Venlafaxine Sandoz XR

Venlafaxine Hydrochloride, modified release capsules
Consumer Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Venlafaxine Sandoz XR. It does not contain all the information that is known about Venlafaxine Sandoz XR. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What Venlafaxine Sandoz XR is for

The name of your medicine is Venlafaxine Sandoz XR. It contains the active ingredient called venlafaxine hydrochloride.
Venlafaxine Sandoz XR capsules are used in the treatment and prevention of relapse of depression and panic attacks and in the treatment of 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.
Venlafaxine Sandoz XR capsules belong 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.
Venlafaxine Sandoz XR capsules increase the level of these two messengers. Experts think this is how it helps to restore your feeling of wellness.
Venlafaxine Sandoz XR is not addictive.
Your doctor may have prescribed Venlafaxine Sandoz XR capsules for another purpose. Ask your doctor if you have any questions about why Venlafaxine Sandoz XR capsules has been prescribed for you.

Before you take Venlafaxine Sandoz XR

When you must not take Venlafaxine Sandoz XR

Do not take Venlafaxine Sandoz 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.
Do not take Venlafaxine Sandoz XR if you are allergic to it 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 Venlafaxine Sandoz XR to children or adolescents under 18 years of age.
The safety and effectiveness of Venlafaxine Sandoz XR in this age group have not been established.
Do not use Venlafaxine Sandoz XR 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 Venlafaxine Sandoz XR if the packaging is torn or shows signs of tampering.

Before you start to take Venlafaxine Sandoz XR

Tell your doctor or pharmacist if you have allergies to the active ingredient 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.
Venlafaxine Sandoz XR is not recommended for use during pregnancy. Your doctor will discuss the risks and benefits of using Venlafaxine Sandoz XR if you are pregnant. One of these risks is that newborn babies whose mothers have been taking Venlafaxine Sandoz XR 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.
Venlafaxine Sandoz XR passes into breast milk and there is a possibility that the breast-fed baby may be affected. For this reason, the use of Venlafaxine Sandoz XR 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
A history of aggression
Blood pressure problems
Glaucoma (increased pressure in the eye)
A tendency to bleed more than normal
Raised cholesterol levels
Problems with your kidneys or liver
Problems with your heart
Your doctor may wish to do some heart tests such as an electrocardiogram (ECG) or blood tests during treatment with Venlafaxine Sandoz XR.
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 Venlafaxine Sandoz XR.

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 Johns Wort or tryptophan supplements.
Do not start to take any other medicine while you are taking Venlafaxine Sandoz XR, unless it is prescribed or approved by your doctor.
Some medicines may interfere with Venlafaxine Sandoz XR or Venlafaxine Sandoz XR 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 depression, anxiety, obsessive-compulsive disorder or premenstrual dysphoric disorder, including St John's Wort
Haloperidol, risperidone, lithium or clozapine (used to treat mental disorders)
Tramadol (a pain killer)
Cimetidine (used to treat reflux and stomach ulcers)
Triptans (used to treat migraine)
Amiodarone or quinidine (used to treat irregular heart beats)
Your doctor may wish to do some heart tests such as an electrocardiogram (ECG) or blood tests if you are using either of these medicines whilst taking Venlafaxine Sandoz XR:
Warfarin (used to prevent blood clotting)
Indinavir (an antiviral)
Erythromycin and linezolid (used to treat infections)
Ketoconazole or fluconazole (used as antifungal medicines)
Medications for weight loss, including sibutramine
Metoprolol (used to treat high blood pressure or angina).
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 Venlafaxine Sandoz XR.

How to take Venlafaxine Sandoz XR

Swallow the capsules whole with a glass of water or other non-alcoholic liquid. Do not divide, crush, chew or place the capsules in water.
Inside Venlafaxine Sandoz XR capsules are tablets that contain the venlafaxine active ingredient. As the medicine travels the length of your gastrointestinal tract, venlafaxine is slowly released.

How much to take

The usual starting dose is 75mg taken once daily. If necessary, after two weeks, your doctor may increase your dose.
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 Venlafaxine Sandoz XR. If you have heart problems and your doctor wishes to increase your dose of Venlafaxine Sandoz XR, your doctor may first do some blood tests or heart tests such as an electrocardiogram (ECG).

When to take it

Venlafaxine Sandoz XR 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 Venlafaxine Sandoz XR.

How long to take Venlafaxine Sandoz XR

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 Venlafaxine Sandoz XR time to work.
Even when you feel well again, you may need to keep taking Venlafaxine Sandoz XR for several months to make sure the benefits last. Discuss this with your doctor and don't stop taking Venlafaxine Sandoz XR until gaining your doctor's agreement.

If you forget to take Venlafaxine Sandoz 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. Contact your doctor if you have missed more than two doses in a row.
Always finish the capsules 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 Venlafaxine Sandoz XR capsules 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 Venlafaxine Sandoz XR capsules, 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.
If you take too many Venlafaxine Sandoz 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.

While you are taking Venlafaxine Sandoz XR

Things you must do

Visit your doctor regularly for a check up. Always discuss any questions you have about Venlafaxine Sandoz XR capsules with your doctor.
Take Venlafaxine Sandoz XR capsules as your doctor has prescribed.
Keep enough Venlafaxine Sandoz XR capsules to last weekends and holidays. You need a prescription from your doctor to get more Venlafaxine Sandoz XR capsules.
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

Venlafaxine Sandoz XR capsules 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 suddenly stop taking Venlafaxine Sandoz XR capsules if you have been taking it for some time.
Check with your doctor for the best way to slowly reduce the amount of Venlafaxine Sandoz XR you are taking before stopping completely.
Side effects from stopping treatment with Venlafaxine Sandoz XR may include:
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 Venlafaxine Sandoz XR being taken reduces the possibility of these effects occurring.
Some of these symptoms may impair driving, or the operation of dangerous machinery. These activities should be avoided if you experience these symptoms.
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, passing urine more frequently, or urinary incontinence.
Changes in your behaviour such as:
Difficulty sleeping or abnormal dreams
Sexual function problems such as delayed ejaculation, problems with erection, decreased sex drive or difficulties achieving orgasm
Nervousness
Teeth grinding
Muscle tremors, spasms, twitching, jerky movements or sustained muscle contractions
Impaired co-ordination and balance
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.
Difficulty thinking or working because of:
Yawning
Feeling sedated or drowsy
Fainting or dizziness after standing up
Changes in muscle tone
Muscle weakness or fatigue
Restlessness or difficulty sitting still
Headache
Rapid heart beat
Problems with breathing
Heavy or irregular menstrual periods.
Changes in your appearance such as:
Sweating (including night sweats)
Hot flushes
Rash
Hair loss
Itchiness
Weight loss or weight gain
Flow of milk in women who are not breastfeeding
Bleeding or bruising more easily than normal.
In some people, Venlafaxine Sandoz XR may lead to changes in the way your blood clots.
Changes in your sight, hearing, taste or touch such as:
Blurred vision
Dilated pupils
Visual disturbances
Sensitivity to sunlight
Ringing in the ears
Altered taste
Dry mouth
Numbness or pins and needles.
Other changes you may not be aware of:
Increased blood pressure
Increase in blood cholesterol levels.
Tell your doctor immediately, or go to your nearest hospital if you notice any of the following:
Fits or seizures, which may be accompanied by a sudden fever
Signs of allergy such as rash or hives, swelling of the face, lips or tongue, wheezing or difficulty breathing
Symptoms of sudden fever with sweating, rapid heart beat and muscle stiffness, which may lead to loss of consciousness
Palpitations, fainting, shortness of breath or chest pain
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
These symptoms are usually rare but may be serious and need urgent medical attention.
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 Venlafaxine Sandoz XR

Storage

Keep your Venlafaxine Sandoz XR capsules in their blister pack until it is time to take them.
The capsules may not last as well if you take them out of the blister pack.
Keep Venlafaxine Sandoz XR capsules in a cool dry place where the temperature stays below 25°C.
Do not store Venlafaxine Sandoz XR capsules or any other medicine in the bathroom or near a sink. Do not leave Venlafaxine Sandoz XR capsules in the car or on windowsills.
Heat and dampness can destroy some medicines.
Keep Venlafaxine Sandoz XR capsules 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 Venlafaxine Sandoz XR looks like

There are two strengths of Venlafaxine Sandoz XR capsules, containing 75 mg or 150 mg of venlafaxine in an extended release formulation, which allows for once-a-day dosing.
Venlafaxine Sandoz XR 75mg capsules are presented as flesh opaque capsules. Venlafaxine Sandoz XR 150mg capsules are presented as scarlet opaque capsules.

Ingredients

Venlafaxine Sandoz XR capsules contain venlafaxine hydrochloride as the active ingredient.
Venlafaxine Sandoz XR 75 mg and 150 mg capsules contain the following inactive ingredients:
Hypromellose
Sodium lauryl sulfate
Magnesium stearate
Ammonio methacrylate copolymer
Basic butylated methacrylate copolymer
Titanium dioxide (E171)
Gelatin.
The 75mg capsules also contain red iron oxide (E172). The 150mg capsules also contain Erythrosine (E127) and Indigo carmine (E132)

Supplier

Venlafaxine Sandoz XR capsules are supplied by:
Sandoz Pty Ltd
19 Harris St
Pyrmont NSW 2009
Tel: 1800 634 500
 
Australian Registration Numbers:
75 mg blister packs: AUST R 151880
150 mg blister packs: AUST R 151875
 
Available in blister packs of 28 capsules.
 
This leaflet was prepared March 2012