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Trofenac-SP Tablet

Manufactured byELINOR PHARMACEUTICALS PVT LTD
ContainsAceclofenac (100 mg) + Paracetamol (325 mg) + Serratiopeptidase (10 mg)
Description

Trofenac-SP Tablet is a combination of medicine that may be used to relieve symptoms such as fever, mild to moderate pain, swelling, redness, etc. associated with conditions such as osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, headache, toothache, surgeries, etc. This medicine should be used with caution in patients suffering from liver diseases due to the increased risk of severe adverse effects.

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Side effects

Major & minor side effects for Trofenac-SP Tablet

  • Nausea or Vomiting
  • Fever
  • Allergic skin reaction
  • Gastric / Mouth Ulcer
  • Bloody and cloudy urine
  • Anemia
  • Fatigue
  • Diarrhea
  • Abdominal pain
  • Constipation

Uses of Trofenac-SP Tablet

What is it prescribed for?

  • Fever
  • Mild to Moderate pain
  • Post Immunization Pyrexia
  • Inflammation and edema
Read More
Concerns

Commonly asked questions

  • Onset of action
    The pain-relieving effect of this medicine can be observed within an hour of administration. For fever reduction, the time taken to show the effect is about 30 minutes.
  • Duration of effect
    The amount of time for which this medicine remains active in the body is not clinically established.
  • Safe with alcohol?
    Consumption of alcohol is not recommended during treatment with this medicine due to the increased risk of serious side effects such as severe gastrointestinal bleeding, dizziness, fatigue, weakness, rashes, nausea, joint pain, fever, jaundice, etc.
  • Is it habit forming?
    No habit-forming tendencies were reported.
  • Usage in pregnancy?
    This medicine is not recommended for use in pregnant women unless absolutely necessary. All the risks and benefits should be discussed with the doctor before taking this medicine.
  • Usage while breast-feeding?
    This medicine is not recommended for use in breastfeeding women unless absolutely necessary. All the risks and benefits should be discussed with the doctor before taking this medicine.

Allergy

This medicine is not recommended for use in patients with a known allergy to paracetamol, aceclofenac, serratiopeptidase, any other NSAIDs, any other proteolytic enzymes, or any other inactive ingredients present along with these medicines.

Analgesic Nephropathy (Kidney Disease)

This medicine is not recommended for use in patients suffering from kidney diseases associated with the excessive use of painkillers.

Severe liver impairment

This medicine is not recommended for use in patients suffering from a severe impairment of liver function due to the increased risk of worsening of the patient's condition.

NSAID-induced asthma

This medicine is not recommended for use in patients suffering from NSAID-sensitive asthma due to the increased risk of worsening of the patient's condition.

Gastrointestinal bleeding

This medicine is not recommended for use in patients with a known history of gastrointestinal bleeding due to the increased risk of worsening of the patient's condition.

Peptic Ulcer

This medicine is not recommended for use in patients with peptic ulcer disease due to the increased risk of worsening of the patient's condition.

Severe renal impairment

This medicine is not recommended for use in patients with a severe kidney function impairment due to the increased risk of serious adverse effects.

Cardiovascular Disease

This medicine is not recommended for use in patients with a known history of severe cardiovascular diseases due to the increased risk of worsening of the patient's condition.
Warnings for special population

Pregnancy

This medicine is not recommended for use in pregnant women unless absolutely necessary. All the risks and benefits should be discussed with the doctor before taking this medicine.

Breast-feeding

This medicine is not recommended for use in breastfeeding women unless absolutely necessary. All the risks and benefits should be discussed with the doctor before taking this medicine.
General warnings

Overdose

Read the label carefully before consuming this medicine to avoid overdosage. An overdose of this medicine may cause liver damage. Seek emergency medical attention if an overdose of this medicine is suspected.

Liver Disease

This medicine should be used with extreme caution in patients suffering from liver function impairment or active liver diseases due to the increased risk of severe adverse effects. Close monitoring of liver function is necessary while receiving this medicine. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition.

Chronic Malnutrition

This medicine should be used with extreme caution in patients suffering from malnourishment due to the increased risk of severe adverse effects. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition.

Long term use

Use of this medicine for more than 4 weeks is not advised since the safety and efficacy of long-term use are not clinically established.

Bleeding disorders

This medicine should be used with extreme caution in patients with any bleeding disorders due to the increased risk of excessive bleeding. Report any unusual bruising or bleeding to the doctor immediately. Appropriate dose adjustments or replacement with a suitable alternative may be necessary based on the clinical condition.

Surgeries

The use of this medicine should be stopped at least 10-14 days before a scheduled surgery since it may increase the risk of bleeding during and/or after the procedure.

Gastro-intestinal bleeding

This medicine may cause severe gastrointestinal bleeding and perforation after prolonged usage. These adverse events may occur with or without warning symptoms. This risk is especially higher in the elderly population and in patients with a history of gastrointestinal diseases. Appropriate dose adjustments or replacement with a suitable alternative may be required based on the clinical condition.

Impaired kidney function

This medicine should be used with caution in patients suffering from kidney diseases due to the increased risk of severe adverse effects. Close monitoring of kidney function, appropriate dose adjustments, or replacement with a suitable alternative may be required in some cases based on the clinical condition.

Driving or Operating machinery

Use of this medicine may cause symptoms such as dizziness, drowsiness, etc. in some patients. It is advised that you do not perform any activities such as driving a vehicle or operating machinery if you experience any of these symptoms during treatment with this medicine.

Missed Dose

The missed dose should be taken as soon as you remember. It is advisable to skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up for the missed dose.

Overdose

Seek emergency medical treatment or contact the doctor in case of an overdose.
All drugs interact differently for person to person. You should check all the possible interactions with your doctor before starting any medicine.
Interaction with Alcohol

Description

N/A

Instructions

Consumption of alcohol is not recommended during treatment with this medicine due to the increased risk of serious side effects such as severe gastrointestinal bleeding, dizziness, fatigue, weakness, rashes, nausea, joint pain, fever, jaundice, etc.
Interaction with Medicine

Carbamazepine

Lithium

Phenytoin

Sodium Nitrite

Leflunomide

Prilocaine

Digoxin

Corticosteroids

Aspirin

Antihypertensives

Disease interactions

Alcoholism

This medicine should be used with extreme caution in patients with chronic alcohol use due to the increased risk of serious liver injuries. Close monitoring of liver function is recommended for such patients. Report any unusual symptoms to the doctor immediately. Appropriate dose adjustments or replacement with a suitable alternative may be required based on the clinical condition of the patient.

Liver Disease

This medicine should be used with extreme caution in patients with liver function impairment or active liver diseases due to the increased risk of severe adverse effects. Close monitoring of liver function is necessary while receiving this medicine. Report any symptoms such as nausea, fever, rashes, dark urine, etc. to the doctor on priority. Appropriate dose adjustments or replacement with a suitable alternative may be required based on the clinical condition.

Bleeding disorders

This medicine should be used with extreme caution in patients with any bleeding disorders due to the increased risk of excessive bleeding. Report any unusual bruising or bleeding to the doctor immediately. Appropriate dose adjustments or replacement with a suitable alternative may be necessary based on the clinical condition.

Asthma

This medicine is not recommended for use in patients with a known history of NSAID-sensitive asthma. Replacement with a suitable alternative should be done under your doctor's supervision.

Gastro-Intestinal toxicity

This medicine may cause damage to the stomach, intestines, liver, etc., especially on prolonged use. Report any symptoms such as chronic indigestion, blood in stool or vomit, etc. to the doctor immediately. Appropriate dose adjustments or replacement with a suitable alternative may be required based on the clinical condition.

Impaired kidney function

This medicine should be used with caution in patients with kidney diseases due to the increased risk of severe adverse effects. Close monitoring of kidney function, appropriate dose adjustments, or replacement with a suitable alternative may be required based on the clinical condition.
Food interactions
Information not available.
Lab interactions

5-HIAA Urine Test

You may get a false-positive result for this test while taking this medicine. It is advised that you inform the doctor and lab technician about all your current medicines including herbs and supplements before undergoing any lab tests.
Take this medicine exactly as prescribed by the doctor. Do not take in larger or smaller quantities than recommended. Do not take this medicine for longer durations than recommended. Report any unusual symptoms to the doctor immediately. Do not stop the use of this medicine without consulting your doctor.
Miscelleneous

To be taken with food

To be taken as instructed by doctor

May cause sleepiness

How it works
Paracetamol increases the pain threshold and decreases swelling; it also brings down an elevated body temperature. Aceclofenac works by reducing the formation of certain substances in the body that causes pain and swelling. Serratiopeptidase reduces swelling and redness through the breakdown of proteins present at the site of swelling.
Legal Status

Unknown

Unknown

Unknown

Unknown

Classification

Category

Nonsteroidal anti-inflammatory agents, Miscellaneous analgesics

Schedule

Schedule H

[Internet]. Dailymed.nlm.nih.gov. 2017 [cited 2 March 2017]. Available from:

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a023942-01e8-4849-aa3c-1a640ffc7fd3

Acetaminophen | C8H9NO2 - PubChem [Internet]. Pubchem.ncbi.nlm.nih.gov. 2017 [cited 22 February 2017]. Available from:

https://pubchem.ncbi.nlm.nih.gov/compound/1983#section=Top

Acetaminophen: MedlinePlus Drug Information [Internet]. Medlineplus.gov. 2017 [cited 22 September 2017]. Available from:

https://medlineplus.gov/druginfo/meds/a681004.html

Serrapeptase | Ca7Zn+16 - PubChem [Internet]. Pubchem.ncbi.nlm.nih.gov. 2017 [cited 13 April 2017]. Available from:

https://pubchem.ncbi.nlm.nih.gov/compound/72941625#section=Top
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Information on this page was last updated on 5 Sep 2018

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