Depressionet.org.au

Zactin®
contains the active ingredient fluoxetine hydrochloride
Consumer Medicine Information
• flecainide, a medicine used to treat some This leaflet answers some common questions Tell your doctor if you are allergic to any
• St John's Wort (Hypericum perforatum), a other medicines, foods, dyes or preservatives.
It does not contain all the available information.
Tell your doctor if you are pregnant or plan to
These medicines may be affected by Zactin or It does not take the place of talking to your doctor become pregnant.
may affect how well it works. You may need Your doctor will discuss the risks and benefits oftaking Zactin during pregnancy. If Zactin is taken different amounts of your medicines, or you may All medicines have benefits and risks. Your doctor has weighed the risks of you taking Zactin particularly at the end of your pregnancy.
Some combinations of medicines may increase against the benefits expected for you.
the risk of serious side effects and are potentially If you have any concerns about taking this
reported rarely in the newborn baby after medicine, talk to your doctor or pharmacist.
Keep this leaflet with your medicine.
information on medicines to be careful with or Tell your doctor if you are breastfeeding or
wish to breastfeed.
Do not start taking other medicines for
Like many other medicines, Zactin can pass into depression without checking with your doctor.
breast milk. Your doctor will discuss the risks Zactin is used to treat depression and obsessive Do this even if you have already stopped
and benefits of taking Zactin when breastfeeding.
taking Zactin.
Tell your doctor if you have or have had any of
Zactin belongs to a group of medicines called Monoamine oxidase inhibitors (MAOIs), which the following medical conditions:
are other medicines used for depression, may selective serotonin reuptake inhibitors (SSRIs).
interfere with Zactin. You should not start a SSRIs are thought to work by their action on brain chemicals called amines which are involved MAOI for at least 5 weeks after stopping Zactin.
Zactin is not recommended for use in children and adolescents under 18 years of age.
• a bleeding disorder or a tendency to bleed Follow all directions given to you by your
doctor and pharmacist carefully.
Tell your doctor if you drink alcohol.
They may differ from the information containedin this leaflet.
Ask your doctor if you have any questions
Although drinking alcohol is unlikely to affect about why Zactin has been prescribed for you.
your response to Zactin, your doctor may suggest If you do not understand the instructions on
avoiding alcohol while you are being treated for the pack, ask your doctor or pharmacist for
Your doctor may have prescribed Zactin for If you have not told your doctor about any of
the above, tell him/her before you start taking
The dose varies from person to person.
Your doctor will tell you how much Zactin you Do not take Zactin if you are allergic to:
Tell your doctor if you are taking any other
The usual dose for Zactin is one capsule taken any other medicines containing fluoxetine medicines, including any that you buy without
once a day in the morning. Your doctor may a prescription from a pharmacy, supermarket
change your dose depending on how you respond • any of the ingredients listed at the end of this or health food shop.
Some medicines and Zactin may interfere with Some of the symptoms of an allergic reaction Swallow the capsules whole with a glass of
may include shortness of breath; wheezing or • monoamine oxidase inhibitors (MAOIs), difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or • You should stop taking MAOIs at least
Zactin is usually taken as a single dose in the Do not take Zactin if you are taking, or have
two weeks before starting Zactin.
morning. If your doctor tells you to take it twice a taken within the last 14 days, another medicine
• lithium, a medicine used to treat mood day, take a dose in the morning and at noon.
for depression called a monoamine oxidase
Take your medicine at about the same time
inhibitor (MAOI). Check with your doctor or
• other medicines for depression or obsessive each day.
pharmacist if you are unsure as to whether or
Taking it at the same time each day will have the not you are taking a MAOI.
best effect. It will also help you remember when Taking Zactin with a MAOI may cause a serious reaction with shaking (tremor), shivering, muscle stiffness, fever, rapid pulse, rapid breathing or Zactin can be taken with or without food.
medicines used to treat certain mental and Do not take Zactin if you are taking another
Continue taking Zactin for as long as your
medicine called pimozide to treat disturbances
doctor tells you to.
in thinking, feelings and behaviour.
Taking pimozide together with Zactin may alter The length of treatment with Zactin will depend on how quickly your symptoms improve. Most medicines of this type take time to work so don't Do not take this medicine after the expiry date
• medicines used to relieve pain, such as be discouraged if you do not feel better right printed on the pack or if the packaging is torn
away. While some symptoms will be relieved or shows signs or tampering.
sooner than others, Zactin commonly takes two to If it has expired or is damaged, return it to your • sumatriptan, a medicine used to treat If you are not sure whether you should start
• tryptophan, an amino acid available in food If you do not start to feel better in about four
taking this medicine, talk to your doctor.
supplements and multivitamin preparations weeks, check with your doctor.
medicines used to prevent blood clots, suchas warfarin Tell your doctor immediately if you become
pregnant while taking Zactin.
If it is almost time for your next dose, skip the
Your doctor will discuss the risks and benefits of dose you missed and take your next dose when
taking Zactin during pregnancy. If Zactin is taken Tell your doctor immediately or go to Accident
you are meant to.
and Emergency at the nearest hospital if any
Otherwise, take the missed dose as soon as you
particularly at the end of your pregnancy.
of the following happen:
remember, and then go back to taking your
medicine as you would normally.
reported rarely in the newborn baby after • shortness of breath, wheezing or trouble Do not take a double dose to make up for the
dose you missed.
• swelling of the face, lips, tongue or other This may increase the chance of you getting an Keep all of your doctor's appointments so that
your progress can be checked.
If you are not sure what to do , ask your
doctor or pharmacist.
Do not take Zactin to treat any other
complaints unless your doctor tells you to.
Immediately telephone your doctor or the
Do not give Zactin to anyone else, even if they
Poisons Information Centre (telephone 13 11
have the same condition as you.
26) for advice, or go to Accident and
Do not stop taking Zactin, or lower the dose,
Emergency at the nearest hospital, if you think
without checking with your doctor.
you or anyone else may have taken too much
Stopping Zactin suddenly may cause unwanted overactivity and uninhibited behaviour.
Zactin. Do this even if there are no signs of
side effects. Some people may suffer symptoms discomfort or poisoning.
The above list includes very serious side effects.
such as dizziness, anxiety, headache, feeling sick, You may need urgent medical attention.
or tingling or numbness of the hands or feet. Your If you have taken too much Zactin, you may feel doctor may decide to gradually reduce the Children and Adolescents
sick in the stomach, vomit, feel restless, agitated amount of Zactin you are taking before stopping Headaches are very common side effects.
Do not take the herbal remedy St John's Wort
Weight loss and decreased height gain have been (Hypericum perforatum) while you are being
observed in association with the use of Zactin in treated with Zactin.
children and adolescent patients. This is similar to If you are already taking the herbal remedy, stop other medicines that belong to the group ofmedicines called selective serotonin reuptake Persons taking Zactin may be more likely to
taking it and mention it to your doctor at your think about killing themselves or actually
trying to do so, especially when Zactin is first
Do not let yourself run out of Zactin over the
Tell your doctor or pharmacist if you notice
started or the dose is changed. Tell your
weekend or on holidays.
anything that is making you feel unwell.
doctor immediately if you have any suicidal
Other side effects not listed above may also occur thoughts or other mental/mood changes.
in some people. Some of these side effects (for Occasionally, the symptoms of depression or Be careful driving or operating machinery
example, changes in liver function) can only be other psychiatric conditions may include thoughts until you know how Zactin affects you.
found when your doctor does tests from time to of harming yourself or committing suicide. These Zactin may cause drowsiness in some people. If symptoms may continue or get worse during the you experience drowsiness, do not drive, operate first one to two months of treatment until the full machinery or do anything else that could be antidepressant effect of the medicine becomes apparent. This is more likely to occur in children, adolescents and young adults under 25 years of Keep your capsules in the pack until it is time
Tell your doctor or pharmacist as soon as
to take them.
Contact your doctor or a mental health
possible if you do not feel well while you are
If you take the capsules out of the pack they will professional immediately or go to the nearest
taking Zactin.
hospital for treatment if you or someone you
Like all other medicines, Zactin may have Keep your capsules in a cool dry place where
know is demonstrating any of the following
unwanted side effects in some people. Sometimes the temperature stays below 30°C.
warning signs:
they are serious, most of the time they are not.
Do not store Zactin or any other medicine in
You may need medical treatment if you get some the bathroom or near a sink.
• thoughts or talk about death or suicide Do not leave Zactin in the car or on a window
• thoughts or talk of self-harm or harm to Side effects vary from person to person and often Heat and dampness can destroy some medicines.
Do not be alarmed by the following list of
Keep Zactin where children cannot reach it.
possible side effects.
increase in aggressive behaviour, irritability A locked cupboard at least one-and-a-half metres above the ground is a good place to store Ask your doctor or pharmacist to answer any
questions you may have.
All mentions of suicide or violence must be
taken seriously.
Tell your doctor if you notice any of the
If your doctor tells you to stop taking Zactin,
following and they worry you:
If you are about to be started on any new
or if it has passed the expiry date, ask your
medicine, tell your doctor or pharmacist that
pharmacist what to do with any medicine that
you are taking Zactin.
is left over.
Tell any other doctors, dentists and
• loss of appetite, weight loss, changes in taste, pharmacists who are treating you that you are
taking Zactin.
Zactin capsules are green and purple, marked FL The active ingredient in Zactin is fluoxetine (as fluoxetine hydrochloride). Each Zactin capsule The capsules also contain the following inactiveingredients:• starch - maize• dimethicone 350• gelatin• titanium dioxide• erythrosine CI45430• indigo carmine CI73015• quinoline yellow CI47005• brilliant blue FCF CI42090• edible black ink.
Zactin capsules are gluten free.
Zactin is supplied by:
Alphapharm Pty Limited
(ABN 93 002 359 739)
Chase Building 2
Wentworth Park Road
Glebe NSW 2037
Phone: (02) 9298 3999
Australian registration number:AUST R 70502 Zactin® is a registered Trade Mark.
This leaflet was prepared on29 January 2009.

Source: http://depressionet.org.au/wp-content/uploads/2010/12/cmi_zactin.pdf