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Aspicam Meloxicamum 7,5 mg
Meloxicamum 15 mg The active subtancess The active substance in the tablets is meloxicam. The quantity of the active substance in tablets is 7.5 mg or 15 mg. Excipients Auxiliary substances include: lactose, polyvinylpyrrolidone, magnesium stearate. Marketing Authorization Holder Biofarm Sp. z o.o., 60-198 Poznań, ul. Wałbrzyska 13. What is Aspicam and what it is used for? The active substance included in Aspicam is meloxicam, a nonsteroidal anti-inflammatory
drug that exhibits anti-inflammatory, antipyretic and analgesic effects.
The mechanism of action of the drug is connected with selective inhibition of cyclooxygenase
COX-2, an enzyme which plays an important role in inflammatory processes. By contrast to other nonsteroidal anti-inflammatory drugs, meloxicam only slightly inhibits cyclo-oxygenase COX-1. Thanks to this, meloxicam produces favourable therapeutic effects and does not give rise to undesirable gastrointestinal and renal symptoms so frequently. Aspicam is recommended in - long-term symptomatic treatment of chronic rheumatic arthritis,
- long-term treatment of selected forms of arthrosis,
- symptomatic treatment and short-term treatment of certain painful forms of arthrosis.
Before you take Aspicam Aspicam should not be given to patients with known hypersensitivity to meloxicam or any other component of the medication. Moreover, the drug is contraindicated if patients previously experienced attacks of breathlessness or asthma, itchy rash or angioedema during
the administration of other nonsteroidal anti-inflammatory drugs.
The drug should not be used in patients with chronic active gastric and duodenal ulcer disease
and severe hepatic or renal failure.
It should not be given to children under 15 years of age, pregnant women and during
lactation. Precautions and special warning In patients with a history of peptic ulcer disease, the administration of the preparation should be carefully monitored.
If Aspicam is taken in conjunction with anticoagulant drugs, it is necessary to monitor blood clotting parameters.
In the case of bleeding from the alimentary tract (tarry-black stools, coffee-grounds
vomiting), skin changes, gingivitis or conjunctivitis, the drug should be discontinued
immediately.
As with other nonsteroidal anti-inflammatory drugs, Aspicam can sporadically cause interstitial nephritis, glomerulonephritis, papillary necrosis or nephrotic syndrome. Such
complications usually appear in patients suffering from chronic renal insufficiency who
underwent major surgical interventions (which can potentially lead to hypovolaemia) and in
patients with hepatic cirrhosis. Consult your doctor even if the warning information specified above concerns the past. Taking Aspicam during pregnancy and breast-feeding The drug should not be given to pregnant women and during lactation. Driving and using machines There are no data available concerning the effect of Aspicam on the ability to drive motor
vehicles. If you experience dizziness or drowsiness, you should consider discontinuing those activities which require good psychophysical efficiency.
Taking other medicines If meloxicam is administered in conjunction with diuretics, it may trigger acute renal insufficiency in dehydrated patients. Aspicam may also diminish the effect of drugs which
lower blood pressure (e.g. beta-adrenolytics, angiotensine converting enzyme inhibitors).
If Aspicam is given to women who use IUD, the contraceptive effect of IUD may be decreased.
Do not take meloxicam with other nonsteroidal anti-inflammatory drugs (e.g. acetylsalicylic
acid, ibuprofen), as this can increase the risk of ulceration and bleeding from the alimentary
tract.
Meloxicam is not recommended in conjunction with orally administered anticoagulant drugs,
as well as ticlopidine and heparin, as the synergic effect of platelet aggregation inhibition may increase the risk of bleeding from the alimentary tract.
It is not advisable to use meloxicam with lithium salts, as nonsteroidal anti-inflammatory
drugs reduce lithium excretion by kidneys, which can lead to lithium accumulation and toxic
lithium concentration.
Meloxicam should not be taken with methotrexate, as it can increase the toxic effect of
methotrexate on the haematopoietic system. Always inform your doctor of any medications which you have taken recently, including nonprescription drugs. How to take Aspicam In chronic rheumatic arthritis, 15 mg of meloxicam is to be taken daily, however if the
efficacy of the drug is sufficient, the dose can be reduced to 7.5 mg/day.
In symptomatic treatment of arthrosis (degenerative affection of joints), 7.5 mg of meloxicam is usually administered per day. If necessary, the dose may be increased to 15 mg/day.
In patients with potential increased risk of undesirable side-effects, therapy should begin with doses of 7.5 mg/day.
Aspicam is to be taken orally with meals. Wash down the tablet.
The maximum daily dose is 15 mg (two 7.5 mg tablets or one 15 mg tablet).
In patients with major liver damage and dialysed patients, the maximum daily dose is 7.5 mg. If you take more Silenil that you should Meloxicam overdosage results mainly in gastrointestinal ailments (vomiting, stomach ache, nausea) and symptoms related to the nervous system (headaches, dizziness). In the case of overdosage, lavage of the stomach should be applied, followed by symptomatic treatment.
The elimination of meloxicam from the alimentary tract is sped up by cholestyramine. No
antidote is known. If you take a dose that is higher than the daily recommended dose, consult your doctor or
pharmacist immediately.
If you forget to take Silenil If you fail to take a dose of Aspicam as prescribed, continue the treatment following the
recommended dosage instructions. Do not take a double dose to make up for a missed one. Possible side-effects As with every type of drug, Aspicam may produce undesirable side-effects.
Alimentary tract: indigestion (or dyspeptic ailments), stomach ache, constipation, flatulence with winds, diarrhoea, stomatitis, oesophagitis. In rare cases, severe side-effects may occur, including peptic ulcers, perforation or bleeding from the alimentary tract.
Haematopoietic system: patients treated with meloxicam were reported to exhibit changes of the blood picture, anaemia, leucopenia (decrease in white blood cells) and thrombocytopenia (decrease in the number of platelets). In some cases, these conditions were attributed to the drug therapy. Also, one case of agranulocytosis has been recorded in a patient treated with meloxicam and methotrexate.
Hypersensitivity reaction:
General: occasionally, patients were reported to experience anaphylactic or
pseudoanaphylactic reactions and angioedema.
Skin reactions: itch, rash, urticaria, hypersensitivity to sunlight.
In extremely rare cases, vesical lesions may occur, including bullous erythema multiforme, Stevens-Johnson syndrome and epidermal toxic-colliquative necrosis.
Respiratory system: some patients suffering from allergy to acetylsalicylic acid or other
nonsteroidal anti-inflammatory drugs were reported to experience asthma attacks.
Central nervous system: dizziness of different intensity, headaches, ear buzzing and
drowsiness can occur.
Cardiovascular system: swelling, lower extremity oedema, palpitations, flush and hot
sensation of the face.
Urinary and sexual system: deviations from standard results in kidney function
tests (e.g. increased creatinine or urea concentration).
Liver: temporary deviations from standard results in liver function tests (e.g. increased
aminotransferase activity or increased bilirubin concentration); hepatitis was reported in a few cases. Storing Aspicam Keep out of the reach and sight of children.
Do not store above 25°C. Store in dry places.
Do not use after the expiry date stated on the cartoon. Further information In order to obtain any additional information about the drug, please contact a representative of the entity responsible.
Biofarm Sp. z o.o.
Ul. Wałbrzyska 13
60-198 Poznań
POLAND
Telephone no.: 061 66 51 500 Date of issue of this leaflet May 2003 Available packaging Cardboard boxes of 10, 20 or 30 tablets in blister packs. | 
