Ibuprofen 600mg film-coated tablets (POM)

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Ibuprofen is and what it is 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

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• if you have had allergic reactions such as asthma, runny nose, itchy skin rash or swelling of the lips, face, tongue, or throat after you have taken medicines containing acetylsalicylic acid (such as aspirin) or other drugs for pain and inflammation (NSAIDs).
• if you have suffered from gastrointestinal bleeding or perforation related to previous use of drugs for pain and inflammation (NSAIDs)
• if you are suffering from an ulcer or bleeding in the stomach or small intestine (duodenum) or if you have had two or more of these episodes in the past
• if you suffer from severe liver, kidney or heart problems
• if you are in the last 3 months of pregnancy
• if you are suffering from significant dehydration (caused by vomiting, diarrhoea or insufficient fluid intake)
• if you have any active bleeding (including in the brain)
• if you suffer from a condition of unknown origin resulting in abnormal formation of blood cells

Do not give Ibuprofen 600 mg and film-coated tablets to children and adolescents younger than 15 years.

Talk to your doctor before taking Ibuprofen

• if you have Systemic Lupus erythematosus(SLE) or mixed connective tissue diseases
• if you have inherited a disorder of the red blood pigment haemoglobin (porphyria)
• if you have chronic inflammatory intestinal diseases such as inflammation of the colon with ulcers (ulcerative colitis), inflammation affecting the digestive tract (Crohn’s disease) or other stomach or intestinal diseases
• if you have disturbances in the formation of blood cells
• if you have problems with normal blood clotting mechanism
• if you suffer from allergies, hay fever, asthma, chronic swelling of nasal mucosa, sinuses, adenoids, or chronic obstructive disorders of the respiratory tract because the risk for developing narrowing of the airways with difficulty in breathing (bronchospasm) is greater
• if you have liver, kidney or heart problems
• if you have just had major surgery
• if you are in the first six months of pregnancy
• if you are breast-feeding
• if you have an infection - please see heading “Infections” below
• if you are taking ibuprofen for longer than the recommended time or at higher than recommended doses you are at risk of serious harms. These include serious harms to the stomach/gut and kidneys, as well as very low levels of potassium in your blood. These can be fatal (see section 4).

Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck region (angioedema), chest pain have been reported with ibuprofen. Stop immediately Ibuprofen tablets and contact immediately your doctor or medical emergencies if you notice any of these signs.

Infections

Ibuprofen may hide signs of infections such as fever and pain. It is therefore possible that Ibuprofen may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.

Elderly

If you are elderly you will be more prone to side effects, especially bleeding and perforation in the digestive tract, which may be fatal.

Ulcers, perforation and bleeding in the stomach or intestines

If you have earlier had an ulcer in the stomach or intestines, especially if this has been complicated by perforation or accompanied by bleeding, you should look out for any unusual symptoms in the abdomen, and report them at once to your doctor, especially if these symptoms occur at the beginning of treatment.

This is because the risk for bleeding or ulceration of the digestive tract is higher in this case, especially in elderly patients. If bleeding or ulceration of the digestive tract occurs, the treatment has to be stopped.

Bleeding, ulceration or perforation in the stomach or intestines may occur without any warning signs even in patients who have never had such problems before. It may also be fatal.

The risk of ulcers, perforation or bleeding in the stomach or intestines generally increases with higher doses of ibuprofen. The risk also increases if certain other medicines are taken at the same time as ibuprofen (see other medicines and Ibuprofen, below).

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

Skin reactions

Serious skin reactions have been reported in association with Ibuprofen treatment. You should stop taking Ibuprofen tablet and seek medical attention immediately, if you develop any skin rash, lesions of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction. See section 4.

During varicella it is advisable to avoid use of this drug.

Effects on the heart and brain

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 or 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, or have a family history of heart disease or stroke, or if you are a smoker.

Effects on the kidneys

Ibuprofen may cause problems with kidney function even in patients who have not had kidney problems before. This may result in swelling of the legs and may even lead to heart failure or high blood pressure in predisposed individuals.

Ibuprofen may cause kidney damage especially in patients who already have kidney, heart or liver problems, or are taking diuretics or ACE inhibitors, as well as in the elderly. Stopping Ibuprofen however generally leads to recovery.

Aseptic meningitis (inflammation of the brain membrane without bacterial infection)

During treatment with ibuprofen, some cases of meningitis (presenting as stiff neck, headache, nausea, vomiting, fever or disorientation) have been seen. Although it is probably more likely to occur in patients with existing autoimmune disorders such as systemic lupus erythematosus or mixed connective tissue diseases, it has been reported in patients who do not have an existing long-term disease.

Other precautions

Very rarely, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed. Stop treatment immediately at the first signs of hypersensitivity reaction after taking Ibuprofen and tell immediately to your doctor.

Ibuprofen can temporarily inhibit blood platelet function (blood platelet aggregation). Patients with blood clotting disorders should therefore be carefully monitored.

During long-term, high-dose use of pain killers, headache may occur which should not be treated with high doses of this medicine. The habitual use of painkillers may cause permanent damage to the kidneys and a risk of kidney failure.

Ibuprofen may hide the symptoms or signs of an infection (fever, pain and swelling) and temporarily prolong bleeding time.

Ibuprofen may decrease your chance of becoming pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Adolescents

Ibuprofen is contraindicated in children and adolescents younger than 15 years of age (See section 3).

Ibuprofen may cause kidney problems in adolescents who are dehydrated.

Take special care with Ibuprofen film-coated tablets

Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Stop using Ibuprofen film-coated tablets and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

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

The side effects of Ibuprofen may be increased if certain medicines are taken at the same time. On the other hand, Ibuprofen may increase or decrease the effect of other medicines or increase their side effects when taken at the same time.

Ibuprofen may affect or be affected by some other medicines.

For example:

• other NSAIDs including COX-2 inhibitors, since this may increase the risk of gastrointestinal ulcers and bleeding
• anticoagulants (against clotting) such as warfarin or heparin, since the effect of the anticoagulant may be enhanced
• platelet aggregation inhibitors (against clotting) such as clopidogrel and ticlopidine
• methotrexate (used to treat cancer and auto-immune diseases)
• digoxin (for treatment of various heart conditions) ) since the effect of digoxin may be enhanced
• phenytoin (used in prevention of the occurrence of epileptic seizures) since the effect of phenytoin may be enhanced
• lithium (used to treat depression and mania) since the effect of lithium may be enhanced
• diuretics (water tablets) since the effect of the diuretics may be weakened,
• potassium-sparing diuretics since this may lead to hyperkalaemia
• medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensi-II receptor antagonists such as losartan)
• cholestyramine (used in the treatment of high cholesterol)
• aminoglycosides (medicines against certain types of bacteria) since NSAIDs may decrease excretion of aminoglycosides
• SSRIs (medicines against depression) such as paroxetin, sertralin, citalopram as these may increase risk of gastrointestinal bleeding
• ciclosporine, tacrolimus (for immuno-suppression after organ transplant) since kidney damage may occur
• zidovudine or ritanovir (used to treat patients with HIV)
• mifepristone since NSAIDs can reduce the effect of mifepristone
• probenecid or sulfinpyrazone (for treating gout) since the excretion of ibuprofen may be delayed
• quinolone antibiotics since the risk of convulsions (fits) may be increased
• sulphonylureas (to treat type 2 diabetes) since the blood sugar levels can be affected
• glucocorticoids (used against inflammations) since this may increase the risk of gastrointestinal ulcers or bleeding
• bisphosphonates (used in osteoporosis, Paget’s disease and to reduce high blood calcium levels)
• oxpentifylline ((pentoxifylline) used in the treatment of circulatory disease of the arteries of the legs or arms)
• baclofen (a muscle relaxant) because of elevated baclofen toxicity
• Gingko biloba herbal medicine (there is a chance you may bleed more easily if you are taking this with ibuprofen).
• voriconazole and fluconazole (CYP2C9 inhibitors) (used for fungal infections), since the effect of ibuprofen may increase.
  Reduction of the ibuprofen dose should be considered, particularly when high-dose ibuprofen is used with either voriconazole or fluconazole.

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 use Ibuprofen with other medicines.

Avoid alcohol since it may enhance the side effects of Ibuprofen, especially those affecting the stomach, intestines or central nervous system.

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.

Do not take ibuprofen if you are in the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney, lung and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected. You should not take ibuprofen during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, ibuprofen can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.

Ibuprofen 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.

Ibuprofen appears in breast milk in a very small amount and breastfeeding will usually not need to be stopped during short-term treatments. If, however, longer treatment is prescribed, early weaning should be considered.

Ibuprofen generally has no adverse effects on the ability to drive or operate machinery. However since at high dosage side effects such as fatigue, somnolence, vertigo (reported as common) and visual disturbances (reported as uncommon) may be experienced, the ability to take part actively in road traffic or operate machinery may be impaired in individual cases. This effect is potentiated by simultaneous consumption of alcohol.

Ibuprofen contain Sodium: This medicine contains less than 1 mmol sodium (23 mg) per 600 mg film-coated tablets, that is to say essentially ‘sodium-free’.

If you have taken more ibuprofen than you should, or if children have taken this medicine by accident always contact a doctor or nearest hospital to get an opinion of the risk and advice on action to be taken.

The symptoms of overdose can include nausea, stomach pain, vomiting (may be blood streaked), or more rarely diarrhoea. In addition, headache, gastrointestinal bleeding, blurred vision, ringing in the ears, confusion and shaky eye movement, and exacerbation of asthma in asthmatics. At high doses, drowsiness, excitation, disorientation, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), vertigo, weakness and dizziness, blood in urine, low levels of potassium in your blood, hyperkalaemia, metabolic acidosis, increased prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis, cold body feeling, and breathing problems have been reported. Also agitation, somnolence or coma may occur. Furthermore, there may be low blood pressure and reduced breathing.

Do not take a double dose to make up for a forgotten dose.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substances isIbuprofen.
  Each film-coated tablet contains 600 mg ibuprofen.
• The other ingredients are:
  Tablet core: Maize starch, starch, pregelatinised (maize starch), silica, colloidal anhydrous, croscarmellose sodium, talc, stearic acid.
  Film coating: Talc (E553b), polyvinyl alcohol, macrogol 3350 (E1521), titanium dioxide (E171).

Film-coated tablet.

Ibuprofen 600 mg film-coated tablet

White to off-white, oval shaped, film-coated tablets with break line on one side and plain on the other side. The tablet can be divided into equal doses.

Ibuprofen film-coated tablets are available in blister packs

Pack sizes: 10, 20, 24, 30, 40, 50, 56, 60, 84 and 100 film-coated tablets

Not all pack sizes may be marketed.

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