General Information
Consumer Medicine Information
What is in
this leaflet
This leaflet answers some
common questions about ZOLOFT.
It does not
contain all the available information.
It
does not take the place of talking to your doctor
or pharmacist.
All medicines have risks and
benefits.
Your doctor has weighed the risks
of you taking ZOLOFT against the benefits it is
expected to have for you.
If you have any
concerns about taking this medicine, ask your
doctor or pharmacist.
Keep this leaflet
with the medicine. You may need to read it again.
What ZOLOFT is used for
ZOLOFT is
used to treat depression and conditions called
obsessive compulsive disorder (OCD), panic
disorder, social phobia (social anxiety disorder)
and premenstrual dysphoric disorder (PMDD).
PMDD affects some women in the days before
their period. PMDD is different from premenstrual
syndrome (PMS). The mood symptoms (anger, sadness,
tension, etc) in PMDD are more severe than in PMS
and affect the woman's daily activities and
relationships with others.
ZOLOFT belongs
to a group of medicines called selective serotonin
reuptake inhibitors (SSRIs). Theyare thought to
work by blocking the uptake of a chemical called
serotonin into nerve cells in the brain. Serotonin
and other chemicals called amines are involved in
controlling mood.
Your doctor, however, may
prescribe ZOLOFT for another purpose.
Ask
your doctor if you have any questions about why
ZOLOFT has been prescribed for you.
This
medicine is only available with a doctor's
prescription.
There is no evidence that
ZOLOFT is addictive.
Before you take
ZOLOFT
When you must not take it
Do
not take ZOLOFT if:
1. you have ever had an
allergic reaction to ZOLOFT or any of the
ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction
to ZOLOFT may include a skin rash, itchiness,
difficulty breathing and swelling of the face.
2. you have epilepsy not properly controlled
by medication.
3. you are taking another
medicine for depression called a monoamine oxidase
inhibitor (MAOI) or have been taking it within the
last 14 days.
Taking ZOLOFT with a MAOI (eg
Aurorix, Eldepryl, Nardil, Parnate) may cause a
serious reaction with a sudden increase in body
temperature, extremely high blood pressure and
convulsions (fits).
4. you are taking
phentermine (used to help weight loss),
tryptophan, tramadol or medicines used to treat
migraine, eg sumatriptan (Imigran).
These
medicines can cause an exaggerated response to
ZOLOFT.
5. you are taking pimozide (used to
treat disturbances in thinking, feeling and
behaviour).
Ask your doctor or pharmacist
if you are not sure if you have been taking one of
these medicines.
Do not give ZOLOFT to
children unless the doctor has prescribed it for
the treatment of OCD. ZOLOFT is not suitable for
children under 6 years of age.
If you are
not sure whether you should be taking ZOLOFT, talk
to your doctor.
Do not take ZOLOFT if:
the expiry date marked on the packaging has
passed, even though the tablets may look alright.
the packaging is torn or shows signs of
tampering.
If this is the case, take the
tablets to your pharmacist.
Before you
start to take it
Tell your doctor if:
You are allergic to any foods, dyes,
preservatives or any other medicines
You
have any health problems, including:
any other
mental illness
epilepsy or seizures
liver
or kidney problems
a tendency to bleed more
than normal
You are pregnant or intend to
become pregnant
The effects of ZOLOFT on
the developing baby are not yet known.
There have been reports that babies exposed to
ZOLOFT and other antidepressants during the second
or third trimester of pregnancy may develop
complications after birth.
You are
breastfeeding or wish to breastfeed
ZOLOFT
passes into breast milk and may affect your baby.
Your doctor will discuss the risks
and
benefits of using ZOLOFT when pregnant or
breastfeeding.
Taking other medicines
Tell your doctor if you are taking any other
medicines, including medicines you buy without a
prescription from a pharmacy, supermarket or
health food shop. Some medicines should not be
taken with ZOLOFT.
These include:
other
medicines for the treatment of depression called
monoamine oxidase inhibitors (MAOIs).
Taking ZOLOFT with, or within 14 days of
stopping a MAOI may cause a serious reaction with
a sudden increase in body temperature, extremely
high blood pressure and convulsions.
medicines
that can increase the effects of ZOLOFT such as
tramadol, tryptophan, or
phentermine (weight-
reducing medicines) and medicines used to treat
migraine, eg sumatriptan.
pimozide (used to
treat disturbances in thinking, feeling and
behaviour)
You may respond differently to
ZOLOFT, or to some other medicines, if you take
them together. These include (not all brands
given):
other medicines for depression, panic
disorder, social anxiety disorder or obsessive
illnesses (eg Prothiaden, Pertofran, Prozac,
Aropax, Luvox, Cipramil, Efexor)
other
medicine for PMDD (eg Prozac and Lovan)
St
John's wort, a herbal remedy used to treat mood
disorders
clozapine, (eg Clozaril) a medicine
used to treat schizophrenia
medicines for
irregular heart beat (eg Tambocor)
warfarin
(eg Marevan, Coumadin) or other medicines that
stop the blood from clotting
medicines used to
relieve pain, swelling and other symptoms of
inflammation, including arthritis (eg aspirin or
NSAIDs such as ibuprofen or diclofenac)
lithium (eg Lithicarb), a medicine used to
treat mood swings
phenytoin (eg Dilantin), a
medicine used to treat epilepsy
sumatriptan
(eg Imigran), a medicine used to treat migraine
diazepam or other medicines that act on the
brain or nervous system (eg Serepax, Valium)
cimetidine (eg Tagamet), a medicine used to
treat reflux and ulcers
tolbutamide (eg
Rastinon), a medicine used to treat diabetes
methadone, a medicine used to treat drug
addiction
Your doctor or pharmacist has
more information on medicines to be careful with
or avoid while taking ZOLOFT.
If you have
not told your doctor or pharmacist about these
things, tell them before you start taking ZOLOFT.
How to take ZOLOFT
Take ZOLOFT
exactly as your doctor has prescribed.
Follow all directions given to you by your
doctor. They may differ from the information
contained in this leaflet.
How much to
take
For DEPRESSION IN ADULTS the usual
starting dose for ZOLOFT is one 50 mg tablet each
day. The dose can be increased gradually up to 200
mg a day if necessary.
For OBSESSIVE
COMPULSIVE DISORDER IN CHILDREN (6-12 YEARS) the
usual starting dose for ZOLOFT is 25 mg/day (half
a 50 mg tablet), increasing to 50 mg/day after one
week.
For OBSESSIVE COMPULSIVE DISORDER IN
ADULTS AND ADOLESCENTS (13-18 YEARS) the usual
starting dose for ZOLOFT is one 50 mg tablet each
day.
For PANIC DISORDER IN ADULTS the usual
starting dose for ZOLOFT is 25 mg per day,
increasing to 50 mg per day after one week.
For SOCIAL PHOBIA (SOCIAL ANXIETY DISORDER) IN
ADULTS the usual starting dose for ZOLOFT is 25 mg
per day, increasing to 50 mg per day after one
week.
The maximum recommended dose of
ZOLOFT for the conditions listed above is 200 mg
per day.
For PREMENSTRUAL DYSPHORIC
DISORDER the usual starting dose for ZOLOFT is one
50 mg tablet each day, either throughout the
menstrual cycle (to a maximum of 150 mg daily) or
for
the last 14 days before the start of menses
(to a maximum of 100 mg daily).
However,
depending on your condition and how you react to
the medicine, your doctor may ask you to take some
other dose.
How to take it
Swallow
the tablet(s) with a glass of water.
Try to
take your tablet(s) at the same time each day,
either morning or evening.
ZOLOFT can be
taken with or without food.
How long to
take it
Most medicines for depression and
obsessive illnesses take time to work, so do not
be discouraged if you do not feel better straight
away. It may take 2 to 4 weeks or even longer to
feel the full benefit of ZOLOFT.
Even when
you feel well, you may need to take ZOLOFT for
several months or longer. Continue taking ZOLOFT
until your doctor tells you to stop.
If you
have PMDD, your doctor may ask you to take this
medicine only at certain times of the month.
Do not stop taking ZOLOFT, or change the dose,
without first checking with your doctor.
If
you forget to take it
Do not take an extra
dose. Wait until the next day and take your normal
dose then.
Do not try to make up for the
dose you missed by taking more than one dose at a
time.
If you take too much (overdose)
Immediately telephone your doctor or Poisons
Information Centre (telephone 13 11 26) for
advice, or go to Accident and Emergency
(Casualty) at your nearest hospital if you think
you or anyone else may have taken too much ZOLOFT,
even if there are no signs of discomfort or
poisoning. You may need urgent medical attention.
Keep telephone numbers for these places
handy.
If you take too many tablets, you
may feel drowsy, sick in the stomach, have a fast
heart beat, suffer from tremors, feel agitated or
dizzy. Coma has also been reported with overdose.
While you are taking ZOLOFT
Things
you must do
Tell all doctors, dentists and
pharmacists who are treating you that you are
taking ZOLOFT.
Tell your doctor or
pharmacist that you are taking ZOLOFT if you are
about to be started on any new medicines.
Tell your doctor if you become pregnant while
taking ZOLOFT.
If you are a woman of child-
bearing age, you should avoid becoming pregnant
while taking ZOLOFT.
Tell your doctor
immediately if you have any suicidal thoughts or
other mental/mood changes. A worsening of
depressive symptoms including thoughts of suicide
or self-harm may occur in the first one or two
months of you taking Zoloft or when the doctor
changes your dose. These symptoms should be
controlled when the full effect of Zoloft takes
place.
Children, adolescents or young
adults under 24 years of age are more likely to
experience these effects during the first few
months of treatment.
Patients and
caregivers should be alert and monitor for these
effects.
Signs and symptoms of suicide
include:
Thoughts or talk of death or suicide
Thoughts or talk of self-harm or harm to
others
Any recent attempts of self-harm
Increase in aggressive behaviour, irritability
or agitation
Worsening of depression
Mention of suicide or violence must be taken
seriously.
If you or someone you know is
demonstrating these warning signs of suicide while
taking ZOLOFT, contact your doctor or a mental
health professional right away.
Things you
must not do
Do not stop taking ZOLOFT, or
change the dose, without first checking with your
doctor.
Do not let yourself run out of
tablets over the weekend or on holidays. Suddenly
stopping ZOLOFT may cause dizziness,
lightheadedness, numbness, unusual tingling
feelings or shakiness.
Do not give this
medicine to anyone else, even if their symptoms
seem similar to yours.
Do not use ZOLOFT to
treat any other complaints unless your doctor says
to.
Things to be careful of
Be
careful driving or operating machinery until you
know how ZOLOFT affects you. Some medicines for
depression may affect your ability to drive or
operate machinery or do things that could be
dangerous if you are not alert.
Although
drinking moderate amounts of alcohol is unlikely
to affect your response to ZOLOFT, your doctor may
suggest avoiding alcohol while you are taking
ZOLOFT.
You should wait at least 14 days
after stopping ZOLOFT before starting medicines
for depression or obsessive illnesses from the
MAOI group, such as Aurorix, Eldepryl, Nardil,
Parnate.
All of the above precautions are
important even after you have stopped taking
ZOLOFT.
The effects of ZOLOFT may last for
some days after you have stopped taking it.
Side effects
Check with your doctor as
soon as possible if you have any problems while
taking ZOLOFT, even if you do not think the
problems are connected with the medicine or are
not listed in this leaflet. Like other medicines,
ZOLOFT can cause some side effects. If they occur,
most are likely to be minor and temporary.
However, some may be serious and need medical
attention.
Tell your doctor immediately, or
go to your nearest hospital if you notice any of
the following:
fits or seizures
signs of
allergy such as rash or hives, swelling of the
face, lips or tongue, wheezing or difficulty
breathing
symptoms of sudden fever with
sweating, fast heart beat and muscle stiffness,
which may lead to loss of consciousness
palpitations or chest pain
abnormal
bleeding
difficulty in passing urine or blood
in the urine
severe blisters and bleeding in
the lips, eyes, mouth, nose and genitals
fever, sore throat, swollen glands, mouth
ulcers, unusual bleeding or bruising under the
skin
symptoms of agitation, anxiety,
confusion, dizziness, feeling tense and restless,
feeling of tiredness, drowsiness, or lack of
energy, headache, irritability, nausea, trouble
sleeping and tingling or numbness of the hands and
feet after stopping ZOLOFT.
These symptoms
are usually rare but may be serious and need
urgent medical attention.
Tell your doctor
if you experience:
headache, dizziness,
shakiness, muscle stiffness or weakness, decrease
or loss of touch or other senses
dry mouth,
increased sweating, feeling sick, diarrhoea,
indigestion, vomiting, constipation, stomach pain
tiredness, hot flushes, fever, feeling unwell
weight increase or loss
sleeping
difficulties, sleepiness
sexual problems
agitation, nervousness, anxiety, frightening
dreams, yawning, abnormal thinking, teeth
grinding, loss of appetite, impaired concentration
vision disturbance
menstrual
irregularities
loss of control of your bladder
unusually overactive
shaking or tremors
unusual hair loss or thinning
swelling of
hands, ankles or feet
tingling or numbness of
the hands or feet
breast enlargement in men or
the unusual secretion of breast milk in men or
women
increased sensitivity of the skinto sun
ringing or other persistent noise in the
ears
These side effects are usually mild.
This is not a complete list of all
possible side effects. Others may occur in some
people and there may be some side effects not yet
known.
Tell your doctor if you notice
anything else that is making you feel unwell, even
if it is not on this list.
Ask your doctor
or pharmacist if you do not understand anything in
this list.
After taking ZOLOFT
Storage
Keep your tablets where young
children cannot reach them. A locked cupboard at
least one and a half metres above the ground is a
good place to store medicines.
Keep ZOLOFT
in a cool, dry place where the temperature stays
below 30 °Celsius. Do not store
it or any other medicine in the bathroom or near a
sink.
Do not leave it in the car or on
window sills. Heat and dampness can destroy some
medicines.
Keep your tablets in their
blister pack until it is time to take them.
Disposal
If your doctor tells you to
stop taking ZOLOFT, or the tablets have passed
their expiry date, ask your pharmacist what to do
with any left over.
Product description
What it looks like
ZOLOFT tablets come
in two strengths:
ZOLOFT 50 mg - white,
capsule-shaped scored tablets marked with ZLT 50
on one side and the Pfizer logo on the other.
ZOLOFT 100 mg - white, capsule-shaped tablets
marked with ZLT-100 on one side and the Pfizer
logo on the other.
A box contains 30
tablets.
Ingredients
Active
ingredients
ZOLOFT 50 mg -
50 mg sertraline
per tablet
ZOLOFT 100 mg -
100 mg
sertraline per tablet
Other ingredients
Cellulose (microcrystalline), calcium hydrogen
phosphate, hydroxypropyl cellulose, sodium starch
glycollate, magnesium stearate, white Opadry,
clear Opadry.
ZOLOFT does not contain gluten,
lactose or sugar.
Manufacturer
ZOLOFT is supplied in Australia by:
Pfizer
Australia Pty Ltd
ABN 5000 8422 348
38-42
Wharf Road
West Ryde NSW
2114
Australia
Toll Free Number: 1800 675
229
Australian Registration Number:
ZOLOFT 50 mg - AUST R 42979
ZOLOFT 100 mg -
AUST R 42950
This leaflet was prepared on 13
October 2008
* Registered
Trademark
© Pfizer Australia
Pty Ltd
All rights reserved