Nurofen For Children 200 mg/5 ml Suspension

The active ingredient (which makes this medicine to work) is Ibuprofen which belongs to a group of medicines called Non - Steroidal Anti - Inflammatory Drugs (NSAIDs). These medicines work by changing how the body responds to pain and high body temperature. NUROFEN® FOR CHILDREN 4 % is used in children from 7 to 12 years old for relief of rheumatic or muscular pain, headache, dental pain, feverishness, symptoms of cold and influenza.

Do NOT give NUROFEN® FOR CHILDREN 4 % to children who:

• are allergic to ibuprofen or other similar painkillers (NSAIDs) or any of the other ingredients of NUROFEN® FOR CHILDREN 4 % (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 failure.
• has kidney impairment, or severe acute (sudden) or chronic (long term) kidney disease
• 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 NUROFEN® FOR CHILDREN 4 % if you are in the last 3 months of pregnancy.

Warnings and precautions:

Take special care and check with a doctor or pharmacist before using NUROFEN® FOR CHILDREN 4 % 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 (see section 4 “Possible side effects”).
• has ever had or currently has high blood pressure and/or heart failure.
• 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 NUROFEN® FOR CHILDREN 4 %”).
• has or has had asthma or allergic diseases as shortness of breath may occur.
• suffers from hay fever, 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.

Do not share medicines prescribed for you with any other person. Always take NUROFEN® FOR CHILDREN 4 % exactly as described in this leaflet or as your doctor, or pharmacist, or nurse have told you. Check with your doctor or pharmacist or nurse if you are not sure. NUROFEN® FOR CHILDREN 4 % is twice the strength of normal ibuprofen suspension and you should be careful that you take the correct dose:

The usual dose for pain and fever:

Child’s age How much How often in 24 hour?

• 7 to 9 years 5 ml (equivalent to 200 mg ibuprofen) (use the 5 ml end of the measuring spoon) 3 times
• 10 to 12 years 7,5 ml (equivalent to 300 mg ibuprofen) (use the measuring spoon twice: 5 ml end + 2.5 ml end) 3 times

*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

Duration of treatment: NUROFEN® FOR CHILDREN 4 % is for short - term use only. If NUROFEN® FOR CHILDREN 4 % is required for more than 3 days or if symptoms worsen or persist, consult your doctor.

NUROFEN® FOR CHILDREN 4 % can have side effects. Not all side - effects reported for NUROFEN® FOR CHILDREN 4 % are included in this leaflet. Should your child's general health worsen or if the child experiences any untoward effects while taking NUROFEN® FOR CHILDREN 4 %, please consult your health care provider for advice.

Side effects may be minimised by taking the lowest dose for the shortest time if necessary to relieve the symptoms. If any of the following happens, stop using NUROFEN® FOR CHILDREN 4 % and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Hypersensitivity (allergic) reactions with hives and itch
• 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 reactions 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 NUROFEN® FOR CHILDREN 4 %.
• 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 of eosinophils (a type of white blood cells).
• Severe forms of skin reactions such as skin rash with redness and blistering (e.g. Stevens - Johnsons syndrome, erythema multiforme, toxic epidermal necrolysis/Lyell’s syndrome), hair loss (alopecia) These are all very serious side effects. If you have them, you may have had a serious reaction to NUROFEN® FOR CHILDREN 4 %. You or your child may need urgent medical attention or hospitalisation.

Store all medicines out of reach of children. Store at or below 25 ° C. Keep bottle well closed and away from light. Do not store in a bathroom. Do not use after the expiry date stated on the carton and label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).