EFEXOR®-XR

Venlafaxine Hydrochloride Modified Release Capsules

What is in this leaflet

This leaflet answers some common questions about Efexor-XR capsules. 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 Efexor-XR against the expected benefits it will have for you.

If you have any questions about Efexor-XR, ask your doctor or
pharmacist.

Keep this leaflet with your Efexor-XR capsules. You may need to read it
again.

What Efexor-XR is for

The name of your medicine is Efexor-XR. It contains the active ingredient
called venlafaxine hydrochloride.

Efexor-XR capsules are used in the treatment and prevention of depression
and in the treatment of anxiety, including avoidance or fear of social
situations and the treatment of panic attacks.

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.

Efexor-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. 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.

Your doctor may have prescribed Efexor-XR capsules for another purpose.

Ask your doctor if you have any questions about why Efexor-XR capsules has
been prescribed for you. Your doctor should discuss with you the benefits and
risks of taking any medicine including Efexor-XR, before prescribing it for
you.

Before you take Efexor-XR

When you must not take Efexor-XR

Do not take 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.

Do not take Efexor-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 Efexor-XR to a patient under 18 years of age.

The safety and effectiveness of Efexor-XR in this age group has not been
established.

Do not use Efexor-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 Efexor-XR if the packaging is torn or shows signs of
tampering.

Before you start to take Efexor-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.

Efexor-XR is not recommended for use during pregnancy. Your doctor will
discuss the risks and benefits of using Efexor-XR 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.

Tell your doctor or pharmacist if you are breast-feeding or planning to
breast-feed.

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 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 heart, kidneys or liver
• 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 Efexor-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 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 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)
• 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 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.

How much to take

The usual starting dose for the treatment of depression and anxiety is 75mg
taken once daily. For panic attacks, treatment is usually started with a dose
of 37.5mg once daily for the first 4 to 7 days. After that time the dose
should be increased to 75mg 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
Efexor-XR.

When to take it

Efexor-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 Efexor-XR.

How long to take Efexor-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 Efexor-XR time to
work.

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

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. 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 Efexor-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 Efexor-XR capsules, call your nearest
Poisons Information Centre for advice (0800 POISON or 0800 764 766), 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 Efexor-XR capsules you may:

• Feel sleepy
• Vomit
• Have an increased heart rate
• Have a seizure (fits)
• Have breathing difficulties
• Become unconscious
• Have dilated pupils.

While you are taking Efexor-XR

Things you must do

Visit your doctor regularly for a check up. Always discuss any questions
you have about Efexor-XR capsules with your doctor.

Take Efexor-XR capsules as your doctor has prescribed.

Keep enough Efexor-XR capsules to last weekends and holidays. You need a
prescription from your doctor to get more Efexor-XR capsules.

Watch carefully for signs that your depression or anxiety is getting
worse, especially in the first few weeks of treatment, or if your dose is
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.

• 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

Efexor-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 Efexor-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
Efexor-XR you are taking before stopping completely.

Side effects from stopping treatment with Efexor-XR may include:

• Headache
• Nausea and vomiting
• Dizziness
• Insomnia
• Nervousness
• Anxiety
• Confusion and agitation
• Diarrhoea
• Sweating
• Loss of appetite
• 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. Some of these symptoms may impair driving,
or the operation of dangerous machinery. Avoid these activities 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.

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 coordination 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 menstrual periods.

Changes in your appearance such as:

• Sweating (including night sweats)
• Hot flushes
• Rash
• Hair loss
• Itchiness
• Weight loss or weight gain
• Bleeding or bruising more easily than normal
• Flow of milk in women who are not breastfeeding.

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
• 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.

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 Efexor-XR

Storage

Keep your Efexor-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 Efexor-XR capsules in a cool dry place where the temperature stays
below 30°C.

Do not store Efexor-XR capsules or any other medicine in the bathroom or
near a sink. Do not leave Efexor-XR capsules in the car or on windowsills.

Heat and dampness can destroy some medicines.

Keep Efexor-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 Efexor-XR looks like

There are three strengths of Efexor-XR capsules, containing 37.5 mg, 75 mg
or 150 mg of venlafaxine in an extended release formulation, which allows for
once-a-day dosing.

The 37.5 mg capsules are grey and peach in colour. The 75 mg capsules are
opaque peach in colour and the 150 mg capsules are opaque dark orange. The
capsules are printed with a "W" and the capsule strength.

Efexor-XR 37.5 mg, 75 mg and 150 mg are available in blister packs
containing 28 capsules.

Ingredients

Efexor-XR capsules contain venlafaxine hydrochloride as the active
ingredient.

Efexor-XR 37.5 mg, 75 mg and 150 mg capsules contain the following inactive
ingredients:

• Iron oxide yellow CI 77492
• Iron oxide red CI 77491
• Cellulose-microcrystalline
• Ethyl cellulose
• Hypromellose
• Gelatin
• Talc, purified
• Titanium dioxide
• Red Ink Opacode S-1-15094/S-1-15095 (37.5mg and 75mg strengths)
• White ink TekPrint SB-0007P (150mg strength).

In addition to these, Efexor-XR 37.5 mg capsules also contain iron oxide
black CI 77499.

Efexor-XR does not contain gluten, sucrose, tartrazine or any other azo
dyes.