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KETOCID 200MG CAPSULES

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PACKAGE LEAFLET: INFORMATION FOR THE USER
®

Ketocid 200 mg Capsules
ketoprofen

Important things you need to know about Ketocid
• Ketocid is a non-steroidal anti-inflammatory medicine, prescribed to reduce
swelling and ease inflammation in conditions affecting the joints and muscles.
• You need to take it regularly to get the maximum benefit. Do not stop taking it
without talking to your doctor.
• Ketocid can cause serious side effects in some people (read Section 4 for
details). If you experience difficulty in breathing, an allergic reaction such as
skin rashes, signs of bleeding from your intestines or vomit blood contact your
doctor immediately.
• If you are elderly, your doctor may regularly monitor your condition to check you
are taking the correct dose of Ketocid.
• Taking other medicines, including other NSAIDs, may sometimes cause problems.
Check with your doctor or pharmacist before taking any other medicines.
• If you are (or might become) pregnant while taking Ketocid, it is important to
talk to your doctor about this.
Read all of this leaflet carefully before you start taking this medicine.
- 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 any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
This leaflet was last updated on 01/2009.

In this leaflet:
1. What Ketocid is and what it is used for
2. Before you take Ketocid
3. How to take Ketocid
4. Possible side effects
5. How to store Ketocid
6. Further information
1. What Ketocid is and what it is used for
Ketocid Capsules contain ketoprofen which belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs) that reduce pain and inflammation. They are
called modified-release capsules because they are manufactured in a way that allows the
ketoprofen to be released and slowly absorbed by your body over a period of several hours.
Ketocid Capsules relieve pain, reduce swelling and ease inflammation in the following
conditions:
• rheumatoid arthritis, osteoarthritis, ankylosing spondylitis (form of spinal arthritis)
• musculoskeletal conditions such as bursitis, capsulitis, synovitis, tendinitis, fibrositis
and low back pain
• sciatica (pain which is felt in the buttocks, the back of the thigh and the outside and
front of the leg), period pain and gout

2. Before you take Ketocid
Do not take Ketocid:
• if you are allergic to ketoprofen, aspirin, ibuprofen, any other NSAID or any of the
other ingredients in the capsules (these are listed in section 6, Further Information).
Signs of an allergic reaction include breathing problems, runny nose, or a skin rash.
• if you have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your
stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or
perforation.
• if you have severe heart, liver or kidney problems.
• if you are pregnant (you will need to discuss this with your doctor).
Take special care with Ketocid and always tell your doctor if:
• you have kidney or liver problems
• you have, or have ever suffered from a disease of the bowel or intestine, such as
ulcerative colitis or Crohn’s disease
• you have, or have ever suffered from asthma
• you have heart problems, previously had a stroke or think that you might be at risk of
these conditions (for example, if you have high blood pressure, diabetes or high
cholesterol or are a smoker)
• you have SLE (systemic lupus erythematosis) or any similar condition with symptoms
such as joint pain, skin rash and fever
• you experience skin redness, itching and scalling or blistering of the skin, mouth, eyes
and genitals
Ketocid 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.
Medicines such as Ketocid may be associated with a small increased risk of heart attack
or stroke. Any risk is more likely with high doses and prolonged treatment. Do not
exceed the recommended dose or duration of treatment.
If you are elderly, suffer from kidney, liver or heart problems or have been taking this
medicine or similar NSAIDs for a long time, your doctor may want to perform regular tests
to monitor your condition and may need to carry out blood tests from time to time.
Taking other medicines
Before starting treatment, please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained without a prescription. If
you have to go to a doctor, dentist or hospital for any reason, tell them that you are taking
Ketocid.
In particular, tell your doctor if you are taking:
• lithium, to treat depression
• methotrexate, to treat some inflammatory diseases and cancers
• aspirin, ibuprofen or any other NSAIDs
• ciclosporin, to treat some inflammatory diseases and after transplants
• quinolone antibiotics, such as ciprofloxacin to treat bacterial infections
• water tablets (diuretics), such as amiloride
• anticoagulants, such as warfarin to stop the blood clotting
• sulphonamides, to treat bacterial infections
• hydantoins, such as phenytoin to treat seizures
• medicines to treat diabetes, such as gliclazide
• aminoglycosides, such as gentamycin to treat bacterial infections
• probenecid, to treat gout
• medicines to treat high blood pressure, such as beta-blockers
• cardiac glycosides, such as digoxin to treat heart problems
• mifepristone, used to terminate pregnancy
• oral steroids, such as prednisolone
• tacrolimus, used to dampen down the body’s immune response and may be used for
severe skin complaints and following organ transplantation
• zidovudine, used to treat viral infections
• anti-platelet agents such as aspirin, used to reduce the formation of blood clots
• antidepressants of the selective serotonin reuptake inhibitors type (SSRIs)
Please read the back of this leaflet →

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, or could become pregnant, talk to your doctor
before taking your tablets.
Driving and using machines:
If you experience headaches, fatigue, nausea, confusion, blurred vision, dizziness or
drowsiness after taking these capsules, then do not drive or operate machinery.
Important information about some of the ingredients of Ketocid
Ketocid contains 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 Ketocid
Always take your capsules exactly as your doctor has told you to. You should check with
your doctor or pharmacist if you are not sure.
Dosage
• Ketocid is formulated so that you only have to take your capsule once a day. The
label on the carton will tell you how many capsules you should take and when.
• Take your capsules at the same time each day, with or after food.
• Swallow your capsules whole, do not break or chew your capsules.
• Do not stop treatment even if you feel better unless told to do so by your doctor.
Adults and the elderly
The usual daily dose is one Ketocid 200 mg capsule once a day.
If you are elderly and are frail or have a low body weight your doctor will prescribe the
lowest effective dose for you to take. Your doctor may monitor you for any bleeding from
your stomach during the first four weeks after you start your treatment and may need to
carry out blood tests from time to time.
Children must not take this medicine.
If you take more Ketocid than you should
If you accidentally take more Ketocid than you should, contact your nearest casualty
department or tell your doctor or pharmacist immediately. Remember to take the pack
and any remaining capsules with you.
If you forget to take Ketocid
Do not worry. Simply leave out that dose completely and then take your next dose at the
right time. Do not take a double dose to make up for a missed dose.

4. Possible side effects
Like all medicines, Ketocid can cause side effects, although not everyone gets them.
Allergic reactions have been reported. If you experience any of these, contact your
doctor or nearest casualty department immediately.
- tight chest, severe difficulty in breathing or anaphylaxis where symptoms may be a
rapid pulse, profuse sweating, fever and if severe, shock and collapse
- skin rashes including itching, “nettle" rash or hives, purple spots and patches on the
skin, swelling of the face and throat, peeling, scaling and blistering.
If you experience any of the following serious side effects stop taking your capsules and
contact your doctor or nearest casualty department immediately.
• blood in the stools or
bloody diarrhoea
• pass black tarry stools

• vomiting blood or dark particles • perforations or ulcers of
that look like coffee grounds the stomach or small
intestine
• inflammation of the
stomach lining

Stop taking your medicine and tell your doctor if you experience:
• indigestion or heartburn
• abdominal pain (pains in your stomach) or other abnormal stomach symptoms.
The following side effects have also been reported, tell your doctor or pharmacist if you
notice any of these:
















feeling sick
constipation
diarrhoea
mouth ulcers
sensitivity to sunlight
swelling of your feet and
ankles
high blood pressure
heart failure
changes in the way your
kidneys work, including
kidney failure
blurred vision
headache
pins and needles
depression
painful inflammation of the
optic nerve in your eye
confusion

• changes in liver function
that may cause yellowing of
the skin or eyes or affect
the results from liver
function tests
• hallucinations
• ringing in the ears
• dizziness or “spinning”
• feeling generally unwell
• tiredness and drowsiness
• mood changes
• difficulty in sleeping
• vomiting
• flatulence
• reduction in blood
platelets, which increases
risk of bleeding or bruising
• small increased risk of
heart attack or stroke

• severe reduction in
number of white blood
cells which makes
infections more likely
• severe reduction in blood
cells which can cause
weakness, bruising or
make infections more likely
• reduction in red blood cells
which can make the skin
pale yellow and cause
weakness or
breathlessness
• aseptic meningitis causing stiff neck, fever,
disorientation
• pancreatitis - causing
abdominal pain, nausea,
vomiting

If any side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

5. How to store Ketocid
• Keep out of the reach and sight of children.
• Do not use Ketocid after the expiry date which is stated on the blister and carton. The
expiry date refers to the last day of that month.
• Do not store above 25ºC. Store in the original packaging.
• Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.

6. Further Information
What Ketocid contains:
The active substance in your capsules is ketoprofen. Each capsule contains 200 mg of
ketoprofen.
The other ingredients are sucrose, corn starch, macrogol 4000, polymers of methacrylic
acid, acrylic acid esters and methacrylic acid esters, ethylcellulose, stearic acid, talc,
gelatin, titanium dioxide (E171) and erythrosine (E127).
What Ketocid looks like and the contents of the pack:
Ketocid 200 mg capsules are transparent and pink marked with "KET 200 CR". It is
packed in blister packs of 28 capsules.
Marketing Authorisation Holder and Manufacturer:
The Marketing Authorisation holder and manufacturer is Chiesi Limited, Cheadle Royal
Business Park, Highfield, Cheadle, SK8 3GY, UK.

Is this leaflet hard to see or read? Phone 0161 488 5555 for help.
00143 V4/CP0008/1

Expand Transcript

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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