Brufen 400 Mg Effervescent Granules
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PACKAGE LEAFLET: INFORMATION FOR THE USER Brufen 400 mg Effervescent Granules
Ibuprofen
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- 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.
What is in this leaflet:
1. What Brufen is and what it is used for
2. What you need to know before you take Brufen
3. How to take Brufen
4. Possible side effects
5. How to store Brufen
6. Contents of the pack and other information
1. WHAT BRUFEN IS AND WHAT IT IS USED FOR
Brufen belongs to a group of medicines called ‘non-steroidal anti-inflammatory drugs’ or NSAIDs. One sachet of medicine contains 400 mg of ibuprofen.
This medicine is for short-term use
• to relieve mild to moderate pain such as headache and toothache ,
• to relieve period pain
• to reduce fever (high temperature)
It can be used in adults and adolescents over 12 years (40 kg and above).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BRUFEN
Do not give/take Brufen:
• to children younger than 12 years of age
• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6)
• if you have ever had an allergic reaction to ibuprofen, acetylsalicylic acid or other NSAIDs - the signs include a reddening or rash of the skin, swollen face or lips, runny nose, wheezing or shortness of breath
• if you have (or have had two or more episodes of) a stomach/duodenal ulcer (peptic ulcer) or bleeding
• if you have ever had bleeding or a tear in your stomach or gut when taking NSAIDs
• if you have severe liver or kidney problems
• if you have severe heart failure or coronary heart disease
• if you are suffering from bleeding on the brain (cerebrovascular bleeding) or other active bleeding
• if you have an illness that may make you more likely to bleed
• if you are suffering from significant dehydration (caused by vomiting, diarrhoea or insufficient fluid intake)
• if you are in the last 3 months of pregnancy. See ‘Pregnancy, breast-feeding and fertility’ below for more information.
Do not take Brufen if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking Brufen:
• if you have chronic inflammatory intestinal diseases such as inflammation of the colon with ulcers (ulcerative colitis), inflammation affecting the digestive tract (Crohn’s disease) or other stomach or intestinal diseases
• if you have disturbances in the formation of blood cells
• if you have problems with normal blood clotting mechanism
• if you suffer from allergies, hay fever, chronic swelling of nasal mucosa, sinuses, adenoids, or chronic obstructive respiratory disorders, because the risk for developing narrowing of the airways with difficulty in breathing (bronchospasm) is greater
• if you have ever had asthma
• if you suffer from circulation problems in the arteries of your arms or legs
• if you have liver, kidney, heart problems or high blood pressure
• if you have just had major surgery
• if you are in the first six months of pregnancy
• if you are planning a pregnancy (see "Pregnancy, breast-feeding and fertility” below for more information)
• if you are breast-feeding
• if you have chickenpox
• if you have Systemic Lupus Erythematosus (SLE) or other autoimmune diseases
• if you have inherited a disorder of the red blood pigment haemoglobin (porphyria)
Talk to your doctor or pharmacist before taking Brufen if any of the above apply to you.
Elderly
Elderly people should be aware of their increased risk of adverse events, especially bleeding and perforation in the digestive tract, which may be fatal.
Lowest effective dose
The lowest effective dose should always be used to minimise the risk for adverse events. Using a higher dose than recommended may cause serious risks.
With Brufen, there is a risk of serious side effects. Please refer to section 4 for information on what action to take if this occurs.
Heart attack and stroke
Talk to a doctor or pharmacist before taking this medicine if you have heart problems, have had a stroke or if you think that you are likely to get these conditions. This is, for example, if you have high blood pressure, diabetes, high cholesterol levels or if you smoke.
This medicine may lead to a small increased risk of heart attack or stroke. This increased risk is more likely with high doses and long-term treatment. Do not take more than the recommended dose of this medicine.
Renal effects
There is a risk of kidney damage in dehydrated adolescents.
Children under 12 years of age
This medicine should not be given to children under 12 years of age.
Other medicines and Brufen
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Brufen can affect the way some other medicines work. Also, some other medicines can affect the way Brufen works.
In particular tell your doctor or pharmacist if you are taking any of the following medicines:
• acetylsalicylic acid
• Do not use this medicine if you are taking other NSAID painkillers.
• other medicines containing ibuprofen, such as those you can buy without a prescription
• medicines for heart problems - such as digoxin
• medicines for diabetes (so-called sulphonylureas)
• medicines to stop blood clots - such as acetylsalicylic acid warfarin or ticlopidine
• medicines that suppress your immune system - such as ciclosporin or tacrolimus
• medicines for high blood pressure - including ACE-inhibitors (such as captopril), beta blockers or angiotensin-II receptor antagonists
• diuretics (water tablets)
• steroids - used for inflammatory conditions
• selective serotonin reuptake inhibitors (SSRIs) - used for depression
• some antibiotics for infections - including aminoglycosides and quinolones
• zidovudine - used for HIV or AIDS
• methotrexate - used for some cancers
• cholestyramine - used to lower cholesterol
• lithium - used for some forms of depression
• voriconazole or fluconazole - used for fungal infections
• mifepristone - used for medical termination of pregnancy
• ginkgo biloba - a herbal medicine often used in dementia
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Brufen.
Brufen with alcohol
If you drink alcohol whilst taking this medicine, you may be more likely to get side effects.
Pregnancy, breast-feeding and fertility Pregnancy
• Do not take this medicine if you are in the last 3 months of pregnancy.
• Talk to your doctor or pharmacist before taking this medicine if you are planning a pregnancy, or are in the first 6 months of pregnancy. You should only take this medicine on the advice of your doctor.
Breast -feeding
Ibuprofen is excreted in breast milk but is not likely to have an effect on the infant. Consult a doctor if you use Brufen more often than temporarily while breast-feeding.
Fertility
Ibuprofen belongs to a group of medicines (NSAIDs) which may impair the 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 or pharmacist before taking this medicine if you are having problems getting pregnant.
Driving and using machines
This medicine may make you feel dizzy or sleepy. If this happens, do not drive or use any tools or machines. Do not do anything else where you need to be alert.
Brufen contains sucrose
Sucrose is a sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.
Brufen contains sodium
Brufen contains 100 mg sodium per sachet. This should be taken into account if you are on a low sodium diet. You may need to have less sodium in your diet because of the sodium in this medicine.
3. HOW TO TAKE BRUFEN
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 product is intended for short-term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms.
How much to take
Adults and adolescents over 12 years of age (40 kg or above)
Take one sachet (400 mg) as a single dose or up to 3 times a day with an interval of 4 to 6 hours. More than 400 mg at a time does not give a better analgesic effect.
Do not take more than a total of 3 sachets (1200 mg) in any 24 hours.
People with liver or kidney problems
If you have liver or kidney problems, your doctor will tell you the correct dose to take. This will be the lowest dose possible.
The elderly (over 65 years)
If you are elderly, your doctor will tell you the correct dose to take. This will be the lowest dose possible.
Taking this medicine
In order to achieve a faster onset of action, the dose may be taken on an empty stomach.
• Empty the granules from one sachet into a small glass of water (about 125 ml).
• Make sure that you use all of the granules in the sachet.
• Stir the medicine until it stops bubbling and the granules have dissolved - this will make an orange flavoured, fizzy drink.
If you take more Brufen than you should
If you have taken more of this medicine than you should, contact a doctor or go to the nearest hospital straight away. Take the medicine pack with you.
The signs of an overdose can include: feeling sick, stomach pain, being sick (may have blood in it), headache, ringing in the ears, confusion and shaky eye movement. At high doses, there may be loss of consciousness, fits (mainly in children), feeling weak or dizzy, blood in the urine, feeling cold and breathing problems.
If you usually take painkillers, especially combinations of different substances with painkilling effect, you may damage your kidneys permanently, with the risk of kidney failure. This risk may be increased if you are dehydrated. Therefore you should avoid excessive use of any painkillers.
If you use painkillers for a long time, this can cause headaches, which should not be treated with more painkillers. If you think this applies to you, talk to your doctor or pharmacist.
If you forget to take Brufen
• If you forget a dose, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects
Stop taking this medicine and see your doctor straight away if you notice any of the following serious side effects - you may need urgent medical attention:
Uncommon (may affect up to 1 in 100people):
• Black tarry stools (faeces/motions) or blood in the stools
• Vomiting any blood or dark particles that look like coffee grounds
Very rare (may affect up to 1 in 10,000people):
• Swelling of the face, tongue or throat (larynx) which can cause great difficulty in breathing (angioedema), rapid heartbeat, severe fall in blood pressure or life threatening shock
• A sudden allergic reaction with shortness of breath, wheezing and drop of blood pressure
• Severe rash with blisters on the skin, especially on the legs, arms, hands and feet which can also involve the face and lips (erythema multiforme, Stevens-Johnson syndrome). This can get even more severe, where the blisters get larger and spread out and parts of the skin may slough off (toxic epidermal necrolysis). There may also be severe infection with destruction (necrosis) of skin, subcutaneous tissue and muscle.
• 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.
Stop taking this medicine and see your doctor straight away if you notice any of the side effects above.
Stop taking this medicine and tell your doctor if you notice any of the following:
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 such as sensitivity to light
• Hypersensitivity reactions such as skin rash, itching, asthma attacks (sometimes with low blood pressure)
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
Stop taking this medicine and tell your doctor if you notice any of the side effects above.
Other 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, vertigo, dizziness, fatigue, agitation, insomnia and irritability
Uncommon (may affect up to 1 in 100 people):
• Digestive tract ulcer with or without perforation
• Bowel inflammation and worsening of inflammation of the colon (colitis) and digestive tract (Crohn’s disease) and complications of diverticula of the large bowel (perforation or fistula)
• Microscopic bleeding from the intestine which may result in anemia
• Mouth ulcers and inflammation
• Inflammation of the stomach lining
• Kidney problems including development of oedema, inflammation of the kidneys and kidney failure
• Runny nose
• Difficulty breathing (bronchospasm)
Rare (may affect up to 1 in 1,000 people):
• Depression, confusion, hallucinations
• Lupus erythematosus syndrome
• Increase of blood urea nitrogen and other liver enzymes, decrease in haemoglobin and
haematocrit values, inhibition of platelet aggregation and prolonged bleeding time, decrease of serum calcium and increase in serum uric acid values
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
• Acute inflammation of the liver, yellowish discolouration of the skin or whites of the eyes, liver dysfunction, damage or failure
• Inflammation of the brain membrane (without bacterial infection)
• Damage of the kidney tissue • Hair loss
The following side effects have also been reported with other NSAIDs:
• High blood pressure or heart failure
• Worsening of ulcers in the large intestine and Crohn’s disease (bowel disease)
• A small increased risk of heart attack or stroke.
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 at: 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 BRUFEN
Keep out of the sight and reach of children.
Store below 25°C. Store in the original package in order to protect from light and moisture.
Do not use this medicine after the expiry date stated on the sachet and carton. The expiry date refers to the last day of that month.
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 Brufen contains
• The active substance is ibuprofen. One sachet contains: ibuprofen 400 mg.
• The other ingredients are malic acid, saccharin sodium, sucrose, povidone, orange flavour, sodium laurilsulfate, sodium hydrogen carbonate and anhydrous sodium carbonate.
What Brufen looks like and contents of the pack
Brufen is a white powder with an orange flavour. Your medicine will be contained in sachets.
Each pack contains 12, 15, 20, 30 or 40 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation holder:
BGP Products Ltd., Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, SL6 4XE, UK
Manufacturer:
AbbVie S.r.L., S.R.148 Pontina, Km 52 snc, 04011 Campoverde di Aprilia (LT), Italy
This medicinal product is authorised in the Member States of the EEA under the following names:
|
Sweden Austria Belgium Bulgaria Czech Republic Estonia Spain Hungary Ireland Italy Lithuania Luxembourg Latvia Netherlands Poland Portugal Romania Slovenia Slovakia UK |
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This leaflet was last revised in January 2015
This information is confidential