Ibuprofene Pensavital

Do not take IBUPROFENE PENSAVITAL if:

• you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
  Symptoms of an allergic reaction can include swelling of the eyelids, lips, tongue, or throat 
• you have ever had an allergic reaction (such as bronchospasm – stiffening of the lung muscles that can cause asthma and shortness of breath, asthma attacks, dripping nose, swelling of the airways, skin reactions, or sudden swelling) after taking acetylsalicylic acid or other similar painkillers (NSAIDs), or you suffer from unspecified blood disorders
• you have recurring gastric/duodenal ulcers (peptic ulcers) or bleeding (at least 2 separate episodes of ulcers or bleeding confirmed), you have a history of bleeding or perforation of the stomach or intestines associated with previous treatment with NSAIDs, you suffer from any active bleeding (including brain bleeding)
• you suffer from severe liver, kidney, or heart impairment
• you have severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake)
• you suffer from chronic alcoholism (from 14 to 20 drinks/week or more)
• you are a child aged under 12 years old or adolescent weighing less than 40 kg
• you are in the last three months of pregnancy

Warnings and precautions
Talk to your doctor or pharmacist before taking Ibuprofene Pensavital:

Side effects can be minimised by using the minimum dose that effectively controls symptoms for the shortest possible treatment period. 

You must discuss treatment with the doctor or pharmacist before taking IBUPROFENE PENSAVITAL if:

• you have Systemic Lupus Erythematosus (SLE, sometimes simply called “lupus”) or mixed connective tissue diseases (an autoimmune disease that affects connective tissue), you have or have had diseases of the stomach or intestines (like ulcerative colitis, Crohn’s disease) because your condition may worsen
• you suffer from any hereditary blood disorder (e.g. acute intermittent porphyria) 
• you have reduced liver and kidney function
• you have recently undergone major surgery 
• you suffer from hay fever, nasal polyps, or chronic obstructive pulmonary disease, because there is an increased risk of allergic reactions. Allergic reactions can take the form of asthma attacks (known as “analgesic-induced asthma”), Quincke’s oedema (rapid swelling), or urticaria 
• you are dehydrated
• you have an infection – see the section on “Infections” below.

Gastrointestinal side effects 

The combined use of IBUPROFENE PENSAVITAL with another non-steroidal anti-inflammatory drug (NSAID), called a COX-2 inhibitor (cyclooxygenase-2 inhibitor), must be avoided.

Ulcers, perforation and bleeding in the stomach or intestines

With all NSAIDs, bleeding of the stomach or intestines, ulcers and perforations have been reported, sometimes with fatal outcomes. These have occurred at any time during treatment, with or without previous warning symptoms or a history of severe events involving the stomach or intestines.

The risk of bleeding, ulceration and perforation in the stomach or intestines is greater as the dose of the NSAIDs increases and is higher in patients with a history of ulcers, particularly with complications involving bleeding or perforation (see section 2 “Do not take IBUPROFENE PENSAVITAL”) and in elderly patients. These patients must start treatment with the lowest dose available.

For these patients, just like for patients requiring additional treatment with low doses of acetylsalicylic acid or other medicines that can increase the risk of disorders of the stomach or intestines, a treatment associated with protective medicines (such as misoprostol or proton pump inhibitors) should be considered.

If you have a history of side effects involving the stomach or intestines and above all if you are elderly, contact a doctor if you experience any unusual abdominal symptoms (especially gastrointestinal bleeding), in particular at the start of treatment.

Caution is recommended if you are also taking other medicines that can increase the risk of ulcers and bleeding, such as oral corticosteroids, anticoagulant drugs (blood thinners) like warfarin, selective serotonin re-uptake inhibitors (used to treat psychiatric disorders including depression) or platelet aggregation inhibitors like acetylsalicylic acid (see section 2 “Other medicines and IBUPROFENE PENSAVITAL”).

Treatment must be suspended and a doctor consulted if you begin bleeding or develop ulcers of the stomach or intestines during treatment with IBUPROFENE PENSAVITAL. 

Cardiovascular side effects

Anti-inflammatory/analgesic medicines like ibuprofen can be associated with a slight increase in the risk of heart attack or stroke, particularly if used at high doses. Do not exceed the recommended dose or treatment duration.

You must discuss treatment with the doctor or pharmacist before taking IBUPROFENE PENSAVITAL 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”).
• you have high blood pressure, diabetes, high cholesterol, or have a family history of heart disease or stroke, or if you are a smoker.

Kidney side effects

Caution must be applied when starting treatment with ibuprofen in patients suffering from significant dehydration. There is a risk of kidney impairment, particularly in dehydrated children, adolescents and the elderly.

Like with other NSAIDs, long-term administration of ibuprofen has caused renal papillary necrosis and other pathological kidney alterations. Kidney toxicity has also been observed in patients whose renal prostaglandins have a compensatory role in maintaining kidney perfusion. In these patients, the administration of an NSAID can cause a dose-dependent reduction in the formation of prostaglandins and, secondarily, of the kidney blood flow, which can cause kidney failure. The patients at greatest risk of this reaction are those with impaired kidney function, heart failure, impaired liver function, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of treatment with NSAIDs is usually followed by recovery of pre-treatment condition.

Skin reactions

Severe skin reactions have been reported in association with treatment with ibuprofen. Stop taking IBUPROFENE PENSAVITAL and contact a doctor immediately if you develop any skin rash, lesions of the mucous membranes, blisters or other signs of allergy since these can be the first signs of a very serious skin reaction. See section 4.

During varicella (chicken pox) it is advisable to avoid use of IBUPROFENE PENSAVITAL.

Infections

IBUPROFENE PENSAVITAL may mask signs of infection such as fever and pain. It is therefore possible that IBUPROFENE PENSAVITAL may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in bacterial pneumonia 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, immediately consult a doctor.

Breathing problems and hypersensitivity reactions 

Very rarely, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed. Stop treatment immediately at the first signs of hypersensitivity reaction after intake/administration of IBUPROFENE PENSAVITAL and tell your doctor immediately. The medical measures necessary, according to the symptoms experienced, must be taken by healthcare staff.

Haematological side effects

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

Prolonged use of IBUPROFENE PENSAVITAL calls for frequent monitoring of liver function, kidney function and regular blood tests.

If IBUPROFENE PENSAVITAL is taken before surgery, consult/inform the doctor or dentist.

SLE and mixed connective tissue disease

In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders, there may be an increase in the risk of aseptic meningitis (see below and section 4.8).

Aseptic meningitis

Aseptic meningitis has been observed on rare occasions in patients treated with ibuprofen. Although it is probably more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has also been reported in patients with no underlying chronic illness.

Patients reporting eye problems during treatment with ibuprofen must stop treatment and have their eyes properly examined.

When using NSAIDs, adverse reactions, in particular those affecting the gastrointestinal tract or central nervous system can be increased by the concomitant consumption of alcohol.

Elderly

In elderly patients, side effects are more frequently observed after use of non-steroidal anti-inflammatory drugs, in particular gastrointestinal bleeding and perforation, which can be life-threatening in some cases. This is why it is so important to medically monitor elderly patients closely.

Children and adolescents

It may cause kidney problems in adolescents who are dehydrated.

Other medicines and IBUPROFENE PENSAVITAL

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

IBUPROFENE PENSAVITAL can influence or be influenced by other medicinal products. For example:

• Digoxin, phenytoin and lithium: the combined use of IBUPROFENE PENSAVITAL and digoxin (used to strengthen the heart), phenytoin (used to treat seizures/epilepsy) or lithium (used to treat depression, for example) can increase the concentration of these medicines in the blood. Serum lithium levels must be monitored. Serum digoxin and serum phenytoin levels should be monitored.
• Anticoagulants (which make the blood more fluid/prevent clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine). NSAIDs may enhance the effects of anticoagulants, such as warfarin.
• Diuretics (water tablets) and high blood pressure medicines:
• e.g. ACE-inhibitors, beta blockers and angiotensin-II receptor antagonists. The combined administration of IBUPROFENE PENSAVITAL and potassium-sparing diuretics (a type of tablet for urination) can lead to an increase in blood potassium levels. Serum potassium levels should therefore be monitored.
• Medicines used to reduce high blood pressure (ACE-inhibitors such as captopril, beta blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan): IBUPROFENE PENSAVITAL can reduce the effect of ACE-inhibitors (used to treat heart failure and high blood pressure). In addition, during combined use, the risk of possible kidney failure is increased.
• Cholestyramine (a medicine used to lower cholesterol levels) used in association with IBUPROFENE PENSAVITAL can reduce the absorption of IBUPROFENE PENSAVITAL in the gastrointestinal tract. The clinical significance of this is, however, unknown.
• Other pain-killers: The combined use of IBUPROFENE PENSAVITAL with other anti-inflammatory and analgesic NSAIDs, including COX-2 inhibitors (such as celecoxib) can increase the risk of gastrointestinal ulcers and bleeding.
• Platelet aggregation inhibitors and some antidepressants (selective serotonin re-uptake inhibitors/SSRIs) can increase the risk of bleeding in the stomach and intestine.
• Methotrexate: the administration of IBUPROFENE PENSAVITAL within 24 hours before or after the administration of methotrexate (used to treat certain types of cancer or rheumatisms) can lead to an increase in the concentrations of methotrexate and increase its side effects.
• Cyclosporin and tacrolimus can damage the kidneys.
• Probenecid or sulfinpyrazone: medicines containing probenecid or sulfinpyrazone (used for treating gout) may delay the excretion of ibuprofen. This can cause IBUPROFENE PENSAVITAL to accumulate in the body, with an increase in its side effects.
• Sulphonylureas: during the combined use of IBUPROFENE PENSAVITAL and sulphonylureas (medicines to treat diabetes), monitoring of blood sugar levels is recommended as a precautionary measure.
• Zidovudine: evidence suggests a higher risk of hemarthrosis (accumulation of blood in the joints) and bruises (haematoma) in HIV-positive haemophiliac patients taking zidovudine (an antiviral drug used to treat HIV infections) together with ibuprofen.
• Quinolone antibiotics: the risk of convulsions (seizures) may be increased when quinolone antibiotics like ciprofloxacin and ibuprofen are taken together.
• Aminoglycosides: the combined use of IBUPROFENE PENSAVITAL with aminoglycosides (a type of antibiotic) and NSAIDs may decrease excretion of aminoglycosides.
• Voriconazole and fluconazole (CYP2C9 inhibitors) used to treat fungal infections, as the effect of the ibuprofen may increase. Consider reducing the dose of ibuprofen, particularly when high-dose ibuprofen is administered together with voriconazole or fluconazole.
• Ginkgo biloba (a herbal medicine) may increase the risk of bleeding with NSAIDs.
• Mifepristone: the combined use of mifepristone with other NSAID group anti-inflammatory drugs and pain-killers (e.g. ibuprofen) can reduce the effect of mifepristone.
• Medicines to treat inflammation (corticosteroids) due to the increased risk of ulcers or bleeding in the stomach or intestine.

Some other medicinal products may also influence or be influenced by treatment with IBUPROFENE PENSAVITAL. You should therefore always seek the advice of the doctor or pharmacist before using IBUPROFENE PENSAVITAL with other medicinal products.

IBUPROFENE PENSAVITAL with alcohol

Alcohol can increase the side effects of IBUPROFENE PENSAVITAL, especially those affecting the gastrointestinal or central nervous system. Avoid drinking alcohol when using IBUPROFENE PENSAVITAL.

Pregnancy, breast-feeding and fertility

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

Pregnancy

Do not take IBUPROFENE PENSAVITAL 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 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 IBUPROFENE PENSAVITAL 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, IBUPROFENE PENSAVITAL 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 baby’s heart. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.

Breastfeeding

Ibuprofen only appears in breast milk in a very small amount and breastfeeding will usually not need to be stopped during short-term treatments at the recommended dose for fever and pain. If, however, longer treatment or higher doses are prescribed, early weaning should be considered.

Fertility

Ibuprofen makes pregnancy more difficult. You should tell your doctor if you are planning to become pregnant or if you have difficulty becoming pregnant.

Driving and using machines

Ibuprofen generally has no or negligible influence on the ability to drive and use machines. However since at high dosages side effects involving the central nervous system can occur, such as fatigue and dizziness, the ability to drive or operate machinery may be impaired in individual cases. This is particularly important if combined with alcohol.

IBUPROFENE PENSAVITAL contains lactose

If the doctor has told you that you are intolerant of certain sugars, contact the doctor before taking this medicine.

IBUPROFENE PENSAVITAL contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say it is essentially ‘sodium-free’.