Tramal

 

 

 

 

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

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

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

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.

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Dose advice of Tramal Sustained Release Tablets (50 mg, 100 mg, 150 mg, 200 mg):

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. The maximum daily dose should not exceed 400 mg, or 300 mg in elderly patients (> 75 years).
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 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.


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;
    Consumed alcohol or taken another drug which affects your brain. These include:
        Some painkillers, including opioid pain killers;
        Hypnotic drugs;
        Psychotrophic drugs;
    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;
    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:
        Medicines which affect the central nervous system (e.g. other painkillers);
        Medicines used to treat depression, sleeplessness and other mental health disorders;
        Coumarin derivatives, including warfarin and other blood-thinning medications;
        Anti-seizure medications;
        Medicines to regulate your heartbeat;
        Medicines containing carbamazepine;
        Antibiotics.


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.


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.

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

Tramal is a Schedule 4 medication.1

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Common side effects of Tramal Sustained Release Tablets (50 mg, 100 mg, 150 mg, 200 mg):

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.


Very common side effects

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

    Nausea;
    Dizziness.


Common side effects

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

    Vomiting;
    Constipation;
    Dry mouth and perspiration;
    Headache;
    Sedation;
    Asthenia (lack of strength);
    Fatigue;
    Sweating.
    

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Uncommon side effects of Tramal Sustained Release Tablets (50 mg, 100 mg, 150 mg, 200 mg):

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;
    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 rarely 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;
    Urination disorders;
    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:

    Worsening of asthma symptoms for people with asthma;
    Respiratory distress or breathing difficulty. This usually occurs when Tramal is used at the same time as other medications which affect breathing, or when Tramal is given in large doses;
    Changes in liver function;
    Syndrome of inappropriate secretion of anti-diuretic hormones (SIADH);
    Visual disturbances (blurred vision).


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

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Reference:

    Tramal SR Tablets [online]. St Leonards, NSW: MIMS Online; 1 November 2008 [cited 16 November 2010]. Available from: URL link
    Consumer Medical Information: Tramal Sustained Release Tablets. Parkville, VIC: CSL Limited; September 2006. Available from: URL link


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