GSL: General Sales Licence
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 00014/0652.
Ibuprofen 3 Months Plus 100mg/5ml Suspension Strawberry Flavour - GSL
Information for the user
Boots Ibuprofen 3 Months Plus 100 mg/5 ml Oral Suspension Strawberry 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.
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.
Do not give:
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.
Take special care with Ibuprofen 3 Months Plus Suspension.
Skin reactions: Serious skin reactions have been reported in association with ibuprofen treatment. You should stop giving this medicine and seek medical attention immediately, if your child develops any skin rash, lesions of the mucous membranes, blisters, or other signs of allergy since this can be the first signs of a very serious skin reaction. See ‘Possible Side Effects’.
Talk to your pharmacist or doctor:
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:
Some other medicines may also affect or be affected by the treatment of Ibuprofen. You should therefore always seek advice of your doctor or pharmacist before you can use this medicine with any other medicines, including herbal and homeopathic remedies.
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.
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 3 months up to 6 months weighing over 5 kg take 2.5 ml 3 times in 24 hours
6 months up to 1 year take 2.5 ml 3 to 4 times in 24 hours
1 year up to 4 years take 5 ml 3 times in 24 hours
4 years up to 7 years take 7.5 ml 3 times in 24 hours
7 years up to 10 years take 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. 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 more than you should: If you have given more than you should, or if children have taken the medicine by accident always contact a doctor or nearest hospital to get an opinion on the risk and advice on action to be taken.
The symptoms can include nausea, stomach pain, vomiting (may be blood streaked), headache, ringing in the ears, confusion and shaky eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, cold body feeling, and breathing problems have been reported.
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:
If your child gets any of the following side effects see your pharmacist or doctor:
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/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.
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, strawberry flavour.
The pack contains 100 ml of off-white, strawberry-flavoured syrupy suspension.
Who makes this medicine
Manufactured by the Marketing Authorisation holder
Leaflet prepared December 2017
If you would like any further information about this medicine, please contact
Artwork Reference WBAG401607