Respiratory Disorders
Patients suffering from or with a history of inflammatory lung disease are at an increased risk when using this medicine. Aceclofenac+Paracetamol have been reported to accelerate spasm of a bronchial smooth muscle in such patients. The patient should be cautious when using Aceclofenac+Paracetamol in patients suffering from or with a history of inflammatory lung disease.
Liver Damage
Patient taking
alcohol (more than 3 drinks) every day, an adult taking a dose of more than 4000 mg in 24 hours are at an increased risk. Also, a child taking > 5 doses in 24 hours and if taken with other drugs containing paracetamol are at a higher risk when using these medicines. If paracetamol is taken more than the recommended dose, it can cause liver damage. Due to large doses of paracetamol allergic reactions such as swelling of the face, throat, and mouth, breathing difficulty, a rash may happen.
Heart and Brain Disorders
Patients with heart disease (e.g. high blood pressure, high level of
cholesterol, high sugar level,
smoking) are at an increased risk while using this medicine. Use of Aceclofenac+Paracetamol (at high doses and in long term treatment) may lead to a small increased risk of blood clot disorders (e.g heart attack or
stroke), fluid retention and swelling. Patients with uncontrolled high blood pressure, heart failure, established heart disease, peripheral arterial disease, or heart disease should be treated only after careful monitoring. The patient should be careful before starting long-term therapy in patients with risk factors for heart disease.
Stomach & Intestinal Disorders
Elderly patients, patients with a history of
ulcer (especially
hemorrhage or perforation) are at higher risk when using this medicine. There is a risk of stomach and intestine disorders, which can be fatal any time during treatment. Patients should be cautious when receiving Aceclofenac+Paracetamol in combination with oral
corticosteroids,
anticoagulants, antiplatelet agents, and
SSRIs. Monitoring patients with stomach-intestinal disorders, colon inflammation, or blood disorders as it may get worse. Patients who are at increased risk should start their treatment on a low dose and with protective agents. Therapy with Aceclofenac+Paracetamol should be discontinued if stomach and intestine
bleeding occurs.
Mixed Connective Tissue Disorders
Patients with mixed connective tissue disorders including systemic
lupus erythematosus (
SLE) are at an increased risk when using this medicine. These patients may have a risk of inflammation of the brain linings.
Skin Related Disorders
Patients who were using Aceclofenac+Paracetamol in the first month of treatment are at highest risk for these reactions. Serious skin reactions including redness and scaling of the skin have been reported rarely with the use of Aceclofenac+Paracetamol. There is a risk of severe liver damage when doses are higher than the recommended one. Discontinue the drug at the first sign of skin rash, mucosal lesions, or any allergic reaction. Perform liver function tests if liver damage is suspected.
Allergic Reactions
Allergic reactions may occur without exposure to the drug with any of the
NSAIDs including Aceclofenac+Paracetamol.
Blood Disorders
Aceclofenac+Paracetamol use can block clumping of
platelets.
Long-term Treatment
Patients with an abnormality of heart, liver or functioning of kidneys and elderly patients are at an increased risk while using this medicine. Precaution should be taken in patients who are at increased risk of suffering from conditions such as coagulation disorders, history of stomach
ulcers. Also from inflammation of the digestive tract,
pregnancy, and
lactation,
bleeding in the brain, skin or nerve problems having enzyme deficiency in the liver. Caution is also needed in patients on
diuretic or at risk of decreased blood volume. Patients receiving prolonged therapy should be monitored regularly for liver function, functioning of kidneys tests, and blood counts.
