Active ingredients: Ibuprofen
NUROFEN 200 mg coated tablets
NUROFEN 400 mg coated tablets
Nurofen package inserts are available for pack sizes: - NUROFEN 200 mg coated tablets, NUROFEN 400 mg coated tablets
- NUROFEN 200 mg Effervescent tablets
Why is Nurofen used? What is it for?
Nurofen contains ibuprofen. Ibuprofen belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines work by reducing pain and swelling caused by inflammation and fever.
Nurofen is used for the treatment of various types of pain: headache, toothache, neuralgia, muscle and bone and joint pain, menstrual pain. Adjuvant in the symptomatic treatment of fever and flu.
Contraindications When Nurofen should not be used
Do not take Nurofen:
- if you are allergic (hypersensitive) to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
- if you have previously shown hypersensitivity reactions (such as bronchospasm, asthma, rhinitis, angioedema or urticaria) after taking ibuprofen, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs)
- if you have severe liver, kidney or heart failure
- if you have experienced gastric bleeding or perforation following treatment with non-steroidal anti-inflammatory drugs
- if you have or have ever had a stomach ulcer or stomach bleeding
- is in the last trimester of pregnancy (see "Pregnancy, Breastfeeding and Fertility)
- Do not administer to children under 12 years of age
Precautions for use What you need to know before taking Nurofen
Talk to your doctor or pharmacist before taking Nurofen:
- if you suffer from systemic lupus erythematosus (chronic autoimmune disease that causes disorders in various parts of the body, especially the skin) or from mixed connective tissue disease
- if you have suffered from hypertension (high blood pressure) and / or heart failure - Medicines such as Nurofen may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke. The risk increases with high doses of the drug and prolonged treatments. Do not exceed the recommended dose or duration of treatment - If you have heart problems, if you have had a stroke or if you think you are at risk for these conditions (for example if you have high blood pressure, diabetes or high cholesterol or you smoke), consult your doctor or pharmacist. - Caution is required (discuss with your doctor or pharmacist) before starting treatment in patients with a history of hypertension and / or heart failure as fluid retention, hypertension and edema (swelling due to "accumulation of fluids in the tissues).
- if you have reduced kidney function
- if you suffer from liver dysfunction
- if you have bleeding defects
- if you have or have suffered from disorders of the gastrointestinal tract (ulcerative colitis or Crohn's disease)
In the elderly and in patients who have suffered from ulcers, particularly if complicated with 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. At any time, with or without warning symptoms, gastrointestinal bleeding, ulceration or perforation, sometimes fatal, has occurred.
- if you have or have suffered from asthma or allergic reactions, as bronchospasm (which causes difficulty in breathing) may occur
- Do not take the medicine together with other non-steroidal anti-inflammatory drugs, including those medicines that belong to the group of selective cyclooxygenase-2 inhibitors (see "other medicines and Nurofen")
- There is a risk of impaired renal function in dehydrated adolescents.
- if you are planning a pregnancy.
These undesirable effects can be minimized by using the lowest effective dose for the shortest possible time. In general, the habitual use of (different types of) analgesics can lead to permanent severe kidney problems (with possible onset of kidney failure).
Caution is also required for those patients taking medications such as cortisones, anticoagulants (eg warfarin), certain medications prescribed for depression or antiplatelet medications (eg aspirin), as it may increase the risk of bleeding (see others medicines and Nurofen)
Interactions Which drugs or foods can modify the effect of Nurofen
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, if you are taking:
- corticosteroids (medicinal products containing cortisone or cortisone-like substances), aspirin or other NSAIDs (anti-inflammatories and analgesics): this may increase the risk of gastrointestinal ulcers or bleeding.
- Anticoagulants (medicines to thin the blood such as warfarin) as NSAIDs can increase the effects of these medicines.
- Selective serotonin reuptake inhibitors (medicines used for depression) as these may increase the risk of gastrointestinal adverse reactions.
- Antihypertensives (Ace inhibitors, angiotensin II antagonists) and diuretics (used to treat high blood pressure) as NSAIDs may decrease the effects of these medicines and in some cases there may be further deterioration of renal function with possible renal failure acute, usually reversible.
Diuretics may increase the risk of NSAID nephrotoxicity.
- Lithium (a medicine for manic depressive disorders and depression) as the effect of lithium can be increased.
- Methotrexate (a medicine for cancer or rheumatoid arthritis) as the effect of methotrexate may be increased.
- Zidovudine (a medicine for treating AIDS) as the use of Nurofen may lead to an increased risk of haemarthrosis (bleeding in the joints) or bruising
- Cardiac glycosides: NSAIDs can worsen heart failure, reduce VGF (glomerular filtration rate) and increase plasma levels of glycosides.
- Ciclosporins: increase the risk of nephrotoxicity.
- Mifepristone: NSAIDs should not be taken for 8-12 days after Mifepristone administration as NSAIDs can reduce the effects of Mifepristone.
- Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with Tacrolimus.
- Quinolone antibiotics: Data from animal studies indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures.
Nurofen with food and drink
It is recommended to take Nurofen on a full stomach in subjects with gastric hypersensitivity.
Warnings It is important to know that:
Pregnancy, breastfeeding 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.
Pregnancy
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.
Feeding time
This medicine passes into breast milk but can be used during breastfeeding when taken at recommended doses and for short periods of time.
Fertility
Taking the medicine should be avoided if you are trying to get pregnant.
Driving and using machines
For short periods of treatment, Nurofen has no or negligible influence on the ability to drive or use machines.
Nurofen contains sucrose and sodium
Sucrose
This medicinal product contains sucrose: if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Sodium
This medicine contains sodium. To be taken into consideration in people on a low sodium diet.
Dosage and method of use How to use Nurofen: Dosage
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Nurofen should not be taken by children under 12 years of age. Unless otherwise prescribed by your doctor, the standard dose is: NUROFEN 200 mg coated tablets
NUROFEN 400 mg coated tablets
Warning: do not exceed the indicated doses.
Warning: use only for short periods of treatment.
If the use of the medicine is necessary for more than 3 days in adolescents, or in the case of worsening of symptoms, the doctor should be consulted.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
It is recommended to take Nurofen on a full stomach in subjects with gastric hypersensitivity.
Overdose What to do if you have taken too much Nurofen
If you take more Nurofen than you should:
In case of accidental ingestion / intake of an excessive dose of Nurofen, notify your doctor immediately or go to the nearest hospital. If you take too much of the medicine, the following symptoms may occur: nausea, vomiting, stomach pain, headache, dizziness, sleepiness, nystagmus, blurred vision, ringing in the ears. Rarely: hypotension (low blood pressure) and loss of consciousness.
If you forget to take Nurofen
Do not take a double dose to make up for a forgotten tablet.
IF YOU HAVE ANY DOUBTS ABOUT THE USE OF THIS MEDICINAL PRODUCT, PLEASE ASK YOUR DOCTOR OR PHARMACIST.
Side Effects What are the side effects of Nurofen
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking this medicine and see your doctor immediately if you get any of the following serious side effects:
- severe forms of skin reactions characterized by rash with redness and blistering or blisters in the skin and / or mucous membranes (erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis).
- severe hypersensitivity reactions - symptoms may be: swelling of the face, tongue and throat, wheezing (difficulty in breathing), tachycardia (fast heart rate), hypotension (low blood pressure), anaphylaxis, angioedema or severe shock. Worsening of asthma.
The other side effects that can occur are:
Uncommon (may affect up to 1 in 100 people)
- stomach upset, such as heartburn, stomach pain and nausea
- headache, dizziness
- hypersensitivity reactions with hives and itching
- skin rashes
Rare (may affect up to 1 in 1000 people)
- diarrhea, vomiting, flatulence and constipation
Very rare (may affect up to 1 in 10,000 people)
- peptic ulcers, gastrointestinal perforation and bleeding, black stools and bloody vomiting, worsening of existing intestinal problems (ulcerative colitis or Crohn's disease), ulcerative stomatitis, gastritis
- edema (swelling due to the accumulation of fluid in the tissues), hypertension (high blood pressure) and heart failure
- decrease in the normal amount of urine throughout the day and edema (kidney failure is also possible), kidney damage (papillary necrosis) or increased concentration of urea in the blood (first signs are: urinating less than normal, malaise general).
- liver damage especially following long-term treatments
- decreased number of blood cells (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis) - early signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nose and skin bleeding, unexplained bruising .
- symptoms of aseptic meningitis in patients with existing autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease) - early signs are: neck stiffness, headache, nausea, vomiting, fever or disorientation.
- Decrease in the level of hemoglobin 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.
Reporting of side effects
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 at: www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use Nurofen after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of the month. Nurofen 400 mg coated tablets: store at a temperature not exceeding 30 ° C.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
It is important that you always have the information about the medicine available, so keep both the box and this leaflet.
Composition and pharmaceutical form
What Nurofen contains
Nurofen 200 mg coated tablets The active ingredient is ibuprofen. Each tablet contains 200 mg of ibuprofen.
The other ingredients are: croscarmellose sodium, sodium laurilsulfate, sodium citrate, stearic acid, colloidal anhydrous silica, carmellose sodium, talc, dried nebulized gum arabic, sucrose, titanium dioxide, macrogol 6000, ink (shellac, black iron oxide E172, propylene glycol E1520).
Nurofen 400 mg coated tablets
The active ingredient is ibuprofen. Each tablet contains 400 mg of ibuprofen.
The other ingredients are: croscarmellose sodium, sodium laurilsulfate, sodium citrate, stearic acid, colloidal anhydrous silica, carmellose sodium, talc, dried nebulized gum arabic, sucrose, titanium dioxide, macrogol 6000, ink (shellac, red iron oxide (E 172), propylene glycol (E1520), ammonium hydroxide (E527), simethicone).
Description of the appearance of Nurofen and contents of the pack
Nurofen comes in tablet form. The contents of the pack are 12 or 24 tablets.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
NUROFEN TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
200 mg coated tablets: each tablet contains 200 mg of ibuprofen
400 mg coated tablets: Each tablet contains 400 mg of ibuprofen
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Coated tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Pain of various kinds: headache, toothache, neuralgia, muscle and bone and joint pain, menstrual pain. Adjuvant in the symptomatic treatment of fever and flu.
04.2 Posology and method of administration
Oral administration
Do not give to children under the age of 12.
Patients with gastric sensitivity problems are advised to take Nurofen on a full stomach.
If symptoms persist or worsen after a short period of treatment, consult your doctor.
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.4).
NUROFEN 200 mg coated tablets
Adults and children over 12 years: 1-2 tablets, 2-3 times a day. Do not exceed the dose of 1200 mg (6 tablets) in 24 hours.
Elderly: No modification of the dosage regimen is required.
NUROFEN 400 mg coated tablets
Adults and children over 12 years old
One tablet 2-3 times a day. Do not exceed the dose of 1200 mg (3 tablets) in 24 hours.
Elderly: No modification of the dosing schedule is required.
04.3 Contraindications
- Patients with hypersensitivity to the active substance or to any of the excipients.
- Patients who have experienced bronchospasm, asthma, rhinitis or urticaria following the use of acetylsalicylic acid or other non-steroidal anti-inflammatory products.
- Patients with severe hepatic, renal or cardiac insufficiency.
- Patients with a history of gastrointestinal bleeding or perforation related to previous NSAID therapy (non-steroidal anti-inflammatory drugs).
- Patients with recurrent peptic ulcers / bleeding in place or in the past (two or more distinct episodes of proven ulceration or bleeding).
- During the last trimester of pregnancy (see section 4.6).
- Children under 12 years old.
This medicinal product contains sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
04.4 Special warnings and appropriate precautions for use
Caution is needed in patients with:
- systemic lupus erythematosus or with mixed connective tissue disease (see section 4.8);
- history of hypertension and / or heart failure since fluid retention and edema have been reported in association with NSAID therapy;
- renal changes;
- liver dysfunctions.
- coagulation defects
The use of Nurofen should be avoided in conjunction with other NSAIDs, including selective cyclooxygenase-2 inhibitors.
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see gastrointestinal and cardiovascular risks below).
Caution is required (discuss with your doctor or pharmacist) before starting treatment in patients with a history of hypertension and / or heart failure as fluid retention, hypertension and edema have been reported in association with NSAID treatment.
Cardiovascular and cerebrovascular effects: clinical studies and epidemiological data suggest that the use of ibuprofen, particularly at high doses (2400 mg per day) and for long-term treatments, may be associated with a slightly increased risk of arterial thrombotic events (for e.g. myocardial infarction or stroke) Overall, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1200 mg per day) are associated with an increased risk of myocardial infarction.
Particular caution should be exercised in the treatment of patients with impaired hepatic or renal function. In such patients, periodic monitoring of clinical and laboratory parameters should be used, especially in case of prolonged treatment.
Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section 4.2).
Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported during treatment with all NSAIDs, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events.
In the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), the risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of NSAIDs. These patients should start treatment with the lowest available dose.
Concomitant use of protective agents (eg misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events (see section 4.5). .
Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.
Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (see section 4.5).
When gastrointestinal bleeding or ulceration occurs in patients taking Nurofen, the treatment should be discontinued.
NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8).
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). In the early stages of therapy, patients appear to be be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. Nurofen should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.
Bronchospasm may occur in patients with bronchial asthma or current or previous allergic diseases.
Older people are at increased risk of consequences from adverse reactions.
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible time.
During prolonged treatment with analgesic medicinal products at doses higher than those indicated, headaches may arise which should not be treated with higher doses of the product.
In general, the habitual use of analgesics, especially combinations of different analgesic active ingredients, can lead to permanent renal lesions with the risk of renal failure (analgesic nephropathy).
04.5 Interactions with other medicinal products and other forms of interaction
Ibuprofen (like other NSAIDs) should be used with caution in combination with:
Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4).
Anticoagulants: NSAIDs may increase the effects of anticoagulants, such as warfarin (see section 4.4).
Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4).
Acetylsalicylic acid and other NSAIDs: These substances may increase the risk of adverse reactions affecting the gastrointestinal tract.
Diuretics, ACE inhibitors and Angiotensin II antagonists:
NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (eg dehydrated patients or elderly patients with impaired renal function) co-administration of an ACE inhibitor or an angiotensin antagonist II and agents that inhibit the cyclo-oxygenase system can lead to further deterioration of renal function, including possible acute renal failure, usually reversible. These interactions should be considered in patients taking NUROFEN concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients.
Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy.
Lithium: There is evidence of the possibility of a potential increase in blood lithium levels, with the possibility of reaching the toxic threshold. If this combination is necessary, monitor lithemia in order to adjust the lithium dosage during concomitant treatment with ibuprofen.
MethotrexateThere is evidence of the possibility of increased plasma methotrexate levels.
ZidovudineThere is evidence of an increased risk of haemarthrosis and hematoma in HIV-positive haemophilia patients when treated concomitantly with zidovudine and ibuprofen.
Antidiabetics: NSAIDs can increase the hypoglycemic effect of sulfonylureas by displacing them from binding sites with plasma proteins.
Experimental data indicate that ibuprofen may inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when drugs are administered concomitantly. However, the limited data and uncertainties relating to their application to the clinical situation do not allow to draw firm conclusions for continued use of ibuprofen; there appears to be no clinically relevant effect from occasional use of ibuprofen (see section 5.1).
04.6 Pregnancy and lactation
Pregnancy
Inhibition of prostaglandin synthesis can adversely affect the pregnant woman and / or the embryo / fetal development. Data obtained from epidemiological studies suggest an increased risk of abortion, cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor during the first period of pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period.
During the first and second trimester of pregnancy, ibuprofen should not be administered except in strictly necessary cases. If used by women about to conceive or during the first and second trimester of pregnancy, the dose and duration of treatment should be as low and as short as possible, respectively.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to:
- cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension);
- renal dysfunction which can progress to renal failure with oligohydroamniosis;
- the mother and the newborn, at the end of pregnancy, to:
- possible prolongation of bleeding time, an antiplatelet effect that can occur even at very low doses;
- inhibition of uterine contractions resulting in delayed or prolonged labor.
Consequently, ibuprofen is contraindicated during the third trimester of pregnancy.
Feeding time
Ibuprofen and its metabolites can pass in low concentrations into breast milk. No dangerous effects for newborns are known to date, so for short treatments with the recommended dose for pain and fever, interruption of breastfeeding is generally not necessary.
Fertility
There is evidence that medicinal products that inhibit cyclooxygenase / prostaglandin synthesis can cause a weakening of female fertility by effect on ovulation. This effect is reversible upon discontinuation of treatment.
Nurofen administration should be discontinued in women who have fertility problems or who are undergoing fertility investigations.
04.7 Effects on ability to drive and use machines
For short periods of treatment, Nurofen has little or no influence on the ability to drive and use machines.
04.8 Undesirable effects
The most commonly observed adverse reactions are gastrointestinal in nature.
Alterations of the blood and lymphatic system:
Very rare (≤1 / 10,000): haematopoietic disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first manifestations are: fever, sore throat, superficial oral ulcers, flu-like symptoms, severe exhaustion, nasal and skin bleeding.
Alterations of the immune system
Very rare (≤1 / 10,000): in patients with pre-existing autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease) isolated cases of aseptic meningitis symptoms such as neck rigidity, headache, nausea, vomiting, fever or disorientation.
Alterations of the nervous system:
Uncommon (≥1 / 1000, ≤1 / 100): headache and dizziness.
Eye disorders
Very rare (≤1 / 10000): some rare cases of ocular alteration with consequent visual disturbances
Cardiac alterations:
Uncommon (≤1 / 10,000): Edema, hypertension and heart failure have been reported in association with NSAID treatments.
Alterations of the gastro-intestinal system:
Uncommon (≥1 / 1000, ≤1 / 100): gastrointestinal disorders such as dyspepsia, abdominal pain and nausea.
Rare (≥1 / 10,000, ≤1 / 1,000): diarrhea, flatulence, constipation and vomiting.
Very rare (≤1/10000):
peptic ulcers, gastrointestinal perforation or haemorrhage, sometimes fatal, particularly in the elderly, may occur (see section 4.4)
melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4)
gastritis was observed less frequently.
Alterations of the hepatobiliary system:
Very rare (≤1 / 10,000): liver disorders, especially following long-term treatments
Skin and subcutaneous tissue changes:
Very rare (≤1/10000):
severe forms of skin reactions such as erythema multiforme may arise
bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis.
Renal and urinary disorders:
Very rare (≤1/10000):
decreased urea excretion and edema may occur, as well as acute renal failure
papillary necrosis, particularly following long-term treatments
increased serum urea concentrations.
General disorders and changes in the administration site
Uncommon (≥1 / 1000, ≤1 / 100): hypersensitivity reactions with hives and itching.
Very rare (≤1/10000):
severe hypersensitivity reactions. Symptoms can be: swelling of the face, tongue and larynx, dyspnoea, tachycardia, hypotension or severe shock.
Exacerbation of asthma.
Clinical studies and epidemiological data suggest that the use of ibuprofen, particularly at high doses (2400 mg per day) and for long-term treatment, may be associated with a slightly increased risk of arterial thrombotic events (eg myocardial infarction or stroke) (see section 4.4)
04.9 Overdose
Symptoms of overdose
Symptoms of overdose may include nausea, vomiting, abdominal pain, headache, dizziness, somnolence, nystagmus, blurred vision, tinnitus, and rarely hypotension, metabolic acidosis, renal failure and loss of consciousness.
Therapy in case of overdose
There is no specific antidote. Appropriate symptomatic treatment and supportive measures should be put in place if necessary. Within 1 hour of ingestion, it is possible to resort to the administration of activated charcoal or, if the benefits outweigh the risks, to gastric lavage followed by the administration of activated charcoal in the case of ingestion of high doses of medicine.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: non-steroidal anti-inflammatory and antirheumatic drugs, derivatives of proprionic acid.
ATC code: M01AE01
Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) whose efficacy has been demonstrated, in common experimental models of inflammation in animals, with the inhibition of prostaglandin synthesis. In humans, ibuprofen reduces pain, swelling and fever caused by inflammation. In addition, ibuprofen reversibly inhibits platelet aggregation.
The clinical efficacy of ibuprofen has been demonstrated in painful conditions associated with headache, toothache, dysmenorrhea and fever; also, in patients with flu-induced pain and fever and in pain patterns such as sore throat, muscle aches or soft tissue injuries, and lower back pain.
Experimental data indicate that ibuprofen may inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when the drugs are administered concomitantly. In one study, following administration of a single 400 mg dose of ibuprofen, taken within 8 hours before or 30 minutes after the administration of acetylsalicylic acid (81 mg), there was a decrease in the effect of acetylsalicylic acid on thromboxane formation and platelet aggregation. However, the limited data and the uncertainties relating to their application to the clinical situation do not allow definitive conclusions to be drawn for the continued use of ibuprofen; there appears to be no clinically relevant effect from the occasional use of ibuprofen.
05.2 Pharmacokinetic properties
Ibuprofen is well absorbed from the gastrointestinal tract, binds extensively to plasma proteins and diffuses into the synovial fluid.
The peak plasma concentration is reached 1-2 hours after administration. Maximum plasma levels may be delayed after ingestion with food.
Ibuprofen is metabolised in the liver to two major metabolites which are excreted predominantly via the kidneys, as such or conjugated, together with a negligible amount of unmodified ibuprofen. Renal excretion is rapid and complete.
The half life is approximately 2 hours.
No relevant differences in the pharmacokinetic profile are observed in the elderly.
05.3 Preclinical safety data
In animal experiments the chronic and subchronic toxicity of ibuprofen mainly manifested itself in the form of lesions and ulcerations of the gastrointestinal tract. in vitro and in vivo have not given clinical relevance of the mutagenic potential of ibuprofen. In studies in rats and mice there was no evidence of the carcinogenic effects of ibuprofen.
Ibuprofen leads to ovulation inhibition in rabbits, as well as implantation disturbance in various animal species (rabbits, rats, mice). Experimental research has shown that ibuprofen passes through the placenta; with maternally toxic doses, an increased incidence of malformations (eg ventricular septal defects) has been observed.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Nurofen 200 mg coated tablets
Croscarmellose sodium, sodium lauryl sulfate, sodium citrate, stearic acid, colloidal anhydrous silica, carmellose sodium, talc, dried nebulized gum arabic, sucrose, titanium dioxide, macrogol 6000, black iron oxide (E 172).
Nurofen 400 mg coated tablets
Croscarmellose sodium, sodium lauryl sulfate, sodium citrate, stearic acid, colloidal anhydrous silica, carmellose sodium, talc, dried nebulized gum arabic, sucrose, titanium dioxide, macrogol 6000, red iron oxide (E 172).
06.2 Incompatibility
Not known.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
Nurofen 400 mg coated tablets: store at a temperature not exceeding 30 ° C.
06.5 Nature of the immediate packaging and contents of the package
Nurofen 200 mg coated tablets
Boxes containing 12 or 24 coated tablets of 200 mg, packed in blisters, consisting of heat-sealed PVC on lacquered aluminum foil.
Rigid plastic box containing 12 coated tablets of 200 mg, packed in blister packs, consisting of heat-sealed PVC on lacquered aluminum foil.
Nurofen 400 mg coated tablets
Blister pack consisting of PVC heat-sealed on lacquered aluminum sheet or PVC / PVdC heat-sealed on lacquered aluminum sheet. The blister contains 12 tablets.
06.6 Instructions for use and handling
No special instructions.
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
Reckitt Benckiser Healthcare International Ltd - 103-105 Bath Road, Slough SL1 3UH, Berkshire (UK)
Representative for Italy:
Reckitt Benckiser Healthcare (Italy) S.p.A. - via G. Spadolini 7 - 20141 Milan
08.0 MARKETING AUTHORIZATION NUMBER
Nurofen 12 tablets: A.I.C. n ° 025634015
Nurofen 12 tablets in rigid plastic case: AIC n ° 025634092
Nurofen 24 tablets: A.I.C. n ° 025634041
Nurofen 400 mg coated tablets, 12 tablets, PVC / aluminum: 025634128
Nurofen 400 mg coated tablets, 12 tablets, PVC / PVdC / aluminum: 025634130
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Nurofen 200 mg coated tablets: September 1985
10.0 DATE OF REVISION OF THE TEXT
March 2008
