Ibuprofen Tablets 200mg
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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
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to your doctor if you do not feel better or if you feel worse after 10 days.
What is in this leaflet:
1. What this medicine is for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information
1. WHAT THIS MEDICINE IS FOR
Ibuprofen Tablets 200mg 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 200mg are used to treat:
• 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 THIS MEDICINE
Do not take this medicine ifyou:
• Are allergic to ibuprofen or any of the other ingredients in this medicine. These are listed in section 6.
• Have previously had a reaction e.g. asthma, runny nose, itchy skin or swelling of the lips, face or throat after taking these types of medicines (NSAIDs including aspirin)
• Have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding in the past
• Have had gastrointestinal bleeding or perforation when previously taking NSAIDs (you may have been sick and it contained blood or dark particles that look like coffee grounds, passed blood in your stools or passed black tarry stools)
• If you have severe liver or kidney problems or have heart failure
• Are in the last 3 months of pregnancy.
Warnings and precautions
Talk to your pharmacist or doctor before you
take 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 200mg belongs to a group of medicines which may impair female fertility. This is reversible on stopping the medicine. It is unlikely that Ibuprofen Tablets 200mg 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 200mg 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 or pharmacist 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 anti-inflammatory 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
• Ginko biloba the herbal extract used to treat memory disturbances
• Anticoagulants such as warfarin to prevent bleeding. If co-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
Tell your doctor if you become pregnant while taking Ibuprofen Tablets 200mg. Do not take this medicine in the last 3 months of pregnancy. You should also avoid use of ibuprofen during the first 6 months of pregnancy unless your doctor has advised you otherwise.
You should talk to your doctor or pharmacist before taking these tablets if you are breast-feeding.
Driving and using machines
These tablets may make you feel dizzy, drowsy and you may have a headache orvisual disturbances. If you think that you are affected after taking these tablets do not drive, operate tools or machinery.
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 THIS MEDICINE
These tablets are for short term use only. You should take the lowest dose for the shortest time possible.
Swallow the tablets whole with a glass ofwater.
Adults, the elderly and children over 12 years:
• Take 1 or 2 tablets up to three times a day as required.
• Leave at least 4 hours between doses. Do not take more than 6 tablets in 24 hours.
Do not give to children under 12 years old.
Ifyou take too many tablets
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.
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 of the lining of the 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 of a 'spinning sensation' (vertigo)
• Depression, confusion, tingling of hands and feet, difficulty sleeping, malaise.
Medicines such as Ibuprofen Tablets 200mg have been associated with a small increased risk of heart attack (myocardial infarction) orstroke.
4. POSSIBLE SIDE EFFECTS
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.
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 200mg 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 of a 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 or a 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, fever or feeling 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 sickor being sick
• Pains in your stomach or other unusual stomach problems.
5. HOW TO STORE THIS MEDICINE
Keep out of the sight and reach of children
Check the expiry date printed on the label or side of the box. Do not use after the expiry date stated on the label.
Store in a cool dry place protected from moisture, below 25°C.
Medicines should not be disposed ofvia waste water or household waste. Take any leftover tablets to your pharmacist.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Ibuprofen Tablets 200mg contain:
Each tablet contains the active substance ibuprofen 200mg.
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, polyvinyl acetate phthalate, stearic acid (E570).
What Ibuprofen Tablets 200mg look like and contents of the pack
Ibuprofen Tablets 200mg are pink sugar coated biconvex tablets.
Ibuprofen Tablets 200mg are supplied in 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 September 2014