Ibuprofen Tablets 600mg
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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, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet (see section 4).
What is in this leaflet
1. What Ibuprofen Tablets 600mg are and what they are used for
2. What you need to know before you take Ibuprofen Tablets 600mg
3. How to take Ibuprofen Tablets 600mg
4. Possible side effects
5. How to store Ibuprofen Tablets 600mg
6. Contents of the pack and other information
1. WHAT IBUPROFEN TABLETS 600MG ARE AND WHAT THEY ARE USED FOR
Ibuprofen Tablets 600mg contain the active ingredient ibuprofen. They belong to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
They work by relieving pain, reducing inflammation, swelling and fever.
Ibuprofen Tablets 600mg are used to treat mild to moderate pain including:
• Rheumatic and muscular pain
• Backache
• Headache
• Dental pain
• Migraine
• Neuralgia
• Period pain
• Symptoms of colds and flu
• Fever.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN TABLETS 600MG
Do not take Ibuprofen Tablets 600mg if:
• You are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6)
• You have ever had an allergic reaction to (e.g. asthma, rhinitis, angioedema) ibuprofen, aspirin, other NSAIDS (e.g. diclofenac)
• You have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding in the past
• You have had gastrointestinal bleeding or perforation when previously taking NSAIDs
• You suffer from severe liver, kidney or heart failure
• You are in the last 3 months of pregnancy.
Warnings and precautions
Talk to your pharmacist or doctor before taking
this medicine ifyou:
• Have or have had asthma
• Have kidney, liver or bowel problems
• Have Systemic Lupus Erythematosus (SLE) a condition of the immune system affecting connective tissue resulting in joint pain, skin change and disorders of other organs
• Are currently taking other NSAIDs
• Have a history of gastrointestinal disease
• Are in the first 6 months of pregnancy
• Have heart problems, have previously had a 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).
Otherwarnings
Ibuprofen Tablets 600mg belongs to a group of medicines which may impair female fertility. This is reversible on stopping the medicine. It is unlikely that Ibuprofen Tablets 600mg used occasionally will affect your chances of becoming pregnant. However, tell your doctor before taking this medicine if you have problems becoming pregnant.
Ibuprofen Tablets 600mg may be associated with a small increased risk of heart attack or stroke. Any risk is more likely with high doses or prolonged treatment. Do not exceed the recommended dose or duration of treatment.
There is an increased risk of the elderly having side effects.
If you are not sure if any of the above apply to you, talk to your doctor, pharmacist or nurse before taking this medicine.
Other medicines and Ibuprofen
Some medicines may affect or be affected by treatmentwith Ibuprofen.
You should avoid taking these tablets with the following:
• Aspirin or other non-steroidal antiinflammatory drugs (NSAIDs) for pain relief
• Corticosteroids (e.g hydrocortisone) given to treat a variety of conditions such as allergies and hormone imbalances
• Quinolones e.g ciprofloxacin (antibiotics used to treat infections) may cause fits and aminoglycosides (e.g. gentamicin) used to treat infections
• Gingko biloba the herbal extract used to treat memory disturbances
• Anticoagulants such as warfarin to prevent bleeding. Ifco-administration is unavoidable you will be closely monitored by your doctor
• Cardiac glycosides such as digoxin (used for some heart conditions) may worsen heart failure
• Diuretics (water tablets) effects may be decreased. Potassium sparing diuretics may increase the blood level of potassium
• Ciclosporin or tacrolimus (medicines used to prevent rejection after transplant) may harm kidney function
• Lithium (medicine to treat depression) or digoxin (medicine to treat impaired heart function) increase in blood levels of these medicines
• Selective serotonin reuptake inhibitors
(SSRIs) e.g fluoxetine used to treat depression
• Mifepristone (used to induce abortion).
NSAIDs should not be used 8-12 days after taking mifepristone as NSAIDs can reduce mifepristone's effectiveness
• Methotrexate (to treat psoriasis, rheumatoid arthritis and certain tumors)
• Medicines to treat HIV (e.g. zidovudine)
• ACE-inhibitors e.g captopril (medicines used to treat high blood pressure). Blood pressure lowering effect may be reduced.
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.
Ibuprofen Tablets should not be used in late pregnancy (the last three months) and should only be taken in the first six months of pregnancy on the advice of your doctor.
Driving and using machines
These tablets may make you feel dizzy, drowsy and you may have a headache or visual disturbances. If you think that you are affected after taking these tablets do not drive or operate machinery until you feel better.
Ibuprofen Tablets contain sucrose
If you have been told by your doctor that you have an intolerance to some sugars you should talk to your doctor before taking this medicine.
3. HOW TO TAKE IBUPROFEN TABLETS 600MG
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Take your tablets with or after food, with a glass of water. The tablets should be swallowed whole.
Adults, the elderly and children over 12 years:
• Take 1 tablet up to three times a day as required.
• Leave at least 4 hours between doses. Do not take more than 4 tablets in 24 hours.
Do not give to children under 12 years old.
Ifyou take more Ibuprofen Tablets than you should
You should contact a doctor or go to the nearest hospital casualty department IMMEDIATELY taking your tablets with you.
If you forget to take your tablets
Take them 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.
If you have any further questions on the use of this medicine, ask your doctor, or pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you suffer from any of the following at any time during your treatment STOP TAKING Ibuprofen Tablets 600mg and SEEK IMMEDIATE MEDICAL HELP:
• Signs of intestinal bleeding such as bright red faeces (stools/motions), black tarry stools, vomiting blood or dark particles that look like coffee grounds
• Signs ofa serious allergic reaction such as:
■ Difficulties in breathing or unexplained wheezing
■ Dizziness
■ Severe forms of skin reactions such as itchiness, Stevens-Johnson syndrome (symptoms include flushing, fever, blisters and ulcers), Toxic Epidermal Necrolysis (symptoms include reddening, peeling and swelling of the skin often resembling burns), Erythema multiforme (symptoms include circular, irregular red patches of skin) and photosensitivity reactions with unexpected sunburn ora dry, bumpy or blistering rash on sun-exposed skin
■ Swelling of the face, tongue or throat
• Signs of kidney problems such as
■ Passing less or more urine
■ Cloudy urine or blood in the urine
■ Pain in the back and or swelling (particularly in the legs)
• Signs of aseptic meningitis with symptoms such as neck stiffness, headache, feeling sick, being sick, feverorfeeling disorientated. Patients with existing autoimmune disorders (e.g. lupus, mixed connective tissue disease) may be more likely affected
• Signs of liver problems such as yellowing of the skin or whites of the eyes (jaundice).
STOP TAKING the tablets and tell your doctor if you experience the following side effects:
• Indigestion, heartburn, feeling sick or being sick
• Pains in your stomach or other unusual stomach problems.
TELL YOUR DOCTOR if you have any of the following side effects:
• Allergic reactions such as skin rashes, itching and peeling
• Headaches
• Flatulence (wind), diarrhoea, constipation
Changes in your blood (which will be identified in a blood test) such as unexplained or unusual bruising or bleeding, fever, sore throat, mouth ulcers, flu-like symptoms and severe exhaustion
Stomach or intestinal ulcers, sometimes with bleeding and perforation, inflammation ofthe lining ofthe mouth with ulceration (ulcerative stomatitis), inflammation of the stomach (gastritis)
Swelling (oedema), high blood pressure, heart failure or attack
Worsening of colitis and Crohn's disease Blurred or disturbed vision or seeing/hearing strange things
Ringing in the ears, feeling ofa 'spinning sensation' (vertigo)
Depression, confusion, tingling ofhands and feet, difficulty sleeping, malaise.
Medicines such as Ibuprofen Tablets 600mg have been 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, pharmacist or nurse. This includes 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 IBUPROFEN TABLETS 600MG
Keep this medicine out ofthe sight and reach ofchildren.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Store in a cool dry place protected from moisture below 25°C.
Do not use this medicine if you notice visible signs ofdeterioration.
Do not throw away any medicines via wastewater or household waste. Return any left over tablets to your pharmacist. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Ibuprofen Tablets 600mg contains
Ibuprofen 600mg Tablets contains 600mg of the active ingredient ibuprofen.
The other ingredients are: Colloidal anhydrous silica, starch, povidone, croscarmellose sodium, microcrystalline cellulose, alginic acid, magnesium stearate, sodium lauryl sulphate, sucrose, E171, E127, sodium starch glycollate, Opaseal (polyvinyl acetate phthalate, stearic acid (E570)).
What Ibuprofen Tablets looks like and contents of the pack
Ibuprofen Tablets 600mg are pink sugar coated biconvex tablets.
Ibuprofen Tablets 600mg are packed into packs of 12or16 tablets.
Marketing Authorisation Holder
Ennogen Pharma Ltd
Unit G4, Riverside Industrial Estate
Riverside Way, Dartford
DA1 5BS, United Kingdom
Manufacturer
Pharmaserve Limited Clifton Technology Park Wynne Avenue, Swinton Manchester, M27 8FF, United Kingdom
This leaflet was last revised in October 2014.