, tell your doctor.

Blood-sugar lowering medicines
Blood-sugar lowering medicines may also increase the risk of fits when used alone or in combination with Mysimba. Blood-sugar lowering medicines include:

• insulin,
• sulphonylureas like glyburide or glibenclamide; and
• meglitinides such as nateglinide or repaglinide.

If you are taking any of these, tell your doctor.

Sleep medicines
Medicines to help you to sleep including sedatives like diazepam may also increase the risk of fits when used alone or in combination with Mysimba. If you are taking any of these, tell your doctor.

Other medicines you should tell your doctor you are taking

Depression
Tell your doctor if you are taking medicines to treat depression including:

• desipramine,
• venlafaxine,
• imipramine,
• paroxetine, or
• citalopram.

Mental health
Tell your doctor if you are taking medicines to treat other mental health problems including:

• risperidone,
• haloperidol, and
• thioridazine.

Blood pressure
Tell your doctor if you are taking medicines to treat high blood pressure including:

• beta-blockers like metoprolol; and
• clonidine, a centrally acting antihypertensive.

Irregular heart rhythm
Tell your doctor if you are taking medicines to treat irregular heart rhythm like:

• propafenone, and
• flecainide.

Cancer
Tell your doctor if you are taking medicines to treat cancer like:

• cyclophospamide,
• ifosphamide, and
• tamoxifen.

Parkinson’s disease
Tell your doctor if you are taking medicines for Parkinson’s disease like:

• levodopa,
• amantadine, and
• orphenadrine.

Heart disease or stroke
Tell your doctor if you are taking:

• ticlopidine, or
• clopidogrel.

These are mainly used to treat heart disease or stroke.

HIV and AIDS
Tell your doctor if you are taking medicines used to treat HIV infection and AIDS, like:

• efavirenz; and
• ritonavir.

Epilepsy
Tell your doctor if you are taking medicines used to treat epilepsy like:

• valproate,
• carbamazepine,
• phenytoin, or
• phenobarbital.

Your doctor will closely monitor you for side effects and they may need to adjust the dose of the other medicines you take or of Mysimba.
If you are taking any other medicines including any non-prescription medicines, supplements or herbal medicines, please tell your doctor before taking Mysimba.

IE/MYS/1017/0077e(1) | Date of preparation: February 2018

Information placed on this digital platform is not intended as a substitute for consultation with your healthcare professional. Please consult your doctor or nurse for further information Copyright ©2017 Consilient Health. All rights reserved.

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