Nurofen Plus

Always take this medicine exactly as described in the leaflet or as your doctor or pharmacist have 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 the leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you start to feel worse.

• have or have had asthma
• have kidney, heart, liver or bowel problems or are dehydrated
• have low or high blood pressure
• have a head injury or raised intracranial pressure
• suffer from a thyroid disorder
• have Systemic Lupus Erythematosus (a condition of the immune system causing joint pain, skin changes and other organ disorders)
• have high cholesterol
• have had a heart attack or stroke
• have a history of gastrointestinal disease (such as ulcerative colitis, Crohn’s disease)
• are a smoker
• have gallstones
• suffer from myasthenia gravis (a condition that causes muscle weakness)
• have an infection - please see heading "Infections" below.

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.

Infections

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.

Skin reactions

Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), 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.

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

Some anticoagulant medicines (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine), some medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol, or angiotensin-II receptor antagonists such as losartan), and other medicines may affect or be affected by treatment with ibuprofen. The following medicines are know to interact with codeine (present in this medicine).

Moclobemide (for depression), Hydroxyzine (an anti-anxiety medicine), loperamide and kaolin (medicines to treat diarrohoea), Qunidine or Mexiletine (to treat abnormal heart rhythms), metoclopromide or domperidone (anti-sickness medicines), Cimetidine (to treat stomach ulcers and naloxone. Gabapentin or pregabalin to treat epilepsy or pain due to nerve pain (neuropathic pain) Medicines called Monoamine oxidase inhibitors (MAOIs) for the treatment of depression may affect or be affected by treatment with codeine.

You should therefore always seek the advice of your doctor or pharmacist before you take this medicine with other medicines.

• 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.
• Medicines such as this medicine 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 your treatment with your doctor or pharmacist.
• 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.
• Sleep-related breathing disorders: Nurofen Plus 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.
• 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.

Tolerance, dependence and addiction

Nurofen Plus contains codeine which is an opioid medicine. Repeated use of Nurofen Plus can result in the drug being less effective (you becoming accustomed to it and needing to take higher doses, known as tolerance).

Repeated use of Nurofen Plus can also lead to dependence, abuse and addiction, which may result in life-threatening overdose. If you are taking Nurofen Plus 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 Nurofen Plus 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 Nurofen Plus, talk to your doctor or pharmacist as it could be a sign that you have become dependent or addicted:

• You need to take the 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 medical reasons, for instance, ‘to stay calm’ or to ‘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).

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.

Do not take this product during pregnancy 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 Nurofen Plus 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, Nurofen Plus 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. Do not take codeine while you are breastfeeding. Codeine and morphine passes into breast milk.

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

• Do not drive while taking this medicine until you know how it affects you
• If affected, do not drive or operate machinery
• It may be an offence to drive when taking this medicine
• However, you would not be committing an offence if:
  • The medicine has been taken to treat a medical or dental problem and
  • You have taken it according to 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.

Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here: https://www.gov.uk/drug-driving-law.

This medicine contains less than 1 mmol sodium (23 mg) per dose, 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 longer than 3 days unless your doctor tells you to. If symptoms persist or the pain or fever worsen, or if any new symptoms occur, consult your doctor or pharmacist.

This product 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 of 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 three 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

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

• fever, sore throat, mouth ulcers, shivering or body aches, fatigue, easy or unexpected bleeding or bruising,
• Stiff neck,
• liver and kidney problems

Not known: frequency cannot be estimated from the available data: Palpitations or irregular heartbeats, confusion

• worsening of asthma
• Seizures
• Weakness, lack of coordination, tinnitus
• sweating, thirst, muscle weakness or tremors, sleeplessness
• chest pain (which can be a sign of a potentially serious allergic reaction called Kounis syndrome), or fast, irregular heart beat
• dizziness or drowsiness
• decreased appetite, depression, hallucination, blurred vision
• Sleep apnoea
• 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 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

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 at: 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.

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