Catafast granules for oral solution :
Every sachet contains diclofenac potassium 50 mg.
Catafast sachets excipients :
saccharose, aspartame, potassium bicarbonate, anise eromatic powder, mint aromatic powder, menthol, sodic saccharine
Catafast sachets pharmaceutical form and content :
9 sachets of granulated product, oral solution, each containing 50mg.
Catafast sachets pharmacotherapeutic category :
Anti-inflammatory, anti-rheumatic non-steroidal substance.
Catafast sachets indications and potential uses :
Short-term treatment (maximum 2 weeks) of the following acute conditions:
-postoperative inflammations and pain e.g following dental or orthopeadic surgery.
– painful post traumatic pain inflammatory states e.g due to sprains.
-painful and/or inflammatory gynaecological conditions ,e.g. primary dysmenorrhoea or adnxitis.
– Migraine attacks.
– As an adjunct in severe painful inflammatory infections of the ear nose or throat.
– painful syndromes of the vertebral column
– non articular rheumatism.
– In keeping with standard therapeutic principles the undertying diseasae should be treated with specific therapy as appropriate.
– Fever alone is not an indication.
Catafast sachets contraindications :
Peptic and gastric ulcers, hypersensitivity to the components and/or other substances. Particular hyper-sensitivity to acetyl salicylic acid and in general to the non-steroidal analgesic, antipyretic and anti-inflammatory drugs, progressive liver diseases and
grave renal dyslunction (insufficiency). It is contraindicated in patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated or worsened by acetylsalicylic acid or other drugs with prostaglandin synthetase inhibiting activities.
Catafast sachets precautions on use :
The physician must take great care in case of treatment of patients with gastrointestinat symptoms, a history of peptic/gastric ulcer, ulcerative colitis, Crohn’s disease of grave impaired hepatic function. In all such cases,
treatment shall be kept under close medical supervision. In general, gastro-intestinal bleeding of ulceration and perforation have even more serious consequences in the elderly. They can occur at any time during treatment without warning symptoms of previous history. In the rare events
of gastrointeslinal bleeding or ulceration, the drug should be withdrawn.
Owing to the importance of prostaglandins in maintaining renal blood flow, particular caution is called in patients with impaired renal or cardiac blood flow, the elderty patients being treated with diuretics and those with extracellular volume depletion. In such cases, monitomg of renal function
during treatment is recommended. Withdrawal of the drug is usualfy followed by a return to the pre-treatment state.
In any case, particular caution is indicated in old patients or those with a low bodyweigh; in particular it is recommended to administer the lowest effective dosage.
Catafast sachets use in pregnancy and lactation :
During pregnancy, this drug may be administered only after careful precuation of risk/benefit analysis and in any case, with the lowest effective dosage.This drug may not be used during the third trimester of pregnancy owing to the possibility of delaying delivery and slackening labour. It is necessary to underline the risk of haemorrhage that can arise from administration of NSAIDs during the terminal phase of pregnancy. After oral
doses of 50 mg every 8 hours, diclofenac excreted in breast milk is so small that adverse effects in the neonate are unlikely.
Catafast sachets effects on the capacity to drive motorcars or operate machines:
those patients who have experienced vertigo. fits of dizziness or other CNS disturbances shall refrain from guiding cars or operating machines requiring attention.
Catafast sachets dosage method and time of administration :
–In post-traumatic pains, postoperative cases and in the treatment of severe acute rheumatic pain. the attack dose in adults is in the range of 100-150mg per day divided into 2-3 administrations. In milder cases as well as for adolescents over 14 years of age, a dose ranging between 50 and 100 mg daily will generally suffice. In primary dysmenorrhoea, the daily dosage, which should be individually adjusted, is generally between 50 to 150 mg and, if necessary, it may be raised over the course of other menstrual cycles until it reaches a maximum of 200 mg daily. It is advisable to start treatment upon onset of the early symptoms and continue it for a few days depending on symptomatology.
Migraine: An initial dose of 50 mg is recommended at the first sign of an
impending attack. In cases where pain relief is inadequate approx. 2 hours after ingestion of the first dose a further dose of 50 mg may be taken. If necessary, further 50 mg doses may be taken at intervals of 4-6 hours. although a total dose 01200 mg must not be exceeded within a 24 hours period don’t exceed the doses recommended. The content of the sachet is to be melted in a hall glass of natural water prelerably before meals. Possible opalescence of the solution does not indicate impairment of the efficacy of the preparation.
Catafast sachets overdosage :
The procedure of management to be adopted in case of acute poisoning with NSAIDs is essentially a procedure of supportive or symptomatic measures. No typical clinical picture associated with overdosage of diclofenac exists. In case of overdosage, it is necessary to prevent absorption as soon as possible by means of gastric lavage and activated charcoal.
Adequate symptomatic or supportive measures to combat hypotension, renal damage, convulsions. gastrointestinal lesions and respiratory depression must be employed and taken.
Catafast sachets undesired effects and adverse reactions’ :
Git disturbances like nausea, vomiting, diarrhoea. abdominal cramps. dyspepsia, anorexia (loss of appetite), gastrointestinal bleeding, haematemesis, peptic ulceration with or without bleeding or perforation, bloody diarrhoea In isolated cases· lower gastrointestinal disorders (such as haemorrhagic inflammation and ulcerative colitis) pancreatitis (the cause/effect relationship is not known well), aphthous stomatitis, glossitis, oesophageal lesions, diaphragm disease. Special attention must be paid to possible appearance of superficial lesions or ulcers in the stomach. Sometimes these lesions happen without previous warning symptoms other than those noted above, namely loss of occult blood or emission of black faeces.
Catafast sachets central and peripheral nervous system :
headache, vertigo drowsiness
In isolated cases : sensory disturbances, Paraesthesias, memory dis turbances. disorientation, disturbances of vision, impaired hearing. tinnit- us, insomnia, irritability. convulsions. depression. anxiety, nightmares, tremor, psychotic reactions, taste alterations.
Storage conditions :
Store below 30”C and protect from moisture
Catafast sachets attention:
Do not use this medicine beyond the expiry date indicated on the package. Such dates are applicable only if both packing and storing are sound.
pack of 9 sachets
Produced by :
NOVARTIS PHARMA S.A.E. – Cairo