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Nurofen For Children 200mg/5ml Orange Oral Suspension

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PACKAGE LEAFLET INFORMATION FOR THE USER

Nurofen for Children 200mg/5ml Orange Oral Suspension

PL 00063/0606 For children 6 to 12 years

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

This medicine is available without prescription. However, you still need to take it 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 consult your doctor if your symptoms worsen or do not improve after 3 days.

-    If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Nurofen for Children is and what it is used for

2.    Before you use Nurofen for Children

3.    How to use Nurofen for Children

4.    Possible side effects

5.    How to store Nurofen for Children

6.    Further information

1. What Nurofen for Children is and what it is used for

Ibuprofen belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines work by changing how the body responds to pain, swelling and high body temperature. This product has been specifically formulated for children as it is given by mouth to:

•    reduce fever

•    relieve symptoms of mild to moderate pain

2 Before you give/take Nurofen for Children Do not give Nurofen for Children to children who:

•    are under 6 years of age

•    are allergic (hypersensitive) to ibuprofen or other similar painkillers (NSAIDs) or to any of the other ingredients of the product (see section 6 for further information)

•    have ever suffered from shortness of breath, asthma, a runny nose or hives after using aspirin (acetylsalicylic acid) 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, kidney or heart failure

•    have inherited problems coping with with fructose/fruit sugar (see important information about the ingredients)

•    have bleeding of the brain (cerebrovascular bleeding) or other active bleeding

•    suffer from blood clotting disorders as ibuprofen may increase bleeding time

•    suffer from unclarified blood-formation disturbances such as thrombocytopenia

•    are taking another NSAID medicine (including COX-2 inhibitors such as celecoxib or etoricoxib)

If an adult is taking this product do not use Nurofen for Children during the last 3 months of pregnancy

Take special care with Nurofen for Children if they:

•    are taking any other NSAID painkillers or aspirin with a daily dose above 75mg

•    have certain diseases of the skin (systemic lupus erythematosus (SLE) or mixed connective tissue disease)

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

•    have disorders of the rectum or anus

•    have ever had a high blood pressure and/or heart failure

• have reduced renal function

• have liver disorders

•    have gastrointestinal bleeding, ulcer or perforation, related to use of this medicine. These diseases are not necessarily preceded by warning signals and are not reserved to patients with a history of such diseases and can be fatal. When gastrointestinal bleeding or ulceration occurs, the treatment should be stopped immediately.

•    caution should be advised if you take other 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 agents (such as acetylsalicylic acid).

•    undesirable effects may be minimised by using the minimum effective dose for the shortest duration.

•    in general, the habitual use of (several sorts of) analgesics can lead to lasting severe kidney problems.

•    shortness of breath may occur if you have or have had asthma, a chronic runny nose, nasal polyps or allergic diseases.

•    serious skin reactions (such as Steven-Johnson syndrome) have been reported very rarely in association with the used of NSAIDs. The use of Nurofen for Children should be stopped immediately at the first appearance of skin rash, mucosal lesions, or any other signs of allergic reactions.

•    medicines such as Nurofen for Children may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment [3 days].

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

•    during chicken pox (varicella) it is advisable to avoid use of Nurofen for Children

•    have just undergone major surgery

Consult a doctor before using Nurofen for Children if any of the above mentioned conditions concern your child.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

In particular, tell them if you are taking:

•    corticosteroids (such as prednisolone) since this may increase the risk of gastrointestinal ulceration or bleeding

•    another NSAID medicine (including COX-2 inhibitors such as celecoxib or etoricoxib)

•    some medicines that are anti-coagulants (against clotting) (e.g. acetylsalicylic acid/aspirin, warfarin, ticlopidin), some medicines against high blood pressure (ACE-inhibitors,e.g. captopril, betareceptor blocking medicines, angiotensin II antagonists), and even some other medicines may affect or be affected by the treatment of ibuprofen. Therefore always seek the advice of a doctor before you use ibuprofen with other medicines.

•    anti-platelet agents (such as acetylsalicylic acid) and selective serotonin-reuptake inhibitors (a medicine for depression) since this may increase the risk of gastrointestinal side effects

•    medicines for high blood pressure and water tablets since NSAIDs may diminish the effects of these medicines and there could be a possible increased risk for the kidney. In this case make sure you drink enough water during the day.

•    lithium (a medicine for depression), since the effect of lithium may be enhanced

•    methotrexate (a medicine for cancer or rheumatism) since the effect of methotrexate may be enhanced

•    tacrolimus (a medicine to suppress the immune reaction) since the risk of kidney toxicity is increased

•    cyclosporin (a medicine to suppress the immune reaction) since there is limited evidence on an increased risk for kidney toxicity

•    zidovudine.(a medicine for treating Aids) since the use of Nurofen for Children may result in an increased risk of bleeding into a joint or a bleeding that leads to swelling

•    sulphonylureas: Clinical investigations have shown interactions between NSAIDs and antidiabetics (sulphonylureas). Although interactions between ibuprofen and sulphonylureas have not been described to date, a check of blood-glucose values is recommended as a precaution on concomitant intake.

•    probenecid and sulfinpyrazone: Medicinal products that contain probenecid or sulfinpyrazone may delay the excretion of ibuprofen

•    baclofen: Baclofen toxicity may develop after starting ibuprofen.

•    ritonavir: Ritonavir may increase the plasma concentrations of NSAIDs.

•    digoxin, phenytoin: Digoxin or phenytoin may increase plasma concentrations of NSAIDs.

•    quinolone antibiotics, since taking these and NSAIDs can increase the risk of having convlusions

Pregnancy and breast-feeding

If an adult is taking this medicine:

Pregnancy

Tell your doctor if you become pregnant during intake of Nurofen for Children. Do not use this medicine if you are in the last 3 months of pregnancy. Avoid the use of this medicine in the first 6 months of pregnancy unless your doctor advises you otherwise.

Breast-feeding

Only small amounts of ibuprofen and its decomposition products pass into breast milk. As no harmful effects to infants are known to date, it is not usually necessary to interrupt breastfeeding during short-term use of ibuprofen at the recommended doses.

Female fertility

Nurofen for Children belongs to a group of medicines (NSAIDs) which may impair the fertility in women. This effect is reversible on stopping the medicine.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

For short-term use this medicine has no or negligible influence on the ability to drive and use machines.

Important information about some of the ingredients of Nurofen for Children

• Nurofen for Children contains maltitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO USE NUROFEN FOR CHILDREN

Always take Nurofen for Children exactly as indicated. You should check with your doctor or pharmacist if you are unsure.

The usual dose for pain and fever:

Child’s Age (Weight)

How much?

How often in 24h?1

6 - 9 years (20-30kg)

5ml

3 times

10 - 12 years (30-40kg)

7.5ml (use spoon twice: 5ml + 2.5ml)

3 times

* Doses should be given approximately every 6 to 8 hours.

Shake well before use

WARNING: do not exceed the stated dose.

Method of administration using the spoon

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. Store out of the reach and sight of children

Duration of treatment

This medicine is for short-term use only. Do not give to children over 6 years for longer than 3 days. If symptoms persist or worsen contacts your doctor.

If you or your child forget to take Nurofen for children:

Do not take a double dose to make up for the forgotten dose. If you do forget to take a dose, take it as soon as you remember and then take the next dose according to the dose interval detailed above.

If you or your child take more Nurofen for Children than you should

If you accidentally give or take more than the recommended dose of Nurofen for Children, contact your doctor straight away.

If you have any further questions on the use of this product ask your doctor.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Nurofen for Children can cause side effects, although not everyone 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 product are at increased risk of developing problems associated with side effects.

The following frequencies are taken as a basis when evaluating side effects: 2 1

•    inflammation of the oesophagus or pancreas, blockages in the gut

•    Severe forms of skin reactions including rash with redness and blistering which may peel accompanied by fever, chills, aching muscles and feeling unwell, Stevens-Johnson syndrome. In exceptional cases, serious infections of the skin have occurred during chicken pox (varicella).

•    .

•    passing less urine than normal and swelling (acute kidney failure or inflammation may be possible). Damage to the kidney or increased urea concentrations in the blood (first signs are passing less urine than normal, cloudy urine, blood in the urine, back pain, swelling, possibly of the legs and generally feeling miserable)

•    problems in blood cell production (first signs are fever, sore throat, mouth ulcers, flu-like symptoms, severe exhaustion, nose and skin bleeding, unexplained or unusual bruising)

•    psychotic reactions and depression

•    worsening of inflammation due to infection. If signs of an infection occur or get worse during use of Nurofen for Children, speak to your doctor.

•    swelling, high blood pressure, palpitations, heart failure, heart attack.

•    liver problems or inflammation of the liver. Liver failure or damage, particularly in longterm term use, shown by yellowing of the skin and eyes or pale stools and dark urine

•    very rarely, the 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. Contact a doctor at once, if these occur.

The elderly have an increased frequency of undesirable reactions to NSAIDs especially gastrointestinal bleeding.

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

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 safety of this medicine.

5. HOW TO STORE NUROFEN FOR CHILDREN

Keep out of reach and sight of children.

Do not use Nurofen for Children after the expiry date which is stated on the carton and label. The expiry date refers to the last day of that month. Do not store above 25 °C.

Shelf life after opening the bottle: 6 months

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

6 FURTHER INFORMATION

What Nurofen for Children contains:

Each 1ml oral suspension contains 40mg ibuprofen

Each 5ml spoonful of oral suspension contains 200mg ibuprofen .

Each 2.5ml spoonful of oral suspension contains 100mg ibuprofen.

The ibuprofen content is equivalent to 4.0%w/v

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

What Nurofen for Children looks like and contents of the pack


Nurofen for Children is an off-white, orange flavoured oral suspension. Each bottle contains either 30ml, 50ml, 100ml, 150ml, or 200ml.

The pack contains a double-ended measuring spoon (with a 2.5 ml bowl with 1.25ml inner mark at one end and a 5 ml bowl at the other end) to measure the dose correctly. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

To be completed nationally

Manufacturer:

To be completed nationally

Last updated October 2014

very common: affects more than 1 user in 10

common: affects 1 to 10 users in 100_

uncommon: affects 1 to 10 users in 1,000_

rare: affects 1 to 10 users in 10,000

very rare: affects less than 1 user in 10,000_

not known: frequency cannot be estimated from the available data


1

   stomach ulcers which may burst or bleed

•    mouth ulcers and/or swelling and irritation of the mouth

•    hypersensitivity reactions with skin rashes and itching, and asthma attacks

Rare (affects 1 to 10 users in 10,000)

•    tinnitus (ringing in the ears)

Very rare (affects less than 1 user in 10,000

2

STOP TAKING 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.

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

Common (affects 1 to 10 users in 100)

•    heart burn, abdominal pain, feeling sick, being sick, flatulence (wind), diarrhoea, constipation.

Uncommon (affects 1 to 10 users in 1,000)

•    inflammation of the stomach, worsening of colitis and Crohn's disease

•    headache, dizziness, sleeplessness, agitation, irritability or tiredness

•    visual disturbances