Boots Cold and Flu Relief with Ibuprofen

Boots Cold & Flu Relief with Ibuprofen

(Ibuprofen, Pseudoephedrine Hydrochloride)

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.

• Keep this leaflet, you may need to read it again



• Ask your pharmacist if you need more information or advice

What this medicine is for

This medicine contains Ibuprofen and Pseudoephedrine. Ibuprofen relieves pain and reduces fever. Pseudoephedrine relieves nasal congestion.

It can be used to relieve the symptoms of cold and flu including congestion, aches and pains, headache, fever, sore throat, blocked noses and sinuses.

Before you take this medicine

This medicine can be taken by adults and children aged 12 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

Do not take:

• If you have a stomach ulcer, or have had one



• If you have had perforation or a bleeding stomach after taking a non-steroidal anti-inflammatory medicine (you may have been sick and it contained blood or dark particles that look like coffee grounds, passed blood in your stools or passed black tarry stools)



• If you are allergic to ibuprofen or any other ingredients of the product, aspirin or other non-steroidal anti-inflammatory medicines (you have ever had asthma, runny nose, itchy skin or swelling of the lips, face or throat after taking these medicines)



• If you are taking aspirin with a daily dose above 75 mg, or other non-steroidal anti-inflammatory medicines



• If you have severe liver, kidney or heart failure



• If you have severe heart or blood vessel disease, including fast heart rate, angina



• If you have high blood pressure



• If you have an overactive thyroid, diabetes, a tumour near your kidney (phaeochromocytoma)



• If you have glaucoma



• If you are taking monoamine oxidase inhibitors (for depression) or have taken them in the last 14 days



• If you are a man with prostate problems



• If you are pregnant

Talk to your pharmacist or doctor:

• If you have asthma, a history of asthma or other allergic disease, bowel problems



• If you have other kidney, heart or liver problems (see above)



• If you are elderly – you may get more side effects (see back of leaflet)



• If you are taking any other painkillers or receiving regular treatment from your doctor



• If you have had a stroke, or have heart problems, diabetes, high cholesterol, or you smoke – see ‘Risk of heart attack or stroke’ below

Other important information

Breastfeeding: You can use this medicine

Women of childbearing age: If you take this medicine, it may reduce your ability to become pregnant. This effect will be reversed when you stop the medicine.

Risk of heart attack or stroke: Ibuprofen may increase the risk if you take large amounts for a long time. The risk is small. Take the lowest amount for the shortest possible time to reduce this risk.

Information about some of the ingredients: The colour sunset yellow (E110) may cause allergic reactions.

If you take other medicines

Before you take these tablets, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

• Other pain killers



• Tablets to thin your blood (e.g. warfarin)



• Water tablets (diuretics), medicines to treat high blood pressure



• Digoxin, quinidine (for heart problems)



• Corticosteroids, lithium, methotrexate, zidovudine



• Other decongestants or medicines to reduce your appetite



• Guanethidine, reserpine, methyldopa (for high blood pressure)



• Tricyclic antidepressants



• Ergot alkaloids (for migraine)

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

How to take this medicine

Check that the foil is not broken before use. If it is, do not take that tablet.

Adults and children of 12 years and over.

Take two tablets to start with. After that, take one or two tablets every 4 hours, if you need to. Don’t take more than 6 tablets in 24 hours.



Take the lowest amount for the shortest possible time to relieve your symptoms.

Swallow each tablet with water.

Do not give to children under 12 years.

Do not take more than the amount recommended above.

If your symptoms worsen at any time, talk to your doctor.

If your symptoms do not go away within 7 days, talk to your doctor.

If you take too many tablets:

Talk to a doctor straight away. Take your medicine and this leaflet with you.

Possible side effects

Most people will not have problems, but some may get some.

If you are elderly you may be more likely to have some of these side effects.

If you get any of these serious side effects, stop taking the tablets. See a doctor at once:

• You are sick and it contains blood or dark particles that look like coffee grounds



• Pass blood in your stools or pass black tarry stools



• Stomach problems including pain, indigestion or heartburn



• Allergic reactions such as skin rash (which can sometimes be severe and include peeling and blistering of the skin), swelling of the face, neck or throat, worsening of asthma, difficulty in breathing

These other effects are less serious. If they bother you talk to a pharmacist:

• Kidney problems, which may lead to kidney failure



• Feeling sick or being sick



• Dizziness, headache, hearing problems



• Dry mouth, thirst, sweating, loss of appetite



• Chest pain, fast or irregular heart beat, high blood pressure, heart failure



• Fluid retention, which may cause swelling of the limbs



• Rarely, liver problems, diarrhoea, wind, constipation, worsening of colitis or Crohn’s disease, meningitis (e.g. stiff neck, fever and disorientation), difficulty in passing urine, muscle weakness, tremors, anxiety, hallucinations (particularly in children)



• Very rarely, tiredness or severe exhaustion, changes in the blood which may cause unusual bruising and an increase in the number of infections that you get (e.g. sore throats, mouth ulcers, flu-like symptoms)

If any side effect becomes severe, or if you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Do not store above 25°C.

Store in the original package.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton.

What is in this medicine

Each tablet contains Ibuprofen 200 mg and Pseudoephedrine Hydrochloride 30 mg, which are the active ingredients.

As well as the active ingredients, the tablets also contain tricalcium phosphate, croscarmellose sodium, povidone, microcrystalline cellulose, hydroxypropylmethyl cellulose, magnesium stearate, talc, sunset yellow (E110), quinoline yellow (E104), titanium dioxide (E171), printing ink (containing black iron oxide E172, shellac and propylene glycol).

The pack contains 12 or 24 round orange tablets. They have B600 printed on one side.

Who makes this medicine

Manufactured for the Marketing Authorisation holder

The Boots Company PLC

Nottingham

NG2 3AA

by

Hamol Limited

Nottingham

NG90 2DB

Leaflet prepared November 2007

If you would like any further information about this medicine, please contact

The Boots Company PLC

Nottingham

NG2 3AA

BTC 17454 vE 25/03/08

Legal Status:

P

Licence Number: PL00014/0600