Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
1. Why am I taking EFEXOR-XR?
EFEXOR-XR contains the active ingredient venlafaxine hydrochloride. EFEXOR-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.
2. What should I know before I take EFEXOR-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.
3. What if I am taking other medicines?
Some medicines may interfere with EFEXOR-XR and affect how it works.
4. How do I take EFEXOR-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 taking EFEXOR-XR?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using EFEXOR-XR.
Watch carefully for signs that your depression or anxiety is getting worse, especially
in the first few weeks of treatment, or if your dose has changed.
Tell your doctor immediately if you have any symptoms of serotonin syndrome, or if
you have any thoughts about suicide or doing harm to yourself.
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Things you should not do
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Do not suddenly stop taking this medicine or lower the dose if you have been taking
it for some time.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how EFEXOR-XR
affects you.
EFEXOR-XR capsules may make you feel drowsy.
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Drinking alcohol
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Avoid drinking alcohol while you are taking EFEXOR-XR.
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Looking after your medicine
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Store it in a cool dry place below 30°C away from moisture, heat or sunlight.
Keep it where children cannot reach it.
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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.
Active ingredient:
Venlafaxine hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using EFEXOR-XR. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using EFEXOR-XR.
Where to find information in this leaflet:
1. Why am I taking EFEXOR-XR?
EFEXOR-XR contains the active ingredient
venlafaxine hydrochloride
. It belongs to a class of medications for depression and anxiety, called Serotonin-Noradrenaline
Reuptake Inhibitors (SNRIs).
Serotonin and noradrenaline are chemical messengers that allow certain nerves in the
brain to work. EFEXOR-XR capsules increase the level of these two messengers. Experts
think this is how it helps to restore your feeling of wellness.
EFEXOR-XR is not addictive.
EFEXOR-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.
Depression can affect your whole body and may cause emotional and physical symptoms
such as feeling low in spirit, being unable to enjoy life, poor appetite or overeating,
disturbed sleep, loss of sex drive, lack of energy and feeling guilty over nothing.
Excessive anxiety is a condition in which you feel constantly and uncontrollably worried
and distressed. It may also make you feel irritable, and cause difficulty in thinking
and sleeping. Other common symptoms associated with anxiety may include a dry mouth,
a lump in the throat, cold clammy hands, diarrhoea and nausea.
Depression and anxiety are treatable illnesses. Anxiety or tension associated with
the normal stress of everyday life usually does not require treatment with medicines.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
Your doctor may have prescribed it for another reason.
Use in Children
Do not give EFEXOR-XR to children or adolescents under 18 years of age.
The safety and effectiveness of EFEXOR-XR in this age group have not been established.
2. What should I know before I take EFEXOR-XR?
Warnings
Do not use EFEXOR-XR if:
you are taking other medications for depression known as monoamine oxidase inhibitors,
even if you have stopped taking them now, but have taken them within the last 14 days.
you are allergic to venlafaxine, or any of the ingredients listed at the end of this
leaflet.
Symptoms of an allergic reaction may include:
Rash, itching or hives on the skin
Swelling of the face, lips, tongue, throat or other parts of the body
Shortness of breath, wheezing or troubled breathing; difficulty swallowing.
Always check the ingredients to make sure you can use this medicine.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Check with your doctor or pharmacist if you:
have any other medical conditions
take any medicines for any other condition
have allergies to any other medicines, foods, preservatives or dyes.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor or pharmacist if you are pregnant or intend to become pregnant.
EFEXOR-XR is not recommended for use during pregnancy. Your doctor will discuss the
risks and benefits of using this medicine if you are pregnant. One of these risks
is that newborn babies, whose mothers have been taking EFEXOR-XR in the last few months
of pregnancy, may experience problems soon after delivery, including breathing difficulties,
seizures and lack of oxygen in their blood.
If you take EFEXOR-XR or similar anti-depressants mid to late in your pregnancy, you
may develop a condition known as "pre-eclampsia", which is characterised by persistent
high blood pressure during or after pregnancy. Symptoms of preeclampsia can include
headaches, abdominal pain, shortness of breath or burning behind the sternum, nausea
and vomiting, confusion, heightened state of anxiety, and/or visual disturbances such
as oversensitivity to light, blurred vision, or seeing flashing spots or auras.
If you take EFEXOR-XR or similar antidepressants in the last month of your pregnancy,
you may experience heavy vaginal bleeding shortly after birth (postpartum haemorrhage).
Continuing treatment with EFEXOR-XR or similar antidepressants during pregnancy should
be strictly as directed by your doctor. Symptoms of a relapse may occur if treatment
is discontinued, even if major depression was previously under control.
Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.
EFEXOR-XR passes into breast milk and there is a possibility that the breast-fed baby
may be affected. For this reason, the use of EFEXOR-XR is not recommended in breast-feeding
women.
Tell your doctor if you have or have had any of the following medical conditions:
A history of fits (seizures or convulsions)
A personal history or family history of bipolar disorder
A history of aggression
A history of restlessness or difficulty sitting still
Diabetes
Blood pressure problems
Glaucoma (increased pressure in the eye)
A tendency to bleed more than normal or you are taking medicines to prevent blood
clots
Raised cholesterol levels or you are taking medicines to lower cholesterol
Problems with your kidneys or liver
Problems with your heart, especially conditions causing irregular heartbeats.
Your doctor may wish to do some heart tests such as an electrocardiogram (ECG) or
blood tests during treatment with EFEXOR-XR.
Tell your doctor if you plan to have surgery.
If you have not told your doctor about any of the above, tell them before you start
taking EFEXOR-XR.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you take any other medicines, including:
all prescription medicines
medicines for weight loss
all medicines, vitamins, herbal supplements or natural therapies you buy without a
prescription from a pharmacy, supermarket, naturopath or health food shop.
Do not start to take any other medicine while you are taking EFEXOR-XR, unless it
is prescribed or approved by your doctor.
Some medicines may interfere with EFEXOR-XR, or EFEXOR-XR may interfere with these
medicines. These include:
Medications for depression known as monoamine oxidase inhibitors (such as moclobemide,
linezolid, phenelzine and tranylcypromine), even if you have stopped taking them now,
but have taken them within the last 14 days. Your doctor or pharmacist can tell you
what to do if you are taking any of these medicines
Allow at least 7 days after stopping EFEXOR-XR before starting a MAOI.
Taking this medicine with a MAOI, or within 7 days of taking a MAOI, may cause a serious
reaction with a sudden increase in body temperature, extremely high blood pressure
and severe convulsions.
The appropriate washout period is needed to prevent severe adverse reactions.
Any other medications for depression, anxiety, obsessive-compulsive disorder or premenstrual
dysphoric disorder, including St John's wort
Medicines for treating mental disorders such as haloperidol, risperidone, lithium
or clozapine
Tramadol, fentanyl, tapentadol, pethidine and methadone used to treat strong pain
Medicines used to treat Attention Deficit Hyperactivity Disorder (ADHD) such as dexamphetamine
and Lisdexamphetamine
Cimetidine for reflux and stomach ulcers
Triptans used to treat migraine
Amiodarone or quinidine used to treat irregular heartbeats.
Your doctor may do some tests such as an electrocardiogram (ECG) or blood tests if
you are taking either of these medicines whilst taking EFEXOR-XR.
Metoprolol for high blood pressure or angina
Medicines used to prevent blood clotting such as anti-coagulants and platelet inhibitors
Indinavir for viral infections
Antibiotics such as erythromycin and linezolid for bacterial infections
Ketoconazole or fluconazole for fungal infections.
You may need to use different amounts of your medicine, or you may need to take different
medicines. Your doctor will advise you.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
4. How do I take EFEXOR-XR?
Follow all directions given to you by your doctor or pharmacist carefully.
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.
How much to take
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.
Depression and Anxiety
The usual starting dose is 75mg taken once daily. After 2 weeks, your doctor may increase
the dose to 150 mg a day.
Panic attacks
The usual starting dose is 37.5 mg taken once daily for the first 4 to 7 days, then
increased to 75 mg taken once daily.
Do not change your dose unless your doctor tells you to.
If you have kidney or liver problems, you may need a lower dose of EFEXOR-XR.
If you have heart problems your doctor may first do some blood tests or heart tests
such as an electrocardiogram (ECG) before increasing your dose of EFEXOR-XR.
How to take EFEXOR-XR
Swallow the capsules whole with a glass of water or other non-alcoholic liquid.
Do not divide, crush, chew or dissolve the capsules in water.
Do not be concerned if you see small white granules or balls in your stools after
taking EFEXOR-XR.
Inside EFEXOR-XR capsules are spheroids or small white balls that contain the venlafaxine
active ingredient. These spheroids are released from the capsule into your gastrointestinal
tract. As the spheroids travel the length of your gastrointestinal tract, venlafaxine
is slowly released. The spheroid 'shell' remains undissolved and is eliminated in
your stools. Therefore, even though you may see spheroids in your stools, your dose
of venlafaxine has been absorbed.
When to take EFEXOR-XR
Take your medicine once daily with food, at approximately the same time each day.
This could be either in the morning or in the evening.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
How long to take EFEXOR-XR
Continue taking your medicine for as long as your doctor tells you.
Although you may begin to feel better after two weeks, it may take several weeks before
you feel much better. It is important to give EFEXOR-XR time to work.
This medicine helps to control your condition, but does not cure it. It is important
to keep taking your medicine even if you feel well.
If you forget to take EFEXOR-XR
If it is less than 12 hours until your next dose, skip the dose you missed and then
take your next dose when you are meant to. Otherwise, take it as soon as you remember,
and then go back to taking as you would normally.
Do not take a double dose to make up for the dose you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you take too much EFEXOR-XR
If you think that you or anyone else may have taken too much EFEXOR-XR, you may need
urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
If you take too many EFEXOR-XR capsules you may:
Feel sleepy
Vomit
Have an increased heart rate or changes in heart rhythm
Have a seizure (fits)
Have breathing difficulties
Become unconscious
Have dilated pupils.
Keep the telephone number for these places handy whilst taking any medications.
5. What should I know while taking EFEXOR-XR?
Things you should do
Visit your doctor regularly for a checkup so that your progress can be checked.
Your doctor may do some tests (such as an electrocardiogram (ECG) or blood tests)
from time to time to make sure the medicine is working and to prevent unwanted side
effects.
Always discuss any questions you have about EFEXOR-XR capsules with your doctor.
If you are going to have surgery, tell your doctor that you are taking this medicine.
Some agents used to assist your doctor during surgery may interact with EFEXOR-XR
leading to unwanted side effects.
If you are about to have any urine tests, tell your doctor that you are taking this
medicine.
It may interfere with the results of some tests.
Take EFEXOR-XR capsules as your doctor has prescribed.
Keep enough EFEXOR-XR capsules to last weekends and holidays.
This medicine helps to control your condition, but does not cure it. It is important
to keep taking your medicine even if you feel well.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking
this medicine.
Watch carefully for signs that your depression or anxiety is getting worse, especially
in the first few weeks of treatment, or if your dose has changed.
Sometimes people with depression can experience a worsening of their depressive symptoms.
This can happen even when taking an antidepressant.
Information from clinical trials has suggested that children, adolescents and young
adults (18-24 years), particularly those with depression, may be at increased risk
of suicidal behaviour (including suicide attempts) when treated with EFEXOR- XR, especially
during initial treatment.
Tell your doctor immediately if you experience any of the following symptoms, especially
if they are severe, you have not had these symptoms before or they happen very suddenly.
Call your doctor straight away if you experience:
Anxiety or agitation
Panic attacks
Difficulty sleeping
Irritability
Aggressiveness
Hostility or impulsiveness
Restlessness
Overactivity or uninhibited behaviour
Other unusual changes in behaviour
Thoughts of suicide
Tremor, sweating, fast heart rate
Muscle rigidity.
Symptoms of serotonin syndrome may include mental status changes (e.g. agitation,
confusion, hallucinations, and coma), autonomic instability (e.g. excessive sweating,
fast heart rate, and increased body temperature), neuromuscular aberrations (e.g.
overactive reflexes, incoordination, tremor) and/or gastrointestinal symptoms (e.g.
nausea, vomiting, and diarrhoea).
Tell your doctor immediately if you have any thoughts about suicide or doing harm
to yourself.
Warning signs of suicide
If you or someone you know is showing the following warning signs, either contact
your doctor or a mental health advisor right away or go to the nearest hospital for
treatment.
All thoughts or talk about suicide or violence are serious.
Thoughts or talk about death or suicide
Thoughts or talk about self-harm or doing harm to others
Any recent attempts of self-harm
An increase in aggressive behaviour, irritability or agitation.
Things you should not do
Do not suddenly stop taking this medicine or lower the
dose if you have been taking it for some time.
If possible, your doctor will gradually reduce the amount
you take each day before stopping the medicine
completely.
If you stop taking it suddenly, your condition may worsen
or you may have unwanted side effects such as:
Headache
Nausea and vomiting
Dizziness
Insomnia
Nervousness
Anxiety
Confusion and agitation
Diarrhoea
Sweating
Loss of appetite
Tremor
Flu-like symptoms
Impaired coordination and balance
Tingling or numbness of the hands and feet.
Slowly reducing the amount of EFEXOR-XR being taken reduces the possibility of these
effects occurring.
Do not give this medicine to anyone else even if they have the same condition as you.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how EFEXOR-XR
affects you.
EFEXOR-XR capsules may make you feel drowsy.
Some of the aforementioned symptoms may impair driving, or the operation of dangerous
machinery. Avoid these activities if you experience these symptoms.
Things to be careful of
If you are feeling drowsy or are uncoordinated, be careful that you do not fall over.
EFEXOR-XR, like other medicines in this class, may increase your risk of bone fracture.
Drinking alcohol
Avoid drinking alcohol while you are taking EFEXOR-XR.
Alcohol can cause dizziness and lightheadedness. Alcohol may also worsen your condition.
Looking after your medicine
Keep your capsules in their blister pack until it is time to take them.
If you take the capsules out of the blister pack they may not keep well.
Follow the instructions on the carton on how to take care of your medicine properly.
Store it in a cool dry place below 30°C away from moisture, heat or sunlight; for
example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If your doctor tells you to stop taking this medicine or the expiry date has passed,
ask your pharmacist what to do with any medicine that is left over.
Do not take this medicine after the expiry date (EXP) printed on the pack or if the
packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
6. Are there any side effects?
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking EFEXOR-XR.
All medicines can have side effects. Sometimes they are serious; often 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 this medicine,
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.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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Stomach, bowel or urinary tract problems:
Nausea or vomiting
Loss of appetite
Diarrhoea
Constipation
Difficulty passing urine, passing urine more frequently, or urinary incontinence
Changes in your behaviour:
Difficulty sleeping or abnormal dreams
Paranoia
Aggression
Sexual function problems such as delayed ejaculation, problems with erection, decreased
sex drive or difficulties achieving orgasm. Medicines like EFEXOR-XR (so called SNRIs)
may cause symptoms of sexual dysfunction. In some cases, these symptoms have continued
after stopping treatment.
Nervousness
Teeth grinding
Impaired coordination and balance
Difficulty thinking or working because of:
Yawning
Feeling sedated or drowsy
Fainting or dizziness after standing up
Restlessness or difficulty sitting still
Headache
Rapid heartbeat
Heavy or irregular menstrual periods
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Speak to your doctor or pharmacist if you have any of these less serious side effects
and they worry you.
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Less serious side effects
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What to do
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Others:
Sweating
Hot flushes
Rash
Hair loss
Itchiness
Weight loss
Weight gain
Flow of milk in women who are not breastfeeding
Blurred vision
Ringing in the ears
Altered taste
Dry mouth.
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Speak to your doctor or pharmacist if you have any of these less serious side effects
and they worry you.
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Serious side effects
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Serious side effects
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What to do
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Muscle tremors, spasms, twitching, jerky movements or sustained muscle contractions
Abnormal facial movements such as tongue thrusting, repetitive chewing, jaw swinging,
or grimacing
A feeling of apathy or not caring about things
Hallucinations
Agitation
Confusion
Unusually overactive
Changes in muscle tone, muscle weakness or fatigue
Numbness or pins and needles.
Problems with breathing, shortness of breath
Cough
Bleeding or bruising more easily than normal
Sensitivity to sunlight.
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Call your doctor straight away, if you notice any of these serious side effects.
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More Serious side effects
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More Serious side effects
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What to do
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Fits or seizures, which may be accompanied by a sudden fever
Signs of allergy such as rash or hives, swelling of the face, lips, tongue or throat,
wheezing or difficulty breathing or swallowing
Symptoms of sudden fever with sweating, rapid heartbeat and muscle stiffness, which
may lead to loss of consciousness (symptoms resembling neuroleptic malignant syndrome)
Palpitations, shortness of breath, intense chest pain, or irregular heartbeats
Dark, red or cola-coloured urine, muscle weakness and tenderness, stiffness or aching
Stomach pain, yellowing of the skin, nausea, fever, clammy skin and sweating
Yellowing of the skin or eyeballs, fever, fatigue, loss of appetite, dark coloured
urine or light coloured bowel movements
A severe skin reaction with painful red areas and large blisters, accompanied by fever
and chills, aching muscles and generally feeling unwell
Symptoms of a high fever, agitation, confusion, trembling and abrupt contractions
of muscles
Signs of an infection such as severe chills, fever, sore throat and mouth ulcers
Black sticky bowel motions or bloody diarrhoea.
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Call your doctor straight away, or go to Accident and Emergency at your nearest hospital
if you notice any of these more serious side effects.
These symptoms are usually rare but may be serious and need urgent medical attention.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Some of these side effects (for example, increase in blood pressure or blood cholesterol)
can only be found when your doctor does tests from time to time to check your progress.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What EFEXOR-XR contains
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Active ingredient
(main ingredient)
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Venlafaxine hydrochloride
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Other ingredients
(inactive ingredients)
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Iron oxide yellow
Iron oxide red
Microcrystalline cellulose
Ethylcellulose
Hypromellose
Gelatin
Purified talc
Titanium dioxide
Red ink Opacode S-1-15094/S-1-15095 (Efexor-XR 37.5 mg and 75 mg strengths)
White ink TekPrint SB-0007P (Efexor-XR 150 mg only)
Iron oxide black (Efexor-XR 37.5 mg only).
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Do not take this medicine if you are allergic to any of these ingredients.
What EFEXOR-XR looks like
EFEXOR-XR 37.5 mg capsules are grey and peach in colour with a 'W' printed on the
cap and "37.5" on the body in red ink. (AUST R 99802).
EFEXOR-XR 75 mg capsules are peach in colour with red printing of "W" and "75" (AUST
R 60858).
EFEXOR -XR 150 mg capsules are dark orange in colour with white printing of "W" and
"150" (AUST R 60859).
Each blister pack contains 28 capsules.
Who distributes EFEXOR-XR
Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in January 2024.
EFEXOR® is a Viatris company trade mark
EFEXOR-XR_cmi\Jan24/00