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Ibuprofen Tablets 200mg

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Document: leaflet MAH GENERIC_PL 04556-0022 change

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PATIENT INFORMATION LEAFLET

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 or nurse 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 or nurse. This includes any possible side effects not listed in this leaflet.

•    You must talk to a doctor if you do not feel better or if you feel worse.

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 Tablets

4.    Possible side effects

5.    How to store Ibuprofen Tablets

6.    Contents of the pack and other information

1. What is Ibuprofen and what is it used for

Ibuprofen belongs to a group of drugs termed Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).

Ibuprofen tablets are used for the relief of rheumatic and muscular pain, backache, neuralgia, migraine, headache, dental pain, period pain, feverishness and the symptoms of cold and flu.

2. What you need to know before you take Ibuprofen

•    DO NOT TAKE Ibuprofen if you:

•    are allergic to Ibuprofen or any other ingredients of the product (these are listed in Section 6), aspirin or other related painkillers

•    have or have had stomach ulcer, perforation or bleeding

•    are taking more than 75mg of aspirin a day

•    suffer from severe liver, kidney or heart failure

•    are in the last 3 months of pregnancy

♦ Warnings and precautions

Talk to your doctor or pharmacist before taking these tablets if you are:

•    asthmatic or suffer from kidney, liver or bowel problems

•    taking a low dose aspirin (up to 75mg daily)

•    suffering from systemic lupus erythematosus (SLE) a condition of the immune system affecting connective tissue resulting in joint pain, skin changes and disorders of other organs

•    trying to become 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 in becoming pregnant

•    in the first 6 months of pregnancy

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) without consulting your doctor or pharmacist.

If you have heart problems, previous stroke or think that you may be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker), you should discuss your treatment with your doctor or pharmacist.

There is a risk of renal impairment in dehydrated children and adolescents.

•    Other medicines and Ibuprofen

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially:

•    medication to help increase urine excretion (water tablets e.g. furosemide)

•    any other painkillers (e.g. aspirin and other NSAIDs) as it may increase the incidence of unwanted reactions

•    medication to prevent blood clotting (e.g. warfarin)

•    lithium (used in the treatment of certain mental illnesses)

•    corticosteroids (used to treat various illnesses that involve inflammation in the body e.g. prednisolone, cortisone)

•    antihypertensive (medicines which lower your blood pressure e.g. propranolol, atenolol, metoprolol, prazosin, alfuzosin, terazosin)

•    methotrexate (medicines for treating cancer)

•    antiplatelet agents and selective serotonin reuptake inhibitors

•    immunosuppressants (e.g. ciclosporin, tacrolimus)

•    cardiac glycosides, such as digoxin, used to treat heart conditions

•    quinoline antibiotics (e.g. ciprofloxacin)

•    mifepristone, zidovudine, cyclooxygenase-2 selective inhibitors

♦ Pregnancy and breast-feeding

Ibuprofen belongs to a group of medicines which may impair fertility in women. This effect is reversible on stopping the medicine. The use of Ibuprofen whilst pregnant or breast feeding should be avoided. Ibuprofen should not be used in the last three months of pregnancy and should only be taken in the first six months of pregnancy on the advice of your doctor.

♦ Ibuprofen Tablets contains sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine as it contains sucrose.

3. How to take Ibuprofen

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist or nurse have told you. Check with your doctor or pharmacist or nurse if you are not sure.

Adults, the elderly and children 12 years and over: 1 to 2 tablets, as required to be taken up to 3 times daily with or after food. Do not take more

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than 6 tablets in 24 hours. Leave at least 4 hours between each dose.

This product is intended for short term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms. You should not take these tablets for longer than 10 days unless your doctor tells you to. If symptoms persist or worsen consult your doctor. If in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

Do not give to children under the age of 12 years.

♦    If you take more tablets than you should

If you take too many tablets, contact your doctor or hospital immediately. Bring any remaining tablets with you to show the doctor.

Symptoms of overdose: headache, drowsiness, low blood pressure, sickness.

♦    If you forget to take a dose

If you forget to take a dose, take as soon as you remember, unless it is almost time for your next dose. If it is, do not take the missed dose at all. Never double up on a dose to make up for the one you have missed.

4. Possible side effects

Like all medicines, your medicine can cause side effects, although not everybody gets them. The following side effects are very rare (less than 1 in

10,000 people) but if you experience any of the effects then STOP TAKING this medicine immediately and contact your doctor or pharmacist.

   Severe allergic reactions: symptoms could include dizziness or fainting, faster heart rate, swelling of the face, tongue and throat.

   Severe skin reactions (Steven’s Johnson-Syndrome, toxic epidermal necrolysis): symptoms could include blistering of the skin,

mouth, eyes and genitals. Skin rash, easy bruising

or bleeding from the skin or nose.

   Peptic ulceration or perforation: symptoms could include severe abdominal pain, vomiting blood (or liquid with what looks like coffee grounds), blood in the faeces (stools/ motions) or passing black tarry stools.

   Inflammation of the brain lining: symptoms could include stiff neck, feeling or being sick, fever or feeling disorientated.

   Worsening of asthma and wheezing or difficulty in breathing.

If you experience any of the above mentioned side effects then STOP TAKING this medicine immediately and contact your doctor or pharmacist.

•    Other possible side effects

Less than 1 in 100 people may experience the following uncommon side effects:

•    allergic reactions such as hives, skin rashes and itching (or SLE)

•    stomach: abdominal pain, indigestion, heartburn and feeling sick

•    nervous system: headache

Less than 1 in 1000 people may experience the following rare side effects:

•    diarrhoea, constipation, wind and being sick

Less than 1 in 10,000 people may experience the following very rare side effects:

•    reduction in blood cells, which can make the skin and/or eye pale or yellow, sore throat, mild mouth ulcers, flu like symptoms, exhaustion or weakness, high blood pressure, heart failure or chest pain

•    nervousness, visual disturbance, ringing in the ears and vertigo

•    unexpected sensitivity of the skin to the sun

•    liver problems: symptoms could include yellowing of the skin or the whites of the eyes

•    kidney problems: symptoms could include swelling of the ankles, fluid retention

Medicines such as Ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

If any of the side effects mentioned get serious or if you notice any side effects not listed in this leaflet, contact your doctor or pharmacist.

Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.

5. How to store Ibuprofen

•    This medicine should not be used after the “expiry date” printed on the pack.

•    Store in a cool and dry place protected from light.

•    Do not store above 30°C. Do not freeze.

Keep all medicines out of the sight and reach of children.

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 to protect the environment.

6. Contents of the pack and other information

•    What Ibuprofen 200mg tablets contain

   The active substance (the ingredient that makes the tablet work) is Ibuprofen. Each tablet contains 200mg of the active ingredient Ibuprofen BP.

   The other ingredients are pregelatinised starch, maize starch, povidone, sodium lauryl sulphate, silicon dioxide, magnesium stearate, sucrose, purified talc, titanium dioxide and erythrosine aluminium lake (E127), bees wax (white), carnauba wax.

•    What Ibuprofen tablets look like and contents of the pack

•    Ibuprofen 200mg are pink sugar coated tablets.

•    The pack sizes are 12 and 16 tablets in blister packs. Not all pack sizes may be marketed.

The Marketing Authorization Holder and

company responsible for manufacture:

Pharmvit Ltd, 177 Bilton Road, Perivale,

Greenford, Middlesex, UB6 7HQ.

Telephone: 0208 997 5444

Fax:    0208 997 5433

To request a copy of this leaflet in large print or audio format, please contact the licence holder at the address (or telephone, fax) above.


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PATIENT INFORMATION LEAFLET

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 or nurse 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 or nurse. This includes any possible side effects not listed in this leaflet.

•    You must talk to a doctor if you do not feel better or if you feel worse.

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 Tablets

4.    Possible side effects

5.    How to store Ibuprofen Tablets

6.    Contents of the pack and other information

1. What is Ibuprofen and what is it used for

Ibuprofen belongs to a group of drugs termed Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).

Ibuprofen Tablets can be used to treat painful conditions such as rheumatic or muscular pain, pain of non-serious arthritis, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of cold and flu.

2. What you need to know before you take Ibuprofen

•    DO NOT TAKE Ibuprofen if you:

•    are allergic to Ibuprofen or any other ingredients of the product (these are listed in Section 6), aspirin or other related painkillers.

•    have or have had stomach ulcer, perforation or bleeding

•    are taking more than 75mg of aspirin a day

•    suffer from severe liver, kidney or heart failure

•    are in the last 3 months of pregnancy

•    Warnings and precautions

Talk to your doctor or pharmacist before taking these tablets if you are:

•    asthmatic or suffer from kidney, liver or bowel problems

•    taking a low dose aspirin (up to 75mg daily)

•    suffering from systemic lupus erythematosus (SLE) a condition of the immune system affecting connective tissue resulting in joint pain, skin changes and disorders of other organs

•    trying to become 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 in becoming pregnant

•    in the first 6 months of pregnancy 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) without consulting your doctor or pharmacist.

If you have heart problems, previous stroke or think that you may be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker), you should discuss your treatment with your doctor or pharmacist.

There is a risk of renal impairment in dehydrated children and adolescents.

•    Other medicines and Ibuprofen

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially:

•    medication to help increase urine excretion (water tablets e.g. furosemide)

•    any other painkillers (e.g. aspirin and other NSAIDs) as it may increase the incidence of unwanted reactions

•    medication to prevent blood clotting (e.g. warfarin)

•    lithium (used in the treatment of certain mental illnesses)

•    corticosteroids (used to treat various illnesses that involve inflammation in the body e.g. prednisolone, cortisone)

•    antihypertensive (medicines which lower your blood pressure e.g. propranolol, atenolol, metoprolol, prazosin, alfuzosin, terazosin)

•    methotrexate (medicines for treating cancer)

•    antiplatelet agents and selective serotonin reuptake inhibitors

•    immunosuppressants (e.g. ciclosporin, tacrolimus)

•    cardiac glycosides, such as digoxin, used to treat heart conditions

•    quinoline antibiotics (e.g. ciprofloxacin)

•    mifepristone, zidovudine, cyclooxygenase-2 selective inhibitors

♦    Pregnancy and breast-feeding

Ibuprofen belongs to a group of medicines which may impair fertility in women. This effect is reversible on stopping the medicine. The use of Ibuprofen whilst pregnant or breast feeding should be avoided. Ibuprofen should not be used in the last three months of pregnancy and should only be taken in the first six months of pregnancy on the advice of your doctor.

♦    Ibuprofen Tablets contains sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine as it contains sucrose.

3. How to take Ibuprofen

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist or nurse have told you. Check with your doctor or pharmacist or nurse if you are not sure.

Adults, the elderly and children 12 years and over: 1 to 2 tablets, as required to be taken up to 3 times daily with or after food. Do not take more than 6 tablets in 24 hours. Leave at least 4 hours between each dose.

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This product is intended for short term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms. You should not take these tablets for longer than 10 days unless your doctor tells you to. If symptoms persist or worsen consult your doctor. If in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

Do not give to children under the age of 12 years.

♦    If you take more tablets than you should

If you take too many tablets, contact your doctor or hospital immediately. Bring any remaining tablets with you to show the doctor.

Symptoms of overdose: headache, drowsiness, low blood pressure, sickness.

♦    If you forget to take a dose

If you forget to take a dose, take as soon as you remember, unless it is almost time for your next dose. If it is, do not take the missed dose at all. Never double up on a dose to make up for the one you have missed.

4. Possible side effects

Like all medicines, your medicine can cause side effects, although not everybody gets them. The following side effects are very rare (less than 1 in

10,000 people) but if you experience any of the effects then STOP TAKING this medicine immediately and contact your doctor or pharmacist.

•    Severe allergic reactions: symptoms could include dizziness or fainting, faster heart rate, swelling of the face, tongue and throat.

•    Severe skin reactions (Steven’s Johnson-Syndrome, toxic epidermal necrolysis): symptoms could include blistering of the skin, mouth, eyes and genitals. Skin rash, easy bruising or bleeding from the skin or nose.

•    Peptic ulceration or perforation: symptoms could include severe abdominal pain, vomiting blood (or liquid with what looks like coffee grounds), blood in the faeces (stools/ motions) or passing black tarry stools.

•    Inflammation of the brain lining: symptoms could include stiff neck, headache, feeling or being sick, fever or feeling disorientated.

•    Worsening of asthma and wheezing or difficulty in breathing.

If you experience any of the above mentioned side effects then STOP TAKING this medicine immediately and contact your doctor or pharmacist.

•    Other possible side effects

Less than 1 in 100 people may experience the following uncommon side effects:

•    allergic reactions such as hives, skin rashes and itching (or SLE)

•    stomach: abdominal pain, indigestion, heartburn and feeling sick

•    nervous system: headache

Less than 1 in 1000 people may experience the following rare side effects:

•    diarrhoea, constipation, wind and being sick

Less than 1 in 10,000 people may experience the following very rare side effects:

•    reduction in blood cells, which can make the skin and/or eye pale or yellow, cause fever, sore throat, mild mouth ulcers, flu like symptoms, exhaustion or weakness

•    high blood pressure, heart failure or chest pain

•    nervousness, visual disturbance, ringing in the ears and vertigo

•    unexpected sensitivity of the skin to the sun

•    liver problems: symptoms could include yellowing of the skin or the whites of the eyes

•    kidney problems: symptoms could include swelling of the ankles, fluid retention

Medicines such as Ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

If any of the side effects mentioned get serious or if you notice any side effects not listed in this leaflet, contact your doctor or pharmacist.

Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.

5. How to store Ibuprofen

•    This medicine should not be used after the “expiry date” printed on the pack.

•    Store in a cool and dry place protected from light.

•    Do not store above 30°C. Do not freeze.

Keep all medicines out of the sight and reach of children.

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 to protect the environment.

6. Contents of the pack and other information

•    What Ibuprofen 200mg tablets contain

•    The active substance (the ingredient that makes the tablet work) is Ibuprofen. Each tablet contains 200mg of the active ingredient Ibuprofen BP.

•    The other ingredients are pregelatinised starch, maize starch, povidone, sodium lauryl sulphate, silicon dioxide, magnesium stearate, sucrose, purified talc, titanium dioxide and erythrosine aluminium lake (E127), bees wax (white), carnauba wax.

•    What Ibuprofen tablets look like and contents of the pack

•    Ibuprofen 200mg are pink sugar coated tablets.

•    The pack sizes are “25, 50, 100 tablets in plastic containers and 24, 48, 84 and 96” tablets in blister packs.

The Marketing Authorization Holder and company responsible for manufacture:

Pharmvit Ltd, 177 Bilton Road, Perivale, Greenford, Middlesex, UB6 7HQ.

Telephone: 0208 997 5444 Fax:    0208 997 5433

To request a copy of this leaflet in large print or audio format, please contact the licence holder at the address (or telephone, fax) above.

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PATIENT INFORMATION LEAFLET

IBUPROFEN 200MG TABLETS

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 Tablets

4.    Possible side effects

5.    How to store Ibuprofen Tablets

6.    Contents of the pack and other information


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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

1. What is Ibuprofen and what is it used for

Ibuprofen belongs to a group of drugs termed Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).

Ibuprofen is used for its anti-inflammatory and analgesic effect in the treatment of rheumatoid arthritis (including juvenile rheumatoid arthritis or still’s diseases), ankylosing spondylitis, osteoarthritis and other nonrheumatoid (seronegative) arthropathies.

2. What you need to know before you take Ibuprofen_

♦    DO NOT TAKE Ibuprofen if you:

•    are allergic to Ibuprofen or any other ingredients of the product (these are listed in Section 6), aspirin or other related painkillers

•    have or have had stomach ulcer, perforation or bleeding

•    are taking more than 75mg of aspirin a day

•    suffer from severe liver, kidney or heart failure

•    are in the last 3 months of pregnancy

♦    Warnings and precautions

Talk to your doctor or pharmacist before taking these tablets if you are:

•    asthmatic or suffer from kidney, liver or bowel problems

•    suffering from systemic lupus erythematosus (SLE) a condition of the immune system affecting connective tissue resulting in joint pain, skin changes and disorders of other organs

•    trying to become 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 in becoming pregnant

•    you are in the first 6 months of pregnancy 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) without consulting your doctor or pharmacist.

If you have heart problems, previous stroke or think that you may be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker), you should discuss your treatment with your doctor or pharmacist.

There is a risk of renal impairment in dehydrated children and adolescents.

♦    Other medicines and Ibuprofen

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially:

•    medication to help increase urine excretion (water tablets e.g. furosemide)

•    any other painkillers (e.g. aspirin and other NSAIDs) as it may increase the incidence of unwanted reactions

•    medication to prevent blood clotting (e.g. warfarin)

•    lithium (used in the treatment of certain mental illnesses)

•    corticosteroids (used to treat various illnesses that involve inflammation in the body e.g. prednisolone, cortisone)

•    antihypertensive (medicines which lower your blood pressure e.g. propranolol, atenolol, metoprolol, prazosin, alfuzosin, terazosin)

•    methotrexate (medicines for treating cancer)

•    anti platelet agents and selective serotonin reuptake inhibitors

•    lithium, ciclosporin, mifepristone, quinoline antibiotics, tacrolimus, zidovudine, cardiac glycosides, cyclooxygenase-2 selective inhibitors

♦    Driving and using machines

Dizziness, drowsiness, fatigue, visual disturbances or headaches are possible undesirable effects after taking NSAIDs. If affected, patients should not drive or operate machinery.

♦    Pregnancy and breast-feeding

Ibuprofen belongs to a group of medicines which may impair fertility in women. This effect is reversible on stopping the medicine. The use of Ibuprofen whilst pregnant or breast feeding should be avoided. Ibuprofen should not be used in the last three months of pregnancy and should only be taken in the first six months of pregnancy on the advice of your doctor.

♦    Ibuprofen Tablets contains sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine as it contains sucrose.

3. How to take Ibuprofen

You should take your medicine as directed by your doctor. The pharmacist’s label should tell you how much to take and how often. If it does not or you are not sure ask your doctor or pharmacist.

Leave at least 4 hours between each dose.

Adult: The recommended initial dose of Ibuprofen is 1200mg daily in divided doses.

Some patients can be maintained on 600-1200mg daily. It can be advantageous in severe conditions to increase the dosage to 1600mg daily in divided

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doses until the acute phase is brought under control.

Elderly: The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.

Children: 20mg of Ibuprofen per kg of body weight daily, except that in children weighing less than 30 kg, the total of Ibuprofen given in 24 hours should not exceed 500mg.

♦    If you forget to take a dose:

If you forget to take a tablet, take as soon as you remember, then go on as before. Do not take a double dose to make up for a forgotten dose.

♦    If you take more tablets than you should:

If you take too many tablets, contact your doctor or hospital immediately. Bring any remaining tablets with you to show the doctor.

Symptoms of overdose: Headache, drowsiness, low blood pressure, sickness.

4. Possible side effects

Like all medicines, your medicine can cause side effects, although not everybody gets them. The following side effects are very rare (less than 1 in

10,000 people) but if you experience any of the effects then STOP TAKING this medicine immediately and contact your doctor or pharmacist

•    severe allergic reactions: symptoms could include dizziness or fainting, faster heart rate, swelling of the face, tongue and throat

•    severe skin reactions (Steven’s Johnson-Syndrome, toxic epidermal necrolysis): symptoms could include blistering of the skin,

mouth, eyes and genitals. Skin rash, easy

bruising or bleeding, from the skin or nose

•    peptic ulceration or perforation: symptoms could include severe abdominal pain, vomiting blood (or liquid with what looks like coffee grounds), blood in the faeces (stools / motions) or passing black tarry stools

•    inflammation of the brain lining: symptoms could include stiff neck, severe headache, feeling or being sick, fever or feeling disorientated

•    worsening of asthma and wheezing or difficulty in breathing

If you experience any of the above mentioned side effects then STOP TAKING this medicine immediately and contact your doctor or pharmacist

♦ Other possible side effects:

Less than 1 in 100 people may experience the following uncommon side effects:

•    allergic reactions such as hives, skin rashes and itching (or SLE)

•    stomach: abdominal pain, indigestion, heartburn and feeling sick

•    nervous system: headache

Less than 1 in 1000 people may experience the following rare side effects:

•    diarrhoea, constipation, wind and being sick Less than 1 in 10,000 people may experience the following very rare side effects:

•    reduction in blood cells, which can make the skin and/or eye pale or yellow, sore throat, mild mouth ulcers, flu like symptoms, exhaustion or weakness

•    high blood pressure, heart failure or chest pain

•    nervousness, visual disturbance, ringing in the ears and vertigo

•    unexpected sensitivity of the skin to the sun

•    liver problems: symptoms could include yellowing of the skin or the whites of the eyes

•    kidney problems: symptoms could include swelling of the ankles, fluid retention

Medicines such as Ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

If any of the side effects mentioned get serious or if you notice any side effects not listed in this leaflet, contact your doctor or pharmacist.

Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.

5. How to store Ibuprofen

•    This medicine should not be used after the expiry date printed on the pack.

•    Store in a cool and dry place protected from light.

•    Do not store above 30°C. Do not freeze.

Keep all medicines out of the sight and reach of children

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 to protect the environment.

6. Contents of the pack and other information

♦    What Ibuprofen 200mg tablets contain:

•    The active substance (the ingredient that makes the tablet work) is Ibuprofen. Each tablet contains 200mg of the active ingredient Ibuprofen BP.

•    The other ingredients are pregelatinised starch, maize starch, povidone, sodium lauryl sulphate, Silicon Dioxide, magnesium stearate, sucrose, purified talc, titanium dioxide and erythrosine aluminium lake (E127), bees wax (white), carnauba wax.

♦    What Ibuprofen tablets look like and contents of the pack:

•    Ibuprofen 200mg are pink sugar coated tablets.

Ibuprofen 200mg tablets are available in pack size of 500 in plastic container.

The Marketing Authorization Holder and company responsible for manufacture:

Pharmvit Ltd, 177 Bilton Road, Perivale, Greenford, Middlesex, UB6 7HQ.

Telephone: 0208 997 5444 Fax:    0208 997 5433

To request a copy of this leaflet in large print or audio format or additional copies, please contact the licence holder at the address (or telephone, fax) above.

PL 04556 / 0022

Reference: 00221215/02 PoM

Date leaflet last revised: December 2015