PACKAGE LEAFLET: INFORMATION FOR THE USER

Ibuprofen 600 mg Film-coated Tablets (Ibuprofen)

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 of the 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 Ibuprofen Tablets are and what they are used for

2.    What you need to know before you take Ibuprofen

3.    How to take Ibuprofen

4.    Possible side effects

5.    How to store Ibuprofen

6.    Contents of the pack and other information

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

Ibuprofen belongs to a group of medicines called Non Steroidal Anti-Inflammatory Drugs (known as NSAIDs), which relieve pain and reduce inflammation in joints and soft tissues such as muscles and ligaments.

Ibuprofen tablets are used to:

•    relieve mild to moderate pain e.g. post-operative pain, toothache, period pain and soft tissue injury

(muscles and ligaments)

•    relieve stiffness and pain in the back and other muscles

•    reduce inflammation in different types of arthritis.

2.    What you need to know before you take Ibuprofen

Do NOT take Ibuprofen if you:

•    are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).

•    have or had an allergic reaction to aspirin or any other NSAID (you have ever had asthma, runny nose, itchy skin or swelling of the lips, face or throat after taking these medicines)

•    have an increased tendency of bleeding

•    are suffering from or have a history of repeated stomach ulcers or other gastric complaint

•    are suffering from heart failure, which can cause shortness of breath or ankle swelling

•    suffer from kidney or liver problems

•    are in last 3 months of your pregnancy

•    have systemic lupus erythematosus (SLE, sometimes known as lupus) or a connective tissue disease (autoimmune diseases affecting connective tissue).

Do not take 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.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking ibuprofen. If you:

•    are elderly

•    are suffering from or have a history of bronchial asthma

•    have a history of stomach or bowel problems

•    have problems with your kidneys, heart or liver

•    have systemic lupus erythematosus (SLE, sometimes known as lupus) or a connective tissue disease (autoimmune diseases affecting connective tissue).

•    have a history of gastrointestinal disease

•    are severely dehydrated

•    have problems conceiving or are in the first 6 months of pregnancy

•    are taking any non-steroidal anti-inflammatory medicine, including aspirin as this may result into increased tendency of ulceration or bleeding

•    have ulcerated colitis or Crohn’s disease

If you suffer from any of the following at any time during your treatment STOP TAKING the medicine and seek immediate medical help:

•    Pass blood in your faeces (stools/ motions)

•    Pass black tarry stools

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

STOP TAKING the medicine and tell your doctor if your experience:

•    Indigestion or heartburn

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

Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss your treatment with your doctor or pharmacist before taking Ibuprofen if you:

-    have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass

surgery, peripheral artery disease (poor circulation in the legs of feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack “TIA”).

-    have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if

you are a smoker.

Other medicines and Ibuprofen

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines of the following:

•    any other pain-relieving medication, including aspirin

•    medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)

•    diuretics ('water tablets')

•    medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)

•    medicines for heart problems e.g. digoxin, digitoxin

•    lithium, a drug used in the treatment of depression

•    methotrexate, a treatment for leukaemia

•    medicines known as immunosuppressants such as ciclosporin and tacrolimus (used to dampen down your immune response)

•    mifepristone in the last 8 - 12 days, used to end a pregnancy

•    corticosteroids (medicines to treat a variety of conditions such as allergies and hormone imbalances), e.g. aldosterone, hydrocortisone or prednisolone

•    quinolone antibiotics, e.g. ciprofloxacin, norfloxacin or levofloxacin

•    zidovudine (an anti-viral drug)

•    medicines known as selective serotonin reuptake inhibitors (SSRIs), used for the treatment of depression

•    any other ibuprofen preparations, such as those you can buy without a prescription

•    cholestyramine (a drug used to lower cholesterol)

•    medicines known as sulphonylureas such as glibenclamide and glipizide (used to treat diabetes)

•    voriconazole or fluconazole (types of anti-fungal drugs)

•    Gingko biloba herbal medicine (there is a chance you may bleed more easily if you are taking this with ibuprofen)

•    aminoglycosides (a type of antibiotic).

Some other medicines may also affect or be affected by the treatment of Ibuprofen You should therefore always seek the advice of your doctor or pharmacist before you take Ibuprofen with other medicines.

Pregnancy, breast-feeding and fertility

The use of Ibuprofen whilst pregnant or breast feeding should be avoided.

Ibuprofen should not be used in the last 3 months of pregnancy and should only be taken in the first six months of pregnancy on the advice of your doctor.

Driving and using machines

Ibuprofen may make you feel dizzy or drowsy. If the tablets affect you in this way do not drive or operate machinery

3. How to take Ibuprofen

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

If you suffer from heart, liver or kidney problems your doctor may lower your dose and carry out regular tests. If you see another doctor or go into hospital, let the doctor or the staff know what medicines you are taking.

Ibuprofen with food and drink

The tablets should be swallowed preferably with a drink of water. Take with or after food.

The recommended dose is:

•    Adults

Initially 1200 mg per day in divided doses. Larger doses up to 1800 mg per day may be taken if necessary. The maintenance dose will be determined on an individual basis (between 600 - 1200 mg a day).

Do not take more than 2400 mg in a 24-hour period.

•    Use in children and adolescents

Ibuprofen 600 mg tablets are not recommended for use in children.

•    Elderly people

To reduce the possibility of side effects if you are elderly, you should take the smallest dose for the shortest possible time. Your doctor may monitor you for bleeding in the stomach.

If you take more Ibuprofen than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause stomach pain, feeling sick, being sick, diarrhoea, ringing in the ears, headache, bleeding in the stomach or intestines.

Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Ibuprofen

If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose. Take the remaining doses at the correct time.

If you stop taking Ibuprofen

Do not stop taking your medicine without talking to your doctor first even if you feel better.

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

4. Possible side effects

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

If any of the following happen, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:

•    an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives)

•    Stevens-Johnson syndrome (severe blisters and bleeding in the mucous membranes of the lips, eyes, mouth, nasal passage, and genitals) or severe headache, high temperature, stiffness of the neck, a skin reaction causing blistering and flaking of the skin, intolerance to light

•    you pass blood in your faeces (stools/motions)

•    you pass black tarry stools

•    you vomit any blood or dark particles that look like coffee grounds.

•    blood disorders such as low numbers of red or white blood cells, reduction in blood platelets (which may increase the risk of bleeding and bruising), neutropenia (which may cause fever or chills, sore throat, ulcers in your mouth or throat)

•    heart problems causing symptoms such as shortness of breath when exercising or lying flat, wheezing and a cough, weight gain.

These are very serious but rare side effects. You may need urgent medical attention or hospitalisation.

The following side effects have been reported at the approximate frequencies shown:

Rare: may affect up to 1 in 1,000 people

Stop taking the medicine and tell your doctor if you experience:

•    abdominal pain (pains in your stomach) or other abnormal stomach symptoms, indigestion, heartburn, feeling sick and/or being sick

•    unexplained wheezing, shortness of breath, skin rash, itching or bruising

•    yellowing of the eyes and/or skin

•    severe sore throat with high fever

•    blurred or disturbed vision, or seeing/hearing strange things

•    fluid retention (e.g. swollen ankles).

Very rare: may affect up to 1 in 10,000 people

Very rarely Ibuprofen Tablets may cause aseptic meningitis (inflammation of the protective membrane surrounding the brain) especially in patients with an auto-immune disease e.g. Systemic Lupus Erythematosus (SLE) or mixed connective tissue disease; symptoms may include stiff neck, headache, nausea, vomiting, fever, disorientation.

Other side effects (Frequency unknown)

Other side effects that have been reported while taking Ibuprofen:

•    peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach

•    pancreatitis (inflammation of the pancreas)

•    diarrhoea

•    constipation

•    flatulence (wind)

•    inflammation or ulceration of the mouth e.g. mouth ulcers and cold sores (ulcerative stomatitis)

•    high blood pressure

•    kidney problems such as inflammation of the kidneys, kidney damage or kidney failure

•    liver problems such as abnormal liver function test results, inflammation of the liver (hepatitis)

•    breathlessness and wheezing in patients suffering from or with a previous history of asthma or allergic disease e.g. allergy to house dust mites, cats or dogs

•    runny nose

•    problems with the senses such as vision problems, inflammation of the optic nerve, pins-and-needles or numbness, ringing in the ears or impaired hearing

•    headaches, hallucinations, depression, confusion, dizziness and vertigo (a feeling of dizziness or “spinning”, drowsiness and a general feeling of being unwell, lethargy

•    difficulty in sleeping, anxiety

Ibuprofen has also been shown to sometimes worsen the symptoms of Crohn’s disease or colitis

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

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

You can minimise the risk of side effects by taking the least amount of tablets for the shortest amount of time necessary to control your symptoms.

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 Ibuprofen

Keep this medicine out of the sight and reach of children.

These tablets should be stored in a dry place, at or below 25° C, protected from light in the package or container supplied. Do not transfer them to another container.

Do not use Ibuprofen after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6.    Contents of the pack and other information

What Ibuprofen tablets contain:

•    The active ingredient is ibuprofen.

•    The other ingredients are pregelatinised maize starch, maize starch, colloidal silicon dioxide, sodium starch glycolate, and stearic acid. The tablet coating contains hydroxypropyl methylcellulose E464), talc, erythrosine (E127) and titanium dioxide (E171).

What Ibuprofen tablets look like and contents of the pack:

•    The Ibuprofen 600 mg tablets are pink, capsule-shaped film coated tablets. They are coded 600 over 0531 and plain on the reverse.

•    The tablets are available in pack sizes of 7, 10, 14, 21, 28, 30, 50, 56, 60, 84, 90, 100, 110, 112, 120, 150, 160, 168, 250, 500, and 1000 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation holder and company responsible for manufacture is TEVA UK Limited, Eastbourne, BN22 9AG England.

This leaflet was last revised: August 2015

PL 00289/0280

Teva Pharmaceuticals Europe B.V 1.3.1 pil-uk-pl-00289-0280-ibuprofen-600mg-film-coated-tablets

Approvals

Signed by	Meaning of Signature	Server Date
Darryl Hill	Regulatory Affairs Approval	09-Sep-2015 09:57:42 AM

REG0077715 Version 2.11 Approved Page 7 of 7