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Zydol™

Tramadol hydrochloride


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Zydol. 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 Zydol 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 Zydol is used for

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

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

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

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

Before you use Zydol

When you must not use it

Do not use Zydol if:

  • you have a known allergy to Zydol 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 have an allergy to any other medicines known as opioid analgesics, e.g. morphine or codeine.
  • you are taking medicine to treat depression containing a "monoamine oxidase inhibitor" (MAOI), such as Nardil or Parnate, or have taken one within the past two weeks.
  • you have taken large amounts of alcohol or other substances which can affect your level of consciousness.
  • you are having treatment for withdrawal from narcotics.
  • any capsules look damaged or discoloured.

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

Do not give Zydol to children. There is no experience with the use of Zydol in children.

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

Before you use it

You must tell your doctor if:

  1. you have a known allergy to Zydol 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.
  1. you have or have had any problems with drug or alcohol dependence.
  2. you are pregnant or intend to become pregnant. Zydol is not recommended for use during pregnancy. Talk to your doctor about the risks and benefits of using Zydol during pregnancy.
  3. you are breast-feeding or plan to breast-feed.

Zydol is not recommended for use during breast-feeding. Talk to your doctor about the risks and benefits of using Zydol when breast- feeding.

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

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 Zydol. 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 Zydol, 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 Zydol.

How Zydol is used

Zydol is available as capsules to swallow.

Your doctor will decide:

  • what dose of Zydol you will receive and
  • for how long.

How much to take

For moderate pain, one Zydol 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 Zydol 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 Zydol 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

Zydol capsules should be swallowed whole, with water.

When to take it

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

How long to take it

Depending on the medical condition for which you require Zydol, 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) or go to accident and emergency at your nearest hospital, if you think that you or anyone else may have taken too much Zydol. 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 Zydol

Things you must do

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

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

If your pain is not severe and you feel that you do not need as much Zydol 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 Zydol. Zydol may affect the results of some tests.

Things you must not do

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

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

Things to be careful of

Zydol may make you drowsy or dizzy. Ask your doctor for advice about whether it is safe for you to drive or operate machinery while taking Zydol.

Side effects

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

Can Zydol be addictive?

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

If you are taking Zydol 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 Zydol only as directed by your doctor. Do not suddenly stop taking it. Your dosage may need to be gradually reduced.

After using Zydol

Storage

Keep your Zydol in the pack until it is time to take them. If you take Zydol 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 11/2 metres above the ground is a good place to store medicines.

Disposal

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

Zydol description

What it looks like

Zydol is available as capsules.

Each capsule has one-half green and one-half yellow. The capsule is imprinted with the black GRUNENTHAL logo. They are available in packs of 20 capsules.

Ingredients

Active ingredient:

50 mg tramadol hydrochloride per capsule.

Inactive ingredients:

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

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

Manufacturer/Distributor

Zydol is made in Germany and supplied in Australia by:

CSL Limited
ABN 99 051 588 348
45 Poplar Road
Parkville 3052 Victoria Australia

and distributed by:

Arrow Pharmaceuticals Limited
24 Rothschild Avenue
Rosebery
NSW 2018
Australia

Date of Preparation of this Information: July 2001

Capsules 50mg:
AUST R 80744

Zydol™ is a trademark of Grunenthal GmbH.

Published by MIMS February 2003

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