Ibuprofen 200mg Tablets
90 mm
90 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER_
| IBUPROFEN 200MG TABLETS |
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 have 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 you do not feel better or if you feel worse. What is in this leaflet:
1. What Ibuprofen Tablets are and what are they used for
2. What you need to know before you take Ibuprofen Tablets
3. How to take Ibuprofen Tablets
4. Possible Side Effects
5. How to store Ibuprofen Tablets
6. Contents of the pack and other information
1. What Ibuprofen Tablets are and what they are used for The active substance used in these tablets is Ibuprofen.
Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which helps relieve pain, reduces inflammation and lower temperature when you have a fever.
These tablets are used to treat rheumatic or muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, and the symptoms of cold and influenza.
| 2. What you need to know before you take Ibuprofen Tablets |
Do not take these tablets if you:
• have ever been told you are allergic to ibuprofen, aspirin, other nonsteroidal anti-inflammatory drugs, or to any of the other ingredients (listed in section 6).
• if you have had perforation or a bleeding stomach after taking non steroidal anti-inflammatory medicines (you may have been sick and it contained blood or dark particles that looked like coffee grounds, passed blood in your stools or passed black tarry stools)
• if you have a stomach ulcer, perforation or bleeding, or have had one twice or more in the past
• suffer from severe heart, liver or kidney problems
• are in the last 3 months of pregnancy
• have had a skin rash, itchy runny nose or facial swelling when previously taking ibuprofen, aspirin or similar medicines.
• have had gastrointestinal bleeding or perforation when previously taking NSAIDs (Non-Steroidal anti inflammatory drugs)
• have breathing difficulties
• are under 12 years of age
• are taking aspirin at a daily dose above 75mg.
Warnings and Precautions
Talk to your doctor or pharmacist if you:
• suffer from asthma, or have a past history of asthma.
• have a connective tissue disorder such as SLE (Systemic Lupus Erythematosus)
• have a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) or suffer from bowel problems.
• have kidney or liver problems
• are elderly, as it increase the frequency of adverse reactions
• have high cholesterol or previously have had a heart attack or stroke
• are in the first 6 months of pregnancy
• have heart problems, previous stroke or think you might be at risk of these conditions (for example, high blood pressure, diabetes, high cholesterol or are a smoker)-See ‘Risk of heart attack or stroke' below
There is a risk of renal impairment in dehydrated children and adolescents. Other important information Risk of heart attack or stroke:
Medicines such as Ibuprofen may be associated with a small increased risk of heart attack (‘myocardial infarction') or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment (10 days)
Women of childbearing age:
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.
Other medicines and Ibuprofen Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The following medicine can affect Ibuprofen:
• other painkillers, including non-steroidal anti inflammatory medicines e.g. indometacin or diclofenac, and COX-2 inhibitors e.g. celecoxib
• anti-platelet agents and anticoagulants e.g. aspirin and warfarin (drugs to thin the blood)
• diuretics e.g. furosemide (drugs to increase urine output)
• corticosteroids (used to treat inflammatory conditions)
• methotrexate (used to reduce inflammation)
• lithium (used as a mood stabilizer)
• zidovudine (used in retroviral disease like HIV)
• selective serotonin reuptake inhibitors (SSRIs), e.g. fluoxetine (used for depression)
• ciclosporin or tacrolimus (given after transplant surgery, or used in psoriasis or rheumatism)
• mifepristone (for termination of pregnancy)- do not take ibuprofen if you have taken mifepristone in the last 12 days
• quinolone antibiotics e.g. ciprofloxacin (for infections)
• drugs to treat high blood pressure e.g. ramipril, atenolol or drugs for heart disease or to stimulate your heart e.g. glycosides such as digoxin.
Pregnancy, breast-feeding and fertility
• Do NOT take this medicine if you are in the last 3 months of pregnancy.
• Speak to your doctor or pharmacist before taking this medicine if you are in the first 6 months of pregnancy, are breast feeding or are planning to breastfeed.
• Always ask your doctor or pharmacist for advice before taking any other medicine.
Ibuprofen Tablets contains Lactose Monohydrate, Sucrose and
Sunset Yellow
• If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine as it contains Lactose Monohydrate and Sucrose
• Also Sunset Yellow (E110) used in this medicine may cause allergic reactions.
| 3. How to take Ibuprofen Tablets |
• The tablets should be swallowed with a drink of water.
• Take with or after food to reduce the possibility of side effects
• You should check with your doctor or pharmacist if you are not sure.
Adults, the elderly adolescents of 12 to 17 years:
• Take one or two tablets up to 3 times a day.
• The dose should not be repeated more frequently than every 4 hours.
Ibuprofen Tablets
200 mg (GSL) 430 mm
Insert
• Do not take more than 6 tablets in any 24 hour period.
This product is intended for short term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms.
Adults and the elderly: If this medicinal product is required for more than 10 days, or if symptoms persist or worsen, consult your doctor. Adolescents: If this medicinal product is required for more than 3 days, or if symptoms persist or worsen, consult your doctor.
Do not give to children under 12 years of age.
If you take more Ibuprofen Tablets than you should Contact your nearest hospital A&E (casualty department) or your doctor immediately. Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily.
If you forget to take a dose of Ibuprofen Tablets
If necessary, take the missed dose when you remember.
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, Ibuprofen Tablets may sometimes cause side effects, although not everybody gets them.
STOP TAKING this medicine and seek immediate medical help if you suffer from any of the following:
• Allergic reactions, which may include skin rashes (which can sometimes be severe and include peeling and blistering of the skin of the face, mouth and genitals), itching, hives, swelling of the face, neck or throat, worsening of asthma, difficulty in breathing, increased heart rate and low blood pressure (Anaphylaxis, angioedema and severe shock). Severe allergic reactions occur very rarely.
• Are sick and it contains blood or dark particles that look like coffee grounds
• Pass blood in your stools or pass black tarry stools-bright red faeces (stools/motions)
• Stiff neck, headache, feeling sick (nausea), being sick (vomiting), fever and disorientation (not knowing where you are). These may be signs of aseptic meningitis, which has been reported in patients with connective tissue disorders like systemic lupus erythematosus. It is not known how commonly this occurs.
STOP TAKING the medicine and tell your doctor if you experience:
• indigestion or heartburn
• Abdominal pain (pains in your stomach) or other abnormal stomach symptoms
• Blood disorders (signs of this may include unexplained bleeding and bruising, fever, flu-like symptoms, severe exhaustion, sore throat and superficial mouth ulcers). This occurs very rarely.
The most commonly observed side effects of Ibuprofen are related to the
gastrointestinal tract.
The following side effects are uncommon (may affect up to 1 in 100
people)
• Headache
• Nausea (feeling sick)
• Various skin rashes
The following side effects are rare (may affect up to 1 in 1,000 people)
• Diarrhoea
• Flatulence (passing wind)
• Constipation
• Vomiting (being sick)
• dyspepsia
The following side effects are very rare (may affect up to 1 in 10,000
people)
• Red, swollen and painful gums (ulcerative stomatitis)
• Liver problems
• Kidney problems, which may result in kidney failure, and fluid retention (oedema)
• Severe forms of skin reactions including peeling and blistering of the skin of the face, mouth and genitals (Stevens Johnson syndrome, erythema multiforme and toxic epidermal necrolysis)
It is not known how commonly the following side effects occur:
• Worsening of bowel conditions like ulcerative colitis or Crohn's disease
• High blood pressure (hypertension), heart failure (when the heart is unable to pump blood and oxygen effectively around the body with increased breathlessness and ankle swelling), and fluid retention, which may cause swelling of the legs (oedema)
• Medicines such as Ibuprofen may be associated with a small increased risk of heart attack ("myocardial infarction”) 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 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.
I 5. How to store Ibuprofen Tablets I
• Keep this medicine out of the sight and reach of children
• Do not store above 250C. Store in the original package in order to protect the tablets from moisture.
• Do not use this medicine after the expiry date (EXP.) which is stated on the carton. The expiry date refers to the last day of that month.
• Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw medicines you no longer use. These measures will help protect the environment.
I 6. Contents of the pack and other infotmation |
What Ibuprofen Tablets contain:
• The active substance is Ibuprofen
• The other ingredients are: lactose monohydrate, potato starch, methyl cellulose, sodium starch glycollate, colloidal anhydrous silica, magnesium stearate, sucrose, talc, titanium dioxide (E171), sunset yellow (E110), erythrosine (E127), sodium benzoate, pregelatinised starch, maize starch and carnauba wax.
What Ibuprofen Tablets look like and contents of the pack:
• Ibuprofen tablets are pink sugar coated.
• They are available in packs of 16 tablets.
Marketing Authorisation Holder and Manufacturer:
Name and address: Bristol Laboratories Limited,
Unit 3 Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom Telephone: 0044 (0) 1442 200922
Fax: 0044 (0) 1442 873717
E-mail: info@bristol-labs.co.uk
Ibuprofen 200mg Tablets; PL 17907/0505 This leaflet was last revised in June 2015
To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.
V6 18-06-15 D0
SAME SIZE ARTWORK 430 x 140 mm
430 mm
90 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER_
| IBUPROFEN 200MG TABLETS |
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 have 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 you do not feel better or if you feel worse. What is in this leaflet:
1. What Ibuprofen Tablets are and what are they used for
2. What you need to know before you take Ibuprofen Tablets
3. How to take Ibuprofen Tablets
4. Possible Side Effects
5. How to store Ibuprofen Tablets
6. Contents of the pack and other information
1. What Ibuprofen Tablets are and what they are used for The active substance used in these tablets is Ibuprofen.
Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which helps relieve pain, reduces inflammation and lower temperature when you have a fever.
These tablets are used to treat rheumatic or muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, and the symptoms of cold and influenza.
| 2. What you need to know before you take Ibuprofen Tablets |
Do not take these tablets if you:
• have ever been told you are allergic to ibuprofen, aspirin, other nonsteroidal anti-inflammatory drugs, or to any of the other ingredients (listed in section 6).
• if you have had perforation or a bleeding stomach after taking non steroidal anti-inflammatory medicines (you may have been sick and it contained blood or dark particles that looked like coffee grounds, passed blood in your stools or passed black tarry stools)
• if you have a stomach ulcer, perforation or bleeding, or have had one twice or more in the past
• suffer from severe heart, liver or kidney problems
• are in the last 3 months of pregnancy
• have had a skin rash, itchy runny nose or facial swelling when previously taking ibuprofen, aspirin or similar medicines.
• have had gastrointestinal bleeding or perforation when previously taking NSAIDs (Non-Steroidal anti inflammatory drugs)
• have breathing difficulties
• are under 12 years of age
• are taking aspirin at a daily dose above 75mg.
Warnings and Precautions
Talk to your doctor or pharmacist if you:
• suffer from asthma, or have a past history of asthma.
• have a connective tissue disorder such as SLE (Systemic Lupus Erythematosus)
• have a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) or suffer from bowel problems.
• have kidney or liver problems
• are elderly, as it increase the frequency of adverse reactions
• have high cholesterol or previously have had a heart attack or stroke
• are in the first 6 months of pregnancy
• have heart problems, previous stroke or think you might be at risk of these conditions (for example, high blood pressure, diabetes, high cholesterol or are a smoker)-See ‘Risk of heart attack or stroke' below
There is a risk of renal impairment in dehydrated children and adolescents. Other important information Risk of heart attack or stroke:
Medicines such as Ibuprofen may be associated with a small increased risk of heart attack (‘myocardial infarction') or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose
Women of childbearing age:
Ibuprofen betongs to a group of medicines whch 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.
Other medicines and Ibuprofen Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The following medicine can affect Ibuprofen:
• other painkillers, including non-steroidal anti inflammatory medicines e.g. indometacin or diclofenac, and COX-2 inhibitors e.g. celecoxib
• anti-platelet agents and anticoagulants e.g. aspirin and warfarin (drugs to thin the blood)
• diuretics e.g. furosemide (drugs to increase urine output)
• corticosteroids (used to treat inflammatory conditions)
• methotrexate (used to reduce inflammation)
• lithium (used as a mood stabilizer)
• zidovudine (used in retroviral disease like HIV)
• selective serotonin reuptake inhibitors (SSRIs), e.g. fluoxetine (used for depression)
• ciclosporin or tacrolimus (given after transplant surgery, or used in psoriasis or rheumatism)
• mifepristone (for termination of pregnancy)- do not take ibuprofen if you have taken mifepristone in the last 12 days
• quinobne antibiotics e.g. ciprofloxacin (for infections)
• drugs to treat high blood pressure e.g. ramipril, atenolol or drugs for heart disease or to stimulate your heart e.g. glycosWes such as digoxin.
Pregnancy, breast-feeding and fertility
• Do NOT take this medicine if you are in the last 3 months of pregnancy.
• Speak to your doctor or pharmacist before taking this medicine if you are in the first 6 months of pregnancy, are breast feeding or are planning to breastfeed.
• Always ask your doctor or pharmacist for advice before taking any other medicine.
Ibuprofen Tablets contains Lactose Monohydrate, Sucrose and Sunset Yellow
• If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine as it contains Lactose Monohydrate and Sucrose
• Also Sunset Yellow (E110) used in this medicine may cause allergic reactions.
| 3. How to take Ibuprofen Tablets |
• The tablets should be swallowed with a drink of water.
• Take with or after food to reduce the possibility of side effects
• You should check with your doctor or pharmacist if you are not sure.
Adults, the elderly and adolescents of 12 to 17 years:
• Take one or two tablets up to 3 times a day.
• The dose should not be repeated more frequently than every 4 hours.
Ibuprofen Tablets
200 mg (GSL) 430 mm
Insert
• Do not take more than 6 tablets in any 24 hour period.
This product is intended for short term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms.
Adults and the elderly: If this medicinal product is required for more than 10 days, or if symptoms persist or worsen, consult your doctor.
Adolescents: If this medicinal product is required for more than 3 days, or if symptoms persist or worsen, consult your doctor.
Do not give to children under 12 years of age.
If you take more Ibuprofen Tablets than you should Contact your nearest hospital A&E (casualty department) or your doctor immediately. Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily.
If you forget to take a dose of Ibuprofen Tablets
If necessary, take the missed dose when you remember.
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, Ibuprofen Tablets may sometimes cause side effects, although not everybody gets them.
STOP TAKING this medicine and seek immediate medical help if you suffer from any of the following:
• Allergic reactions, which may include skin rashes (which can sometimes be severe and include peeling and blistering of the skin of the face, mouth and genitals), itching, hives, swelling of the face, neck or throat, worsening of asthma, difficulty in breathing, increased heart rate and low blood pressure (Anaphylaxis, angioedema and severe shock). Severe allergic reactions occur very rarely.
• Are sick and it contains blood or dark particles that look like coffee grounds
• Pass blood in your stools or pass black tarry stools-bright red faeces (stools/motions)
• Stiff neck, headache, feeling sick (nausea), being sick (vomiting), fever and disorientation (not knowing where you are). These may be signs of aseptic meningitis, which has been reported in patients with connective tissue disorders like systemic lupus erythematosus. It is not known how commonly this occurs.
STOP TAKING the medicine and tell your doctor if you experience:
• indigestion or heartburn
• Abdominal pain (pains in your stomach) or other abnormal stomach symptoms
• Blood disorders (signs of this may include unexplained bleeding and bruising, fever, flu-like symptoms, severe exhaustion, sore throat and superficial mouth ulcers). This occurs very rarely.
The most commonly observed side effects of Ibuprofen are related to the
gastrointestinal tract.
The following side effects are uncommon (may affect up to 1 in 100
people)
• Headache
• Nausea (feeling sick)
• Various skin rashes
The following side effects are rare (may affect up to 1 in 1,000 people)
• Diarrhoea
• Flatulence (passing wind)
• Constipation
• Vomiting (being sick)
• dyspepsia
The following side effects are very rare (may affect up to 1 in 10,000
people)
• Red, swollen and painful gums (ulcerative stomatitis)
• Liver problems
• Kidney problems, which may result in kidney failure, and fluid retention (oedema)
• Severe forms of skin reactions including peeling and blistering of the skin of the face, mouth and genitals (Stevens Johnson syndrome, erythema multiforme and toxic epidermal necrolysis)
It is not known how commonly the following side effects occur:
• Worsening of bowel conditions like ulcerative colitis or Crohn's disease
• High blood pressure (hypertension), heart failure (when the heart is unable to pump blood and oxygen effectively around the body with increased breathlessness and ankle swelling), and fluid retention, which may cause swelling of the legs (oedema)
• Medicines such as Ibuprofen may be associated with a small increased risk of heart attack ("myocardial infarction”) 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 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 Tablets |
• Keep this medicine out of the sight and reach of children
• Do not store above 250C. Store in the original package in order to protect the tablets from moisture.
• Do not use this medicine after the expiry date (EXP.) which is stated on the carton. The expiry date refers to the last day of that month.
• Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw medicines you no longer use. These measures will help protect the environment.
I 6. Contents of the pack and other information |
What Ibuprofen Tablets contain:
• The active substance is Ibuprofen
• The other ingredients are: lactose monohydrate, potato starch, methyl cellulose, sodium starch glycollate, colloidal anhydrous silica, magnesium stearate, sucrose, talc, titanium dioxide (E171), sunset yellow (E110), erythrosine (E127), sodium benzoate, pregelatinised starch, maize starch and carnauba wax.
What Ibuprofen Tablets look like and contents of the pack:
• Ibuprofen tablets are pink sugar coated.
• They are available in packs of 16 tablets.
Marketing Authorisation Holder and Manufacturer:
Name and address: Bristol Laboratories Limited,
Unit 3 Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom Telephone: 0044 (0) 1442 200922
Fax: 0044 (0) 1442 873717
E-mail: info@bristol-labs.co.uk
Ibuprofen 200mg Tablets; PL 17907/0505 This leaflet was last revised in June 2015 To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.
V6 18-06-15 D0
SAME SIZE ARTWORK 430 mm
430 x 150 mm
Kaypee Design