IBUPROFEN DERMOGEN

Posology The ibuprofen dose depends on patient’s age or body weight. Pain and/or fever Adults and adolescents from 12 years of age (≥ 40 kg body weight): Initial dose 400 mg ibuprofen. If necessary, additional doses of 400 mg ibuprofen can be taken.

The respective dosing interval should be chosen in line with the observed symptoms and the maximum recommended daily dose. It should not be below 6 hours. A total dose of 1200 mg ibuprofen should not be exceeded in any 24-hour period.

Rheumatic diseases Adults The recommended dose is 1200 – 1800 mg daily in divided doses. Some patients can be maintained on 600 – 1200 mg daily. In severe or acute conditions, it can be advantageous to increase the dose until the acute phase is brought under control, provided that the total daily dose does not exceed 2400 mg in divided doses Age Single dose Maximum daily dose Adults 400 - 800 mg ibuprofen (1 – 2 tablets) 1200 - 2400 mg ibuprofen (3 – 6 tablets) Adolescents from 15 to 17 years of age The recommended dose should be adjusted by weight: 20-40 mg/kg daily (max 2400 mg daily) in 3-4 divided doses.

4). The treating physician decides on the duration of treatment. In rheumatic diseases the use of Ibuprofen Dermogen can be required for a longer period.

Special populations Elderly:

No special dose adjustments are required. 4), it is recommended to monitor the elderly particularly carefully. 3). 3).

Paediatric population:

Ibuprofen Dermogen 400 mg film-coated tablets is contraindicated in children younger than 12 years of age and in adolescents below 40 kg body weight. Method of administration Oral use. The tablets should be swallowed whole with a glass of water.

It is recommended that patients with a sensitive stomach take Ibuprofen Dermogen with food.

With the following adverse drug reactions, it must be accounted for that they are predominantly dose-dependent and vary interindividually. The most commonly observed adverse reactions are gastrointestinal in nature. 4). 4) have been reported following administration.

Less frequently, gastritis has been observed. Particularly the risk of gastrointestinal bleeding occurring is dependent on the dose range and the duration of use. Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.

4). Please note that within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

The following frequency groupings for undesirable effects are used:

Very common (≥1/10), Common (≥1/100 to 1/10), Uncommon (≥1/1,000 to 1/100), Rare (≥1/10,000 to 1/1,000), Very rare ( 1/10,000) and Not known (cannot be estimated from the available data). g. development of necrotising fasciitis) coinciding with the use of nonsteroidal antiinflammatory drugs has been described.

This is possibly associated with the mechanism of action of the nonsteroidal antiinflammatory drugs. If signs of an infection occur or get worse during use of Ibuprofen Dermogen, 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. The symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever or clouding of consciousness have been observed under ibuprofen.

Blood and lymphatic system disorders Very rare Anaemia Leukopenia Thrombocytopenia Pancytopenia Agranulocytosis Eosinophilia Coagulopathy (changes in coagulation) Aplastic anemia Hemolytic anemia Neutropenia The first signs may be fever, sore throat, superficial wounds in the mouth, influenza-like complaints, severe lassitude, nosebleeds and skin bleeding.

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 Dermogen 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. Very rare Hypoglycemia Hyponatremia Metabolism and nutrition disorders Unknown Hypokalaemia* Psychiatric disorders Very rare Psychotic reactions Hallucinations Confusion Depression Anxiety Common Central nervous disturbances such as dizziness, headaches, sleeplessness, agitation, irritability or tiredness Nervous system disorders Unknown Paraesthesiae Optic neuritis Eye disorders Uncommon Visual disturbances Ear and labyrinth disorders Rare Tinnitus Loss of hearing Cardiac disorders Very rare Palpitations Heart failure Myocardial infarction Vascular disorders Very rare Hypertension Vasculitis Respiratory, thoracic and mediastinal disorders Very rare Asthma Dyspnea Bronchospasm Unknown Rhinitis.

Very common Gastro-intestinal complaints such as pyrosis, abdominal pain, nausea, vomiting, flatulence, diarrhoea, constipation and slight gastro-intestinal blood losses that may cause anaemia in exceptional cases. Common Gastrointestinal ulcers, potentially with bleeding and perforation.

4) Uncommon Gastritis Gastrointestinal disorders 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 dysfunction Hepatic damage, particularly in long-term therapy Hepatic failure Acute hepatitis Jaundice Skin and subcutaneous tissue disorders Very rare Bullous reactions including Stevens-Johnson Syndrome and toxic epidermal necrolysis (Lyell syndrome) Erythema multiforme Severe skin infections and soft-tissue complications may occur during a varicella infection (see also "Infections and infestations") Alopecia Purpura Unknown Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalised exanthematous pustulosis (AGEP).

Photosensitivity reactions Uncommon Formation of oedemas, particularly in patients with arterial hypertension or renal insufficiency, nephrotic syndrome, interstitial nephritis that may be accompanied by acute renal insufficiency. Renal function should therefore be checked regularly.

Rare Kidney-tissue damage (papillary necrosis), elevated uric acid concentrations in the blood, elevated urea concentration in the blood Renal and urinary disorders Unknown Impaired renal function Renal tubular acidosis* *Renal tubular acidosis and hypokalaemia have been reported in the post- marketing setting typically following prolonged use of the ibuprofen component at higher than recommended doses.

Reporting of suspected adverse […]

Undesirable effects may be minimised by using the lowest effective dose for the shortest possible duration necessary to control symptoms (see Gastrointestinal and cardiovascular risks below). g. 8) • directly after major surgery • in patients who react allergically to other substances, as an increased risk of hypersensitivity reactions occurring also exists for them on use of Ibuprofen Dermogen • in patients who suffer from hay fever, nasal polyps or chronic obstructive respiratory disorders as an increased risk exists for them of allergic reactions occurring.

These may present as asthma attacks (so-called analgesic asthma), Quincke’s oedema or urticaria. 5) and should be avoided. 2).

Gastrointestinal bleeding, ulceration and perforation:

GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events. When GI bleeding or ulceration occurs in patients receiving ibuprofen, it is advised to withdraw the treatment.

3), and in the elderly. These patients should commence treatment on the lowest dose available. g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low-dose acetylsalicylic acid, or other medicinal products likely to increase gastrointestinal risk.

5). Patients with a history of GI toxicity, particularly the elderly, are advised to report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment. 5). 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.

8). NSAIDs may mask symptoms of infection and fever. 8). Patients appear to be at highest risk of 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.

Acute generalised exanthematous pustulosis (AGEP) has been reported in relation to ibuprofen-containing products. Patients should be advised to discontinue the intake of Ibuprofen Dermogen at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Exceptionally, varicella can be at the origin of serious cutaneous and soft tissues infectious 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 Dermogen in case of varicella.

Cardiovascular and cerebrovascular effects:

Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention 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. Other notes Severe acute hypersensitivity reactions (for example anaphylactic shock) are observed very rarely.

At the first signs of hypersensitivity reaction after taking/administering Ibuprofen Dermogen therapy must be stopped. Medically required measures, in line with the symptoms, must be initiated by specialist personnel. Ibuprofen may temporarily inhibit the blood-platelet function (thrombocyte aggregation).

Therefore, it is recommended to monitor patients with coagulation disturbances carefully. In prolonged administration of Ibuprofen […]

1. g. bronchospasm, asthma, rhinitis, angioedema or urticaria) associated with the use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs). - Patients with severe heart failure (NYHA Class IV). - Patients with severe liver failure or severe renal failure.

- Patients with unclarified blood-formation disturbances. - Patients with cerebrovascular or other active bleeding. - History of gastrointestinal bleeding or perforation associated with previous NSAIDs therapy. - Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).

- Patients with severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake) - Last three months of pregnancy. - Children younger than 12 years of age and adolescents