Consumer medicine information

Norgesic

Orphenadrine citrate; Paracetamol

BRAND INFORMATION

Brand name

Norgesic

Active ingredient

Orphenadrine citrate; Paracetamol

Schedule

SUMMARY CMI

NORGESIC^®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using NORGESIC?

NORGESIC contains the active ingredients orphenadrine citrate and paracetamol. NORGESIC is used to treat tension headache and headaches caused by muscle spasms in the back of your head and neck. It also helps relax certain muscles in your body and to relieve the pain and discomfort caused by sprains, strains or other injury to your muscles.

For more information, see Section 1. Why am I using NORGESIC? in the full CMI.

2. What should I know before I use NORGESIC?

Do not use if you have ever had an allergic reaction to NORGESIC 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 NORGESIC? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with NORGESIC 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 use NORGESIC?

The usual dose of NORGESIC in adults is two tablets three times a day. Your doctor will prescribe the correct dose for you. Follow instructions provided on the pack.

More instructions can be found in Section 4. How do I use NORGESIC? in the full CMI.

5. What should I know while using NORGESIC?

Things you should do	Remind any doctor, dentist or pharmacist you visit that you are using NORGESIC. Contact your doctor if you become pregnant while using NORGESIC.
Things you should not do	Do not give NORGESIC to anyone else even if they have the same condition as you. Do not take NORGESIC to treat any other complaints unless your doctor tells you to.
Driving or using machines	Be careful driving or operating machinery until you know how NORGESIC affects you. NORGESIC may cause blurred vision, drowsiness, dizziness or for you to feel less alert than normal.
Drinking alcohol	Avoid drinking alcohol while using NORGESIC. It may increase the occurrence or severity of side effects such as drowsiness.
Looking after your medicine	Store below 30°C in a cool dry place away from moisture, heat or sunlight. Keep out of reach of children.

For more information, see Section 5. What should I know while using NORGESIC? in the full CMI.

6. Are there any side effects?

Side effects include nausea, dry mouth, blurred vision, drowsiness, rash, trouble urinating, fainting, fast or pounding heartbeat, hallucinations, trouble breathing, unusual bruising or bleeding, confusion and constipation.

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.

FULL CMI

NORGESIC^®

Active ingredients: orphenadrine citrate and paracetamol

Consumer Medicine Information (CMI)

This leaflet provides important information about using NORGESIC. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using NORGESIC.

Where to find information in this leaflet:

1. Why am I using NORGESIC?
2. What should I know before I use NORGESIC?
3. What if I am taking other medicines?
4. How do I use NORGESIC?
5. What should I know while using NORGESIC?
6. Are there any side effects?
7. Product details

1. Why am I using NORGESIC?

NORGESIC contains the active ingredients orphenadrine citrate and paracetamol. Orphenadrine citrate is a skeletal muscle relaxant. It acts in the central nervous system to produce muscle relaxant effects. Paracetamol is used to treat or prevent pain and reduce fever.

NORGESIC is used to treat tension headache and headaches caused by spasm of the muscles in the back of your head and neck.

It is also used to help relax certain muscles in your body and to relieve the pain and discomfort caused by sprains, strains or other injury to your muscles.

2. What should I know before I use NORGESIC?

Warnings

Do not use NORGESIC if:

You are allergic to orphenadrine citrate, paracetamol or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
You have any of the following conditions:
- Glaucoma
- Intestinal blockage or oesophageal disease
- An enlarged prostate or bladder obstruction
- Myasthenia gravis (muscle weakness)
The packaging shows signs of tampering or is after the expiry date.

Check with your doctor if you:

have any heart, liver, or kidney problems
have Gilbert's syndrome
have Glucose–6–phosphate–dehydrogenase deficiency
have any alcohol abuse problems
are sensitive to aspirin or other anti-inflammatory medicines or intolerant to pain relievers
are malnourished
have asthma
have any other medical conditions
are taking other medicines containing paracetamol
take any medicines for any other condition.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Children under 12 years old

Do not give NORGESIC to children under the age of 12 years.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with NORGESIC and affect how it works including:

Phenothiazine medicines used to treat serious emotional and mental disorders

Medicines used to relieve stomach cramps or spasms

Medicines which have a sedating effect
Alcohol
Medicines to prevent blood clots
Medicines that affect how quickly food leaves the stomach, such as metoclopramide, domperidone, propantheline, some antidepressants and narcotic painkillers
Antibiotics such as chloramphenicol, rifampicin or flucloxacillin
Probenecid used for gout
Zidovudine used for HIV/AIDS
Cholestyramine
Anti-epileptic medicines.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect NORGESIC.

4. How do I use NORGESIC?

How much to take

The usual dose is two tablets three times a day.
Do not take more than the recommended dose unless your doctor tells you to.
Follow the instructions provided and use NORGESIC until your doctor tells you to stop.

When to take NORGESIC

NORGESIC should be used as directed by your doctor or pharmacist.
Do not change the dose unless your doctor tells you to do so.

If you forget to take NORGESIC

NORGESIC should be used regularly at the same time each day. If you miss your dose at the usual time and remember within an hour or so of the missed dose, take it straight away.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you use too much NORGESIC

If you think that you have used too much NORGESIC, you may need urgent medical attention. Overdose with paracetamol-containing medicines can lead to liver damage.

You should immediately:

phone the Poisons Information Centre
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.

Do this even if there are no signs of discomfort or poisoning.

5. What should I know while using NORGESIC?

Things you should do

Call your doctor straight away if you:

become pregnant

Remind any doctor, dentist or pharmacist you visit that you are using NORGESIC.

NORGESIC may cause dryness of the mouth. For temporary relief use sugarless gum or sweets, melt some ice in your mouth or use a saliva substitute. If dry mouth persists, talk to your dentist.

Things you should not do

Do not give NORGESIC to anyone else even if they have the same condition as you.
Do not take NORGESIC to treat any other complaints unless your doctor tells you to.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how NORGESIC affects you.

NORGESIC may cause blurred vision or drowsiness in some people.

Drinking alcohol

Tell your doctor if you drink alcohol.

Drinking alcohol whilst using NORGESIC may increase the occurrence or severity of side effects such as drowsiness.

Looking after your medicine

Follow the instructions on the carton on how to take care of your medicine properly.

Store NORGESIC below 30°C in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

in the bathroom or near a sink, or
in the car or on windowsills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects	What to do
Nausea Dry mouth Blurred vision Drowsiness Rash Trouble urinating Stomach cramps or pain Constipation Fainting Drop in blood pressure Fast or pounding heartbeat Sweating Trouble breathing Hallucinations Confusion	Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

Signs of an allergic reaction including tightness in the chest and/or wheezing, shortness of breath and skin rash
Unusual bleeding or bruising
Unusual tiredness or weakness
Sores, ulcers or white spots on lips or in the mouth
Skin pain, red rashes, blisters and sores on the skin, peeling skin, cough and fever
Abdominal pain, muscle or joint pain, yellowing of the skin, dark urine or clay-coloured stools.
Chest pain
Rapid heartbeat, rapid shallow breathing, confusion, loss of appetite, feeling very tired, sleepiness.

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What NORGESIC contains

Active ingredients (main ingredients)	Orphenadrine citrate Paracetamol
Other ingredients (inactive ingredients)	Magnesium stearate Colloidal anhydrous silica Microcrystalline cellulose Pregelatinised maize starch Gelatin

Do not take this medicine if you are allergic to any of these ingredients.

What NORGESIC looks like

NORGESIC is a white tablet with N/C marked on one side and no marking on the other. It is packaged in blister packs containing 8, 24 or 100 tablets.

Registration number: AUST R 156623.

Who distributes NORGESIC

iNova Pharmaceuticals (Australia) Pty Limited
Level 10, 12 Help Street
Chatswood NSW 2067
Tel: 1800 630 056

This leaflet was prepared June 2025

Published by MIMS August 2025

BRAND INFORMATION

Brand name

Norgesic

Active ingredient

Orphenadrine citrate; Paracetamol

Schedule

1 Name of Medicine

Orphenadrine and paracetamol.

2 Qualitative and Quantitative Composition

Orphenadrine citrate 35 mg and paracetamol 450 mg tablets.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Tablet, uncoated.
White, scored, immediate release tablets marked N/C on one side and no markings on the other side.

4 Clinical Particulars

4.1 Therapeutic Indications

Tension headache, occipital headaches associated with spasm of skeletal muscles in the region of the head and neck. Acute and traumatic conditions of the limbs and trunk: sprains, strains, whiplash injuries, acute torticollis, prolapsed intervertebral disc.

4.2 Dose and Method of Administration

2 tablets three times daily.

4.3 Contraindications

Glaucoma.
Prostatic hypertrophy or obstruction at the bladder neck.
Myasthenia gravis.
Oesophageal spasm and pyloric or duodenal obstruction.
Hypersensitivity to paracetamol, orphenadrine citrate or any of the excipients.

4.4 Special Warnings and Precautions for Use

Identified precautions.

Orphenadrine citrate should be used with caution in patients with tachycardia, cardiac decompensation, coronary insufficiency or cardiac arrhythmias, Gilbert's syndrome and glucose-6-phosphate dehydrogenase deficiency.
Norgesic may be dangerous when used in large amounts or for long periods. Hepatotoxicity may occur with paracetamol even at therapeutic doses, after short treatment duration and in patients without pre-existing liver dysfunction. Hepatotoxicity may develop following as little as 10 to 15 g of paracetamol and hepatic failure is known to occur occasionally with long term use of paracetamol.
Caution is advised in patients with underlying sensitivity to aspirin and/or to non-steroidal anti-inflammatory drugs (NSAIDs).
Caution is advised in patients with known analgesic intolerance or known bronchial asthma as hypersensitivity reactions including bronchospasm are possible.
Severe cutaneous adverse reactions (SCARs): Life threatening cutaneous reactions Stevens-Johnson Syndrome (SJS), and Toxic Epidermal Necrolysis (TEN) have been reported with the use of paracetamol.
Patients should be advised of the signs and symptoms and monitored closely for skin reactions. If symptoms or signs of SJS and TEN (e.g. progressive skin rash often with blisters or mucosal lesions) occur, patients should stop treatment immediately and seek medical advice.
Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis have been reported in patients with severe illness such as severe renal impairment and sepsis, or in patients with malnutrition or other sources of glutathione deficiency (e.g. chronic alcoholism) who were treated with paracetamol at therapeutic doses for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring, including measurement of urinary 5-oxoproline, is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.
Concomitant treatment with other medicines that contain orphenadrine or paracetamol is not recommended.
Safety of continuous long term therapy with orphenadrine has not been established. Therefore if orphenadrine is prescribed for prolonged use, periodic monitoring of blood, urine and liver function is recommended.

Use in hepatic impairment.

Use with caution in patients with impaired liver function: underlying liver disease increases the risk of paracetamol-related liver damage.
Cases of hepatic dysfunction/failure have been reported in patients with depleted glutathione levels, such as those who are severely malnourished, anorexic, have a low body mass index, are chronic heavy users of alcohol or have sepsis.
In patients with glutathione depleted states the use of paracetamol may increase the risk of metabolic acidosis.

Use in renal impairment.

Use with caution in patients with impaired kidney function. Administration of paracetamol to patients with moderate to severe renal impairment may result in accumulation of paracetamol conjugates.

Use in the elderly.

The elderly should be advised to take a reduced dosage as they may be more susceptible to anticholinergic side effects at regular doses.

Paediatric use.

Norgesic is not recommended for children under 12 years of age.

Effects on laboratory tests.

Uric acid and blood glucose.

Intake of paracetamol may affect the laboratory determination of uric acid by phosphotungstic acid and of blood glucose by glucose oxidase-peroxidase.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Interactions have been reported between orphenadrine and phenothiazines and other drugs with anti-muscarinic properties. Concomitant use with alcohol or other CNS depressants should be avoided.

Anticoagulants.

Paracetamol may increase the risk of bleeding in patients taking warfarin and other antivitamin K medicines. Anticoagulant dosage may require reduction, and patients should be monitored for appropriate coagulation and bleeding complications.

Chloramphenicol.

Paracetamol may increase chloramphenicol concentrations by slowing down excretion, entailing the risk of increased toxicity.

Cholestyramine.

Reduces the absorption of paracetamol if given within 1 hour of paracetamol. Chelating resins can decrease the intestinal absorption of paracetamol and potentially decrease its efficacy if taken simultaneously. In general, there must be an interval of more than 2 hours between taking the resin and taking paracetamol, if possible.

Drugs which affect motility.

Paracetamol absorption is increased by drugs which increase gastric emptying e.g. metoclopramide and domperidone.
Paracetamol absorption is decreased by drugs which decrease gastric emptying such as propantheline, antidepressants with anticholinergic properties, and narcotic analgesics.

Flucloxacillin.

Co-administration of flucloxacillin with paracetamol may lead to high anion gap metabolic acidosis due to pyroglutamic acidosis, particularly in patients presenting risk factors of glutathione depletion, such as sepsis, malnutrition or chronic alcoholism.

Probenecid.

Paracetamol excretion may be affected and plasma concentrations altered when given probenecid.

Zidovudine.

When used concurrently with zidovudine, an increased tendency for neutropenia may develop. Combination of paracetamol and zidovudine should be avoided.

Hepatotoxic drugs and liver microsomal enzyme inducers.

The risk of paracetamol toxicity may be increased in patients receiving other potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes, such as antiepileptics (such as phenobarbital, phenytoin, carbamazepine, topiramate), alcohol, barbiturates and rifampicin. The induced metabolism results in an elevated production of the hepatotoxic oxidative metabolite of paracetamol. Hepatotoxicity will occur if this metabolite exceeds the normal glutathione binding capacity.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B2)
Norgesic is not recommended for use during pregnancy.
Norgesic should not be taken during lactation as orphenadrine and paracetamol are excreted into breast milk.

4.7 Effects on Ability to Drive and Use Machines

Orphenadrine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; ambulatory patients should therefore be cautioned accordingly.

4.8 Adverse Effects (Undesirable Effects)

Adverse effects are mainly due to the anti-cholinergic action of orphenadrine and are usually associated with higher doses.

Orphenadrine citrate.

More common reactions.

The known adverse effects include dryness of the mouth, tachycardia, palpitation, urinary hesitancy or retention, blurred vision, dilation of the pupils, increased ocular tension, weakness, nausea, headache, dizziness, constipation and drowsiness. These effects can usually be eliminated by reducing the dose.

Less common reactions.

Sedation, skin rashes and other allergic reactions are very uncommon adverse effects. Infrequently an elderly patient may experience some degree of mental confusion. Very rare cases of aplastic anaemia associated with the use of orphenadrine have been reported.

Paracetamol.

Reports of adverse reactions are rare.
The following reactions have been reported: dyspepsia, sweating, erythema, urticaria, anaphylactic shock, angioneurotic oedema, difficulty breathing, drop in blood pressure, nausea, allergic reactions such as skin rashes, hypersensitivity reactions and haematological reactions, including thrombocytopenia, leukopenia, neutropenia, agranulocytosis and pancytopenia. Toxic Epidermal Necrolysis (TEN), Stevens-Johnson Syndrome (SJS), acute generalised exanthematous pustulosis, fixed drug eruption (see Section 4.4 Special Warnings and Precautions for Use) and cytolytic hepatitis, which may lead to acute hepatic failure, have also been reported.
Bronchospasm may be triggered in patients having a tendency of analgesic asthma.
Haemolytic anaemia, particularly in patients with underlying glucose-6-phosphate dehydrogenase deficiency has been reported. Kounis syndrome has been reported, as has high anion gap metabolic acidosis due to pyroglutamic acidosis in patients with pre-disposing factors for glutathione depletion.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
No specific information is available on overdosage with Norgesic.
Elderly persons, small children, patients with liver disorders, chronic alcohol consumption or chronic malnutrition, as well as patients concomitantly treated with enzymes-inducing drugs are at an increased risk of intoxication, including fatal outcome. Overdosage with paracetamol if left untreated can result in severe, sometimes fatal liver damage and rarely, acute renal tubular necrosis.

Symptoms and signs.

Orphenadrine overdosage.

Known symptoms of overdose with orphenadrine include tachycardia, excitement, confusion and delirium leading to coma. Convulsions, dilated pupils and urinary retention may occur.

Paracetamol overdosage.

In adults, hepatotoxicity may occur after ingestion of a single dose of paracetamol 10 to 15 g; a dose of 25 g or more is potentially fatal.
Symptoms during the first two days of acute poisoning by paracetamol do not reflect the potential seriousness of the intoxication. Major manifestations of liver failure such as jaundice, hypoglycaemia and metabolic acidosis may take at least three days to develop.
Toxic symptoms include vomiting, abdominal pain, hypotension and sweating. Nausea, vomiting, anorexia, pallor and abdominal pain generally appear during the first 24 hours of overdosage with paracetamol. Overdosage with paracetamol may cause hepatic cytolysis which can lead to hepatocellular insufficiency, gastrointestinal bleeding, metabolic acidosis, encephalopathy, disseminated intravascular coagulation, coma and death. Increased levels of hepatic transaminases, lactate dehydrogenase and bilirubin with a reduction in prothrombin level can appear 12 to 48 hours after acute overdosage. Overdosage can also lead to pancreatitis acute renal failure and pancytopenia.

Treatment.

Despite lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention.
Activated charcoal may reduce absorption of paracetamol if given within one hour after oral 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.
Where paracetamol intoxication is suspected, intravenous administration of SH group donators such as acetylcysteine may be indicated. Although acetylcysteine is most effective if initiated within this period, it can still offer some degree of protection if given as late as 48 hours after ingestion; in this case it is taken for longer.
Further measures will depend on the severity, nature and course of clinical symptoms of intoxication and should follow standard intensive care protocols.
Convulsions and delirium respond to relatively large doses of diazepam, preferably by mouth. Adequate hydration of the patient is important.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Orphenadrine is a skeletal muscle relaxant. Paracetamol is an analgesic and antipyretic.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, gelatin and pregelatinised maize starch.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

PP jars with PP child-resistant closure: 8 (sample pack), 24, 100, and 500s^#.
PVC/Al blisters: 8 (sample pack), 24, 100's.
^# - not marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Orphenadrine citrate is white or almost white, crystalline powder. It is sparingly soluble in water, and slightly soluble in alcohol. Paracetamol is a white or almost white, crystalline powder that is sparingly soluble in water and freely soluble in alcohol.

Chemical structure.

Orphenadrine citrate.

Chemical name: (RS)-N,N-Dimethyl-2-[(2-methylphenyl) phenylmethoxy] ethanamine dihydrogen 2-hydroxypropane-1,2,3-tricarboxylate.
Chemical structure:

C₁₈H₂₃NO.C₆H₈O₇. M.W. 461.51.

Paracetamol.

Chemical name: N-(4-Hydroxyphenyl) acetamide.
Chemical structure:

CAS number.

Orphenadrine citrate: 4682-36-4.
Paracetamol: 103-90-2.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine - S4.

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Consumer medicine information

Norgesic

Orphenadrine citrate; Paracetamol

Keep track of your medicines

BRAND INFORMATION

Norgesic 35 mg/450 mg Tablets