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Ketoprofen Capsules Bp 100mg

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PACKAGE LEAFLET: INFORMATION FOR THE USER


inogen Pharma


Ketoprofen Capsules 50mg and 100mg

(Ketoprofen)


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 or 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, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Ketoprofen Capsules are and what they are used for

2.    What you need to know before you take Ketoprofen Capsules

3.    How to take Ketoprofen Capsules

4.    Possible side effects

5.    How to store Ketoprofen Capsules

6.    Contents ofthe pack and other information


1. WHAT KETOPROFEN CAPSULES ARE AND WHAT THEY ARE USED FOR


Ketoprofen Capsules contain a medicine called Ketoprofen. This belongs to a group of medicines called 'non-steroidal anti-inflammatory drugs' (NSAIDs).

Ketoprofen Capsules are used to relieve symptoms of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, fibrositis, cervical spondylitis, low back pain, painful musculoskeletal conditions and period pain.

Ketoprofen reducesjoint pain and inflammation, and facilitates an increase in mobility and functional independence.


2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE KETOPROFEN CAPSULES


Do not take Ketoprofen Capsules ifyou:

•    Are allergic (hypersensitive) to Ketoprofen, other NSAIDs or any of the other ingredients in this medicine (see Section 6)

•    Suffer from asthma, hives or a runny nose caused by an allergy to salicylates (e.g. aspirin) or other NSAIDs such as ibuprofen as it may increase the risk of bronchospasm

•    Have severe liver, kidney or heart failure

•    Are in the last three months of pregnancy

   Previously have had a stomach or intestinal ulcer, bleeding or perforation

•    Currently have a stomach or intestinal ulcer, bleeding or perforation

•    Currently have or have a history of gastrointestinal disorders (inflammation of the stomach or intestines) that predispose to bleeding disorders such as ulcerative colitis, Crohn's disease, gastrointestinal cancers, diverticulitis (inflamed or infected pouches/pockets of the colon)

•    Bruise more easily than usual and have bleeding that lasts a long time.

Ketoprofen Capsules should not be used in children.

Ifany ofthese apply to you, you should not be given Ketoprofen Capsules. Tell your doctor immediately.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking Ketoprofen Capsules ifyou:

•    Are taking other NSAIDs including COX-2 selective NSAIDs and acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever (see section Other medicines and Ketoprofen Capsules)

•    Have reduced kidney or liver function, there may be an increased risk ofjaundice (see section 4 Possible side effects)

•    Have recently had or you need to have surgery

•    Are elderly, your doctor may wish to minimise treatment duration and to see you more often while you are taking this medicine

•    Are elderly, or taking other medicines like corticosteroids or certain drugs for depression called selective serotonin reuptake inhibitors


(SSRIs), or aspirin to prevent blood clotting, your doctor may like to prescribe you, together with Ketoprofen Capsules, a medicine for protecting your stomach and intestines

•    Suffer from liver porphyria (disorder of the red blood pigment)

•    Suffer from SLE (systemic lupus erythema) or other connective tissue disorders

•    Have heart problems, have 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 should discuss your treatment with your doctor or pharmacist.

•    Have been treated with diuretics for water retention

•    Are being treated for high blood pressure

•    Are trying to get pregnant (See section on Pregnancy and Breast-feeding).

Ifyou notice any ofthe following symptoms then you should talk to your doctor immediately as you may need to stop taking the capsules immediately:

Visual distrubances, skin rashes or signs of an allergic reaction such as swollen face, tongue or throat, or suddenly feeling faint and breathing difficulties, symptoms such as stiff neck, headache, fever, tiredness and feeling disorientated as these may be signs ofmeningitis, indigestion or heartburn, stomach pains, vomiting, blood in your faeces, yellowing of the skin or eyes.

Medicines such as Ketoprofen Capsules may cause a small increased risk of heart attack

(“myocardial infarction”) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not take more than the recommended dose or use for longer than recommended.

Other medicines and Ketoprofen Capsules

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Remember to take your medicine with you if you have to go to hospital.

In particular tell your doctor or pharmacist if you are taking any of the following:

   Aspirin or other non-steroidal antiinflammatory drugs for pain relief

   Corticosteroids (e.g. hydrocortisone) given to treat a variety ofconditions such as allergies and hormone imbalances

   Anticoagulants such as warfarin to prevent blood clots as there is an increased risk of bleeding. Ifco-administration is unavoidable you will be closely monitored by your doctor

   Lithium (medicine to treat depression) or digoxin (medicine to treat impaired heart function) - increase in blood levels ofthese medicines

•    Selective serotonin re-uptake inhibitors

(SSRIs) e.g. fluoxetine used to treat depression

   Diuretics (water tablets) - the effect may be decreased. Potassium-sparing diuretics may increase the blood levels of potassium

   ACE-inhibitors e.g.captopril (medicines to treat high blood pressure). Blood pressure lowering effect may be reduced

•    Ciclosporin or tacrolimus (medicines used to prevent rejection after a transplant) - may harm kidney function especially in elderly patients

•    Quinolones e.g. ciprofloxacin (antibiotics to treat infections) - may cause fits

•    Medicines to treat diabetes e.g. metformin - a dose adjustment of these medicines may be necessary as blood sugar may drop too low

   Methotrexate (to treat psoriasis, rheumatoid arthritis and certain tumours)

   Mifepristone - (used to induce abortion) NSAIDs should not be used for 8-12 days after taking mifepristone as NSAIDs can reduce mifepristone's effectiveness

   Cardiac glycosides such as digoxin (used for some heart conditions) - may worsen heart failure

   Probenecid used to treat gout.

Laboratory tests

Regular liver and kidney function tests and monitoring of blood counts are necessary during long-term treatment.

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant or are breast-feeding.


Ketoprofen Capsules may make it more difficult for you to become pregnant. You should talk to your doctor if you are planning on becoming pregnant or if you have any problems becoming pregnant.

You should not take Ketoprofen Capsules during the first six months of pregnancy unless directed by your doctor. You must not take Ketoprofen Capsules during the last 3 months of pregnancy as damage to the baby and reduced labour may occur.

You should not take Ketoprofen Capsules if you are breast-feeding. This is because small amounts may pass into mother's milk.

Ask your doctor or pharmacist for advice before taking any medicines if you are pregnant or breastfeeding.

Driving and using machines

You may feel sleepy, dizzy, faint, have eyesight problems or you may have a fit while taking this medicine.

Ketoprofen Capsules contain lactose

Ifyou have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.


3. HOW TO TAKE KETOPROFEN CAPSULES


Always take Ketoprofen Capsules exactly as your doctor has told you. You should checkwith your doctor or pharmacist ifyou are not sure.

Ketoprofen Capsules should be swallowed whole with a glass ofwater, with food.

Adults:

1-2 capsules (50-100mg), twice a day.

This dose may be altered by your doctor.

For dysmenorrhoea:

1 capsule (50mg), up to three times a day. Treatment is usually for 3-4 days from the onset of menstruation.

Elderly:

As adult dose. The lowest effective dose should be given.

Your doctor will monitor you regularly.

Children:

Ketoprofen Capsules should not be used in children under 12 years ofage.

Ifyou take more Ketoprofen Capsules than you should

Contact your doctor, casualty department or pharmacist immediately if you have taken more Ketoprofen Capsules than is stated in this leaflet, or more than prescribed to you by your doctor.

Symptoms ofoverdose may include stomach pain, feeling or being sick, diarrhoea, drowsiness, kidney failure, fits, headache, disorientation, ringing in the ears, excitement, coma, fainting and liver damage.

Ifyou forget to take Ketoprofen Capsules

If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

Continue treatment as advised by your doctor.

Ifyou stop taking Ketoprofen Capsules

Do not stop taking Ketoprofen Capsules without talking to your doctor.


STOP TAKING your capsules and tell your doctor ifyou experience:

•    Indigestion or heartburn

•    Abdominal pain (pains in your stomach) or other abdominal stomach symptoms

•    Yellowing of the skin and eyes which may indicate jaundice

•    Blurred vision

•    Stevens-Johnson Syndrome (severe skin rash with flushing, fever, blisters and ulcers) or Lyell's syndrome (severe rash with reddening, peeling and swelling of skin that looks like severe burns), hair loss, sensitivity to light.

Medicines such as Ketoprofen Capsules may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.

The most common side effects are:-

•    Indigestion, heartburn, stomach pain or cramps, feeling or being sick, diarrhoea, flatulence, loss ofappetite, constipation, mouth ulcers, worsening of ulcerative colitis or Crohn's disease, inflammation of the pancreas or tongue

•    Skin rash, itching, skin eruptions, eczema, Erythema multiforme (round, red patches on skin).

Other less common side effects are:-

•    Changes in kidney function, blood or protein in the urine

•    Changes in liver function causing yellowing of your skin or the whites of the eyes or increased liver enzyme levels in the body

•    Blood disorders including anaemia

•    Palpitations, chest pain, high blood pressure, heart failure

•    Headache, dizziness, 'spinning' sensation, drowsiness or tiredness, disturbances of sensation, 'pins and needles', memory disturbance, disorientation, disturbance of vision, sleeplessness, impaired hearing, ringing in the ears, irritability, convulsions, depression, anxiety, nightmares, confusion, hallucinations, tremor, psychotic reactions or taste alteration disorders, impotence.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 KETOPROFEN CAPSULES


Keep out of the sight and reach of children.

Do not store above 25°C. Store in the original package. Protect from moisture.

Do not use Ketoprofen Capsules after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Medicines should not be disposed ofvia wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.


6. CONTENTSOFTHEPACKANDOTHER INFORMATION


What Ketoprofen Capsules 50mg and 100mg contain:


If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist.


POSSIBLE SIDE EFFECTS


Like all medicines, this medicine, may cause you some problems, although not everybody gets them.

Ifyou experience any ofthe following side effects with Ketoprofen Capsules at any time during your treatment, STOP TAKING your capsules and seek immediate medical help:

•    Passing blood in your faeces (stools / motions)

•    Passing black tarry stools

•    Vomiting any blood or dark particles that look like coffee grounds

•    An allergic reaction such as itching, swelling of the face, lips, tongue, mouth and throat, which may cause shortness of breath or difficulty swallowing

•    A formof meningitis (aseptic)causing a combination ofsymptoms such as headache, fever, stiff neck, tiredness, feeling or being sick and disorientation.


Ketoprofen Capsules 50mg contain 50mg ofthe active ingredient ketoprofen.

The other ingredients are: magnesium stearate and lactose. The capsule shell contains gelatin, erythrosine (E127), indigotine (E132), titanium dioxide (E171) and quinoline yellow (E104).

Ketoprofen Capsules 100mg contain 100mg ofthe active ingredient ketoprofen.

The other ingredients are: magnesium stearate and lactose. The capsule shell contains gelatin, red iron oxide (E172) and titanium dioxide (E171).

What Ketoprofen Capsules 50mg and 100mg look like and contents ofthe pack

Ketoprofen Capsules 50mg and 100mg

Available in amber glass bottles in pack sizes of 28, 30, 56, 60, 84, 90, 100, 112 and 500.

Not all pack sizes may be marketed.

Marketing Authorisation Holderand Manufacturer

Ennogen Pharma Limited

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK.


This leaflet was last revised in November 2014.