TRAMAL®

Tramadol hydrochloride CAPSULES and INJECTIONS

What is in this leaflet

This leaflet answers some common questions about TRAMAL. It does not
contain all the available information. 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
you taking TRAMAL against the benefits this medicine is expected to have for
you.

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

Keep this leaflet. You may need to read it again.

What TRAMAL is used for

TRAMAL is used to relieve moderate to severe pain and belongs to a group of
medicines called analgesics (pain relievers).

Your doctor may have prescribed TRAMAL for another reason. Ask your doctor
why TRAMAL has been prescribed for you.

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

TRAMAL is not normally addictive although some cases have been reported.

Before you use TRAMAL

When you must not use it

Do not use TRAMAL if:

• you have a known allergy to TRAMAL or any of the ingredients listed
  at the end of this leaflet. Some of the symptoms of an allergic reaction
  may include skin rash, itching, difficulty breathing and swelling of the
  face (including lips, tongue, throat etc)
• you are taking medicine for depression containing a "monoamine
  oxidase inhibitor" (such as Nardil, Parnate), or have taken one within the
  past two weeks.

Do not use TRAMAL after the expiry date printed on the pack. If you
take this medicine after the expiry date has passed, it may not work as well.

Do not use TRAMAL if the packaging is torn or shows signs of tampering.

Do not give TRAMAL Capsules to children under 12 years. There is no
experience with the use of TRAMAL Capsules in children.

If you are not sure whether you should be using TRAMAL, talk to your
doctor.

Before you use it

You must tell your doctor if:

1. you have a known allergy to TRAMAL or any of the ingredients listed at
   the end of this leaflet.
2. you are known to be sensitive to opioids.
3. you drink alcohol every day.
4. you have or ever had any other health problems, including:
   • any lung or breathing problems
   • any diseases of the kidney, liver or pancreas
   • severe stomach problems
   • a serious head injury
   • any fits or convulsions/ epilepsy.
5. you have or have had any problems with drug or alcohol dependence.
6. you are pregnant or intend to become pregnant. TRAMAL is not recommended
   for use during pregnancy. Talk to your doctor about the risks and benefits
   of using TRAMAL during pregnancy.
7. you are breast-feeding or plan to breast-feed. TRAMAL is not recommended
   for use during breast-feeding. Talk to your doctor about the risks and
   benefits of using TRAMAL when breast- feeding.

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

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines
that you buy without a prescription from your pharmacy, supermarket or health
food shop. Some medicines may interfere with TRAMAL. These include:

• carbamazepine (eg. Tegretol)
• coumarin derivatives (eg. Warfarin: Some Brand names are Coumadin, or
  Marevan)
• medicine for irregular or rapid heart beat
• medicines for depression, sleeplessness or mental conditions such as
  selective serotonin reuptake inhibitors (SSRI's), tricyclic
  anti-depressants, quinidine, phenothiazines or anti-psychotics
• some antibiotics.

These medicines may be affected by TRAMAL, or may affect how well it works.
You may need different amounts of your medicine, or you may need to take
different medicines. Other interactions not listed above may also occur.

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

How TRAMAL is used

TRAMAL is available as capsules (to swallow) and injections (to be given
into a vein or muscle).

Your doctor will decide:

• how you will receive TRAMAL,
• what dose and
• for how long.

TRAMAL INJECTIONS

TRAMAL Injection may be given to adults, adolescents or children over the
age of 2 years. TRAMAL Injection should only be given to children over the
age of 2 years under supervision of your doctor.

If you or your child has been prescribed TRAMAL injections, your doctor or
nurse will administer them for you. Take them with you when you visit your
doctor. TRAMAL injections can be injected into a vein or a muscle.

TRAMAL CAPSULES

How much to take

Do not give TRAMAL Capsules to children under 12 years. There is no
experience with the use of TRAMAL Capsules in children.

For moderate pain, one TRAMAL capsule may be
enough for the first dose, followed by one or two capsules two or three times
a day as required.

For moderate to severe pain, two TRAMAL
capsules are usually required for the first dose, followed by one or two
capsules every four to six hours as required.

Patients over 75 years of age may require a lower daily dose.

Do not take more than eight TRAMAL capsules per day.

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

These directions may differ from the information in this leaflet.

If you do not understand the instructions on the pack, ask your doctor or
pharmacist for help.

How to take it

TRAMAL capsules should be swallowed whole, with water.

When to take it

You can take TRAMAL before, with, or after food.

How long to take it

Depending on the medical condition for which you require TRAMAL, your
doctor may tell you to take it for only a day or two or longer, up to a few
months or more.

If you forget to take it

If you forget to take a dose, you can take it as soon as you remember. The
next dose should be taken after four or six hours, or as prescribed by your
doctor.

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

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (tel:
131 126 in Australia or 0800 POISON (0800 764 766) in New Zealand) or go
to accident and emergency at your nearest hospital, if you think that you or
anyone else may have taken too much TRAMAL. Do this even if there are no signs
of discomfort or poisoning.

You may need urgent medical attention.

If you take too many capsules, this may result in breathing difficulty and
fits or convulsion.

While you are using TRAMAL

Things you must do

If you become pregnant while you are taking TRAMAL, tell your doctor
immediately.

If you are about to be started on any new medicine, tell your doctor and
pharmacist that you are taking TRAMAL.

If your pain is not severe and you feel that you do not need as much TRAMAL
as your doctor ordered, consult your doctor.

Tell your doctor if your pain gets worse. Do not take extra doses without
checking with your doctor.

If you have to have any tests tell your doctor you are taking TRAMAL.
TRAMAL may affect the results of some tests.

Things you must not do

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

Do not use TRAMAL to treat any other complaints unless your doctor tells
you to.

Things to be careful of

Be careful driving or operating machinery until you know how TRAMAL affects
you. TRAMAL may make you drowsy or dizzy.

Side effects

Check with your doctor as soon as possible if you have any problems while
taking TRAMAL, even if you do not think the problems are connected with the
medicine or are not listed in this leaflet.

Like other medicines, TRAMAL can cause side effects. If they occur, most
are likely to be minor and temporary. However, some may be serious and need
medical attention.

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

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

Common side effects:

• dizziness
• sedation, fatigue
• headache
• constipation
• nausea or vomiting
• sweating
• dry mouth

Less common side effects:

• indigestion
• changes in appetite
• skin reactions
• sudden onset of low blood pressure, collapse
• muscle weakness
• tremor
• seizures
• respiratory depression
• improvement in mood
• confusion
• sleep disturbance
• blurred vision
• difficulty in passing urine
• Serotonin Syndrome: signs of this vary and are not specific: they may
  include fever, sweating, confusion, agitation, diarrhoea, muscle twitching,
  difficulty with walking and balance. Serotonin Syndrome may result from
  interaction of tramadol with other medicines which increase serotonin
  effects, for example, the SSRI antidepressants.

Tell your doctor immediately if you
experience any of the following side-effects, as urgent medical treatment may
be required:

• skin rash (red spots or patches), itching, hives, skin lumps
• swelling or puffiness of the eyelids, face or lips
• chest tightness, wheezing or pain in the chest
• heart palpitations, faintness or collapse
• hallucinations
• convulsions.

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

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

Can TRAMAL be addictive?

When used as prescribed by your doctor, addiction to TRAMAL is unlikely.

If you are taking TRAMAL for a prolonged period of time, your body may
become used to the medicine and mild withdrawal symptoms may occur if you
suddenly stop taking the medicine.

It is important therefore to take TRAMAL only as directed by your doctor,
and do not suddenly stop taking it. Your dosage may need to be gradually
reduced.

After using TRAMAL

Storage

Keep your TRAMAL in the pack until it is time to take them. If you
take TRAMAL out of the pack it may not keep well.

Keep it in a cool dry place where the temperature stays below 30°C. Do
not store it in the bathroom or near a sink.

Do not leave it in the car or on window sills. Heat and dampness can
destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least
1½ metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking TRAMAL or it passes its expiry
date, ask your pharmacist what to do with any TRAMAL that is left over.

TRAMAL description

What it looks like

TRAMAL is available as capsules or injections.

Capsules: Each capsule has one-half green and one-half yellow, and
is imprinted with the black GRUNENTHAL logo. They are available in packs of
10, 20, 30 or 50 capsules.

Injections: Clear liquid contained in 1mL or 2mL glass ampoules.
Available in packs of 5 ampoules.

Ingredients

Active ingredient:

TRAMAL capsules: contain 50 mg tramadol hydrochloride per capsule.

TRAMAL injections: contain tramadol hydrochloride either:

• 50 mg in 1 mL ampoules or
• 100 mg in 2 mL ampoules

Inactive ingredients:

TRAMAL capsules:

• cellulose-microcrystalline
• magnesium stearate
• sodium starch glycollate
• silica-colloidal anhydrous
• indigo carmine (CI 173015)
• iron oxide yellow (CI 77492)
• titanium dioxide
• capsugel ink black (1007)
• gelatin.

TRAMAL injections:

• sodium acetate
• water for injections.

TRAMAL does not contain lactose, sucrose, tartrazine or any other azo
dyes.