NUROFEN FOR CHILDREN 200 MG / 5 MG STRAWBERRY ORAL SUSPENSION - patient leaflet, side effects, dosage

1. What this medicine is and what it is used for

2. What you need to know before you use this medicine

3. How to use this medicine

4. Possible side effects

5. How to store this medicine

6. Contents of the pack and other information

1. what this medicine is and what it is used for

The active ingredient (which makes this medicine 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. This medicine 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.

This medicine is twice the strength of normal ibuprofen suspension and you should be careful that you use The correct dose.

2. what you need to know before you use this medicine

medicines that reduce high blood pressure (ace-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-ii receptor antagonists such as losartan) some other medicines may also affect or be affected by the treatment this medicine. you should therefore always seek the advice of your doctor or pharmacist before you use this medicine with other medicines.

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

• Other NSAIDs including COX-2 inhibitors – this may increase the risk of side effects.
• Digoxin (for heart insufficiency) – the effect of digoxin may be enhanced.
• Glucocorticoids medicines containing cortisone or cortisone-like substances) – this may increase the risk of gastrointestinal ulcers or bleeding.
• Anti-platelet medicines – this may increase the risk of bleeding.
• Aspirin (low dose) – the blood-thinning effect may be impaired.
• Medicines for thinning the blood (such as warfarin) – ibuprofen may enhance the effects of these medicines.
• Phenytoin (for epilepsy) – the effect of phenytoin may be enhanced.
• Selective serotonin reuptake inhibitors (medicines used for depression) – these may increase the risk of gastrointestinal bleeding.
• Lithium (a medicine for manic depressive illness and depression) – the effect of lithium may be enhanced.
• Probenecid and sulfinpyrazones (medicines for gout) – the excretion of ibuprofen may be delayed.
• Medicines for high blood pressure and water tablets – ibuprofen may diminish the effects of these medicines and there could be a possible

increased risk for the kidney.

Potassium sparing diuretics e.g. amiloride, potassium canreoate, spironolactone, triamterene – this may lead to hyperkalaemia.

Methotrexate (a medicine for cancer or rheumatism) – the effect of methotrexate may be enhanced.

Tacrolimus and cyclosporine (immunosuppressive medicines) – kidney damage may occur.

Zidovudine: (a medicine for treating HIV/Aids) -the use of this medicine may result in an increased risk of bleeding into a joint or a bleeding that leads to swelling in HIV (+) haemophiliacs.

Sulfonylureas (antidiabetic medicines) – the blood sugar levels can be affected.

• Quinolone antibiotics – the risk for convulsions (fits) may be increased.
• Voriconazole and fluconazole (CYP2C9 inhibitors) used for fungal infections – the effect of ibuprofen may increase. Reduction of the ibuprofen dose should be considered, particularly when high-dose ibuprofen is administered with either voriconazole or fluconazole.

Baclofen – Baclofen toxicity may develop after starting ibuprofen.

• Ritonavir — it may increase the plasma concentrations of NSAIDs.
• Aminoglycosides – NSAIDs may decrease the excretion of aminoglycosides.

This medicine with alcohol

You should not drink alcohol while using this medicine. Some side effects, such as those affecting the gastrointestinal tract or the central nervous system can be more likely when alcohol is taken at the same time as this medicine.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may

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be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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. This medicine may be used during breast-feeding, if it used at the recommended dose and for the shortest possible time.

Fertility

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

Driving and using machines

• For short-term use this medicine has no or negligible influence on the ability to drive and use machines. 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 Maltitol liquid: If you or your child have been told by your doctor that you or your child have an intolerance to some sugars, contact your doctor before taking this medicine or giving it to your child.
• Sodium: This medicine contains less than 1mmol sodium (23 mg) per 7.5 ml dose, that is to say essentially ‘sodium-free’.
• Wheat starch (only for Orange

RB00000 flavour suspension): Wheat starch in this medicine contains only very low levels of gluten, regarded as gluten-free, and is very unlikely to cause problems if you or your child have coeliac disease. One ml contains no more than 0.06 micrograms of gluten. If you or your child have wheat allergy (different from coeliac disease) you should not take this medicine or give it to your child.

• Propylene Glycol (only for Strawberry flavour) This medicine contains 16.45 mg propylene glycol in each 5 ml.

3. how to use this medicine

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:

• *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.

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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 i----------------------------------------------------------------------------------------------------------------------------

This medicine is for short-term use only. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If your child has an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2). If this medicine is required for more than 3 days or if symptoms worsen, a doctor should be consulted.

If you use 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.

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The symptoms can include nausea, stomach pain, vomiting (may be blood streaked), or more rarely diarrhoea. In addition, headache, gastrointestinal bleeding, blurred vision, ringing in the ear, confusion and shaky eye movement, and exacerbation of asthma in asthmatics. At high doses, drowsiness, excitation, disorientation, chest pain, palpitations, loss of consciousness, coma convulsions (mainly in children), vertigo, weakness and dizziness, blood in urine, low blood pressure, hyperkalaemia, metabolic acidosis, increased prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis, cold body feeling, and breathing problems have been reported.

If you or your child forget to take this medicine:

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 have any further questions on the use of this medicine ask your doctor or pharmacist.

4. possible side effects

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) See also section 2.

Tell your doctor if your child has any of the following side effects, they become worse or you notice any effects not listed. general 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. Patients with autoimmune disorders (SLE, mixed connective tissue disease) may be more likely to be affected. Contact a doctor at once, if these occur.
• severe forms of skin reactions such as skin rash with redness and blistering (e.g. Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis/Ly­ell’s syndrome), hair loss (alopecia)

Not known : (frequency cannot be estimated from the available data)

• Respiratory tract reactivity comprising asthma, bronchospasm or dyspnoea.
• Skin becomes sensitive to light

5. how to store this medicine

Keep this medicine out of the sight and reach of children.

Do not use this medicine 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.

After opening: use within 6 months

Do not throw away any medicines via waste water. Ask your pharmacist how to throw away medicines that you no longer use. These measures will help to protect the environment.

6. contents of the pack and other information

What this medicine contains:

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.

What this medicine looks like and contents of the pack

This medicine is an off-white, viscous oral suspension with an orange or strawberry flavour.

Each bottle contains either 30 ml, 50 ml, 100 ml. The pack contains a double-ended measuring spoon (with a 2.5 ml bowl with 1.25ml inner mark at one end and a 5ml 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:

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

Manufacturer:

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

PL00063/0742 and PL 00063/0743

This leaflet was last revised in February 2021