Essmol 3 PLUS Side effects
Gastrointestinal: The most commonly-observed adverse events are gastrointestinal in nature.
Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely.
Hypersensitivity: Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
Cardiovascular and Cerebrovascular: Edema, HTN and cardiac failure have been reported in association with NSAID treatment.
Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long-term treatment) may be associated with an increased risk of arterial thrombotic events.
The majority of adverse reactions reported have been reversible and of a minor nature. The most frequent are gastrointestinal disorders, in particular dyspepsia, abdominal pain, nausea and diarrhea, and occasional occurrence of dizziness. Edema, HTN and cardiac failure have been reported in association with NSAID treatment.
Investigations: Abnormal hepatic enzyme and serum creatinine levels have also been reported.
Other adverse reactions reported less commonly include: Renal: Nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome and renal failure.
Hepatic: Abnormal liver function, hepatitis and jaundice.
Neurological and Special Senses: Visual disturbances, optic neuritis, headaches, paresthesia, reports of aseptic meningitis with symptoms eg, stiff neck, headache, nausea, vomiting, fever or disorientation, depression, confusion, hallucinations, tinnitus, vertigo, dizziness, malaise, fatigue and drowsiness.
Hematological: Agranulocytosis, aplastic anemia and hemolytic anemia.
Dermatological: Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare). Photosensitivity.
If serious adverse reactions occur, Aceclofenac (Essmol 3 PLUS) should be withdrawn.
The following is a table of adverse reactions reported during clinical studies and after authorization, grouped by system-organ class and estimated frequencies.
Hypersensitivity to aceclofenac or any of the excipients of Aceclofenac (Essmol 3 PLUS). Not to be given to those patients who have history of: Shock (cerebrovascular accident); heart attack (myocardial infarction); coronary artery bypass graft; congestive heart failure (CHF) NYHA II-IV.
Active or history of recurrent peptic ulcer/hemorrhage (≥2 distinct episodes of proven ulceration or bleeding).
Patients who have previously shown hypersensitivity reactions (eg, asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin or other NSAIDs. Severe heart failure, hepatic failure and renal failure.
History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
Use in Children: There are no clinical data in children and therefore it is not recommended for use in children <18 years.
Use in Pregnancy: Congenital abnormalities have been reported in association with NSAID administration in man; however, these are low in frequency and do not appear to follow any discernible pattern. In view of the known effects of NSAIDs on the fetal cardiovascular system (risk of closure of the ductus arteriosus) and on the possible risk of persistent pulmonary hypertension (HTN) of the new born, use in the last trimester of pregnancy is contraindicated. The regular use of NSAIDs during the last trimester of pregnancy may decrease uterine tone and contraction. The onset of labor may be delayed and the duration increased with an increased bleeding tendency in both mother and child. NSAIDs should not be used during the first 2 trimesters of pregnancy or labor unless the potential benefit to the patient outweighs the potential risk to the fetus.
Animal studies indicate that there was no evidence of teratogenesis in rats although the systemic exposure was low and in rabbits, treatment with aceclofenac (10 mg/kg/day) resulted in a series of morphological changes in some fetuses.
Aceclofenac should not be prescribed during pregnancy, especially during the last trimester of pregnancy, unless there are compelling reasons for doing so. The lowest effective dosage should be used.
Get emergency medical help if you have any of these signs of an allergic reaction to Paracetamol (Essmol 3 PLUS): hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:
low fever with nausea, stomach pain, and loss of appetite;
dark urine, clay-colored stools; or
jaundice (yellowing of the skin or eyes).
This is not a complete list of Paracetamol (Essmol 3 PLUS) side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Effects due to the presence of acetylsalicylic acid.
Accidents awareness with respiratory or skin reactions (angioedema, urticaria, asthma, anaphylactic shock);
Cross hypersensitivity reactions with NSAIDs and with tartrazine;
At low doses recommended for the use of Paracetamol (Essmol 3 PLUS), side effects of aspirin are generally limited to some irritation of the gastro-intestinal tract.
At higher doses, side effects include gastrointestinal mucosal erosions, gastric ulcer or duodenal ulcer, occult blood loss, melena.
Acetylsalicylic acid may also increase the tendency to bleeding and bleeding time (the lengthening of bleeding continues 4-6 days after stopping the drug).
It may also worsen renal function including cases of pre-existing condition (the long-term use can cause chronic kidney disease).
The signs of salicylic overdose described under.
Effects due to the presence of Paracetamol (Essmol 3 PLUS).
At the doses and duration of recommended treatment, side effects are usually negligible, but the prolonged use of Paracetamol (Essmol 3 PLUS) in therapeutic doses large (2-4 g per day, or 10-20 tablets Paracetamol (Essmol 3 PLUS)) may cause the appearance chronic hepatitis. This justifies the recommendations of caution especially in patients with liver disease prior.
Very rarely, it can produce thrombocytopenia.
The acute liver toxicity in overdose massive (doses greater than 8 g of Paracetamol (Essmol 3 PLUS)) is described in paragraph overdose.
There are many brands and forms of Paracetamol (Essmol 3 PLUS) available and not all brands are listed on this leaflet.
Do not use more of this medication than is recommended. An overdose of Paracetamol (Essmol 3 PLUS) can cause serious harm. The maximum amount of Paracetamol (Essmol 3 PLUS) for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more Paracetamol (Essmol 3 PLUS) could cause damage to your liver. If you drink more than three alcoholic beverages per day, talk to your doctor before taking Paracetamol (Essmol 3 PLUS) and never use more than 2 grams (2000 mg) per day.
Do not use this medication without first talking to your doctor if you drink more than three alcoholic beverages per day or if you have had alcoholic liver disease (cirrhosis). You may not be able to use Paracetamol (Essmol 3 PLUS).
Before using Paracetamol (Essmol 3 PLUS), tell your doctor if you have liver disease or a history of alcoholism.
Do not use any other over-the-counter cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. Paracetamol (Essmol 3 PLUS) is contained in many combination medicines. If you use certain products together you may accidentally use too much Paracetamol (Essmol 3 PLUS). Read the label of any other medicine you are using to see if it contains Paracetamol (Essmol 3 PLUS), acetaminophen or APAP. Avoid drinking alcohol while taking this medication. Alcohol may increase your risk of liver damage while taking Paracetamol (Essmol 3 PLUS).
Paracetamol (Essmol 3 PLUS) should not be used in patients who have previously exhibited hypersensitivity to aspirin and/or nonsteroidal antiinflammatory agents. Paracetamol (Essmol 3 PLUS) should not be given to patients with a recent history of gastrointestinal bleeding or in patients with bleeding disorders (e.g., hemophilia).
Abnormal blood cell, Blisters on skin, Diarrhoea, Shortness of breath, Nausea, Skin redness, Vomiting, Running nose, Liver damage
There are no reviews yet. Be the first to write one!
Information checked by Dr. Sachin Kumar, MD Pharmacology