Nurofen 400 mg - analgesic anti-inflammatory 12 coated tablets

Product Description

Nurofen 400mg coated tablets is a medicine based on Ibuprofen, useful in case of pain of various kinds.

Indications

Nurofen 400 mg contains ibuprofen, an active ingredient that works to reduce pain in case of:

• Headache;
• Muscle pain;
• Bone and joint pain;
• Toothache;
• Neuralgia;
• Menstrual pain.

Furthermore, it can be used as an adjunct in the symptomatic treatment of fever and influenza.

Dosage and method of use

Paediatric population:

• Do not administer to children under 12 years of age.

Adults and adolescents over 12 years of age:

• One tablet 2-3 times a day.
• The interval between doses must not be less than 4 hours.
• Do not exceed the dose of 1200 mg (3 tablets) in 24 hours.

Elderly:

• No changes to the dosage regimen are required.

Method of use Administration:

• Oral use.
• Patients with gastric sensitivity problems are advised to take Nurofen on a full stomach.

Composition

Active ingredient: each tablet contains 400 mg of ibuprofen.
Excipients: croscarmellose sodium, sodium lauryl sulfate, sodium citrate, stearic acid, colloidal anhydrous silica, carmellose sodium, talc, dried spray gum arabic, sucrose, titanium dioxide, macrogol 6000, ink (shellac, red iron oxide (E 172), propylene glycol (E1520), ammonium hydroxide (E527), simethicone).

When not to use Nurofen

If you are allergic (hypersensitive) to ibuprofen or any of the other ingredients of this medicine.
If you have previously shown hypersensitivity reactions (such as bronchospasm, asthma, rhinitis, angioedema, or urticaria) after taking ibuprofen, acetylsalicylic acid, or other nonsteroidal anti-inflammatory drugs (NSAIDs).
If you suffer from severe liver, kidney, or heart failure.
If you have experienced gastric bleeding or perforation following treatment with nonsteroidal anti-inflammatory drugs.
If you suffer or have suffered from gastric ulcer or gastric bleeding.
If you are in the last trimester of pregnancy.

Do not administer to children under 12 years of age.

Warnings and precautions

Ask your doctor or pharmacist for advice before taking Nurofen:

If you suffer from systemic lupus erythematosus (a chronic autoimmune disease that causes problems in various parts of the body, especially the skin) or mixed connective tissue disease.
If you have suffered from hypertension (high blood pressure) and/or heart failure? Caution is required (discuss this with your doctor or pharmacist) before starting treatment in patients with a history of hypertension and/or heart failure, as fluid retention, hypertension, and oedema (swelling due to the accumulation of fluid in the tissues) have occurred in association with treatment with NSAIDs.
If you have reduced kidney function.
If you suffer from liver dysfunction.
If you have coagulation defects.
If you suffer or have suffered from gastrointestinal tract disorders (ulcerative colitis or Crohn's disease).
In the elderly and in patients who have suffered from ulcers, especially if complicated by bleeding or perforation, the risk of gastrointestinal bleeding, ulceration, or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. In such situations, it is advisable to consult your doctor. Gastrointestinal bleeding, ulceration, or perforation, sometimes fatal, has occurred at any time, with or without warning symptoms. If you suffer or have suffered from asthma or allergic reactions, as bronchospasm (causing breathing difficulty) may occur.
Do not take the medicine together with other nonsteroidal anti-inflammatory drugs, including those belonging to the group of selective cyclooxygenase-2 inhibitors.
There is a risk of impaired kidney function in dehydrated adolescents.
If you are planning to become pregnant.
Anti-inflammatory/painkilling medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when taken in high doses.

Do not exceed the recommended dose or duration of treatment.

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

Heart problems, including heart attack, angina (chest pain), or if you have had a heart attack, coronary artery bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries), or any type of stroke (including a ‘mini-stroke' or “TIA”, transient ischaemic attack);
high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

These side effects can be minimized by using the lowest effective dose for the shortest possible time.

In general, habitual use of (different types of) painkillers can lead to serious permanent kidney problems (with possible onset of kidney failure).

Caution is also required for patients taking drugs such as corticosteroids, anticoagulants (e.g. warfarin), some drugs prescribed for depression, or antiplatelet drugs (e.g. aspirin), as this may increase the risk of bleeding.

Contraindications

In the elderly and in patients who have suffered from ulcers, especially if complicated by bleeding or perforation, the risk of gastrointestinal bleeding, ulceration, or perforation is higher with increased doses of NSAIDs. These patients should start treatment on the lowest available dose. In such situations, it is advisable to consult your doctor. Gastrointestinal bleeding, ulceration, or perforation, sometimes fatal, has occurred at any time, with or without warning symptoms.

Medicines such as Nurofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk increases with high doses of the drug and prolonged treatment. Do not exceed the recommended dose or duration of treatment (3 to 5 days). If you have heart problems, have had a stroke, or think you may be at risk of these conditions (for example, if you have high blood pressure, diabetes, high cholesterol, or smoke), consult your doctor or pharmacist.

Patients with liver and kidney problems should consult their doctor before taking the medicine. He or she will decide whether to request periodic checks of clinical tests. It is also advisable to consult your doctor if these conditions have occurred in the past.

Pregnancy and breastfeeding

Do not take this medicine during the last 3 months of pregnancy. Avoid using this medicine during the first 6 months of pregnancy unless prescribed by your doctor. Avoid taking the medicine if you are trying to become pregnant. This medicine passes into breast milk, but can be used during breastfeeding if taken at the recommended doses and for short periods of time.

Other medicines and Nurofen

Nurofen may affect or be affected by other medicines. For example:

Medicines that have an anticoagulant effect (i.e. substances that thin the blood by preventing clots, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine);
Medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan);
Corticosteroids (medicinal products containing cortisone or cortisone-like substances), aspirin or other NSAIDs (anti-inflammatory and analgesic drugs): this may increase the risk of gastrointestinal ulcers or bleeding;
Selective serotonin reuptake inhibitors (medicines used for depression) as these may increase the risk of gastrointestinal adverse reactions;
Diuretics (used to treat high blood pressure) as they may increase the risk of gastrointestinal ulcers or bleeding; NSAIDs may reduce the effects of these medicines and in some cases there may be further deterioration of kidney function with possible acute renal failure, which is usually reversible. Diuretics may increase the risk of nephrotoxicity of NSAIDs.
Lithium (a medicine for manic-depressive disorder and depression) as the effect of lithium may be increased;
Methotrexate (a medicine for cancer or rheumatoid arthritis) as the effect of methotrexate may be increased;
Zidovudine (a medicine for the treatment of AIDS) as the use of Nurofen may lead to an increased risk of haemarthrosis (bleeding into the joints) or haematomas;
Cardiac glycosides: NSAIDs may worsen heart failure, reduce GFR (glomerular filtration rate), and increase plasma glycoside levels;
Cyclosporins: Increase the risk of nephrotoxicity;
Mifepristone: NSAIDs should not be taken for 8-12 days after administration of mifepristone as NSAIDs may reduce the effects of mifepristone;
Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are administered with tacrolimus;
Quinolones: Data from animal studies indicate that NSAIDs may increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.

Some other medicines may also affect or be affected by treatment with Nurofen. Therefore, tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Side effects

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

Stop taking this medicine and consult your doctor immediately if you notice any of the following serious side effects:

severe forms of skin reactions characterised by rashes with redness and blisters or bullae on the skin and/or mucous membranes (erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis).
severe hypersensitivity reactions, which may manifest as: swelling of the face, tongue and throat, dyspnoea (difficulty breathing), tachycardia (rapid heartbeat), hypotension (low blood pressure), anaphylaxis, angioedema or severe shock.
Worseness of asthma.

Other side effects that may occur are:

Uncommon (may affect up to 1 in 100 people)
Stomach problems, such as heartburn, stomach pain and nausea.
Headache and dizziness.
Hypersensitivity reactions with hives and itching.
Skin rashes.

Rare (may affect up to 1 in 1,000 people)
Diarrhoea, vomiting, flatulence and constipation.

Very rare (may affect up to 1 in 10,000 people)
Peptic ulcers, perforation and gastrointestinal bleeding, black stools and vomiting blood, worsening of existing intestinal problems (colitis ulcerative or Crohn's disease), ulcerative stomatitis, gastritis.
Edema, hypertension and heart failure.
Reduced normal urine output and edema (renal failure is also possible), kidney damage (papillary necrosis) or increased blood urea concentration.
Liver damage, especially following long-term treatment.
Reduction in the number of blood cells (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis).
Symptoms of aseptic meningitis in patients with existing autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease).
Decreased haemoglobin level in the blood.
Visual disturbances.

Not known (frequency cannot be estimated from the available data)
Respiratory tract reactivity including asthma, worsening of asthma, bronchospasm and dyspnoea.

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

Format

Pack containing 12 coated tablets.