nogen Pharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ibuprofen Tablets 600mg

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

What is in this leaflet

1.    What Ibuprofen Tablets 600mg are and what they are used for

2.    What you need to know before you take Ibuprofen Tablets 600mg

3.    How to take Ibuprofen Tablets 600mg

4.    Possible side effects

5.    How to store Ibuprofen Tablets 600mg

6.    Contents of the pack and other information

1. WHAT IBUPROFEN TABLETS 600MG ARE AND WHAT THEY ARE USED FOR

Ibuprofen Tablets 600mg contain the active ingredient ibuprofen. They belong to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

They work by relieving pain, reducing inflammation, swelling and fever.

Ibuprofen Tablets 600mg are used to treat mild to moderate pain including:

•    Rheumatic and muscular pain

•    Backache

•    Headache

•    Dental pain

•    Migraine

•    Neuralgia

•    Period pain

•    Symptoms of colds and flu

•    Fever.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN TABLETS 600MG

Do not take Ibuprofen Tablets 600mg if:

•    You are allergic to or have ever had an allergic reaction (e.g asthma, inflammation of the insides ofthe nose, swelling ofthe skin) to other NSAIDs like aspirin or diclofenac or any other ingredients in this medicine

•    You have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding in the past

•    You have had gastrointestinal bleeding or perforation when previously taking NSAIDs

•    You suffer from severe liver, kidney or heart failure

•    You are in the last 3 months of pregnancy.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before

taking this medicine ifyou:

•    Have or have had asthma

•    Have kidney, heart, liver or bowel problems

•    Have Systemic Lupus Erythematosus (SLE) a condition of the immune system affecting connective tissue resulting in joint pain, skin change and disorders of other organs

•    Are currently taking other NSAIDs

•    Have a history of gastrointestinal disease (such as ulcerative colitis, Crohn's disease)

•    Are in the first 6 months of pregnancy

•    Have high cholesterol or previously have had a heart attack or stroke

•    Are a smoker.

Otherwarnings

Ibuprofen Tablets 600mg belongs to a group of medicines which may impair female fertility. This is reversible on stopping the medicine. It is unlikely that Ibuprofen Tablets 600mg used occasionally will affect your chances of becoming pregnant. However, tell your doctor before taking this medicine if you have problems becoming pregnant.

Medicines such as Ibuprofen Tablets 600mg may be associated with a small increased risk of heart attack (myocardial infarction) 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 Tablets 600mg ifyou:

•    Have heart problems including heart failure, angina (chest pain) or you have had a heart attack, bypass surgery or peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries)

•    Have any kind of stroke or think that you might be at risk of these conditions (e.g. if you have a family history of heart disease or stroke, high blood pressure, diabetes, high cholesterol or are a smoker).

There is a risk of renal impairment in dehydrated children and adolescents.

There is an increased risk of the elderly having side effects.

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

Other medicines and Ibuprofen Tablets 600mg

Some medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlodipine), some medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol, or angiotensin-ll receptorantagonists such as losartan) and other medicines may affect or be affected by treatment with ibuprofen. You should therefore always seek the advice of your doctor or pharmacist before you use ibuprofen with other medicines. In particular you should tell your doctor or pharmacist if you are taking any of the following medicines in addition to those mentioned above.

You should avoid taking these tablets with the following:

•    Aspirin or other non-steroidal antiinflammatory drugs (NSAIDs) for pain relief

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

•    Quinolones e.g ciprofloxacin (antibiotics used to treat infections) may cause fits and aminoglycosides (e.g. gentamicin) used to treat infections

•    Gingko biloba the herbal extract used to treat memory disturbances

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

•    Diuretics (water tablets) effects may be decreased. Potassium sparing diuretics may increase the blood level of potassium

•    Ciclosporin or tacrolimus (medicines used to prevent rejection after transplant) may harm kidney function

•    Lithium (medicine to treat depression) or digoxin (medicine to treat impaired heart function) increase in blood levels of these medicines

•    Selective serotonin reuptake inhibitors

(SSRIs) e.g fluoxetine used to treat depression

•    Mifepristone (used to induce abortion).

NSAIDs should not be used 8-12 days after taking mifepristone as NSAIDs can reduce mifepristone's effectiveness

•    Methotrexate (to treat psoriasis, rheumatoid arthritis and certain tumors)

•    Medicines to treat HIV (e.g. zidovudine)

•    Cholestyramine (a drug used to lower cholesterol)

•    Medicines known as sulphonylureas such as glibenclamide (used to treat diabetes)

•    Medicines to treat fungal infections such as voriconazole or fluconazole.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Ibuprofen Tablets should not be used in late pregnancy (the last three months) and should only be taken in the first six months of pregnancy on the advice of your doctor.

Driving and using machines

These tablets may make you feel dizzy, drowsy and you may have a headache or visual disturbances. If you think that you are affected after taking these tablets do not drive or operate machinery until you feel better.

Ibuprofen Tablets contain sucrose

If you have been told by your doctor that you have an intolerance to some sugars you should talk to your doctor before taking this medicine.

3. HOW TO TAKE IBUPROFEN TABLETS 600MG

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Take your tablets with or after food, with a glass of water. The tablets should be swallowed whole.

Adults, the elderly and children over 12 years:

The usual dose is 600mg (one tablet) to 1800mg (three tablets) spread throughout the day. Your doctor may choose to increase this depending on what you are being treated for but no more than 2400mg (FOUR tablets) should be taken in one day.

Do not give to children under 12 years old.

Ifyou take more Ibuprofen Tablets than you should

You should contact a doctor or go to the nearest hospital casualty department IMMEDIATELY taking your tablets with you.

If you forget to take your tablets

Take them as soon as you remember, unless it is almost time for your next dose. If it is, do not take the missed dose at all. Never double up on a dose to make up for the one you have missed.

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

Rare (affects up to1 ina 1000 people):

•    Feeling depressed or confused

•    Fluid retention (oedema)

•    A brain infection called 'non-bacterial meningitis'

•    Loss of vision

•    Changes in blood count - the first signs are: high temperature, sore throat, mouth ulcers, flu-like symptoms, feeling very tired, bleeding from the nose and the skin

•    Reduction in blood cells (anaemia)

•    Serious allergic reaction which causes difficulty in breathing or dizziness

•    Severe sore throat with high fever (agranulocytosis).

4. POSSIBLE SIDE EFFECTS

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

STOP TAKING Ibuprofen Tablets 600mg and seek immediate medical help ifyou experience:

•    Signs ofaseptic meningitis such as severe headache, high temperature, stiffness ofthe neck or intolerance to bright light.

•    Signs ofintestinal bleeding such as

►    Passingbloodinyourfaeces (stools/motions)

►    Passing black tarry stools

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

TELL YOUR DOCTOR AND STOP TAKING IBUPROFEN TABLETS 600MG IF YOU EXPERIENCE:

•    Unexplained stomach pain (abdominal pain) or other abnormal stomach symptoms, indigestion, heartburn, feeling sickand/or vomiting

•    Unexplained wheezing, shortness of breath, skin rash, itching or bruising (these may be symptoms ofan allergic reaction)

•    Yellowing of the eyes and/or skin (jaundice)

•    Severe sore throat with high fever (these may be symptoms of a condition known as agranulocytosis)

•    Blurred or disturbed vision (visual impairment) or seeing/hearing strange things (hallucinations)

•    Fluid retention e.g. swollen ankles (this may be a sign of kidney problems)

•    Severe spreading skin rash (Stevens-Johnson Syndrome and erythema multiforme, symptoms include severe skin rash, blistering ofskin, including inside mouth, nose, and genitals, as well as skin peeling which may be accompanied with symptoms such as aching, headaches, and feverishness).

Medicines such as Ibuprofen Tablets 600mg have been associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Medicines such as Ibuprofen Tablets 600mg have in exceptional cases been associated with severe skin problems for patients with chicken pox or shingles

Very rare (affects up to 1 in 10,000 people):

•    Liverfailure

•    Heart failure

•    Heart attack

•    Inflammation of the pancreas

•    Skin problems (which can also affect inside your mouth, nose or ears) such as 'Stevens-Johnson syndrome', 'toxic epidermal necrolysis' or 'erythema multiforme'

•    High blood pressure.

Not known (frequency cannot be estimated from available data):

• Worsening of ulcerative colitis or Crohn's Disease (inflammation of the colon).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes 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 TABLETS 600MG

Keep this medicine out ofthe sight and reach ofchildren.

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

Store in a cool dry place protected from moisture below 25°C.

Do not use this medicine if you notice visible signs ofdeterioration.

Do not throw away any medicines via wastewater or household waste. Return any left over tablets to your pharmacist. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Ibuprofen Tablets 600mg contains

Ibuprofen 600mg Tablets contains 600mg of the active ingredient ibuprofen.

Blood disorders, kidney problems, liver problems or severe skin reactions may occur rarely with ibuprofen.

Very rarely Ibuprofen Tablets 600mg may cause aseptic meningitis (inflammation of the protective membrane surrounding the brain).

The other ingredients are: Colloidal anhydrous silica, starch, povidone, croscarmellose sodium, microcrystalline cellulose, alginic acid, magnesium stearate, sodium lauryl sulphate, titanium dioxide (E171), ponceau 4R lake (E124), FD&C No.2 lake (E132), methocel, macrogol and sodium starch glycolate.

Ibuprofen Tablets 600mg have also been shown to

sometimes worsen the symptoms of Crohn's

disease or colitis.

Other side effects

Common (affects uptol in10 people):

•    Rash

•    Feeling dizzy or tired

•    Stomach pain, indigestion, diarrhoea, feeling sick, being sick, wind, constipation

•    Headache - if this happens while you are taking this medicine it is important not to take any other medicines for pain to help with this.

Uncommon (affects up to1 ina100 people):

•    Feeling drowsy

•    Feeling anxious

•    Feeling a tingling sensation or 'pins and needles'

•    Difficulty sleeping

•    Hives, itching

•    Skin becomes sensitive to light

•    Visual disturbances, hearing problems

•    Hepatitis, yellowing of your skin or eyes, reduced liver function

•    Reduced kidney function, inflammation of the kidneys, kidney failure

•    Sneezing, blocked, itchy or runny nose (rhinitis)

•    Stomach or gut ulcer, hole in the wall of the digestive tract

•    Inflammationofyourstomachlining

•    Small bruises on your skin or inside your mouth, nose or ears

•    Difficulty breathing, wheezing or coughing, asthma or worsening of asthma

•    Ringing in ears (tinnitus)

•    Sensation of feeling dizzy or spinning (vertigo)

•    Mouth ulcers

•    Serious allergic reaction which causes swelling of the face or throat.

What Ibuprofen Tablets looks like and contents of the pack

Ibuprofen tablets 600mg are pink oval film coated tablets.

Ibuprofen Tablets 600mg are packed into securitainers of50, 100, 250, or500 tablets.

Marketing Authorisation Holder

Ennogen Pharma Ltd

Unit G4, Riverside Industrial Estate

Riverside Way, Dartford

DA1 5BS, United Kingdom

Manufacturer

Pharmaserve Limited Clifton Technology Park Wynne Avenue, Swinton Manchester, M27 8FF, United Kingdom

This leaflet was last revised in August 2016.