Consumer medicine information

What is in this leaflet

This leaflet answers some of the common questions people ask about Quetia 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 will have weighed the risks of you taking Quetia against the benefits they expect it will 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 Quetia are used for

Quetia belongs to a group of medicines called antipsychotics.
It helps to correct chemical imbalances in the brain and is used to treat conditions such as:

• schizophrenia, an illness with disturbances in thinking, feelings and behaviour

• bipolar disorder, an illness in which there are sustained mood swings either up (mania) or down (depression). During mania, patients experience episodes irritability. During depression, patients may feel depressed or guilty, lack energy, lose their appetite and have trouble sleeping.

Before you take it

When you must not take it

• quetiapine, the active ingredient in Quetia tablets

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

Before you start to take it

• any other medicines

• any other substances, such a foods, dyes or preservatives.

• heart or blood vessel problems or a family history of heart or blood vessel problems including low blood pressure, stroke, problems with your circulation or any condition that affects blood flow to the brain, problems with the way your heart beats or a history of heart attack.

• liver problems

• diabetes (or a family history of diabetes). Patients with diabetes or who have a higher chance of diabetes should have their blood sugar checked before and during treatment with Quetia tablets.

• epilepsy (seizures or fits)

• dementia or related behavioural disorders (especially in elderly patients)

• low white blood cell count

• sleep apnoea - a condition where you stop breathing for short periods during your normal nightly sleep

• urinary retention (a condition where you can't completely empty your bladder)

• an enlarged prostate

• a blockage in your intestines

• increased pressure inside your eyes or glaucoma

• history of alcohol or drug abuse.

Taking other medicines

• medicines used to treat anxiety, depression, mood swings, attention deficit hyperactivity disorder (ADHD) or other mood disorders

• lorazepam; a medicine used to help you sleep

• phenytoin or carbamazepine; medicines for epilepsy

• medicines for high blood pressure (including diuretics or fluid tablets) or heart conditions

• some antibiotics such as rifampicin and erythromycin

• medicines used for fungal infections such as ketoconazole

• medicines for Human Immunodeficiency Virus (HIV)

• thioridazine; an antipsychotic medicines

• medicines used to treat Parkinson's disease

• stimulants such as amphetamines

• glucocorticoids; medicines used to treat inflammation

• medicines that have anti-cholinergic (muscarinic) effects.

How to take it

Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.

How much to take

When to take it

How long to take it

If you forget to take it

If you take too much (overdose)

While you are taking it

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 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 it.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. Some side effects may be related to the dose of Quetia tablets or may be more likely to occur during long term treatment.
Therefore, it is important that you tell your doctor as soon as possible if you notice anything that is making you feel unwell, even if you think the problems are not connected with this medicine. Your doctor may then decide to adjust your dose or use a different medicine.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:

• feeling sleepy

• weight gain, increased appetite

• feeling weak

• dry mouth

• runny or stuffy nose (particularly in children)

• indigestion, upset stomach, constipation, vomiting (mainly in elderly)

• swelling of your hands, feet or ankles

• blurred vision

• abnormal dreams, nightmares

• irritability

• shortness of breath, difficulty in breathing and/or tightness in the chest

• fast or irregular heartbeats (palpitations).

• falling, feeling dizzy or faint on standing up

• difficulty in speaking

• difficulty swallowing

• rapid heart beat

• symptoms of high sugar levels in the blood (including passing large amounts of urine, excessive thirst, increase in appetite with a loss of weight, feeling tired, drowsy, weak, depressed, irritable and generally unwell)

• breast enlargement, unusual secretion of breast milk.

• long lasting and painful erection

• fainting (particularly in children)

• signs of frequent infections such as fever, chills, sore throat or mouth ulcers

• bleeding or bruising more easily than normal

• very marked drowsiness

• reduced consciousness

• abnormal muscle movements, including difficulty starting muscle movements, shaking, restlessness or muscle stiffness without pain.

• worm-like movements of the tongue or other uncontrolled movements of the tongue, mouth, cheeks or jaw which may progress to the arms and legs

• a sudden increase in body temperature, with sweating, or a fast heart beat

• fits (seizures)

• widespread skin rash that may include blistering, fever, swelling of the face and/or swollen lymph nodes (painful, warm, or red lump under your skin - often under your chin, on your neck, groin, armpit or behind your ear). These symptoms may also be associated with changes in your blood (eg white blood cell increase) or liver function. Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS)

• severe allergic reaction (may include severe difficulty breathing, shock, swelling of the face, lips, tongue or other parts of the body, skin rash, hayfever, or you may feel faint)

• severe upper stomach pain, often with nausea and vomiting (particularly in patients with other risk factors such as gallstones, alcohol consumption and/or increased levels of certain fats within the blood). These are symptoms of pancreatitis

• Combination of fever, very marked drowsiness, muscle stiffness, marked increase in blood pressure or heartbeats and reduced consciousness (a disorder called "neuroleptic malignant syndrome").

After taking it

Storage

Disposal

Product description

What Quetia tablets looks like

Ingredients

• lactose monohydrate

• sodium starch glycollate (type A)

• calcium hydrogen phosphate

• povidone

• microcrystalline cellulose

• magnesium stearate

• opadry complete film coating system 03B84929 pink (ARTG No.106711) [25 mg tablet only]

• opadry complete film coating system 03B52117 yellow (ARTG No.106712) [100 mg tablet only]

• hypromellose [200 mg, 300 mg tablets only]

• macrogol 400 [200 mg, 300 mg tablets only]

• titanium dioxide [200 mg, 300 mg tablets only].

Sponsor

1 Name of Medicine

Quetiapine fumarate.

2 Qualitative and Quantitative Composition

Quetia 25, 100, 200 and 300 tablets contain quetiapine fumarate equivalent to 25 mg, 100 mg, 200 mg and 300 mg quetiapine free base respectively.
Excipient(s) with known effect. Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Quetia 25 is a pink coloured, round, biconvex, film-coated tablet plain on both sides.
Quetia 100 is a yellow coloured, round, biconvex, film-coated tablet plain on both sides.
Quetia 200 is a white to off white, round, biconvex, film-coated tablet plain on both sides.
Quetia 300 is a white to off white, capsule shaped, biconvex, film-coated tablet with '300' debossed on one side and plain on other side.

4 Clinical Particulars

4.9 Overdose

In clinical trials, experience with quetiapine in overdosage is limited. Estimated doses of quetiapine up to 30 g have been taken, without fatal consequences, and with patients recovering without sequelae, however, death has been reported in a clinical trial following an overdose of 13.6 g of quetiapine alone. In postmarketing experience, there have been very rare reports of overdose of quetiapine alone resulting in death or coma.
In postmarketing experience, there were cases reported of QT prolongation with overdose.
Patients with pre-existing severe cardiovascular disease may be at an increased risk of the effects of overdose (see Section 4.4 Special Warnings and Precautions for Use, Concomitant cardiovascular illness).
In general, reported signs and symptoms were those resulting from an exaggeration of the drug's known pharmacological effects, i.e. drowsiness and sedation, tachycardia and hypotension.
Management of overdose. There is no specific antidote to quetiapine. In cases of severe signs, the possibility of multiple drug involvement should be considered, and intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system. Whilst the prevention of absorption in overdose has not been investigated, administration of activated charcoal together with a laxative should be considered.
In cases of quetiapine overdose, refractory hypotension should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents (adrenaline and dopamine should be avoided, since β-stimulation may worsen hypotension in the setting of quetiapine induced α-blockade).
Close medical supervision and monitoring should be continued until the patient recovers.
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

Acute toxicity studies. Quetiapine has low acute toxicity. Findings in mice (median lethal dose > 500 mg/kg PO; 100 mg/kg IP), rats (median lethal dose > 500 mg/kg PO; 100 mg/kg IP) and dogs (dose limit study 10-75 mg/kg PO) were typical of neuroleptic agents and included decreased motor activity, ptosis, loss of righting reflex, prostration, fluid around the mouth and convulsions.
Repeat dose toxicity studies. In multiple dose studies in rats, dogs and monkeys, anticipated central nervous system effects of an antipsychotic drug were observed with quetiapine (e.g. sedation at lower doses and tremor, convulsions or prostration at higher exposures).
Hyperprolactinaemia, induced through the dopamine D₂ receptor antagonist activity of quetiapine or its metabolites, varied between species but was most marked in the rat, and a range of effects consequent to this were seen in the 12 month study, including mammary hyperplasia, increased pituitary weight, decreased uterine weight and enhanced growth of females. Reversible morphological and functional effects on the liver, consistent with hepatic enzyme induction, were seen in mouse, rat and monkey.
Thyroid follicular cell hypertrophy was seen in mice, rats and monkeys. This hypertrophy was secondary to compensatory elevations of circulating thyroid stimulating hormone (TSH) brought about by increased hepatic metabolism of thyroid hormones.
Pigmentation of a number of tissues, particularly the thyroid, was not associated with any morphological or functional effects.
Transient increases in heart rate were not accompanied by consistent effects on blood pressure in dogs.
Posterior triangular cataracts seen after 6 months in dogs at 100 mg/kg/day were consistent with inhibition of cholesterol biosynthesis in the lens. No cataracts were observed in Cynomolgus monkeys dosed up to 225 mg/kg/day, although an increase in lens relucency was seen at the highest dose. No effects on the lens were seen in rodents. Monitoring in clinical studies did not reveal drug related corneal opacities in man (see Section 4.8 Adverse Effects (Undesirable Effects), Clinical study experience, Other findings observed during clinical studies).
No evidence of neutrophil reduction or agranulocytosis was seen in any of the toxicity studies; however, there was evidence for reduced lymphocytes in the bone marrow of dogs and in the circulation of monkeys.
Genotoxicity. Genetic toxicity studies with quetiapine show that it is not a mutagen or clastogen. Quetiapine showed no evidence of genotoxicity in a series of assays for gene mutation (bacteria and Chinese hamster ovary cells) and chromosomal damage (human lymphocytes and the in vivo micronucleus test).
Carcinogenicity. In the rat study (20, 75 and 250 mg/kg/day) the incidence of mammary adenocarcinomas was increased at all doses in female rats, consequential to prolonged hyperprolactinaemia. The incidence of carcinoma of the adrenal cortex was increased in male rats at the highest dose.
In male rat (250 mg/kg/day) and mouse (250 and 750 mg/kg/day), there was an increased incidence of thyroid follicular cell benign adenomas, consistent with known rodent specific mechanisms resulting from enhanced hepatic thyroxine clearance.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Quetiapine fumarate is white to off white powder. It is a weak acid (pKa 3.3, 6.8) which exhibits moderate pH dependent solubility and lipophilicity characteristics (Log P) which vary with pH (0.45 in water, 1.37 at pH 5, 2.65 at pH 7 and 2.59 at pH 9).
Quetiapine fumarate displays good solid state stability, has moderate aqueous solubility at 25°C and exhibits suitable tableting properties when combined with appropriate excipients.
Chemical structure. Chemical name: bis[2-[2-[4-(dibenzo[b,f][1,4]-thiazepin-11-yl)piperazin-1-yl] ethoxy] ethanol] fumarate.
Structural formula:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSQUETIA.gif Quetiapine fumarate has a molecular formula of C₄₆H₅₄N₆O₈S₂ and a molecular weight of 883.1. It has no chiral centres and only one morphological entity has been detected throughout development.
CAS number. 111974-72-2.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine (S4).

Summary Table of Changes

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