IBUPROFEN FARMALIDER

4). The dosage is in line with the details in the following table. Body weight (Age) Single dose Maximum daily dose ≥ 40 kg (Adults and 200-400 mg (1-2 tablets) 1200 mg ibuprofen (6 tablets) adolescents from 12 years) The respective dosing interval should be chosen in line with the symptomatology and the maximum daily dose.

The interval between doses should not be below 6 hours. The recommended maximum daily dose should not be exceeded. Paediatric population Ibuprofen Farmalider is not intended for use in adolescents under 40 kg body weight or children under 12 years of age.

Elderly patients No special dosage adjustment is required. 4), it is recommended to monitor the elderly particularly carefully. 3). 3). For short-term use only. If in adolescents from 12 years this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

If in adults this medicinal product is required for more than 3 days in the case of fever or for more than 4 days in the treatment of pain, or if symptoms worsen a doctor should be consulted. Method of administration For oral use. The tablets should be swallowed whole with a glass of water.

In patients with a sensitive stomach, it is recommended to take this medicine during meals.

4). The most commonly observed adverse events are gastrointestinal in nature. 4). 4) have been reported following administration Less frequently, gastritis has been observed. Oedema, hypertension and cardiac failure have been reported in association with NSAIDs treatment.

The list of the following undesirable effects comprises all undesirable effects that have become known under treatment with ibuprofen, also those under high-dose long- term therapy in rheumatism patients. The stated frequencies, which extend beyond very rare reports, refer to the short-term use of daily doses up to a maximum of 1200 mg ibuprofen for oral dosage forms and a maximum of 1800 mg for suppositories.

With the following adverse drug reactions, it must be accounted for that they are predominantly dose-dependent and vary interindividually. The following frequencies are taking as a basis when evaluating undesirable effects: Very common (≥ 1/10), Common (≥ 1/100, < 1/10), Uncommon (≥ 1/1000, < 1/100), Rare (≥ 1/10,000, < 1/1,000), Very rare (< 1/10,000), Not known (cannot be estimated from the available data).

g. development of necrotising fasciitis) coinciding with the use of NSAIDs has been described. This is possibly associated with the mechanism of action of the non-steroidal anti- inflammatory drugs. If signs of an infection occur or get worse during use of ibuprofen, the patient is therefore recommended to go to a doctor without delay.

It is to be investigated whether there is an indication for an antiinfective/antibiotic therapy. Very rare: the symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever or consciousness clouding has been observed under ibuprofen.

Patients with autoimmune disorders (SLE, mixed connective-tissue disease) appear to be predisposed.

Blood and lymphatic system disorders:

Very rare: disturbances of blood formation (thrombocytopenia, leukopenia, pancytopenia, agranulocytosis or anaemia). The first signs may be fever, sore throat, superficial wounds in the mouth, flu-like symptoms, severe fatigue, nasal and skin bleeding.

In such cases, the patient should be advised to discontinue the medicinal product immediately, to avoid any self-medication with analgesics or antipyretics and to consult a physician. The blood count should be checked regularly in long-term therapy.

Immune system disorders:

Uncommon: hypersensitivity reactions with skin rashes and itching, as well as asthma attacks (possibly with drop in blood pressure). The patient is to be instructed to inform a doctor at once and no longer to take ibuprofen in this case.

Very rare: severe general hypersensitivity reactions. They may present as face oedema, swelling of the tongue, swelling of the internal larynx with constriction of the airways, respiratory distress, racing heart, drop in blood pressure up to life- threatening shock.

If one of these symptoms occurs, which can happen even on first use, the immediate assistance of a doctor is required.

Psychiatric disorders:

Very rare: psychotic reaction, depression.

Nervous system disorders:

Uncommon: central nervous disturbances such as sleeplessness, headache, dizziness, agitation, irritability or tiredness.

Eye disorders:

Uncommon: visual disturbances. In this case, the patient should be instructed to inform the doctor immediately and to discontinue ibuprofen. Rare: reversible toxic amblyopia.

Ear and labyrinth disorders:

Rare: tinnitus, hearing disorders.

Cardiac disorders:

Very rare: palpitation, heart failure, myocardial infarction Not known: Kounis syndrome Vascular disorders Very rare: arterial hypertension Gastrointestinal disorders: Common: gastrointestinal complaints such as pyrosis, abdominal pain, nausea, vomiting, flatulence, diarrhoea, constipation and slight gastro-intestinal blood losses that may cause anaemia in exceptional cases.

Uncommon: gastrointestinal ulcers, potentially with bleeding and perforation. 4), gastritis. Very rare: oesophagitis, pancreatitis, formation of intestinal, diaphragm-like strictures. The patient is to be instructed to withdraw the medicinal product and to go to a doctor immediately if relatively severe pain in the upper abdomen or melaena or haematemesis occurs.

Hepatobiliary disorders Very rare: hepatic damage, particularly in long-term therapy, hepatic dysfunction, hepatic failure, acute hepatitis and jaundice.

Skin and subcutaneous tissue disorders:

Uncommon: skin rash, urticaria, pruritus, purpura (including allergic purpura).

Very rare:

Severe cutaneous adverse reactions (SCARs) (including Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis), alopecia, photosensitivity reactions and allergic vasculitis. In exceptional cases, severe skin infections and soft tissue complications in varicella infection.

Not known:

Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalised exanthematous pustulosis (AGEP). Photosensitivity reactions.

Metabolism and Nutrition Disorders Not known:

Hypokalaemia* Renal and urinary disorders: Rare: renal tissue damage (papillary necrosis), particularly in long-term therapy, increased serum uric acid […]

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

Elderly:

The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal. The elderly are at increased risk of the consequences of adverse reactions. 8). g. acute intermittent porphyria).

8). 8). 8). 8). -Directly after major surgery. -In dehydration. -In patients who suffer from hayfever, nasal polyps, chronic swelling of the nasal mucosa or chronic obstructive respiratory disorder as there is an increased risk of allergic reaction occurring.

These may present as asthma attacks (so-called analgesic asthma), Quincke´s oedema or urticaria. In patients who react allergically to other substances, as an increased risk of hypersensitivity reactions occurring also exists for them on use of ibuprofen.

Respiratory Bronchospasm may be precipitated in patients suffering from, or with a history of, bronchial asthma or allergic disease. Other NSAIDs Use with concomitant NSAIDs including cyclo-oxygenase-2 selective inhibitors should be avoided.

Gastrointestinal risks Gastrointestinal bleeding, ulceration or perforation, which can fatal, have been reported with all. NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events.

3), and in the elderly. These patients should commence treatment on the lowest dose available. g. 5). Patients with a history of gastrointestinal toxicity, particularly with elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stage of treatment.

5). When gastrointestinal bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn. 8). 8). Most of these reactions occurred within the first month. If signs and symptoms suggestive of these reactions appear ibuprofen should be withdrawn immediately and an alternative treatment considered (as appropriate).

Exceptionally, varicella can be at the origin of serious cutaneous and soft tissues infections complications. To date, the contributing role of NSAIDs in the worsening of these infections cannot be ruled out. Thus, it is advisable to avoid use of ibuprofen in case of varicella.

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 (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). g. ≤ 1200 mg/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.

g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen (2400 mg/day) are required. Cases of Kounis syndrome have been reported in patients treated with Ibuprofen Farmalider 200 mg. Kounis syndrome has been defined as cardiovascular symptoms secondary to an allergic or hypersensitive reaction associated with […]

1 - history of bronchospasm, asthma, rhinitis, urticaria, angioneurotic oedema or other allergic reactions after having used other non-steroidal anti- inflammatory drugs (NSAIDs). - history of gastrointestinal haemorrhage or perforation related to previous treatment with NSAIDs.

- active, or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or haemorrhage). - severe heart failure (NYHA Class IV). - severe renal or severe hepatic impairment. - unclarified blood-formation disturbances.

). - cerebrovascular or other active bleeding. - severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).