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KENFEN TABLETS B.P. 400MG

Active substance(s): IBUPROFEN

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Package leaflet:
Information for the patient Ibuprofen Tablets BP 200mg AND 400mg
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 questions, ask your doctor or pharmacist.
• 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 or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
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
4. Possible side effects
5. How to store Ibuprofen
6. Further Information
1. WHAT IBUPROFEN IS AND WHAT IT IS USED FOR
Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs
(NSAID). Ibuprofen works by reducing swelling and pain in the body and also reducing a high
temperature.
Ibuprofen is used to treat:
 rheumatoid arthritis
 inflammation of the area surrounding the joints
 juvenile rheumatoid arthritis
 lower back pain
 Still’s disease
 post operative pain
 inflammation of the joints of the spine
 sprains
 osteoarthritis
 muscle strains
 non- rheumatoid joint diseases
 tooth ache
 frozen shoulder
 headache
 inflammation of the tendons
 migraine
 period pain
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN
DO NOT take Ibuprofen if you:
 are allergic (hypersensitive) to ibuprofen or any of the other ingredients in these tablets (listed
in section 6).
 ever had an allergic reaction caused by aspirin or other related non-steroidal antiinflammatory painkillers (e.g. swelling of the face or throat, shortness of breath, skin rash,
asthma, irritation of the nose)
 suffer from severe heart failure, kidney failure or liver failure
 are taking other non-steroidal anti-inflammatory painkillers, or aspirin with a daily dose
above 75mg
 have (or have had two or more episodes of) a stomach ulcer perforation or bleeding
 have or ever had stomach ulcer perforation or bleeding because of taking NSAIDs in the past
 are in the last trimester (last 3 months) of pregnancy
 suffer with conditions involving an increased tendency to bleeding
2.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ibuprofen.
 if you have a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease), stomach
or bowel problems
 suffer from asthma or a history of asthma
 suffer from Systemic Lupus Erythematosus (SLE) or mixed connective tissue disease
 have high blood pressure
 have kidney, liver or heart problems
 are elderly
 have a blood clotting disorder e.g. thrombocytopenia, haemophilia
 have rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or
glucose-galactose malabsorption
Anti-inflammatory/ pain-killer medicines like Ibuprofen may be associated with a small increased
risk of heart attack (myocardial infraction) or stroke. Any risk is more likely with high doses and
prolonged treatment. Do not exceed the recommended dose or duration of treatment.
You should discuss your treatment with your doctor or pharmacist before taking Ibuprofen if you:
 have heart problems including heart failure, angina (chest pain), or if you have a heart attack,
bypass surgery, peripheral artery disease (poor circulation in the legs of feet dues to narrow or
blocked arteries) or any kind of stroke (including “mini-stroke” or transient ischaemic attack
“TIA” )
 have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or
are a smoker)

Other medicines and ibuprofen
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Ibuprofen may affect or be affected by some other medicines. For example:

medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g.
aspirin/acetylsalicylic acid, warfarin, ticlopidine)


medicines that reduce high blood pressure (ACE-inhibitors such as captopril, betablockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)

Some other medicines may also affect or be affected by the treatment of ibuprofen. You should
therefore always seek the advice of your doctor or pharmacist before you use ibuprofen with
other medicines.
Warning: The use of Ibuprofen with other NSAIDs including cyclooxygenase- 2 selective
(COX-2) inhibitors should be avoided.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
What should you avoid when you are taking this medicine:
 anticoagulants (against clotting e.g acetylsalicylic acid/ aspirin, warfarin, ticlopidin)
 blood pressure medicines (ACE- inhibitors e.g. captopril, beta-receptor blocking
medicines, angiotensin II antagonists)
 diuretics (water tablets)
















cardiac glycosides e.g. digoxin (used to treat heart conditions)
methotrexate (used to treat cancer, rheumatoid arthritis, psoriasis)
lithium, venlafaxine or SSRIs (used to treat depression)
zidovudine (an anti-viral medicine, used to treat AIDS and HIV)
aspirin, with a daily dose above 75mg or other anti- inflammatory painkillers
corticosteroids (used to treat inflammation)
amino-glycosides (antibiotics that fight against bacteria)
Immuno-suppressants (used to treat patients who had an organ transplant, or to treat other
problems with immune system e.g. ciclosporin and tracrolimus)
mifepristone (to terminate pregnancy) in the last 12 days
quinolone antibiotics (used to treat infections e.g. levofloxacin, ciprofloxacin)
ginko bilboba, a herbal remedy used as a memory and concentration enhancer
cholestyramine (used with diet changes to reduce the amount of cholesterol and certain
fatty substances in your blood)
sulfonylureas (used to increase the amount of insulin produced by the pancreas)
antifungal agents (including voriconazole and fluconazole)

Some other medicines may affect or be affected by the treatment of Ibuprofen.
Always seek advice of a doctor before you use Ibuprofen with other medicines.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
 DO NOT take Ibuprofen tablets if you are in the last three months (last trimester) of
pregnancy. The use of ibuprofen should be avoided during the first 6 months of
pregnancy, unless the potential benefits to the patient outweighs the potential risk to the
foetus on advice of the doctor.
Note: Ibuprofen may make it more difficult to become pregnant. You should inform your doctor
if you are planning to become pregnant or if you have problems becoming pregnant.
In the limited studies so far available, ibuprofen appears in the breast milk in very low
concentrations. Ibuprofen should, if possible, be avoided when breast-feeding.
Driving and using machines
Ibuprofen tablets may cause drowsiness, problems with your eyesight, dizziness, drowsiness and
tiredness. If affected do not drive or operate machinery.
Ibuprofen Tablets contain Sucrose
 If you have been told by your doctor that you have an intolerance to some sugars contact your
doctor before taking this medicinal product

3. HOW TO TAKE IBUPROFEN
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Note to patient: This medicine is intended for short-term use only. You should take the lowest
dose for the shortest time necessary to relieve your symptoms. This may reduce side effects.

Dosage
For oral use
Take your medicine with or after food with a glass of water. This will reduce stomach upset.
Ibuprofen tablets should be swallowed whole and not chewed, broken, crushed or sucked on to
avoid oral discomfort and throat irritation.
The recommended dose is:
Adults and children over 12 years
The usual dosage is 600 to 1800 mg spread throughout the day. Your doctor may choose to
increase this depending on what you are being treated for, but no more than 2400 mg should be
taken in one day.
Elderly
If you are elderly you are more likely to suffer from side effects when you take your tablets. A
lower dose should be considered for elderly patients and those with liver and kidney problems.
Children under 12 years
Please take exactly as prescribed by your doctor. The usual daily dosage of Ibuprofen for children
is 20mg per kilogram of body weight in divided doses. This may be doubled in the case of
juvenile rheumatoid arthritis. In children weighing less than 30kg the total daily dose should not
exceed 500mg. In children weighing less then 7kg the use of ibuprofen is not recommended.
If you take more Ibuprofen than you should
If you (or somebody else) take too many Ibuprofen tablets, or you begin to feel unwell after
taking Ibuprofen tablets, contact your doctor or go to the nearest hospital casualty department
immediately.
If you forget to take Ibuprofen
If you forget to take a dose, take it as soon as you remember it, unless it is almost time for your
next dose. Do not take a double dose to make up for the 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, this medicine can cause side effects, although not everybody gets them. Do
not be alarmed by the possible side effects. Most people taking this medicine find it causes them
no problems.
Note: Medicines such as Ibuprofen may be associated with a small increased risk of heart attack
(myocardial infraction) or stroke.
STOP taking Ibuprofen and tell your doctor immediately or go to your nearest hospital
emergency department if you:
 have an allergic reaction to the tablets (symptoms include swelling of the face and throat,
wheezing, difficulty breathing, itching and skin rash that may include blistering or peeling of
the skin)
 pass blood in your faeces (stools/ motions)
 pass black tarry stools
 vomit any blood or dark particles that look like coffee grounds

STOP TAKING Ibuprofen and tell your doctor as soon as possible if you experience:
 indigestion (dyspepsia) or heart burn
 hypertension (high blood pressure) and heart problems (heart failure) or stroke
 flatulence (wind) and constipation
 worsening of colitis and Crohn’s disease
 nausea, vomiting, diarrhoea
 aseptic meningitis with symptoms such as stiff neck, headache, nausea, vomiting, fever and
disorientation
 depression
 insomnia
 anxiety
 fatigue (tiredness)
 malaise
 pancreatitis (inflammation of the pancreas) symptoms include abdominal pain, fever and
increased heart rate
 abdominal pains (pain in your stomach) or other abdominal symptoms
 swelling of the legs or ankles caused by water retention
 kidney problems or kidney failure (blood in the urine, difficulty in passing urine)
 liver problems (nausea, vomiting, loss of appetite, fever, light coloured stools)
 jaundice (yellowing of the skin or eyes)
 hepatitis
 anaemia or other blood disorders (fever, sore throat, mouth ulcers, exhaustion, unexplained
bleeding or bruising)
 skin disorders including Stevens Johnson Syndrome, blistering of the skin and increased
sensitivity of the skin to sunlight
 headaches, confusion, hallucinations, ringing in the ears, hearing impaired, vertigo dizziness,
drowsiness, problems with vision, pins and needles
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 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
Do not use the medicine after the expiry date shown on the label.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
Do not store above 25oC (room temperature). Store in a dry place and protect them from light.
Keep the tablets in the original container.
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 contains
The active ingredient is Ibuprofen.
The other ingredients are: magnesium stearate, talc, stearic acid, aerosil, kollidon C, starch, water,
FD&C Red No. 3 (E127), quinoline yellow (E104), sodium benzoate, titanium dioxide (E171),
sucrose, beeswax, carnauba wax, ethanol, and shellac.

What Ibuprofen looks like and contents of the pack
The tablets are available in two different strengths containing either 200mg or 400mg of
ibuprofen.
Ibuprofen Tablets BP 200mg and 400mg are pink, sugar coated tablets containing 200mg or
400mg of the active ingredient ibuprofen.
Ibuprofen tablets are available in containers of 84, 250 or 500 tablets or in white blister packs of
12, 24, 48, 84, 96 or 100.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Athlone Laboratories Limited, Ballymurray, Co. Roscommon,
Ireland
Manufacturer responsible for release: Kent Pharmaceuticals Limited, Wotton Road, Ashford,
Kent TN23 6LL, United Kingdom

This leaflet was last revised 26/04/16

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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