Ibuprofen 100 Mg/5 Ml Oral Suspension
Package leaflet: Information for the user
IBUPROFEN 100 mg/5 ml oral suspension
Ibuprofen
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 or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
- You must talk to a doctor if your child's symptoms worsen or do not improve after 1 day (infants aged 3-6 months, weighing more than 5kg) or after 3 days (children aged 6 months and over).
What is in this leaflet
1. What IBUPROFEN is and what it is used for
2. What you need to know before you take IBUPROFEN
3. How to take IBUPROFEN
4. Possible side effects
5. How to store IBUPROFEN
6. Contents of the pack and other information
1. What IBUPROFEN is and what it is used for
This medicine contains ibuprofen. Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) which relieve pain, reduce swelling and lower temperature when you have a fever.
IBUPROFEN is used in children, aged 3 months and older (weighing more than 5 kg) for short-term symptomatic treatment of:
- Mild to moderate pain such as headache and toothache
- Fever
- Feverishness and symptoms of cold and flu
2. What you need to know before you take IBUPROFEN Do not give IBUPROFEN to children who:
- are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
- have ever suffered from shortness of breath, asthma, a runny nose, swelling or hives after using acetylsalicylic acid or other similar painkillers (NSAIDs);
- are taking other NSAID painkillers, or acetylsalicylic acid with a daily dose above 75mg;
- have (or have had two or more episodes of) a stomach or duodenal ulcer or bleeding of the stomach;
- have or ever had gastrointestinal bleeding or perforation related to previous use of NSAIDs;
- have severe liver, kidney or heart failure;
- have an illness that may make you more likely to bleed;
- are suffering from significant dehydration (caused by vomiting, diarrhoea or insufficient fluid intake);
- are suffering from bleeding on the brain (cerebrovascular bleeding) or other active bleeding;
- are younger than 3 months or weigh less than 5 kg.
If an adult is taking this product, do not take if you are in the last 3 months of pregnancy. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist. Warnings and precautions
Talk to your doctor or pharmacist before using IBUPROFEN if your child:
- has or has had asthma or allergic disease as shortness of breath may occur;
- has kidney or liver problems;
- has or has ever had high blood pressure or heart failure;
- has or has ever had stomach or bowel disorders (including ulcerative colitis or Crohn's disease);
- has systemic lupus erythematosus (SLE) or mixed connective tissue disease -illnesses that affect the immune system causing joint pain, skin changes and disorders of other organs;
- is taking other NSAIDs. The use with concomitant NSAIDs, including cyclooxygenase-2 specific inhibitors, increases the risk of adverse reactions (see section “Other medicines and IBUPROFEN” below) and should be avoided;
- has disturbances in the formation of blood cells;
- has just had major surgery;
- has chickenpox;
- has inherited a disorder of the red blood pigment haemoglobin (porphyria).
If an adult is using this product, talk to your doctor or pharmacist before using IBUPROFEN:
- if you are planning a pregnancy (see ’’Pregnancy, breast-feeding and fertility” below for more information);
- if you are in the first six months of pregnancy;
- if you are breast-feeding.
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 (1 day for infants aged 3-6 months, weighing more than 5kg or 3 days for children aged 6 months and over).
You should discuss your treatment with your doctor or pharmacist before taking IBUPROFEN 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 of feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke' or transient ischaemic attack “TIA”).
- have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.
Very rare reports of potentially life-threatening skin rashes (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of NSAIDs. Patients are at higher risk of such reactions during the first month of therapy. Stop taking IBUPROFEN and talk to your doctor or pharmacist if you notice a skin rash, mucosal lesions, or any other signs of allergic reactions.
There is a risk of renal impairment in dehydrated children, adolescents and the elderly. Undesirable effects may be minimised by using the minimum effective dose for the shortest period of time. The elderly are at increased risk of side effects.
Other medicines and IBUPROFEN
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
IBUPROFEN may affect or be affected by some other medicines. For example:
- acetylsalicylic acid, or other NSAIDs - since they may increase the risk of gastrointestinal ulcers or bleeding;
- digoxin (for heart insufficiency) - since the effect of digoxin may be enhanced;
- glucocorticoids (medicinal products containing cortisone or cortisone-like substances) - since this may increase the risk of gastrointestinal ulcers or bleeding;
- acetylsalicylic acid (low dose - up to 75 mg daily) - since the blood-thinning effect may be impaired;
- medicines that are anticoagulants (i.e. thin blood/prevent clotting e.g. acetylsalicylic acid, warfarin, ticlopidine) - since ibuprofen may enhance the effects of these medicines and may increase the risk of gastrointestinal bleeding;
- selective serotonin reuptake inhibitors (medicines used for depression) - since this may increase the risk of gastrointestinal bleeding;
- lithium (a medicine for manic depressive illness and depression) - since the effect of lithium may be enhanced;
- medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan) and water tablets (diuretics) - since ibuprofen may diminish the effects of these medicines and there could be a possible increased risk for the kidney;
- potassium spearing diuretics - since this may lead to high potassium levels in the blood;
- methotrexate (a medicine for cancer or rheumatism) -since the effect of methotrexate may be enhanced;
- medicines for diabetes (so-called sulphonylureas);
- tacrolimus and ciclosporin (immunosuppressive medicines) - since kidney damage may occur;
- mifepristone (for pregnancy termination) - since the effect of mifepristone may be reduced;
- zidovudine (a medicine for treating HIV/AIDS) - since the use of ibuprofen may result in an increased risk of bleeding into a joint or a bleeding that leads to swelling in HIV (+) haemophiliacs;
- quinolone antibiotics - since the risk for convulsions may be increased;
- aminoglycoside antibiotics;
- voriconazole or fluconazole - used for fungal infections;
- cholestyramine - used to lower cholesterol;
- Ginkgo biloba - a herbal medicine often used in dementia.
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 food, drink and alcohol
It is recommended that patients with sensitive stomachs take IBUPROFEN with food. Alcohol consumption increases the risk of side effects.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine in the last 3 months of pregnancy. Avoid the use of this medicine in the first 6 months of pregnancy unless the doctor advises otherwise.
Only small amounts of ibuprofen and its decomposition products pass into breast milk. This medicine may be taken during breast-feeding if it is used at the recommended dose and for the shortest possible time.
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. Driving and using machines
For short-term use and at the recommended dosage, this medicine has little or no influence on the ability to drive and use machines. If side-effects such as tiredness, dizziness, drowsiness and visual disturbances occur, do not drive or operate machines. Alcohol consumption increases the risk of these side effects. IBUPROFEN contains 1.5 g sorbitol in 5 ml. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Doses above 600 mg may have a mild laxative effect. Calorific value 2.6 kcal/g sorbitol.
IBUPROFEN contains aspartame which is a source of phenylalanine. May be harmful for people with phenylketonuria.
IBUPROFEN contains 0.884 mmol (or 20.34 mg) sodium in the maximum single dose (10 ml). To be taken into consideration by patients on a controlled sodium diet.
3. How to take IBUPROFEN
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. It is recommended that patients with sensitive stomachs take IBUPROFEN with food. Doses should be given every 6-8 hours. Leave at least 4 hours between doses. The respective dosing interval should be chosen in line with the symptomatology. The maximal daily dose should not be exceeded.
The doses are:
|
Age (Weight) |
Frequency |
Single dose |
Maximal daily dose |
|
3 - 6 months (5 - 7.6 kg) |
3 times a day |
50 mg (2.5 ml) |
150 mg (7.5 ml) |
|
6 - 12 months (7.7 - 9 kg) |
3 to 4 times a day |
50 mg (2.5 ml) |
150-200 mg (7.5-10 ml) |
|
1 - 3 years (10 - 15 kg) |
3 times a day |
100 mg (5 ml) |
300 mg (15 ml) |
|
4 - 6 years (16 - 20 kg) |
3 times a day |
150 mg (7.5 ml) |
450 mg (22.5 ml) |
|
7 - 9 years (21 - 29 kg) |
3 times a day |
200 mg (10 ml) |
600 mg (30 ml) |
|
10 - 12 years (30 - 40 kg) |
4 times a day |
200 mg (10 ml) |
800 mg (40 ml) |
Bulgaria
Croatia
Czech Republic Hungary
Poland
Romania
Slovenia
Spain
United Kingdom
ALKALOID
There is a 5 ml plastic dosing syringe in the pack which should be used to administer the medicine.
Directions for using the dosing syringe:
1. Shake the bottle well before each use.
2. Remove the cap from the bottle.
3. Remove the cap from the syringe.
4. While the bottle is sitting on a firm, flat surface, insert the syringe into the bottle.
5. Slowly pull back the plunger of the syringe up to the graduation mark on the syringe corresponding to the quantity in millilitres (ml) according to the dosing table.
6. Remove the syringe from the bottle.
7. Make sure your child is supported in an upright position.
8. Place the tip of the syringe into the child's mouth and slowly press the plunger of the syringe down to gently release the medicine.
9. Allow your child some time to swallow the medicine.
10. Repeat steps 4-9 in the same way until the whole dose has been given.
11. After use replace the cap on the bottle. Wash the syringe with warm water and allow to dry.
Duration of treatment
This product is intended for short term use only. You should give the lowest dose for the shortest time necessary to relieve your child's symptoms.
For infants aged 3 - 6 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 this medicinal product is required for 3 days, or if symptoms worsen a doctor should be consulted.
If you take more IBUPROFEN than you should
You may experience, nausea, stomach ache or headache, vomiting, diarrhoea, ringing in the ears, dizziness, vomiting blood and blood in stools. More serious poisoning can lead to drowsiness, excitation, disorientation, low blood pressure, reduced breathing (respiratory depression), blue discolouring of the skin and mucosa (cyanosis), loss of consciousness, coma, convulsions, cramps in children and increased bleeding tendency. Worsening of asthma in asthmatics may occur. You should seek immediate medical advice in the event of an overdose.
If you forget to take IBUPROFEN
If you forget a dose, give the next dose when needed, provided that the last dose was taken at least 4 hours ago.
Do not give 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 the symptoms. Elderly people using this product are at increased risk of developing problems associated with side effects.
Medicines such as IBUPROFEN may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.
Do not take this medicine if you are taking acetylsalicylic acid at doses of above 75 mg daily. If you are on low-dose acetylsalicylic acid (up to 75 mg daily) speak to your doctor or pharmacist before you take IBUPROFEN.
If any of the following occurs, stop taking this medicine and consult your doctor immediately or go to the emergency department of the nearest hospital:
- signs of very rare (may affect up to 1 in 10,000 people) but serious allergic reaction such as, swelling of the face, tongue or throat, difficulty breathing, racing heart, drop in blood pressure leading to shock. These can happen even on first use of this medicine.
- asthma attacks (possibly with drop in blood pressure), worsening of asthma, unexplained wheezing or shortness of breath.
- severe very rare skin reactions (may affect up to 1 in 10,000 people) such as rashes covering the whole body, peeling, blistering or flaking skin (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis).
- disorders of blood cell formation (agranulocytosis, with symptoms like fever, sore throat, surface mouth ulcers, flu-like symptoms, severe fatigue, nasal and skin bleeding). Your doctor will need to check the amount of blood cells in your blood.
If you suffer from any of the following at any time during your treatment, STOP TAKING the medicine and seek immediate medical help:
- Pass blood in your faeces (stools/motions)
- Pass black tarry stools
- Vomit any blood or dark particles that look like coffee grounds STOP TAKING the medicine and tell your doctor if you experience:
Common (may affect up to 1 in 10 people):
- Heartburn, abdominal pain, indigestion Uncommon (may affect up to 1 in 100 people):
- Blurred vision or other eye problems
- Hypersensitivity reactions such as hives, skin rash, itching, asthma attacks (sometimes with low blood pressure)
- Sensitivity to light
Rare (may affect up to 1 in 1,000 people):
- Vision loss
Very rare (may affect up to 1 in 10,000 people):
- Sudden filling of lungs with water resulting in difficulty to breathe, high blood pressure, water retention and weight gain
Tell your doctor if you experience any of the below side effects:
Common (may affect up to 1 in 10 people):
- Disturbances in the digestive tract, such as diarrhoea, feeling sick, vomiting, wind, constipation
- Headache, sleepiness, dizziness, agitation, insomnia, irritability, vertigo
- Microscopic bleeding from the intestine which may result in anemia
- Tiredness
Uncommon (may affect up to 1 in 100 people):
- Digestive tract ulcer with or without perforation
- Complications of diverticula of the large bowel (perforation or fistula)
- Mouth ulcers and inflammation
- Inflammation of the stomach lining
- Runny nose
- Difficulty breathing (bronchospasm)
- Anxiety
- Pins and needles
- Difficulty hearing
- Asthma
- Acute inflammation of the liver, yellowish discolouration of the skin or whites of the eyes, liver dysfunction
Rare (may affect up to 1 in 1,000 people):
- Depression, confusion, hallucinations
- Lupus erythematosus syndrome
- Liver damage
- Oedema
Very rare (may affect up to 1 in 10,000 people):
- Unpleasant awareness of heart beat, heart failure, heart attack or high blood pressure
- Ringing or buzzing in the ears
- Inflammation of the oesophagus or pancreas
- Narrowing of the bowel
- Liver failure
- Inflammation of the brain membrane (without bacterial infection)
- Damage of the kidney tissue
- Kidney problems including inflammation of the kidneys and kidney failure
- Hair loss
Not known (frequency cannot be estimated from the available data)
- Worsening of ulcers in the large intestine and Crohn's disease (bowel disease) 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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store IBUPROFEN
Keep this medicine out of the sight and reach of children.
After first opening the suspension can be stored for 3 months.
Do not use this medicine after the expiry date which is stated on the carton after “Expiry date:”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 IBUPROFEN contains
- The active substance is ibuprofen.
5 ml oral suspension contains 100 mg ibuprofen.
- The other ingredients are: glycerol, sorbitol, 70% liquid non-crystallizing (E420), xanthan gum, microcrystalline cellulose and carmellose sodium, polysorbate grade 80, disodium edetate, saccharin sodium, citric acid monohydrate, sodium citrate dihydrate, sodium benzoate (E211), emulsion simethicone 30%, sodium chloride, purified water;
Flavour Apricot containing: propylene glycol, flavouring substance, natural flavouring substance, orange oil, lemon oil
Taste masking flavour containing: potato maltodextrin, flavouring components, aspartame (E951), acesulfame-K (E950)
What IBUPROFEN looks like and contents of the pack IBUPROFEN is off white to brownish homogenous suspension with apricot odour. 100 ml oral suspension is immediate packed in a 125 ml brown neutral glass bottle supplied with a polypropylene screw cap with a polyethylene sealing or alternative polypropylene screw cap child-resistant tamper evident ring with embossing and liner.
Cardboard box contains one (1) bottle, one plastic 5 ml graduated oral syringe for dosing, and an instruction leaflet. The 5 ml plastic oral syringe for dosing is graduated on 2.5 ml and 5 ml for measuring of the doses.
Marketing Authorisation Holder and Manufacturer Alkaloid-INT d.o.o, Slandrova ulica 4, 1231 Ljubljana-Crnuce, Slovenia tel.: +386 1 300 42 90; fax: +386 1 300 42 91; e-mail: info@alkaloid.si This medicinal product is authorised in the Member States of the EEA under the following names:
BlokMAX for kids 100 mg/5 ml oral suspension BlokMAX za djecu 100 mg/5 ml oralna suspenzija Ibuprofen Dr.Max 100 mg/5 ml peroralni suspenze IBUPROFEN Alkaloid-INT 100 mg/5 ml besoleges szuszpenzio IBUPROFEN Alkaloid-INT
PADUDEN, cu aroma de casie 20 mg/ml suspensie orala IBUPROFEN Alkaloid-INT 20 mg/ml peroralna suspenzija BYNER 20 mg/ml suspension oral IBUPROFEN 100 mg/5 ml oral suspension
PL 34088/0042
This leaflet was last revised in
Ibuprofen_susp_03_UK_210x297mm_mock up.indd 2 7.9.2016 12:45:46