Sertraline-DRLA 50 mg and 100 mg Tablets
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Sertraline-DRLA tablets.
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 Sertraline-DRLA tablets against the benefits it is expect 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 Sertraline-DRA tablets are used for
Sertraline-DRLA tablets are 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 affects the woman’s daily activities and relationships with others.
Sertraline belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). They are 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 Sertraline-DRA for another purpose.
Ask your doctor if you have any questions about why Sertraline-DRLA tablets have been prescribed for you. This medicine is only available with a doctor’s prescription.
There is no evidence that sertraline is addictive.
Before you take Sertraline-DRLA tablets
When you must not take it
Do not take Sertraline-DRLA tablets if:
- you have ever had an allergic reaction to sertraline or any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction to Sertraline-DRLA tablets may include a skin rash, itchiness, difficulty breathing and swelling of the face.
- you have epilepsy not properly controlled by medication.
- you are taking another medicine for depression called a monoamine oxidase inhibitor (MAOI) or have been taking it within the last 14 days.
Taking Sertraline-DRLA 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).
- you are taking phentermine (used to help weight loss), tryptophan, tramadol or medicines used to treat migraines, eg sumatriptan (Imigran).
These medicines can cause an exaggerated response to Sertraline-DRLA.
- 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 Sertraline-DRLA tablets to children unless the doctor has prescribed it for the treatment of OCD. Sertraline is not suitable for children under 6 years of age.
If you are not sure whether you should be taking Sertraline-DRLA tablets, talk to your doctor.
Do not take Sertraline-DRLA tablets 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 sertraline on the developing baby are not yet known.
There have been reports that babies exposed to sertraline and other antidepressants during the second or third trimester of pregnancy may develop complications after birth.
You are breastfeeding or wish to breastfeed. Sertraline passes into breast milk and may affect your baby.
Your doctor will discuss the risks and benefits of using sertraline 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 Sertraline-DRLA tablets.
- Other medicines for the treatment of depression called monoamine oxidase inhibitors (MAOIs).
Taking Sertraline-DRLA tablets 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 sertraline 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 Sertraline-DRLA tablets, 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 medicines 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 Sertraline-DRLA tablets.
If you have not told your doctor or pharmacist about these things, tell them before you start taking Sertraline-DRLA tablets.
How to take Sertraline-DRLA tablets
Take Sertraline-DRLA tablets 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 Sertraline-DRLA 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 Sertraline-DRLA 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 Sertraline-DRLA is one 50 mg each day.
For PANIC DISORDER IN ADULTS
the usual starting dose for Sertraline-DRLA is 25 mg per day
, increasing to 50
mg/day after one week.
For SOCIAL PHOBIA (SOCIAL ANXIETY DISORDER) IN ADULTS
the usual starting dose for Sertraline-DRLA is 25 mg/day, increasing to 50 mg/day after one week.
The maximum recommended dose of Sertraline-DRLA tablets for the conditions listed above is 200 mg per day.
For PREMENSTRUAL DYSPHORIC DISORDER
the usual starting dose for Sertraline-DRLA tablets 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.
Sertraline-DRLA tablets can be taken with or without food.
How long to take it
Most medicines for depression and obsessive illness 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 Sertraline-DRLA tablets.
Even when you feel well, you may need to take Sertraline-DRLA tablets for several months or longer. Continue taking Sertraline-DRLA tablets 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 Sertraline-DRLA tablets, 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 that you or anyone else may have taken too much Sertraline-DRLA tablets, 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 Sertraline-DRLA tablets
Things you must do
Tell all doctors, dentists and pharmacists who are treating you that you are taking Sertraline-DRLA tablets.
Tell your doctor and pharmacist that you are taking Sertraline-DRLA tablets if you are about to be started on any new medicine.
Tell your doctor if you become pregnant while taking Sertraline-DRLA tablets. If you are a woman of child-bearing age, you should avoid becoming pregnant while taking Sertraline-DRLA tablets.
Tell your doctor immediately if you have any suicidal thought 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 Sertraline-DRLA or when the doctor changes your dose. These symptoms should be controlled when the full effect of Sertraline-DRLA 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
All mentions of suicide or violence must be taken seriously.
If you or someone you know is demonstrating these warning signs of suicide while taking Sertraline-DRLA, contact your doctor or a mental health professional right away.
Things you must not do
Do not stop taking Sertraline-DRLA tablets, 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 Sertraline-DRLA tablets 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 Sertraline-DRLA tablets 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 Sertraline-DRLA tablets affect 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 Sertraline-DRLA tablets, your doctor may suggest avoiding alcohol while you are taking Sertraline-DRLA tablets.
You should wait at least 14 days after stopping Sertraline-DRLA tablets before starting medicines for depression or obsessive illnesses from the MAOI group, such as Aurorix, Elderpryl, Nardil, Parnate.
All of the above precautions are important even after you have stopped taking Sertraline-DRLA tablets.
The effects of Sertraline-DRLA tablets may last for some days after you have stopped taking it.
Check with your doctor as soon as possible if you have any problems while taking Sertraline-DRLA tablets, even if you do not think the problems are connected with the medicine or are not listed in this leaflet. Like other medicines, Sertraline-DRLA tablets 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 Sertraline-DRLA tablets.
These symptoms are usually rare but may be serious and need urgent medical attention.
Tell your doctor if you experience:
- Headaches, 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 disturbances
- 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
unusual secretion of breast milk in men or women
- Increased sensitivity of the skin to 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 Sertraline-DRLA tablets
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 Sertraline-DRLA tablets in a cool, dry place where the temperature stays below 25°C. 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 the blister pack until it is time to take them.
If your doctor tells you to stop taking the Sertraline-DRLA tablets, or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
What it looks like
Sertraline-DRLA tablets come in two strengths:
- Sertraline-DRLA 50 mg tablets – white to off white capsule shaped, biconvex film coated tablets embossed with ‘50’ on one side and ‘SET’ on the other side with a bisect line separating S from ET.
- Sertraline-DRLA 100 mg tablets – white to off white capsule shaped, biconvex film coated tablets embossed with ‘100’ on one side and ‘SET’ on the other side with a bisect line separating S from ET.
A box contains 10, 14, 28 or 30 tablets.
- Sertraline-DRLA 50 mg tablets contain 50 mg of sertraline (as sertraline hydrochloride) per tablet
- Sertraline-DRLA 100 mg tablets contain 100 mg of sertraline (as sertraline hydrochloride) per tablet
- Microcrystalline cellulose,
- calcium hydrogen phosphate,
- colloidal anhydrous silica,
- sodium starch glycollate,
- magnesium stearate,
- polysorbate 80,
- Opadry white OY58900.
Sertraline-DRLA tablets are supplied in Australia by:
Dr Reddy’s Laboratories (Australia) Pty Ltd
Level 1, 181 Bay Street
This leaflet was prepared in January 2011.
Australian Registration Numbers:
Sertraline-DRLA Tablets 50 mg AUST R 160766
Sertraline DRLA Tablets 100 mg AUST R 160777
Published by MIMS March 2015