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Analgesics & Antipyretics

Zengesic

 

Pack sizes:

Box of 10 blisters x 10 film-coated tablets.

Box of 1 bottle x 100 film-coated tablets.


Composition:

Each film-coated tablet contains paracetamol 500 mg

and diclofenac sodium 50 mg.


Shelf-life: 

24 months from the date of manufacturing.

Store in a well-closed container, in a dry place.

Protect from light. Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Anti-inflammatory, analgesic in such cases of: Chronic arthritis, rheumatoid arthritis, aches and pain due to dislocations.
  • Treatment of musculoskeletal disorders (tendinitis, sprains, etc.), acute gout, postoperative pain, reduced pain of renal colic.
  • Reduction of feverish symptoms due to bacterial, pain e.g headache, earache, toothache, aches and pain due to cold and influenza.
     
  • Administered orally after meals.
     
  • To minimize the risk for an adverse cardiovascular event in patients treated with diclofenac, prescribe the lowest effective daily dose for the shortest duration possible (see section Precautions).
    Adults: 1 tablet once x 3 times daily.
    The interval between doses should be at least 4 hours.
     

Or as prescribed by physicians.

 

  • Hypersensibility to paracetamol, diclofenac, aspirin or other NSAIDs (asthma, rhinitis, urticaria after aspirin use).
  • Active peptic ulcer.
  • Patients with asthma or bronchospasm, bleeding disorders, cardiovascular diseases, severe liver or renal failure.
  • Patients who are receiving coumarin anticoagulants.
  • Patients with congestive heart failure, diuretic-induced volume depletion or renal impairment, glomerular filtration rate < 30 ml/min (because of high risk of developing renal disfunction).
  • Patients with collagen disease (risk of developing aseptic meningitis. Note that in all case of aseptic meningitis, there has been some form of auto-immune disease in the patient history as predisposing factor).
  • Patients with known glucose-6-phosphate dehydrogenase deficiency.
  • Patients with established congestive heart failure (NYHA class II-IV), ischaemic heart disease, peripheral arterial disease or cerebrovascular disease.

     


Paracetamol

  • Skin rash and other allergic reactions occur occasionally. The rask is usually erythematosus or urticarial, but sometimes it is more serious and may be accompanied by drug fever and mucosal lesions.

Uncommon

  • Rash.
  • Nausea, vomiting.
  • Blood dyscrasias (neutropenia, pancytopenia, leukopenia), anemia.
  • Nephropathy, nephrotoxicity with chronic abuse.

Rare

  • Hypersensitivity reactions.

Diclofenac sodium

  • 5 - 15% of all patients experienced some types of gastrointestinal side effects.
  • Cardiovascular thrombosis risk: Clinical trial and epidemiological data suggest that the use of diclofenac, particularly at high doses (150 mg daily) and in long term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section Precautions).

Common

  • Headache, nervousness.
  • Epigastric pain, nausea, vomiting, diarrhoea, flatulence, anorexia, dyspepsia.
  • Elevation of transaminase levels.
  • Tinnitus.

Uncommon

  • Oedema, allergic reactions (particularly bronchospasm in patients with asthma), anaphylactic reactions including hypotension, rhinitis, urticaria.
  • Abdominal pain, gastrointestinal bleeding, activation of peptic ulcer, hematemese, melena, bleeding diarrhoea.
  • Drowsiness, depression, insomnia, anxiety, malaise, irritability.
  • Urticaria.
  • Bronchospasm.
  • Blurred vision, scotoma, eye pain, diplopia.

Rare

  • Oedema, rash, Stevens-Johnson syndrome, alopecia.
  • Aseptic meningitis.
  • Leukopenia, thrombocytopenia, neutropenia, eosinophilia, agranulocytosis, anaemias.
  • Dyskynesia of gallbladder, abnormalities in liver function tests, hepatotoxicity (jaundice, hepatitis).
  • Cystitis, haematuria, acute renal failure, interstitial nephritis, nephrotic syndrome.

     

Paracetamol

  • Paracetamol is relatively nontoxic in therapeutic doses. Dermatologic have been reported and reactions including pruritic maculopapular rash and urticaria; other sensitivity reactions including laryngeal edema, angioedema, and anaphylactoid reactions may occur rarely. Thrombocytopenia, leukopenia, and pancytopenia have been associated with the use of p-aminophenol derivatives, especially with prolonged administration of large doses. Neutropenia and thrombocytopenic purpura have been reported with paracetamol use. Rarely, agranulocytosis has been reported in patients receiving paracetamol.
  • Individuals with phenylketonuria (i.e., homozygous deficiency of phenylalanine hydroxylase) who must restrict their intake of phenylalanine should be warned that some paracetamol preparations contian aspartame, which is metabolized in the gastrointestinal tract to phenylalanine following oral administration.
  • Some commercially available formulations of paracetamol contain sulfites that may cause allergic-type reactions, including anaphylaxis and life-threatening or less severe asthmatic episodes, in certain susceptible individuals.
  • Paracetamol should be used with caution in patients with preexisting anemia, since cyanosis may not be apparent despite dangerously high blood concentrations of methemoglobin.
  • Excessive intake of alcohol may increase the risk of paracetamol induced hepatotoxicity; avoid or limit alcohol intake.
  • The physicians need to warn the patients of the signs of serious skin reactions known as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN) or Lyell's syndrome, acute generalized exanthematous pustulosis (AGEP).

Diclofenac sodium

  • Previous history of gastro-intestinal ulceration, bleeding or perforation.
  • Patients with renal or hepatic insufficiency, patients with systemic lupus erythrematosus.
  • Hypertension or cardiac conditions aggravated by fluid retention and edema.
  • History of liver dysfunction. Liver function should be monitored periodically during long-term therapy with diclofenac.
  • Pre-existing infection.
  • History of coagulation bleeding defects.
  • Risk of cardiovascular thrombotic events: Systemic non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, either of which can be fatal. This risk may occur as early as the first weeks of treatment and may increase with duration of use. The cardiovascular thrombotic risk has been observed most consistently at higher doses.
  • Physicians should assess periodically appearance of cardiovascular adverse events, even in the absence of previous cardiovascular symptoms. Patients should be warned about the symptoms of serious cardiovascular events and seek physicians immediately if these symptoms occur.
  • To minimize the risk for an adverse cardiovascular event in patients treated with diclofenac, prescribe the lowest effective daily dose for the shortest duration possible.
  • Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration.
  • Pregnancy: Avoid use drug in the third trimester because of possible premature closure of the ductus arteriosus; avoid use late in pregnancy because of possible delay in labor or parturition. Diclofenac should be used only if clearly necessary.
  • Lactation: Discontinue nursing or the drug because of potential risk in nursing infants.
  • Effects on ability to drive and use machines: Patients who experience dizziness, drowsiness, fatigue or visual disturbances, while taking NSAIDS should refrain from driving or operating machinery.


 

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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