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: PL00014/0662.


Boots Ibuprofen and Codeine 200mg/12.8mg film-coated Tablets

Information for the user

Boots Ibuprofen and Codeine 200 mg/12.8 mg Tablets

Ibuprofen, Codeine Phosphate Hemihydrate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

  • Keep this leaflet, you may need to read it again
  • Ask your pharmacist if you need more information or advice
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4
  • You must talk to a doctor if you do not feel better or if you feel worse within 3 days
  • This medicine can only be used for the short term treatment of acute moderate pain such as headaches, rheumatic and muscular pain, backache, migraine, period pain, dental pain and neuralgia that is not relieved by aspirin, ibuprofen or paracetamol alone
  • This medicine should only be taken when necessary
  • You should only take this product for a maximum of 3 days at a time. If you need to take it for longer than 3 days you should see your doctor or pharmacist for advice
  • This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it
  • If you take this medicine for headaches for more than 3 days it can make them worse
    1. What ibuprofen and Codeine 200 mg/12.8mg Tablets are and what they are used for
    2. What you need to know before you take ibuprofen and Codeine 200 mg/12.8mg Tablets
    3. How to take Ibuprofen and Codeine 200 mg/12.8 mg Tablets
    4. Possible side effects
    5. How to store Ibuprofen and Codeine 200 mg/12.8 mg Tablets
    6. Contents of the pack and other information

1. What Ibuprofen and Codeine 200 mg/12.8 mg Tablets are and what they are used for

This medicine contains Codeine. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain.

This medicine also contains Ibuprofen. Ibuprofen, a non-steroidal anti-inflammatory medicine (NSAID), also acts to reduce swelling (inflammation).

This medicine can be used for the short term treatment of acute moderate pain such as headaches, rheumatic and muscular pain, backache, migraine, period pain, dental pain and neuralgia that is not relieved by aspirin, ibuprofen or paracetamol alone.

This codeine-containing medicine can be used in adults and children aged 12 years and over.

2. What you need to know before you take Ibuprofen and Codeine 200 mg/12.8 mg Tablets

This medicine contains codeine which can cause addiction (physiological and psychological dependence) if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine (such as restlessness and irritability) when you stop taking it. If you find you need to take this medicine all the time, it is important to talk to your doctor.

  • If you take a painkiller for headaches for more than 3 days it can make them worse
    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 Ibuprofen and Codeine Tablets:

  • For pain relief in children and adolescents (0-18 years of age) after removal of their tonsils or adenoids due to obstructive sleep apnoea syndrome
  • If you know that you metabolise very rapidly codeine into morphine
  • 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, codeine, or any other ingredient of this medicine (listed in section 6), 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 heart, kidney or liver failure
  • If you have difficulty breathing or breathing problems
  • If you have constipation on a regular basis or are continually constipated
  • If you are pregnant, and in the last 3 months of pregnancy
  • If you are breastfeeding (see “Other important information”)

Warning and precautions

Talk to your doctor or pharmacist before taking Ibuprofen and Codeine tablets:

  • 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 “Do not take”)
  • If you have a connective tissue disorder such as SLE (Systemic Lupus Erythematosus)
  • If you have low blood pressure or an underactive thyroid
  • If you have a head injury or a condition where there is raised pressure in the head
  • If you are taking monoamine oxidase inhibitors (MAOIs for depression), or have taken them in the last 14 days
  • 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 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’ below
  • 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 are pregnant, and in the first 6 months of pregnancy
  • During chicken pox (varicella) as it is advisable to avoid the use of ibuprofen.

Other important information

Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that produces pain relief. Some people have a variation of this enzyme and this can affect people in different ways. In some people, morphine is not produced or produced in very small quantities, and it will not provide enough pain relief. Other people are more likely to get serious side effects because a very high amount of morphine is produced. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.

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.

Take special care with Ibuprofen and Codeine Tablets.

Skin reactions: Serious skin reactions have been reported in association with ibuprofen treatment. You should stop taking this medicine and seek medical attention immediately, if you develop any skin rash, lesions of the mucous membranes, blisters or other signs of allergy since this can be the first stage of a very serious skin reaction. See ‘Possible Side Effects’.

Children and adolescents:

Codeine should not be used for pain relief in children and adolescents after removal of their tonsils or adenoids due to obstructive sleep apnoea syndrome.

Codeine is not recommended in children with breathing problems, since the symptoms of morphine toxicity may be worse in these children.

Other medicines and ibuprofen and Codeine Tablets

Tell your doctor or pharmacist it you are taking, have taken or might take any other medicines. Ibuprofen and Codeine tablets may affect or be affected by some other medicines. For example

  • Other painkillers (including NSAIDs)
  • Aspirin 75 mg (to prevent heart attacks or strokes) – the protection may be reduced when you take ibuprofen
  • Medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
  • Mifepristone (for termination or pregnancy) – do not take ibuprofen if you have taken mifepristone in the last 12 days
  • Water tablets (diuretics)
  • Medicines that reduce high blood pressure (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, rheumatism, Crohn’s disease)
  • Zidovudine (for HIV infection)
  • Quinolone antibiotics (for infections)
  • Medicines for depression (including SSRIs and MAOIs)
  • Ciclosporin or tacrolimus (given after transplant surgery, or for psoriasis or rheumatism)

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

Ibuprofen and Codeine tablets with alcohol

Do not drink alcohol (wine, beer, spirits) whilst taking this medicine. Alcohol may make you feel more drowsy

Pregnancy, breast-feeding and fertility

Pregnancy: During the last 3 months of pregnancy do not take this medicine. During the first 6 months of pregnancy talk to your pharmacist or doctor.

Breastfeeding: Do not take codeine while you are breastfeeding. Codeine and morphine pass into breast milk.

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

Driving and using machines

This medicine can affect your ability to drive or use machines as it may make you feel sleepy or dizzy.

  • Do not drive or use machines while taking this medicine until you are sure you are not affected
  • It is an offence to drive if this medicine affects your ability to drive
  • However, you would not be committing an offence if:
    • The medicine has been prescribed to treat a medical or dental problem and
    • You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
    • It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Ibuprofen and Codeine 200 mg/12.8 mg film-coated tablets contain sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take Ibuprofen and Codeine 200 mg/12.8 mg Tablets

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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

Children aged 12 years to 18 years: Take one or two tablets every 6 hours, if you need to.

Don’t take more than 6 tablets in 24 hours.

Adults over 18 years: Take one or two tablets every 4 to 6 hours, if you need to.

Don’t take more than 6 tablets in 24 hours.

Do not take more often than every 4 hours.

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

Swallow each tablet with water.

Do not take for more than 3 days. If you need to use this medicine for more than 3 days you must speak to your doctor or pharmacist for advice.

Do not take more than the amount recommended above.

If your symptoms worsen at any time, or do not go away within 3 days, you must speak to your doctor or pharmacist.

Use in children

Do not give to children under 12 years, due to the risk of severe breathing problems.

If you take more Ibuprofen and Codeine 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.

If you forget to take Ibuprofen and Codeine Tablets

If you forget to take the tablets, take them as soon as you remember. Do not make up for the missed tablets by taking more than 2 tablets at a time.

Possible withdrawal effects when stopping treatment

This medicine contains codeine and can cause addiction if you take it continuously for more than 3 days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.

4. Possible side effects

Like all medicines, this medicine can cause side effects although not everybody gets them. If you are elderly you may be more likely to have some of these side effects (especially stomach bleeding which can be fatal in the elderly).

If you have any unwanted side effects you should seek advice from your doctor, pharmacist or other healthcare professional.

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
  • Unexplained wheezing (asthma), worsening of existing asthma, difficulty in breathing, swelling of the face, tongue, neck or throat, fast heart rate, feeling faint or dizzy or collapse (severe allergic reactions)
  • Allergic skin reactions such as itchy red, raised rash (which can sometimes be severe and include peeling, blistering and lesions of the skin)
  • Frequency “Not known”: A red, scaly widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop taking this medicine if you develop these symptoms and seek medical attention immediately.
    See also “Before to take this medicine”
  • 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)
  • Meningitis (e.g. stiff neck, fever, disorientation)
  • Kidney problems, which may lead to kidney failure (you may pass more or less urine, have blood in the urine or cloudy urine, or 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
  • Headache, blurred vision, drowsiness – do not drive or use machines if you feel drowsy or have blurred vision
  • High blood pressure, heart failure (you may be tired, have difficulty breathing or swollen legs)
  • Fluid retention, which may cause swelling of the limbs
  • Slow or shallow breathing, problems clearing catarrh or phlegm from the chest
  • Very rarely, yellowing of the skin or eyes, pale stools or upper abdominal pain (these may be signs of liver problems)
  • Swelling or ulcers of the stomach or mouth lining, constipation
  • Rarely, diarrhoea, wind, worsening of colitis or Crohn’s disease
  • Very rarely, tiredness or severe exhaustion, changes in the blood which may cause unusual bruising or unexplained bleeding and an increase in the number of infections that you get (e.g. sore throats, mouth ulcers, flu-like symptoms including fever)
  • A small increased risk of heart attack or stroke if you take large amounts for a long time

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

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 in 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 do I know if I am addicted?

If you take the medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor:

  • You need to take the medicine for longer periods of time
  • You need to take more than the recommended amount
  • When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again

5. How to store Ibuprofen and Codeine 200 mg/12.8 mg Tablets

These film-coated tablets do not require any special storage conditions. Keep this medicine in a safe place out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the foil or flap of the carton. Do not throw any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Ibuprofen and Codeine Tablets contain

Each film-coated tablet contains Codeine Phosphate Hemihydrate 12.8 mg, Ibuprofen 200 mg, which are the active ingredients.

As well as the active ingredients, the film-coated tablets also contain microcrystalline cellulose, sodium starch glycolate, pregelatinised maize starch, hypromellose. The tablet coating contains hypromellose, titanium dioxide (E171), talc.

What Ibuprofen and Codeine Tablets look like and contents of the pack

The pack contains 16 or 32 white capsule-shaped tablets embossed with I+.

Marketing Authorisation Holder

The Boots Company PLC
Nottingham
NG2 3AA
UK

Manufacturer

Custom Pharmaceuticals Ltd
Conway Street
Hove
East Sussex
BN3 3LW
UK

This leaflet was revised in November 2019

Other sources of information

To request a copy of this leaflet in Braille, large print or audio please call free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name: Ibuprofen and Codeine 200 mg/12.8 mg Tablets

Reference Number: 00014/0662

This is a service provided by the Royal National Institute of Blind People.

Artwork Refence: WBAG402439