What are the ingredients in Breclomol Tablet #10?
Aceclofenac BP (100 mg), Paracetamol BP (500 mg), Serratiopeptidase (15 mg), and excipients.
Aceclofenac: Inhibits prostaglandin production by blocking COX enzymes.
Paracetamol: Reduces prostaglandin production in the CNS, though its exact mechanism is unknown.
Serratiopeptidase: Breaks down proteins, reducing inflammation by decreasing capillary permeability and promoting wound healing.
Resolution of inflammation due to bone and soft tissue injuries, and resolution of post-operative pain, inflammation, and edema.
Patients with hypersensitivity to the ingredients.
Active or recurrent peptic ulcers/haemorrhage.
Severe heart failure, hepatic failure, or renal failure.
History of gastrointestinal bleeding or perforation related to previous NSAID therapy.
Pregnant women, especially in the last trimester.
Aceclofenac: Gastrointestinal problems, hypersensitivity reactions, cardiovascular effects, renal problems, hepatic problems, neurological problems.
Paracetamol: Hypersensitivity reactions, blood dyscrasias, methaemoglobenaemia.
Serratiopeptidase: Hypersensitivity, diarrhea, nausea, vomiting, epistaxis, haemoptysis.
Use the lowest effective dose for the shortest duration possible.
Avoid concomitant use with other NSAIDs.
Caution required in patients with asthma, hypertension, or congestive heart failure.
Close monitoring for patients with gastrointestinal disease.
May impair female fertility and not recommended in women attempting to conceive.
Avoid use during breastfeeding unless benefits outweigh risks.
Elderly are at increased risk of adverse reactions.
Careful monitoring required in patients with renal or hepatic impairment.
Oral administration.
Adults: one tablet twice daily.
Children under 6: not recommended unless prescribed by a doctor.
Dosage may need to be adjusted in patients with renal or hepatic impairment.
Aceclofenac: Interacts with various medications including antihypertensives, diuretics, cardiac glycosides, lithium, methotrexate, cyclosporine, mifepristone, corticosteroids, anticoagulants, quinolone antibiotics, anti-platelet agents, SSRIs, tacrolimus, zidovudine, and other NSAIDs.
Paracetamol: Interacts with cholestyramine, metoclopramide, domperidone, warfarin, and chloramphenicol.
Serratiopeptidase: May potentiate anticoagulant effects.
Seek immediate medical attention. Treatment usually includes activated charcoal, gastric lavage, and other measures based on the severity.
Store in a dry place below 30°C, protected from light, and out of reach of children.