CLOELITE - TH 4

10X10 ALU ALU PACK

CLOELITE – TH Tablet is a combination of Aceclofenac and Thiocolchicoside. It is a painkiller medicine that provides relief from the pain associated with muscle spasms such as low back pain, neck pain, sprains/strains, etc. It works by relaxing your muscles and preventing muscle contraction. It also prevents the release of a chemical substance that causes pain and swelling in your body.

CLOELITE – TH  Tablet can cause side effects such as nausea, vomiting, heartburn, stomach pain, diarrhoea, and sleepiness. These effects are mild and subside by themselves. Contact your doctor if they last for a long time or if they become severe.

CLOELITE – TH Tablet can be taken with food to avoid stomach irritation. Your doctor will determine the dose and duration of treatment depending on the severity of your health condition. For the ease of remembering and better results, take it at around the same time every day. Avoid taking it for a longer duration than prescribed by your doctor as it may lead to undesired effects.

CLOELITE – TH Tablet is not recommended for use if you are allergic to it. Use it cautiously if you have heart, liver, and/or kidney problems. CLOELITE – TH Tablet is not recommended in children below 16 years of age. Consult your doctor if you are pregnant, planning a pregnancy, or are breastfeeding before taking this medicine.

Major & minor side effects for CLOELITE – TH Tablet

• Itching and skin rash
• Swelling of face, lips, eyelids, tongue, hands and feet
• Drowsiness
• Nausea and Vomiting
• Diarrhoea
• Yellowing of skin and eyes
• Dry mouth
• Headache
• Stomach pain
• Heartburn
• Loss of appetite
• Dizziness

What is it prescribed for?

Muscle spasm with acute pain

CLOELITE – TH Tablet is used to treat pain and swelling due to contraction of the muscle. It is used in conditions such as muscle pain, low back pain, neck pain, sprain/strains, etc. It is also used to relieve pain due to bone and joint conditions like ankylosing spondylitis (pain and stiffness of bones of the spine), osteoarthritis (tender and painful joints due to wear down of protective cartilage between the ends of the bones), rheumatoid arthritis (swelling and pain in the small joints of your body), etc. v

Commonly asked questions

How long does it take for this medicine to take effect?

The amount of time required for CLOELITE – TH Tablet to show its action is not clinically established.

How long do the effects of this medicine last?

The amount of time for which CLOELITE – TH Tablet remains active in your body is not clinically established.

Is it safe to consume alcohol while taking this medicine?

Avoid consumption of alcohol while taking CLOELITE – TH Tablet as it may increase the risk of side effects such as stomach and intestinal bleeding, and excessive drowsiness.

Is this a habit forming medicine?

No habit-forming tendencies were reported for CLOELITE – TH Tablet.

Can this medicine be taken during pregnancy?

CLOELITE – TH Tablet is not recommended for use during pregnancy as it may harm your foetus. Hence, consult your doctor if you are pregnant.

Can this medicine be taken while breast-feeding?

CLOELITE – TH Tablet is not recommended while breastfeeding as it may pass into breastmilk. Hence, consult your doctor if you are breastfeeding before taking this medicine.

Allergy

Avoid taking CLOELITE – TH Tablet if you are allergic to it. Serious allergic reactions to this medicine are rare. However, seek immediate medical attention if you notice any symptoms such as skin rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, breathing difficulty, etc.

Gastrointestinal bleeding

Peptic ulcers are sores on the lining of your stomach and intestine. It may further lead to bleeding in the stomach and intestine. The symptoms are blood in stools/vomit, black coloured stool, and cramps in the stomach. CLOELITE – TH Tablet is not recommended for use if you have active or a history of peptic ulcers and bleeding as it may worsen your condition.

Severe Liver/Kidney Impairment

CLOELITE – TH Tablet is not recommended for use if you have severe liver and/or kidney problems. This medicine may further damage your liver and/or kidneys and worsen your condition.

Asthma

Asthma is a condition in which your airways narrow and cause breathing difficulty. CLOELITE – TH Tablet is not recommended for use if you have a history of asthma after taking NSAIDs (non-steroidal anti-inflammatory medicines like Paracetamol, Ibuprofen, Aspirin, Aceclofenac, etc.).

Warnings for special population

Pregnancy

CLOELITE – TH Tablet is not recommended for use during pregnancy as it may harm your foetus. Hence, consult your doctor if you are pregnant.

Breast-feeding

CLOELITE – TH Tablet is not recommended while breastfeeding as it may pass into breastmilk. Hence, consult your doctor if you are breastfeeding before taking this medicine.

General warnings

Other medicines

Inform your doctor about all your current medicines including herbs and supplements to avoid the chances of possible interaction with CLOELITE – TH Tablet.

Driving or operating machines

CLOELITE – TH Tablet may cause drowsiness and/or dizziness. Hence, avoid performing activities that require high mental alertness such as driving vehicles or operating heavy machines if you experience such symptoms after taking the medicine.

Use in children

CLOELITE – TH Tablet is not recommended for use in children below 18 years of age due to lack of safety and efficacy data.

Use in women of childbearing potential

Women of childbearing potential should use effective contraceptive measures to avoid pregnancy during treatment with CLOELITE – TH Tablet. A pregnancy test should be done to rule out pregnancy before beginning the treatment. If pregnancy is suspected during treatment, consult your doctor for further guidance.

Impairment of fertility in men

CLOELITE – TH Tablet may cause damage to sperm cells and lead to fertility problems in men. Therefore, discuss all the risks and benefits with your doctor before taking this medicine.

Missed Dose

Try not to skip the scheduled dose of CLOELITE – TH Tablet. If you miss a dose, take it as soon as you remember. If it is time for the 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 of CLOELITE – TH Tablet. Seek emergency medical attention in case of overdose for further guidance.

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 consumption of alcohol while taking CLOELITE – TH Tablet as it may increase the risk of side effects such as stomach and intestinal bleeding, and excessive drowsiness.

Interaction with Medicine

• Lithium
• Digoxin
• Corticosteroids
• Antihypertensives
• Warfarin

Disease interactions

Gastro-Intestinal toxicity

Avoid long term use of CLOELITE – TH Tablet as it may cause damage to your stomach and intestine. Conditions like bleeding, ulceration (sores in the lining of your stomach and intestine), and perforation (holes that form in the walls of the stomach and intestine) can occur. Any symptom indicating ulceration and bleeding like chronic indigestion, the appearance of coffee coloured dry blood in stool or vomiting of blood should be reported to your doctor immediately.

Impaired kidney function

Use CLOELITE – TH Tablet with caution if you have kidney problems. Prolonged use of high doses of this medicine may further damage your kidneys. Hence, your doctor may suggest tests to closely monitor your kidney function while taking this medicine.

Heart Disease

Avoid long-term use of a high dose of CLOELITE – TH Tablet if you have pre-existing heart conditions like heart failure (a condition in which your heart is unable to pump a sufficient amount of blood), ischaemic heart diseases (heart problems due to narrowing of the blood vessels that supply oxygen to the heart), etc. This medicine may cause fluid retention (abnormal build-up of fluid in the body) and also increase the risk of a heart attack. Consult your doctor before taking this medicine.

Impaired liver function

Use CLOELITE – TH Tablet with caution if you have pre-existing liver problems due to the increased risk of side effects. It may also cause further liver damage. Your doctor may suggest tests to closely monitor your liver function while taking this medicine.

Food interactions

Information not available.

Lab interactions

Information not available.

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.

Take CLOELITE – TH Tablet with food to avoid stomach irritation. Do not break, chew or crush the tablet.

Avoid taking more or less than the prescribed dose. Take this medicine for the recommended duration. Avoid the discontinuation of this medicine without consulting your doctor as your symptoms may come back.

Avoid consuming alcohol while taking this medicine as it may make you feel dizzy or sleepy and also increase the risk of stomach bleeding.

Miscelleneous

To be taken with food

To be taken as instructed by doctor

May cause sleepiness

How it works

CLOELITE – TH Tablet is a combination of Aceclofenac and Thiocolchicoside. It is effective in relieving pain and swelling associated with muscle spasms.

Aceclofenac works by reducing the formation of certain substances in your body that cause pain and swelling.

Thiocolchicoside works on your brain and spinal cord centre to prevents muscle contractions. Thus, it provides relief from muscle spasms.

Legal Status

Approved

Unknown

Unknown

Unknown

Classification

Category

Nonsteroidal anti-inflammatory agents, Muscle relaxants, Analgesics

Schedule

Schedule H

Iasispharma.com. 2021. [online] Available at: < [Accessed 20 September 2021].

https://iasispharma.com/wp-content/uploads/pdf/RELIEF_PIL_ENG.pdf>

Ema.europa.eu. 2021. [online] Available at: < [Accessed 20 September 2021].

http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Thiocolchicoside-containing_medicines/WC500155449.pdf>

Dailymed.nlm.nih.gov. 2021. DailyMed - CLANZA CR- aceclofenac tablet, film coated. [online] Available at: < [Accessed 20 September 2021].

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

Medicines.org.uk. 2021. Aceclofenac 100 mg Film-coated Tablets - Summary of Product Characteristics (SmPC) - (emc). [online] Available at: < [Accessed 20 September 2021].

https://www.medicines.org.uk/emc/medicine/32903#productinfo>

European Medicines Agency. 2021. European Medicines Agency recommends restricting use of thiocolchicoside by mouth or injection -. [online] Available at: < [Accessed 1 September 2021].

https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-restricting-use-thiocolchicoside-mouth-injection>

Hospitals, M., 2021. Aceclofenac | Side Effects | Dosage | Precautions | Medicine. [online] Medicoverhospitals.in. Available at: < [Accessed 27 August 2021].

https://www.medicoverhospitals.in/medicine/aceclofenac>

Medicines.org.uk. 2021. [online] Available at: < [Accessed 20 September 2021].

https://www.medicines.org.uk/emc/files/pil.2389.pdf>