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CLOELITE-SP TABLETS
Aceclofenac 100 mg, Paracetamol 325 mg, Serratiopeptidase 15 mg Tablets I.P
PACKING SIZE / TYPE
10x10 Alu Alu Pack
Summary
CLOELITE-SP TABLETS is a combination medicine that consists of Aceclofenac, Paracetamol and Serratiopeptidase. It is used to relieve pain and swelling in conditions like muscle pain, joint pain, ankylosing spondylitis (a condition causing pain due to the fusing of bones in the spine), osteoarthritis (a type of arthritis that causes pain on movement due to wearing of the protective covering at the ends of the bones) and rheumatoid arthritis (a condition where the body's immunity attacks the joints and damages).
CLOELITE-SP TABLETS shows common side effects like nausea, vomiting, heartburn, stomach pain, loss of appetite, and diarrhoea. If any of these side effects persist for a long time, consult your doctor. Do not take this medicine if you are allergic to any components present in this medicine.
CLOELITE-SP TABLETS should be taken with food to avoid any stomach discomfort. The dose and duration will be decided by your doctor based on your condition and how well it relieves your symptoms.
CLOELITE-SP TABLETS may affect or get impacted by other medicines that you are taking. Hence, inform your doctor if you have peptic ulcers or liver/kidneys problems and about your ongoing medicines before taking this medicine.
CLOELITE-SP TABLETS may increase the side effects such as dizziness, drowsiness and stomach bleeding if taken with alcohol. Hence avoid consuming alcohol while using this medication. Consult your doctor before taking this medication if you are pregnant, planning a pregnancy or are breastfeeding.
Side Effects
Major & minor side effects for CLOELITE-SP TABLETS
- Nausea or vomiting
- Fever
- Allergic skin reaction
- Gastric / Mouth Ulcer
- Bloody and cloudy urine
- Anaemia
- Fatigue
- Diarrhoea
- Abdominal pain
- Constipation
Usage
What is it prescribed for?
Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a condition when your body's immune system attacks the lining of your joints. It may also affect other parts of your body. CLOELITE-SP TABLETS is used to relieve swelling and pain in the joints due to RA.
Swelling and pain
Inflammation or swelling is a part of your body's immune response to protect the body from infection, injury, or disease. CLOELITE-SP TABLETS works by helping the body in the breakdown of proteins that are present at the site of the swelling. Hence it is used to relieve swelling and pain associated with conditions due to muscle injury, post-surgery, joint pain, etc.
Post Immunization Pyrexia
CLOELITE-SP TABLETS is used to provide relief from the pain and fever that sets in after vaccinations.
Osteoarthritis
Osteoarthritis (OA) is the most common form of arthritis. OA develops when the protective cartilage between the joints breaks down, so joint bones begin to rub against one another. This can cause pain, stiffness, and make it difficult to walk, stand or perform other activities. CLOELITE-SP TABLETS is used to relieve pain and stiffness due to OA.
Ankylosing Spondylitis
Ankylosing spondylitis is a kind of arthritis that mainly affects the spine causing inflammation. Some symptoms that cause a decrease in spine flexibility are back and joint pain.CLOELITE-SP TABLETS is used to relieve stiffness and pain (especially in the lower back, hip, and pelvis) associated with ankylosing spondylitis.
Concerns
How long does it take for this medicine to take effect?
The pain-relieving effect of CLOELITE-SP TABLETS can be observed within an hour after taking it.
How long do the effects of this medicine last?
The amount of time for which CLOELITE-SP TABLETS remains active in the body is not known.
Is it safe to consume alcohol while taking this medicine?
Avoid consuming alcohol while using CLOELITE SP TABLETS as it may lower your blood pressure and can cause dizziness, gastrointestinal damage, headache and fluctuations in heart rate.
Is this a habit forming medicine?
No habit-forming tendencies were reported for CLOELITE-SP TABLETS.
Can this medicine be taken during pregnancy?
CLOELITE-SP TABLETS is not recommended for use during pregnancy due to increased risk of harmful effects on your foetus. Your physician may prescribe an alternative with the same therapeutic response.
Can this medicine be taken while breast-feeding?
You should avoid taking CLOELITE-SP TABLETS in breastfeeding, since traces of the medicine pass into breast milk and can affect your infant. Discuss the benefits and risks with your doctor before taking this medicine.
When not to use?
Allergy
Avoid taking CLOELITE-SP TABLETS if you are allergic to it. Serious allergic reactions to this medicine are rare. However, seek immediate medical attention if you notice any symptoms like skin rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, breathing difficulty, etc.
Kidney diseases
CLOELITE-SP TABLETS is not recommended for use if you have kidney problems. Long term use and higher doses of some painkillers may harm normal kidney function. Ask your doctor how this medicine affects your kidney function.
Severe liver disease
CLOELITE-SP TABLETS is not recommended for use if you have severe liver problems. This medicine gets broken down and absorbed in the liver. Therefore, if you take large amounts of this medicine, it may accumulate in your liver and may cause further damage.
NSAID-induced asthma
NSAID-induced asthma is an allergic condition of the respiratory system caused by the use of NSAIDs (Non-steroidal Anti-inflammatory Drugs). In this condition, there is a narrowing of the airways of your lungs leading to severe breathing difficulty. CLOELITE-SP TABLETS is not recommended for use if you have NSAID-induced asthma as it may worsen your condition.
Gastrointestinal bleeding
CLOELITE-SP TABLETS may cause stomach and intestinal bleeding and ulcers. Therefore, it is not recommended for use if you have gastrointestinal bleeding or perforation disorders since it may worsen your condition.
Peptic Ulcer
Avoid taking CLOELITE-SP TABLETS if you have a peptic ulcers. It could cause severe swelling and bleeding in the stomach, colon, or anus.
Cardiovascular disease
CLOELITE-SP TABLETS is not recommended for use if you have heart problems due to the increased risk of worsening your condition.
Warnings
Warnings for special population
Pregnancy
CLOELITE SP TAB is not recommended for use during pregnancy due to increased risk of harmful effects on your foetus. Your physician may prescribe an alternative with the same therapeutic response.
Breast-feeding
You should avoid taking CLOELITE SP TAB in breastfeeding, since traces of the medicine pass into breast milk and can affect your infant. Discuss the benefits and risks with your doctor before taking this medicine.
General warnings
Overdose
Never take more than the prescribed dose of CLOELITE SP TAB as it may cause liver damage. Seek emergency medical attention if an overdose of this medicine is suspected.
Chronic malnutrition
Malnutrition and fasting can increase the risk of CLOELITE SP TAB overdose. Your doctor will adjust the dose based on your body weight.
Long term use
Use of CLOELITE SP TAB for more than 4 weeks is not advised due to the lack of safety and efficacy data for long-term use.
Bleeding disorders
CLOELITE SP TAB may interfere with blood clotting and results in bleeding or bruising. Use it cautiously if you have bleeding disorders. Report any unusual bruising or bleeding to your doctor immediately. Your doctor may adjust the dose of this medicine or may prescribe a suitable alternative based on your clinical condition.
Surgeries
Stop taking CLOELITE SP TAB at least 10-14 days before a scheduled surgery as it may increase the risk of bleeding during and/or after the procedure.
Driving or operating machines
CLOELITE SP TAB may cause sleepiness or dizziness. Hence, avoid driving vehicles and operating heavy machines after taking this medicine.
Dosage
Missed Dose
If you forget to take a dose of CLOELITE-SP TABLETS at a scheduled time, take it as soon as you remember. However, if it is time for your next dose, skip the missed dose. Do not double the dose to make up for the missed one.
Overdose
Never take more than the prescribed dose. If you suspect that you might have taken an overdose of CLOELITE-SP TABLETS, seek immediate medical attention.
Interactions
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
Avoid consuming alcohol while using CLOELITE-SP TABLETS as it may lower your blood pressure and can cause dizziness, gastrointestinal damage, headache and fluctuations in heart rate.
Interaction with Medicine
- Carbamazepine
- Lithium
- Phenytoin
- Sodium Nitrite
- Leflunomide
- Prilocaine
- Digoxin
- Corticosteroids
- Aspirin
- Antihypertensives
Disease interactions
Alcoholism
CLOELITE-SP TABLETS should be used with extreme caution in people with chronic alcohol use due to the increased risk of severe liver damage. Report any unusual symptoms to the doctor immediately. Your doctor may adjust the dose of this medicine or may prescribe a suitable alternative based on your clinical condition.
Liver disease
Avoid taking CLOELITE-SP TABLETS if you have liver problems. This medicine can accumulate in the liver leading to further liver damage. Your doctor may suggest tests to monitor your liver functions while you are on treatment with this medication. Report any symptoms such as nausea, fever, rashes, dark urine, etc., to the doctor on priority. Your doctor may adjust the dose of this medicine or may prescribe a suitable alternative based on your clinical condition.
Bleeding disorders
CLOELITE-SP TABLETS should be used with extreme caution if you have any bleeding disorders due to the increased risk of worsening your condition. Report any unusual bruising or bleeding to your doctor immediately. Your doctor may adjust the dose of this medicine or may prescribe a suitable alternative based on your clinical condition.
Asthma
CLOELITE-SP TABLETS should be used with caution if you have asthma and if you are sensitive to NSAIDs (the medicines used to relieve pain and fever) as this medicine can trigger an asthma attack or cause allergic reactions like skin rashes, itching/swelling on your body, etc.
Gastro-Intestinal toxicity
Long term use of CLOELITE-SP TABLETS can cause damage to your stomach and intestine. Serious conditions like bleeding, ulceration, and perforation of the stomach or intestinal wall may occur. Report any unusual symptoms to the doctor immediately. Your doctor may adjust the dose of this medicine or may prescribe a suitable alternative based on your clinical condition.
Impaired kidney function
Prolonged use of high doses of CLOELITE SP TABLETS may cause kidney problems, such as painful urination and protein or blood in the urine. Your doctor may suggest tests to monitor your kidney functions while you are on treatment with this medication. Your doctor may adjust the dose of this medicine or may prescribe a suitable alternative based on your clinical condition.
Food interactions
Information not available.
Lab interactions
5-HIAA Urine Test
5-HIAA urine test measures the amount of serotonin (a key hormone that stabilizes our mood, feelings of well-being, and happiness) in the body. CLOELITE SP TABLETS can interfere with urine test and may give a false-positive result. Inform your doctor and lab technician about all your current medicines before undergoing any lab test.
This is not an exhaustive list of possible drug interactions. You should consult your doctor about all the possible interactions of the drugs you’re taking.
General Instructions
Take CLOELITE-SP TABLETS with food to avoid stomach irritation. Never take more than the prescribed dose.
It may cause dizziness and sleepiness. Do not drive or do anything that requires your mental focus until you know how CLOELITE-SP TABLETS affects you.
Avoid consuming alcohol while taking CLOELITE-SP TABLETS as it may cause excessive drowsiness and increase the risk of liver damage.
Avoid taking CLOELITE-SP TABLETS with any other medicine containing acetaminophen (a medicine used to relieve pain and fever) without consulting your doctor first.
Take CLOELITE-SP TABLETS at around the same time daily. Do not stop taking this medicine without consulting your doctor. Do not break, crush or chew the tablet in the mouth. take it immediately after peeling it from the strip.
Keep the medicine out of reach of children and pets. Do not use the medicine after the date of expiry. Ensure that the unused or expired medicine is disposed of properly.
Other Details
Miscelleneous
To be taken with food
To be taken as instructed by doctor
May cause sleepiness
How it works
CLOELITE-SP TABLETS is a combination of Aceclofenac, Paracetamol and Serratiopeptidase.
Paracetamol works by blocking the signals that are responsible for fever and pain.
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 the swelling.
Classification
Category
Non-steroidal anti-inflammatory agents, Miscellaneous analgesics
Schedule
Schedule H
References
CiplaMed. 2021. VOLTANEC SP Tablets. [online] Available at: < [Accessed 5 November 2021].
https://www.ciplamed.com/content/voltanec-sp-tablets>
Pubchem.ncbi.nlm.nih.gov. 2021. Aceclofenac. [online] Available at: < [Accessed 7 May 2021].
https://pubchem.ncbi.nlm.nih.gov/compound/Aceclofenac>
Drugs, H., 2021. Acetaminophen: MedlinePlus Drug Information. [online] Medlineplus.gov. Available at: < [Accessed 27 July 2021].
https://medlineplus.gov/druginfo/meds/a681004.html>
Pubchem.ncbi.nlm.nih.gov. 2021. Serrapeptase. [online] Available at: < [Accessed 8 April 2021].
https://pubchem.ncbi.nlm.nih.gov/substance/347911427>
Pubchem.ncbi.nlm.nih.gov. 2020. Acetaminophen. [online] Available at: < [Accessed 7 May 2021].
https://pubchem.ncbi.nlm.nih.gov/compound/Acetaminophen>
Medicines.org.uk. 2021. Aceclofenac 100 mg film-coated Tablets - Summary of Product Characteristics (SmPC) - (emc). [online] Available at: < [Accessed 2 August 2021].