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