Patient Leaflet Updated 01-Feb-2021 | Aspire Pharma Ltd
Ibuprofen Twelve Plus pain relief 200mg/5ml oral suspension
Package leaflet: Information for the user
Ibuprofen Twelve Plus pain relief 200mg/5ml oral suspension
The name of your medicine is Ibuprofen Twelve Plus pain relief 200mg/5ml oral suspension which will be referred to as ‘Twelve Plus pain relief’ throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.
What is in this leaflet:
1. What this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information
1 What this medicine is and what it is used for
The active ingredient (which makes this medicine work) is Ibuprofen. It belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the body’s response to pain, swelling and high temperature.
This medicine is used for the relief of:
2 What you need to know before you take this medicine
This medicine is suitable for the majority of people, but certain people should not use it. Talk to your pharmacist or doctor if you are at all unsure or if you have an infection (please see heading “infections” below).
Do not take this medicine if you or your child:
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if you or your child:
Serious skin reactions have been reported in association with ibuprofen treatment. You should stop taking Twelve Plus pain relief and seek medical attention immediately, if you develop 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 section 4.
Do not exceed the recommended dose or duration of treatment.
Other medicines and Twelve Plus pain relief
To reduce the risk of side effects, do not take this product with other NSAID containing products (e.g. aspirin, ibuprofen or naproxen). If you are on low-dose aspirin (up to 75mg daily), speak to your doctor or pharmacist before taking this medicine.
Ibuprofen may affect or be affected by some other medicines.
Avoid taking this product with corticosteroid tablets, quinolone, antibiotics or drugs that are prescribed:
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 you use Ibuprofen with other medicines.
Ibuprofen with alcohol
You should avoid alcohol while taking this medicine.
Pregnancy, breast-feeding and fertility
Tell your doctor if you become pregnant whilst taking this medicine.
Ibuprofen belongs to a group of medicines which may impair fertility in women. This 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.
You should only take this product on a doctor’s advice during the first 6 months of pregnancy.
DO NOT take this medicine if you are in the last 3 months of your pregnancy.
Speak to your doctor or pharmacist before taking this medicine if you are breast-feeding.
This medicine contains maltitol liquid and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains 57.9mg of sodium (main component of cooking/table salt) in each 10ml dose. This is equivalent to 2.9% of the recommended maximum daily dietary intake of sodium for an adult.
Ibuprofen oral suspension may hide signs of infections such as fever and pain. It is therefore possible that Ibuprofen oral suspension may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chicken pox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.
3 How to take this medicine
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).
Always shake the bottle vigorously before use.
To remove the cap, push it down and turn it anti-clockwise. There is a 5ml oral syringe (graduated in 0.25ml steps), which should be used to give the medicine.
Using the 5ml dosing syringe
Adults, the elderly and children and adolescents aged 12 to 18 years.
One 5ml to 10ml dose up to three times a day as required. Leave at least four hours between doses. Do not take more than 30ml (1200mg) in 24 hours. Ibuprofen should be taken with or after food.
Duration of treatment
This product is intended for short term use only. You should only take the lowest dose for the shortest time necessary to relieve your symptoms.
If in children and adolescents between 12 and 18 years this medicinal product is required for more than 3 days, or if symptoms worsen, a doctor should be consulted.
Adults must not take this product for more than 10 days unless your doctor tells you to. If symptoms persist or worsen consult your doctor.
Do not give to children under 12 years
If you take more medicine than you should
If you have taken more medicine than you should, or if children have taken this medicine by accident always contact a doctor or nearest hospital to get an opinion of the risk and advice on action to be taken.
The symptoms of an overdose 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, coma, convulsions (mainly in children), weakness and dizziness, blood in urine, cold body feeling, and breathing problems have been reported.
If you forget to take this medicine
If you forget a dose, take the next dose when needed, provided that the last dose was taken at least 4 hours ago. Do not take more than advised. 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 or pharmacist.
4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects may be minimised by taking the lowest dose for the shortest time necessary to relieve symptoms.
You may suffer one of the known side effects of NSAIDs (see below). If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
STOP TAKING the medicine and seek immediate medical help if you or your child develop:
STOP TAKING this medicine and tell your doctor if you or your child experience the following uncommon side effects WHICH may affect up to 1 in 100 people:
Tell your doctor if you or your child have any of the following side effects, they become worse or you notice any effects not listed:
Uncommon side effects (may affect up to 1 in 100 people):
Rare side effects (may affect up to 1 in 1000 people):
Very rare side effects (may affect up to 1 in 10,000 people):
Side effects for which the frequency cannot be estimated from available data:
Medicines such as Twelve Plus pain relief may be associated with a small increased risk of heart attack (‘myocardial infarction’) or stroke. See section 2 ‘Other warnings’.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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.
5 How to store this medicine
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle after ‘EXP’. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Once opened, this product is stable at room temperature for 6 months.
Do not throw away any medicines via wastewater or household waste. 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 Twelve Plus pain relief contains
The active substance is ibuprofen.
5ml oral suspension contains 200mg ibuprofen.
The other ingredients are:
Sodium benzoate (E211), citric acid anhydrous, sodium citrate, saccharin sodium, sodium chloride, hypromellose, xanthan gum, maltitol liquid, glycerol (E422), thaumatin (E957), strawberry flavour (natural flavouring preparations, maize maltodextrin, triethyl citrate (E1505), propylene glycol (E1520) and benzyl alcohol), purified water.
What Twelve Plus pain relief looks like and contents of the pack
This medicine is a white or off-white viscous suspension.
Twelve Plus pain relief is available in bottles of 30ml and 100ml with a child-resistant closure.
Not all pack-sizes may be marketed.
For accurate dosing a polypropylene oral syringe for oral administration, graduated in 0.25ml steps up to 5ml, is included in the pack.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
This leaflet was last revised in 01/2021
4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK
+44 (0)1730 231148
+44 (0)1730 231148
+44 (0)1730 231148