Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Pristiq tablets. It does not contain all the available information.
It does not take the place of talking
to your doctor or pharmacist or asking questions.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking Pristiq against the expected benefits it will have for you.
If you have any questions about Pristiq, ask your doctor or pharmacist.
Keep this leaflet with your Pristiq tablets. You may need to read it again.
What Pristiq is for
The name of your medicine is Pristiq. It contains the active ingredient called desvenlafaxine succinate.
Pristiq is used in the treatment of depression. 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.
Pristiq tablets belong to a class of medications called
Serotonin-Noradrenaline Reuptake Inhibitors (SNRIs).
Pristiq is not addictive.
Your doctor may have prescribed Pristiq tablets for another purpose. Ask your doctor if you have any questions about why Pristiq tablets has been prescribed for you.
Before you take Pristiq
When you must not take Pristiq
Do not take Pristiq 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.
Do not take Pristiq if you are allergic to desvenlafaxine, venlafaxine or to any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction include:
Skin rash
Itching or hives on the skin
Swelling of the face, lips, tongue or other parts of the body
Shortness of breath, wheezing or troubled breathing.
Do not give Pristiq to children or adolescents under 18 years of age.
The safety and effectiveness of Pristiq in this age group have not been established.
Do not use Pristiq after the expiry date (EXP) printed on the pack. If you take this medicine after the expiry date has passed, it may not work as well as it should.
Do not use Pristiq if the packaging is torn or shows signs of tampering.
Before you start to take Pristiq
Tell your doctor or pharmacist if you have allergies to desvenlafaxine, venlafaxine or any of the other ingredients listed at the end of this leaflet.
Tell your doctor or pharmacist if you are pregnant or intend to become pregnant. Pristiq is not recommended for use during pregnancy. Your doctor will discuss the risks and benefits of
using Pristiq if you are pregnant.
One of these risks is that newborn babies whose mothers have been taking Pristiq may have several problems including breathing difficulties, seizures and lack of oxygen in their blood.
Tell your doctor or pharmacist if you are breast-feeding or planning to breast-feed. Pristiq passes into breast milk and there is a possibility that the
breast-fed baby may be affected. For this reason, the use of Pristiq is not recommended in breast-feeding women.
Tell your doctor if you have, or have had, any medical conditions, especially the following:
A history of fits (seizures or convulsions)
A personal history or family history of bipolar disorder
Blood pressure problems
Glaucoma (increased pressure in the eye)
A tendency to bleed more than normal or you are taking a blood thinning medication
Raised cholesterol or lipid levels
Problems with your kidneys or liver
Problems with your heart
Low sodium levels in your blood
Any other medical conditions.
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 take Pristiq.
Taking other medicines
Tell your doctor or pharmacist if you take any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop, such as St John's Wort or tryptophan supplements.
Do not start to take any other medicine while you are taking Pristiq, unless it is prescribed or approved by your doctor. Some medicines may interfere with Pristiq or Pristiq may interfere with these medicines. These include:
Medications for depression known as monoamine oxidase inhibitors (such as 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
Any other medications for
bipolar disorder, depression, anxiety, obsessive-compulsive disorder or premenstrual dysphoric disorder, including St John's Wort
Medicines for weight loss, including sibutramine
Triptans (used to treat migraine)
Tramadol (a pain killer)
Linezolid (used to treat 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 or pharmacist has more information on medicines to be careful with or to avoid while taking Pristiq.
How to take Pristiq
Swallow the tablets whole with a glass of water or other
non-alcoholic liquid. Do not
divide, crush, chew or place the tablets in water.
Do not be concerned if you see a tablet 'shell' in your faeces after taking Pristiq. As the tablet travels the length of your gastrointestinal tract, the active ingredient desvenlafaxine is slowly released. The tablet 'shell' remains undissolved and is eliminated in your faeces. Therefore, even though, you may see a tablet 'shell' in your faeces, your dose of desvenlafaxine has been absorbed.
How much to take
For the treatment of depression, the usual dose is 50 mg taken once daily.
Do not change your dose unless your doctor tells you to.
If you have kidney problems, you may need a lower dose of Pristiq.
When to take it
Pristiq should be taken once daily with food, at approximately the same time each day.
This could be either in the morning or in the evening.
Avoid drinking alcohol while you are using Pristiq.
How long to take Pristiq
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 Pristiq time to work.
Even when you feel well again, you may need to keep taking Pristiq for several months. Discuss this with your doctor and don't stop taking Pristiq until gaining your doctor's agreement.
If you forget to take Pristiq
If you miss a dose, take it as soon as you remember.
However, if it is almost time for your next dose, skip the missed dose. Don't try to "make up" for the missed dose by taking two doses at the same time.
Do not take more than the prescribed daily amount of Pristiq.
If you take more Pristiq than the amount prescribed, contact your healthcare professional immediately.
Always finish the tablets you are taking in the current pack before you start a new pack.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
It is important that you do not take more Pristiq tablets than your doctor has prescribed. If you do take more than you have been prescribed, contact your doctor immediately for advice.
If anyone accidentally swallows any Pristiq tablets, call your nearest Poisons Information Centre for advice (tel: 13 11 26), or go to Accident and Emergency at your nearest hospital. Keep the telephone number for these places handy whilst taking any medications.
While you are taking Pristiq
Things you must do
Visit your doctor regularly for a check up. Always discuss any questions you have about Pristiq tablets with your doctor.
Take Pristiq tablets as your doctor has prescribed.
Keep enough Pristiq tablets to last weekends and holidays. You need a prescription from your doctor to get more Pristiq tablets.
If you are taking Pristiq for depression, watch carefully for signs that your depression is getting worse, especially in the first few weeks of treatment or if your dose has changed.
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.
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.
Tell your doctor immediately if you have any thoughts about suicide or doing harm to yourself.
Warning signs of suicide:
All thoughts or talk about suicide or violence are serious. 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:
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 to be careful of
Pristiq tablets may make you feel drowsy. Be careful driving or operating dangerous machinery until you know how it affects you.
Things you must not do
Do not stop taking Pristiq or change the dose of Pristiq without the advice of your doctor, even if you feel better.
Your doctor may want to slowly decrease your dose of Pristiq to help avoid side effects. Side effects are known to occur when people stop using Pristiq, especially when they suddenly stop therapy.
Some of these side effects include:
Headache
Nausea
Dizziness
Tiredness
Irritability
Anxiety
Abnormal dreams
Diarrhoea
Excessive sweating.
Slowly reducing the amount of Pristiq being taken reduces the possibility of these effects occurring.
Some of these symptoms may impair driving, or the operation of dangerous machinery. Avoid these activities if you experience these symptoms.
Ask your doctor for advice if any of these side effects become troublesome.
Do not give this medicine to
anyone else even if they have the same condition as you.
Side effects
All medicines can have side effects. Sometimes they are serious; often they are not.
Tell your doctor if you develop any of the following side effects or if they become troublesome.
Stomach, bowel or urinary tract problems such as:
Nausea or vomiting
Loss of appetite
Diarrhoea
Constipation
Difficulty passing urine.
Changes in your behaviour such as:
Difficulty sleeping, abnormal sleepiness or abnormal dreams
Sexual function problems such as decreased sex drive, delayed ejaculation, problems achieving erection or difficulties achieving orgasm
Nervousness or anxiety
Feeling jittery or irritable
Muscle stiffness or movement disorders
A feeling of apathy or not caring about things
Feeling detached from yourself
Seizures.
Difficulty thinking or working because of:
Yawning
Disturbances in concentration
Fainting or dizziness after standing up
Muscle weakness
Fatigue
Rapid heart beat
Chills
Headache.
Changes in your appearance such as:
Excessive sweating
Hot flushes
Rash
Weight loss or weight gain
Bleeding or bruising more easily
than normal.
Changes in your sight, hearing, taste or touch such as:
Blurred vision
Dilated pupils
Visual disturbances
Ringing in the ears
Altered taste
Dry mouth
Numbness or pins and needles.
Other changes you may not be aware of:
Increased blood pressure
Changes in blood tests for liver function
Occurrences of protein in the urine
Increase in blood cholesterol levels.
This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.
Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.
After using Pristiq
Storage
Keep your Pristiq tablets in their blister pack until it is time to take them. The tablets may not last as well if you take them out of the blister pack.
Keep Pristiq tablets in a cool dry place where the temperature stays below 25 °C.
Do not store Pristiq tablets or any other medicine in the bathroom or near a sink. Do not leave Pristiq tablets in the car or on windowsills. Heat and dampness can destroy some medicines.
Keep Pristiq tablets and all medication where young children cannot reach it. A locked cupboard, at least
one-and-a-half metres above the ground, is a good place to store medicines.
Disposal
Return any unused medicine to your pharmacist.
Product Description
What Pristiq looks like
There are two strengths of Pristiq tablets, containing 50 mg or, 100 mg of desvenlafaxine in an extended release formulation, which allows for once-a-day dosing.
Tablets come in different colours, depending on their strengths:
The 50 mg tablet is a light pink, square pyramid tablet debossed with "W" (over) "50" on the flat side. The 100 mg tablet is a
reddish-orange, square pyramid tablet debossed with "W" (over) "100" on the flat side.
Pristiq 50 mg and 100 mg are available in cartons containing 28 tablets.
Ingredients
Pristiq tablets contain desvenlafaxine succinate as the active ingredient.
Pristiq 50 mg and 100 mg tablets contain the following inactive ingredients:
Cellulose-microcrystalline
Hypromellose
Talc, purified
Magnesium stearate
Carboxymethylcellulose sodium
Maltodextrin
Glucose
Titanium dioxide
Stearic acid
Red iron oxide.
Pristiq 100 mg tablets also contain black iron oxide.
Supplier
Pristiq tablets are supplied by:
Wyeth Australia Pty Limited
ABN: 16 000 296 211
17-19 Solent Circuit,
Norwest Business Park,
Baulkham Hills, NSW 2153.
Telephone: (02) 8850-8200 or (02) 9761-8200
For further information please contact Wyeth Australia on toll-free 1800 500 498 or E-mail:
[email protected]Australian Registration Numbers:
Pristiq 50 mg tablets: AUST R 133520 Pristiq 100 mg tablets: AUST R 133527 This leaflet was last revised 30 July 2008 ® Registered Trade Mark PRISTIQ®