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Analgesics & Antipyretics

Aceclofenac STADA® 100 mg

 

Pack size:

Box of 5 blisters x 10 film-coated tablets.

 

Composition:

Each film-coated tablet contains aceclofenac 100 mg.

 

Shelf-life:

36 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

  • For the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
     
  • Administered orally, it should be swallowed whole with a sufficient quantity of liquid. To be taken preferably with or after food.
     
  • In adults:
    The recommended dose is 200 mg (two tablets) daily, taken as two separate 100 mg doses, one tablet in the morning and one in the evening.
  • In children:
    There are no clinical data on the use of aceclofenac in children and therefore it is not recommended for use in children.
  • In elderly:
    The pharmacokinetics of aceclofenac are not altered in elderly patients, therefore it is not considered necessary to modify the dose or dose frequency.
  • Hepatic insufficiency:
    There is some evidence that the dose of aceclofenac should be reduced in patients with hepatic impairment and it is suggested that an initial daily dose of 100 mg be used.
     

Or as prescribed by physicians.

 

  • Patients with previous hypersensitivity to aceclofenac or any of excipients.
  • Patients with a history of or active or suspected peptic ulcer or gastro-intestinal bleeding.
  • Patients with moderate to severe renal impairment.

     

  • Risk of cardiovascular thrombotic events (see section Precautions).
     

Common:

  • Dizziness.
  • Dyspepsia, abdominal pain, nausea, diarrhoea.
  • Hepatic enzyme increased.

Uncommon:

  • Flatulence, gastritis, constipation, vomiting, mouth ulceration.
  • Pruritus, rash, dermatitis, urticaria.
  • Blood urea increased, blood creatinine increased.

Rare:

  • Anaemia.
  • Anaphylactic reaction (including shock), hypersensitivity.
  • Visual disturbance.
  • Dyspnoea.
  • Melaena.
  • Face oedema.
     

  • Gastrointestinal bleeding or ulcerative perforation, haematemesis and melaena have in general more serious consequences in the elderly. They can occur at any time during treatment, with or without warning symptoms or a previous history.
  • Close medical surveillance is also imperative in patients suffering from severe impairment of hepatic function.
  • Hypersensitivity reactions, including anaphylactic/ anaphylactoid reactions, can also occur without earlier exposure to the drug.
  • Patients with mild renal or cardiac impairment and the elderly should be kept under surveillance, since the use of NSAIDs may result in deterioration of renal function. The lowest effective dose should be used and renal function monitored regularly.
  • Use of aceclofenac in patients with hepatic porphyria may trigger an attack.
  • NSAIDs should be given with care to patients with a history of heart failure or hypertension since oedema has been reported in association with NSAID administration.
  • NSAIDs may impair fertility and is not recommended in women trying to conceive. The temporary discontinuation of aceclofenac should be considered in women having difficulties to conceive or undergoing investigations for infertility.
  • Use with caution in patients suffering from or with a history of bronchial asthma since NSAIDs have been known to cause bronchospasm in such patients.
  • 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 Aceclofenac STADA® 100 mg, prescribe the lowest effective daily dose for the shortest duration possible. 
  • The use of aceclofenac should be avoided in pregnancy unless the potential benefits to the other outweigh the possible risks to the foetus.
  • In limited studies so far available, NSAIDs can appear in breast milk in very low concentrations. NSAIDs should, if possible, be avoided when breastfeeding.
  • Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate 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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