What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 00014/0600.


Boots Cold and Flu Relief with Ibuprofen

Information for the user

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 of 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, perforation or bleeding, or have had one twice or more in the past
  • 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 or kidney 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 within the last 14 days
  • If you are a man with prostate problems
  • If you are pregnant
  • Other important information
  • Risk of heart attack or stroke: Anti-inflammatory/pain-killer medicines like 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.

Talk to your pharmacist or doctor:

  • If you have asthma, a history of asthma or other allergic disease, bowel problems, or Crohn’s disease
  • If you have other kidney, heart or liver problems (see above)
  • If you have a connective tissue disorder such as SLE (Systemic Lupus Erythematosus)
  • 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 heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack “TIA” – see ‘Risk of heart attack or stroke’ under “Other important information”
  • If you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker
    If you develop a feverish generalised erythema associated with pustules, stop taking this medicine and contact your doctor or seek medical attention immediately. See section ‘Possible side effects’.

Other 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.

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 doctor or pharmacist about ANY other medicines you might be using at the same time. Boots Cold and Flu Relief with Ibuprofen may affect or be affected by some other medicines. For example:

  • Other painkillers
  • Aspirin 75 mg (to prevent heart attacks and strokes) – the protection may be reduced when you take ibuprofen
  • Tablets to thin your blood (e.g. warfarin, ticlopidine)
  • Mifepristone (for termination of pregnancy) – do not take ibuprofen if you have taken mifepristone in the last 12 days
  • Water tablets (diuretics)
  • Medicines to treat high blood pressure (e.g. ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan), medicines for heart problems
  • Corticosteroids (used for many conditions such as pain, swelling, allergy, asthma, rheumatism and skin problems)
  • Lithium (for bipolar disorder)
  • Methotrexate (for cancer, psoriasis, or rheumatism)
  • Zidovudine (for HIV infection)
  • Quinolone antibiotics (for infections)
  • Medicines for depression
  • Ciclosporin or tacrolimus (given after transplant surgery, or for psoriasis or rheumatism)
  • Other decongestants or medicines to reduce your appetite
  • Ergot alkloids (for migraine)

Some other medicines may also affect or be affected by the treatment of Boots Cold and Flu Relief with Ibuprofen. You should therefore always seek advice of your doctor or pharmacist before you can use this medicine with any other medicines, including herbal and homeopathic remedies.

How to take this medicine

Check 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 more tablets than you should: If you have taken more tablets than you should, or if children have taken the medicine by accident always contact a doctor or nearest hospital to get an opinion on the risk and advice on action to be taken.

The symptoms can include nausea, stomach pain, vomiting (may be blood streaked), headache, ringing in the ears, confusion and shaky eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, cold body feeling, and breathing problems have been reported.

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
  • A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and 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) may occur within the first 2 days of treatment with this medicine. See section ‘Before you take this medicine’.
  • Meningitis (e.g. stiff neck, fever, disorientation)
  • Kidney problems, which may lead to kidney failure (you may feel breathless, very tired or weak, have no appetite, or have swollen ankles)

If you get any of the following side effects see your pharmacist or doctor.

  • 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 (you may be tired, have difficulty breathing or swollen legs)
  • Fluid retention, which may cause swelling of the limbs
  • Restlessness, difficulty sleeping
  • Rarely, diarrhoea, wind, constipation, yellow skin or eyes, upper abdominal pain, worsening of colitis or Crohn’s disease, 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)
  • A small increased risk of heart attack or stroke if you take large amounts for a long time

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed on this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

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 or on the foil edge.

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).

The pack contains 12 or 24 round orange tablets. They are marked with CF on one side.

Who makes this medicine

Manufactured for the Marketing Authorisation holder

The Boots Company PLC
Nottingham
NG2 3AA

by

Famar SA Anthoussa
Attiki 15344
Greece

Leaflet prepared May 2018

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

The Boots Company PLC
Nottingham
NG2 3AA