This medicine contains two active ingredients. These are lbuprofen and Pseudoephedrine Hydrochloride. Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by reducing pain, swelling and high temperature. Pseudoephedrine belongs to a group of medicines called vasoconstrictors which act on the blood vessels in the nose to relieve nasal congestion. NUROFEN COLD AND FLU is indicated for the relief of symptoms of colds and flu, including aches and pains, headaches, fever, sore throat, blocked nose and sinuses.
1. What NUROFEN COLD AND FLU is and what it is used for
2. What you need to know before you take NUROFEN COLD AND FLU
Do not take NUROFEN COLD AND FLU:
- If you are hypersensitive (allergic) to ibuprofen, pseudoephedrine or any of the other ingredients of NUROFEN COLD AND FLU (listed in section 6).
- If you have had a worsening of asthma, skin rash, itchy runny nose or facial swelling when previously taking aspirin or similar medicines.
- If you are under 12 years of age.
- If you are taking Monoamine Oxidase Inhibitors (for depression and known as MAOIs) or have taken these in the last 14 days.
- If you have had gastrointestinal bleeding or perforation when previously taking (non-steroidal anti-inflammatory drugs) (NSAIDs).
- If you have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding.
- If you have severe heart disease or very high blood pressure.
- If you have severe heart, kidney or liver problems.
- If you are pregnant or breastfeeding.
Warnings and precautions
Take special care with NUROFEN COLD AND FLU:
- If you are presently taking monoamine oxidase inhibitors or other medicines for depression, psychiatric or emotional conditions or high blood pressure.
- If you have heart disease, high blood pressure, diabetes, phaeochromocytoma (a rare tumour of the adrenal glands, which sit above the kidneys), glaucoma (high pressure inside the eye) or prostate problems.
- Anginal pain (severe pain in the chest).
- History of high blood pressure and/or heart failure.
- Have asthma.
- If you are receiving coumarin anticoagulants (to prevent blood clots).
- If you are sensitive to aspirin.
- If you have a history of gastrointestinal disease (such as ulcerative colitis, Crohn’s disease).
- If you are over 65 years of age (elderly).
- If you have skin reactions.
- If you have Systemic Lupus Erythematosus (SLE) - an illness affecting the immune system causing joint pain, skin changes and other problems.
- If you have kidney or liver problems.
- If you have an infection as this medicine may hide signs of infection such as fever and pain.
- If you are pregnant or planning on becoming pregnant.
Children: Do not give NUROFEN COLD AND FLU to children under 12 years.
You need to discontinue NUROFEN COLD AND FLU treatment and consult your doctor if these occur during treatment:
- Drug reaction with eosinophilia and systemic symptoms (DRESS): a life-threatening reaction which may resemble a flu-like infection, other signs may include rash, facial swelling, abdominal pain and abdominal heartbeat.
- Serious skin reactions including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis: these are indicated by severe skin peeling, painful blisters and starts by flu-like illness.
3. How to take NUROFEN COLD AND FLU
Do not share medicines prescribed for you with any other person. Always take NUROFEN COLD AND FLU exactly as described in this leaflet or as your doctor or pharmacist or nurse has told you. Check with your doctor or pharmacist or nurse if you are not sure. The usual dose is:
- Adults and children over 12 years: Initial dose: 2 tablets taken with water, then, if necessary, 1 or 2 tablets every 4 to 6 hours. Do not exceed 6 tablets in any 24 hours. If symptoms persist for more than 3 days, consult your doctor. Use the lowest possible dose for the shortest possible duration of treatment.
Not suitable for children under 12 years.
If you take more NUROFEN COLD AND FLU than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.
If you forget to take NUROFEN COLD AND FLU: Do not take a double dose to make up for forgotten individual doses.
4. Possible side effects
NUROFEN COLD AND FLU can have side effects. Not all side effects reported for NUROFEN COLD AND FLU are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking NUROFEN COLD AND FLU, please consult your health care provider for advice. If any of the following happens, stop taking NUROFEN COLD AND FLU and tell your doctor immediately or go to the casualty department at your nearest hospital.
Signs of intestinal bleeding such as:
- bright red faeces (stools/motions)
- black tarry stools
- vomiting
- blood or dark particles that look like coffee grounds.
Signs of serious allergic reaction such as:
- Difficulties in breathing
- Dizziness or faster heartbeat
- Severe forms of skin reactions such as itchiness, skin rash with redness, peeling, flaking or blistering (e.g. Steven-Johnson syndrome)
- Swelling of your face, tongue or throat
Signs of aseptic meningitis with:
- neck stiffness
- headache
- feeling sick
- being sick
- fever or consciousness
Patients with autoimmune disorders (lupus, mixed connective tissue disease) may be more likely to be affected. A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include:
- skin rash
- fever
- swelling of lymph nodes
- an increase of eosinophils (a type of white blood cells)
Sudden onset of fever, reddening of the skin, or many small pustules (possible symptoms of Acute Generalized Exanthematous Pustulosis - AGEP) that may occur within the first 2 days of treatment with NUROFEN COLD & FLU.
5. How to store NUROFEN COLD AND FLU
Store all medicines out of the reach of children. Store at or below 25 °C. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). Do not use after the expiry date stated on the pack.