Consumer medicine information

Norflex 100 mg Slow release tablets

Orphenadrine citrate

BRAND INFORMATION

Brand name

Norflex

Active ingredient

Orphenadrine citrate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Norflex 100 mg Slow release tablets.

1. Why am I using NORFLEX?


NORFLEX contains the active ingredient orphenadrine citrate. NORFLEX is 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. It is also useful for tension headache and persistent hiccups.
For more information, see Section 1. Why am I using NORFLEX? in the full CMI.

2. What should I know before I use NORFLEX?


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

3. What if I am taking other medicines?


Some medicines may interfere with NORFLEX 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 NORFLEX?

  • The usual dose is one tablet twice daily. Follow the instructions provided on the pack.

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

5. What should I know while using NORFLEX?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using NORFLEX.
  • Contact your doctor if you become pregnant whilst using NORFLEX.
Things you should not do
  • Do not give NORFLEX to anyone else even if they have the same condition as you.
  • Do not take NORFLEX to treat any other complaints unless your doctor tells you to.
Driving or using machines
  • NORFLEX may cause drowsiness or blurred vision. Be careful driving or operating machinery until you know how NORFLEX affects you.
Drinking alcohol
  • Avoid drinking alcohol while using NORFLEX.
  • 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 NORFLEX? 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, 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.

BRAND INFORMATION

Brand name

Norflex

Active ingredient

Orphenadrine citrate

Schedule

S4

 

1 Name of Medicine

Orphenadrine citrate.

2 Qualitative and Quantitative Composition

Norflex slow release (modified release) tablets contain orphenadrine citrate 100 mg.
Excipients with known effect. Sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Slow release (modified release) tablet, 100 mg: white, round, biconvex tablet. Markings N/X on one side and no markings on the other side.

4 Clinical Particulars

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
Symptoms. Symptoms of orphenadrine overdosage are excitement, confusion, delirium leading to coma. Convulsions and tachycardia with dilated pupils and urinary retention may occur.
Treatment. Convulsions and delirium respond to relatively large doses of diazepam, preferably by mouth. Adequate hydration of the patient is important.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Orphenadrine citrate is white or almost white, crystalline powder. It is sparingly soluble in water, and slightly soluble in alcohol. Its chemical name is (RS)-N,N-Dimethyl-2-[(2-methylphenyl)phenylmethoxy]ethanamine dihydrogen 2-hydroxypropane-1,2,3-tricarboxylate.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSORPCIT.gif Molecular Formula: C18H23NO.C6H8O7.
CAS number. 4682-36-4.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine - S4.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/NORFLEST.gif