Consumer medicine information

Nurofen Cold and Flu

Ibuprofen; Pseudoephedrine hydrochloride

BRAND INFORMATION

Brand name

Nurofen Cold & Flu with Decongestant

Active ingredient

Ibuprofen; Pseudoephedrine hydrochloride

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Nurofen Cold and Flu.

FULL CMI

Nurofen® Cold and Flu

Active ingredients: Ibuprofen 200mg and pseudoephedrine hydrochloride 30mg

Consumer Medicine Information (CMI)

This leaflet provides important information about using Nurofen Cold and Flu. 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 Nurofen Cold and Flu.

Where to find information in this leaflet:

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

1. Why am I using Nurofen Cold and Flu?

Nurofen Cold and Flu contains the active ingredients ibuprofen and pseudoephedrine hydrochloride.

Ibuprofen is used for the relief of the symptoms of colds and flu, including aches and pains, headache, fever and sore throat. It belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

Pseudoephedrine is used for the relief of the congestion associated with colds and flu including runny nose, blocked nose and sinuses. It belongs to a group of medicines called sympathomimetic decongestants and works by reducing congestion in the upper respiratory tract, making it easier to breathe.

Nurofen Cold and Flu is used for the fast effective temporary relief of the symptoms of colds and flu.

2. What should I know before I use Nurofen Cold and Flu?

Warnings

Do not use Nurofen Cold and Flu if:

  • you are allergic to any medicine containing pseudoephedrine, ibuprofen, aspirin or other NSAIDs, or any of the ingredients listed at the end of this leaflet.
    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 Nurofen Cold and Flu if you have the following conditions:

  • liver or kidney disease
  • heart problems
  • asthma
  • a stomach 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
  • high blood pressure
  • taken Monoamine oxidase inhibitors, medicines used to treat depression, in the last 14 days
  • taken other NSAIDs including cyclo-oxygenase-2-specific inhibitors
    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 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:
    - asthma
    - stomach or duodenal ulcer
    - signs of gastrointestinal bleeding, such as vomiting blood or bleeding from the back passage (rectum)
    - liver or kidney disease
    - high blood pressure
    - overactive thyroid gland
    - diabetes
    - heart disease and poor blood flow in the blood vessels of the heart
    - glaucoma (high pressure in the eyes)
    - prostate problems
  • take any medicines for any other condition
  • are aged 65 years or older

Taking this medicine may increase the risk of you getting stomach, heart or kidney problems.

If you are not sure whether you should start taking this medicine, talk to your pharmacist or doctor

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.

Ask your pharmacist or doctor about taking this medicine if you are breastfeeding.

Pseudoephedrine and small amounts of ibuprofen may pass into the breast milk. Your pharmacist or doctor will discuss the potential benefits and risks of taking this medicine if you are breastfeeding.

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 Nurofen Cold and Flu and affect how it works. These include:

  • warfarin, a medicine used to prevent blood clots
  • diuretics - medicines used to help reduce the amount of excess fluid in the body by increasing the amount of urine produced.
  • lithium and other medicines used to treat mood swings and other types of depression
  • medicines used to treat behavioural disorders
  • medicines used to lower blood pressure
  • methotrexate, a medicine used to treat arthritis and some types of cancer
  • medicines used to treat heart failure and other heart conditions
  • medicines such as cyclosporin, quinolone, prednisone, prednisolone, mifepristone, tacrolimus and cortisone, which reduce the activity of your immune system
  • zidovudine, a medicine used to treat HIV infection medicines used to treat urinary tract infections and bladder problems aspirin, salicylates and other nonsteroidal anti-inflammatory drugs (NSAIDs)
  • medicines used to treat diabetes
  • phenylephrine, a medicine used to treat congestion
  • amphetamine-like psychostimulants
  • appetite suppressants

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

4. How do I use Nurofen Cold and Flu?

How much to take

  • Adults and children from 12 years:
    - 2 tablets, then 1 or 2 tablets every 4 hours as necessary (maximum 6 tablets in 24 hours).
  • Take Nurofen Cold and Flu by mouth with water
  • Follow the instructions provided with the medicine.
  • Do not exceed the recommended dosage.
  • Do not take for more than 3 days at a time except with your doctor's advice

If you use too much Nurofen Cold and Flu

If you think that you have used too much Nurofen Cold and Flu, 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.

5. What should I know while using Nurofen Cold and Flu?

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 Nurofen Cold and Flu.

Things you should not do

  • Do not take Nurofen Cold and Flu 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.

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 Nurofen Cold and Flu affects you.

Nurofen Cold and Flu 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 this 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 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.

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.

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.

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

Less serious/common side effects

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

Children and people over 65 years of age may have an increased chance of getting side effects.

Less serious side effectsWhat to do
  • buzzing or ringing in the ears
  • change in mood, for example, depression, restlessness, irritability
  • sore or dry mouth or tongue
  • nausea, heartburn, or stomach pain
  • loss of appetite
  • diarrhoea
  • dizziness
  • drowsiness
  • headache
  • nervousness
  • difficulty sleeping
  • excitability
  • restlessness
  • fear or anxiety
  • rapid heartbeat
  • tremor
  • hallucinations
Speak to your doctor or pharmacist if you have any of these less serious side effects and they worry you.

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.

Serious side effectsWhat to do
  • severe pain or tenderness in the stomach
  • eye problems such as blurred vision, sore red eyes, itching
  • severe dizziness, spinning sensation
  • severe or persistent headache
  • tingling or numbness of the hands or feet
  • fast or irregular heartbeats, also called palpitations
  • difficulty hearing, deafness
  • signs of frequent or worrying infections such as fever, severe chills, sore throat or mouth ulcers
  • bleeding or bruising more easily than normal, reddish or purplish blotches under the skin
  • signs of anaemia, such as tiredness, being short of breath, and looking pale
  • a change in the colour of urine
  • passed, blood in the urine
  • a change in the amount or frequency of urine passed, burning feeling when passing urine
  • yellowing of the skin and eyes, also called jaundice
  • unusual weight gain, swelling of ankles or legs
  • symptoms of sunburn (such as redness, itching, swelling, blistering) which may occur more quickly than normal
Tell your doctor as soon as possible if you notice any of these serious side effects.

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.

Very serious side effectsWhat to do
  • fainting, seizures or fits
  • pain or tightness in the chest
  • fluid or urine retention
  • vomiting blood or bleeding from the back passage
  • shortness of breath
  • asthma, wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin
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.

7. Product details

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

What Nurofen Cold and Flu contains

Active ingredient
(main ingredient)		Each Nurofen Cold and Flu tablet contains:
  • 200 mg of ibuprofen and
  • 30 mg of pseudoephedrine hydrochloride
Other ingredients
(inactive ingredients)
  • Cellulose - microcrystalline,
  • calcium phosphate,
  • croscarmellose sodium,
  • hypromellose,
  • magnesium stearate,
  • mastercoat yellow FA 0156 or opaspray Yellow MI-IF-6168, povidone, talc-purified and
  • opacode monogramming ink S-1-277001 BLACK
Potential allergensThis medicine does not contain lactose, sucrose, gluten, wheat or preservatives.

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

What Nurofen Cold and Flu looks like

Nurofen Cold and Flu is a yellow round tablet with a black logo picturing a letter “N” in a letter “C”. (Aust R 65640).

Pack of 24 tablets.

Who distributes Nurofen Cold and Flu

Reckitt Benckiser Pty Ltd
Sydney, NSW, Australia

This leaflet was prepared in October 2022.

Published by MIMS February 2023

BRAND INFORMATION

Brand name

Nurofen Cold & Flu with Decongestant

Active ingredient

Ibuprofen; Pseudoephedrine hydrochloride

Schedule

S3

 

1 Name of Medicine

Nurofen Cold and Flu with Decongestant tablets.

2 Qualitative and Quantitative Composition

The active ingredients in Nurofen Cold and Flu with Decongestant tablets are ibuprofen 200 mg and pseudoephedrine hydrochloride 30 mg.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Nurofen Cold and Flu with Decongestant tablet is a round tablet with a yellow-coloured film-coating inscribed with a black logo of a letter 'N' in a letter 'C'.

4 Clinical Particulars

4.1 Therapeutic Indications

For the temporary relief of the symptoms of colds and flu with associated congestion, including aches and pains, headaches, fever, sore throat, runny nose, blocked nose and sinuses.

4.2 Dose and Method of Administration

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see Section 4.4).

Adults and children 12 years and over.

Initial dose of 2 tablets then, if necessary, 1 or 2 tablets every 4 hours. Not to be given to children under 12 years.
Do not exceed 6 tablets in any 24 hour period.
Do not use for a period of more than three days at a time except on medical advice, in which case the patient should be reviewed regularly with regards to efficacy, risk factors and ongoing need for treatment.

Children.

Do not use in children under 12 years of age.

Pregnancy.

See Section 4.3 Contraindications; Section 4.6 Fertility, Pregnancy and Lactation.

Method of administration.

For oral administration.

4.3 Contraindications

Known hypersensitivity to ibuprofen, pseudoephedrine hydrochloride or any of the excipients.
Hypersensitivity (e.g. asthma, rhinitis or urticaria) to aspirin or other non-steroidal anti-inflammatory drugs.
Use with concomitant NSAIDs including cyclo-oxygenase-2 specific inhibitors. Current receipt or receipt within the last two weeks, of therapy with monoamine oxidase inhibitors.
As with other non-steroidal anti-inflammatory agents, ibuprofen should not be used in patients with active or a history of gastrointestinal bleeding or in the presence of peptic ulceration.
Patients with serious coronary heart disease or cardiovascular disorders, heart failure, kidney or liver disease, tachycardia, hypertension, angina pectoris, hyperthyroidism, diabetes, phaeochromocytoma, closed angle glaucoma, prostatic enlargement, undergoing treatment of perioperative pain in setting of coronary artery bypass surgery (CABG).
Not to be used in the third trimester of pregnancy (see Section 4.6 Fertility, Pregnancy and Lactation).
Not to be used in children under the age of 12 years.
Monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping treatment (see Section 4.5).

4.4 Special Warnings and Precautions for Use

Nurofen Cold and Flu with Decongestant should be administered with caution, and at the lowest effective dose, in patients with a history of gastrointestinal haemorrhage or ulcer, asthma and particularly those with aspirin-sensitive asthma and in patients with hepatic, renal or cardiac impairment. In patients with renal impairment, renal function should be monitored since it may deteriorate following the use of any NSAID.

Cardiovascular and cerebrovascular effects.

Observational studies have indicated that NSAIDs may be associated with an increased risk of serious cardiovascular events, including myocardial infarction and stroke, which may increase with dose or duration of use.
Patients with cardiovascular disease, history of atherosclerotic cardiovascular disease or cardiovascular risk factors may also be at greater risk.
Patients should be advised to remain alert for such cardiovascular events, even in the absence of previous cardiovascular symptoms. Patients should be informed about signs and/or symptoms of serious cardiovascular toxicity and the steps to take if they occur.
Fluid retention, hypertension and oedema have been reported in association with NSAID therapy. Patients taking antihypertensives with NSAIDs may have an impaired antihypertensive response.
Nurofen Cold and Flu with Decongestant tablets should be used with caution in patients with hypertension (also see Section 4.3 Contraindications).

Hepatic.

As with other NSAIDs elevations of one or more liver function tests may occur in up to 15% of patients. These abnormalities may progress, may remain essentially unchanged or may resolve with continued therapy. Meaningful elevations (three times the upper limit of normal) of ALT or AST occurred in controlled clinical trials in less than 1% of patients.
Patients should be advised to remain alert for hepatotoxicity and be informed about the signs and/or symptoms of hepatotoxicity (e.g. nausea, fatigue, lethargy, pruritus, jaundice, abdominal tenderness in the right upper quadrant and "flu-like" symptoms).

Gastrointestinal effects.

NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as their condition may be exacerbated (see Section 4.8 Adverse Effects (Undesirable Effects)).
Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events.
The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see Section 4.3 Contraindications) and in the elderly. These patients should commence treatment on the lowest dose available.
Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.
Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
When GI bleeding or ulceration occurs in patients receiving Nurofen Cold and Flu with Decongestant, the treatment should be withdrawn.

Ischaemic colitis.

Some cases of ischaemic colitis have been reported with pseudoephedrine. Pseudoephedrine should be discontinued and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop.

Ischaemic optic neuropathy.

Cases of ischaemic optic neuropathy have been reported with pseudoephedrine. Pseudoephedrine should be discontinued if sudden loss of vision or decreased visual acuity such as scotoma occurs.

Respiratory.

Use of ibuprofen may precipitate bronchospasm in patients suffering from or with a previous history of bronchial asthma or allergic disease.

SLE and mixed connective tissue disease.

Use of ibuprofen in patients with systemic lupus erythematosus (SLE) and mixed connective tissue disease can increase the risk of aseptic meningitis.

Renal.

Risk of renal impairment as renal function may deteriorate, especially in dehydrated children and adolescents (see Section 4.3 Contraindications; Section 4.8 Adverse Effects (Undesirable Effects)).

Skin and subcutaneous tissue disorders.

Dermatological effects.

Serious skin reactions, some of them fatal including exfoliative dermatitis, Stevens-Johnson syndrome, Drug Reaction with Eosinophilia with Systemic Symptoms (see DRESS and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see Section 4.8 Adverse Effects (Undesirable Effects)). Patients appear to be at highest risk for these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Nurofen Cold and Flu with Decongestant should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.

Severe skin reactions.

Severe skin reactions such as acute generalised exanthematous pustulosis (AGEP) may occur with ibuprofen and pseudoephedrine-containing products. This acute pustular eruption may occur within the first 2 days of treatment, with fever, and numerous, small, mostly non-follicular pustules arising on a widespread oedematous erythema and mainly localised on the skin folds, trunk, and upper extremities. Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema, or many small pustules are observed, administration of this product should be discontinued and appropriate measures taken if needed.

Drug reaction with eosinophilia with systemic symptoms (DRESS).

DRESS has been reported in patients using NSAIDs. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling. Other clinical manifestations may include hepatitis, nephritis, haematological abnormalities, myocarditis, or myositis. Sometimes symptoms of DRESS may resemble an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its presentation, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, discontinue the NSAID and evaluate the patient immediately.

Masking of symptoms of underlying infections.

Nurofen Cold and Flu with Decongestant can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection. This has been observed in bacterial community acquired pneumonia and bacterial complications to varicella. When Nurofen Cold and Flu with Decongestant is administered for fever or pain relief in relation to infection, monitoring of infection is advised. In non-hospital settings, the patient should consult a doctor if symptoms persist or worsen.

Use in the elderly.

Ibuprofen should not be taken by adults over the age of 65 without careful consideration of co-morbidities and co-medications because of an increased risk of adverse effects, in particular heart failure, gastro-intestinal ulceration and renal impairment (also see Section 4.3 Contraindications).

Paediatric use.

Nurofen Cold and Flu with Decongestant is not recommended for use in children under 12 years. Nurofen for Children suspension should be used for this age group.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

This product should be avoided in combination with.

Acetylsalicylic acid (aspirin).

Unless low-dose acetylsalicylic acid (aspirin) (not above 75 mg daily) has been advised by a doctor, as this may increase the risk of adverse reactions (also see Section 4.4 Special Warnings and Precautions for Use). Experimental data suggest that ibuprofen may inhibit the effect of low-dose acetylsalicylic acid (aspirin) on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical setting imply that no firm conclusions can be made for regular ibuprofen use and no clinically relevant effect is considered to be likely for occasional ibuprofen use.

Other NSAIDs including cyclooxygenase‐2 selective inhibitors.

Avoid concomitant use of two or more NSAIDs as this may increase the risk of adverse effects (see Section 4.3 Contraindications).

Monoamine oxidase inhibitors and/ or reversible inhibitors of monoamine oxidase A (RIMAs).

Increased risk of hypertensive crisis (see Section 4.3). Pseudoephedrine should not be given to patients receiving MAOI therapy or within 14 days of ceasing such treatment.

This product should be used with caution in combination with.

Anticoagulants.

Concurrent use of NSAIDs and warfarin has been associated with severe, sometimes fatal haemorrhage. The mechanism of this interaction is not known but may involve increased bleeding from NSAID-induced gastrointestinal ulceration or an additive effect of NSAID inhibition of platelet function with the anticoagulant effect of warfarin.
Nurofen Cold and Flu with Decongestant should only be used in patients taking warfarin if absolutely necessary. Patients taking this combination should be closely monitored.

Antihypertensives and diuretics.

The combined use of the three classes of drugs, diuretics, an ACE inhibiting drug (ACE inhibitor or angiotensin receptor antagonist) and an anti-inflammatory drug (NSAID or cyclooxygenase-2 (COX-2) inhibitor) all at the same time increases the risk of renal impairment. The combination of drugs from these three classes should be used with caution particularly in elderly patients or those with pre-existing renal impairment.
NSAIDS and pseudoephedrine may diminish the effect of these drugs. Diuretics can also increase the risk of nephrotoxicity of NSAIDs.

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

Increased risk of gastrointestinal bleeding when co-administered with ibuprofen.

Cardiac glycosides.

NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels. Sympathomimetics such as pseudoephedrine may increase risk of dysrhythmias.

Methotrexate.

There is a potential for an increase in plasma levels of methotrexate when co-administered with ibuprofen.

Cyclosporin.

Increased risk of nephrotoxicity when co-administered with ibuprofen.

Corticosteroids.

Increased risk of gastrointestinal ulceration or bleeding when coadministered with ibuprofen.

Lithium.

Ibuprofen has been shown to decrease the renal clearance and increase plasma concentrations of lithium. Lithium plasma concentrations should be monitored in patients on concurrent ibuprofen therapy.

Mifepristone.

NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.

Quinolone antibiotics.

Animal data indicate that NSAIDS can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.

Ergot alkaloids (ergotamine and methysergide).

Increased risk of ergotism with concomitant use of sympathomimetics.

Tacrolimus.

Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.

Zidovudine.

Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV positive haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

Other sympathomimetics (including appetite suppressants and amphetamine‐like psychostimulants).

Risk of hypertension with concomitant use of sympathomimetics.

Oxytocin.

Risk of hypertension with concomitant use of sympathomimetics.

Anticholinergics (including tricyclic antidepressants).

Enhanced effects of anticholinergic drugs, thus increasing risk of hypertension.
Ibuprofen may also interact with salicylates, probenecid, anti-diabetic medications and phenytoin.
The effect of pseudoephedrine may be diminished by antihypertensive agents such as methyldopa and may be diminished or enhanced by tricyclic antidepressants. Pseudoephedrine may also increase the possibility of arrhythmias in digitalised patients or in those receiving quinidine or tricyclic antidepressants.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There is limited evidence that drugs which inhibit cyclo-oxygenase/prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment. If ibuprofen is used by a woman attempting to conceive, the dose should be kept as low and duration of treatment as short as possible.
(Category C)
Category C: Inhibition of prostaglandin synthesis by ibuprofen may adversely affect pregnancy and/or the embryo/ foetal development. During the first and second trimester of pregnancy, this product should not be given unless clearly necessary, and is contraindicated in the third trimester.
During the third trimester, all prostaglandin synthesis inhibitors may expose the foetus to cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension) and renal dysfunction, which may progress to renal failure with oligohydramnios. At the end of pregnancy, prostaglandin synthesis inhibitors may expose the mother and the neonate to possible prolongation of bleeding time and inhibition of uterine contractions, which may result in delayed or prolonged labour.
Data from epidemiological studies suggest an increased risk of miscarriage after the use of a prostaglandin synthesis inhibitor in early pregnancy.
There is a possible association between the development of foetal abnormalities and the first trimester exposure to pseudoephedrine and whilst no teratogenic effects have been demonstrated in animal studies, the use of Nurofen Cold and Flu with Decongestant should, if possible, be avoided during pregnancy.

Oligohydramnios and neonatal renal impairment.

Use of NSAIDs from about 20 weeks gestation may cause neonatal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.
These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation. Oligohydramnios is often, but not always, reversible with treatment discontinuation.
Complications of prolonged oligohydramnios may, for example, include limb contractures and delayed lung maturation. In some post-marketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.
If, after careful consideration of alternative treatment options for pain management, NSAID treatment is necessary from about 20 weeks, limit use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if treatment extends beyond 48 hours. Discontinue treatment with NSAIDs if oligohydramnios occurs.
 Although ibuprofen appears in breast milk in very low concentrations, significant amounts of pseudoephedrine are secreted into breast milk and therefore use of Nurofen Cold and Flu with Decongestant during lactation should be avoided.

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)

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.
The list of the following adverse events relates to those experienced with ibuprofen at OTC doses (maximum 1200 mg per day) and sympathomimetics including pseudoephedrine in short-term use. In the treatment of chronic conditions, under long-term treatment, additional adverse events may occur.
Adverse events which have been associated with ibuprofen and sympathomimetics including pseudoephedrine are given below, listed by system organ class and frequencies. Frequencies are defined as: 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); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness. See Table 1.

4.9 Overdose

In adults the dose response effect is less clear cut than in children where ingestion of more than 400 mg ibuprofen per kg bodyweight may cause symptoms. The half-life of ibuprofen in overdose is 1.5 to 3 hours.

Symptoms.

Ibuprofen.

Symptoms of overdosage include headache, nausea, vomiting, epigastric pain or more rarely diarrhoea, tinnitus, gastrointestinal bleeding. 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 prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.

Pseudoephedrine.

Symptoms of overdose may include symptoms of irritability, palpitations, hypertension, convulsions, tremor, hyperactivity, hyperpyrexia, dryness of the skin and mucous membranes, urinary retention, difficulty in micturition, nausea, vomiting, tachycardia and cardiac arrhythmias.

Management.

For more information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Ibuprofen is a non-steroidal anti-inflammatory agent that possesses analgesic, anti-inflammatory and anti-pyretic activities. Ibuprofen acts through the inhibition of cyclooxygenase (COX) 1 and 2, preventing the conversion of arachidonic acid to prostaglandin H2, a critical intermediate in the biosynthesis of prostaglandins, thromboxanes and other mediators.
Pseudoephedrine hydrochloride is a sympathomimetic agent with direct and indirect effects on adrenergic receptors, producing vasoconstriction which in turn relieves nasal congestion.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

After administration of a single dose of two Nurofen Cold and Flu with Decongestant tablets to healthy, fasting volunteers, the following pharmacokinetic parameters were derived:
Tmax: ibuprofen 0.5-2.5 hours; pseudoephedrine 1-3 hours.
Cmax: ibuprofen 25-65 microgram/mL; pseudoephedrine 150-369 nanogram/mL.
t1/2: ibuprofen 2 hours; pseudoephedrine 7 hours.

Absorption.

The rate and extent of absorption of ibuprofen and pseudoephedrine when Nurofen Cold and Flu with Decongestant is taken with food is not known.

Distribution.

Ibuprofen.

The apparent volume of distribution of ibuprofen is 0.14 L/kg. Ibuprofen and its metabolites readily cross the placental barrier in pregnant rabbits and rats.
Ibuprofen appears in very low concentrations in breast milk. It is not known if the drug enters the CSF. 99% of ibuprofen is plasma protein bound.

Pseudoephedrine.

The apparent volume of distribution of pseudoephedrine is 2-3 L/kg. It is excreted in breast milk at concentrations consistently higher than those in maternal placenta. The fraction of the dose excreted in milk has been estimated at approximately 0.5% of a single oral dose over 24 hours. Pseudoephedrine is likely to cross the placenta. There is no specific information concerning its penetration into the CNS. The extent of plasma protein binding of pseudoephedrine is unknown.

Metabolism.

90% of ibuprofen is metabolized in the liver to produce two major metabolites, a hydroxylated and carboxylated compound.
Less than 1% of pseudoephedrine is metabolized by hepatic metabolism.

Excretion.

Both the inactive metabolites and a small amount of unchanged ibuprofen are excreted rapidly and completely by the kidney with 95% of the administered dose eliminated in the urine within 4 hours of ingestion.
Pseudoephedrine is excreted essentially unchanged in urine (< 90% of the dose in 24 hours). Alkaline urinary pH may delay the excretion of pseudoephedrine.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

It also contains: cellulose microcrystalline, calcium phosphate, croscarmellose sodium, hypromellose, magnesium stearate, mastercoat yellow FA 0156 or opaspray Yellow MIIF-6168, povidone, talc-purified and opacode monogramming ink S-1-277001 BLACK. This medicine does not contain lactose, sucrose, gluten, wheat or preservatives.

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

Container type.

Tablets are packed in aluminium blister packs in cartons.

Pack sizes.

Packs of 24 tablets (marketed).
Pack sizes 4, 6 are 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

Chemical structure.


Ibuprofen.

Molecular formula: C13H18O2. MW: 206.3. 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.

Pseudoephedrine.

Molecular formula: C10H15NO. MW: 201.70. Chemical name: (1S,2S)-(+)-Pseudoephedrine hydrochloride. It is white to off-white crystals or powder; odorless or faint characteristic odor, soluble in water.

CAS number.

Ibuprofen.

CAS: 15687-27-1.

Pseudoephedrine hydrochloride.

CAS: 345-78-8.

7 Medicine Schedule (Poisons Standard)

Pharmacist Only Medicine (S3).

Summary Table of Changes