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Tramal Sustained Release Tablets (50 mg, 100 mg, 150 mg, 200 mg)

Generic Name: Tramadol hydrochloride
Product Name: Tramal Sustained Release Tablets (50 mg, 100 mg, 150 mg, 200 mg)

Indication

Tramal is a painkiller prescribed to individuals with moderate to severe pain. It can be used by adults and adolescents aged > 12 years.

Action

Tramal is an analgesic, which means it relieves pain. The active ingredient in Tramal is tramadol hydrochloride. The ways in which it relieves pain are not fully understood, though it is known to affect the areas of the brain which transmit pain signals.

Dose advice

Dose information

The recommended dose is 100–200 mg (1–2 tablets) twice daily, preferably in the morning and evening. Your doctor will adjust the dose depending on your pain and its response to Tramal therapy. Your doctor may prescribe a lower initial starting dose.

Sustained release (SR) tablets must be swallowed whole with sufficient liquid. They should not be crushed or chewed. Crushing or chewing the tablets cause immediate release of the ingredients and increases the risk of adverse events. The maximum daily dose should not exceed 400 mg, or 300 mg in elderly patients (> 75 years). If you miss a dose, take the dose as soon as you remember, or take the next dose as normal. Do not take a double dose to catch up for a dose you missed.

Other forms Tramal is available in several different forms. For more information on other available forms, see Tramal Immediate Release Capsules, Tramal Oral Drops and Tramal Solution for Injection.

Your doctor will determine the correct dose depending on the severity of your pain and the extent to which the pain is relieved by the treatment. Always follow your doctor’s advice about how much Tramal to take. Do not give Tramal to anybody else, even if they are in pain.

While you are taking the medicine, it is important to tell your doctor if:

  • You begin taking any other medication;
  • Your pain reduces and you feel you do not need to take as much Tramal;
  • Your pain gets worse;
  • You are going to undergo surgery;
  • You need to have any tests;
  • You become pregnant.

Tramal is a sedative. Do not drive or operate machinery while affected by it. 

The medicine should be stored below 30oC and protected from light. Do not use Tramal if it has passed its expiry date or the package is damaged. Store the medicine in a locked cabinet at least 1.5 m above the ground


If you have any queries about the correct way to use Tramal, please ask
your doctor.


Overdose

Overdose from Tramal has been reported rarely. Symptoms of Tramal overdose include miosis (contracted pupils), vomiting, heart and breathing problems, convulsions and unconsciousness. If you display these symptoms after taking Tramal, go to a hospital emergency department or contact the Poisons Information Hotline immediately. If another person who may have taken your Tramal displays these symptoms, they should be taken to the emergency department.


Contraindications

Tramal should not be used under certain conditions. Tell your doctor if you have:

  • Allergy to tramadol hydrochloride or any other ingredients in the medicine;
  • Allergy to medicines called opioid antagonists (e.g. codeine, morphine);
  • Consumed alcoholor taken another drug which affects your brain. These include:
  • Used monoamine oxidase inhibitors (MAOIs) such as phenelzine (Nardil) or tranylcypromine (Parnate) in the past 14 days;
  • Epilepsy;
  • Addiction or are recovering from addiction to another medication.


Precautions

Special care needs to be taken when using Tramal under certain conditions. Tell your doctor if you have:

  • History of breathing difficulties;
  • Galactose intolerance: Tramal SR Tablets contain lactose. You will need to seek medical advice from a specialist before you start using Tramal;
  • Head injury, recent shock or reduced levels of consciousness: These factors may lead to increased intracranial pressure (pressure in the skull) from brain swelling and make Tramal use dangerous. Tramal may also make it more difficult for your doctor to diagnose any conditions in your skull;
  • Liver or kidney condition;
  • Serious gastrointestinal disorder;
  • Previous addiction or dependency on another painkiller or opioid;
  • Previously experienced seizures;
  • Previous allergic reaction to medication;
  • Current use of any other medications, particularly:


Pregnancy

Tramal is a Pregnancy Category C medication. It is not recommended for use by pregnant women. No studies in pregnant women have been conducted. However, studies in mice indicate Tramal may impair foetal development if taken during pregnancy. Long-term use during pregnancy may lead to withdrawal symptoms in the newborn baby. Tramal is not recommended for pain relief during labour and delivery. Tramal crosses the placenta. Your baby may be born with breathing problems if Tramal is used during labour and delivery.

If you plan to become pregnant, tell your doctor before taking Tramal.

Breastfeeding

Tramal is not recommended for use by breastfeeding women. It is passed on through breastmilk and may be dangerous for breastfed babies.


Use in children

Tramal is approved for use by children aged over 12 years, but cannot be used by younger children.

Schedule

Tramal is a Schedule 4 medication.1

Common side effects

All medicines have side effects. Most commonly the side effects are minor; however, some can be more serious. Usually the benefits of taking a medication outweigh the associated side effects. Your doctor would have considered these side effects before starting you on Tramal.

It is not known how often some of the side effects of Tramal, including speech disorders and mydriasis (dilation of the pupils), occur. Other symptoms, including dizziness, perspiration, tendency to collapse, tachycardia (rapid heartbeat) and nausea/urge to vomit, are more likely to occur when large doses of Tramal are taken.

Very common side effects

Very common side effects are those that occur in more than 10% of people given Tramal. These include:


Common side effects

Common side effects are those that occur in 1–10% of people given Tramal. These include:

Uncommon side effects

Side effects that occur in less than 1% of people given Tramal are considered uncommon. People do not necessarily experience any of these side effects, so do not become alarmed by this list:

  • Increased tendency to collapse;
  • Increased risk of cardiovascular collapse;
  • Tachycardia (abnormally rapid heart beat);
  • Flushing;
  • Dyspepsia (indigestion);
  • Diarrhoea;
  • Abdominal pain;
  • Flatulence;
  • Urge to vomit;
  • Trembling;
  • Skin reactions;
  • Pruritis (skin irritation);
  • Rash.


Rare side effects

Rare side effects are those that occur in 0.01–0.1% of people given Tramal. These include:

  • Increased blood pressure;
  • Bradycardia (abnormally slow heartbeat);
  • Dyspnoea (difficulty breathing);
  • Appetite changes;
  • Mood changes, most commonly elevated mood, and sometimes dysphoria (low mood);
  • Paraesthesia (pins and needles);
  • Hallucinations;
  • Confusion;
  • Disturbed coordination;
  • Disturbed sleep;
  • Anxiety;
  • Nightmares;
  • Weakness;
  • Tremor;
  • Seizures;
  • Involuntary muscle contractions;
  • Changes in activity levels (usually reduced, sometimes increased);
  • Cognitive and sensory changes, including changes in decision behaviour and perception;
  • Syncope (temporary loss of consciousness);
  • Shock reactions;
  • Anaphylaxis (severe allergic reaction);
  • Allergic reactions;
  • Visual disturbances (blurred vision);
  • Urination disorders (e.g. urinary retention);
  • Dysuria (difficulty or pain on urination).


Very rare side effects

Very rare side effects are those that occur in less than 0.01% of people given Tramal. These include:


If you experience any of the listed side effects, or any other symptoms that appear abnormal or unusual, please tell your doctor.
 

References:

  1. Product Information: Tramal Sustained Release Tablets. Parkville, VIC: CSL Limited; 14 January 2011. Available from: URL link
  2. Consumer Medical Information: Tramal Sustained Release Tablets. Parkville, VIC: CSL Limited; September 2006. Available from: URL link 

Related documents:

DOWNLOAD
CMI DOCUMENT

Symptoms associated with Tramal Sustained Release Tablets (50 mg, 100 mg, 150 mg, 200 mg):

 

For further information talk to your doctor.

Dates

Posted On: 22 July, 2003
Modified On: 2 July, 2012
Reviewed On: 9 August, 2011

 



Created by: myVMC
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