Ibuprofen 100mg/5ml Oral Suspension
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.
• 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.
• If your child gets any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if your child does not feel better or feels worse:
- after 24 hours if your child is aged under 6 months
- after 3 days if your child is aged over 6 months.
• The full name of this medicine is Ibuprofen 100mg/5ml Oral Suspension but within the leaflet it will be referred to as Ibuprofen Oral Suspension.
What is in this leaflet
j What Ibuprofen Oral Suspension is and what it is used for
^ What you need to know before giving Ibuprofen Oral Suspension to your child ^ How to use Ibuprofen Oral Suspension 4^ Possible side effects ^ How to store Ibuprofen Oral Suspension 6| Contents of the pack and other information
j What Ibuprofen Oral Suspension is and what it is used for
Ibuprofen Oral Suspension contains ibuprofen which belongs to a group of medicines called non-steroidal antiinflammatory drugs (NSAIDs) which act to relieve pain, swelling (inflammation) and reduce fever.
Ibuprofen Oral Suspension can be used for the relief of mild to moderate pain such as sore throat, teething pain, toothache, earache, headache, minor aches and sprains. It can also be used to relieve the symptoms of colds and flu and to reduce fever, including fever after vaccination at 3 months of age.
^ What you need to know before giving Ibuprofen Oral Suspension to your child
This medicine is suitable for the majority of people but certain people should not use it. Talk to your doctor or pharmacist if you are at all unsure.
Do not give this medicine to your child if:
• they are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6)
• they have ever had a reaction (e.g. asthma, runny nose, rash, swelling of the face, tongue, lips or throat) after taking ibuprofen, acteylsalicylic acid (aspirin) or other nonsteroidal-anti-inflammatory (NSAID) medicines
• they weigh less than 5kg or are under 3 months of age
• they are taking any other anti-inflammatory (NSAID) medicines, or acteylsalicylic acid (aspirin) with a daily dose above 75mg (acteylsalicylic acid should not generally be given to children under 16, but doctors may occasionally prescribe it)
• they have a stomach ulcer, perforation or bleeding, or they have had one twice or more in the past
• they have had perforation or a bleeding ulcer after taking a non-steroidal anti-inflammatory (NSAID) 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)
• they have severe kidney, heart or liver failure
• they have a condition which increases their tendency to bleeding.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before giving Ibuprofen Oral Suspension.
This is especially important if:
• your child has asthma, a history of asthma or other allergic disease
• your child has or has had kidney, liver or heart problems
• your child is dehydrated as there is a risk of kidney problems
• your child has connective tissue disorders such as SLE (Systemic Lupus Erythematosus)
• your child suffers from chronic inflammatory bowel disease such as Crohn's disease or ulcerative colitis
• your child has chickenpox.
Like other anti-inflammatory drugs, Ibuprofen Oral Suspension can mask signs of infection.
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.
You should discuss your child's treatment with your doctor or pharmacist before giving Ibuprofen Oral Suspension if your child:
• has heart problems including heart failure, angina (chest pain), or if they have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries), or any kind of stroke (including 'mini-stroke' or transient ischaemic attack "TIA").
Ibuprofen 100mg/5ml Oral Suspension
• has high blood pressure, diabetes, high cholesterol, or has a family history of heart disease or stroke.
Aseptic meningitis (inflammation of the brain membrane without bacterial infection)
During treatment with ibuprofen, some cases of meningitis (presenting as stiff neck, headache, nausea, vomiting, fever or disorientation) have been seen. Although it is probably more likely to occur in patients with existing autoimmune disorders such as systemic lupus erythematosus or mixed connective tissue diseases, it has been reported in patients who do not have an existing long-term disease.
Other medicines and Ibuprofen Oral Suspension
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
Ibuprofen Oral Suspension may affect or be affected by some other medicines. For example:
• Other medicines containing ibuprofen or other NSAIDs, including those you can buy over the counter.
• Acteylsalicylic acid (aspirin).
• Medicines that are anti-coagulants (i.e. thin blood/ prevent clotting e.g. aspirin/acetlsaslyclic acid, warfarin, ticlopidine).
• Antiplatelet drugs (e.g. dipyridamole, clopidogrel).
• Mifepristone (for termination of pregnancy).
• Zidovudine (for HIV infection).
• Medicines known as sulfonylureas such as glibenclamide (used to treat diabetes).
• Methotrexate (for psoriasis, arthritis and types of cancer).
• Cardiac glycosides (e.g. digoxin - used to treat particular heart problems).
• Diuretics ('water tablets').
• Medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan).
• Corticosteroids (an anti-inflammatory drug).
• SSRI antidepressant drugs (for depression).
• Aminoglycoside antibiotics (for infection).
• Lithium (for mood disorders).
• Ciclosporin or tacrolimus (to prevent organ rejection after transplant).
• Cholestyramine (used to lower cholesterol).
• Voriconazole or fluconazole (types of anti-fungal drugs).
Seek the advice of your doctor or pharmacist if any of the above apply.
Some other medicines may also affect or be affected by the treatment of Ibuprofen Oral Suspension. You should therefore always seek the advice of your doctor or pharmacist before your child uses Ibuprofen Oral Suspension with other medicines.
If you are not sure what types of medicines your child is taking, show the medicine to the doctor or pharmacist.
Other important information
Ibuprofen Oral Suspension contains maltitol liquid and sodium
If you have been told by your doctor that your child has an intolerance to some sugars, contact your doctor before using this medicinal product.
Maltitol liquid may have a mild laxative effect.
Each 5ml spoonful contains 2g of maltitol liquid. This provides 4.6kcal per 5ml spoonful.
This medicinal product contains 7.37mg of sodium in each 5ml dose. To be taken into consideration by patients on a controlled sodium diet.
If you are an adult intending to take this medicine:
All the information in this leaflet applies to you as well.
In addition:
• If you are elderly you may be more likely to have some of the possible side effects listed later in the leaflet. Talk to your doctor before taking this medicine.
• 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.
Pregnancy, breast-feeding and fertility
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.
Pregnancy
During the first 6 months of pregnancy you should only take this product if advised to do so by your doctor.
DO NOT take Ibuprofen Oral Suspension if you are in the last 3 months of your pregnancy.
Breast-feeding
In limited studies, ibuprofen appears in the breast milk in very low concentration and is unlikely to affect the breastfed infant adversely.
Fertility
Ibuprofen belongs to a group of medicines (NSAIDs) which may impair fertility in women. This effect is reversible on stopping the medicine. It is unlikely that this medicine, used occasionally, will affect your chances of becoming pregnant, however, tell your doctor before taking this medicine if you have problems becoming pregnant.
^ How to use Ibuprofen Oral Suspension
Always give this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
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The recommended dose is:
|
Fever caused by immunisation | ||
|
Your child's weight (and age) |
How much? |
How often? |
|
Over 5kg (3 months and over) |
2.5ml |
Up to twice in 24 hours* |
|
* If necessary, the second dose should be given 6 hours after the first dose. • Do not give more than 2 doses in a 24 hour period. • Do not give any more medicine after second 2.5ml. See a doctor if fever continues. | ||
|
Fever, Pain and Symptoms of Cold and Flu | ||
|
Your child's weight (and age) |
How much? |
How often in 24 hours?** |
|
Over 5kg (3 to 6 months) |
2.5ml |
3 times Do not use for more than 24 hours |
|
7 - 10kg (6 to 12 months) |
2.5ml |
3 or 4 times |
|
10 - 15kg (1 to 4 years) |
5ml |
3 times |
|
15 - 20kg (4 to 7 years) |
7.5ml (5ml + 2.5ml) |
3 times |
|
20 - 30kg (7 to 10 years) |
10ml (5ml + 5ml) |
3 times |
|
30 -40kg (10 years and older) |
15ml (5ml + 5ml + 5ml) |
3 times |
|
** Doses should be given every 6 - 8 hours. Leave at least 4 hours between doses. | ||
Always shake the bottle thoroughly before use.
Always use the syringe supplied with the pack. The syringe can be used to measure 2.5ml or 5ml by drawing the liquid to the correct mark on the syringe.
Do not give to a child under 3 months of age, unless advised to do so by your doctor.
For Short-term use only
• Do not give to babies aged 3-6 months for longer than 24 hours.
• Do not give to children aged 6 months or over for longer than 3 days.
Consult your doctor if symptoms worsen or persist.
Give the lowest amount for the shortest possible time to relieve the symptoms.
Do not give more than the amount recommended above.
Directions for using the syringe:
1. Shake the bottle thoroughly 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 (2.5ml or 5ml) 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 5ml 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 use more Ibuprofen Oral Suspension than you should
If you accidently give or take more Ibuprofen Oral Suspension than the recommended dose, contact a doctor straight away.
If you forget to use Ibuprofen Oral Suspension
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 take 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, pharmacist or nurse.
4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Medicines such as Ibuprofen Oral Suspension may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Water retention (oedema), high blood pressure and heart failure have been reported in association with NSAIDs.
If your child experiences any of the following serious side effects, stop giving this medicine and tell a doctor immediately:
Very rare (affects less than 1 user in 10,000 users):
• Passing blood in their stools or passing black tarry stools.
• Vomiting blood or dark particles that look like coffee grounds.
• Severe allergic reactions. Symptoms could be swelling of the face, tongue, neck or throat, difficulty breathing, fast heart rate, feeling faint or dizzy or collapse.
• Unexplained wheezing (asthma), worsening of existing asthma, difficulty in breathing.
• Severe allergic skin reactions which may 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).
• 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).
Not known (cannot be estimated from the available data):
• Severe skin infections and complications of the soft tissue during a chicken pox or shingles infection.
• Heart failure (your child may be tired, have difficulty breathing or swollen legs).
• Inflammation of the brain membrane without bacterial infection (aseptic meningitis).
If your child experiences any of the following side effects, stop giving this medicine and tell your doctor:
Uncommon (affects 1 to 10 in 1,000 users):
• Allergic skin reactions such as itchy, red, raised rash
• Unexplained stomach pain, indigestion, heartburn or nausea.
Rare (affects 1 to 10 in 10,000 users):
• Unexplained vomiting.
Very rare (affects less than 1 user in 10,000 users):
• Yellowing of the skin or eyes, pale stools or upper abdominal pain (these may be signs of liver problems).
• Tiredness or severe exhaustion, 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). This could be caused by changes in the blood.
Other side effects which may occur are:
Uncommon (affects 1 to 10 in 1,000 users):
• Headache.
Rare (affects 1 to 10 in 10,000 users):
• Diarrhoea, constipation and wind. Tell your doctor if these last for more than a few days or become troublesome.
Very rare (affects less than 1 user in 10,000 users):
• Worsening of colitis or Crohn's disease.
• Swellings or ulcers of the mouth lining.
Not known (cannot be estimated from the available data):
• Fluid retention, which may cause swelling of the limbs.
• High blood pressure.
• A small increased risk of heart attack or stroke is posssible if a high dose of ibuprofen is taken for a long time. This is unlikely at the dose level given to children.
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 Website: www.mhra.gov.uk/vellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
^1 How to store Ibuprofen Oral Suspension
This medicine does not require any special storage conditions.
Shelf life after first opening the bottle: 6 months.
Keep this medicine out of the sight and reach of children. Shake well before use.
Do not use this medicine after the expiry date which is stated on the bottle label and carton after EXP.
The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater. 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 Ibuprofen Oral Suspension contains
• The active substance is ibuprofen.
• 5ml of oral suspension contains 100mg of ibuprofen.
• The other ingredients are: sodium benzoate (E211), citric acid anhydrous, maltitol liquid, xanthan gum, hypromellose, glycerol, sodium chloride, polysorbate 80, sodium cyclamate, acesulfame potassium, sucralose, orange flavour ('Orange Juice 055604TEU' containing flavouring components (flavouring preparations, flavouring substances, natural flavouring substances), alpha-tocopherol (E307), benzyl alcohol), vanillin, purified water.
What Ibuprofen Oral Suspension looks like and contents of the pack
Ibuprofen Oral Suspension is a white to almost white suspension with orange-vanilla flavour.
Ibuprofen Oral Suspension is supplied in an amber glass bottle containing 100ml, or an amber plastic bottle containing 100ml. The bottle is closed with a child-resistant plastic screw cap. Each pack also contains a plastic oral dosing syringe.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavikurvegi 76-78 220 Hafnarfjorbur Iceland
Manufacturer
Balkanpharma Troyan AD 1, Krayrechna Str.,
Troyan 5600 Bulgaria
This leaflet was last revised in May 2016
If you would like a leaflet with larger text, please contact 01271 385257.
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^actav/s
Actavis, Barnstaple, EX32 8NS, UK