Nurofen Double Strength For Children 7-12 years Strawberry Flavour Nurofen Double Strength For Children 7-12 years Strawberry Flavour

Do NOT give this medicine to children who: • are allergic to ibuprofen or other similar painkillers (NSAIDs) or to any of the other ingredients of this medicine (listed in section 6). • have ever suffered from shortness of breath, asthma, a runny nose, swelling on their face and/or hands or hives after using Aspirin or other similar painkillers (NSAIDs). • have ever had a gastrointestinal bleeding or perforation, related to previous use of NSAIDs. • currently have or have had recurrent stomach/duodenal ulcers (peptic ulcers) or bleeding (two or more episodes of proven ulceration and bleeding). • have severe liver or severe kidney failure. • have severe heart failure. • have bleeding of the brain (cerebrovascular bleeding) or other active bleeding. • have unclarified blood-formation disturbances. • have severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).

Do not take if you are in the last 3 months of pregnancy.

 Warnings and precautions Talk to your doctor or pharmacist before using this medicine if your child: • has certain hereditary blood formation disorders (e.g. acute intermittent porphyria). • suffers from coagulation disturbances. • has certain diseases of the skin (systemic lupus erythematosus (SLE) or mixed connective tissue disease). • has or has ever had bowel disease (ulcerative colitis or Crohn’s disease) as these conditions may be exacerbated • has ever had or currently has high blood pressure and/or heart failure. • has reduced kidney function. • has liver disorders. In prolonged administration of this medicine regular checking of the liver values, the kidney function, as well as of the blood count, is required. • is taking medicines which could increase the risk of ulceration or bleeding, such as oral corticosteroids (such as prednisolone), medicines for thinning the blood (such as warfarin), selective serotonin-reuptake inhibitors (a medicine for depression) or anti-platelet medicines (such as aspirin). • is taking another NSAID medicine (including COX-2 inhibitors such as celecoxib or etoricoxib) as taking these together should be avoided (see section “Other medicines and this medicine”). • has or has had asthma or allergic diseases as shortness of breath may occur. • suffers from hayfever, nasal polyps or chronic obstructive respiratory disorders an increased risk of allergic reactions exists. The allergic reactions may present as asthma attacks (so-called analgesic asthma), Quincke’s oedema or urticaria. • has just undergone major surgery as medical surveillance is required. • is dehydrated as there is a risk of kidney problems in dehydrated children. • has an infection. This medicine may hide signs of an 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 give this medicine to your child while they have an infection and their symptoms of the infection persist or worsen, consult a doctor without delay. • During chicken pox (varicella) it is advisable to avoid use of this medicine. Skin reactions • Serious skin reactions have been reported in association with this medicine. You should stop giving this medicine to your child and seek medical attention immediately, if they develop any skin rash, lesion of the mucous membranes, blisters or other signs of allergy 0since this can be the first signs of a very serious skin reaction.  • Side effects may be minimized by using the minimum effective dose for the shortest duration. • In general terms, the habitual use of (several sorts of) analgesics can lead to lasting severe kidney problems. The risk may be increased under physical strain associated with loss of salt and dehydration. Therefore it should be avoided. • Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medicines. • Gastro-intestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious gastro-intestinal events. When gastrointestinal bleeding or ulceration occurs, the treatment should be stopped immediately. This medicine contains maltitol liquid and propylene glycol for Nurofen for Children 200mg/5ml Strawberry oral suspension and maltitol liquid and wheat starch for Nurofen for Children 200mg/5ml Orange oral suspension

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects may be minimised by taking the lowest dose for the shortest time necessary to relieve the symptoms. Although side effects are uncommon, your child may get one of the known side effects of NSAIDs. If they do, or if you have concerns, stop giving this medicine to your child and talk to your doctor as soon as possible. Elderly people using this medicine are at increased risk of developing problems associated with side effects.

STOP USING this medicine and seek immediate medical help if your child develops: • 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 rare but serious allergic reaction such as 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 of this medicine. If any of these symptoms occur, call a doctor at once. • severe skin reactions such as rashes covering the whole body, peeling, blistering or flaking skin. • A severe skin reaction known as DRESS (Drug reaction with eosinophilia and systemic symptoms) syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase ofeosinophils (a type of white blood cells). • A red, scaly widespread rash with bumps under the skin and blisters mainly localised on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis) (frequency not known) 

 Tell your doctor if your child has any of the following side effects, they become worse or you notice any effects not listed. Common (may affect up to 1 in 10 people) • Stomach and intestinal complaints such as as acid burn, stomach pain and nausea, indigestion, diarrhoea, vomiting, flatulence (wind) and constipation and slight blood losses in stomach and/or bowel that may cause anaemia in exceptional cases Uncommon (may affect up to 1 in 100 people) • gastrointestinal ulcers, perforation or bleeding, inflammation of the mucous membrane of the mouth with ulceration, worsening of existing bowel disease (colitis or Crohn’s disease), gastritis • headache, dizziness, sleeplessness, agitation, irritability or tiredness • visual disturbances • various skin rashes • hypersensitivity reactions with hives and itch Rare (may affect up to 1 in 1000 people) • tinnitus (ringing in the ears) • increased urea concentrations in blood, pain in the flanks and/or the abdomen, blood in the urine and a fever may be signs of damage to kidneys (papillary necrosis) • increased uric acid concentrations in the blood • decreased haemoglobin levels Very rare (may affect up to 1 in 10,000 people) • oesophagitis, pancreatitis, and formation of intestinal diaphragm-like strictures • heart failure, heart attack and swelling in the face or hands (oedema) • 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 may lead to acute kidney failure. If one of the above mentioned symptoms occur or if you have ageneral miserable feeling, stop taking this medicine and consult your doctor immediately as these could be first signs of a kidney damage or kidney failure. • Psychotic reactions, depression • high blood pressure, vasculitis • palpitations • liver dysfunction, damage to the liver (first signs could be discoloration of the skin), especially during long-term treatment, liver failure, acute inflammation of the liver (hepatitis) • problems in the blood cell production - first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nose and skin bleeding and unexplained bruising. In these cases you must stop the therapy immediately and consult a doctor. Any self-treatment with pain killers or medicinal products that reduce fever (antipyretic medicinal products) mustn’t be done. • severe skin infections and soft tissue complications during chicken pox (varicella) infection • worsening of infection-related inflammations (e.g. necrotizing fasciitis) associated with the use of certain painkillers (NSAIDs) has been described. If signs of an infection occur or get worse, you must go to the doctor without delay. It is to be investigated whether there is an indication for an anti-infective/antibiotic therapy • symptoms of aseptic meningitis with stiff neck, headache, nausea, vomiting, fever or clouding of consciousness have been observed when using ibuprofen.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. This product is twice the strength of normal ibuprofen suspension and you should be careful that you use the correct dose.

The usual dose for pain and fever

7-9 years 10-12 years  5ml (equivalent to 200 mg ibuprofen) (use the 5ml end of the measuring spoon)  up to 3 times in 24 hrs

10-12 years 7.5ml (equivalent to 300 mg ibuprofen) (use the measuring spoon twice: 5ml end 2.5ml end) up to 3 times in 24 hrs

Doses should be given approximately every 6 to 8 hours. Leave at least 4 hours between doses. Do not give more than the recommended dose in 24 hours.

 Not intended for children under 7 years old and weighing less than 20 kg.

WARNING: Do not exceed the stated dose. Method of administration using the spoon For oral use 1. Shake the bottle well 2. Use the end of the spoon that corresponds to the required dose 3. Pour the medicine onto the spoon 4. Place the spoon in the child’s mouth and administer the dose 5. After use replace the cap. Wash the spoon in warm water and allow to dry.

Each ml oral suspension contains 40 mg ibuprofen Each 5 ml measuring spoon of oral suspension contains 200 mg ibuprofen.

 Each 2.5ml measuring spoon of oral suspension contains 100 mg ibuprofen.

The other ingredients are: polysorbate 80, glycerol, maltitol liquid, saccharin sodium, citric acid monohydrate, sodium citrate, xanthan gum, sodium chloride, orange flavour (containing wheat starch) or strawberry flavour, domiphen bromide and purified water.