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Introduction About DEROFEN SP TABLET

DEROFEN SP TABLET is a combination of Diclofenac, Paracetamol, and Serratiopeptidase, which belongs to the group of medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs), Analgesics, and Anti-pyrectics. It is used to relieve symptoms such as fever, pain, and inflammation associated with musculoskeletal and joint disorders.

DEROFEN SP TABLET is not recommended for use in patients with asthma (aspirin-sensitive asthma), urticaria or acute rhinitis precipitated by aspirin or other NSAIDs, severe liver disease or kidney disease, severe congestive heart failure, ischemic heart disease (heart attack), blockages of blood vessels to the heart, and in patients with history or active peptic ulcer, bleeding (blood in stools, vomiting blood) or perforation or active gastrointestinal bleeding.

DEROFEN SP TABLET should be used with caution in patients with pre-existing asthma, seasonal allergic rhinitis, nasal polyps, chronic obstructive pulmonary disease or chronic infections of the respiratory tract, mild to moderate congestive heart failure, and high blood pressure.

DEROFEN SP TABLET is not recommended for use in children. It should be used with caution in elderly patients (aged 65 years or older). Consult your doctor before taking DEROFEN SP TABLET.

The most common side effects of taking DEROFEN SP TABLET are nausea, vomiting, stomach pain, diarrhea, indigestion, flatulence, and gastritis. Consult your physician if any of the side effects worsen during or after management with DEROFEN SP TABLET.

Uses Of DEROFEN SP TABLET

Relieves symptoms such as fever, pain, and inflammation associated with musculoskeletal and joint disorders

How DEROFEN SP TABLET Works

DEROFEN SP TABLET helps to manage pain, where Diclofenac inhibits COX-1 and COX-2 and blocks the production of prostaglandins (which are responsible for pain), while paracetamol works by decreasing fever by acting on the hypothalamus (heat-regulation center in the brain) and producing peripheral vasodilation, resulting in increased blood flow through the skin, sweating, and heat loss. It also increases the pain threshold by inhibiting COX-1 and COX-2 enzymes, and serratiopeptidase is an anti-inflammatory agent that reduces inflammation and swelling in the affected area. It also breaks abnormal proteins at the site of inflammation and promotes healing. Together, they relieve fever and pain effectively.

How to use DEROFEN SP TABLET

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

Side Effects Of DEROFEN SP TABLET

Common

Nausea, vomiting, stomach pain, diarrhea, indigestion
Rash, itching
Flatulence, constipation, burping, gastritis (indigestion, stomach ache, vomiting)
Ulcers in the stomach or intestines, bleeding/perforation, heartburn
Headache, dizziness, feeling sleepy
Difficulty sleeping
Inflammation of the intestines causing nausea, diarrhea, and abdominal pain
Abnormal formation of the foetus

Uncommon

Swelling of the mouth
Urticaria
Drowsiness, tiredness, shakiness
Oedema (fluid retention in the body causing swelling of legs and feet)
Bleeding from the vagina, menstrual disturbances like heavy or light bleeding, and delayed periods
Purpura (purple spots on the skin)
Infection of the vagina (itching, burning, soreness, pain during intercourse, or urination)
Blurred vision
Depression and anxiety
High blood pressure
Fever, chills, loss of appetite
Ulcers in mouth, dryness of mouth
Vertigo or tinnitus (ringing in ears)
Pricking or tingling sensation (pins and needles)

Rare

Inflammation of the lungs causing coughing and increased sputum
Breast pain
Vomiting blood
Worsening of ulcerative colitis
Damage to the gullet
Swelling of the tongue
Low blood pressure
Hair loss
Increased sensitivity to light
Nightmares

Stop taking DEROFEN SP TABLET and contact your physician immediately if you experience any of the following side effects:

Symptoms of liver damage or elevated liver enzymes such as fever, chills, headache, rash, anorexia, nausea, vomiting, fatigue, right upper quadrant pain, dark urine, or jaundice (yellowish discolouration of skin and whites of the eye).
Symptoms of pancreatitis (inflammation of the pancreas, causing severe abdominal pain radiating to the back)
Severe allergic reactions such as skin rash, reddening, blisters, swelling of the hands, feet, ankles, face, lips, or throat, which may cause difficulty in swallowing or breathing or wheezing, or anaphylactic shock (collapse)
Swelling of the hands, feet, ankles, face, lips, or throat, which may cause difficulty in swallowing or breathing
Symptoms of stroke such as weakness or inability to move one side of the body (paralysis) and slurred speech
Chest pain, heart failure, or change in heart rate
A decrease in white blood cells can lead to infections with symptoms such as fever, chills, sore throat, or flu-like symptoms
Passing black or bloodstained stools or vomiting blood and severe stomach pain due to bleeding or hole formation in the stomach or intestines.
Symptoms of Stevens-Johnson syndrome, exfoliative dermatitis, and toxic epidermal necrolysis such as rash, blistering, or peeling of the skin
Symptoms of meningitis such as neck stiffness, headache, nausea, vomiting, fever, or loss of consciousness
Difficulty breathing

How To Manage Side Effects

Constipation

Eat fiber-rich foods such as fresh fruits, vegetables, and cereals. Drink more water and exercise regularly. Consult your doctor if constipation did not improve.

Diarrhea

Drink a lot of fluids, such as water or fruit juices, to keep yourself hydrated. Do not take any medicine on your own for managing diarrhea. Consult your doctor if diarrhea does not improve.

Headache

Rest and relax. Drink plenty of fluids, such as water or electrolytes, and apply a pain-relieving balm on the forehead if necessary. Do not consume alcohol. Consult your doctor if the headache worsens.

Nausea And Vomiting

Take DEROFEN SP TABLET with or just after meals. Stick to simple meals. Avoid eating oily, spicy, or fried foods. Consult your doctor if nausea and vomiting do not improve.

Stomach Pain

Rest and relax. Eat and drink slowly or try to have smaller and more frequent meals. Keep a heat pad on your stomach. Do not self-manage on your own and consult your doctor if the symptom does not improve.

Warning & Precautions

Pregnancy

Contraindicated

DEROFEN SP TABLET is generally not recommended for use during pregnancy and in women planning for pregnancy. Consult your doctor before taking DEROFEN SP TABLET.

Breastfeeding

Contraindicated

DEROFEN SP TABLET is not recommended for use in breastfeeding women as it may pass through the breast milk. Consult your doctor before taking DEROFEN SP TABLET.

Driving and Using Machines

Contraindicated

Do not drive or operate any machines if you experience dizziness or drowsiness after taking DEROFEN SP TABLET.

Alcohol

Contraindicated

Avoid consumption of alcohol while taking DEROFEN SP TABLET, as it may lead to unwanted effects.

Kidney

Consult your doctor

DEROFEN SP TABLET is not recommended for use in patients with severe kidney disease. It should be used with caution in patients with impaired kidney function. Consult your doctor before taking DEROFEN SP TABLET.

Liver

Consult your doctor

DEROFEN SP TABLET is not recommended for use in patients with severe liver disease. It should be used with caution in patients with impaired liver function. Consult your doctor before taking DEROFEN SP TABLET.

Allergy

Contraindicated

Do not take DEROFEN SP TABLET if you are either allergic to diclofenac, paracetamol, serratiopeptidase, acetylsalicylic acid, misoprostol, or other NSAIDs such as ibuprofen or naproxen.

Lungs

Consult your doctor

DEROFEN SP TABLET is not recommended for use in patients with asthma (aspirin-sensitive asthma), acute rhinitis precipitated by aspirin, or other NSAIDs and should be used with caution in patients with pre-existing asthma, seasonal allergic rhinitis, nasal polyps, chronic obstructive pulmonary diseases, or chronic infections of the respiratory tract. Consult your doctor before taking DEROFEN SP TABLET.

Heart Disease

Consult your doctor

DEROFEN SP TABLET is not recommended for use in patients with severe congestive heart failure, ischemic heart disease (heart attack), blockages of blood vessels to the heart, and in the setting of coronary artery bypass graft surgery (CABG). It should be used with caution in patients with impaired cardiac function, mild to moderate congestive heart failure, and high blood pressure. Consult your doctor before taking DEROFEN SP TABLET.

Use In Pediatrics

Contraindicated

DEROFEN SP TABLET is not recommended for use in children. Consult your child’s doctor for advice.

Use In Geriatrics

Use with Caution

DEROFEN SP TABLET should be used with caution in elderly patients (aged 65 years or above). Consult your doctor before taking DEROFEN SP TABLET.

Others

DEROFEN SP TABLET is not recommended for use if you have:

Active peptic ulcer, bleeding (blood in stools, vomiting blood), perforation, or active bleeding such as gastro-intestinal bleeding or cerebrovascular bleeding
Urticaria due to acetylsalicylic acid or other NSAIDs
Peripheral arterial disease (problems with blood circulation)
Inflammation of the intestines, such as ulcerative colitis or Crohn’s disease
Cerebrovascular disease (stroke) such as stroke, mini-stroke (TIA), or blockages of blood vessels to the brain
Dehydration problems

Before taking DEROFEN SP TABLET, inform your doctor if you have:

Low body weight
Systemic lupus erythematosus (SLE)
Mixed connective tissue disorders
Have aseptic meningitis
Blood clotting disorders or haematological abnormalities
Allergic to other substances such as skin reactions, pruritus, or urticaria
Hyperlipidaemia
Diabetes mellitus
Smoking habit

Interactions

A. Drug-Drug interactions:

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

Aspirin or ibuprofen (medicines used to manage pain)
Corticosteroids such as (used to manage inflammation)
Methotrexate, imatinib (used to manage cancer)
Cyclosporine, tacrolimus (medicines used to manage rejection of transplanted organs)
Lithium (medicines used to manage mania)
Enalapril, furosemide, and propranolol (medicines used for high blood pressure and heart diseases)
Mifepristone (medicines used for abortion)
Ciprofloxacin, trimethoprim, and chloramphenicol (medicines used for bacterial infections)
Metoclopramide and domperidone (medicines used for nausea and vomiting)
Colestipol and cholestyramine (medicines used to decrease high cholesterol levels)
Zidovudine (medicines used for HIV infection)
Anti-platelet agents Ex. aspirin (medicines used to manage platelet aggregation)
Selective serotonin reuptake inhibitors (SSRIs) Ex. fluoxetine, sertraline (medicines used to manage depression)
Antidiabetics such as (Ex. glimepiride)
Ketoconazole, fluconazole, miconazole, and voriconazole (medicines used to manage fungal infections)
Digoxin (medicines used for heart failure)
Phenytoin (medicines used to manage fits)
Potassium-sparing drugs Ex. spironolactone (medicines used to manage high blood pressure)
Magnesium-containing antacids (medicines used to manage heartburn)
Sulfinpyrazone (used to manage gout)
Amiodarone (medicines used to manage heart rhythm disorders)
Warfarin (medicines used to manage or to manage blood clots)

Overdosage:

If you or anyone else accidentally take too much of DEROFEN SP TABLET, consult your doctor immediately or visit the nearby hospital. Overdosage symptoms of DEROFEN SP TABLET include headache, nausea, vomiting, diarrhea, epigastric pain, gastrointestinal bleeding, dizziness, disorientation, excitation, coma, drowsiness, tinnitus, fainting, occasionally convulsions, acute kidney failure, and liver damage.

Synopsis

Drug	:	Diclofenac, Paracetamol, and Serratiopeptidase
Pharmacological Category	:	Nonsteroidal Anti-inflammatory Drugs, Analgesics, and Anti-pyrectics
Therapeutic Indication	:	Relieves fever, pain, and inflammation
Dosage Forms	:	Tablet

More Information

Storage

Keep DEROFEN SP TABLET out of reach of children
Store DEROFEN SP TABLET at room temperature

FAQs About DEROFEN SP TABLET

Q: What is DEROFEN SP TABLET and why is it prescribed?

A: DEROFEN SP TABLET is a combination of Diclofenac, Paracetamol, and Serratiopeptidase, which belongs to the group of medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs), Analgesics, and Anti-pyrectics. It is used to relieve symptoms such as fever, pain, and inflammation associated with musculoskeletal and joint disorders.

Q: What are the common side effects of taking DEROFEN SP TABLET?

A: The most common side effects of taking DEROFEN SP TABLET are nausea, vomiting, stomach pain, diarrhea, indigestion, ulcers in the stomach or intestines, bleeding/perforation, and heartburn. Consult your physician if any of the side effects worsen.

Q: Does DEROFEN SP TABLET cause bleeding?

A: Yes, DEROFEN SP TABLET may increase the risk of bleeding, ulceration, and perforation in the stomach and intestine, and it is not recommended for use in patients with a history of an active gastric or intestinal ulcer, bleeding (blood in stools, vomiting blood), or perforation. Consult your doctor before taking DEROFEN SP TABLET.

Q: Can DEROFEN SP TABLET be used in patients with liver problems?

A: DEROFEN SP TABLET is not recommended for use in patients with severe liver disease. It should be used with caution in patients with impaired liver function. Consult your doctor before taking DEROFEN SP TABLET.

Q: Is DEROFEN SP TABLET safe to use in pregnant women?

A: No. DEROFEN SP TABLET is generally not recommended for use during pregnancy and in women planning for pregnancy. Consult your doctor for advice before taking this medicine if you are pregnant or planning to get pregnant.

Q: Does DEROFEN SP TABLET cause constipation?

A: Yes, DEROFEN SP TABLET may cause constipation in some individuals. Eat fiber-rich foods such as fresh fruits, vegetables, and cereals. Drink more water and exercise regularly. Consult your doctor if constipation did not improve.

Q: How does DEROFEN SP TABLET work?

A: DEROFEN SP TABLET helps to relieve pain, where Diclofenac inhibits COX-1 and COX-2 and blocks the production of prostaglandins (which are responsible for pain), while paracetamol works by decreasing fever by acting on the hypothalamus (heat-regulation center in the brain) and producing peripheral vasodilation, resulting in increased blood flow through the skin, sweating, and heat loss. It also increases the pain threshold by inhibiting COX-1 and COX-2 enzymes, and serratiopeptidase is an anti-inflammatory agent that reduces inflammation and swelling in the affected area. It also breaks abnormal proteins at the site of inflammation and promotes healing. Together, they relieve fever and pain effectively.

Q: Can I take DEROFEN SP TABLET during kidney disease?

A: DEROFEN SP TABLET is not recommended for use in patients with severe kidney disease. It should be used with caution in patients with impaired kidney function. Consult your doctor before taking.

Q: How do you take DEROFEN SP TABLET?

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

Q: Is DEROFEN SP TABLET safe for kids?

A: DEROFEN SP TABLET is not recommended for use in children. Consult your child’s doctor for advice.

References

1. K.D. Tripathi. NSAIDs and Antipyretic-Analgesics. Essentials of Medical Pharmacology. Seventh Edition. 2013. Page – 204, 206.

2. Bethesda (MD). Diclofenac. National Institute of Health. NLM. National Centre for Biotechnology Information. PubChem Compound Summary. 2004. [Accessed on 17th July 2024] https://pubchem.ncbi.nlm.nih.gov/compound/3033

3. Bethesda (MD). Paracetamol. National Institute of Health. NLM. National Centre for Biotechnology Information. PubChem Compound Summary. 2004. [Accessed on 17th July 2024] https://pubchem.ncbi.nlm.nih.gov/compound/1983

4. Cipla Ltd. Cipzen-d-plus (Diclofenac, Paracetamol, and Serratiopeptidase). Ciplamed. [Revised in January 2020] [Accessed on 17th July 2024] https://www.ciplamed.com/product-index/cipzen-d-plus-tablets

5. Painwell-SP. (Diclofenac, Paracetamol, and Serratiopeptidase). Wellona Pharma. [Accessed on 17th July 2024] https://wellonapharma.com/product/finished/diclofenac-potassium-paracetamol-and-serratiopeptidase-tablets

6. Volvib-Plus. (Diclofenac, Paracetamol, and Serratiopeptidase). Vibcare. [Accessed on 17th July 2024] https://vibcare.co.in/diclofenac-paracetamol-serratiopeptidase/

Useful Diagnostic Tests

Complete Blood Count (CBC)/ Hemogram
Liver Function Test (LFT)
Kidney Function Test (KFT)
Rheumatoid Factor (RF)/RA Test Rheumatoid Arthritis Factor, Qualitative
Basic Arthritis Care
Comprehensive Arthritis Care
Advance Bone Care
Bone Strength Package
Bone Profile – Advanced
Advanced Arthritis Care
Autoimmune Arthritis Panel

Author Details

Written By Dr. N. Sai Swaroop - Pharm.D

Reviewed For Accuracy By Dr. Sankara Babu Gorle - MBBS, MD (Pharmacology)

Last updated on 18 Jul 2024 | 04:38 PM(IST)

Lab updated