Training Academy Module - Microsoftmel0207lsprod.blob.core.windows.net/uploads/terrywhite/trdoc... · • Maxigesic® has a number of patents granted around the world including

Training Academy Module

What is Maxigesic®?• Maxigesic® is a world-first specific combination analgesic that combines

Paracetamol 500mg and Ibuprofen 150mg in a patented formulation

• From 1st June, packs of 12 tablets or less can be sold as Pharmacy Medicines (S2), meaning they can be advertised and promoted to the general public for the first time.

• Pack of more than 12 tablets, and less than 30, remain as Pharmacist Only (S3) medicines.

• Maxigesic® is available in the following pack sizes:

– 10 tablets (S2)

– 12 tablets (S2) – from July 2016

– 16 tablets (S3)

– 24 tablets (S3) – from July 2016 EXCLUSIVE TO PHARMACY GUILD MEMBERS

– 30 tablets (S3)

• Maxigesic® has a number of patents granted around the world including Australia, and is now licensed in 109 countries worldwide.

Use only as directed. Incorrect use can be harmful. If symptoms persist see your healthcare professional.

What is Maxigesic®?

• Maxigesic® provides double action relief for a wide range of pain

– without codeine.

• It is indicated for the temporary relief of pain associated with:

headache, migraine headache, tension headache, toothache,

dental procedures, period pain, backache, muscular pain,

arthritis, rheumatic pain, sinus pain, sore throat, tennis elbow,

and aches and pains associated with colds and flu.

• Maxigesic® also reduces fever.

Use only as directed. Incorrect use can be harmful. If symptoms persist see your healthcare professional.

How does Maxigesic® work?

• The mechanism of action differs for the two active ingredients in Maxigesic®.

The mechanism of action for paracetamol is still not completely understood

but it is believed to act centrally in the brain via the endogenous cannabinoid

system. Ibuprofen however acts via inhibition of COX-1 & COX-2 enzymes.

• Animal studies have shown synergies between paracetamol and ibuprofen in

combination1. These studies showed that the actual ED50 (median effective

dose) for the combination was significantly less [9.6 mg/kg] than the

theoretically predicted ED50 [25.1 mg/kg]. The results demonstrate potent

interactions between paracetamol and NSAIDs, and validate the clinical use of

combinations of these drugs in the treatment of pain conditions.

• Combining paracetamol and ibuprofen in a product like Maxigesic® has a

synergistic effect that helps relieve pain and fever, as well as reducing

inflammation.

1: Miranda HF et al (2006). Synergism between paracetamol and non-steroidal anti-inflammatory drugs in experimental acute pain.

PAIN 121: 22-28.

Always read the label. Use only as directed. Incorrect use can be harmful. If symptoms persist see your healthcare professional.

Proven Pain Relief

• The effectiveness of Maxigesic has been clinically proven in an

acute pain study of post-operative pain relief after removal of 1-4

wisdom teeth1.

• Maxigesic® was given pre-operatively and for 48 hours after.

• Double blind study [n=135] in 4 divided doses:

1. Merry, A. F., Gibbs, R. D., Edwards, J., Ting, G. S., Frampton, C., Davies, E. and Anderson, B. J. (2010). “Combined acetaminophen and

ibuprofen for pain relief after oral surgery in adults: a randomised controlled trial” British Journal of Anaesthesia 104(1): 80-88.


Proven Pain Relief



Maxigesic® reduced pain

levels by at least 32%

more than either

paracetamol or

ibuprofen alone1.


Maxigesic® is the ONLY Paracetamol/Ibuprofen combination

clinically proven to be more effective than a full daily OTC dose of

either Paracetamol or Ibuprofen alone1,2



2. Mehlisch, D. R., Aspley, S., Daniels, S. E., & Bandy, D. P. (2010). Comparison of the analgesic efficacy of concurrent ibuprofen and

paracetamol with ibuprofen or paracetamol alone in the management of moderate to severe acute postoperative dental pain in

adolescents and adults: A randomized, double-blind, placebo-controlled, parallel-group, single-dose, two-center, modified factorial

study. Clinical Therapeutics, 32(5), 882–895. doi:10.1016/j.clinthera.2010.04.


Main Product Features of Maxigesic®

• Maxigesic® provides combination pain relief without codeine.

• Maxigesic® is indicated for temporary relief from a wide range

of pain.

• The simple, flexible dosage regimen of 1-2 tablets every six

hours, up to 8 tablets maximum daily, delivers up to the

maximum recommended OTC dose of 4,000mg paracetamol

and 1,200mg ibuprofen per day.

• Maxigesic® is the ONLY combination analgesic that delivers the

maximum recommended daily OTC dose of paracetamol

(4,000mg) and ibuprofen (1,200mg), if required*.

*2 tablets taken every 6 hours over a 24 hour period (8 tablets total).


Main Product Features of Maxigesic®

• Maxigesic® is clinically proven to reduce pain levels by 32%

more than a full daily OTC dose of paracetamol and 35% more

than a fully daily OTC dose of ibuprofen on their own1.

• Maxigesic® is the ONLY Paracetamol/Ibuprofen combination

clinically proven to be more effective than both a full daily OTC

dose of either Paracetamol or Ibuprofen alone1,2.

• Available only in pharmacies, the patented Maxigesic®

combination cannot be replicated by combining individual OTC

products.

1. Merry, A. F., Gibbs, R. D., Edwards, J., Ting, G. S., Frampton, C., Davies, E. and Anderson, B. J. (2010). “Combined acetaminophen

and ibuprofen for pain relief after oral surgery in adults: a randomised controlled trial” British Journal of Anaesthesia 104(1): 80-88.

2. Mehlisch, D. R., Aspley, S., Daniels, S. E., & Bandy, D. P. (2010). Comparison of the analgesic efficacy of concurrent ibuprofen and

paracetamol with ibuprofen or paracetamol alone in the management of moderate to severe acute postoperative dental pain in

adolescents and adults: A randomized, double-blind, placebo-controlled, parallel-group, single-dose, two-center, modified factorial

study. Clinical Therapeutics, 32(5), 882–895. doi:10.1016/j.clinthera.2010.04.


Product Benefits of Maxigesic®

• TOLERABILITY: Being codeine-free, Maxigesic® provides a more tolerable analgesic option for patients that avoids the potential risk of misuse, addiction, and unpleasant side effects associated with codeine.

• BROAD USAGE: Suitability for use across a wide range of acute pain makes Maxigesic® a highly versatile choice for the analgesic needs of your patients.

• DOSAGE: The simple dosage regimen of 1-2 tablets for Maxigesic® provides flexibility and control in managing a patient’s daily pain, up to the maximum recommended daily OTC dose of both paracetamol and ibuprofen, if required.


Product Benefits of Maxigesic®

• PROVEN PAIN RELIEF: Maxigesic® can provide relief for your

patients that is clinically proven to be more effective in reducing

pain than the most widely used unscheduled medicines

(paracetamol and ibuprofen) on their own1.

• UNIQUE AND EXCLUSIVE: Maxigesic® is a patented formulation

that can’t be replicated by combining individual OTC products,

and it is only available from pharmacies.

1. Merry, A. F., Gibbs, R. D., Edwards, J., Ting, G. S., Frampton, C., Davies, E. and Anderson, B. J. (2010). “Combined

acetaminophen and ibuprofen for pain relief after oral surgery in adults: a randomised controlled trial” British Journal of

Anaesthesia 104(1): 80-88.


When to recommend Maxigesic®

Maxigesic® is indicated for the temporary relief of pain associated with:

• Headache

• Migraine Headache

• Tension Headache

• Sinus Pain

• Toothache

• Dental procedures

• Backache

• Sore Throat

• Arthritis

• Tennis Elbow

• Period Pain

• Muscular Pain

• Rheumatic Pain

• Aches and pains associated with colds & flu

Maxigesic® also reduces fever


How is Maxigesic® different to Nuromol®?

• Maxigesic® and Nuromol® are both Paracetamol/Ibuprofen

combination analgesics registered and available in Australia.

• Maxigesic® and Nuromol® are both indicated for the short term

relief of a wide range of acute pain.

• Each tablet of Maxigesic® contains 500mg Paracetamol and

150mg Ibuprofen. The approved dose for Maxigesic® is 1-2

tablets every 6 hours up to a maximum of 8 tablets per day.

• Each tablet of Nuromol® contains 500mg Paracetamol and

200mg Ibuprofen. The approved dose for Nuromol® is 1 tablet

every 8 hours up to a maximum of 3 tablets per day.

Nuromol® is a registered trademark of Reckitt Benckiser Group PLC.


How is Maxigesic® different to Nuromol®?

• Maxigesic® provides 2.7 times more Paracetamol and 2 times more Ibuprofen than Nuromol® at maximum recommended daily dosage, if required.*

• Maxigesic® is the ONLY combination analgesic that delivers the maximum recommended daily OTC dose of paracetamol (4,000mg) and ibuprofen (1,200mg), if required*.

• Maxigesic® is the ONLY Paracetamol/Ibuprofen combination clinically proven to be more effective than both a full daily OTC dose of either Paracetamol or Ibuprofen alone1,2.

*2 tablets taken every 6 hours over a 24 hour period (8 tablets total).

Nuromol® is a registered trademark of Reckitt Benckiser Group PLC.

1. Merry, A. F., Gibbs, R. D., Edwards, J., Ting, G. S., Frampton, C., Davies, E. and Anderson, B. J. (2010). “Combined acetaminophenand ibuprofen for pain relief after oral surgery in adults: a randomised controlled trial” British Journal of Anaesthesia 104(1): 80-88.

2. Mehlisch, D. R., Aspley, S., Daniels, S. E., & Bandy, D. P. (2010). Comparison of the analgesic efficacy of concurrent ibuprofen and paracetamol with ibuprofen or paracetamol alone in the management of moderate to severe acute postoperative dental pain in adolescents and adults: A randomized, double-blind, placebo-controlled, parallel-group, single-dose, two-center, modified factorial study. Clinical Therapeutics, 32(5), 882–895. doi:10.1016/j.clinthera.2010.04.


Use and Dosage

• For the temporary relief of pain, and the reduction of fever and

inflammation.

• Take 1 or 2 tablets with a large glass of water.

• Repeat dose every six hours, as required, up to a maximum of 8

tablets in 24 hours.

• Maxigesic® is not recommended for children under 12 years.

• Do not combine Maxigesic® with any other Paracetamol or

Ibuprofen containing medicines.

• Only take Maxigesic® tablets for a few days at a time for adults,

or 48 hours at a time for children and adolescents aged 12-18

years, unless a healthcare professional advises to take it for

longer.


Product Warnings

• Patients should not take Maxigesic®:

– If they have a stomach ulcer or other stomach disorders

– If they are allergic to ibuprofen, paracetamol, aspirin or

other anti-inflammatory medicines

– If they are pregnant or breastfeeding

– If they have impaired kidney function, impaired liver

function or heart problems

– If they are a heavy drinker.


Product Cautions

• Unless a doctor has advised to the contrary, patients

should not take Maxigesic®:

– With other medicines they are taking regularly

– With other medicines containing ibuprofen, paracetamol,

aspirin or other anti-inflammatory medicines

– If they have asthma

– If they are aged 65 or over

– If they have bleeding or vision problems

– If they are taking anticoagulant medication, medication for

high blood pressure, diuretics, lithium, methotrexate or

other medicines for pain relief.


Codeine Combination Analgesics

• The primary concern about codeine relates to potential harm from misuse or

abuse of codeine products, but there are also question marks about their

efficacy compared to other OTC analgesics.

• The efficacy of codeine 60mg in combination with paracetamol (versus

paracetamol alone) has been shown to be in the range of only 4-5%1.

• Other literature shows that codeine 60 mg enhanced the analgesic effect of

ibuprofen 400 mg by about 8% in the total pain-relief scale, but also

increased its adverse effects2.

• 7-10% of the population also lack the enzyme required to metabolise

codeine3.

1. De Craen AJM, Di Guilio G, Lampe-Schoenmaeckers AJEM, Kessels AGH, Kleijnen J. “Analgesic efficacy and safety of paracetamol-codeine

combinations versus paracetamol alone: a systematic review”. BMJ 1996;313:321-5.

2. Li Wan Po A., Zhang W.Y. “Analgesic efficacy of ibuprofen alone and in combination with codeine or caffeine in post-surgical pain: a

meta-analysis.” European Journal of Clinical Pharmacology Jan 1998; Vol 53, Issue 5: 303-311.

3. Murnion B.P. “Combination analgesics in adults.” Aust Prescr 2010; 33:113-5.


Make the Switch to Maxigesic®

• Clinically proven pain relief - without the potential risks of codeine.

• A patented product that is exclusive to pharmacy – can’t be

replicated by combining other products or substituted by generics.

• Premium analgesic product offering to help hold and grow

category value and profitability in the possible absence of OTC

codeine.

• Fill any potential codeine gap by helping your customers make the

switch to Maxigesic® for their acute pain needs.


Selling Tips for Maxigesic®

• Consult with your patient about the type of pain they are

suffering from, what they have been using to treat it, and how

effective it has been for them.

• Determine whether Maxigesic® is a suitable option for treating

their pain.

• If you are transitioning a patient from a medicine with

potentially addictive properties (e.g. codeine-based analgesics),

you may wish to consider a phased dosage regimen that

gradually increases Maxigesic® over time while reducing the use

of the other medicine to help aid their transition.


Documents

Training Academy Module - Microsoftmel0207lsprod.blob.core.windows.net/uploads/terrywhite/trdoc... · • Maxigesic® has a number of patents granted around the world including