Boots Ibuprofen and Codeine 200mg/12.8mg Film-Coated Tablets

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 medicine 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/12.8 mg Tablets are and what they are used for
2. What you need to know before you take Ibuprofen and Codeine 200 mg/12.8 mg 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

• If you have (or have had two or more episodes of) a stomach ulcer, perforation, or bleeding
• If you have breathing difficulties
• If you are allergic to ibuprofen, codeine, or any other ingredient of this medicine (listed in section 6), or to aspirin or other painkillers
• If you suffer from severe liver, kidney or heart problems
• If you suffer from chronic constipation
• If you have had gastrointestinal bleeding or perforation when previously taking NSAIDs
• If you have had a worsening of asthma, skin rash, itchy runny nose or facial swelling when previously taking ibuprofen, aspirin or similar medicines
• If you are taking other NSAID painkillers or aspirin with a daily dose above 75mg
• If you are pregnant, and in the last 3 months of pregnancy
• If you are breastfeeding (see “Other important information”)
• If you are under 12 years old
• If you are taking monoamine oxidase inhibitors or if you have taken them in the last 14 days
• 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

Tolerance, dependence, and addiction

This medicine contains codeine, which is an opioid medicine. Repeated use of opioids can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of Ibuprofen and Codeine Tablets can also lead to dependence, abuse and addiction, which may result in life-threatening overdose. If you are taking Ibuprofen and Codeine Tablets for longer than the recommended time or at higher than recommended doses the risk of these side effects can increase and you are also at risk of serious harms to the stomach/gut and kidneys, as well as very low levels of potassium in your blood. These can be fatal (see section 4).

Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it.

The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent on or addicted to Ibuprofen and Codeine Tablets if:

• You or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”).
• You are a smoker.
• You have ever had problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs whilst taking Ibuprofen and Codeine Tablets it could be a sign that you have become dependent or addicted:

• You need to take this medicine for longer than advised by your doctor
• You need to take more than the recommended dose
• You might feel that you need to carry on taking your medicine, even when it doesn’t help to relieve your pain.
• You are using the medicine for reasons other than prescribed, for instance, 'to stay calm' or 'help you sleep'
• You have made repeated, unsuccessful attempts to quit or control the use of the medicine
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again ('withdrawal effects')

If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (See section 3, When you stop taking Ibuprofen and Codeine Tablets).

• If you have or have had asthma
• If you are between 12 and 18 years old and you are dehydrated, you may get kidney problems
• If you have kidney problems (these can be made worse if you are dehydrated, especially if you are elderly, or between 12 and 18 years old)
• If you have heart, liver or bowel problems
• If you have low or high blood pressure
• If you have a head injury or raised intracranial pressure
• If you suffer from a thyroid disorder
• If you have Systemic Lupus Erythematosus (a condition of the immune system causing joint pain, skin changes and other organ disorders)
• If you have a history of gastrointestinal disease (such as ulcerative colitis, Crohn’s disease)
• 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”)
• 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
• If you have an infection - please see heading "Infections" below
• If you have gallstones
• If you suffer from myasthenia gravis (a condition that causes muscle weakness)
• You experience pain or increased sensitivity to pain (hyperalgesia) which does not respond to a higher dosage of your medicine.

This medicine may hide signs of infections such as fever and pain. It is therefore possible that this medicine may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.

Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalised exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Stop using this medicine and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

This medicine can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.

You should always seek the advice of your doctor or pharmacist before you take this medicine with any other medicines, including herbal and homeopathic remedies.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This medicine may affect or be affected by some other medicines, for example:

• Medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin,
ticlopidine)
• Medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)
• Water tablets (diuretics)
• Medicines for depression or anxiety, including moclobemide, selective serotonin-reuptake inhibitors (SSRIs), selective serotonin- and norepinephrine-reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs) and hydroxyzine.
• Depressants of the central nervous system such as alcohol, anaesthetics, hypnotics, sedatives, tricyclic antidepressants or antipsychotics and phenothiazines.
• Lithium (for bipolar disorder)
• Gabapentin or pregabalin to treat epilepsy or pain due to nerve pain (neuropathic pain)
• Loperamide and kaolin (for diarrhoea)
• Metoclopramide or domperidone (for sickness)
• Cimetidine (for stomach ulcers)
• Quinolone antibiotics (for infections)
• Medicines for heart problems such as quinidine or mexiletine (to treat abnormal heart rhythms)
• Corticosteroids (used for many conditions such as pain, swelling, allergy, asthma, rheumatism and skin problems)
• Methotrexate (for cancer, psoriasis, rheumatism, Crohn’s disease)
• Zidovudine (for HIV infection)
• Ciclosporin or tacrolimus (given after transplant surgery, or for psoriasis or rheumatism)
• Mifepristone (for termination of pregnancy) – do not take ibuprofen if you have taken mifepristone in the last 12 days

Care should be taken in elderly patients due to increased risk of breathing problems.

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.

Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck region (angioedema), chest pain have been reported with ibuprofen. Stop taking this medicine immediately and immediately contact your doctor or medical emergency department if you notice any of these signs.

Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your prescriber about your treatment.

Contact your doctor if you experience severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever as this could be symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system.

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

Anti-inflammatory/painkiller medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke. Any risk is more likely with high doses or prolonged treatment. Do not exceed the recommended dose or take for longer than necessary to control your symptoms (3 days).

If you have heart problems, have had a stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes, high cholesterol, or are a smoker), you should discuss this treatment with your doctor or pharmacist.

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

Use in children and adolescents after surgery: 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.

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

Pregnancy: Do not take this medicine if you are in the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected.

You should not take this medicine during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, this medicine can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.

Breast-feeding: Do not take codeine while you are breast-feeding. Codeine and morphine pass into breast milk.

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

• 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.

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

Swallow 1 or 2 tablets with water, up to three times a day as required. Leave at least four hours between doses.

Do not take more than 6 tablets in any 24-hour period.

This medicine should not be taken by children below the age of 12 years, due to the risk of severe breathing problems.

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.

If symptoms persist, or pain or fever worsen, or if any new symptoms occur, consult your doctor or pharmacist.

This medicine is for short-term use only. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

If you have taken more of this medicine than you should, or if children have taken this 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.

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.

If Ibuprofen and Codeine Tablets have been prescribed to you, before starting treatment and regularly during treatment, your doctor will discuss with you what you may expect from using Ibuprofen and Codeine Tablets, when and how long you need to take it, when to contact your doctor, and when you need to stop it.

Uncommon: may affect up to 1 in 100 people

• indigestion, heartburn, nausea
• stomach pain or other abnormal stomach symptoms
• rashes, itching
• headache.

Rare: may affect up to 1 in 1,000 people

• constipation.

Very rare: may affect up to 1 in 10,000 people

• liver and kidney problems.

Not known: frequency cannot be estimated from the available data

• worsening of asthma
• sweating, thirst, muscle weakness or tremors, sleeplessness
• fast, irregular heart beat
• dizziness or drowsiness
• increased sensitivity to pain
• skin becomes sensitive to light
• symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system (a problem affecting a valve in the intestines known as sphincter of Oddi dysfunction), e.g. severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever.

Medicines such as this medicine may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

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.

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 dose
• When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again.

Each film-coated tablet contains Codeine Phosphate Hemihydrate 12.8 mg and 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.

The pack contains 16, 18, 24 or 32 white capsule-shaped tablets embossed with I+. Not all pack sizes may be marketed.