Zyban tablets contain the active ingredient bupropion
hydrochloride, which is a medicine used to help people who are dependant on
nicotine to give up smoking. It acts in the brain but is not the same as
nicotine replacement therapy.
It is not fully understood how this medicine works to help
people give up smoking, but it is known that bupropion affects
neurotransmitters in the brain. Neurotransmitters are chemicals that are stored
in nerve cells and are involved in transmitting messages between the nerve
cells.
Neurotransmitters are released from nerve cells as a message is
transmitted. Once the message has been transmitted, the nerve cells then
reabsorb the neurotransmitter.
Bupropion prevents two of these neurotransmitters,
noradrenaline and dopamine, from being reabsorbed back into the nerve cells.
Noradrenaline and dopamine are responsible for moderating mood and various
other processes in the brain. It is thought that bupropion helps people to quit
smoking by increasing the amount of noradrenaline and dopamine free to act in
the brain.
Bupropion is used in combination with motivational support
techniques. You should seek help and support as much as possible while giving
up smoking, even while taking this medicine, as this will increase your chance
of success.
You should start taking this medicine while you are still
smoking and set a 'target stop date' for within the first two weeks of
treatment, preferably in the second week. This is because the medicine needs
time to start working.
The starting dose is one tablet once a day for six days,
increasing on day seven to one tablet twice a day. There should be an interval
of at least eight hours between doses. It is best to take your first dose when
you get up in the morning and your second dose at least eight hours later. Try
to avoid taking your second dose at bedtime, as difficulty sleeping (insomnia)
is a common side effect of the medicine.
If you have not managed to stop smoking by the seventh week of
treatment, your doctor will ask you to stop taking this medicine.
Zyban tablets should be swallowed whole with water - do not
chew, crush or break them.
This medicine may reduce your ability to drive or operate
machinery safely. Do not drive or operate machinery until you know how this
medicine affects you and you are sure it won't affect your
performance.
You should minimise your consumption of alcohol or avoid it
entirely while you are taking this medicine. This is because there have been
rare reports of reduced tolerance to alcohol, or adverse psychiatric reactions
in people who drank alcohol while taking this medicine.
Stop taking this medicine and inform your doctor if you get any
of the following symptoms during treatment: skin rash, blistering of the skin,
itching, fever, chest pain, collapse, swelling of any part of the body,
shortness of breath or pain in the muscles or joints. These are symptoms of
allergy to this medicine.
Do not exceed the prescribed dose of this medicine. Doing so
increases the risk of fits (seizures), which is a rare side effect of this
medicine.
If you have a fit (seizure) while taking this medicine,
treatment should be stopped and not restarted.
Consult your doctor before using nicotine replacement therapy,
such as nicotine patches or gum, in combination with this medicine. If you do
use nicotine replacement therapy at the same time, your blood pressure should
be monitored every week.
Certain medicines should not be taken with Zyban. Tell your
doctor or pharmacist if you are taking any other medicines before you start
Zyban. It is also important to tell your doctor or pharmacist that you are
taking Zyban before you take any new medicines, including those bought without
a prescription. See below for more details.
People taking any other medicinal product that contains
bupropion.
This medicine is not recommended for children and adolescents
under 18 years of age, as there is no information regarding its safety and
efficacy in this age group.
This medicine should not be used if you are allergic to one or
any of its ingredients. Please inform your doctor or pharmacist if you have
previously experienced such an
allergy.
If you feel you have
experienced an allergic reaction, stop using this medicine and inform your
doctor or pharmacist immediately.
Pregnancy and Breastfeeding
Certain medicines should not be used during pregnancy or
breastfeeding. However, other medicines may be safely used in pregnancy or
breastfeeding providing the benefits to the mother outweigh the risks to the
unborn baby. Always inform your doctor if you are pregnant or planning a
pregnancy, before using any medicine.
The safety of this medicine during pregnancy has not been
established, therefore it should not be used by pregnant women. Talk to your
doctor or pharmacist for advice on giving up smoking if you are
pregnant.
This medicine passes into breast milk. Women taking this
medicine should not breastfeed. Seek medical advice from your doctor.
Label warnings
This medication is to be swallowed whole, not
chewed.
Side effects
Medicines and their possible side effects can affect individual
people in different ways. The following are some of the side effects that are
known to be associated with this medicine. Because a side effect is stated
here, it does not mean that all people using this medicine will experience that
or any side effect.
Difficulty in sleeping (insomnia)
Headache
Concentration disturbance
Tremor
Dizziness
Anxiety and agitation
Depression
Dry mouth
Disturbances of the gut such as constipation, nausea, vomiting
or abdominal pain
Fever (pyrexia)
Sweating
Rash or itching
Increased heart rate (tachycardia)
Increased blood pressure
Loss of appetite
Visual disturbances
Chest pain
Seizures
Hypersensitivity reactions such as narrowing of the airways
(bronchospasm), swelling of the lips, throat and tongue (angioedema), itchy
blistering rash or anaphylactic shock
The side effects listed above may not include all of the side
effects reported by the drug's
manufacturer.
For more
information about any other possible risks associated with this medicine,
please read the information provided with the medicine or consult your doctor
or pharmacist.
How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines
you are already taking, including those bought without a prescription and
herbal medicines, before you start treatment with this medicine. Similarly,
check with your doctor or pharmacist before taking any new medicines while
taking this one, to ensure that the
combination is safe.
There is a rare risk of seizures (fits) occuring with this
medicine. This risk is greater if you take other medicines that can increase
the likelihood of seizures in combination with this medicine. These include the
following:
This medicine must not be taken by pepole taking monoamine
oxidase inhibitor antidepressants (MAOIs). At least 14 days should pass after
stopping an MAOI (eg phenelzine, tranylcypromine, isocarboxazide) before
starting treatment with bupropion hydrochloride.
Bupropion may increase blood levels of the following medicines.
As this may result in an increased risk of side effects, your doctor may
decrease the dose of these medicines if you are taking them with Zyban:
certain antidepressants, eg desipramine, imipramine,
paroxetine, citalopram
antipsychotics, eg thioridazine, risperidone
beta-blockers, eg metoprolol
medicines for abnormal heart rhythm, eg flecainide,
propafenone.
The following medicines may affect the blood level of
bupropion:
carbamazepine
cimetidine
clopidogrel
cyclophosphamide
ifosfamide
orphenadrine
phenobarbitone
phenytoin
ritonavir
sodium valproate
There may be an increase in side effects if this medicine is
taken with levodopa or amantadine (for Parkinson's disease).
The components of tobacco smoke can cause certain medicines to
be removed from the body faster than normal. When you stop smoking, they are
removed slower, so their blood levels may increase. Tell your doctor you are
giving up smoking if you take any medicines, in particular:
theophylline
tacrine
clozapine
olanzapine
pentazocine
some benzodiazepines, eg oxazepam
some beta-blockers, eg propranolol
flecainide
tricyclic antidepressants, such as imipramine
fluvoxamine
phenylbutazone
dextropropoxyphene.
People with diabetes who smoke normally need more insulin, as
smoking reduces the amount of insulin that is absorbed into the blood from an
injection under the skin. Therefore if people with diabetes give up smoking,
they may subsequently need a reduction in their insulin dose. Discuss this with
your doctor.
Using nicotine replacement therapy in combination with bupropion
(Zyban) is not currently recommended. However, if it is used with this
medicine, your blood pressure should be monitored weekly.
Other medicines containing the same active ingredient
There are currently no other medicines available in the UK that
contain bupropion as the active ingredient.
