Nuromol^®

Active ingredient(s): Ibuprofen 200 mg and paracetamol 500 mg

This leaflet provides important information about using Nuromol. 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 Nuromol.

Where to find information in this leaflet:

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

Nuromol contains the active Ibuprofen and paracetamol. Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Paracetamol works to stop the pain messages from getting through to the brain.

Nuromol^® is an analgesic (pain reliever). It works to relieve acute (short term) pain and / or inflammation associated with headache, migraine headache, tension headache, sinus pain, toothache, dental procedures, backache, muscular aches and pains, period pain, sore throat, tennis elbow, rheumatic pain and arthritis, and the aches and pains associated with colds and flu.

Warnings

Do not use Nuromol if:

• you are allergic to ibuprofen, paracetamol or any of the ingredients listed at the end of this leaflet.
• you are allergic to any other medicine for pain relief
  Some of the symptoms of an allergic reaction may include:
  - shortness of breath
  - wheezing or difficulty breathing
  - swelling of the face, lips, tongue or other parts of the body
  - rash, itching or hives on the skin

Always check the ingredients to make sure you can use this medicine.

Do not use Nuromol if you have the following conditions:

• liver or kidney disease
• heart problems
• asthma
• a stomach ulcer or duodenal ulcer or if you have had either of these conditions or gastric bleeding or other gastrointestinal diseases in the past
• recently vomited blood or material that looks like coffee grounds
• recently bled from the back passage (rectum), had black sticky bowel motions or bloody diarrhoea
  Some of the symptoms of liver problems may include:
  - nausea
  - feeling tired
  - itching of the skin,
  - yellow colouring of your skin
  - flu-like symptoms
  - tenderness in your abdomen

If you develop any of these symptoms or heart problems, talk to your doctor.

Do not take this medicine if you are taking any other product containing paracetamol, ibuprofen or other NSAIDs or if you are taking any other medicine for pain relief.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

Check with your doctor or pharmacist if you:

• have allergies to any other medicines, foods, preservatives or dyes
• have, or have had, any other medical conditions:
  - diabetes
  - asthma
  - liver or kidney disease
  - heart problems
• take any medicines for any other condition
• are not sure whether you should start taking Nuromol

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

Do not take this medicine if you are pregnant or plan to become pregnant.

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

Small amounts of ibuprofen and paracetamol pass into the breast milk.

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 Nuromol and affect how it works. These include:

• warfarin, a medicine used to prevent blood clots
• lithium, a medicine used to treat mood swings and some types of depression
• medicines used to lower blood pressure
• methotrexate, a medicine used to treat arthritis and some types of cancer
• medicines used to treat heart failure
• medicines such as prednisone, prednisolone and cortisone, which reduce the activity of your immune system
• zidovudine, a medicine used to treat HIV infection
• aspirin, salicylates and other nonsteroidal anti-inflammatory drugs (NSAIDs)
• medicines used to treat diabetes
• metoclopramide, a medicine used to control nausea and vomiting
• medicines used to treat epilepsy or fits
• chloramphenicol, an antibiotic used to treat ear and eye infections
• alcohol

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

How much to take

• Adults under 65 and children from 12 years:
  - Take one tablet every 8 hours with water when necessary
• Follow the instructions provided with the medicine.
• Do not exceed the recommended dosage.
  - Adults: do not take Nuromol for more than 3 days at a time.
  - Adolescents (12 to 17 years): do not take Nuromol for more than 2 days at a time.

Do not take more than 3 tablets in 24 hours.

When to take Nuromol

• Nuromol should be used when required for pain.
• If your symptoms persist, worsen or new symptoms develop, talk to your pharmacist or doctor.

If you use too much Nuromol

If you think that you have used too much Nuromol, you may need urgent medical attention.

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.

You should do this even if there are no signs of discomfort or poisoning.

Things you should do

• Talk to your pharmacist or doctor if your symptoms do not improve. Your pharmacist or doctor will assess your condition and decide if you should continue to take the medicine.

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

Things you should not do

• Do not take Nuromol for more than 3 days at a time (2 days for adolescents 12 to 17 years) unless your doctor tells you to.
• Do not take more than the recommended dose unless your pharmacist or doctor tells you to.
• Do not take Nuromol to treat any other complaints unless your pharmacist or doctor tells you to.
• Do not give your medicine to anyone else, even if they have the same condition as you.
• Do not take Nuromol if you are aged 65 years or older.

Things to be careful of

• Taking this medicine may increase the risk of you getting unwanted effects, such as stomach or heart problems

Driving or using machines

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

Drinking alcohol

Tell your doctor or pharmacist if you drink alcohol.

• Only drink small quantities of alcohol (beer, wine or spirits) while taking paracetamol.
• Drinking large quantities of alcohol while taking paracetamol may increase the risk of liver side effects

Looking after your medicine

• Keep your medicine in the original pack until it is time to take it.
• Keep your medicine in a cool dry place where the temperature stays below 30°C.

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

Store it 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 window sills.

Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

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.

Tell your pharmacist or doctor as soon as possible if you do not feel well while you are taking Nuromol.

This medicine helps most people with relief of pain, but it may have unwanted side effects in a few people.

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.

It is rare to get side effects from ibuprofen and paracetamol if taken for a short period of time and in the doses in OTC medicines.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

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

Less serious/common side effects

This list includes the more common side effects of your medicine. They are usually mild.

Serious/rare side effects

This list includes serious side effects that may require medical attention. Serious side effects are rare for low doses of this medicine and when used for a short period of time.

Very serious/ very rare side effects

This list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare for low doses of this medicine and when used for a short period of time.

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.

This medicine is available over-the-counter without a doctor's prescription.

What Nuromol contains

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

What Nuromol looks like

Nuromol tablets are a white to off white, pearlescent, oval shaped, film coated tablet, de-bossed with an identifying helix (AUST R 225322).

Who distributes Nuromol

Reckitt Benckiser Pty Ltd
Sydney, NSW, Australia

This leaflet was prepared in October 2022.

Published by MIMS February 2023

1 Name of Medicine

Ibuprofen and paracetamol.

2 Qualitative and Quantitative Composition

Nuromol Dual Action Pain Relief tablets contain 200 mg of ibuprofen and 500 mg of paracetamol.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Nuromol Dual Action Pain Relief is available in off-white, pearlescent, oval-shaped film coated tablets de-bossed with an identifying helix.

4 Clinical Particulars

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).
Paracetamol. Liver damage is possible in adults who have taken 10 g (equivalent to 20 tablets) or more of paracetamol. Ingestion of 5 g (equivalent to 10 tablets) or more of paracetamol may lead to liver damage if the patient has one or more of the risk factors below.
a) Is on long-term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.
b) Regularly consumes alcohol in excess of recommended amounts.
c) Is likely to be glutathione depleted, e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms. Symptoms of paracetamol overdose in the first 24 hours include pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion as liver function tests become abnormal. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management. Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable).
Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however the maximum protective effect is obtained up to 8 hours postingestion. The effectiveness of the antidote declines sharply after this time.
If required, the patient should be given intravenous N-acetylcysteine in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital.
Patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should be managed in accordance with established guidelines.
Ibuprofen. Symptoms. Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning, metabolic acidosis may occur and prolong the prothrombin time (PT) and increase the international normalised ratio (INR), probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur if there is coincident dehydration. Exacerbation of asthma is possible in asthmatics.
Management. Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No information is available regarding Nuromol Dual Action Pain Relief and genotoxicity.
Carcinogenicity. No information is available regarding Nuromol Dual Action Pain Relief and carcinogenicity.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Ibuprofen. Chemical name: 2-(4-isobutylphenyl) propionic acid. It is a white or almost white powder or crystals with a characteristic odour. Practically insoluble in water, soluble 1 in 1.5 of alcohol, 1 in 1 of chloroform, 1 in 2 of ether and 1 in 1.5 of acetone; soluble in aqueous solutions of alkali hydroxides and carbonates.
Paracetamol. Chemical name: N-(4-hydroxyphenyl)acetamide. White or almost white crystalline powder. Odourless. Sparingly soluble in water (14 g/L (20°C)), freely soluble in alcohol, very slightly soluble in methylene chloride.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSIBUPRF.gif MW: 206.3.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPARCET.gif MW: 151.16.
Chemical formula. Ibuprofen: C₁₃H₁₈O₂.
Paracetamol: C₈H₉NO₂.
CAS number. Ibuprofen: CAS: 15687-27-1.
Paracetamol: CAS: 103-90-2.

7 Medicine Schedule (Poisons Standard)

Pharmacist-only medicine (S3) pack sizes of: 16, 20, 24, 30.
Pharmacy Medicine (S2) pack sizes of: 2, 3, 4, 5, 6, 8, 9, 10, 12.

Summary Table of Changes

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