Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Sertraline generichealth.
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 generichealth 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 Sertraline generichealth is used for

Sertraline generichealth 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.
Sertraline generichealth 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 generichealth for another purpose.
Ask your doctor if you have any questions about why Sertraline generichealth has been prescribed for you.
Sertraline generichealth should not be used in children and adolescents under the age of 18 years for the treatment of any medical condition other than obsessive compulsive disorder (OCD). The safety and efficacy of Sertraline generichealth for the treatment of medical conditions (other than OCD) in this age group has not been satisfactorily established.
For the treatment of OCD, Sertraline generichealth is not recommended for use in children under the age of 6, as the safety and efficacy in children of this age group has not been established.
This medicine is only available with a doctor's prescription.
There is no evidence that sertraline tablets are addictive.

Before you take Sertraline generichealth

When you must not take it

• any medicine containing sertraline;

• any of the ingredients listed at the end of this leaflet.

• shortness of breath;

• wheezing or difficulty breathing;

• swelling of the face, lips, tongue or other parts of the body;

• rash, itching or hives on the skin.

• phentermine (used to help weight loss);

• tryptophan (contained in protein-based foods or dietary proteins);

• methadone (used to treat drug addiction);

• medicines used to treat migraine, eg. sumatriptan (Imigran);

• dextromethorphan (used as a cough suppressant in cold and flu medication);

• medicines used for pain management such as fentanyl, tapentadol (Palexia), tramadol or pethidine.

• 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.

Before you start to take it

• any other mental illness;

• epilepsy or seizures;

• liver or kidney problems;

• heart conditions causing irregular heartbeats;

• a tendency to bleed more than normal;

• diabetes mellitus;

• glaucoma, an eye condition.

Taking other medicines

• all prescription medicines;

• all medicines, vitamins, herbal supplements or natural therapies you buy without a prescription from a pharmacy, supermarket, naturopath or health food shop.

• other medicines for the treatment of depression called monoamine oxidase inhibitors (MAOIs). Taking Sertraline generichealth 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;

• other MAOI drugs such as linezolid, an antibiotic used to treat pneumonia and certain skin infections;

• other medicines for depression, panic disorder, social anxiety disorder or obsessive illnesses (eg. Prothiaden, Prozac, Aropax, Luvox, Cipramil, Efexor XR, Xydep);

• lithium (eg. Lithicarb), a medicine used to treat mood swings;

• other medicines for PMDD (eg. Prozac, Lovan, Xydep);

• tryptophan (contained in protein-based foods or dietary proteins);

• phentermine (weight-reducing medicines);

• dextromethorphan (used in cold and 'flu medicines to suppress cough);

• medicines for strong pain management such as fentanyl, tapentadol (Palexia), tramadol or pethidine;

• methadone (used to treat drug addiction);

• other medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis (eg. aspirin or NSAIDs such as ibuprofen or diclofenac);

• pimozide (used to treat disturbances in thinking, feeling and behaviour);

• St John's Wort, a herbal remedy used to treat mood disorders;

• medicines for treating psychotic illness such as clozapine, (eg. Clozaril) which is used to treat schizophrenia;

• medicines for irregular heartbeats (eg. Tambocor);

• warfarin (eg. Marevan, Coumadin) or other medicines that stop the blood from clotting;

• phenytoin (eg. Dilantin), a medicine used to treat epilepsy;

• metamizole (used for pain relief)

• 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;

• medicine used to treat Attention Deficit Hyperactivity Disorder (ADHD) such as dexamphetamine and lisdexamphetamine;

• antibiotics.

How to take Sertraline generichealth

Follow all directions given to you by your doctor.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.
Sertraline generichealth is available in 50 mg and 100 mg strengths. If your doctor has prescribed a dose such as 25 mg or 75 mg, please note that Sertraline generichealth 50 mg tablets have a scoreline and can be broken in half to allow such doses to be taken.

How much to take

How to take it

How long to take it

If you forget to take it

If you take too much (overdose)

• feeling drowsy

• nausea, diarrhoea, vomiting

• fast or irregular heartbeats

• tremors

• feeling agitated or dizzy.

While you are taking Sertraline generichealth

Things you must do

• thoughts or talk of death or suicide;

• thoughts or talk of self-harm or harm to others;

• any recent attempts of suicide or self-harm;

• increase in aggressive behaviour, irritability or agitation;

• worsening of depression.

Things you must not do

Things to be careful of

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Sertraline generichealth.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
It can be difficult to tell whether side effects are the result of taking Sertraline generichealth, effects of your condition or side effects of other medicines you may be taking. For this reason it is important to tell your doctor of any change in your condition.
Do not be alarmed by the list of side effects.
You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if…

• headache, dizziness, shaking or tremors, unusually overactive, muscle stiffness or weakness, decrease or loss of touch or other senses, sleepiness, drowsiness, impaired concentration;

• dry mouth, nausea, feeling sick, diarrhoea, indigestion, vomiting, stomach pain, constipation;

• increased sweating, rash and hives;

• tiredness, fever, feeling unwell;

• hot flush, high blood pressure;

• weight increase or loss;

• increased or decreased appetite;

• sleeping difficulties, sexual problems;

• vision disturbance;

• menstrual irregularities, sexual dysfunction including impaired sexual function in males, difficulty in passing urine, or increased frequency;

• persistent noise in the ears

• tingling and numbness of hands and feet;

• inflammation of the colon (causing diarrhoea).

Tell your doctor as soon as possible if...

• agitation, nervousness, anxiety, frightening dreams, yawning, abnormal thinking, teeth grinding, symptoms of agitation, anxiety dizziness, headache, nausea and tingling or numbness of the hands and feet after stopping Sertraline generichealth;

• uncontrollable muscle spasms affecting the eyes, head, neck and body, temporary paralysis or weakness of muscles;

• lockjaw;

• painful, swollen joints;

• difficulty in breathing, wheezing or coughing;

• uncontrollable movements of the body, shuffling walk, unusual weakness;

• palpitations, fainting or chest pain;

• irregular heartbeats;

• abnormal bleeding including vaginal bleeding;

• sudden onset of severe headache.

Go to hospital if…

• 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 heartbeat and muscle stiffness, which may lead to loss of consciousness;

• thoughts of suicide or attempting suicide or self-harm.

• agitation

• hallucinations

• coma

• fast heart beat

• fluctuating blood pressure readings

• high body temperature

• twitching and spastic body movements

• lack of body co-ordination

• nausea

• vomiting

• diarrhoea

After taking Sertraline generichealth

Storage

Disposal

Product description

What it looks like

Ingredients

• microcrystalline cellulose;

• calcium hydrogen phosphate;

• hyprolose;

• sodium starch glycolate;

• magnesium stearate;

• Opadry complete film coating system 13B50666 blue (50 mg strength);

• Opadry complete film coating system 13B52105 yellow (100 mg strength).

Australian Registration Numbers

Sponsor

1 Name of Medicine

Sertraline hydrochloride.

2 Qualitative and Quantitative Composition

Each tablet contains 50 mg or 100 mg sertraline (as hydrochloride).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Sertraline Generichealth 50 mg tablets are blue coloured, capsule shaped, biconvex, film coated tablets debossed with "SER" on one side and debossed with "5" and "0" on either side of breakline on the other side.
Sertraline Generichealth 100 mg tablets are yellow coloured, capsule shaped, biconvex, film coated tablets debossed with "SER" on one side and "100" on the other side.

4 Clinical Particulars

4.9 Overdose

On the evidence available, sertraline has a wide margin of safety in overdose. Overdoses in adults of 700 to 2100 mg have not resulted in serious symptoms. Ingestion of 4000 mg resulted in seizures in an adolescent. The largest known ingestion is 13.5 g with recovery reported. Another overdose of 2.5 g of sertraline alone resulted in death. Overdosage of 400 and 500 mg in two children have resulted in serotonin syndrome.
Signs and symptoms. Symptoms of overdose include serotonin mediated side effects such as electrocardiogram QT prolonged, TdP (see Section 4.4 Special Warnings and Precautions for Use; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions; Section 5.1 Pharmacodynamic Properties, Clinical trials), somnolence, gastrointestinal disturbances (such as nausea, diarrhoea and vomiting), tachycardia, tremor, agitation and dizziness. Other important adverse events reported with sertraline overdose (single or multiple drugs) include bradycardia, bundle branch block, coma, convulsions, delirium, hallucinations, hypertension, hypotension, manic reaction, pancreatitis, QT-interval prolongation, stupor and syncope. Hyperthermia, increased respiration and cutaneous vasodilation have also been reported. Minor ECG abnormalities, palpitations, prolonged tachycardia and increased pulse rate have also been reported following paediatric overdose. Seizures have been reported rarely. Serotonin syndrome may result following significant overdose, and onset may be delayed. A death due to asthma exacerbation has been reported following sertraline overdose.
Deaths have been reported involving overdoses of sertraline, primarily in combination with other drugs and/or alcohol. Therefore any overdosage should be treated aggressively.
Elevated liver enzymes and elevated creatine phosphokinase levels have been noted following acute overdose. Hyponatraemia secondary to SIADH has been reported following overdose and has been severe enough to cause seizures.
Treatment of overdosage. In managing overdosage, consider the possibility of multiple drug involvement. Treatment should consist of those general measures employed in the management of overdosage with any antidepressant. Cardiac and vital signs monitoring is recommended along with general symptomatic and supportive measures. Establish and maintain an airway, ensure adequate oxygenation and ventilation, if necessary. Patients should be monitored for potential cardiovascular, gastrointestinal or hepatic abnormalities. Also monitor for signs/ symptoms of serotonin syndrome (mental status changes, hyperthermia, myoclonus, autonomic instability, high CK levels) and possible seizures.
There are no specific antidotes for sertraline. Activated charcoal should be considered in treating overdose and is most effective when administered within one hour of ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via nasogastric tube once the airway is protected. Routine use of a cathartic with activated charcoal is not recommended as there is no evidence that cathartics reduce drug absorption and cathartics are known to cause adverse effects such as nausea, vomiting, abdominal cramps, electrolyte imbalances and occasionally hypotension.
Induction of emesis is not recommended because of the potential for CNS depression and seizures. Due to the large volume of distribution of sertraline, forced diuresis, dialysis, haemoperfusion and exchange transfusion are unlikely to be of benefit.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Sertraline had no genotoxic effects, with or without metabolic activation, based on the following assays; bacterial mutation assay; mouse lymphoma mutation assay; and tests for cytogenetic aberrations in vivo in mouse bone marrow and in vitro in human lymphocytes.
Carcinogenicity. The carcinogenic potential of sertraline has not been fully elucidated. Lifetime carcinogenicity studies were carried out in CD-1 mice and Long-Evans rats (at doses up to 40 mg/kg), giving rise to plasma drug exposure levels similar to or slightly higher than that achieved following the maximum recommended human dose of 200 mg. There was a dose related increase in the incidence of liver adenomas in male mice receiving sertraline at 10 mg/kg to 40 mg/kg. No increase was seen in female mice or in rats of either sex receiving the same treatments, nor was there an increase in hepatocellular carcinomas. Liver adenomas have a variable rate of spontaneous occurrence in the CD-1 mouse and are of unknown significance to humans. There was an increase in follicular adenomas of the thyroid in female rats receiving sertraline at 40 mg/kg; this was not accompanied by thyroid hyperplasia. While there was an increase in uterine adenocarcinomas in rats receiving sertraline at 10 mg/kg to 40 mg/kg compared to placebo controls, this effect was not clearly drug related.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Sertraline Generichealth is an antidepressant for oral administration and contains the active ingredients sertraline hydrochloride. Sertraline hydrochloride is chemically unrelated to tricyclic, tetracyclic or other available antidepressant agents.
Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol and sparingly soluble in ethanol.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSSERHYD.gif Chemical name: (1S,4S)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride.
Molecular formula: C₁₇H₁₇NCl₂.HCl.
Molecular weight: 342.7.
CAS number. 79559-97-0.

7 Medicine Schedule (Poisons Standard)

(S4) Prescription Only Medicines.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/SERGENST.gif