Partamol Extra

OTC

Indications

• Management of mild to moderate pain and inflammation in conditions: Dysmenorrhea, headache, migraine, postoperative pain, dental pain; musculoskeletal and joint disorders such as ankylosing spondylitis, osteoarthritis, rheumatoid arthritis, peri-articular disorders, soft-tissue disorders such as sprains and strains.

Dosage

• Adults and children 12 years old and above: 1 tablet every 6 hours, not exceed 6 tablets /day, not exceed 10 days.

Usage

• Partamol Extra is administered orally.

• Patients who have shown hypersensitivity or idiosyncrasy to any components of drug.
• Patients with severe hepatic failure, renal failure or severe heart failure.
• Patients with alcohol dependence.
• Patients with deficiency of glucose-6-phosphate dehydrogenase.
• Patients with active peptic ulceration.
• History of upper gastrointestinal bleeding or perforation, related to previous NSAID therapy.
• Patients in whom bronchospasm, asthma, angioedema, or urticaria, severe rhinitis, severe allergic reaction or shock are precipitated by aspirin or other NSAIDs.
• Pregnancy, especially during the last trimester.

Common

• Fever, fatigue;
• Abdominal discomfort, nausea and vomiting;
• Headache, dizziness, nervousness;
• Rash, exanthema.

Uncommon

• Rash;
• Nausea, vomiting;
• Blood dyscrasias (neutropenia, pancytopenia, leukopenia), anemia;
• Nephropathy, nephrotoxicity with chronic abuse;
• Allergic reactions (particularly bronchospasm in patients with asthma), rhinitis, urticaria; abdominal pain, gastro-intestinal bleeding, activation of peptic ulcer;
• Drowsiness, insomnia, tinnitus;
• Troubles of vision;
• Decrease of hearing;
• Prolonged bleeding time.

• Treatment with Partamol Extra, prescribe the lowest effective dose for the shortest duration possible.
• It should not be used:
  – For self-medication of pain for longer than 10 days in adults;
  – For self-medication of marked fever (greater than 39.5^oC), fever persisting longer than 3 days, or recurrent fever.
• Caution is advised when use for:
  – The elderly and patients with haemorrhagic disorders, hypertension, and impaired renal, hepatic, or cardiac function;
  – Patients suffering from, or with a history of, bronchial asthma or allergic disease NSAIDs have been reported to precipitate bronchospasm;
  – Patient with systemic lupus erythematosus (SLE) and mixed connective tissue disease disorders there may be an increased risk of aseptic meningitis.
• 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).
• 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.
• Gastrointestinal (GI) bleeding, ulceration and perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events.
• The use of the product may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of the product should be considered.
• Partamol Extra contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• Partamol Extra contains the azo colouring agent e.g., sunset yellow, which may cause allergic reactions.
• Use Partamol Extra with caution in nursing women.
• Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected patients should not drive or operate machinery.