Method of administration:For oral administration.To be taken preferably with or after food.Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).Posology:The recommended starting dose is 120mg/day in divided doses, increasing to 180mg/day in divided doses, depending on patient response.
Special populations:Elderly: The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.
Paediatric population:The safety in children and adolescents is not established
PregnancyInhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5 %. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, acemetacin should not be given unless clearly necessary. If acemetacin is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:- cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);- renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;the mother and the neonate, at the end of pregnancy, to:- possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.- inhibition of uterine contractions resulting in delayed or prolonged labour.Consequently, acemetacin is contraindicated during the third trimester of pregnancy.
Breast-feedingIn limited studies so far available, NSAIDs can appear in breast milk in very low concentrations. NSAIDs should, if possible, be avoided when breastfeeding.
FertilitySee section 4.4 Special warnings and precautions for use, regarding female fertility.
Infections and infestationsIn very rare cases, exacerbation of inflammation caused by infection (e.g. development of necrotising fasciitis) has been described in a temporal relationship with the systemic use of non-steroidal anti-inflammatory agents. This may be associated with the mechanism of action of NSAIDs.Therefore, the patient should contact a doctor if any symptoms of the infection recur or become worse under treatment with Emflex. The doctor shall check whether an anti-infectious /antibiotic therapy should be indicated.
Blood and the lymphatic system disordersVery rare: anaemia caused by occult blood loss from the gastrointestinal tract, haemolytic anaemia, pancytopenia (anaemia including aplastic anaemia, leucopenia, agranulocytosis, thrombocytopenia). The initial symptoms may include: fever, sore throat, superficial lesions in the mouth, flu-like symptoms, severe tiredness, epistaxis and subcutaneous haemorrhage.In these cases, use of the medicinal product must be discontinued immediately and a doctor must be consulted. Any self-medication with analgesic agents and/or antipyretics shall not happen.In case of long-term treatment, the blood count should be checked at regular intervals.An influence on thrombocytes aggregation as well as increased haemorrhagic diathesis is possible.
Immune system disordersCommon: hypersensitivity reactions, such as skin rashes and pruritus.Uncommon: urticariaVery rare: severe general hypersensitivity reactions. These may manifest in the form of: oedema of the face and the eyelids, swollen tongue, internal laryngeal oedema with stenosis of the airways (angioneurotic oedema), respiratory distress that may lead to an asthma attack, aggravated asthma, tachycardia, blood pressure decrease leading to life-threatening shock.Should the patient experience any of these phenomena (which may occur as early as upon the first use of this medicinal product), medical assistance will be required.Very rare: allergy-related vasculitis and pneumonitis.
Endocrine disordersVery rare: hyperglycaemia and glucosuria.Metabolism and nutrition disorders:Rare: hyperkalaemia
Psychiatric disordersCommon: agitation.Rare: irritability, confusion.Very rare: mental disorders, disorientation, anxiety, nightmares, tremor, psychosis, hallucination, depression and transitory loss of consciousness that may lead to coma.Treatment with Emflex may intensify the symptoms of preexisting psychiatric diseases.
Nervous system disordersCommon: central nervous disorders such as headache, sleepiness/fatigue, dizziness, malaise and drowsiness.Very rare: sensibility disorders, muscular asthenia, hyperhidrosis, dysgeusia, impaired memory, sleep disorders, seizures, reports of aseptic meningitis (especially in patients with existing auto-immune disorders, such as systemic lupus erythematosus, mixed connective tissue disease) with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation (see section 4.4)Administration of Emflex may intensify the symptoms of epilepsy and Parkinson's disease.Frequency not known: optic neuritis, paraesthesia
Eye disordersUncommon: In the course of long-term treatment with indometacin, the main metabolite of acemetacin, pigment degeneration of the retina and corneal opacity have been reported.Blurred or double vision may be a typical symptom (see section 4.4).
Ear and labyrinth disordersVery rare: Tinnitus and transitory hearing impairment.
Cardiac disordersVery rare: palpitations, angina pectoris, cardiac failure
Vascular disordersVery rare: hypertensionFrequency not known: circulatory collapse
Gastrointestinal disordersVery common: gastrointestinal disorders such as nausea, vomiting, abdominal pain, diarrhoea and minor haemorrhage from the gastrointestinal tract which, in exceptional cases, can cause anaemia.Common: dyspepsia, flatulence, abdominal cramps, loss of appetite and gastrointestinal ulcers (sometimes accompanied by bleeding and perforation)Uncommon: blood can appear in vomit, faeces or diarrhoea.Very rare:stomatitis, inflammation of the tongue, lesions on the oesophagus, complaints in the lower abdomen (e.g. non-specific, bleeding inflammation of the colon) exacerbation of Crohn's disease or ulcerative colitis and constipation have been reported. Formation of intestinal diaphragm-like strictures; pancreatitis.The patient shall be instructed to discontinue the medicinal product and to consult a doctor immediately in case of any severe abdominal pain and/or the occurrence of meleana or haematemesis.
Hepatobiliary disordersCommon: hepatic enzyme increasedUncommon: hepatic damage (toxic hepatitis with or without icterus, cholestasisVery rare: taking a fulminant course in cases and at times without prodromal symptoms).The patient's liver values should therefore be monitored at regular intervals.
Skin and subcutaneous tissue disordersUncommon: alopeciaVery rare: eczema, enanthema, erythema, photosensitivity reaction, minor and extensive cutaneous bleeding, exfoliative dermatitis and rash with bullous eruption, which may also take a grave course such as Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome).
Renal and urinary disordersUncommon: development of oedema (e.g. peripheral oedema), in particular in patients with hypertension and/or impaired renal function.Very rare: micturition disorders, increase in blood urea, acute renal insufficiency, proteinuria, haematuria or renal damage (interstitial nephritis, nephrotic syndrome, papillary necrosis).Therefore, the patient's renal function should be checked at regular intervals.
Reproductive system and breast disordersVery rare: vaginal haemorrhage.
Reporting of suspected adverse reactionsReporting 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 professional are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard