Ibuprofen-Hemofarm

GSL

For the relief of mild to moderate pain including rheumatic and muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness and for the relief of the symptoms of cold and influenza.

For the relief of migraine-headaches, backache, dental pain, neuralgia and period pains as well as rheumatic and muscular pains.

Ibuprofen-Hemofarm relieves pain and reduces inflammation and temperature as well as relieving headaches and other types of pain. It also relieves cold and flu symptoms.

For oral administration and short-term use only. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

Adults, the elderly, and children and adolescents over 12 years of age:

If in children and adolescents, between the age of 12 and 18 years, this medicinal product is required for more than 3 days, or if symptoms worsen, a doctor should be consulted.

For adults aged 18 years or older the minimum effective dose should be used for the shortest time necessary to relieve symptoms. If the product is required for more than 10 days or if the symptoms worsen, or persist, the patient should consult a pharmacist or a doctor.

1 or 2 tablets to be taken up to three times a day, as required. The tablets should be taken with water.

Leave at least 4 hours between doses and do not take more than 1200mg (6 tablets) in any 24 hour period.

Not to be given to children under 12 years of age.

For oral administration and short-term use only.

During short-term use, if symptoms persist or worsen the patient should be advised to consult a doctor.

Adults and children and adolescents between 12 and 18 years:

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

If in children and adolescents between 12 and 18 years this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

If in adults the product is required for more than 10 days, or if the symptoms worsen the patient should consult a doctor.

Children and Adolescents between 12 and 18 years: Take 1 or 2 caplets with water, up to three times a day as required.

Adults: Take 1 or 2 caplets with water, up to three times a day as required.

Leave at least four hours between doses.

Do not take more than 6 caplets in any 24 hour period.

Not for use by children under 12 years of age.

Hypersensitivity to Ibuprofen-Hemofarm or any of the constituents in the product.

Ibuprofen-Hemofarm is contra-indicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angiodema or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs.

Active or previous peptic ulcer (two or more episodes of proven ulceration or bleeding).

History of upper gastrointestinal bleeding or perforation, related to previous NSAID therapy.

Patients with severe hepatic failure, renal failure or severe heart failure (NYHA Class IV).

Use in last trimester of pregnancy.

Hypersensitivity to ibuprofen or any of the excipients in the product.

Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs.

Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).

History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.

Severe heart failure (NYHA Class IV), renal failure or hepatic failure

Last trimester of pregnancy

Caution is required in patients with certain conditions:

- Systemic lupus erythematosus as well as those with mixed connective tissue disease due to increased risk of aseptic meningitis.

- Gastrointestinal disorders and chronic inflammatory intestinal disease as these conditions may be exacerbated (ulcerative colitis, Crohn's disease).

- Caution is required prior to starting treatment in patients with a history of hypertension and or heart/failure. Oedema, hypertension and/or cardiac impairment as renal function may deteriorate and/or fluid retention occur.

- Renal impairment as renal function may deteriorate.

- Hepatic dysfunction.

Undesirable effects may be minimised by using the minimum effective dose for the shortest possible duration to control symptoms (see GI and cardiovascular risks below).

The elderly are at increased risk of the serious consequences of adverse reactions especially gastrointestinal bleeding and perforation which may be fatal.

Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease.

Use with concomitant NSAIDs including cyclo-oxygenase-2 specific inhibitors should be avoided .

Cardiovascular and cerebrovascular effects

Clinical studies suggest that use of Ibuprofen-Hemofarm, particularly at high doses (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).

Overall, epidemiological studies do not suggest that low dose Ibuprofen-Hemofarm (e.g. ≤1200mg daily) is associated with an increased risk of arterial thrombotic events.

Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with Ibuprofen-Hemofarm after careful consideration and high doses (2400 mg/day) should be avoided.

Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of Ibuprofen-Hemofarm (2400 mg/day) are required.

There is some evidence that drugs, which inhibit cyclooxygenase/ prostaglandin synthesis, may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment.

Gastro-intestinal (GI) bleeding, ulceration, or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI effects (including ulcerative colitis, Crohn's disease).

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation , and in the elderly. These patients should commence treatment on the lowest dose available.

Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could increase the risk of gastrotoxicity or bleeding, such as corticosteroids, or anticoagulants such as warfarin, selective serotonin uptake inhibitors or anti-platelet agents such as aspirin.

Where GI bleeding or ulceration occurs in patients receiving Ibuprofen-Hemofarm, the treatment should be withdrawn immediately.

Dermatological

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. Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Ibuprofen-Hemofarm should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Patients with rare hereditary problems of fructose intolerance should not take this medicine as this product contains sucrose.

Each tablet contains 67mg of sucrose. This should be taken into account in patients with diabetes mellitus.

There is a risk of renal impairment in dehydrated children and adolescents, between the ages of 12-18 year olds.

The label will include:

12-18 years: if symptoms worsen, or persist for more than 3 days, or you get new symptoms consult your doctor.

Adults: if symptoms worsen, or persist for more than 10 days, or you get new symptoms consult your pharmacist or doctor.

Read the enclosed leaflet before taking this product.

Do not take if you:

- have ever had a stomach ulcer, perforation or bleeding

- are allergic to Ibuprofen-Hemofarm (or anything else in this medicine), aspirin or other related painkillers

- are taking other NSAID painkillers, or aspirin with a daily dose above 75mg

- are in the last 3 months of pregnancy.

Speak to a pharmacist or your doctor before taking if you:

- have asthma, diabetes, high cholesterol, high blood pressure, had a stroke, heart, liver, kidney or bowel problems

- are a smoker

- are pregnant

The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.

Respiratory:

Bronchospasm may be precipitated in patients suffering from, or with a previous history of, bronchial asthma or allergic disease.

Other NSAIDs:

The use of Ibuprofen with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided.

SLE and mixed connective tissue disease:

Systemic lupus erythematosus as well as those with mixed connective tissue disease - increased risk of aseptic meningitis

Renal:

Renal impairment as renal function may further deteriorate.

There is a risk of renal impairment in dehydrated children and adolescents

Hepatic:

Hepatic dysfunction

Cardiovascular and cerebrovascular effects:

Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy.

Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤1200mg/day) is associated with an increased risk of arterial thrombotic events.

Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided.

Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen (2400 mg/day) are required.

Impaired female fertility:

There is limited evidence that drugs which inhibit cyclo-oxygenase/ prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible upon withdrawal of treatment.

Gastrointestinal:

NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated.

GI bleeding, ulceration or perforation, which can be fatal has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of GI events.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation , and in the elderly. These patients should commence treatment on the lowest dose available.

Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin.

When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn.

Dermatological:

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. Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Ibuprofen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Advice for patients with sugar-related disorders:

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Advice for patients on a controlled sodium diet:

This medicinal product contains 1.1 mmol (or 25.3 mg) of sodium per 2 doses (2 tablets). To be taken into consideration by patients on a controlled sodium diet.

The leaflet will include:

The quantity of sodium contained in 2 tablets is approximately 1.1mmol, ie about 25.3 mg. This quantity is to be taken into consideration by patients on a controlled sodium diet.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

The label will include:

Read the enclosed leaflet before taking this product

Do not take if you:

- have (or have had two or more episodes of ) a stomach ulcer, perforation or bleeding

- are allergic to ibuprofen, to any of the ingredients, or to aspirin or other related painkillers

- are taking other NSAID pain killers or aspirin with a daily dose above 75mg

Speak to a pharmacist or your doctor before taking if you:

- have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke, heart, liver, kidney or bowel problems

- Are a smoker

- Are pregnant

If symptoms persist or worsen, or if new symptoms occur, consult your doctor or pharmacist.

None expected at recommended doses and duration of therapy.

None expected at recommended dose and duration of therapy.

Hypersensitivity reactions have been reported and these may consist of

a) Non specific allergic reactions and anaphylaxis,

b) Respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea or

c) Various skin reactions, e.g. pruritus, urticaria, angioedema, and more rarely, exfoliative and bullous dermatoses (including epidermal necrolysis, and erythema multiforme).

The list of the following adverse effects relates to those experienced with Ibuprofen-Hemofarm at OTC doses, from short-term use. In chronic conditions, under long-term treatment, additional adverse effects may occur.

Clinical studies suggest that use of Ibuprofen-Hemofarm, particularly at a high dose (2400mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

Adverse events which have been associated with Ibuprofen are given below, listed by system organ class and frequency. Frequencies are defined as: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1000 to <1/100), rare (>1/10,000 to <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

The list of the following adverse events relates to those experienced with ibuprofen at OTC doses for short-term use. In the treatment of chronic conditions, under long-term treatment, additional adverse events may occur.

The adverse events observed most often are gastrointestinal in nature. Adverse events are mostly dose-dependent, in particular the risk of occurrence of gastrointestinal bleeding is dependent on the dosage range and duration of treatment.

Clinical studies suggest that use of ibuprofen, particularly at a high dose 2400mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke),.

Description of Selected Adverse Reactions

¹ Hypersensitivity reactions have been reported following treatment with ibuprofen. These may consist of (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract activity comprising asthma, aggravated asthma, bronchospasm, dyspnoea or (c) assorted skin disorders, including rashes of various types pruritus, urticaria, purpura, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).

²The pathogenic mechanism of drug-Induced aseptic meningitis is not fully understood. However, the available data on NSAID-related aseptic meningitis points to a hypersensitivity reaction (due to a temporal relationship with drug intake, and disappearance of symptoms after drug discontinuation). Of note, single cases of symptoms of aseptic meningitis (such as stiff neck, headache, nausea, vomiting, fever or disorientation) have been observed during treatment with ibuprofen, in patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

In children ingestion of more than 400mg/kg may cause symptoms. In adults the dose response effect is less clear cut. The half-life in overdose is 1.5-3 hours.

Symptoms

Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as vertigo, headache, respiratory depression, dyspnoea, drowsiness, occasionally excitation and disorientation or coma. Occasionally patents develop convulsions. In serious poisoning, hypotension, hyperkalaemia, and metabolic acidosis may occur and the prothrombin time / INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.

Management

Should be symptomatic and supportive and include maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.

In children ingestion of more than 400mg/kg may cause symptoms. In adults the dose response effect is less clear cut. The half-life in overdose is 1.5-3 hours.

Symptoms:

Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning metabolic acidosis may occur and the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.

Management:

Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.

Pharmacotherapeutic group: Propionic acid derivatives.

ATC Code: M01AE

Ibuprofen-Hemofarm is a phenylpropionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans, Ibuprofen-Hemofarm reduces inflammatory pain, swelling and fever. Furthermore, Ibuprofen-Hemofarm reversibly inhibits platelet aggregation.

Experimental data suggest that Ibuprofen-Hemofarm may competitively inhibit the effect of low dose aspirin (acetylsalicylic acid) on platelet aggregation when they are dosed concomitantly. Some pharmacodynamics studies show that when single doses of Ibuprofen-Hemofarm 400mg were taken within 30 min after immediate release aspirin (acetylsalicylic acid) dosing (81 mg), a decreased effect of aspirin (acetylsalicylic acid) on the formation of thromboxane or platelet aggregation occurred. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of Ibuprofen-Hemofarm may reduce the cardioprotective effect of low-dose aspirin (acetylsalicylic acid) cannot be excluded. No clinically relevant effect is considered to be likely for occasional Ibuprofen-Hemofarm use.

ATC Code: M01AE01

Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans, ibuprofen reduces inflammatory pain, swellings and fever. Furthermore, ibuprofen reversibly inhibits platelet aggregation.

Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose aspirin (acetylsalicylic acid) on platelet aggregation when they are dosed concomitantly. Some pharmacodynamics studies show that when single doses of ibuprofen 400mg were taken within 8 h before or within 30 min after immediate release aspirin dosing (81mg), a decreased effect of (acetylsalicylic acid) on the formation of thromboxane or platelet aggregation occurred. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded. No clinically relevant effect is considered to be likely for occasional ibuprofen use.

Ibuprofen-Hemofarm is rapidly absorbed following administration and is rapidly distributed throughout the whole body. The excretion is rapid and complete via the kidneys.

Maximum plasma concentrations are reached 45 minutes after ingestion if taken on an empty stomach. When taken with food, peak levels are observed after 1 to 2 hours. These times may vary with different dosage forms.

The half life of Ibuprofen-Hemofarm is about 2 hours.

In limited studies, Ibuprofen-Hemofarm appears in the breast milk in very low concentrations.

Ibuprofen is rabidly absorbed following administration and is rapidly distributed throughout the whole body. The excretion is rapid and complete via the kidneys.

Maximum plasma concentrations are reached 45 minutes after ingestion if taken on an empty stomach. When taken with food, peak levels are observed after 1 to 2 hours. These times may vary with different dosage forms.

Elimination half-life is approximately 2 hours.

In limited studies, ibuprofen appears in the breast milk in very low concentrations.

No relevant information additional to that already contained elsewhere in the SmPC.

No relevant information, additional to that contained elsewhere in the SPC.

None known.

Not applicable

Not applicable.

Not applicable