Ibuprofen 100mg/5ml Suspension Orange

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

This medicine is available without prescription to treat minor conditions. However, you still need to give 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
• The leaflet is written in terms of giving this medicine to your child, but if you are an adult who is intending to take this medicine yourself the information in this leaflet will apply to you as well

Do not give:

• If your child is under 3 months old, or weighs less than 5 kg
• If your child has a stomach ulcer, perforation or bleeding, or has had one twice or more in the past
• If your child has had perforation or a bleeding stomach after taking a non-steroidal anti-inflammatory medicine (your child may have been sick and it contained blood or dark particles that look like coffee grounds, passed blood in their stools or passed black tarry stools)
• If your child is allergic to ibuprofen or any other ingredients in the product, aspirin or other non-steroidal anti-inflammatory medicines (your child has ever had asthma, runny nose, itchy skin or swelling of the lips, face or throat after taking these medicines)
• If your child has severe heart, kidney or liver failure
• If your child is taking aspirin with a daily dose above 75 mg, or other non-steroidal anti-inflammatory medicines (aspirin should not generally be given to children under 16, but doctors may occasionally prescribe it)
• If your child has an intolerance to some sugars, unless your doctor tells you to (this medicine contains maltitol liquid)

Talk to your pharmacist or doctor:

• If your child has asthma, a history of asthma or other allergic disease
• If your child has bowel problems, or Crohn’s Disease
• If your child has other kidney, heart or liver problems (see above)
• If your child has connective tissue disorders such as SLE (Systemic Lupus Erythematosus)
• If your child has chickenpox
• If your child is on a low salt (sodium) diet (this medicine contains 11 mg of sodium per 5 ml spoonful)
• If your child has had a stroke, or has heart problems, high blood pressure, diabetes, high cholesterol – see ‘Risk of heart attack or stroke’ in ‘Other important information’

If your child takes other medicines

Before you give this medicine, make sure that you tell your pharmacist about ANY other medicines you might be giving to the child at the same time, particularly the following:

• Other pain killers (including NSAIDs)
• Aspirin 75 mg (to prevent heart attacks or strokes) – the protection may be reduced when you take ibuprofen
• Medicines to thin the blood (e.g. warfarin)
• Water tablets (diuretics), medicines to treat high blood pressure, medicines for heart problems
• Corticosteroids (for pain and swelling)
• Lithium (for bipolar disorder)
• Methotrexate (for cancer, psoriasis or rheumatism)
• Zidovudine (for HIV infection)
• Quinolone antibiotics (for infection)
• Medicines for depression (including SSRIs)
• Ciclosporin or tacrolimus (given after transplant surgery, or for psoriasis or rheumatism)

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for your child, including herbal and homeopathic remedies.

Other important information

Risk of heart attack or stroke: Ibuprofen may increase the risk if your child takes large amounts for a long time. The risk is small. Give the lowest amount for the shortest possible time to reduce this risk.

Information about some of the ingredients: Maltitol liquid may have a mild laxative effect. Each 5 ml spoonful contains 2.1 g maltitol. This provides 5 kcal per 5 ml spoonful.

Information for adults intending to take this medicine

All the information in this leaflet applies to you as well.

If you are elderly you may be more likely to have some of the possible side effects listed later in the leaflet.

If you smoke talk to your pharmacist or doctor before you take this medicine (see “Risk of heart attack or stroke” above).

Pregnancy: Do not take this medicine if you are in the last 3 months of pregnancy. Talk to your pharmacist or doctor if you are in the first 6 months of pregnancy.

Breastfeeding: Talk to your pharmacist or doctor before you take this medicine.

If you are a woman of childbearing age taking this medicine, it may reduce your ability to become pregnant. This effect will be reversed on stopping the medicine.

Do not take this medicine if you have taken mifepristone (for termination of pregnancy) in the last 12 days.

Directions for using the syringe:

1. Shake the bottle for at least 10 seconds before use.
2. Push the syringe firmly into the plug (hole) in the neck of the bottle.
3. To fill the syringe, turn the bottle upside down. Whilst holding the syringe in place, gently pull the plunger down drawing the medicine to the correct mark (2.5 ml or 5 ml) on the syringe.
4. Turn the bottle the right way up, and then gently twist the syringe to remove from the bottle plug.
5. Place the end of the syringe into the child’s mouth, normally to the side of the mouth between the gums and cheek. Press the plunger down to slowly and gently release the medicine.
6. If the table above advises you to give more than 5 ml of the medicine, repeat steps 2 to 5 to give your child the correct amount of medicine.

After use replace the cap on the top of the bottle tightly. Store all medicines out of the sight and reach of children.

Wash the syringe in warm water and allow to dry.

If you give too much: Talk to a doctor straight away. Take the medicine and this leaflet with you.

If your child gets any of these serious side effects, stop giving the medicine. See a doctor at once:

• Your child is sick and it contains blood or dark particles that look like coffee grounds
• Pass blood in their stools or pass black tarry stools
• Tiredness or severe exhaustion, changes in the blood which may cause unusual bruising or unexplained bleeding and an increase in the number of infections that they get (e.g. sore throats, mouth ulcers, flu-like symptoms including fever)
• Stomach problems including pain, indigestion or heartburn
• Unexplained wheezing (asthma), worsening of existing asthma, difficulty in breathing, swelling of the face, tongue, neck or throat, fast heart rate, feeling faint or dizzy or collapse (severe allergic reactions)
• Allergic skin reactions such as itchy, red, raised rash (which can sometimes be severe and include peeling, blistering and lesions of the skin)
• Worsening of existing severe skin infections (you may notice a rash, blistering and discolouration of the skin, fever, drowsiness, diarrhoea and sickness), or worsening of other infections including chicken pox or shingles
• Meningitis (e.g. stiff neck, fever, disorientation)
• High blood pressure, heart failure, (your child may be tired, have difficulty breathing or swollen legs)
• A small increased risk of heart attack or stroke if you take large amounts for a long time
• Yellowing of the skin or eyes, pale stools or upper abdominal pain (these may be signs of liver problems)
• Swellings or ulcers of the stomach
• Kidney problems, which may lead to kidney failure (your child may pass more or less urine, have blood in the urine or cloudy urine, or feel breathless, very tired or weak, have no appetite, or have swollen ankles)

If your child gets any of the following side effects see your pharmacist or doctor:

• Uncommon, feeling sick or rarely, being sick
• Uncommon, headache
• Rarely, diarrhoea, constipation and wind, and very rarely, worsening of colitis or Crohn's disease
• Frequency not known, swellings or ulcers of the mouth lining, fluid retention, which may cause swelling of the limbs