Trichozole

Metronidazole

200mg & 400mg tablets

What is in this leaflet

This leaflet answers some common questions about TRICHOZOLE. It does not
contain all the available information. It does not take place of talking to
your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of
you taking TRICHOZOLE against the benefits they expect it will have for you.

If you have concerns about taking this medicine, ask your doctor or
pharmacist.

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

What TRICHOZOLE is used for

TRICHOZOLE is used in the treatment of various infections caused by
bacteria or other organisms, in different parts of the body.

It is also used to prevent and/or treat certain infections that may occur
because of surgery.

The active ingredient in TRICHOZOLE is metronidazole; it belongs to the
class of medicines known as antiprotozoals and antibacterials.

Your doctor may have prescribed TRICHOZOLE for another reason. Ask our
doctor if you have any questions about why TRICHOZOLE has been prescribed for
you.

This medicine is only available with a doctor's prescription.

There is no evidence TRICHOZOLE is addictive.

Before you take TRICHOZOLE

When you must not take it

Do not take TRICHOZOLE if you have an allergy to metronidazole (the
active ingredient in TRICHOZOLE) or to any of the other ingredients listed at
the end of this leaflet.

Some of the symptoms of an allergic reaction may include, 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 take TRICHOZOLE after the expiry date (EXP) printed on the pack
has passed.

If you take TRICHOZOLE after the expiry date has passed it may not work as
well.

Do not take TRICHOZOLE if the packaging is torn or shows signs of
tampering.

Do not take TRICHOZOLE if you are pregnant or you are breastfeeding.

Before you start to take it

Tell your doctor if you are allergic to any other medicines, dyes or
preservatives.

Tell your doctor if have, or have ever had:

• a disorder of the blood
• liver or kidney problems
• a condition that affects your brain, spinal cord or nerves

Your doctor may want to take special precautions if you have any of the
above conditions.

Tell your doctor if you have any other medical conditions not listed above.

Tell your doctor if you think you may be pregnant or plan to become
pregnant.

Like most medicines, TRICHOZOLE is not recommended during pregnancy. Your
doctor will discuss the risks and benefits of using this medicine if you are
pregnant.

Tell your doctor if you are breastfeeding or planning to breastfeed.

Breastfeeding is not recommended while you are taking TRICHOZOLE. The active
ingredient metronidazole, passes into the breast-milk and could affect your
baby.

If you have not told your doctor about any of the above, tell them before
you start TRICHOZOLE.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines,
including any that you buy without a prescription from your pharmacy,
supermarket or health food shop.

Some medicines may interfere with the absorption of TRICHOZOLE. These
include:

• anticoagulant medication (used to help prevent blood clots) e.g.
  warfarin
• lithium, a medicine used to treat depression and manic depressive
  illnesses
• convulsion or sedative medication e.g. phenobarbitone, phenytoin
• cyclosporin, a medicine used to prevent organ transplant rejection or to
  treat immune system disorders
• disulphiram, a medicines used to treat chronic alcohol dependence
• some anticancer drugs e.g. 5-fluorouracil

These medicines may be affected by TRICHOZOLE, or may affect how well
TRICHOZOLE works. You may need to take different amounts of your medicine or
you may need to take different medicines. Your doctor can tell you what to do
if you are taking any of the above medicines.

If you are not sure whether you are taking any of the above medicines,
check with your doctor or pharmacist.

Your doctor and pharmacist have more information on medicines to be careful
with or avoid while taking TRICHOZOLE.

How to take TRICHOZOLE properly

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

They may differ from the information contained in this leaflet.

If you do not understand the instruction printed on the label, ask your
doctor or pharmacist for help.

Avoid alcohol while taking TRICHOZOLE and for at least one day after
stopping it.

If you drink alcohol while taking TRICHOZOLE, it is likely you will experience
some unpleasant effects. These may include nausea, vomiting, stomach cramps,
fast heart beats, headache and flushing.

How much to take

The usual dose is between 200 and 800mg, taken 2 to 3 times a day. Your
doctor may increase or decrease the dose depending on your condition and how
well you respond to this medicine.

The usual dose in children is less than this. The dose will be calculated
by your doctor depending on the age and weight of the child.

How to take it

Swallow TRICHOZOLE tablets whole with a glass of water, preferably with or
after a meal.

Do not chew the tablets. Chewing the tablets may upset your stomach
and may cause the TRICHOZOLE to not work as well.

How long to take it

Continue to take TRICHOZOLE until you finish the pack or until your doctor
recommends.

Do not stop taking the tablets because you feel better.

If you do not complete the full course prescribed by your doctor, all of the
bacteria/organisms causing your infection may not have been killed. The
bacteria/organisms remaining may continue to grow and multiply so that your
infection may not clear completely or it may return.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take
your next dose when you are meant to. Otherwise, take it as soon as you
remember, and then go back to taking it as you would normally.

Do not take a double dose to make up for the dose you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering when to take your medicine, ask your doctor
for some hints.

If you take too much (overdose)

You should only take the number of tablets that you have been told.

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

Keep telephone numbers for these places handy.

While you are taking TRICHOZOLE

Things you must do

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

If you become pregnant while taking TRICHOZOLE, stop taking it and tell
your doctor immediately.

Tell your doctor or pharmacist that you are taking TRICHOZOLE before you
start any new medicine.

If you plan to have surgery, tell the surgeon or dentist that you are
taking TRICHOZOLE.

If you need to have a blood test while you are taking TRICHOZOLE, tell your
doctor. TRICHOZOLE may affect the results of some laboratory tests.

If you get a sore white tongue while you are taking, or soon after stopping
TRICHOZOLE, tell your doctor. Also, tell your doctor if you get vaginal
itching or unusual discharge. This may mean you have a fungal/yeast infection
called thrush. Sometimes the use of TRICHOZOLE allows fungi/yeast to grow and
the above symptoms to occur.

Things you must not do

Do not drink alcoholic drinks while taking TRICHOZOLE or for at least
one day after finishing treatment. Drinking alcohol may cause some
unpleasant effects such as nausea, vomiting, stomach cramps, fast heartbeat,
headaches or flushing.

Do not give this medicine to anyone else, even if they have the same
condition or their symptoms seem similar to yours.

Do not use TRICHOZOLE to treat any other complaints unless your doctor
tells you to do so.

Do not stop taking your tablets, or lower the dose because you are
feeling better unless advised by your doctor. If you do complete the full
course prescribed by your doctor, not all of the bacteria/organisms causing
your infection may have been killed. These bacteria/organisms may continue to
grow and multiply so that your infection may not completely clear or may
return.

Thing to be careful of

Be careful driving or operating machinery until you know how TRICHOZOLE
affects you.

TRICHOZOLE may cause dizziness or light-headedness in some people, especially
after the first dose. Make sure you know how you react to TRICHOZOLE before
you drive a car, operate machinery, or do anything else that could be
dangerous.

Side effects

Tell your doctor as soon as possible if you do not feel well while
taking TRICHOZOLE.

All medicines can have unwanted side effects. Sometimes they are serious,
most of the time they are not. If they occur, they are usually minor and
temporary.

Sometimes however, side effects can be serious and may need medical
treatment.

Ask you doctor or pharmacist to answer any questions you may have.

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

• oral thrush: white, furry, sore or inflamed tongue and mouth
• vaginal thrush: sore and itchy vagina and/or discharge
• nausea, which may be accompanied by headache, loss of appetite or
  vomiting
• diarrhoea, stomach discomfort, abdominal cramping or constipation
• drowsiness, dizziness or light-headedness
• stuffy nose or dry mouth
• fever, flushing

These are the more common side effects of TRICHOZOLE. Mostly these are mild
and short-lived.

Tell your doctor immediately, or go to accident and emergency at your
nearest hospital if you notice any of the following:

• changes in mood including depression, confusion or hallucination
• tremor, in-coordination or uncoordinated movements
• passing less urine than is normal for you
• disease of the blood cells. Symptoms may include: tiredness; headaches;
  dizziness; being short of breath when exercising and looking pale; frequent
  infections such as fever, severe chills, sore throat or mouth ulcers;
  bleeding or bruising more easily than normal; and nosebleeds

These may be serious side effects of TRICHOZOLE. You may need urgent
medical attention. Serious side effects are rare.

If any of the following happen, stop taking TRICHOZOLE, and tell your
doctor immediately, or go the accident and emergency at your nearest hospital:

• swelling of the face, lips or tongue that may cause difficulty in
  swallowing or breathing
• sudden or severe skin rash, itching or hives
• yellowing of the skin and eyes, also called jaundice
• seizure or fainting
• asthma, wheezing or shortness of breath

These are very serious side effects. If you have them, you may have had a
serious allergic reaction to TRICHOZOLE. You may need urgent medical attention
or hospitalisation. All of these side effects are very rare.

Other side effects not listed above may also occur in some patients.
Tell you doctor if you notice any thing else that is making you feel unwell.

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

After using it

Storage

Keep the tablets in the bottle or pack until it is time to take them.

If you take the tablets out of the pack they may not keep as well.

Keep in a cool dry place that is protected from light and where the
temperature stays below 25°C.

Do not store TRICHOZOLE, or any other medicine in the bathroom or near a
sink. Do not leave it in the car or on the windowsills.

Heat and dampness can destroy some medicines.

Keep TRICHOZOLE out of reach from children.

A locked cardboard at least one-and-a-half metres above the ground is a good
place to store medicines.

Disposal

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

Product description

What it looks like

TRICHOZOLE comes in two strengths:

• TRICHOZOLE 200mg: are white, round tablets imprinted "M" breakline "200"
  on one side and plain on the other.
• TRICHOZOLE 400mg: are yellow, round tablets imprinted "M" over "400" on
  one side and plain on the other.

Each tablet contains either 200mg or 400mg of metronidazole.

The 200mg tablet also contains:

• maize starch
• microcrystalline cellulose
• magnesium stearate
• povidone
• lactose

The 400mg tablet also contains:

• maize starch
• microcrystalline cellulose
• sodium starch glycollate
• magnesium stearate
• povidone
• lactose
• quinoline yellow

Both 200mg and 400mg TRICHOZOLE tablets are gluten free.