Tramal Immediate Release Capsules (50 mg)

Generic Name: Tramadol hydrochloride
Product Name: Tramal Immediate Release Capsules (50 mg)

Indication: What Tramal is used for

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

Action: How Tramal works

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: How to use Tramal

Dose information

The recommended dose of Tramal Immediate Release Capsules for relief of moderate to severe pain is 50–100 mg (1–2 capsules) every 8–12 hours. If you have moderate pain, a 50 mg dose is often adequate for providing pain relief. If you have moderate to severe pain, a 50–100 mg dose every 4–6 hours is recommended. If you have a problem with your kidneys, you may not need to take the medicine as frequently. The maximum daily dose should not exceed 400 mg for most people, or 300 mg for people aged > 75 years.

Tramal is available in several different forms. For more information on other available forms, see Tramal Sustained Release Tablets, 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 with the treatment. Your doctor will adjust the dose of Tramal depending on how much pain relief you experience. Always attend your scheduled doctor’s appointments so the doctor can assess you pain and the effectiveness of Tramal. 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 are going to undergo surgery;
• You become pregnant.

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

The medicine should be stored below 30^oC 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:
  • Some painkillers, including opioid pain killers;
  • Hypnotic drugs;
  • Psychotropic 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 (which is used to treat epilepsy and bipolar disorder);
  • 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. 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.

Children

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

Schedule of Tramal

Tramal is a Schedule 4 medication.¹

Side effects of Tramal

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:

• 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.

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:

• 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).

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 Capsules. Parkville, VIC: CSL Limited; 14 January 2011. Available from: URL link
2. Consumer Medicine Information: Tramal Capsules and Injections. Parkville, VIC: CSL Limited; January 2004. Available from: URL link

Related documents:

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Symptoms associated with Tramal Immediate Release Capsules (50 mg):

• Pain

For further information talk to your doctor.