PACKAGE LEAFLETT INFORMATION FOR THE TJSER

NUROF6N

400mg Soft Capsules

Ibuprofen

For use in adults and adolescents weighing more than 40kg (12 years and over)

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

This medicine is available without prescription. However, you still need to take Jturofen 400mg Soft Capsules 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.

>■ You must contact a doctor if your symptoms women or do not improve r alter 3 days In children and adolescents between 12 and 18 yearn after 3 days if you have fover and 4 days for the treatment of pain in adults r If any of the side effects gels serious, or if you notice any side effects not listed in ; this leaflet, please tell your doctor or pharmacist.

)n this leaflet:

¹1. What Nurofen 400mg Soft Capsules is and what it is used for [2. Before you take Nurofen 400mg Soft Capsules |3. How to take Nurofen 400mg Salt Capsules [4. Possible side effects

|5. Howto store Nurofen 400mg Soft Capsules 16. Further information

1. WHAT NUROFEN 400MG SOFT CAPSULES IS AND WHAT IT IS USED FOR

Ibuprofen belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).

[These medicines provide relief by changing how the body responds to pain and fever.

Nurofen 400mg Soft Capsules is used in adults and adolescents weighing more [than 40kg (12 years and over) for the symptomatic treatment of:

» mild to moderate pain such as headache, period pain, dental pain !• fever and pain associated with the common cold.

• You shouTiTavoMtdldngTfuFoten 400mgGafTCapsules If yoifhave chicken

pox (varicella).

•    When Nurofen 400mg Soft Capsules is taken over a longer period of time, regular liver, kidney and blood checks should be done.

•    Taking Nurofen 400mg Soft Capsules in combination with other NSAIDS including cyclo-oygenase-2 specific inhibitors can increase the risk of side effects and should be avoided, (see section ‘Taking other medicines' below).

•    Using more than one painkilling medicine can increase the risk of severe kidney problems and should be avoided. The risk is increased further by dehydration.

•    There is a risk of renal impairment in dehydrated children and adolescents.

•    Anti-inflammatory/pain-killer medicines like Nurofen 400mg Soft Capsules 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.

•    You should discuss your treatment with your doctor or pharmacist before taking Nurofen 400mg Soft Capsules 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 of feet due to narrow or blocked arteries), or any kind of stroke (including 'mini-stroke' or transient ischaemic attack ‘TIA").

-    have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.

Undesirable effects are minimised by using the minimum effective dose for the shortest period of time. The elderly are at increased risk of side effects.

Consult a doctor before using Nurofen 400mg soft capsules if any of the above mentioned conditions concerns you.

Taking other medicines:

Do not take this medicine if you are taking aspirin (acelylsalicylic acid) at doses above 75mg daily.

If you are on low-dose aspirin (acelylsalicylic acid) up to 75mg daily, speak to your doctor or pharmacist before taking Nurofen 400mg Soft Capsules.

Some other medicines may also affect or be affected by the treatment of Nurofen 400mg Soft Capsules. You should therefore always seek the advice of your doctor or pharmacist before you use Nurofen 400mg Soft Capsules with other medicines, including medicines obtained without a prescription; ^especially:

•    anti-clotting/blood thinning medicines (anti coagulants e.g. aspirin/acelylsalicylic acid, warfarin, ticlopidine)

•    medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-ll receptor antagonists such as losartan); and

Please tell your doctor or pharmacist if you are taking or have recently taken:

2. BEFORE YOU TAKE NUROFEN 400MG SOFT CAPSULES

bo not take Nurofen 400mg Soft Capsules if you:

[• are allergic to ibuprofen, ponceau 4R (El 24) or any of the other ingredients of i this medicine (listed in section 6).

[• have ever suffered from shortness of breath, asthma, a runny nose, swelling or ' hives after using acelylsalicylic acid (known as aspirin) or other similar [ painkillers (NSAIDs).

■ have (or have had Iwo or more episodes of a stomach/duodenal ulcer (peptic [ ulcer) or bleeding of the stomach.

•    have had gastrointestinal bleeding or perforation when previously taking i NSAIDs (Non-steroidal anti-inflammatory drugs)

[• suffer from unclarified blood-foimatlon disturbances

i* suffer from a tendency to uncontrolled bleeding (haemorrhage) or clotting [ (coagulation) disorders

•    have severe liver, kidney or heart follure.

[• are in the last three months of pregnancy (see section 'Pregnancy and ¹ breast-feeding').

[• suffer from severe dehydration (caused by vomiting, diarrhoea or insufficient [ fluid intake).

!• suffer from bleeding on the brain (cerebrovascular bleeding) or other active [ bleeding.

Do not give to adolescents weighing less than 40 kg or children under 12 years of iage.

take special care and talk to your doctor or pharmacist before taking Nurofen |400mg Soft Capsules if you:

•    have systemic lupus erythematosus (SLE) or mixed connective tissue disease

[ (conditions of the immune system causing joint pain, skin rashes and fever).

»have a hereditary blood formation disorder (acute intermittent porphyria) or [ blood clotting problems.

•    have or have ever had bowel disease (ulcerative colitis or Crohn's disease).

[• have reduced kidney function.

;• have liver problems.

i* have recently undergone ma|or surgery.

[• have or have had asthma or allergic disease as shortness of breath may occur, i* suffer from haytever, nasal polyps or chronic obstructive respiratory disorders

[ as there is an increased risk of allergic reactions. These reactions may present as i asthma attacks (so-called analgesic asthma), swelling of skin (Quincke's [ oedema) or a skin rash.

» are taking other medicines which could increase the risk of ulceration or I bleeding such as oral corticosteroids, medicines for thinning the blood (such as [ warfarin), selective serotonin reuptake inhibitors (tor depression) or anti-platelet i agents such as acelylsalicylic acid (aspirin).

[Other warnings

•    Prolonged use of painkillers tor headaches can make them woise. If this happens [ or is suspected, stop taking Nurofen 400mg Soft Capsules and contact your

! doctor.

Taking Nurofen 400mg Sod Capsules with food and drink

Swallow the capsules with wafer. Patients with sensitive stomachs are advised to take Nurofen 400mg Soft Capsules with food. Some side effects, such as those affecting the gastrointestinal system can be more likely when alcohol is taken at the same time as Nurofen 400mg Soft Capsules.

Pregnancy and breast-feeding Pregnancy

Tell your doctor if you become pregnant whilst taking Nurofen 400mg Soft Capsules.

Do not take this medicine in the last 3 months of pregnancy. Avoid the use of this medicine in the first 6 months of pregnancy, unless the doctor advises otherwise. Breastfeeding

Only small amounts of ibuprofen and its metabolites pass into breast-milk.

This may be taken during breast-feeding if if is used at the recommended dose and for the shortest possible time.

femoTelertifify

INurofen 400mg Soft Capsules belongs 1o a group of medicines (NSAIDs) which may impair the fertility in women. This effect is reversible on stopping the medicine. Avoid taking this medicine if you ore trying to become pregnant.

Ask your doctor or pharmacist for advice before taking any medicines, priving and using machines

'For short-term use and at normal dosage this medicine has no or negligible jinfluence on the ability to drive and use machines.

Patients who experience dizziness, drowsiness, vertigo or visual disturbances while they are taking Nurofen 400mg Soft Capsules, should avoid driving or using machinery. These effects may be worse when taken in combination with alcohol, important Information about some of the Ingredients of Nurofen 400mg Soft Capsules

[This medicinal product contains sorbitol. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

[This medicinal product contains the colour ponceau 4R (El 24), which may cause allergic reactions.

3. HOW TO TAKE NUROFEN 400MG SOFT CAPSULES

Always take Nurofen 400mg Soft Capsules exactly as slated in this package leaflet, pheck with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the standard dose is: posage:

Adults and adolescents weighing moro than 40kg (12 years and over):

'Initial dose: Take 1 capsule (400 mg ibuprofen) with water, then if necessary 11 capsule (400 mg ibuprofen) every six hours. Do not exceed 3 capsules ;(1200 mg ibuprofen) in 24 hours.

Do not give Nurofen 400mg Soft Capsules to adolescents weighing under 40 kg or Children under 12 years of age. pflethod of administration:

For oral use. Do not chew.

iPatients with a sensitive stomach are advised to lake Nurofen 400mg Soft Capsules Iwilh food. If taken shortly after eating, the onset of action of Nurofen 400mg Soft Capsules may be delayed, if this happens, do not take more Nurofen 400mg Soft Papsules than recommended within this section or until the correct re-dosing interval has passed.

Duration of treatment

this product is for short term use only. You should only take the lowest dose for the ^shortest time necessary to relieve your symptoms. p children and adolescents

If Nurofen 400mg Soft Capsules is required in children and adolescents between 12 fond 18 years for more than 3 days, or if symptoms worsen, consult o doctor. p adults

If Nurofen 400mg Salt Capsules is required for longer than 3 days for the treatment frf fever and 4 days for treatment of pain or if the symptoms worsen, consult your doctor.

Please speak to the doctor or pharmacist if you feel that the effect ofthis medicine is greater or less than you expected.

)f you take more Nurofen 400mg Soft Capsules than you should

Consult a doctor immediately. The following signs may occur: feeling sick, being sick, stomach pain, diarrhoea, ringing in the ear, headache, blood in stools or yomit (gastrointestinal bleeding), dizziness, drowsiness, contusion, disorientation. Rarely: loss of consciousness.

Ilf you have any further questions on the use of this product, ask your doctor or pharmacist.

•    aflergTc reactions, such as skin rashes, itching and asthma atfocksTYou must stop taking Nurofen 400mg soft capsules and inform your doctor at once.

Rare affects 1 to 10 users in 10,000

•    tinnitus (ringing in the ears)

•    kidney damage (papillary necrosis) and elevated uric acid concentrations in the blood

Very rare affects less than 1 user in 10,000

•    swelling (oedema), high blood pressure (hypertension) and cardiac failure have been reported in association with NSAID treatment.

•    inflammation of the oesophagus or pancreas, formation of membrane-like narrowing in the small and large intestines (intestinal, diaphragm tike structures)

•    serious skin infections and soft-tissue complications may occur if taken when you have chicken pox (varicella) infection.

•    passing less urine than normal and swelling (especially in patients with high blood pressure or reduced kidney function); swelling (oedema) and cloudy urine (nephrotic syndrome); inflammatory kidney disease (interstitial nephritis) that my lead to acute kidney failure. If one of Ihese symptoms occur or if you have a general miserable feeling, stop taking Nurofen 400mg Soft Capsules and consult your doctor immediately as these could be first signs of a kidney damage or kidney failure.

•    blood cell production problems - first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nose and skin bleeding. In these cases, stop treatment Immediately and consult a doctor. You must not

treat these symptoms with pain killers or medicinal products that reduce fever (antipyretic products).

•    psychotic reactions and depression

•    worsening of infection-related inflammations (e.g. necrotising fasciitis) associated with the use of certain painkillers (NSAIDs) has been described.

If signs of an infection occur or get worse during use of Nurofen 400mg Soft Capsules, you must go to a doctor without delay as you may need anti-infecfive/antibiotic treatment.

•    high blood pressure, palpitations, heart failure, heart attack. Medicines such as Nurofen 400mg Soft Capsules may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

•    liver problems, liver damage, especially during long-term treatment, liver failure, acute inflammation of the liver (hepatitis)

•    symptoms of aseptic meningitis with neck stiffness, headache, feeling sick, being sick, fever or consciousness clouding have been observed when using ibuprofen. Patients with autoimmune disorders (SLE, mixed connective-tissue disease) may be more likely to be affected. Confect a doctor at once, if these occur.

•    severe forms of skin reactions such as skin rash with redness and blistering (e.g. Slevens-Johnson syndrome, toxic epidermal necrolysis/Lyell's syndrome), hair loss (alopecia).

•    evere general hypersensitivity reactions

•    worsening of asthma and bronchospasm.

This medicinal product contains Ponceau 4 R (El 24) which may cause allergic reactions.

Tell your doctor if you have any of the above side effects, they become woise or you notice any effects not listed.

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 at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safely of this medicine.

5. HOW TO STORE NUROFEN 400MG SOFT CAPSULES

4. POSSIBLE SIDE EFFECTS

Like all medicines, Nurofen 400mg Soft Capsules can cause side effects, although not everybody gels them.

$ide effects may be minimised by taking the lowest dose tor the shortest time necessary to relieve the symptoms. You may suffer one of the known side effects of iNSAIDs (see below). If you do, or if you have concerns, stop taking this medicine pnd talk to your doctor as soon as possible. Elderly people using this product are at increased risk of developing problems associated with side effects.

&T0P TAKING this medicine and seek Immediate medical help If you develop: signs of Intestinal bleeding such as: severe pain in the abdomen, black tarry stools, vomiting blood or dark particles that look like coffee grounds, signs of very rare but serious allergic reactions such as skin rashes, itching, worsening of asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, difficulty breathing, racing heart, drop in blood pressure leading to shock. These can happen even on first use ofthis medicine.

» severe skin reactions such as redness, peeling, blistering or flaking skin, rashes covering the whole body

[Tell your doctor if you have any of the following side effects, they become worse or you notice any effects not listed.

Common affects more than 1 user in 1000

A gastrointestinal complaints, such as heart bum, abdominal pain, feeling sick and i indigestion, vomiting, wind (flatulence), diarrhoea, constipation !• slight blood losses in stomach and/or bowel that may cause anaemia in ; exceptional cases.

Uncommon affects 1 to 10 users in 100

!• stomach or intestinal ulcers, sometimes with bleeding and perforation,

; inflammation of the stomach (gastritis),inflammation of the lining of the mouth I with ulceration (ulcerative stomatitis), worsening of colitis and Crohn's disease [• central nervous disturbances such as headache, dizziness, sleeplessness,

' agitation, irritability or tiredness A visual disturbances

Keep out of the sight and reach of children. Do not use Nurofen 400mg Soft Capsules after the expiry date which is slated on the carton and blister. The expiry dale refers to the last day of that month. Do not store above 25°C. Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Nurofen 400mg Sail Capsules contains:

Each capsule contains 400mg ibuprofen. The other ingredients are:

What Nurofen 400mg Salt Capsules looks like and contents of the pack

The capsules are red, oval-shaped and transparent with a nurofen logo printed in while. The capsules are available in packs of 2,4,6,8,10,12,16,20,24,30, 40 or 50 soft capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Limited, SL1 4AQ, UK

Manufacturer

Patheon Softgels BV, De Poslhoornstraat 7, Tilburg, NL-5048 AS, Netherlands.

This leaflet was last approved in March 2016 PL 00063/0615

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Reckitt

Benckiser

Reckitt Benckiser Healthcare (UK) Ltd, Dansom Lane, Hull, HU8 7DS, U.K,

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