SUMMARY CMI

BRUFEN^® PAIN

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 Brufen^® Pain?

Brufen^® Pain contains the active ingredient ibuprofen. Brufen^® Pain is used for the temporary relief of 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, arthritis, rheumatic pain, and the aches and pains associated with colds and flu. It also reduces fever.

For more information, see Section 1. Why am I using Brufen^® Pain? in the full CMI.

2. What should I know before I use Brufen^® Pain?

Do not use if you have allergy to ibuprofen, aspirin, NSAIDs or any of the ingredients listed at the end of the CMI.

Talk to your doctor or pharmacist 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 Brufen^® Pain? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Brufen^® Pain 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 Brufen^® Pain?

• Adults and Children from 12 years: One tablet every 4 to 6 hours as necessary. Do not take more than 3 tablets in 24 hours.
• Do not give to children under 12.
• Do not exceed recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage.

More instructions can be found in Section 4. How do I use Brufen^® Pain? in the full CMI.

5. What should I know while using Brufen^® Pain?

For more information, see Section 5. What should I know while using Brufen^® Pain? in the full CMI.

6. Are there any side effects?

• Side effects are uncommon. The most common of these include headache, nausea, abdominal pain and heartburn.

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

BRUFEN^® PAIN

Active ingredient(s): Ibuprofen

Consumer Medicine Information (CMI)

This leaflet provides important information about using Brufen^® Pain. 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 Brufen^® Pain.

Where to find information in this leaflet:

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

1. Why am I using Brufen^® Pain?

Brufen^® Pain contains the active ingredient ibuprofen. Brufen^® Pain belongs to a group of medicines called non-steroidal anti-inflammatory drugs (or NSAIDs).

Brufen^® Pain is used for the temporary relief of 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, arthritis, rheumatic pain, and the aches and pains associated with colds and flu. It also reduces fever.

2. What should I know before I use Brufen^®Pain?

Warnings

Do not use Brufen^® Pain if:

• you are allergic to ibuprofen, aspirin, NSAIDs or any of the ingredients listed at the end of this leaflet.
  Many medicines used to treat headache, period pain and other aches and pains contain aspirin or NSAID medicines. If you are not sure if you are taking any of these medicines, ask your pharmacist.
  Always check the ingredients to make sure you can use this medicine.
  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; and rash, itching or hives on skin.
• you have asthma that is sensitive to aspirin or NSAIDs
• you have a peptic ulcer (ie stomach or duodenal ulcer), or a recent history of one, or have had peptic ulcers before;
• you have recently (or have previously) vomited blood or material that looks like coffee grounds
• you have recently (or previously) bled from the back passage (rectum), had black sticky bowel motions (stools) or bloody diarrhoea
• you have a condition resulting in an increased tendency to bleed
• you have or have had a history of, Ulcerative Colitis or Crohn's Disease
• you have severe kidney disease
• you have severe heart failure
• you have severe liver disease
• you are being treated for pain following heart bypass surgery

Check with your doctor or pharmacist if you:

• have any other medical conditions
• take any medicines for any other condition
• have asthma
• have heart disease or high blood pressure
• have heartburn, indigestion, stomach ulcer or any other stomach problems
• are vomiting blood or bleeding from the back passage
• have severe skin reactions such as Stevens-Johnson syndrome
• have vision problems
• have liver or kidney disease
• have a tendency to bleed or other blood problems
• have bowel or intestinal problems such as ulcerative colitis
• have heart failure
• have swelling of ankles or feet
• have diarrhoea
• If you are over 65 years of age, talk to your pharmacist or doctor about taking Brufen^® Pain. Taking this medicine may increase the risk of you getting unwanted effects, such as stomach or heart problems.
• Tell your doctor or pharmacist if you currently have an infection.
• If you take Brufen^® Pain while you have an infection, it may hide some of the signs and symptoms of an infection. This may make you think, mistakenly, that you are better or that it is not serious.
• Tell your doctor or pharmacist if you plan to have surgery.
• 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?

Brufen^® Pain is only available from your pharmacist.

Brufen^® Pain is not addictive.

Pregnancy and breastfeeding

Do not take Brufen^® Pain if you are pregnant, or intend to become pregnant or during the first 6 months of pregnancy, except on doctor's advice. Do not use at all in the last three months of pregnancy.

It may affect your developing baby if you take it during pregnancy. It may also impair female fertility.

Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed. Like most NSAID medicines, Brufen^® Pain is not recommended while you are breast-feeding.

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 and ibuprofen may interfere with each other. These include:

• warfarin or clopidogrel, medicines used to stop blood clots
• lithium, a medicine used to treat mood swings and some types of depression
• SSRIs such as sertraline, medicines used to treat depression
• medicines used to treat high blood pressure or other heart conditions
• methotrexate, a medicine used to treat arthritis and some types of cancer
• medicines used to treat heart failure such as digoxin
• medicines such as prednisone, prednisolone and cortisone, which reduce the activity of your immune system
• cyclosporine or tacrolimus, medicines used to treat certain problems with the immune system or to help prevent organ transplant rejection
• aminoglycosides, medicines used to treat certain infections
• quinolone antibiotics, medicines used to treat certain infections
• mifepristone, a medicine used to bring about an abortion
• zidovudine, a medicine used to treat HIV infection
• aspirin, salicylates and other non-steroidal anti-inflammatory drugs (NSAIDs)
• medicines used to treat diabetes
• probenecid, a medicine used to treat gout
• phenytoin, a medicine used to treat epilepsy.

These medicines may be affected by Brufen^® Pain, or may affect how well it works. You may need to take different amounts of your medicine, or you may need to take different medicines. Your doctor or pharmacist will advise you.

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

4. How do I use Brufen^® Pain?

How much to take / use

• Adults and Children from 12 years: One tablet every 4 to 6 hours as necessary.
• Do not take more than 3 tablets in 24 hours.
• Do not give to children under 12.
• Follow the instructions provided with the medicine.
• Do not exceed the recommended dosage.
• Excessive use can be harmful and increase the risk of heart attack, stroke and liver damage.

When to take / use Brufen^® Pain

• Take Brufen^® Pain by mouth with water.
• Brufen^® Pain should not be used for more than 3 days at a time, except on medical advice.

If you use too much Brufen^® Pain

If you think that you have used too much Brufen^® Pain, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (Australia telephone 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.

5. What should I know while using Brufen^® Pain?

Things you should do

• If you become pregnant while taking this medicine tell your doctor immediately.
• If you are going to have surgery, make sure the surgeon and anaesthetist know you are taking Brufen^® Pain.
  NSAID medicines can slow down blood clotting.
• Tell your pharmacist or doctor if your symptoms do not improve. Your pharmacist or doctor will assess your conditions and decide if you should continue to take the medicine.

Remind any doctor, dentist or pharmacist you visit that you are using Brufen^® Pain.

Things you should not do

• Do not take Brufen^® Pain with any other medicines containing ibuprofen, aspirin or other anti-inflammatory medicines unless your doctor tells you to.
• Do not take Brufen^® Pain 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 more than the recommended dose unless your pharmacist or doctor tells you to.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Brufen^® Pain affects you.

Brufen^® Pain may cause dizziness in some people. If this happens, do not drive or operate machinery.

Drinking alcohol

Tell your doctor or pharmacist if you drink alcohol.

Looking after your medicine

• Keep your medicine in a cool dry place where the temperature stays below 25°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.

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.

Less serious side effects

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.

7. Product details

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

What Brufen^® Pain contains

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

What Brufen^® Pain looks like

Brufen^® Pain tablets (AUST R 401754) are white to off-white, pillow-shaped, film coated tablets plain on both sides.

Brufen^® Pain is available in cartons with PVC/Aluminium blister packs containing 10, 28 or 50 tablets*

* Not all pack sizes may be marketed.

Who distributes Brufen^® Pain

Sponsor

Medreich Australia Pty Ltd
Unit 8, Homebush Business Village
11-21 Underwood Road,
Homebush, NSW 2140
AUSTRALIA

Distributor

Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276

This leaflet was prepared in August 2023.

BRUFEN^® is a Viatris company trade mark

Brufen Pain_cmi\Aug23/00

Published by MIMS October 2023

1 Name of Medicine

Ibuprofen.

2 Qualitative and Quantitative Composition

Each tablet contains 400 mg of ibuprofen as the active ingredient.

Excipients with known effect.

3 Pharmaceutical Form

White to off-white, pillow-shaped, film coated tablets, plain on both sides.

4 Clinical Particulars

4.1 Therapeutic Indications

For the temporary relief of 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, arthritis, rheumatic pain and aches and pains associated with colds and flu. Reduces fever.

4.2 Dose and Method of Administration

Adults and children 12 years and over.

Pregnancy.

Children under 12 years.

4.3 Contraindications

Ibuprofen is contraindicated for use in patients with:
known hypersensitivity or idiosyncratic reaction to ibuprofen (or any of the inactive ingredients);
known hypersensitivity to aspirin and other NSAIDs;
asthma that is aspirin or NSAID sensitive;
active gastrointestinal bleeding or peptic ulceration;
renal impairment;
heart failure;
severe liver impairment;
undergoing treatment of perioperative pain in a setting of coronary artery bypass surgery (CABG).
Use of ibuprofen is contraindicated during the third trimester of pregnancy (see Section 4.6 Fertility, Pregnancy and Lactation).
Ibuprofen should not be taken with other products containing ibuprofen or with other anti-inflammatory medicines.

4.4 Special Warnings and Precautions for Use

Ibuprofen should be used with caution in patients with:
Previous history of gastrointestinal haemorrhage or ulcers;
Asthma who have not previously taken NSAID;
Hepatic, or cardiac impairment;
Pregnancy (see Section 4.6 Fertility, Pregnancy and Lactation);
Elderly (see Section 4.4 Special Warnings and Precautions for Use, Use in the elderly);
Ibuprofen should be taken with caution with other products containing aspirin or salicylates;
As with other NSAIDs, excessive use of ibuprofen may increase the risk of heart attack, stroke or liver damage in both patients with predisposing cardiovascular risk factors and in normal patients.
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions, for additional information.

Cardiovascular and cerebrovascular effects.

Gastrointestinal (GI).

Respiratory.

SLE and mixed connective tissue disease.

Skin and subcutaneous tissue disorders.

Severe skin reactions.

Drug reaction with eosinophilia with systemic symptoms (DRESS).

Masking of symptoms of underlying infections.

Use in hepatic impairment.

Use in the elderly.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The following interactions with ibuprofen have been noted:

Anticoagulant-including warfarin.

Lithium.

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs).

Cardiac glycosides.

Ciclosporin.

Corticosteroids.

Methotrexate.

Mifepristone.

Quinolone antibiotics.

Tacrolimus.

Zidovudine.

Antidiabetic medicines, probenecid and phenytoin.

ACE inhibitors, beta-blockers and diuretics.

NSAIDs and aspirin.

Lactose.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Adverse effects with non-prescription (OTC) or short-term use ibuprofen are rare and may include:
Gastrointestinal - dyspepsia, heartburn, nausea, loss of appetite, stomach pain, diarrhea.
Central nervous system (CNS) - dizziness, fatigue, headache, nervousness.
Hypersensitivity reactions - skin rashes and itching. Rarely exfoliative dermatitis and epidermal necrolysis have been reported with ibuprofen.
Rare cases of photosensitivity.
Cardiovascular fluid retention and in some cases oedema. These effects are rare at non-prescription doses.
The frequencies of adverse effects are defined as follows:
Very common: > 1/10; common: > 1/100, < 1/10; uncommon: > 1/1,000, < 1/100; rare: > 1/10,000, < 1/1,000; very rare: < 1/10,000, including isolated reports.
Hypersensitivity reactions have been reported following treatment with ibuprofen. These may consist of:
a) non-specific allergic reactions and anaphylaxis;
b) respiratory tract reactivity e.g. asthma, aggravated asthma, bronchospasm, dyspnea;
c) Assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and more rarely bullous dermatoses (including epidermal necrolysis and erythema multiforme).
The following adverse effects relates to those experienced with ibuprofen at OTC doses, for short-term use. In the treatment of chronic conditions, under long term treatment, additional adverse effects may occur.
Allergic reactions such as skin rash, itching, swelling of the face or breathing difficulties may also occur. These are usually transient and reversible on cessation of treatment.

Blood and lymphatic system disorders.

Hypersensitivity reactions.

Gastrointestinal disorders.

Nervous system.

Renal.

Liver.

Haematological.

Skin and subcutaneous tissue disorders.

Immune system.

Cardiovascular and cerebrovascular.

Ocular.

Other.

Pregnancy, puerperium and perinatal conditions.

Reporting suspected adverse effects.

4.9 Overdose

Symptoms include nausea, abdominal pain and vomiting, dizziness, convulsion and rarely, loss of consciousness. Clinical features of overdose with ibuprofen which may result are depression of the central nervous system and the respiratory system.
There is no specific antidote to ibuprofen.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Excipients: lactose monohydrate, cellulose microcrystalline, povidone, croscarmellose sodium, sodium lauryl sulfate, colloidal silica anhydrous, stearic acid, macrogol 6000, hypromellose, titanium dioxide and talc purified.

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 25°C.

6.5 Nature and Contents of Container

Available in cartons with PVC/Aluminium blister packs containing 10, 28, 50* tablets.
* Not all pack sizes may be marketed.

Australian register of therapeutic goods (ARTG).

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Ibuprofen is a (±)-2-(p-isobutylphenyl) propionic acid. Ibuprofen is a white crystalline solid with a melting point of 74 - 77°C and is practically insoluble in water (< 0.1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S2 - Pharmacy Medicine (10 tablet pack sizes).
S3 - Pharmacist Only Medicine (28 and 50 tablet pack sizes).

Summary Table of Changes