Zyban 150 mg prolonged release tablets

Main information

  • Trade name:
  • Zyban 150 mg prolonged release tablets
  • Dosage:
  • 150 milligram(s)
  • Pharmaceutical form:
  • Prolonged-release tablet
  • Prescription type:
  • Product subject to prescription which may not be renewed (A)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Zyban 150 mg prolonged release tablets
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • bupropion

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Authorised
  • Authorization number:
  • PPA0465/089/002
  • Authorization date:
  • 15-09-2017
  • Last update:
  • 13-12-2018

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Package leaflet: Information for the user

Zyban

®

150 mg prolonged release tablets

bupropion hydrochloride

Read all of this leaflet carefully before you start using this medicine because it

contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It

may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any

possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

What Zyban is and what it is used for

What you need to know before you take Zyban

How to take Zyban

Possible side effects

How to store Zyban

Contents of the pack and other information

1.

What Zyban is and what it is used for

Zyban is a medicine prescribed to help you stop smoking, when you also have

motivational support such as taking part in a ‘stop smoking’ programme.

Zyban will be most effective if you are fully committed to giving up smoking.

Ask your doctor or pharmacist for advice on treatments and other support to help you

stop.

2.

What you need to know before you take Zyban

Don’t take Zyban:

if you are allergic to bupropion or any of the other ingredients of this medicine

(listed in section 6)

if you are taking any other medicines which contain bupropion (such as

Wellbutrin, to treat depression)

if you have a condition that causes fits (seizures), such as epilepsy, or if you

have a history of fits

if you have an eating disorder, or had one in the past (for example, bulimia or

anorexia nervosa)

if you have severe liver problems, such as cirrhosis

if you have a brain tumour

if you are usually a heavy drinker and you have just stopped drinking alcohol,

or are going to stop while you’re taking Zyban

if 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

if you have a bipolar disorder (extreme mood swings), as Zyban could bring on

an episode of this illness

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.

The timing may be shorter for some types of MAOIs, your doctor will advise you.

If any of these applies to you, talk to your doctor straight away, and don’t

take Zyban.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Zyban. This is because some

conditions make it more likely that you will have side effects (see also section 4).

Children and adolescents

Zyban is not recommended for people under 18 years.

Adults

Fits (seizures)

Zyban has been shown to cause fits (seizures) in about 1 in 1000 people. (See also

‘Other medicines and Zyban’ later in this section and section 4, ‘Possible side effects’,

for more information). Fits are more likely:

if you regularly drink a lot of alcohol

if you have diabetes for which you use insulin or tablets

if you 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.

If you have a fit (seizure) during treatment:

Stop taking Zyban and don’t take any more. See your doctor.

You may have more risk of side effects:

if you have kidney or liver problems

if you are aged over 65.

You will need to take a lower dose (see section 3) and be checked closely while you

are taking Zyban.

If you have had any mental health problems…

Some people taking Zyban have had hallucinations or delusions (seeing, hearing or

believing things that are not there), disordered thoughts or extreme mood swings.

These effects are more likely in people who have had mental health problems before.

If you feel depressed or suicidal…

Some people become depressed when they try to stop smoking; very occasionally,

they may think about committing suicide, or try to do so. These symptoms have

affected people taking Zyban, most often in the first few weeks of treatment.

If you feel depressed or think about suicide:

Contact your doctor or go to a hospital straight away.

High blood pressure and Zyban…

Some people taking Zyban have developed high blood pressure which needs

treatment. If you already have high blood pressure, it can become worse. This is more

likely if you are also using nicotine patches to help you stop smoking.

You will have your blood pressure checked before you take Zyban and while you

are taking it, especially if you already have high blood pressure. If you are also using

nicotine patches, your blood pressure needs to be checked every week. If your blood

pressure increases, you may need to stop taking Zyban.

Other medicines and Zyban

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

other medicines, including medicines you bought without a prescription.

There may be a higher than usual risk of fits if you take:

medicines for depression or other mental health problems (see also ‘Don’t

take Zyban’ at the beginning of section 2)

theophylline for asthma or lung disease

tramadol, a strong painkiller

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 anti-histamines mainly used to treat allergies, that can cause

sleepiness

medicines for diabetes.

If you take any medicines in this list, talk to your doctor straight away,

before you take Zyban (see section 3 under ‘Some people need to take a lower

dose’).

Some medicines can affect how Zyban works, or make it more likely that you’ll

have side effects. These include:

medicines for depression (such as desipramine, imipramine, paroxetine) or

other mental health problems (such as risperidone, thioridazine)

medicines for Parkinson’s disease (such as levodopa, amantadine or

orphenadrine)

carbamazepine, phenytoin or valproate, to treat epilepsy or some mental

health problems

some medicines used to treat cancer (such as cyclophosphamide, ifosphamide)

ticlopidine or clopidogrel, mainly used to treat heart disease or stroke

some beta blockers (such as metoprolol), mainly used to treat high blood

pressure

some medicines for irregular heart rhythm (such as propafanone, flecainide)

ritonavir or efavirenz, for treatment of HIV infection.

If you take any medicines on this list, check with your doctor. Your doctor

will weigh up the benefits and risks to you of taking Zyban, or may decide to

change the dose of the other medicine you are taking.

Zyban may make other medicines less effective:

If you take tamoxifen used to treat breast cancer

If this applies to you, tell your doctor. It may be necessary to change to another

treatment for smoking cessation.

If you take digoxin for your heart

If this applies to you, tell your doctor. Your doctor may consider adjusting the dose

of digoxin.

The dose of some medicines may need to be reduced when you stop smoking

When you smoke, the chemicals absorbed into your body can cause some medicines

to be less effective. When you stop smoking, your dose of these medicines may need

to be reduced; otherwise, you may get side effects.

If you are taking any other medicines, check with your doctor if you notice any new

symptoms that you think may be side effects.

Zyban with alcohol

Some people find they are more sensitive to alcohol while taking Zyban. Your doctor

may suggest you do not drink alcohol while you’re taking Zyban, or try to drink as little

as possible. If you do drink a lot now, don’t just stop suddenly, because that may put

you at risk of having a fit.

Effect on urine tests

Zyban may interfere with some urine tests to detect other drugs. If you require a urine

test, tell your doctor or hospital that you are taking Zyban.

Pregnancy and breast-feeding

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

have a baby. Ask your doctor or pharmacist for advice before taking this medicine.

Some, but not all studies have reported an increase in the risk of birth defects,

particularly heart defects, in babies whose mothers were taking Zyban. It is not known

if these are due to the use of Zyban.

The ingredients of Zyban can pass into breast milk. You should ask your doctor or

pharmacist for advice before taking Zyban.

Driving and using machines

Some of the side effects of Zyban, such as feeling dizzy or light-headed, may affect

your concentration and judgement.

If you are affected, don’t drive or operate machinery.

3. How to take Zyban

Always take this medicine exactly as your doctor or pharmacist has told you. Check

with your doctor or pharmacist if you are not sure.

Some people need to take a lower dose

… as they may be more likely to get side effects.

if you are aged over 65

if you have liver or kidney disease

if you have a higher risk of fits (see ‘Warnings and Precautions’ and ‘Other

medicines and Zyban’ in section 2)

the maximum recommended dose for you is one 150 mg tablet once a day.

How to take your tablets

Take your Zyban tablets at least 8 hours apart. Don’t take Zyban near to

bedtime — it may cause difficulty in sleeping.

You can take Zyban with or without food.

Swallow your Zyban tablets whole. Don’t chew them, crush them

or split them — if you do, the medicine will be released into your body

too quickly. This will make you more likely to have side effects,

including fits.

If you take more Zyban than you should

If you take too many tablets, you may be more likely to have a fit or other side effects.

Don’t delay. Contact your doctor or your nearest hospital emergency department

immediately.

If you forget to take Zyban

If you miss a dose, wait and take your next tablet at the usual time.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Zyban

You may need to take Zyban for as long as 7 weeks to have its full effect.

Don’t stop taking Zyban without talking to your doctor first. You may need to

reduce your dose gradually.

If you have any further questions about using this medicine, ask your doctor or

pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets

them.

Fits (seizures)

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. Someone

who has had a fit may be confused afterwards, and may not remember what has

happened.

Fits are more likely if you take too much, if you take some other medicines, or if you

are at higher than usual risk of fits (see section 2).

If you have a fit, tell your doctor when you have recovered. Don’t take any more

Zyban.

Allergic reactions

Rarely (up to 1 in 1000) people may have potentially serious allergic reactions to

Zyban. Signs of allergic reactions include:

skin rash (including itchy, bumpy rash). Some skin rashes may need hospital

treatment, especially if you also have a sore mouth or sore eyes.

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 tablets.

Very common side effects

These may affect more than one in 10 people:

difficulty in sleeping (make sure you don’t take Zyban near to bedtime).

Common side effects

These may affect up to one in 10 people:

feeling depressed (see also ‘Warnings and Precautions’ in section 2)

feeling anxious or agitated

difficulty concentrating

feeling shaky (tremor)

headache

feeling sick (nausea), being sick (vomiting)

stomach pain or other upsets (such as constipation), changes in the taste of food,

dry mouth

fever, dizziness, sweating, skin rash (sometimes due to an allergic reaction),

itching.

Uncommon side effects

These may affect up to one in 100 people:

ringing in the ears, visual disturbances

increase in blood pressure (sometimes severe), flushing

loss of appetite (anorexia)

feeling weak

chest pain

feeling confused

rapid heartbeat.

Rare side effects

These may affect up to one in 1,000 people:

fits (see the beginning of this section)

twitching, muscle stiffness, uncontrolled movements, problems with walking or

coordination (ataxia)

palpitations

fainting, feeling faint when you stand up suddenly, because your blood pressure

falls

feeling irritable or hostile; strange dreams (including nightmares)

loss of memory

tingling or numbness

severe allergic reactions; rash together with joint and muscle pains (see the

beginning of this section)

urinating (passing water) more or less than usual

severe skin rashes that may affect the mouth and other parts of the body and can

be life-threatening

worsening of psoriasis (thickened patches of red skin)

your skin or the whites of your eyes turning yellow (jaundice), increase in liver

enzymes, hepatitis

changes in blood sugar levels

feeling unreal or strange (depersonalisation); seeing or hearing things that are not

there (hallucinations).

Very rare side effects

These may affect up to one in 10,000 people:

feeling restless, aggressive

sensing or believing things that are not true (delusions); severe suspiciousness

(paranoia).

urinary incontinence (involuntary urination, leakage of urine)

Other side effects

Other side effects have occurred in a small number of people but their exact

frequency is unknown:

thoughts of harming or killing themselves while taking Zyban or soon after

stopping treatment (see section 2, ‘What you need to know before you take

Zyban’). If you have these thoughts, contact your doctor or go to a hospital

straight away.

loss of contact with reality and unable to think or judge clearly (psychosis); other

symptoms may include hallucinations and/or delusions.

reduced number of red blood cells (anaemia), reduced number of white blood

cells (leucopenia) and reduced number of platelets (thrombocytopenia).

blood sodium decreased (hyponatraemia)

Effects of giving up smoking

People who stop smoking are often affected by nicotine withdrawal. This can also

affect people taking Zyban. Signs of nicotine withdrawal include:

difficulty in sleeping

tremor or sweating

feeling anxious, agitated or depressed, sometimes with thoughts of suicide.

Talk to your doctor if you have any concerns about how you feel.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any side

effects not listed in this leaflet. You can also report side effects directly via HPRA

Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax +353

1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

By reporting side effects you can help provide more information on the safety of this

medicine.

5.

How to store Zyban

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the pack. The expiry

date refers to the last day of that month.

Do not store this medicine above 25 °C.

Store it in the original package.

Do not throw away any medicines via wastewater or household waste. Ask your

pharmacist how to throw away medicines you no longer use. These measures will

help protect the environment.

6.

Contents of the pack and other information

What Zyban contains

Each tablet contains bupropion hydrochloride 150 mg.

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, iron oxide Black (E172).

What Zyban looks like and contents of the pack

Zyban 150 mg tablets are white, film-coated, biconvex, round tablets imprinted with

“GX CH7” on one side. They are available in cartons containing blisters of 100 tablets.

Manufacturer

Glaxo Wellcome SA, Avenida de Extremadura, 3, 09400 Aranda de Duero, Burgos,

Spain.

Product procured from within the EU, repackaged and distributed by the

Parallel Product Authorisation holder:

PCO Manufacturing, Unit 10, Ashbourne Business Park, Rath, Ashbourne, Co. Meath

Parallel Product Authorisation Number

PPA 465/89/2

Zyban is a registered trademark of GLAXO GROUP LIMITED.

This medicinal product is authorised in the Member States of the EEA under the

following names:

Zyban: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland,

Ireland, Italy, Luxembourg, Norway, Portugal, Sweden, The Netherlands, UK

Zyntabac: Spain, The Netherlands

Date leaflet prepared by PCO Manufacturing: February 2018