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Larafen Cr

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Document: leaflet MAH BRAND_PL 40147-0053 change

PACKAGE LEAFLET: INFORMATION FOR THE USER


Larafen CR® Capsules 200mg

(Ketoprofen BP 200mg)


Read all ofthis 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 further questions, please 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 Larafen Capsules are and what they are used for

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

3.    How to take Larafen Capsules

4.    Possible side effects

5.    How to store Larafen Capsules

6.    Contents of the pack and other information


1. WHAT LARAFEN CAPSULES ARE AND WHATTHEYARE USED FOR


Larafen Capsules belong to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Larafen Capsules are used to relieve symptoms caused by osteoarthritis, rheumatoid arthritis and ankylosing spondylitis (rheumatism of the spine) such as swelling, stiffness orjoint pain. It does not cure arthritis and will help you only as long as you continue to take it. It is also useful to relieve pain in the back and leg (sciatica), acute gout and painful periods.


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


Do not take Larafen Capsules if you:

•    Are allergic (hypersensitive) to ketoprofen, other NSAIDs or any of the other ingredients in Larafen Capsules (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 risk of a bronchospasm

•    Have severe liver, kidney or heart failure

•    Are in the last three months of pregnancy

   Previously had a stomach or intestinal ulcer, bleeding or perforation

•    Currently have stomach or intestinal ulcer, bleeding or perforation

•    Have or had a history of gastrointestinal bleeding or perforation associated with NSAID treatment. You should not take this medicine. That is those with inflammation of the stomach or intestines such as ulcerative colitis, Crohn's disease, gastrointestinal cancers and diverticulitis (inflamed or infected pouches/pockets of the colon)

•    Have a history of blood disorders where you bleed for a long time.

If any of these apply to you, you should not be

given Larafen Capsules. Tell your doctor

immediately.

Warnings and precautions

Talk to your doctor, or pharmacist or nurse before

taking Larafen Capsules ifyou:

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

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

•    Have recently had or you need to have surgery

•    Have a history of asthma or have previously shown an allergic reaction to ketoprofen you are at an increased risk of breathing difficulties

   Ifyou are elderly, your doctor may wish to minimise treatment duration and to see you more often while you are taking Larafen Capsules


nogen Pharma


   If you 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 togetherwith Larafen 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 forwater retention

•    Are being treated for high blood pressure

•    Are trying to get pregnant (see section Pregnancy, breastfeeding and fertility).

If you notice any of the following symptoms then you should talk to your doctor immediately as you may need to stop taking the capsules immediately: Visual disturbances, 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 Larafen 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 longerthan recommended.

Other medicines and Larafen Capsules

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

   Aspirin or other non-steroidal antiinflammatory drugs for pain relief

   Corticosteroids (e.g hydrocortisone) given to treat a variety of conditions 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

   Serotonin re-uptake inhibitors (SSRIs) e.g fluoxetine used to treat depression

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

•    Ace-inhibitors e.g captopril (medicines used 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 if you are elderly

•    Quinolones e.g ciprofloxacin (antibiotics used 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, breastfeeding and fertility

Ask your doctor or pharmacist for advice before taking any medicine.

Fertility

Larafen Capsules 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.

Pregnancy and breastfeeding You should not take Larafen Capsules during the first 6 months of pregnancy unless directed byyour doctorand must not take Larafen Capsules during the last 3 months of pregnancy as damage to the baby and reduced labour may occur.

You should only use Larafen Capsules whilst breastfeeding if advised by your doctor.

Driving and using machines

Some patients may experience side effects such as dizziness, drowsiness and visual disturbances which may affect their ability to drive or operate machinery. Make sure you are not affected before driving or operating machinery.

Larafen Capsules contain sucrose

Larafen Capsules contain sucrose. If you 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 LARAFEN CAPSULES


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

Larafen Capsules must not be taken long-term, blood tests should be carried out if taken for more than a few days.

The capsules must be swallowed whole with a glass ofwater, with food.

The usual dose is:

•    Adults: One capsule once a day

•    Elderly: As adult dose. The lowest effective dose should be taken and your doctor will need to monitor you regularly. If you are older then 70 years your doctor may prescribe a lower daily dose and reduce the duration of treatment

•    Children: not recommended.

Ifyou take more Larafen Capsules than you should

Contact your doctor, local hospital casualty department or pharmacist if you have taken more Larafen Capsules than stated in this leaflet or more than what your doctor has prescribed (and you feel unwell).

Symptoms of overdose may be gastrointestinal disorders, feeling or being sick, diarrhoea, kidney failure, fits, headache, disorientation, excitement, coma, drowsiness, dizziness, ringing in the ears, fainting and liver damage.

Ifyou forget to take Larafen Capsules

Do not take a double dose to make up for a forgotten dose. Continue the treatment as advised by your doctor.

Ifyou stop taking Larafen Capsules

Changes to dosage or stopping of treatment should only be as directed by your doctor.


4. POSSIBLE SIDE EFFECTS


•    You have blurred eyesight

•    You bruise more easily than usual or have bleeding that lasts a long time. This could be because of a serious blood problem

•    You have pale skin and feel tired, faint or dizzy, you may have anaemia.

Frequency not known

•    Worsening of your Crohn's disease or colitis

•    Skin reaction to light or sunlamps (photosensitivity)

•    Hairloss

•    You may get more infections more easily than usual. This could be because of a serious blood disorder

•    Fits

•    Pain in youreyes

•    Your eyes or skin go yellow (jaundice). This may be a sign of liver problems.

Other side effects

Common (affects less than 1 in 10 people)

•    Indigestion (dyspepsia), heartburn, stomach pain, these are reduced by taking the medicine with food

•    Feeling sick (nausea) or being sick (vomiting).

Uncommon (affects less than 1 in 100 people)

•    Constipation, diarrhoea, wind or stomach pain (cause by inflammation of the stomach lining)

•    Rash and itching

•    Water retention which may cause swollen arms or legs

•    Headaches, feeling dizzy, feeling sleepy, feeling tired.

Rare (affects less than 1 in 1,000 people)

•    Ringing in yourears (tinnitus)

•    Weight gain

•    Inflamed mouth

•    Changes in liver enzymes (shown by a blood test) and hepatitis (swelling of the liver).

Very rare (affects less than 1 in 10,000 people)

•    Severe stomach or back pain. These could be signs of pancreatitis.

Frequency not known

•    Balance problems (vertigo)

•    Being unable to sleep, changes in mood

•    High blood pressure

•    Changes in the way things taste

•    Runny nose, itching, sneezing and stuffy nose

•    Flushing

•    Depression

•    Feeling confused

•    You see or hear things that are not there

•    Feeling drowsy, feeling unwell

•    Breathlessness.

Blood tests

The results of a blood test may show changes in the way your liver or kidneys are working.

Reporting ofside 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 LARAFEN CAPSULES


Like all medicines, this medicine can cause side effects although not everybody gets them.

Stop taking and see your doctor or go to a hospital straight away if:

Rare (affects less than 1 in 1,000 people)

•    You have an asthma attack

•    You have a burning, aching pain in yourstomach, with an empty feeling and hunger. This may be caused by an ulcer in yourstomach or gut

•    You get swelling of your face, lips or throat which makes it difficult to swallow, breathe or you may have wheezing or tightness in the chest, as well as itching and rashes. This may mean you are having a severe allergic reaction.

Frequency not known

•    You get blistering, peeling or bleeding on any part of your skin with or without an itchy, lumpy rash. This includes your lips, eyes, mouth, nose, genitals, hands orfeet. You may also have flu like symptoms at the same time. You may have a serious skin problem that needs urgent medical treatment

•    You have blood in your urine, change in the amount of urine you produce or swelling especially of your legs, ankles or feet. This may be caused by serious kidney problems

•    You get chest pain or a sudden severe headache. Medicines such as Larafen Capsules may be associated with a small increased risk of heart attack (myocardial infarction) or stroke

•    You are vomiting blood, have severe stomach pains or pass dark, tarry stools

•    A form of meningitis (aseptic) causing a combination of symptoms headache, fever, stiff neck, tiredness, feeling or being sick and disorientation.

Tell your doctor as soon as possible ifyou have any of the following side effects:

Rare (affects less than 1 in 1,000 people)

•    Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on your skin (paresthesia)


Keep all medicines out of the sight and reach of children.

Do not store above 25°C.

Do not use Larafen 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. CONTENTS OF THE PACK AND OTHER INFORMATION


What Larafen Capsules contain

The active substance (the ingredient that makes the capsule work) is ketoprofen.

The other ingredients are polyethylene glycol, ethylcellulose, purified stearic acid, talc, polymers of methacrylic acid, acrylic esters and methacrylic acid esters, sucrose, corn starch, gelatine, erythrosine (E127) and titanium dioxide (E171).

What Larafen Capsules look like and contents of the pack

These capsules are supplied in blister packs of 28, 30, 56,60 and 100.

Marketing Authorisation Holder

Ennogen Pharma Limited

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK.

The Product Licence number is PL 40147/0053

Manufacturer

Ennogen Pharma Limited

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK.

This leaflet was last revised in July 2014.