General Information
onsumer Medicine Information
Important
The name of your medicine is Zydol SR. Before taking Zydol SR , please read this leaflet carefully. It is intended to answer questions you may have about Zydol SR. It does not contain all the available information. It does not replace talking to your doctor or pharmacist.
You may wish to read this leaflet again, do not throw it away until you have finished using this medicine.
All medicines have risks and benefits. If you have any concerns or want more information about your medicine, ask your doctor or pharmacist.
What is Zydol SR used for
Zydol SR is used to relieve moderate to severe pain. It belongs to the group of medicines called analgesics (pain relievers).
Before taking Zydol SR for the first time
Tell your doctor
if you are allergic to any of the ingredients in Zydol SR (see "What is in Zydol SR? on page 3).
if you are known to be sensitive to opioids.
if you have lung or breathing problems.
if you are taking any medicines for depression, or mental or psychiatric disorder or to help you sleep.
if you are taking medication known as SSRI's, tricyclic anti-depressants, quinidine, phenothiazines or anti psychotics.
if you have had any fits or convulsions, or take medicines for epilepsy.
if you are taking the medicine carbamazepine (one brand name is Tegretol).
if you have any disorder of the kidney, liver or pancreas, including any related to alcohol intake, for example, cirrhosis of the liver.
if you have a stomach problem.
if you have a severe headache or have had a head injury.
if you have, or have had, any drug or alcohol dependence.
if you are taking any other medicine, including those you buy from a pharmacy or supermarket.
Use in children
Zydol SR is not recommended for children under 12 years.
Use in elderly
Patients over 75 years may need a reduced daily dose of Zydol SR compared to younger adults.
If you are pregnant or intend to become pregnant:
Zydol SR is not recommended for use during pregnancy. Talk to your doctor about the risks and benefits of using Zydol SR during pregnancy.
If you are breast-feeding or plan to breast feed:
Zydol SR is not recommended for use during breast-feeding. Talk to your doctor about the risks and benefits using Zydol SR when breast-feeding.
If you are driving or operating machinery
Zydol SR 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 SR.
When should Zydol SR not be used
You should NOT use Zydol SR
if you have an allergy to any of the ingredients (see page 3 for details).
if you have an allergy to any other medicines known as opioid analgesics, e.g. morphine or codeine.
if you have taken large amounts of alcohol or other substances which can affect your level of consciousness.
if you are taking medicine for depression containing a "monoamine oxidase inhibitor" also known as MAOI, or have taken any within the past two weeks. Examples of MAOI-containing medicines are Nardil, Parnate.
if you are having treatment for withdrawal from narcotics.
if the packaging is torn or shows signs of tampering.
if any tablets look damaged or discoloured.
if it is after the expiry date which is printed on the carton box.
How should Zydol SR be used
Zydol SR tablets should be swallowed whole with water. They maybe taken, before, with, or after food.
They must NOT be chewed, crushed or dissolved as this will release all their contents with the potential of side effects occuring.
The recommended dosage of Zydol SR is either:
one or two Zydol SR 100 mg tablet(s) twice a day (morning and evening)
OR
one Zydol SR 150 mg or 200 mg tablet twice a day (morning and evening).
Do not take more than four of the 100 mg tablets per day.
Do not take more than two of the 150 mg or of the 200 mg tablets per day.
What to do if you have missed your dose
If you forget to take one dose, take the dose when you remember. The following dose should be taken after twelve hours, or as prescribed by your doctor.
For how long should you take Zydol SR
Zydol SR may be used for acute (short term) or chronic (long term) pain. Ask your doctor for advice on how long you need to take your medicine.
As with all medicine,
take only as your doctor has told you.
if you feel that you do not need as much Zydol SR as your doctor has prescribed for you, talk to your doctor.
tell your doctor if your pain is not helped or gets worse. Do not take increased amounts or extra doses of Zydol SR unless your doctor advises you to.
What are the side effects of Zydol SR
All medicines can cause unwanted effects, and some side effects have been reported with Zydol SR. Side effects reported with Zydol SR are usually minor and temporary, but some may be serious.
The most common side effects of Zydol SR are:
dizziness
drowsiness, confusion
headache
constipation
nausea, vomiting
tremor
sweating
dry mouth.
The following side effects are less common:
improvement in mood
muscle weakness
indigestion
dry mouth
changes in appetite
skin reactions
difficulty in passing urine
sudden onset of low blood pressure, collapse
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.
This is not a complete listing.
Occasionally, other side effects may be experienced. 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.
If you experience any side effects that have not been mentioned here, consult your doctor or pharmacist as soon as possible.
You should remember that all medicines carry some risks. It is possible that some risks might not yet have been detected despite many years of experience with the medicine.
Can Zydol SR be addictive
When used as prescribed by your doctor, addiction to Zydol SR is very unlikely.
If you are taking Zydol SR 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 SR only as directed by your doctor.
What to do in the case of overdosage
In the event of overdose, you should contact your nearest Poisons Information Centre, doctor or hospital emergency department immediately. Overdosage with Zydol SR will result in breathing difficulty and fits or convulsions.
How should Zydol SR be stored
Keep Zydol SR in a safe place, where children cannot reach it.
Store in a cool, dry place, below 30°C.
Keep away from direct sunlight.
Do not use Zydol SR after the use-by-date printed on the label of the pack.
What is in Zydol SR
The active medicine in Zydol SR is called tramadol hydrochloride. It is made up in tablets that allow the body to absorb the tramadol over a long period, so that dosing need be only twice a day.
Zydol SR is available as three distinct strengths of tablet. Each strength of tablet contains a different amount of the active ingredient, tramadol hydrochloride.
Zydol SR Dosage Form / Amount of tramadol hydro-chloride Colour and Description
Tablet, 100 mg
White round tablets imprinted with black GRUNENTHAL logo on one side and engraved with "T1" on the other side. Available in packs of 20 or 60 tablets.
Tablet, 150 mg
Pale orange tablets imprinted with black GRUNENTHAL logo on one side and engraved with "T2" on the other side. Available in packs of 20 or 60 tablets.
Tablet, 200 mg
Deep orange to brown coloured tablets imprinted with black GRUNENTHAL logo on one side and engraved with "T3" on the other side. Available in packs of 20 or 60 tablets.
Zydol SR tablets also contain the inactive ingredients:
hypromellose
silica-colloidal anhydrous
microcrystalline cellulose
magnesium stearate
lactose
macrogol 6000
propylene glycol
talc
titanium dioxide
quinoline yellow aluminium lake CI47005 (150 and 200 mg tablets)
iron oxide red CI77491 (150 and 200 mg tablets)
iron oxide yellow CI77492
iron oxide black CI77499
(200 mg tablets).
Zydol SR tablets are sealed in a blister foil pack.
Other information you need to know about Zydol SR
Zydol SR is available only on a doctor's prescription.
Do not give your medicine to anyone else, even if they have similar symptoms to you. Your medicine is for your use only, it may harm other people.
This leaflet does not contain all the available information about Zydol SR. Contact your doctor or pharmacist if you have any questions about the information in this leaflet or other questions about your medicine.
Zydol SR is made by Grunenthal GmbH in Germany and supplied in Australia by:
Arrow Pharmaceuticals Limited
24 Rothschild Avenue
Rosebery NSW 2018
Date of Preparation of this Information September 2003
AUST R: 80724 Tablets 100mg
AUST R: 80726 Tablets 150mg
AUST R: 80725 Tablets 200mg
Zydol™ is a trademark of Grunenthal GmbH.