90 mm

90 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

_IBUPROFEN 200MG CAPLETS_

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 Caplets are and what they are used for

2.    What you need to know before you take Ibuprofen Caplets

3.    How to take Ibuprofen Caplets

4.    Possible side effects

5.    How to store Ibuprofen Caplets

6.    Contents of the pack and other information

1. What Ibuprofen Caplets are and what they are used for

The active substance used in these caplets is Ibuprofen. Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) which helps relieve pain, reduces inflammation and lowers temperature when you have a fever. These caplets are used for the relief of rheumatic or muscular pain, pain of non-serious arthritis, backache, neuralgia, migraine, headache, dental pain, period pains, feverishness, and the symptoms of colds and influenza.

|    2. What you need to know before you take Ibuprofen Caplets |

Do not take these caplets if you:

•    have ever been told you are allergic to ibuprofen, aspirin, other non-steroidal 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 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 high cholesterol or previously have had a heart attack or stroke.

•    are in the first 6 months of pregnancy

•    have kidney or liver problems

•    are elderly, as it increases the frequency of adverse reactions

•    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 medicines 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 stabiliser)

•    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 you 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 Caplets contains Lactose and Sucrose

•    If you have been told by your doctor that you have intolerance to some sugars, check with your doctor before taking this medicine as it contains LACTOSE and SUCROSE.

3. How to take Ibuprofen Caplets

Always take this medicine exactly as your doctor or pharmacist has told you.

Check with your doctor or pharmacist if you are not sure.

• The caplets 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 caplets up to 3 times a day.

•    The dose should not be repeated more frequently than every 4 hours.

•    Do not take more than 6 caplets in any 24 hour period.    |

140 mm

Ibuprofen Caplets 200 mg 078 Insert

430 mm

Front

SAME SIZE ARTWORK

430 x 140 mm

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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.

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 Caplets 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 Caplets

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 Caplets 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)

•    dyspepsia

•    Constipation

•    Vomiting (being sick)

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 Caplets    |

•    Keep this medicine out of the sight and reach of children

•    Do not store above 25°C. 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.

|    6. Contents of the pack and other information    |

What Ibuprofen Caplets contain:

•    The active substance is Ibuprofen

•    Other ingredients are lactose, potato starch, methylcellulose, sodium starch glycollate, colloidal anhydrous silica, magnesium stearate, sucrose, talc, pregelatinised maize starch, maize starch and titanium dioxide (E171).

What Ibuprofen Caplets look like and contents of the pack:

•    The caplets are white capsule shaped sugar coated.

•    The caplets are available in packs containing 24, 48 or 96 caplets.

•    Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Name and address: Bristol Laboratories Ltd,

Unit 3, Canal side, Northbridge Road,

Berkhamsted, Hertfordshire,

HP4 1EG, United Kingdom Telephone:    0044 (0)1442 200922

Fax:    0044 (o)1442 873717

E-mail:    info@bristol-labs.co.uk

Ibuprofen 200mg Caplets; PL 17907/0078 This leaflet was last revised in December 2014

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.

V5 02-12-14 DO    -

140 mm

430 mm