Zyban

• Smoking cessation medicine
• Nine-week course
• Keep smoking during first week of treatment
• Avoid drinking alcohol while taking this medicine

Zyban contains bupropion and is a medicine prescribed to help you stop smoking. Zyban will be most effective if you are fully committed to giving up smoking and have motivational support (for example through a ‘stop smoking’ programme). Ask your doctor for advice on what support is available to help you stop.

This medicine is prescribed as a course. The tablet should be swallowed with a drink of water. Don’t chew the tablet. The tablet contains a special coating to ensure the medicine is released into your body slowly.

Start taking Zyban while you are still smoking. In the second week of treatment you actually stop smoking. A course usually takes nine weeks.

Dosage

Treatment with Zyban is gradually increased. The general recommended dose for adults is:

• Days 1 to 6: one tablet (150 mg), once a day.
• Day 7 until the end of the course: one tablet (150 mg), twice a day, at least eight hours apart. Avoid taking this medicine late in the evening, as it may cause difficulty sleeping.

Start taking Zyban while you are still smoking. Stop smoking during the second week of taking Zyban.

If you have been able to quit smoking, talk to your doctor for advice on how to stop taking Zyban gradually.

If you have not been able to stop smoking after seven weeks, your doctor will advise you to stop taking Zyban.

Zyban is not recommended for people under 18 years. In patients with certain conditions the dose may need to be adjusted to avoid side effects. Read the package leaflet before use.

Alcohol/driving

Your doctor may suggest you do not drink alcohol while you are taking Zyban, or try to drink as little as possible. If you regularly drink a lot of alcohol, you should not stop drinking suddenly as this increases the risk of fits (seizures).

This medicine may cause side effects such as dizziness or tiredness. If you are affected, don’t drive or operate machinery.

If you use too much/forget to use/stop using Zyban

If you take more Zyban than you were told to, you may be more likely to have a fit or other side effects. Contact your doctor or your nearest hospital emergency department immediately.

If you forget to take a dose of Zyban, wait and take your next tablet at the usual time. Do not take a double dose to make up for the forgotten one.

Do not stop using Zyban without consulting a doctor first.

Zyban is not suitable for everyone. Do not use this medicine if:

• You are allergic to the active ingredient or any of the other ingredient in this medicine (see section 'What Zyban contains').
• You are taking any other medicines which contain bupropion (e.g., Wellbutrin XR).
• You have a condition that causes fits (seizures) such as epilepsy, or if you have a history of fits.
• You have an eating disorder or had one in the past (e.g., bulimia or anorexia nervosa).
• You have severe liver problems, such as cirrhosis.
• You have a brain tumour.
• You are usually a heavy drinker and you have just stopped drinking alcohol, or are going to stop while you’re taking Zyban.
• You have recently stopped taking sedatives or medicines to treat anxiety (especially benzodiazepines or similar medicines), or if you are going to stop them while you’re taking Zyban.
• You have a bipolar disorder (extreme mood swings) as Zyban could bring on an episode of this illness.
• You are taking medicines for depression or Parkinson’s disease called monoamine oxidase
  inhibitors (MAOIs), or have taken them in the last 14 days. The timing may be shorter for some types of MAOIs. Please consult your doctor.

When should this medicine be used with caution?

Talk to you doctor before using Zyban if:

• You regularly drink a lot of alcohol, have diabetes for which you use insulin or tablets, have had a serious head injury or a history of head trauma. If any of these applies to you, don’t take Zyban unless you have agreed with your doctor that there is a strong reason for doing so. This is because these conditions make it more likely that you will have fits.
• You have kidney or liver problems.
• You are 65 years or older.
• You have mental health problems.
• You feel depressed or suicidal. Get immediate medical attention.
• You have high blood pressure.

Pregnancy and breastfeeding

Don’t take Zyban if you are pregnant, think you may be pregnant or are planning to have a baby.

Ask your doctor for advice before taking this medicine if you are breastfeeding.

Other medicines and Zyban

Zyban is known to interact with some medicines. Some medicines can affect how Zyban works or make it more likely that you’ll have side effects. These include:

• Medicines for depression and other mental health problems.
• Theophylline.
• Tramadol.
• Medicines against malaria.
• Stimulants or other medicines to control your weight or appetite.
• Steroids (except creams and lotions for eye and skin conditions).
• Antibiotics called quinolones.
• Some types of antihistamines used to treat allergies.
• Medicines for diabetes.
• Some medicines for Parkinson’s disease.
• Some medicines used to treat cancer (e.g., cyclophosphamide, ifosphamide, tamoxifen).
• Ticlopidine or clopidogrel.
• Some beta blockers (e.g., metoprolol).
• Some medicines for irregular heart rhythm (e.g., propafenone, flecainide).
• Ritonavir or efavirenz for treatment of HIV infection.

Please tell your doctor if you are taking, have recently taken or might take any of these or other medicines. For more information, see the package leaflet.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• Approximately 1 in every 1,000 people taking Zyban is at risk of having a fit. Symptoms of a fit include convulsions and usually loss of consciousness. The chance of this happening is higher if you take too much, if you take certain medicines, or if you are at higher than usual risk of fits. If you have a fit, tell your doctor when you have recovered. Don’t take any more Zyban.
• Rarely (up to 1 in 1,000) people may have potentially serious allergic reactions to Zyban. Signs of allergic reactions include skin rash, unusual wheezing or difficulty in breathing, swollen eyelids, lips or tongue, pains in muscles or joints, collapse or blackout. If you have any signs of an allergic reaction, contact a doctor at once. Don’t take any more Zyban tablets.

Other side effects of Zyban are:

Very common (may affect more than 1 in 10 people):

• Difficulty sleeping (make sure you don’t take Zyban near to bedtime).

Common (may affect up to 1 in 10 people):

• Feeling depressed.
• Feeling anxious or agitated.
• Difficulty concentrating.
• Feeling shaky (tremor).
• Headache.
• Gastrointestinal problems.
• Fever, dizziness, sweating, skin rash, itching.

For a list of uncommon or rare side effects, please see the package leaflet.

Consult a doctor if you experience side effects, also if the side effects are not listed in the package leaflet.

The active substance in Zyban is bupropion hydrochloride.

The other ingredients are:

• Tablet core: microcrystalline cellulose, hypromellose, cysteine hydrochloride monohydrate, magnesium stearate.
• Tablet coating: hypromellose, macrogol 400, titanium dioxide (E171), carnauba wax.
• Printing ink: hypromellose, black iron oxide (E172).

The manufacturers of Zyban are:

Glaxo Wellcome Operations Priory Street
Ware
Hertfordshire SG12 0DJ
United Kingdom

Glaxo Wellcome S.A. Avda. Extremadura, 3
09400 Aranda de Duero
Burgos
Spain

Read the package leaflet before use.