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*10 Tablet(s) in a Strip * Mkt: Rubrics Healthcare Pvt Ltd * Country of Origin: India * Delivery charges if applicable will be applied at checkout


INTRODUCTION

RETROFLAM SP TABLET is a combination of Aceclofenac, Paracetamol, and Serratiopeptidase which belongs to a group of medicines called Nonsteroidal anti-inflammatory agents, Analgesics & Antipyretics, and Proteolytic enzymes, respectively. It is used to provide relief from inflammation and pain due to bone and soft tissue injury in affected individuals.

It is also used to reduce high temperature and provide relief from cold (while sneezing) in affected individuals. The medicine is also indicated for use to resolve post operative inflammation, oedema, and pain which is also used to provide relief from illnesses such as headache, moderate migraine, and musculoskeletal pain.

RETROFLAM SP TABLET is not recommended for use in patients allergic to aceclofenac, paracetamol, serratiopeptidase. It is also not recommended for use in patients having active/recurrent peptic ulcer/hemorrhage (bleeding), severe heart, liver or kidney diseases. 

Before taking RETROFLAM SP TABLET, inform your doctor if you suffer from uncontrolled high blood pressure, diabetes, hyperlipidaemia (high fat level in blood), gastrointestinal diseases such as ulcerative colitis (inflammatory bowel disease), and/or aseptic meningitis (inflammation of brain).

RETROFLAM SP TABLET is not recommended for use in pregnant and breastfeeding women. It is also not recommended for use in children and adolescents (below 18 years). Consult your doctor before taking the medicine.

The most common side effects of taking RETROFLAM SP TABLET are abdominal pain, nausea, vomiting, diarrhea, flatulence, constipation, indigestion, and/or dizziness. Consult and inform your doctor if any of these symptoms gets worse.

USES OF RETROFLAM SP TABLET

  • Provides relief from inflammation and pain due to bone and soft tissue injury in affected individuals.
  • Reduces fever and provides relief from cold (while sneezing) in affected individuals.
  • Reduces post operative inflammation, oedema, and pain which also provides relief from illnesses such as headache, moderate migraine, and musculoskeletal pain

HOW RETROFLAM SP TABLET WORKS

RETROFLAM SP TABLET helps to reduce inflammation and provides relief from pain, where Aceclofenac and Paracetamol reduces pain and fever by blocking certain chemical messengers in the brain, and Serratiopeptidase promote healing by breaking down abnormal proteins at the site of inflammation thereby healing the infected site in affected individuals.

DIRECTIONS FOR USE

Take RETROFLAM SP TABLET as advised by your physician. Swallow RETROFLAM SP TABLET with a glass of water and do not chew or crush the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF RETROFLAM SP TABLET

COMMON

  • abdominal pain, nausea, vomiting, diarrhea, flatulence, constipation, indigestion
  • dizziness, drowsiness
  • stomach upset
  • lack of appetite

UNCOMMON

  • inflammation of stomach
  • inflamed skin, itchy skin, red itchy welts, rash
  • nephrotoxicity (deterioration of kidney due to drugs) that includes interstitial nephritis (kidney disorder), nephritic syndrome (kidney disease marked by blood in urine) and renal failure
  • abnormal liver function, inflamed liver and signs of jaundice such as yellowing of eyes. skin
  • neurological effects such as visual disturbances, optic neuritis (inflammation of optic nerve of eye), headaches, paraesthesia(abnormal sensation), reports of aseptic meningitis (inflammation of brain) especially in patients with existing autoimmune disorders, such as sle and mixed connective tissue disorders with symptoms( such as stiff neck, headache, nausea, vomiting, fever or disorientation, depression, confusion, hallucinations, tinnitus, vertigo, dizziness, malaise, fatigue and drowsiness)
  • hematological effects such as thrombocytopenia (low platelet level), neutropenia (low white blood cell count), agranulocytosis (condition marked by inability to make white blood cell), aplastic anemia (bone marrow disorder) and haemolytic anemia (red blood cell count)

RARE

  • signs of exfoliative and bullous dermatoses (autoimmune skin disorder) including epidermal necrolysis and erythema multiforme such as lesions that crust over, areas of thickened skin, fever, weakness.
  • anemia, signs of vasculitis (inflammation of blood vessel) such as fever, weakness, weight loss
  • signs of anaphylactic reaction (life threatening allergic reaction) such as lightheadedness, wheezing, fast heartbeat
  • face swelling, visual disturbance, shortness of breath
  • skin rash with disease/fever.

Stop taking RETROFLAM SP TABLET and contact your doctor if you experience any of the following side effects:                                               

  • signs of serious skin reactions (exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis) such as skin rash, mucosal lesions

HOW TO MANAGE SIDE EFFECTS

Constipation

Try to eat high-fiber foods such as vegetables, cereals, fresh fruit, and drink plenty of water. Involve in regular exercise (going for a daily walk or run) and if this does not help, consult and inform your doctor for receiving alternate treatments for constipation.

Diarrhea

Drink plenty of water and stay hydrated. Try to avoid taking any medicine on your own to treat diarrhea. Consult your doctor and inform them if the symptom gets worse.

Dizziness Or Drowsiness

Try to rest and get enough sleep. Try to avoid driving or operating any tools or machines while you feel dizzy. Limit consumption of alcohol, as it can aggravate dizziness. Consult and inform your doctor if the symptom worsens.

Indigestion

Try to have smaller and more frequent meals and drink slowly. Reduce consumption of coffee, cola, tea, or alcohol and lose weight if you are obese.  Try to avoid smoking and don’t have rich, fatty or spicy foods. Consult your doctor and inform if the symptom does not improve.

Nausea And Vomiting

Try to take RETROFLAM SP TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult and inform your doctor if the symptom gets worse.

WARNING & PRECAUTIONS

PREGNANCY
Contraindicated

RETROFLAM SP TABLET is not recommended for use in pregnant women. Consult your doctor before taking the medicine.

BREASTFEEDING
Contraindicated

RETROFLAM SP TABLET is not recommended for use in breast-feeding women as it may pass through the breast milk. Consult your doctor before taking the medicine.

DRIVING AND USING MACHINES
Use with Caution

Do not drive or operate any machines as you may feel dizzy after taking RETROFLAM SP TABLET.

ALCOHOL
Use with Caution

Avoid consumption of alcohol while taking RETROFLAM SP TABLET as it may cause liver damage.

KIDNEY
Contraindicated

RETROFLAM SP TABLET is not recommended for use in patients with moderate and severe renal impairment. Consult your doctor before taking the medicine.

LIVER
Contraindicated

RETROFLAM SP TABLET is not recommended for use in patients with severe liver impairment. It should be used with caution in patients having liver disease such as mild to moderate hepatic impairment, hepatic porphyria (genetic disorder). Consult your doctor before taking the medicine.

ALLERGY
Use with Caution

Do not take RETROFLAM SP TABLET if you are allergic to Aceclofenac, Paracetamol, Serratiopeptidase, and/or any other ingredients of this medicine.

LUNGS
Use with Caution

RETROFLAM SP TABLET should be used with caution in patients having or had a history of bronchial asthma.  Consult your doctor before taking the medicine.

HEART DISEASE
Contraindicated

RETROFLAM SP TABLET is not recommended for use in patients with severe heart disease. It should be used with caution in patients having mild-to-moderate congestive heart failure, ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease. Consult your doctor before taking the medicine.

OTHERS

RETROFLAM SP TABLET is not recommended for use if you:

  • have a history of or active, recurrent peptic ulcer or hemorrhage (bleeding)
  • have previously shown hypersensitive reactions to ibuprofen, aspirin or other NSAIDs
  • have a previous history of anaphylactic reaction (life threatening reaction)
  • suffer from severe hypertension (high blood pressure).

Before taking RETROFLAM SP TABLET, inform your doctor if you:

  • have uncontrolled high blood pressure
  • have diabetes
  • are a smoker
  • suffer from hyperlipidemia (condition marked by high fat level in blood)
  • have gastrointestinal bleeding, ulceration/perforation
  • have gastrointestinal diseases such as ulcerative colitis (inflammatory bowel disease)
  • have systemic lupus erythematosus (autoimmune disorder)
  • have mixed connective tissue disorders such as scleroderma, and polymyositis
  • have aseptic meningitis (inflammation of brain)
  • have bleeding disorders such as hemophilia, von willebrand disease,
  • have signs of cerebrovascular bleeding such as sudden severe headache, seizures
  • are on diuretic therapy (common treatment for high blood pressure)

Use in Pediatrics:

RETROFLAM SP TABLET is not recommended for use in children and adolescents (below 18 years). Consult your doctor before taking it.

Use in Geriatrics:

RETROFLAM SP TABLET should be used with caution in elderly patients. Consult your doctor before taking RETROFLAM SP TABLET.

INTERACTIONS

A. Drug-Drug Interactions:

Before taking RETROFLAM SP TABLET, inform your doctor, if you are taking any of the following medicine:

  • other nsaids (medicines used to relieve pain and reduce fever) Ex. aspirin, naproxen, rofecoxib (cox-2 selective inhibitors), ibuprofen, diclofenac
  • antihypertensives (medicines used to treat high blood pressure) Ex. atenolol, metoprolol
  • diuretics (to treat blood pressure) ex. chlorothiazide, chlorthalidone.
  • cardiac glycosides (used to treat heart failure and certain irregular heartbeats) Ex.  digoxin
  • lithium (used to treat mood disorders)
  • methotrexate (used to treat inflammatory conditions such as rheumatoid arthritis)
  • ciclosporin (used to prevent organ rejection)
  • mifepristone (used to end a pregnancy that is less than 70 days in duration)
  • corticosteroids (provide relief for inflamed areas of the body) Ex. cortisone, prednisone, prednisolone.
  • anticoagulants (help to prevent blood clots) such as warfarin, rivaroxaban, dabigatran
  • quinolone antibiotics (used for treating a variety of bacterial infections)
  • tacrolimus (used to treat moderate to severe atopic dermatitis)
  • zidovudine (used to slow the progression of disease in patients infected with hiv)
  • antidiabetic agents (used to treat diabetes) Ex. biguanides, sulfonylureas
  • barbiturates (used to treat seizure disorder)
  • other anticonvulsants ((used to treat seizure disorder) Ex. acetazolamide, carbamazepine
  • probenicid (used to treat chronic gout or gouty arthritis)
  • chloramphenicol (used to treat bacterial infections)
  • antiepileptic drugs (used to treat epilepsy) Ex. phenytoin, phenobarbital, carbamazepine
  • rifampicin (used to treat tuberculosis)
  • st john's wort (herbal medicine used to treat depression)
  • clopidogrel (medicine used to prevent heart attacks and strokes)
  • dalteparin (used to prevent serious or life-threatening complications from angina (chest pain) and heart attacks
  • enoxaparin (used to prevent deep venous thrombosis)
  • heparin (used to to prevent or treat certain blood vessel, heart, and lung conditions)

Overdosage:

If you or anyone else accidentally takes too much of RETROFLAM SP TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are headache, pallor, nausea, vomiting, epigastric pain, gastrointestinal irritation & bleeding, diarrhea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, hypotension, respiratory depression, fainting, convulsions, anorexia and/or abdominal pain.

SYNOPSIS

Drug :   Aceclofenac, Paracetamol, Serratiopeptidase
Pharmacological Category :   Nonsteroidal anti-inflammatory drugs, Analgesics  & Antipyretics, and Proteolytic enzymes
Therapeutic Indication :   Pain relief
Dosage Forms :   Tablet, Capsule

MORE INFORMATION

  • Keep the medicine out of reach in children
  • Store RETROFLAM SP TABLET at room temperature

FAQs ABOUT RETROFLAM SP TABLET

Q. What RETROFLAM SP TABLET is used for?

A. RETROFLAM SP TABLET is used to provide relief from inflammation and pain due to bone and soft tissue injury which is also used to reduce fever and provide relief from cold (while sneezing) in affected individuals. The medicine is also indicated for use to resolve post operative inflammation, oedema, and pain which is also used to provide relief from illnesses such as headache, moderate migraine, and musculoskeletal pain in affected individuals.

Q. Who should avoid taking RETROFLAM SP TABLET ?

A. RETROFLAM SP TABLET is not recommended for use in patients allergic to aceclofenac, paracetamol, and serratiopeptidase, It is also not recommended for use in patients having active/recurrent peptic ulcer/hemorrhage (bleeding), severe heart, liver or kidney disease, pregnant & breastfeeding women, It is also not indicated for use in children and adolescents (aged below 18 years).

Q. What are the side effects of RETROFLAM SP TABLET?

A. The most common side effects of taking RETROFLAM SP TABLET are abdominal pain, nausea, vomiting, diarrhea, flatulence, constipation, indigestion, and/or dizziness. Consult and inform your doctor if any of these symptoms gets worse.

Q. What happens if you take more RETROFLAM SP TABLET than your required dose?

A. If you or anyone else accidentally takes too much of RETROFLAM SP TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are liver damage, headache, pallor, nausea, vomiting, epigastric pain, gastrointestinal irritation & bleeding, diarrhea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, hypotension, respiratory depression, fainting, convulsions, anorexia and abdominal pain.

Q. Can RETROFLAM SP TABLET be taken by pregnant or breastfeeding women?

A. No, RETROFLAM SP TABLET is not recommended for use in pregnant and breastfeeding women since it may affect the fetus and nursing child.. Consult your doctor before taking this medicine.

REFERENCES

1. KD. Tripathi. Aspects of Pharmacotherapy, Clinical Pharmacology and Drug Development and Nonsteroidal Antiinflammatory Drugs & Antipyretic-Analgesics, Seventh edition, 2013. Page – 71, 204 & 206

2. Manju Tiwari. The role of serratiopeptidase in the resolution of inflammation. NIH National Library of Medicine. National Center for Biotechnology Information. PMC PubMed Central. [Revised in May 2017] [Accessed on 21st June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7032259/

3. CiplaMed. VOLTANEC SP Tablets [Revised in November 2013] [Accessed on 21st June 2022] https://www.ciplamed.com/content/voltanec-sp-tablets

4. Laboratories BTT. Electronic medicines compendium (EMC). [Revised in January 2016] [Accessed on 21st June 2022] https://www.medicines.org.uk/emc/files/pil.2389.pdf

5. Narankaa Pharma. ACEDUOZ. [Accessed on 21st June 2022] http://www.narankaapharma.com/img/p/ace-b.jpg

6. Aden Healthcare.Kedac SP. [Accessed on 21st June 2022] https://www.adenhealthcare.com/product/acelofenac-100mg-paracetamol-500mg-serratiopeptidase-10mg

7. Chemo Healthcare Pvt. Ltd. ACIKY-SP TABS. [Accessed on 21st June 2022] https://chemohealthcare.com/Products1.html#Ana

USEFUL DIAGNOSTIC TESTS

  • Blood tests, CRP tests
  • Kidney function test
  • Liver function test

AUTHOR DETAILS

Written By Dr. K .AZEEM HUSSAIN, B.D.S
Last updated on 25 Jan 2023 | 06:57 PM(IST)

PRODUCT DETAILS

    Country Of Origin
    India
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The contents of this website are for informational purposes only and not intended to be a substitute for professional medical advice, diagnosis, or treatment. Please seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition. Do not disregard professional medical advice or delay in seeking it because of something you have read on this website.