Patient leaflet - NUMARK IBUPROFEN 100 MG / 5ML ORAL SUSPENSION, FENPAED IBUPROFEN 100 MG / 5ML ORAL SUSPENSION, IBUPROFEN 100 MG / 5ML ORAL SUSPENSION
1. what ibuprofen oral suspension is and what it is used for
Ibuprofen Oral Suspension contains Ibuprofen as the active ingredient. This belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Ibuprofen Oral Suspension is given to children as a painkiller for relief of mild to moderate muscular pain, headache, sore throat, teething pain and toothache. This medicine can also be used in minor injuries such as sprains and strains. It also reduces the temperature in fever (e.g. colds, influenza and post-immunisation fever).
2. what you need to know before you give ibuprofen oral suspension do not give this medicine if your child:
- is allergic to ibuprofen or any of the other ingredients of this medicine (see Section 6 and end of Section 2: Important information about
ingredients)
- has had an allergic reaction or wheezing after taking aspirin or other non-steroidal anti-inflammatory painkillers. (Symptoms of a rare
allergic reaction are given under Section 4: Possible side effects).
- has ever had a stomach ulcer or a history of bleeding into, or perforation of, the intestine especially after previous NSAID treatment
(symptoms may include severe stomach pain or vomiting blood that contains dark particles)
- is taking any other non-steroidal anti-inflammatory painkillers (NSAIDs)
- has ever had severe kidney, heart or liver problems
- has an inherited intolerance to some sugars
- is less than 3 months old
- is taking aspirin above 75 mg daily
Warnings and Precautions
Skin reactions
Serious skin reactions have been reported in association with Ibuprofen Oral Suspension treatment. You should stop taking Ibuprofen Oral Suspension 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 including a life-threatening widespread rash with blisters and peeling skin, particularly occurring around the mouth, nose, eyes and genitals. These are known as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS). See section 4.
There is a risk of renal (kidney) impairment in dehydrated children.
You should discuss your child’s treatment with your child’s doctor or pharmacist before giving Ibuprofen Oral Suspension, if your child:
- has high blood pressure, kidney or liver problems
- has asthma or diabetes
- has lupus or a mixed connective tissue disease
- has a chronic inflammatory intestinal disease such as ulcerative colitis, Crohn’s disease or gastrointestinal bleeding
- has chickenpox
- has an infection – please see heading “Infections” below.
This product is intended for children aged between 3 months and 12 years. If you are an adult taking this product, all the above statements apply and so do the following additional warnings:
- Do NOT take this product if you are taking aspirin at doses above 75 mg daily. If you are on low dose aspirin (up to 75 mg daily) speak
to your doctor or pharmacist before you take this product.
- Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack (’myocardial
infarction’) or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
- Do not take if you are in the last three months of pregnancy.
Speak to your doctor or pharmacist before taking if;
- you are in the first six months of pregnancy
- you are elderly
- you are trying to get 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 have heart problems including heart failure, angina (chest pain), or if you 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’)
- if you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.
Infections
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 chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.
The use of painkillers for a long period of time has been linked to headaches in some patients, a condition called medication overuse headache (MOH). Patients who have frequent or daily headaches despite (or because of) the regular use of pain killers should not be treated with increased doses of Ibuprofen Oral Suspension. Tell your doctor if you have been having headaches while taking this medicine.
Other medicines and Ibuprofen Oral Suspension
Please tell your doctor or pharmacist if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription. Ibuprofen Oral Suspension may affect or be affected by some medicines. For example:
- Diuretics (drugs to help you pass water)
- Medicines that are anticoagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
- Medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)
- Lithium or Selective serotonin reuptake inhibitors (SSRI’s e.g. Fluoxetine – used to treat mood disorders)
- Methotrexate (used to treat rheumatoid arthritis, psoriasis and some cancers)
- Zidovudine (used to treat HIV)
- Corticosteroids (anti-inflammatory drugs, such as Hydrocortisone)
- Cardiac glycosides (drugs used in the treatment of heart problems, such as Digoxin)
- Ciclosporin or Tacrolimus (used to suppress the body’s immune system)
- Mifepristone (used to terminate a pregnancy)
- Quinolone antibiotics (used to treat a wide range of infections e.g. Ciprofloxacin)
- Aminoglycosides (type of antibiotics)
- Cholestyramines (drugs used to lower cholesterol)
- Sulphonylureas (used to treat diabetes e.g. Glibenclamide)
- any other Ibuprofen preparations, including those you can buy without a prescription
- Voriconazole or Fluconazole (type of anti-fungal drugs)
- Gingko biloba herbal medicine (there is a chance you may bleed more easily if you are taking this with ibuprofen).
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 child’s doctor or pharmacist before you give Ibuprofen Oral Suspension with other medicines.
Ibuprofen Oral Suspension and alcohol
Ibuprofen may cause some side effects including dizziness, drowsiness and stomach problems such as bleeding in the stomach.
Drinking excessive alcohol while taking this medicine might make these side effects worse.
Pregnancy and breast-feeding
Ibuprofen should NOT be taken in the last 3 months of pregnancy, as it may be harmful to the unborn child. Pregnant women intending to use this product should seek medical advice before use as it should only be taken on doctor’s advice during the first 6 months of pregnancy.
Driving and using machines
Ibuprofen may make you feel dizzy or drowsy. If it affects you in this way do not drive, operate machinery or do anything that requires you to be alert.
Important information about some of the ingredients of this medicine
- Maltitol (E965), may have a mild laxative effect. If you have been told that you or your child have an intolerance to some sugars, contact
your doctor before taking/giving this medicine.
- Sodium methyl hydroxybenzoate (E219) and Sodium propyl hydroxybenzoate (E217), may cause allergic reactions (possibly delayed).
- Propylene glycol (E1520). This medicine contains 5.2 mg propylene glycol in each 5 ml which is equivalent to 0.832 mg/g.
- This medicine contains less than 1 mmol sodium (23 mg) per 5 ml dose, that is to say essentially ‘sodium-free’.
-
3. How to give Ibuprofen Oral Suspension
Shake the bottle well before measuring the dose. A measuring spoon is provided to ensure accuracy. The small spoon measures a 2.5 ml dose and the larger spoon measures 5 ml.
Children
This medicine should NOT be given if your child weighs less than 5 kg. The usual daily dose in children is 20 mg per kg of bodyweight in divided doses, every 6 to 8 hours if required. Leave at least 4 hours between doses.
For short term use only. 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). 23LF01808PW
WARNING: DO NOT EXCEED THE STATED DOSE
DOSAGE: Children (A spoon is provided to measure doses of 2.5 ml or 5 ml)
| Babies under 3 months | Do not give | |
| from 3 up to 6 months (weighing over 5 kg) | 2.5 ml 3 times a day | Do not give for more than 24 hours. |
| from 6 months up to 1 year | 2.5 ml 3 to 4 times a day | Do not give to children aged 6 months and older for more than 3 days. |
| from 1 year up to 4 years | 5 ml 3 times a day | |
| from 4 years up to 7 years | 7.5 ml 3 times a day | |
| from 7 years up to 12 years | 10 ml 3 times a day |
For infants aged 3 –5 months medical advice should be sought if symptoms worsen or not later than 24 hours if symptoms persist.
If in children aged from 6 months and in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.
Post-immunisation fever: One small spoonful (2.5 ml), followed by another small spoonful (2.5 ml) 6 hours later if necessary. Not more than 2 doses should be given in 24 hours. If fever is not reduced, consult a doctor.
If you forget to give this medicine
If you forget to give a dose, give it as soon as you remember, unless it is almost time for the next dose. Never give a double dose to make up for the missed dose.
If you give more medicine than you should
If your child or someone else accidentally takes more Ibuprofen Oral Suspension than the stated dose (an overdose), always contact a doctor or nearest hospital to get an opinion of the risk and advice on action to be taken and take the bottle with you if you can.
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.
4. possible side effects
Like all medicines, this medicine can cause side effects although not everybody gets them.
You should STOP giving Ibuprofen and seek advice from your doctor if your child experiences a very rare allergic reaction, including skin rashes, increased sensitivity to light, swelling of the face and tongue, inflammation of the blood vessels, fever or shock. Skin and mucous membrane reactions may also occur.
If your child suffers from the following, stop giving the medicine and seek immediate medical help:
- Passing blood in their faeces (stools/motions)
- Passing black tarry stools
- Vomiting blood or dark particles that look like ground coffee
- Stiff neck, intolerance to bright light, headache, nausea, vomiting, fever and disorientation.
If your child experiences any of the following, stop giving the medicine and tell your doctor immediately:
- Unexplained stomach pain, indigestion, heartburn, feeling sick and/or vomiting
- Unexplained wheezing, shortness of breath, skin rash (which may be severe and include blistering or peeling of the skin), itching or bruising, lightheadedness, racing of the heart or fluid retention e.g. swollen ankles, not passing enough urine
- Loss of vision, blurred or disturbed vision (visual impairment) or seeing/hearing strange things (hallucinations)
- Yellowing of the eyes and/or skin
- Severe sore throat with high fever or unexplained bleeding, bruising and tiredness
- If your child’s skin starts to turn red or they develop a varied skin reaction or their skin starts to blister or peel, this is very rare and known as Stevens-Johnson syndrome. Extensive peeling of the skin known as toxic epidermal necrolysis can also occur.
- A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).
This medicine have been associated with a small increased risk of high blood pressure, heart attack (myocardial infarction), stroke or heart failure. This medicine have in exceptional cases been associated with severe skin problems for patients with chicken pox or shingles.
Blood disorders such as reduction in blood cells and platelet counts – the first signs are: sore throat with high fever, mouth ulcers, flu-like symptoms, bleeding from the mouth, nose, ear and the skin. Kidney problems such as reduced kidney function, fluid retention (oedema), inflammation of the kidney and kidney failure.
Liver problems such as inflammation of the liver, reduced liver function and yellowing of the eyes and/or skin (jaundice) or severe skin reactions may occur rarely with ibuprofen.
Crohn’s disease or ulcerative colitis or other stomach problems may be exacerbated.
Other unusual effects may include the following:
Common (may affect up to 1 in 10 people):
- Feeling dizzy or tired
- Flatulence, diarrhoea, constipation
- Headache – if this happens while you are taking this medicine it is important not to take any other medicines for pain to help with this.
Uncommon (may affect up to 1 in 100 people):
- Drowsiness
- Anxiety
- Feeling a tingling sensation or ‘pins and needles’
- Insomnia
- Hives
- Skin becomes sensitive to light
- Hearing impairment
- Sneezing, blocked, itchy or runny nose (rhinitis)
- Stomach or gut ulcer, hole in the wall of the digestive tract
- Inflammation of your stomach lining
- Ringing in ears (tinnitus)
- Sensation of spinning (vertigo)
- Mouth ulcer.
Rare (may affect up to 1 in 1,000 people):
- Feeling depressed or confused.
Very rare (may affect up to 1 in 10,000 people):
- A life-threatening skin reaction (toxic epidermal necrolysis, Stevens-Johnson syndrome)
- Inflammation of the pancreas.
Not known (frequency cannot be estimated from the available data):
- A red, scaly widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop using Ibuprofen Oral Suspension if you develop these symptoms and seek medical attention immediately. See also section 2.
- Skin becomes sensitive to light.
5. how to store ibuprofen oral suspension
Keep this medicine out of sight and reach of children. Do not use after the expiry date shown on the bottle. Do not store above 25°C.
6. contents of the pack and other information
What Ibuprofen Oral Suspension contains
The active ingredient is ibuprofen 100 mg per 5 ml.
The other ingredients are: Glycerol (E422), Xanthan Gum, Maltitol (E965), Polysorbate 80, Saccharin Sodium (E954), Citric Acid Monohydrate, Sodium Methyl Hydroxybenzoate (E219), Sodium Propyl Hydroxybenzoate (E217), Purified Water and Strawberry Flavour (contains propylene glycol).
What Ibuprofen Oral Suspension looks like and contents of the pack
Ibuprofen Oral Suspension is a colour-free, white oral suspension.
This medicine comes in amber glass bottles of: 100 ml, with a child-resistant closure.
Marketing Authorisation Holder
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
Manufacturer
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland or
CP Pharmaceuticals Ltd., Ash Road North, Wrexham, LL13 9UF, United Kingdom.
PL Number: 04917/0082
Leaflet prepared: May 2021
23LF01808PW