Consumer medicine information

1. Why am I using TEVATIAPINE XR?

TEVATIAPINE XR contains the active ingredient quetiapine fumarate. TEVATIAPINE XR is used to help correct chemical imbalances in the brain. It is used to treat conditions such as: Bipolar disorder, recurrent major depressive disorder, generalised anxiety disorder and schizophrenia. For more information, see Section 1. Why am I using TEVATIAPINE XR? in the full CMI.

2. What should I know before I use TEVATIAPINE XR?

Do not use if you have ever had an allergic reaction to quetiapine or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use TEVATIAPINE XR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with TEVATIAPINE XR and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use TEVATIAPINE XR?

• Your doctor will tell you how many tablets you will need to take each day and how long you need to take it. This depends on your condition and whether or not you are taking any other medicines.

• TEVATIAPINE XR should be taken once a day, at approximately the same time each day. It should be swallowed whole with a full glass of water. Do not split, chew or crush the tablets. It should be taken without food.

5. What should I know while using TEVATIAPINE XR?

6. Are there any side effects?

Common, less serious side effects: weight gain, increased appetite, upset stomach, constipation, dry mouth, blurred vision, feeling sleepy, irritability and abnormal dreams, nightmares.
Serious side effects: symptoms of high sugar levels and widespread skin rash that may include blistering or peeling of the skin, often accompanied by flu like symptoms. Combination of fever, very marked drowsiness, muscle stiffness, marked increase in blood pressure or heartbeats and reduced consciousness (a disorder called “neuroleptic malignant syndrome”)
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Quetiapine fumarate.

2 Qualitative and Quantitative Composition

Each Tevatiapine XR 50 mg, 150 mg, 200 mg, 300 mg and 400 mg tablet contains quetiapine fumarate equivalent to 50 mg, 150 mg, 200 mg, 300 mg or 400 mg of quetiapine free base respectively.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Tablet, modified release.
Tevatiapine XR modified release tablets 50 mg. Brown, biconvex oblong film-coated tablets debossed "Q50" on one side, plain on the other, in blister packs of 60s.
Tevatiapine XR modified release tablets 150 mg. White, biconvex oblong film-coated tablets debossed "Q150" on one side, plain on the other, in blister packs of 60s.
Tevatiapine XR modified release tablets 200 mg. Yellow, biconvex oblong film-coated tablets debossed "Q200" on one side, plain on the other, in blister packs of 60s.
Tevatiapine XR modified release tablets 300 mg. Light yellow, biconvex oblong film-coated tablets debossed "Q300" on one side, plain on the other, in blister packs of 60s.
Tevatiapine XR modified release tablets 400 mg. White, biconvex oblong film-coated tablets debossed "Q400" on one side, plain on the other, in blister packs of 60s.

4 Clinical Particulars

4.9 Overdose

In clinical trials, experience with quetiapine in overdosage is limited. Survival has been reported in acute overdoses of up to 30 grams of quetiapine. Most patients who overdosed reported no adverse events or recovered fully from the reported events. Death has been reported in a clinical trial following an overdose of 13.6 grams of quetiapine alone. In post marketing experience, there have been very rare reports of overdose of quetiapine alone resulting in death or coma.
In post marketing 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, hypotension and anti-cholinergic effects.
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 (epinephrine) 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.
Tevatiapine overdose may lead to gastric bezoar formation.
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. 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 (levothyroxine) clearance.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. The chemical structure of quetiapine fumarate is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSQUETIA.gif Chemical Name: Bis[2-(2-[4-(dibenzo[b,f][1,4]-thiazepin-11-yl)piperazin-1-yl] ethoxy) ethanol] fumarate.
Quetiapine fumarate is a weak acid (pKa 3.3, 6.8) which exhibits moderate pH dependent solubility (94.3 mg/mL to 2.37 mg/mL at pH values from 1 to 9) and lypophilicity 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 has an aqueous solubility of 3.29 mg/mL at 25°C.
CAS number. 111974-72-2.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

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