Consumer medicine information

1. Why am I taking TRAMEDO SR?

TRAMEDO SR contains the active ingredient tramadol hydrochloride. TRAMEDO SR is used to relieve severe pain. For more information, see Section 1. Why am I taking TRAMEDO SR? in the full CMI.

2. What should I know before I use TRAMEDO SR?

Do not take if you have ever had an allergic reaction to tramadol hydrochloride, other opioids or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use TRAMEDO SR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with TRAMEDO SR and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take TRAMEDO SR?

• Swallow the tablets whole with a glass of water.

• Discuss with your doctor the correct dose for you. Do not take more than four of the 100 mg tablets per day or two of the 150 mg or of the 200 mg tablets per day.

5. What should I know while using TRAMEDO SR?

6. Are there any side effects?

Common side effects are dizziness, sedation, fatigue, headache, constipation, nausea or vomiting, sweating or dry mouth, cramps, sleep apnoea. Serious side effects are 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 or convulsions, coma, stupor, personality changes. Tell your doctor if you have extreme fatigue, lack of appetite, severe abdominal pain, nausea, vomiting or low blood pressure.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Notes

Distributed by Alphapharm Pty Ltd trading as Viatris

Boxed Warnings

Limitations of use. Because of the risks associated with the use of opioids, Tramedo SR should only be used in patients for whom other treatment options, including non-opioid analgesics, are ineffective, not tolerated or otherwise inadequate to provide appropriate management of pain (see Section 4.4 Special Warnings and Precautions for Use).
Hazardous and harmful use. Tramedo SR poses risks of hazardous and harmful use which can lead to overdose and death. Assess the patient's risk of hazardous and harmful use before prescribing and monitor the patient regularly during treatment (see Section 4.4 Special Warnings and Precautions for Use).
Life threatening respiratory depression. Serious, life-threatening or fatal respiratory depression may occur with the use of Tramedo SR. Be aware of situations which increase the risk of respiratory depression, modify dosing in patients at risk and monitor patients closely, especially on initiation or following a dose increase (see Section 4.4 Special Warnings and Precautions for Use).
Concomitant use of benzodiazepines and other central nervous system (CNS) depressants, including alcohol. Concomitant use of opioids with benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Limit dosages and durations to the minimum required; and monitor patients for signs and symptoms of respiratory depression and sedation. Caution patients not to drink alcohol while taking Tramedo SR.

1 Name of Medicine

Tramadol hydrochloride.

2 Qualitative and Quantitative Composition

Tramedo SR tablets contain the active ingredient tramadol hydrochloride.
Each modified release (sustained release) tablet contains 100 mg, 150 mg, or 200 mg of tramadol hydrochloride as the active ingredient.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Tramedo SR modified release tablets are available in the three (3) strengths as follows:
100 mg. Off-white, round, biconvex tablets plain on both sides.
150 mg. Off-white, capsule-shaped tablets plain on both sides.
200 mg. Off-white, capsule-shaped tablets plain on both sides.

4 Clinical Particulars

4.9 Overdose

Few cases of overdose with tramadol have been reported.
Symptoms. Symptoms of overdosage with tramadol are similar to those of other centrally acting analgesics (opioids) and include miosis, vomiting, cardiovascular collapse, consciousness disorders including coma, convulsions, respiratory depression and respiratory arrest. Serotonin syndrome has also been reported.
Treatment. Should overdosage occur, general emergency measures should be implemented. Keep the respiratory airways open and maintain respiration and circulation.
If over dosage is due to ingestion of an oral dose form, activated charcoal may reduce absorption of the drug if given within one to two hours after ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube, once the airway is protected. Naloxone will reverse respiratory depression, but not all symptoms caused by overdosage with tramadol. Convulsions occurring in mice following the administration of toxic doses of tramadol could be suppressed with barbiturates or benzodiazepines, but were increased with naloxone. If convulsions are observed, diazepam should be given intravenously. Naloxone did not change the lethality of an overdose in mice.
Tramadol is minimally eliminated from the serum by haemodialysis or haemofiltration. Therefore, treatment of overdosage with tramadol with haemodialysis or haemofiltration alone is not suitable for detoxification.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Tramadol was not mutagenic in the following assays: Ames Salmonella microsomal activation test, CHO/HPRT mammalian cell assay, mouse lymphoma assay (in the presence of metabolic activation), dominant lethal mutation tests in mice, chromosome aberration tests in Chinese hamster cells and bone marrow micronucleus tests in mouse and Chinese hamster cells. Weakly mutagenic results occurred in the presence of metabolic activation in the mouse lymphoma assay and the micronucleus tests in rat cells. Overall, the weight of evidence from these tests indicates tramadol does not possess a genotoxic risk to humans.
Carcinogenicity. A slight, but statistically significant increase in two common murine tumours, pulmonary and hepatic, was observed in a mouse carcinogenicity study, particularly in aged mice dosed orally up to 30 mg/kg for approximately two years. Although the study was not conducted using the maximum tolerated dose or at exposure levels expected in clinical use, this finding is not believed to suggest risk in humans. No such findings occurred in a rat carcinogenicity study.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Tramadol hydrochloride is an odourless, white to off white crystalline powder that is readily soluble in both water and ethanol. The water/n-octanol partition coefficient is 1.35 at pH 7.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSTRAHYD.gif Chemical name: (1RS,2RS)-2-[(dimethylamino)methyl)] -1-(3-methoxyphenyl)cyclohexanol hydrochloride.
Molecular formula: C₁₆H₂₅NO₂.HCl.
Molecular weight: 299.84.
CAS number. 53611-16-8.

7 Medicine Schedule (Poisons Standard)

S4 Prescription Medicine.

Summary Table of Changes

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