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PACKAGE LEAFLET: INFORMATION FOR THE USER Surgam 300 mg Tablets

tiaprofenic acid

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1. What Surgam is and it is used for

The name of your medicine is Surgam 300 mg Tablets (called Surgam in this leaflet). Surgam contains a medicine called tiaprofenic acid. This belongs to a group of medicines called ‘non-steroidal antiinflammatory drugs’ (NSAIDs). It works by blocking some chemicals in your body that normally cause inflammation.

It is used to treat the swelling, pain, heat, redness and stiffness in your joints and muscles in the following:

•    Rheumatoid arthritis (inflammation of the joints)

•    Osteoarthritis (where the cushioning (cartilage) between the bone joints is damaged)

•    Lower back pain

•    Sprains and strains

•    Pain and inflammation after an operation

•    Other painful inflammatory joint or muscle problems

2. Before you take Surgam

Do not take this medicine and tell your doctor if:

You are allergic (hypersensitive) to tiaprofenic acid or any of the other ingredients of Surgam (listed in Section 6 below)

Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

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X You are allergic (hypersensitive) to any other similar medicines (non-steroidal anti-inflammatory drugs or NSAIDs) such as aspirin or ibuprofen X You have or ever had an ulcer (burning, aching pain with an empty feeling and hunger) or bleeding in your stomach or gut

X You have or ever had asthma X You have severe heart problems X You have kidney or liver problems X You have or ever had problems passing water (urine) such as pain, blood in your urine or passing water more often than usual

X You are in the last three months of pregnancy (see ‘pregnancy and breast-feeding’ below)

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Surgam.

Take special care with Surgam

Check with your doctor or pharmacist before taking your medicine if:

▲    You often have or ever had something called ‘rhinitis’ (runny nose, itching, sneezing and stuffy nose - for example if you have hayfever)

▲    You often have or ever had something called ‘urticaria’ (itchy lumpy rash)

▲    You have ulcerative colitis or Crohn’s disease

▲    You have a disease affecting the skin, joints or kidney called ‘Sytemic Lupus Erythematous’ (SLE)

▲    You are elderly

▲    You have blood problems (such as unusual bruising or bleeding)

▲    You have ever had high blood pressure (hypertension)

▲    You have ever had heart problems such as a stroke

▲    You have diabetes

▲    You have ever had a high cholesterol level

▲    You are a smoker

▲    You think you might be at risk of heart problems such as stroke

▲    You are in the first six months of pregnancy (see ‘pregnancy and breast-feeding’ below)

▲    You are planning to become pregnant or you have problems becoming pregnant. Surgam may make it more difficult to become pregnant

If you are not sure if any of the above

apply to you, talk to your doctor or

pharmacist before taking Surgam.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Surgam can affect the way some other medicines work.

Also some medicines can affect the way

Surgam works.

In particular, tell your doctor if you are

taking any of the following:

•    Other non-steroidal anti-inflammatory drugs such as aspirin, ibuprofen, celecoxib, etodolac or meloxicam

•    Water tablets (diuretics) such as spironolactone, triamterene or amiloride used to increase the flow of your water (urine)

•    Antibiotics such as quinolone, sulphonamides or aminoglycosides (for infections)

•    Corticosteroids such as prednisolone (for inflammation, allergies or some types of cancer)

•    Medicines for lowering your blood sugar such as medicines for diabetes

•    Medicines for lowering your blood pressure (antihypertensives)

•    Medicines called ‘cardiac glycosides’ such as digoxin (for heart failure)

•    Medicine to stop your blood clotting such as heparin, warfarin, dopidogrel or tridopidine

•    Medicine to dissolve blood clots such as streptokinase, altepase, reteplase or tenecteplase

•    Ciclosporin - used after an organ transplantation to help prevent rejection

•    Medicines for depression such as fluoxetine, sertraline, citalopram or paroxetine

•    Mifepristone - for terminating a pregnancy. It is important not to use Surgam for at least 8-12 days after taking Mifepristone

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•    Lithium - for some types of mental illness

•    Phenytoin - for epilepsy

•    Methotrexate - for some types of cancer

•    Probenecid - used with a medicine called cidofovir to stop kidney damage

•    Tacrolimus - used after an organ transplant

•    Zidovudine - an antiviral drug Please tell your doctor if you are taking any of these medicines.

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if:

•    You are pregnant, might become pregnant, or think you may be pregnant

•    You are breast-feeding or planning to breast-feed

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

You may feel sleepy, dizzy, faint or your eyesight may be affected while taking this medicine. If this happens, do not drive or use any tools or machines.

3. How to take Surgam

Always take Surgam exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

•    Take this medicine by mouth

•    Take with or after food

•    Swallow the tablets whole with a drink of water

•    Do not crush or chew your tablets

•    If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor

Adults

The usual dose of Surgam is 1 tablet twice a day.

Children

Surgam is not recommended for children.

The elderly (over 65 years)

You are more likely to get side effects while taking Surgam. Your doctor may lower the number of tablets that you take.

If you take more Surgam than you should

If you take more tablets than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken.

High doses of Surgam and prolonged treatment can increase the chances of you having a heart attack or stroke (see Section 4: Possible side effects). Do not exceed the recommended dose or duration of treatment.

If you forget to take Surgam If you forget 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 tablet.

If you stop taking Surgam

Keep taking your medicine until your doctor tells you to stop. Do not stop taking Surgam just because you feel better. If you stop, your illness may get worse.

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

4. Possible side effects

Like all medicines, Surgam can cause side

effects, although not everybody gets them.

Stop taking and see your doctor or

go to a hospital straight away if:

•    You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

•    Your asthma is getting worse - this may be a sign of an allergic reaction

•    You have difficulty breathing, wheezing, tightness in the chest (something called ‘bronchospasm’)

•    You have a heart attack (myocardial infarction) or stroke. Medicines such as Surgam may be associated with a small increased risk of heart attack or stroke (see Section 3: If you take more Surgam than you should)

•    You have blistering or bleeding of the skin around your lips, eyes, mouth, nose and genitals. You may also have flu-like symptoms and fever. This may be something called ‘Stevens-Johnson syndrome’

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•    You have a severe blistering rash where layers of your skin may have peeled off to leave large areas of raw exposed skin over your body. Also you may feel generally unwell, with a fever, chills and aching muscles. This may be something called ‘Toxic epidermal necrolysis’

•    You are vomiting any blood or dark particles that look like coffee grounds, have severe stomach pains or pass blood in your stools (faeces) or have dark tarry stools. These are signs of an ulcer that has made tiny holes in your stomach or gut that are bleeding

•    You have a burning, aching pain in your stomach, with an empty feeling and hunger. You may have an ulcer in your stomach or gut

•    You feel pain when passing water (urine), have to pass water more often than usual or have blood in your urine

•    Your limbs are swollen (signs of fluid retention), you feel tired (fatigued) and generally unwell. You may have something called ‘kidney toxicity’

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

•    You have worsening of your Crohn’s disease or colitis

•    You have severe stomach pain, which may reach through to your back. This could be a sign of inflammation of the pancreas (pancreatitis). This is a very rare side effect

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•    You have a skin reaction to light or sunlamps (photosensitivity)

•    You have skin reactions such as itchy, lumpy rash (‘urticaria’), redness, blood spots (‘purpura’), or hair loss, balding (‘alopecia’)

•    Your eyes or skin go yellow (jaundice). This may be a sign of liver problems. You may have something called ‘hepatitis’. This would also show up in the results of some blood tests

•    You bruise more easily than usual or have bleeding that lasts a long time.

This could be because of a blood problem called ‘thrombocytopenia’

•    You have more infections than usual. This could be because of blood disorders called ‘agranulocytosis’ or ‘neutropenia’

•    You feel tired, faint, dizzy and have pale skin (anaemia)

•    You have pain in your eyes (optic neuritis)

•    You have problems with your eyesight

•    You feel depressed, confused or are having hallucinations

•    You have stiff neck, headache, nausea, vomiting, fever or disorientation.

Tell your doctor or pharmacist if any of the following side effects get serious or last longer than a few days. Also tell them if you notice any side effects not listed in this leaflet.

•    Indigestion, heartburn, stomach pain, constipation or wind (flatulence)

•    Feeling sick (nausea), being sick (vomiting) or diarrhoea

•    Decreased appetite (anorexia)

•    Swelling in the mouth

•    Headaches

•    Drowsiness, dizziness or ringing in the ears (tinnitus)

•    Pins and needles (something called ‘paraesthesia’)

These side effects may go away during treatment as your body gets used to the medicine.

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 Surgam

Keep this medicine in a safe place where children cannot see or reach it.

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

Store below 25°C. Keep the blister strip in the outer carton in order to protect from light. Do not transfer your medicine to another container.

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 to protect the environment.

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6. Further information

What Surgam contains

•    Each tablet contains 300 mg of the active substance, tiaprofenic acid

•    The other ingredients are maize starch, poloxamer, magnesium stearate and purified talc

What Surgam looks like and contents of the pack

Surgam tablets are white to creamy white biconvex tablets with the Roussel logo on one side and a breakline on the other side. ‘Surgam’ and ‘300’ are embossed on the tablet. They are available in blister packs of 56 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sanofi, One Onslow Street, Guildford, Surrey,

GU1 4YS, UK.

Tel: 0845 372 7101

email: uk-medicalinformation@sanofi.com Manufacturer

Sanofi Winthrop Industrie,

56 Route de Choisy-au-Bac,

60205 Compiegne, France.

This leaflet was last revised in October 2013

© sanofi, 1982-2013