Ibuprofen 100mg/5ml Oral Suspension – patient leaflet, side effects, dosage

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

This medicine contains ibuprofen. Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) which relieve pain, reduce swelling and lower temperature when you have a fever.

Ibuprofen 100mg/5ml oral suspension is used in children, aged 3 months and older (weighing more than 5 kg) for short-term symptomatic treatment of:

• Mild to moderate pain such as headache and toothache
• Fever
• Feverishness and symptoms of cold and flu.

2. What you need to know before giving this medicine to your child

Do not give this medicine to your child if:

• are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• have ever suffered from shortness of breath, asthma, a runny nose, swelling or hives after using acetylsalicylic acid or other similar painkillers (NSAIDs);
• are taking other NSAID painkillers, or acetylsalicylic acid with a daily dose above 75 mg;
• have (or have had two or more episodes of) a stomach or duodenal ulcer or bleeding of the stomach;
• have or ever had gastrointestinal bleeding or perforation related to previous use of NSAIDs;
• have severe liver, kidney or heart failure;
• have an illness that may make you more likely to bleed;
• are suffering from significant dehydration (caused by vomiting, diarrhoea or insufficient fluid intake);
• are suffering from bleeding on the brain (cerebrovascular bleeding) or other active bleeding;
• are younger than 3 months or weigh less than 5 kg.

If an adult is taking this product, do not take if you are in the last 3 months of pregnancy.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist.

Adults, the elderly and children over 12 years:

• This medicine is for short-term use only.
• Take the lowest dose for the shortest time necessary.
• Do not take Ibuprofen for longer than 10 days.

If you do not get better, or get worse, talk to your doctor. They will tell you if it is safe to carry on taking the medicine.

Warnings and precautions

Talk to your doctor or pharmacist if:

• has or has had asthma or allergic disease as shortness of breath may occur;
• has kidney or liver problems;
• has or has ever had high blood pressure or heart failure;
• has or has ever had stomach or bowel disorders (including ulcerative colitis or Crohn’s disease);
• has systemic lupus erythematosus (SLE) or mixed connective tissue disease - illnesses that affect the immune system causing joint pain, skin changes and disorders of other organs;
• is taking other NSAIDs. The use with concomitant NSAIDs, including cyclo-oxygenase-2 specific inhibitors, increases the risk of adverse reactions (see section “Other medicines and Ibuprofen” below) and should be avoided;
• has disturbances in the formation of blood cells;
• has just had major surgery;
• has chickenpox;
• has an infection - please see heading “Infections” below;
• has inherited a disorder of the red blood pigment haemoglobin (porphyria).

If an adult is using this product, talk to your doctor or pharmacist before using Ibuprofen:

• if you are planning a pregnancy (see ”Pregnancy, breastfeeding and fertility” below for more information);
• if you are in the first six months of pregnancy;
• if you are breast-feeding.

Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment (1 day for infants aged 3-6 months, weighing more than 5 kg or 3 days for children aged 6 months and over).

You should discuss your treatment with your doctor or pharmacist before taking Ibuprofen if you:

• have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs of feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack “TIA”).
• have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.

Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck region (angioedema), chest pain have been reported with ibuprofen. Stop immediately Ibuprofen and contact immediately your doctor or medical emergencies if you notice any of these signs.

Skin reactions

• Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalised exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Stop using this medicine and seek medical attention immediately, if you notice any of the symptoms related to these serious skin reactions described in section 4.

Infections

Ibuprofen may hide signs of infections such as fever and pain. It is therefore possible that Ibuprofen 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 take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.

If you are taking Ibuprofen for longer than the recommended time or at higher than recommended doses you are at risk of serious harms. These include serious harms to the stomach/gut and kidneys, as well as very low levels of potassium in your blood. These can be fatal (see section 4).

There is a risk of renal impairment in dehydrated children, adolescents and the elderly.

Undesirable effects may be minimised by using the minimum effective dose for the shortest period of time. The elderly are at increased risk of side effects.

Other medicines and Ibuprofen

Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.

Ibuprofen may affect or be affected by some other medicines. For example:

• acetylsalicylic acid, or other NSAIDs - since they may increase the risk of gastrointestinal ulcers or bleeding;
• digoxin (for heart insufficiency) - since the effect of digoxin may be enhanced;
• glucocorticoids (medicinal products containing cortisone or cortisone-like substances) - since this may increase the risk of gastrointestinal ulcers or bleeding;
• acetylsalicylic acid (low dose - up to 75 mg daily) – since the blood-thinning effect may be impaired;
• medicines that are anticoagulants (i.e. thin blood/prevent clotting e.g. acetylsalicylic acid, warfarin, ticlopidine) – since ibuprofen may enhance the effects of these medicines and may increase the risk of gastrointestinal bleeding;
• selective serotonin reuptake inhibitors (medicines used for depression) - since this may increase the risk of gastrointestinal bleeding;
• lithium (a medicine for manic depressive illness and depression) - since the effect of lithium may be enhanced;
• medicines that reduce high blood pressure (ACEinhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan) and water tablets (diuretics) – since ibuprofen may diminish the effects of these medicines and there could be a possible increased risk for the kidney;
• potassium spearing diuretics - since this may lead to high potassium levels in the blood;
• methotrexate (a medicine for cancer or rheumatism) - since the effect of methotrexate may be enhanced;
• medicines for diabetes (so-called sulphonylureas);
• tacrolimus and ciclosporin (immunosuppressive medicines)
• since kidney damage may occur;
• mifepristone (for pregnancy termination) - since the effect of mifepristone may be reduced;
• zidovudine (a medicine for treating HIV/AIDS) – since the use of ibuprofen may result in an increased risk of bleeding into a joint or a bleeding that leads to swelling in HIV (+) haemophiliacs;
• quinolone antibiotics - since the risk for convulsions may be increased;
• aminoglycoside antibiotics;
• voriconazole or fluconazole - used for fungal infections;
• cholestyramine - used to lower cholesterol;
• Ginkgo biloba - a herbal medicine often used in dementia.

Some other medicines may also affect or be affected by the treatment of Ibuprofen. You should therefore always seek the advice of your doctor or pharmacist before you use Ibuprofen with other medicines.

Ibuprofen with food, drink and alcohol

It is recommended that patients with sensitive stomachs take Ibuprofen with food.

Alcohol consumption increases the risk of side effects.

Pregnancy and breast-feeding :

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Ibuprofen in the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected. You should not take Ibuprofen during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, Ibuprofen can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.

Only small amounts of ibuprofen and its decomposition products pass into breast milk. Ibuprofen may be taken during breast-feeding if it is used at the recommended dose and for the shortest possible time.

Fertility:

Ibuprofen 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 Ibuprofen occasionally it will affect your chances of becoming pregnant. If you have problems becoming pregnant talk to your doctor before taking this medicine.

Low dose aspirin

Do not take if you are taking more than 75mg of aspirin a day. If you are on low-dose aspirin (up to 75mg daily) speak to your doctor or pharmacist before you take Ibuprofen suspension.

Gastrointestinal Effects:

If you get any of the following at any time during your treatment

STOP TAKING, and get medical help straight away:

• Pass blood in your stools or motions
• Pass black tarry stools or motions
• Vomit any blood or dark particles that look like coffee grounds

STOP TAKING and tell your doctor if you experience:

• Indigestion or heartburn
• Pains in your stomach (abdomen) or other abnormal stomach problems.

Driving and using machines

For short-term use and at the recommended dosage, this medicine has little or no influence on the ability to drive and use machines. If side-effects such as tiredness, dizziness, drowsiness and visual disturbances occur, do not drive or operate machines. Alcohol consumption increases the risk of these side effects.

Some of the ingredients can cause problems

• Maltitol: This product contains maltitol. If you or your child have been told by a doctor that you or your child have an intolerance to fructose, contact your doctor before taking this medicine or giving it to your child. Maltitol may have a mild laxative effect. Calorific value 2.3 kcal/g maltitol.

• Sodium: This medicine contains 2.96 mg of sodium (main component of common salt/table salt) per ml. This corresponds to 0.15 % of the maximum daily sodium intake recommended for an adult

  with the food.

• Sodium Benzoate: This medicine contains 4 mg of sodium benzoate in each 1 mL, which is equivalent to 4 mg/mL.

3. How to use this medicine

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

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).

It is recommended that patients with sensitive stomachs take Ibuprofen with food.

Doses should be given every 6-8 hours. Leave at least 4 hours between doses. The respective dosing interval should be chosen in line with the symptomatology. The maximal daily dose should not be exceeded.

The doses are:

Use with the enclosed application syringe for oral preparation

• Shake the bottle well/vigorously.
• Remove the cap by pressing it down and turning it anticlockwise.
• Insert the enclosed adapter into the neck of the bottle before first use. The adapter remains in the bottle when it is closed.
• Insert the application syringe into the adapter opening so that it is firmly fits to the adapter.
• To fill the application syringe, turn the bottle upside down. Hold the application syringe firmly and pull the plunger down gently to draw up the suspension up to the mark corresponding to the dose.
• Turn the bottle around again and remove the application syringe from the neck of the bottle by gently turning the application syringe.
• To administer the liquid, keep the end of the application syringe in your child's mouth. Then slowly push the plunger into the syringe barrel to empty the application syringe. Adjust to your child's swallowing speed. Close the bottle again after use.
• Rinse the application syringe carefully with warm water and then dry it.

Duration of treatment

This product is intended for short term use only. You should give the lowest dose for the shortest time necessary to relieve your child’s symptoms.

For infants aged 3 - 6 months medical advice should be sought if symptoms worsen or not later than 24 hours if symptoms persist.

If in children aged from 6 months this medicinal product is required for 3 days, or if symptoms worsen a doctor should be consulted.

If you take more Ibuprofen than you should

If you have taken more Ibuprofen 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.

The symptoms of overdose can include nausea, stomach pain, headache, diarrhoea, ringing in the ears, vomiting (may be blood streaked), blood in stools, confusion and shaky eye movements. At high doses, sleepiness, agitation, disorientation, chest pain, palpitations, low blood pressure, blue discolouring of the skin and mucosa (cyanosis), loss of consciousness, coma, convulsions (mainly in children), increased bleeding tendency, blood in urine, weakness and dizziness, low levels of potassium in your blood, cold body feeling and breathing problems have been reported. Further, the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Worsening of asthma in asthmatics may occur.

If you forget to take Ibuprofen

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 to make up for a forgotten 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, 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. Elderly people using this product are at increased risk of developing problems associated with side effects.

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

Do not take this medicine if you are taking acetylsalicylic acid at doses of above 75 mg daily. If you are on low-dose acetylsalicylic acid (up to 75 mg daily) speak to your doctor or pharmacist before you take Ibuprofen.

If any of the following occurs, stop taking this medicine and consult your doctor immediately or go to the emergency department of the nearest hospital:

• swelling of the face, tongue or throat, difficulty breathing, racing heart, drop in blood pressure leading to shock [serious allergic reaction]. These can happen even on first use of this medicine (very rare).
• unexplained wheezing or shortness of breath [asthma attacks (possibly with drop in blood pressure), worsening of asthma].
• reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis] (very rare).
• widespread rash, high body temperature, enlarged lymph nodes and an increase of eosinophils (a type of white blood cells) [DRESS syndrome] (frequency cannot be estimated from the available data).
• 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 Ibuprofen if you develop these symptoms and seek medical attention immediately. See also section 2. Frequency cannot be estimated from the available data.
• fever, sore throat, surface mouth ulcers, flu-like symptoms, severe fatigue, nasal and skin bleeding [disorders of blood cell formation (agranulocytosis)]. Your doctor will need to check the amount of blood cells in your blood.
• chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

If you suffer from any of the following at any time during your treatment, STOP TAKING the medicine and seek immediate medical help:

• Pass blood in your faeces (stools/motions)
• Pass black tarry stools
• Vomit any blood or dark particles that look like coffee grounds

STOP TAKING the medicine and tell your doctor if you experience:

Common (may affect up to 1 in 10 people):

• Heartburn, abdominal pain, indigestion

Uncommon (may affect up to 1 in 100 people):

• Blurred vision or other eye problems
• Hypersensitivity reactions such as hives, skin rash, itching, asthma attacks (sometimes with low blood pressure)
• Sensitivity to light

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

• Vision loss

Very rare (may affect up to 1 in 10,000 people):

• Sudden filling of lungs with water resulting in difficulty to breathe, high blood pressure, water retention and weight gain

Tell your doctor if you experience any of the below side effects:

Common (may affect up to 1 in 10 people):

• Disturbances in the digestive tract, such as diarrhoea, feeling sick, vomiting, wind, constipation
• Headache, sleepiness, dizziness, agitation, insomnia, irritability, vertigo
• Microscopic bleeding from the intestine which may result in anemia
• Tiredness

Uncommon (may affect up to 1 in 100 people):

• Digestive tract ulcer with or without perforation
• Complications of diverticula of the large bowel (perforation or fistula)
• Mouth ulcers and inflammation
• Inflammation of the stomach lining
• Runny nose
• Difficulty breathing (bronchospasm)
• Anxiety
• Pins and needles
• Difficulty hearing
• Asthma
• Acute inflammation of the liver, yellowish discolouration of the skin or whites of the eyes, liver dysfunction

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

• Depression, confusion, hallucinations
• Lupus erythematosus syndrome
• Liver damage
• Oedema

Very rare (may affect up to 1 in 10,000 people):

• Unpleasant awareness of heart beat, heart failure, heart attack or high blood pressure
• Ringing or buzzing in the ears
• Inflammation of the oesophagus or pancreas
• Narrowing of the bowel
• Liver failure
• Inflammation of the brain membrane (without bacterial infection)
• Damage of the kidney tissue
• Kidney problems including inflammation of the kidneys and kidney failure
• Hair loss

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

• Worsening of ulcers in the large intestine and Crohn’s disease (bowel disease)
• Decreased appetite
• Pain, burning or itching associated with urination
• Severe urinary system pain

Ibuprofen, especially when taken at higher than recommended doses or for a prolonged period of time, can cause damage to your kidneys and affect them removing acids properly from your blood into the urine (renal tubular acidosis). It can also cause very low levels of potassium in your blood (see section 2). This is a very serious condition and will require immediate treatment. Signs and symptoms include muscle weakness and light-headedness.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store this medicine

Keep this medicine out of reach of children.

Do not use this medicine after the expiry date which is stated on the outer packaging and the label after “EXPIRY DATE” or “EXP”. The expiry date refers to the last day of that specified month.

No special storage conditions are required for this medicinal product.

After opening, ibuprofen syrup for fever and pain relief for children has a shelf life of 6 months.

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 pack and other information

What this medicine contains

The active ingredient is Ibuprofen 100 mg per 5 ml.

The other excipients are:

Maltitol solution (E 965), citric acid monohydrate (E 330), sodium citrate (Ph.Eur.) (E 331), saccharin sodium (Ph.Eur.) (E 954), polysorbate 80 (E 433), sodium chloride, glycerol (E 422), xanthan gum (E 415), sodium benzoate (E 211) and orange flavor (contains maltodextrin, natural and nature-identical flavorings and all-rac-α-tocopherol)

How ibuprofen syrup for fever and pain relief for children looks like and content of the pack

Ibuprofen oral suspension is an off-white-coloured syrupy suspension with orange flavour.

It is available in a brown bottle with a child-resistant cap.

One bottle contains 100 ml oral suspension.

Each pack contains a graduated 5 ml syringe and an adapter (LDPE). Graduation at 0.5 ml, 1 ml, 1.5 ml, 2 ml, 2.5 ml, 3 ml, 3.5 ml, 4 ml, 4.5 ml, and 5 ml graduation.

Marketing Authorisation Holder and Manufacturer

Strides Pharma UK Limited

The Metro Centre

Dwight Road, Watford

WD18 9SS

United Kingdom

PL 13606/0342

This leaflet was last revised in 11/03/2026