SUPERDRUG CHILDRENS PAIN AND FEVER RELIEF 100 MG / 5 ML ORAL SUSPENSION, IBUPROFEN 100 MG / 5 ML ORAL SUSPENSION, BELLS HEALTHCARE CHILDRENS PAIN AND FEVER RELIEF 100 MG / 5 ML ORAL SUSPENSION, TESCO HEALTH IBUPROFEN 100 MG / 5 ML ORAL SUSPENSION, ALMUS - patient leaflet, side effects, dosage

1. What Children’s Pain and Fever Relief Oral Suspension is and what it is used for

2. What you need to know before giving Children’s Pain and Fever Relief Oral Suspension to your child

3. How to use Children’s Pain and Fever Relief Oral Suspension

4. Possible side effects

5. How to store Children’s Pain and Fever Relief Oral Suspension

6. Contents of the pack and other information

1. what children’s pain and fever relief oral suspension is and what it is used for

Children’s Pain and Fever Relief Oral Suspension contains 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, swelling and high temperature.

This medicine is used to relieve:

• fever (high temperature) including post immunisation fever
• mild to moderate pain including headache, sore throat, teething pain and toothache, cold and flu symptoms and minor aches and sprains.

2. what you need to know before giving children’s pain and fever relief oral suspension to your child

Do not give this medicine to your child if they:

• have ever had a reaction (e.g., asthma, runny nose, rash, swelling of the face, tongue, lips or throat) after taking Ibuprofen, aspirin or other non-steroidal anti-inflammatory (NSAID) medicines
• weigh less than 5 kg or are under 3 months of age
• are taking any other anti-inflammatory (NSAID) painkillers or aspirin
• have (or have had two or more episodes) of a stomach ulcer, perforation or bleeding
• have severe kidney, heart or liver failure
• have inherited problems coping with fructose/fruit sugar (hereditary fructose intolerance). This is because the body can make some fructose from the ingredient maltitol.
• have a history of stomach bleeding or perforation after taking Ibuprofen or other NSAIDs.

Warnings and Precautions

Talk to your doctor or pharmacist if your:

• child has or has had high blood pressure, heart problems or a stroke because there is a small increased risk of heart problems with Ibuprofen
• child has a condition which may put them at risk of heart problems, such as diabetes or high cholesterol
• child has asthma or any allergic disease of the lungs
• child has or has had liver, kidney, heart or bowel problems
• child is dehydrated as there is a risk of kidney problems
• child has SLE (Systemic Lupus Erythematosus, a condition of the immune system) or any similar disease
• child suffers from chronic inflammatory bowel disease such as Crohn’s disease or ulcerative colitis
• child has chickenpox (Varicella). It is advisable to avoid use of Children’s Pain and Fever Relief Oral Suspension during chickenpox.
• child has an infection – please see heading “Infections” below.

Skin reactions

Serious skin reactions have been reported in association with Children's Pain and Fever Relief Oral Suspension treatment. You or your child should stop taking Children's Pain and Fever Relief Oral Suspension and seek medical attention immediately, if you develop any skin rash, lesions of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction. See section 4.

Infections

Children’s Pain and Fever Relief Suspension may hide signs of infections such as fever and pain. It is therefore possible that Children’s Pain and Fever Relief Suspension 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 your child takes this medicine while having an infection and your child's symptoms of the infection persist or worsen, consult a doctor without delay.

Other medicines and Children's Pain and Fever Relief Oral Suspension

Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines, especially:

• other medicines containing Ibuprofen or other NSAIDs, including those you can buy over the counter
• low dose aspirin (up to 75 mg daily)
• diuretics (to help you pass water)
• anticoagulants (blood thinning medicines e.g., warfarin) medicines for high blood pressure (e.g., captopril, atenolol, losartan)
• lithium (for mood disorders)
• methotrexate (for psoriasis, arthritis and types of cancer)
• zidovudine (for HIV)
• corticosteroids (an anti-inflammatory drug)
• cardiac glycosides (for heart problems)
• ciclosporin or tacrolimus (to prevent organ rejection after transplant)
• mifepristone (for termination of pregnancy)
• quinolone antibiotics (for infections)
• SSRI antidepressant drugs
• antiplatelet drugs e.g., dipyridamole, clopidogrel.

Seek the advice of your doctor or pharmacist if any of the above apply. If you are not sure what types of medicines your child is taking, show the medicine to the doctor or pharmacist.

Other warnings

The following warnings are more likely to concern adults. In any case, consider them carefully before giving or taking this medicine.

• medicines such as Children’s Pain and Fever Relief Oral Suspension 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.
• 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
• in limited studies, Ibuprofen appears in the breast milk in very low concentration and is unlikely to affect the breast-fed infant adversely
• if you are elderly talk to your doctor before using this medicine.

Pregnancy, breast-feeding and fertility

Do not take Children’s Pain and Fever Relief Oral Suspension if you are in the last 3 months of pregnancy. Talk to your doctor before taking Children’s Pain and Fever Relief Oral Suspension if you are in the first 6 months of pregnancy or are breast-feeding.

Children’s Pain and Fever Relief Oral Suspension belongs to a group of medicines which may affect fertility in women. Fertility goes back to normal when you stop taking the medicine. It is unlikely that if you only take Children's Pain and Fever Relief Oral Suspension occasionally it will affect your chances of becoming pregnant. If you have problems becoming pregnant talk to your doctor before taking this medicine.

Important information about some of the ingredients of this medicine.

This product contains liquid maltitol (E965). If you have been told by your doctor that your child may have an intolerance to some sugars, talk to your doctor before your child takes this medicinal product. May have a mild laxative effect. Each 5 ml measure contains 1.375 g of liquid maltitol (equivalent to 3.2 kcal per 5 ml of the medicine). This product also contains sodium methylparahydro­xybenzoate (E219) and sodium propylparahydro­xybenzoate (E217). These ingredients may cause allergic reactions (possibly delayed). This medicine contains 5 mg benzoate salt in each 5 ml which is equivalent to 1 mg/ml.

3. how to use children’s pain and fever relief oral suspension

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Always shake the bottle thoroughly before use. Give this medicine using the measuring spoon provided.

DO NOT give to babies under 3 months or babies weighing less than 5 kg.

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

For patients with sensitive stomachs the medicine can be taken with or after food.

If your child takes more Children's Pain and Fever Relief Oral Suspension than they 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.

The symptoms can include nausea, stomach pain, vomiting (may be blood streaked), headache, ringing in the ears, confusion and shaky eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, cold body feeling and breathing problems have been reported.

If you forget to give the medicine

If you forget a dose, give the next dose when needed, provided that the last dose was taken at least 4 hours ago. Do not give a double dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, Children's Pain and Fever Relief Oral Suspension can cause side effects, although not everybody gets them. The most common side effect is irritation of the stomach which can cause problems such as indigestion and heartburn.

If your child experiences any of the following, stop giving this medicine and tell your doctor immediately:

• blood in the stools (faeces/motions)
• black tarry stools
• vomiting blood or dark particles that look like coffee grounds
• unexplained wheezing, asthma, shortness of breath, skin rash (which may be severe with blistering or peeling of the skin), itching or bruising, severe skin reactions ncluding Stevens-Johnson syndrome, racing heart, fluid retention (swollen ankles or decreased levels of passing urine)
• stiff neck, headache, nausea, vomiting, fever and disorientation
• face, tongue or throat swelling (these can be signs of serious allergic reactions)
• 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 cell).

If your child experiences any of the following side effects, stop giving this medicine and tell your doctor:

• unexplained stomach pain, indigestion, heartburn, nausea or vomiting
• yellowing of the eyes, pale stools and dark urine (these can be signs of kidney or liver problems)
• severe sore throat with high fever
• unexplained bruising or bleeding, tiredness, getting more infections than normal, such as mouth ulcers, colds, sore throat, fever (these can be signs of anaemia or other blood disorders).

Other side effects which may occur are:

Uncommon: may affect up to 1 in 100 people

• headache.

Rare: may affect up to 1 in 1,000 people

• diarrhoea, wind or constipation. Tell your doctor if these last for more than a few days or become troublesome.

Very Rare: may affect up to 1 in 10,000 people

• kidney or liver problems may occur with Ibuprofen
• stroke or heart problems may occur with Ibuprofen. This is unlikely at the dose level given to children.
• worsening of colitis and Crohn’s disease
• high blood pressure
• stomach ulcer, bleeding of the stomach, inflammation of the stomach lining.

Not known: frequency cannot be estimated from the available data

• in exceptional cases, serious infections of the skin and soft tissues have occurred during chickenpox (Varicella)
• a red, scaly widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop using Children's Pain and Fever Relief Oral Suspension if you or your child develop these symptoms and seek medical attention immediately. See also section 2.
• skin becomes sensitive to light.

5. how to store children’s pain and fever relief oral suspension

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 pack. The expiry date refers to last day of the month.

Do not store above 25°C. Store in the original container. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What is in Children's Pain and Fever Relief

Oral Suspension

The active ingredient is: Ibuprofen 100 mg/5 ml.

The other ingredients are:

Sodium methylparahydro­xybenzoate (E219), sodium propylparahydro­xybenzoate (E217), citric acid monohydrate, saccharin sodium, sodium benzoate f(lEa2vo11u)r, sodium citrate, dispersible cellulose, orange

, polysorbate 80, liquid maltitol (E965), xanthan gum, purified water.

What Children's Pain and Fever Relief Oral Suspension looks like and contents of the pack

Children’s Pain and Fever Relief Oral Suspension is a white opaque smooth suspension available in a bottle containing 100 ml of suspension.

Marketing Authorisation Holder

Relonchem Limited, Cheshire House, Gorsey Lane, Widnes, Cheshire, WA8 0RP, United Kingdom.

Manufacturer

Bell, Sons & Co. (Druggists) Limited, Gifford House, Slaidburn Crescent, Southport, PR9 9AL, United Kingdom.

PL 20395/0259.

[GSL]

This leaflet was last revised in January 2021.

C73–0026 Ver. C.