Boots Ibuprofen 3 Months Plus 100mg/5ml Suspension Orange Flavour
Internal Draft for PRAC Ibuprofen EMA/PRAC/182074/2015 NWG Plus MHRA
Recommendation PL00014/0648 Page 1
Leaflet for Almus Ibuprofen 100 mg/5 ml Suspension Orange Flavour
Information for the user
A'LTS/ITJS •
•••
Almus Ibuprofen 100 mg/5 ml Suspension Orange Flavour
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
What this medicine is for
This medicine contains Ibuprofen which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which act to relieve pain, swelling (inflammation) and reduce fever. It can be used for the fast, effective relief of mild to moderate pain such as teething pain, toothache, other dental pain, sore throat, headaches, minor aches and sprains and rheumatic and muscular pain. 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.
Before you give this medicine
This medicine can be given to children from the age of 3 months. However, some children should not be given this medicine or you should seek the advice of their pharmacist or doctor first.
X 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 antiinflammatory 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 antiinflammatory 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)
Other important information
Risk of heart attack or stroke: 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.
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 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”) - see ‘Risk of heart attack or stroke’ under ‘Other important information’
• If your child has high blood pressure, diabetes, high cholesterol, has a family history of heart disease or stroke
• If your child is dehydrated - they may get kidney problems
If your child takes other medicines
Before you give this medicine, make sure that you tell your doctor or pharmacist about ANY other medicines you might be giving to the child at the same time. Ibuprofen may affect or be affected by some other medicines. For example:
• 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, ticlopidine)
• Water tablets (diuretics)
• Medicines to treat high blood pressure (e.g. ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan), 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)
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 your child uses this medicine with any other medicines, including herbal and homeopathic remedies.
Other information
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
Leaflet for Almus Ibuprofen 100 mg/5 ml Suspension Orange Flavour
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.
J How to give this medicine
Check the cap seal is not broken before first use. If it is, do not give the medicine.
It is important to shake the bottle for at least 10 seconds before use.
Always use the syringe supplied with the pack. The syringe can be used to measure 2.5 ml or 5 ml by drawing the liquid to the correct mark on the syringe.
Give this medicine to your child to swallow.
|
Age |
How much |
How often |
|
3 months up to 6 months weighing over 5 kg |
2.5 ml |
3 times in 24 hours |
|
6 months up to 1 year |
2.5 ml |
3 to 4 times in 24 hours |
|
1 year up to 4 years |
5 ml |
3 times in 24 hours |
|
4 years up to 7 years |
7.5 ml |
3 times in 24 hours |
|
7 years up to 10 years |
10 ml |
3 times in 24 hours |
|
Don’t give more often than every 4 hours | ||
Give the lowest amount for the shortest possible time to relieve the symptoms.
For infants aged 3 to 5 months, if symptoms worsen or do not go away within 24 hours, talk to your doctor.
For a child of 6 months of age and over, if this medicinal product is required for more than 3 days, or if symptoms worsen talk to your doctor.
For fever relief after vaccination at 3 months of age: Give 2.5 ml. Give a second 2.5 ml after 6 hours, if you need to. Don’t give any more medicine. See your doctor if fever continues.
Do not give more than the amount recommended above.
Do not give to children under 3 months of age.
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. T urn 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.
Possible side effects
Most people will not have problems, but some may get some.
! 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
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. By reporting side effects you can help provide more information on the safety of this medicine.
How to store this medicine
Do not store above 25°C.
Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.
Use by the date on the end flap of the carton.
What is in this medicine
Each 5 ml of oral suspension contains Ibuprofen 100 mg, which is the active ingredient.
As well as the active ingredient, the suspension also contains purified water, maltitol liquid (E965), glycerol (E422), xanthan gum, sodium citrate, citric acid, sodium saccharin, sodium chloride, polysorbate 80, domiphen bromide, orange flavour.
The pack contains 100 ml of off-white, orange-flavoured syrupy suspension.
Who makes this medicine
Manufactured for the MA Holder BCM, Nottingham NG2 3AA By BCM Ltd, Nottingham NG2 3AA Leaflet prepared November 2015
PACK MOCK UP BOX
Product Name: Almus Ibuprofen 100 mg/5 ml Suspension Orange Flavour
Product Licence No: 00014/0648
Wording Ref: A4 text internal draft
Pack Size: 100 ml PET bottle
Version No: 1
Date issued: 16/11/2015
Reason For Change: MHRA submission to add PRAC recommendations for medicines containing ibuprofen (systemic formulations) EMA/PRAC/182074/2015 NWG plus MHRA recommendation