TRAMAL ® CAPSULES and INJECTIONS

Tramadol hydrochloride

Consumer Medicine Information

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

Do not use TRAMAL if:

• 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)

• if 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 to children.

There is no experience with the use of TRAMAL in children.

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

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.

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)
• 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.

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

If you have 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.

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.

TRAMAL capsules should be swallowed whole, with water.

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

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 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. \

While you are using TRAMAL

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.

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.

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, drowsiness, confusion
• headache
• nausea or vomiting
• tremor
• sweating

Less common side effects:

• changes in mood
• weakness
• constipation or stomach upsets
• dry mouth
• changes in appetite
• skin reactions
• difficulty in passing urine
• very low blood pressure
• Serotonin Syndrome: signs of this vary but may include fever, sweating, confusion, agitation, diarrhoea, muscle twitching, difficulty with walking and balance. This results 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.

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

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 degrees 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 1 1/2 metres above the ground is a good place to store medicines.

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

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 20 or 30 capsules.

Injections:

Clear liquid contained in 2mL glass ampoules. Available in packs of 5 ampoules.

Active ingredient:
TRAMAL capsules:

• contain 50 mg tramadol hydrochloride per capsule.

TRAMAL injections:
contain tramadol hydrochloride:

• 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
• gelatin.

TRAMAL injections:

• sodium acetate
• water for injections.

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