Consumer medicine information

1. Why am I using APO-VENLAFAXINE XR?

APO-VENLAFAXINE XR contains the active ingredient venlafaxine hydrochloride. APO-VENLAFAXINE XR is used in the treatment and prevention of relapse of depression. It is also used in the treatment of panic attacks and anxiety, including avoidance or fear of social situations. For more information, see Section 1. Why am I using APO-VENLAFAXINE XR? in the full CMI.

2. What should I know before I use APO-VENLAFAXINE XR?

Do not use if you have ever had an allergic reaction to venlafaxine 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 APO-VENLAFAXINE XR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with APO-VENLAFAXINE 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 APO-VENLAFAXINE XR?

• Your doctor will tell you how many capsules you need to take each day. This may depend on your age, your condition and whether or not you are taking any other medicines.

• Swallow the capsules whole with a glass of water. Do not divide, crush, chew or dissolve the capsules in water.

5. What should I know while using APO-VENLAFAXINE XR?

6. Are there any side effects?

Speak to our doctor or pharmacist if you have nausea, vomiting, loss of appetite, diarrhoea, constipation, change in behaviour, feeling drowsy, headache, rapid heartbeat, sweating, hot flushes, rash, itchiness, weight change, blurred vision or dry mouth. Call your doctor immediately if you have muscle tremors, abnormal facial movements, feeling of apathy, hallucinations, agitation, confusion, muscle weakness, numbness, shortness of breath, bleeding, bruising more easily than normal or sensitivity to sunlight. Call your doctor immediately or go to Emergency at your nearest hospital if you have fits or seizures, signs of allergy, sudden fever with sweating, rapid heartbeat and muscle stiffness, palpitation, intense chest pain, dark or red urine, yellowing of skin or eyeballs, signs of infection, black sticky bowel motions, bloody diarrhoea, high fever, confusion and abrupt muscle contraction.
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

Venlafaxine hydrochloride.

2 Qualitative and Quantitative Composition

Each modified release capsule contains venlafaxine 75 mg (as 84.90 mg venlafaxine hydrochloride) or venlafaxine 150 mg (as 169.80 mg venlafaxine hydrochloride) as the active ingredient.
Excipients with known effect. Gelatin (also contains sulfites and phenylalanine).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Venlafaxine XR 75 mg modified release capsules. Peach opaque/ peach opaque size 1 hard capsule with thick and thin radial circular band on the body and cap in red ink. The capsule is filled with white to off white, round, biconvex, film coated mini tablets.
Venlafaxine XR 150 mg modified release capsules. Dark orange/ dark orange size 0 hard capsule with thick and thin radial circular band on the body and cap in white ink. The capsule is filled with white to off white, round, biconvex, film coated mini tablets.

4 Clinical Particulars

4.9 Overdose

In managing overdosage, consider the possibility of multiple medication involvement. The physician should consider contacting the Poison Information Centre on the treatment of any overdose (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Symptoms. During premarketing trials, most patients who have overdosed with venlafaxine were asymptomatic. Of the remainder, somnolence was the most commonly reported symptom. Mild sinus tachycardia and mydriasis have also been reported.
There were no reports of seizures, respiratory distress, significant cardiac disturbances or significant laboratory test result abnormalities among any of the cases reported to date. However, seizures and respiratory distress occurred in one additional patient in an ongoing study who ingested an estimated 2.75 g of venlafaxine with naproxen and thyroxine. Generalised convulsions and coma resulted and emergency resuscitation was required. Recovery was good without sequelae.
In post-marketing experience, overdose with venlafaxine was reported predominantly in combination with alcohol and/or other drugs. The most commonly reported events in overdose include tachycardia, changes in level of consciousness (ranging from somnolence to coma), mydriasis, vomiting and seizures. Other events reported included electrocardiogram changes (e.g. prolongation of QT interval, bundle branch block, QRS prolongation), ventricular fibrillation, ventricular tachycardia (including torsades de pointes), bradycardia, hypotension, vertigo and death. Serotonin toxicity has been reported in association with venlafaxine overdose.
Fatal overdoses. Published retrospective analyses from the United Kingdom (UK) report the rate of antidepressant overdose deaths per million prescriptions. In these analyses, the rate for venlafaxine is higher than that for SSRIs, but lower than that for tricyclic antidepressants. These analyses did not adjust for suicide risk factors.
Epidemiological studies have shown that venlafaxine is prescribed to patients with a higher pre-existing burden of suicide risk factors than patients prescribed SSRIs. The extent to which the finding of an increased risk of fatal outcomes can be attributed to the toxicity of venlafaxine in overdosage as opposed to some characteristics of venlafaxine treated patients is not clear. Prescriptions of venlafaxine should be written for the smallest quantity of drug consistent with good patient management, in order to reduce the risk of overdose (see Section 4.4 Special Warnings and Precautions for Use, Clinical worsening and suicide risk).
Management of overdoses. Severe poisoning may require complex emergency treatment and monitoring. Therefore, in event of suspected overdose involving venlafaxine, prompt contact with Poisons Information Centre on 13 11 26 (Australia) is recommended.
General supportive and symptomatic measures are recommended. Ensure an adequate airway, oxygenation and ventilation. Cardiac rhythm and vital signs must be monitored. Administration of activated charcoal may also limit drug absorption.
Where there is a risk of aspiration, induction of emesis is not recommended. No specific antidotes for venlafaxine are known. Forced diuresis, dialysis, haemoperfusion and exchange transfusion are unlikely to be of benefit.
Venlafaxine and ODV are not considered dialysable because haemodialysis clearance of both compounds is low.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. There was no evidence of gene mutation or chromosomal change in a series of genotoxicity assays using venlafaxine and the main human metabolite ODV.
Carcinogenicity. Venlafaxine was given by oral gavage to mice and rats for 18 and 24 months, respectively, at dosages up to 120 mg/kg/day. There were no clear drug related oncogenic effects in either species. In these studies, animal exposure to the main human metabolite ODV was less and exposure to venlafaxine was more than would be expected in humans taking the recommended therapeutic and maximum doses.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Venlafaxine hydrochloride is a white to off white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride).
Venlafaxine XR capsules are a modified release formulation, which release the active constituent venlafaxine hydrochloride from a tablet or tablets within the capsule. Drug is released by a combination of swelling of the hydrophilic polymer (hypromellose), diffusion and erosion.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSVENHYD.gif Chemical name: 1-[(1RS)-2-(Dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride.
Molecular formula: C₁₇H₂₇NO₂.HCl.
Molecular weight: 313.87.
CAS number. 99300-78-4.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

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