Ibuprofen 100mg/5ml Oral Suspension
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I
Read all of this leaflet carefully because it contains important information on how to use
this medicine.
This medicine is available without a prescription. However, you still need to use Orbis
Ibuprofen For Children 100mg/5ml Oral Suspension (Now called Orbis Ibuprofen For
Children throughout the leaflet) 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.
• For children over 6 months you must contact a doctor if your child's symptoms worsen or do not improve after 3 days.
• For children 3-6 months you must contact a doctor if your child's symptoms worsen or do not improve after 24 hours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet
1. What is Orbis Ibuprofen For Children and what it is used for
2. Before using Orbis Ibuprofen For Children
3. How to use Orbis Ibuprofen For Children
4. Possible side effects
5. Storing Orbis Ibuprofen For Children
6. Further information
1. What is Orbis Ibuprofen For Children and what it is used for
Orbis Ibuprofen For Children belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It is used as a pain killer (an analgesic) to relieve pain. This pain could be mild to moderate muscular pain, teething pain, toothache and minor injuries such as sprains and strains.
Orbis Ibuprofen For Children can also be used to bring down fever (high temperature) -including post-immunisation fever.
2. Before using Orbis Ibuprofen For Children
This medicine is suitable for most people but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist.
Do not give this medicine to babies or children who ...
• weigh less than 5 kg
• have ever had a bad reaction to any of the ingredients (see section 6)
• have or have ever had a stomach ulcer or other gastric complaint
• have or have ever had an allergic reaction or wheezing after taking Ibuprofen, Aspirin or other anti-inflammatory pain killers
• are taking other NSAID painkillers or Aspirin with a daily dose above 75mg
• suffer from severe kidney, liver or heart problems.
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Orbis Ibuprofen Leaflet |
Colours (Printed) |
Colours (Non-Printed) | |
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Title: |
Oral Suspension/Leaflet | ||
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Date: |
06/12/2013 |
Pantone Process Black C | |
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Size: |
297 x 210mm (W x H) |
Orbis Consumer Products Ltd | |
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Code: |
3107/4 |
Cunard Road, Park Royal London, NW10 6PN |
Talk to your doctor or pharmacist before giving Orbis Ibuprofen For Children if your child ...
• has asthma or has suffered from asthma
• has kidney, liver, heart or blood pressure
problems
• has bowel problems
• has Systemic Lupus Erythematosus (SLE)
a condition to the immune system affecting connective tissue resulting in joint pains, skin changes and disorder of other organs.
Taking other medicines
Tell your doctor or pharmacist if your child is taking or has recently taken any other medicines including those obtained without a prescription. This includes herbal medicines. This is because Orbis Ibuprofen For Children can affect the way some medicines work.
Also, some other medicines can affect the way Orbis Ibuprofen For Children works.
In particular, do not give this medicine and tell your doctor or pharmacist if your child is taking any of the following:
•Aspirin •Other NSAIDs
• Medicines used to thin the blood such as Warfarin
•Water tablets (diuretics)
•Medicines for high blood pressure
• Corticosteroids
•Medicines for depression called Selective serotonin reuptake inhibitors (SSRIs) such as paroxetine and fluoxetine or Lithium
• Medicines to prevent blood clots from forming such as clopidogrel
• Digoxin (for heart failure)
• methotrexate (for arthritis, psoriasis or some cancers)
•tacrolimus (for transplant and eczema)
• ciclosporin (for transplant, arthritis or psoriasis)
• mifepristone (for termination of pregnancy) •antibiotics called quinolones (such as
ciprofloxacin)
• Zidovudine (used to treat HIV infection).
If you are not sure about the medicine your child is taking, show the bottle or pack to your pharmacist.
If adults take this medicine:
The following additional warnings are included
in case an adult takes this product.
X Do not take this product if you:
• are in the last 3 months of pregnancy.
Talk to your doctor or pharmacist before taking this medicine:
• If you are in the first 6 months of pregnancy
• If you are planning to become pregnant. Ibuprofen belongs to a group of medicines which may impair fertility in women. This effect is reversible on stopping the medicine. It is unlikely that Ibuprofen, used occasionally, will affect your chances of becoming pregnant, however, tell your doctor before taking this medicine if you have problems becoming pregnant.
• If you are breast feeding
• If you are a smoker.
Important
• Medicines such as Orbis Ibuprofen For Children 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 (3 days).
If your child has heart problems, previous stroke or you think that your child might be at risk of these conditions (for example if your child has high blood pressure, diabetes or high cholesterol or is a smoker) you should discuss the treatment with a doctor or pharmacist.
B Driving and operating machinery
• This medicine is unlikely to affect your ability to drive or to operate machinery.
Important information about some of the
ingredients of Orbis Ibuprofen For Children
• Maltitol liquid (E965): If you have been told by your doctor that you or your child have intolerance to some sugars, contact your doctor before giving this medicinal product.
• Sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217): May cause allergic reactions (possibly delayed).
Continued, please turn over
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Age |
Dosage |
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Under 3 months |
Not recommended |
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Infants from 3 months up to 6 months weighing more than 5 kg1: |
One small 2.5ml spoonful three times a day. Do not use for more than 24 hours |
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Infants from 6 months up to 12 months: |
One small 2.5ml spoonful three times a day |
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Children from 1 year up to 4 years: |
One large 5ml spoonful three times a day |
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Children from 4 years up to 7 years: |
One large 5ml spoonful and one small 2.5ml spoonful three times a day |
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Children from 7 years up to 12 years: |
Two large 5ml spoonfuls three times a day |
3. How to use Orbis Ibuprofen For Children
Orbis Ibuprofen For Children should be taken by mouth. Shake the bottle well before measuring the dose. Use the enclosed double ended spoon to measure the dose. The big spoon measures 5ml and the small spoon measures 2.5ml.
• Do not give to babies under 3 months
• Do not give to babies who weigh less than 5 kg.
For Post Immunisation Fever
One small 2.5ml spoonful. A second dose of one small 2.5ml spoonful can be given 6 hours later if necessary.
• Do not give more than 2 doses in 24 hours
• If the fever is not reduced you should consult your doctor.
For Pain and Fever Relief The usual daily dose in children is 20mg per kg of bodyweight in divided doses which can be given as follows:
• Do not give to babies under 3 months
• Do not give to babies who weigh less than 5 kg.
• Doses should usually be given every 6-8 hours as required. Leave at least 4 hours between doses.
• For short term use only:
♦ Do not give to babies aged 3-6 months for more than 24 hours.
♦ Do not give to children aged 6 months or over for more than 3 days
• If symptoms persist or worsen, consult your doctor promptly.
Do not exceed the stated dose.
If you give more Orbis Ibuprofen For Children than you should
If you, your child or someone you know accidentally takes a lot more than the stated dose (an overdose) of this medicine, either call your doctor straight away, or go to your nearest hospital casualty department. Always take any remaining medicine, the container and the label with you, so that the medicine can be identified.
If you forget to give Orbis Ibuprofen For Children
If you forget to give a dose, give it as soon as you remember, unless it is almost time for the next dose. Don't give two doses at the same time.
If you are worried or are not sure of when or how to use this medicine, ask your doctor or pharmacist for advice.
4. Possible side effects
Like all medicines, Orbis Ibuprofen For Children can cause side effects although not everybody gets them.
The following effects are very rare (less than 1 in 10,000 people) but if your child experiences any of the following side effects then STOP giving this medicine immediately and contact your doctor or pharmacist.
• Peptic ulceration or perforation: Symptoms can include severe abdominal pain, vomiting blood (or liquid with what looks like coffee grounds), blood in the faeces (stools/motions) or passing black tarry stools.
• Inflammation of the brain lining. Symptoms can include stiff neck, headache, nausea, vomiting, fever or feeling disorientated.
•Severe allergic reactions. Symptoms can include dizziness or fainting, faster heart rate, swelling of the face, tongue and throat. •Worsening of asthma and wheezing or difficulty breathing.
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Title: |
Orbis Ibuprofen Leaflet Oral Suspension/Leaflet |
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Date: |
06/12/2013 |
|
Size: |
297 x 210mm (W x H) |
|
Code: |
3107/4 |
Colours (Printed)
Pantone Process Black C
Colours (Non-Printed)
Orbis Consumer Products Ltd
Cunard Road, Park Royal London, NW10 6PN
Other Possible Side Effects
Less than 1 in 100 people may experience the following uncommon side effects:
•Allergic Reactions: Hives, skin rashes and itching.
•Stomach: Abdominal pain, indigestion, heartburn and nausea.
• Nervous system: Headache.
Less than 1 in 1000 people may experience the following rare side effects:
•Diarrhoea, wind, constipation and vomiting.
Less than 1 in 10,000 people may experience the following very rare side effects:
• Reduction in blood cells, which can make the skin pale or yellow, cause fever, sore throat, mild mouth ulcers, flu-like symptoms, exhaustion or weakness, easy bruising, or bleedingfrom the skin or nose.
• High blood pressure, heart failure or chest pain.
• Liver problems. Symptoms could include yellowing of the skin or the whites of the eyes.
• Kidney problems. Symptoms could include swelling of the ankles.
•Severe skin reactions. Symptoms could include blistering.
Medicines such as Orbis Ibuprofen For Children may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.
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. By reporting side effects you can help provide more information on the safety of this medicine.
5. Storing Orbis Ibuprofen For Children
• Keep out of the reach and sight of children
• Do not store above 25°C. Store in the original container.
• Do not use Orbis Ibuprofen For Children after the expiry date which is stated on the bottle after Exp:. The expiry date refers to the last day of that month.
• Medicines should not be disposed via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
Orbis Ibuprofen For Children is a white suspension with an aroma of strawberries.
Each 5ml of suspension contains lOOmg Ibuprofen.
It also contains the following inactive ingredients: Glycerol, polysorbate 80, xanthan gum (E415), maltitol liquid (E965), sodium saccharin (E954), citric acid monohydrate, sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217), strawberry flavour and purified water.
Each bottle contains lOOml of oral suspension. A double ended 5ml and 2.5ml polypropylene spoon is also included to help measure the dose.
Product licence holder (PL 17862/0010) and manufacturer of Orbis Ibuprofen For Children
is:
Orbis Consumer Products Ltd., Cunard Road, Park Royal, London, NW10 6PN
Contact us at the above address for information in large print, audio or Braille
Leaflet Updated December 2013
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