LOXAMINE

Paroxetine 20mg Tablets

What is in this leaflet

This leaflet answers some common questions about LOXAMINE. It does not
contain all the information available on this medicine. It does not take the
place of talking to your doctor or pharmacist. All medicines have risks and
benefits. Your doctor has weighed the risks of taking LOXAMINE against the
benefits they expect it will have for you. If you have any concerns about
taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may want to read it again.

What LOXAMINE is used for

Your LOXAMINE tablets contain the active ingredient, paroxetine
hydrochloride. Paroxetine belongs to a group of medicines known as selective
serotonin reuptake inhibitors (SSRIs).

LOXAMINE is normally used to treat depression and help prevent potential
recurrence of the symptoms of depression. Depression is thought to be caused
by a chemical imbalance in parts of the brain. This affects your whole body
and can cause emotional and physical symptoms such as feeling low in spirit,
loss of interest in activities, being unable to enjoy life, poor appetite or
overeating, disturbed sleep, often waking up early, loss of sex drive, lack of
energy and feeling guilty over nothing. LOXAMINE works by correcting this
chemical imbalance and may help relieve the symptoms of depression.

LOXAMINE is also used to treat the following conditions: Obsessive
Compulsive Disorder, Panic Disorder, Social Anxiety Disorder/Social Phobia,
Generalised Anxiety Disorder and Post-traumatic Stress Disorder.

Your doctor, however, may have prescribed LOXAMINE for another purpose. Ask
your doctor if you have any questions about why LOXAMINE has been prescribed
for you.

LOXAMINE is available only with a doctor's prescription.

Before you take LOXAMINE

When you must not take it

Do not take LOXAMINE if you:

• are allergic to paroxetine hydrochloride or any other ingredients
  listed at the end of this leaflet
• are taking another medicine for depression called a monoamine oxidase
  inhibitor (MAOI) or have been taking a MAOI within the last 14 days. Ask
  your doctor or pharmacist if you are unsure as to whether or not you are
  taking a MAOI.
• are taking thioridazine (an antipsychotic medicine)
• are taking pimozide (an antipsychotic medicine)
• are taking linezolid (a medicine used to treat infections).

Before you start to take it

You must tell your doctor if you:

• are under 18 years of age. LOXAMINE is not recommended for use in
  children or adolescents under 18 years of age.
• have had an allergic reaction to any medicine that you have taken
  previously to treat your current condition
• are pregnant, plan to become pregnant or you are breastfeeding.
  Your doctor will discuss with you the risks and benefits of taking LOXAMINE
  if you are pregnant or breastfeeding.
• have thoughts about harming yourself (suicidal thoughts or
  tendencies), or you have had them in the past
• have or ever had any other health problems, including:
  
  • heart, liver or kidney problems
  • seizures, fits or convulsions (epilepsy)
  • mania (mood with excitement, over-activity and uninhibited
    behaviour) or a history of mania
  • raised pressure in the eye (glaucoma)
  • problems with bleeding or blood clotting
• are allergic to any other medicines, foods, preservatives or dyes.

If you have not told your doctor about any of the above, or any other
medical conditions, tell him/her before you start taking LOXAMINE.

Taking other medicines

Tell your doctor if you are taking any other medicines, or have taken any
other medicines in the past two weeks, including any that you buy without a
prescription from your pharmacy, supermarket or health shop.

Some medicines that may interfere with LOXAMINE include:

• antidepressant drugs known as:
  
  • monoamine oxidase Inhibitors (MAOI'S) (e.g. phenelzine and
    tranylcypromine)
  • selective serotonin reuptake inhibitors (SSRI's) (e.g.
    citalopram and fluoxetine)
  • tricyclic antidepressants (e.g. amitriptyline and imipramine)
• other serotonergic drugs (e.g. tramadol and lithium)
• metoprolol (a medicine used to lower blood pressure)
• medicines used to regulate your heart beat (e.g. flecainide and
  propafenone)
• medicines used to control epilepsy (e.g. phenytoin and
  carbamazepine)
• antipsychotic drugs (e.g. thioridazine, perphenazine and pimozide)
• atomoxetine (a medicine used to treat attention deficit
  hyperactivity disorder (ADHD))
• risperidone (a medicine used to treat schizophrenia)
• procyclidine (a medicine used to treat Parkinson's disease)
• triptans such as sumatriptan (a medicine used to treat migraines)
• warfarin (a medicine used to prevent blood clots)
• medicines used to treat inflammation and pain known as non-steroidal
  anti-inflammatory drugs or NSAIDs (e.g. ibuprofen, ketotifen)
• aspirin (a medicine used to treat inflammation and pain, and to
  prevent blood clots)
• linezolid (a medicine used to treat infections).

These medicines may be affected by LOXAMINE or may affect how well it
works. You may need to take different amounts of your medicine or you may need
to take different medicines. Your doctor will advise you.

Hypericum perforatum (St John's Wort) should be avoided as adverse
interactions have been reported with a range of drugs, including
antidepressants.

Your doctor or pharmacist has more information on medicines to be careful
with or avoid while taking LOXAMINE.

Ask your doctor or pharmacist if you are not sure about this list of
medicines.

How to take LOXAMINE

Follow all directions given to you by your doctor and pharmacist carefully.

How much to take

Take LOXAMINE exactly as your doctor has prescribed.

Your doctor will tell you how many LOXAMINE tablets to take and when to
take them each day. It is important that you take LOXAMINE as directed by your
doctor. Do not take more than the recommended dose.

It usually takes 2 to 3 weeks before any response to LOXAMINE is
noticeable.

For the treatment of depression, the usual daily dose of LOXAMINE is a
single oral dose of 20mg daily. Depending on your response and severity of
depression, your doctor may increase your dose to a maximum of 50mg daily.

LOXAMINE is not recommended for use in children and adolescents under 18
years of age.

How and when to take it

LOXAMINE tablets should be swallowed whole with a glass of water. Do not
crush or chew the tablets but they can be halved.

It is recommended that LOXAMINE is taken once daily in the morning,
preferably with food.

How long to take it

Your length of treatment will depend on the medical condition for which you
require LOXAMINE and your response to it. For depression, treatment is usually
continued for at least six months to prevent potential recurrence.

Continue taking LOXAMINE until your doctor tells you to stop.

If you forget to take it

If you forget to take a dose, take it as soon as you remember. Do not
take more than one dose at a time 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, or have any questions, ask your doctor or pharmacist.

Taking your medicine at the same time each day may help you to remember to
take it regularly. If you have trouble remembering to take your medicine, ask
you pharmacist for some hints.

While you are taking LOXAMINE

Things you must do

Tell all doctors, dentists and pharmacists who are treating you that you
are taking LOXAMINE.

If you are about to be started on any new medicine, remind your doctor or
pharmacist that you are currently taking LOXAMINE.

If you are pregnant, plan to become pregnant or are breastfeeding, tell
your doctor or pharmacist.

If you plan to have surgery, including dental surgery, tell your doctor
(including surgeon and/or anaesthetist) or dentist that you are taking
LOXAMINE.

Keep all appointments you and your doctor have scheduled so that your
progress can be followed.

Tell your doctor if you notice any of the following, especially if they
are severe, abrupt in onset, or were not part of your presenting symptoms:
anxiety, agitation, panic attacks, insomnia (difficulty sleeping),
irritability, hostility (aggressiveness), impulsivity, akathisia (restlessness
or difficulty sitting still), hypomania, mania (mood of excitement,
over-activity and uninhibited behaviour), worsening of depression.

Tell your doctor immediately if you have any distressing thoughts
(thought of suicide or self-harm) or experiences during this initial period or
at any other time.

Do not stop taking LOXAMINE or lower the dose without first checking
with your doctor. Stopping LOXAMINE suddenly may cause dizziness, headache
and nausea. Your doctor may want you to gradually reduce the amount of
LOXAMINE you are taking before stopping completely.

Things you must not do

Do not drive or operate machinery until you know how LOXAMINE affects
you.

LOXAMINE can cause drowsiness, dizziness or fatigue in some people. Be careful
when driving, operating machinery or performing jobs that need you to be
alert, until you are certain that LOXAMINE does not affect your performance.

Do not use LOXAMINE to treat any other conditions unless your doctor tells
you to.

Do not give LOXAMINE to anyone else, even if they have the same condition
as you.

Things to be careful of

Be careful when drinking alcohol while taking LOXAMINE. Combining
LOXAMINE and alcohol may make you more sleepy, dizzy or lightheaded. Your
doctor may suggest you avoid alcohol while being treated with LOXAMINE.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well
while you are taking LOXAMINE.

All medicines can have side effects. Sometimes they are serious, most of
the time they are not. You may need medical treatment if you get some of these
side effects.

Tell your doctor or pharmacist if you notice any of the following and
they worry you:

• nausea, diarrhoea or constipation
• dizziness or drowsiness
• dry mouth
• sweating
• decreased appetite
• difficulty sleeping
• agitation
• tremor
• blurred vision
• yawning
• sexual problems
• weakness or loss of strength
• headache.

These are the more common side effects of LOXAMINE. Mostly they are mild.
Your doctor or pharmacist can help you with these side effects.

Tell your doctor as soon as possible if you notice any of the following:

• abnormal bleeding or bruising
• yellowing of the skin and/or eye (also called jaundice).

The above list includes some serious side effects and may require medical
attention.

Tell your doctor immediately or go to your nearest Accident and
Emergency Centre if you notice any of the following:

• symptoms of an allergic reaction such as skin rash, itching or hives;
  swelling of the face, lips or tongue which may cause difficulty in
  swallowing or breathing; wheezing or shortness of breath
• symptoms of Serotonin Syndrome such as fever, sweating, confusion,
  agitation, diarrhoea and muscle spasms. Serotonin Syndrome symptoms vary,
  are not specific and may result from the interaction of LOXAMINE with other
  medicines, such as SSRIs (refer to Taking other medicines section)
• symptoms of "shock" such as rapid, shallow breathing; cold, clammy skin;
  a rapid, weak pulse; dizziness, weakness and fainting
• heart palpitations, feeling faint or collapsing
• fits or seizures (convulsions)
• seeing, hearing or feeling things that are not there (hallucinations).

These may be serious side effects. You may 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.

If you should suffer from any of these side effects or any other
undesired effect, please tell your doctor or pharmacist.

Do not be alarmed by this list of possible side effects. You may not
experience any of them.

In case of overdose

Immediately telephone your doctor, or the National Poisons Information
Centre (0800 POISON or 0800 764 766) or go to the Accident and Emergency
department at your nearest hospital, if you think that you may have taken too
much, or if anyone else has taken any LOXAMINE by mistake. Do this even if
there are no signs of discomfort or poisoning. You may need urgent medical
attention. Take the pack of LOXAMINE with you if you can.

Keep telephone numbers for these places handy.

Storage conditions

Storage

Always keep your LOXAMINE tablets in the original blister pack and out of
sight and reach of children. Store in a cool dry place where the temperature
stays below 25°C and protect from light, heat and moisture.

Do not store LOXAMINE, or any other medicine, in the bathroom, on
windowsills or in the glove box of the car. Do not refrigerate or freeze your
LOXAMINE tablets.

Do not use this medicine after the expiry date shown on either the outer
pack or blister pack.

Disposal

If your doctor tells you to stop taking LOXAMINE, or your tablets have
passed their expiry date, ask your pharmacist what to do with the remaining
tablets.

Product Description

What LOXAMINE tablets look like

LOXAMINE tablets are white, round, engraved "P" scoreline "2" on one side
and "G" on the other.

Ingredients

Each tablet contains 22.22mg of the active ingredient, paroxetine
hydrochloride, corresponding to 20mg paroxetine base.

Each tablet also contains calcium hydrogen phosphate anhydrous, sodium
starch glycollate, colloidal anhydrous silica, magnesium stearate, purified
talc, titanium dioxide and deanil methacrylate.