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INTRODUCTION
ROLOSOL PLUS TABLET is a combination of Diclofenac, Paracetamol and Serratiopeptidase which belongs to the group of medicines called Nonsteroidal Anti-inflammatory Drugs (NSAID), Analgesics and Anti-pyrectics. It is used to relieve symptoms such as fever, pain and inflammation associated with musculoskeletal and joint disorders.
ROLOSOL PLUS 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.
ROLOSOL PLUS 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.
ROLOSOL PLUS TABLET is not recommended for use in children. It should be used with caution in elderly patients (aged 65 years or above). Consult your doctor before taking ROLOSOL PLUS TABLET.
The most common side effects of taking ROLOSOL PLUS TABLET are nausea, vomiting, stomach pain, diarrhoea, indigestion, flatulence and gastritis. Consult your physician if any of the side effects worsen during or after treatment with ROLOSOL PLUS TABLET.
USES OF ROLOSOL PLUS TABLET
- Relieves symptoms such as fever, pain and inflammation associated with musculoskeletal and joint disorders
HOW ROLOSOL PLUS TABLET WORKS
ROLOSOL PLUS TABLET helps to treat 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 centre in the brain) produces 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 which reduces inflammation and swelling in the affected area. It also breaks abnormal proteins at the site of inflammation and promotes healing. Together, relieves fever and pain effectively.
DIRECTIONS FOR USE
Take ROLOSOL PLUS TABLET as advised by your physician. Swallow ROLOSOL PLUS TABLET with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration of ROLOSOL PLUS TABLET for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF ROLOSOL PLUS TABLET
COMMON
- nausea, vomiting, stomach pain, diarrhoea, indigestion
- rash, itching
- flatulence, constipation, burping, gastritis (indigestion, stomachache, vomiting)
- ulcers in the stomach or intestines, bleeding/perforation, heartburn
- headache, dizziness, feeling sleepy
- difficulty in sleeping
- inflammation of the intestines causing nausea, diarrhoea and abdominal pain
- abnormal formation of 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 and 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 ROLOSOL PLUS 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 eye)
- symptoms of pancreatitis (inflammation of the pancreas, causing severe abdominal pain radiating to 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 body (paralysis) and slurred speech
- chest pain or heart failure or change in heart rate
- decrease in white blood cells and 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 in breathing
HOW TO MANAGE SIDE EFFECTS
Nausea or vomiting:
Take ROLOSOL PLUS TABLET with or just after meals. Stick to simple meals. Avoid eating oily, spicy or fried foods. Consult your doctor if nausea and vomiting 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 headache worsens.
Diarrhoea:
Drink lot of fluids such as water or fruit juices to keep yourself hydrated. Do not take any medicine on your own for treating diarrhoea. Consult your doctor if diarrhoea does not improve.
Constipation:
Eat fibre rich foods such as fresh fruits, vegetables and cereals. Drink more water and exercise regularly. Consult your doctor if constipation did not improve.
Stomach pain:
Rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heat pad on your stomach. Do not self-treat on your own and consult your doctor if the symptom does not improve.
WARNING & PRECAUTIONS
PREGNANCY
ROLOSOL PLUS TABLET is generally not recommended for use during pregnancy and in women planning for pregnancy. Consult your doctor before taking ROLOSOL PLUS TABLET.
BREASTFEEDING
ROLOSOL PLUS TABLET is not recommended for use in breastfeeding women as it may pass through the breast milk. Consult your doctor before taking ROLOSOL PLUS TABLET.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you experience dizziness or drowsiness after taking ROLOSOL PLUS TABLET.
ALCOHOL
Avoid consumption of alcohol while taking ROLOSOL PLUS TABLET as it may lead to unwanted effects.
KIDNEY
ROLOSOL PLUS 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 ROLOSOL PLUS TABLET.
LIVER
ROLOSOL PLUS 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 ROLOSOL PLUS TABLET.
ALLERGY
Do not take ROLOSOL PLUS TABLET if you are either allergic to diclofenac, paracetamol, serratiopeptidase, acetylsalicylic acid, misoprostol or other NSAIDs such as ibuprofen, naproxen.
LUNGS
ROLOSOL PLUS 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 ROLOSOL PLUS TABLET.
HEART DISEASE
ROLOSOL PLUS 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 ROLOSOL PLUS TABLET.
OTHERS
ROLOSOL PLUS TABLET is not recommended for use if you have:
- active peptic ulcer, bleeding (blood in stools, vomiting blood) or 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 ROLOSOL PLUS 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
Use in paediatrics:
ROLOSOL PLUS TABLET is not recommended for use in children. Consult your child’s doctor for advice.
Use in geriatrics:
ROLOSOL PLUS TABLET should be used with caution in elderly patients (aged 65 years or above). Consult your doctor before taking ROLOSOL PLUS TABLET.
INTERACTIONS
A. Drug-Drug interactions:
Before taking ROLOSOL PLUS TABLET, inform your doctor if you are taking any of the following medicines:
- aspirin or ibuprofen (medicines used to treat pain)
- corticosteroids such as (used to treat inflammation)
- methotrexate, imatinib (used to treat cancer)
- cyclosporine, tacrolimus (medicines used to prevent rejection of transplanted organ)
- lithium (medicines used to treat mania)
- enalapril, furosemide, propranolol (medicines used for high blood pressure and heart diseases)
- mifepristone (medicines used for abortion)
- ciprofloxacin, trimethoprim, 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 prevent platelet aggregation)
- selective serotonin reuptake inhibitors (SSRIs) Ex. fluoxetine, sertraline (medicines used to treat depression)
- antidiabetics such as (medicines used to treat diabetes mellitus)
- ketoconazole, fluconazole, miconazole and voriconazole (medicines used to treat fungal infections)
- digoxin (medicines used for heart failure)
- phenytoin (medicines used to treat fits)
- potassium-sparing drugs Ex. spironolactone (medicines used to treat high blood pressure)
- magnesium-containing antacids (medicines used to treat heartburn)
- sulfinpyrazone (used to treat gout)
- amiodarone (medicines used to treat heart rhythm disorders)
- warfarin (medicines used to treat or to prevent blood clots)
Overdosage:
If you or anyone else accidentally take too much of ROLOSOL PLUS TABLET, consult your doctor immediately or visit the nearby hospital. Overdosage symptoms of ROLOSOL PLUS TABLET includes headache, nausea, vomiting, diarrhoea, 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
- Keep ROLOSOL PLUS TABLET out of reach of children
- Store ROLOSOL PLUS TABLET at room temperature
FAQs ABOUT ROLOSOL PLUS TABLET
What is ROLOSOL PLUS TABLET and why is it prescribed?
ROLOSOL PLUS TABLET is a combination of Diclofenac, Paracetamol and Serratiopeptidase which belongs to the group of medicines called Nonsteroidal Anti-inflammatory Drugs (NSAID), Analgesics and Anti-pyrectics. It is used to relieve symptoms such as fever, pain and inflammation associated with musculoskeletal and joint disorders.
What are the common side effects of taking ROLOSOL PLUS TABLET?
The most common side effects of taking ROLOSOL PLUS TABLET are nausea, vomiting, stomach pain, diarrhoea, indigestion, ulcers in the stomach or intestines, bleeding/perforation, heartburn, etc. Consult your physician if any of the side effects worsen.
Does ROLOSOL PLUS TABLET cause bleeding?
Yes, ROLOSOL PLUS TABLET may increase the risk of bleeding, ulceration and perforation in stomach and intestine and it is not recommended for use in patients with history or active gastric or intestinal ulcer, bleeding (blood in stools, vomiting blood) or perforation. Consult your doctor before taking ROLOSOL PLUS TABLET.
Can ROLOSOL PLUS TABLET be used in patients with liver problems?
ROLOSOL PLUS 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 ROLOSOL PLUS TABLET.
Is ROLOSOL PLUS TABLET safe to use in pregnant women?
No, ROLOSOL PLUS 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.
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 27th June 2022] 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 27th June 2022] 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 2nd July 2022] https://www.ciplamed.com/content/cipzen-d-plus-tablets
5. Painwell-SP. (Diclofenac, Paracetamol and Serratiopeptidase). Wellona Pharma. [Accessed on 2nd July 2022] https://wellonapharma.com/product/finished/diclofenac-potassium-paracetamol-and-serratiopeptidase-tablets
6. Volvib-Plus. (Diclofenac, Paracetamol and Serratiopeptidase). Vibcare. [Accessed on 2nd July 2022] https://vibcare.co.in/diclofenac-paracetamol-serratiopeptidase/
USEFUL DIAGNOSTIC TESTS
- Liver function test
- Kidney function test
AUTHOR DETAILS
Written By Dr. R. Dinesh John Rajkumar, Pharm.D
Last updated on 29 Nov 2022 | 12:01 PM(IST)
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.