Nurofen Cold and Flu

Active Ingredients

Each tablet contains:

Ibuprofen 200 mg

Indications

Therapeutic group:

Ibuprofen - belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). These medicines provide relief by reducing pain, swelling and high temperature.

Pseudoephedrine - belongs to a group of drugs called vasoconstrictors which act on the blood vessels in the nose to relieve nasal congestion.

Nurofen Cold and Flu is intended for relief of cold and flu symptoms accompanied by pain, fever and nasal congestion in children older than 12 years and works in the following ways:

• Clears a blocked nose and sinuses

• Relieves pains, headache and high temperature

• Eases the discomfort of a sore throat

Instructions

Swallow the medicine with water. There is no information regarding crushing/halving/chewing.

The usual recommended dosage is:

Adults and children of 12 years and older:

1 tablet every 4-6 hours, as long as the symptoms continue. If there is no response and there is no improvement in the pain or fever upon taking one tablet, 2 tablets can be taken. Do not take more than 6 tablets in 24 hours.

Take the lowest dose and for the shortest period of time necessary to relieve the symptoms.

Do not exceed the recommended dose.

Do not take the medicine for longer than 10 days unless your doctor tells you to.

You should refer to the doctor in case the symptoms persist or pain or fever worsen, or do not get better after 10 days, or if any new symptoms occur.

Warnings

Do not Nurofen Cold and Flu if you are hypersensitive (allergic) to ibuprofen, pseudoephedrine or any of the other ingredients contained in this medicine.

Do not use this medicine if you have previously suffered from allergic reactions (such as: asthma, nose inflammation (rhinitis), subcutaneous swelling (angioedema) or hives (urticaria)) as a result of taking acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs).

Do not use this medicine if you suffer or have previously suffered from bleeding / recurrent stomach ulcer (two or more significant events of perforation or proven bleeding).

Do not use this medicine if you have previously suffered from gastrointestinal bleeding or perforation related to previous treatment with medicines of the NSAID group.

Do not Nurofen Cold and Flu if you suffer from severe heart disease, cardiovascular system disorders or severe hypertension.

Do not use this medicine if you suffer from severe heart, kidney or liver problems.

Do not use this medicine if you are in the last 3 months of pregnancy.

Do not use this medicine if you are under 12 years of age.

Do not use this medicine if you are taking Monoamine Oxidase Inhibitors (for depression, known as MAOIs) or have taken them in the last 14 days.

Before treatment with Nurofen Cold and Flu, tell your doctor if:

• You suffer from asthma
• You suffer from Systemic Lupus Erythematosus (SLE) - an illness affecting the immune system causing joint pain, skin changes and other problems
• You suffer from liver or kidney problems, especially in dehydrated children and adolescents, as kidney problems may worsen
• You suffer from high cholesterol or have previously had a heart attack or a stroke
• You have a history of gastrointestinal disease (such as ulcerative colitis, Crohn’s disease)
• You are a smoker
• You suffer from hyperthyroidism
• You are diabetic, suffer from phaeochromocytoma (a small benign tumor in the internal part of the adrenal gland), glaucoma or prostate problems
• You suffer from heart problems including heart failure, angina (chest pain), or have previously suffered from a heart attack, bypass surgery, peripheral vascular disease (poor feet circulation due to narrowed or blocked arteries), or any type of stroke [including a ‘mini stroke’ or a transient ischemic attack (TIA)]
• You suffer from high blood pressure, have a family history of heart disease or stroke

Nurofen Cold and Flu belongs to a group of medicines, which may impair fertility in women. This is reversible on stopping use of the medicine. It is unlikely that Nurofen Cold and Flu, used occasionally, will affect your chances of becoming pregnant. However, tell your doctor before using this medicine if you have problems becoming pregnant.

Anti-inflammatory/pain-killer medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.

Sudden abdominal pain or rectal bleeding may occur when taking Nurofen Cold and Flu due to

inflammation of the colon (ischemic colitis). If you develop these symptoms - stop using the product and refer to your doctor or seek medical consultation immediately.

The medicine is not intended for children under 12 years of age.

If you are taking or have recently taken any other medicines, including non-prescription drugs and nutrition supplements, please inform your doctor or pharmacist. Nurofen Cold and Flu may affect or be affected by some other medicines such as:

• Anti-coagulants (for blood thinning/clot prevention such as aspirin/acetylsalicylic acid at a dosage less than 75 mg per day, warfarin, ticlopidine) as their effects may be stronger
• This medicine should not be taken in combination with other non-steroidal anti-inflammatory drugs (NSAIDs) or with aspirin at a dosage that exceeds 75 mg per day
• Medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol, angiotensin-II receptor antagonists such as losartan) and diuretics as Nurofen Cold and Flu may reduce the effects of these drugs
• Corticosteroids, anti-platelet medicines, and selective serotonin reuptake inhibitors (SSRIs) as there is an increased risk of gastrointestinal bleeding
• Cardiac glycosides used to stimulate the heart
• Medicines for treating depression (lithium, selective serotonin uptake inhibitors) may affect or be affected by treatment with pseudoephedrine
• Methotrexate, as Nurofen Cold and Flu may increase plasma levels of this medicine
• Ciclosporin and tacrolimus, as there is an increased risk of kidney problems
• This medicine should not be taken within 8-12 days of taking mifepristone (for termination of pregnancy)
• Zidovudine [for AIDS (HIV) treatment]
• Quinolone group antibiotics
• When using monoamine oxidase inhibitors (MAOIs) (such as moclobemide) and/or reversible inhibitors of monoamine oxidase A (RIMAs), or within 14 days of stopping treatment with these medicines
• Ergot alkaloids (ergotamine & methysergide)
• Other sympathomimetic medicines such as decongestants, amphetamine-like psychostimulants and appetite suppressants, as their effect may be increased by the pseudoephedrine contained in this medicine
• Oxytocin, as there is a risk of increase in blood pressure
• Anticholinergics, as they may affect the way that pseudoephedrine works

Avoid as much as possible using Nurofen Cold and Flu during the first 6 months of pregnancy. Do not use this medicine if you are in the last 3 months of pregnancy.

Do not use this medicine if you are breastfeeding.

Please do not consider this information as an alternative to consulting your physician or pharmacist.

For further information on instructions for use, risks and side effects, please read the patient package insert and consult your doctor or pharmacist.
Read the patient package insert carefully before starting to take any medication.