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Simvotin EZ 20 Tablet
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Simvotin EZ 20 Tablet

Manufactured bySun Pharma Laboratories Ltd.
ContainsSimvastatin (20 mg) + Ezetimibe (10 mg)
Description
Simvotin EZ 20 Tablet is a combination medicine used for the treatment of primary hypercholesterolemia, a condition characterized by high levels of cholesterol in the blood. Patients are advised to maintain a strict exercise and diet regimen along with this medicine to get the best possible effect. This medicine is not recommended for use in the patients below 10 years of age.
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Side effectsConcernsUsageRelated products

Side effects

Major & minor side effects for Simvotin EZ 20 Tablet

  • Dizziness
  • Fast heartbeat
  • Dark colored urine
  • Muscle or joint pain
  • Sweating
  • Headache
  • Acid or sour stomach
  • Excessive air or gas in stomach
  • Heartburn
  • Skin Rash
  • Sore throat
  • Runny Nose
  • Sneezing
  • Itching
  • Loss of appetite
  • Fever
  • Cough
  • Nausea and Vomiting

Uses of Simvotin EZ 20 Tablet

What is it prescribed for?

  • Primary Hypercholesterolemia
  • Hyperlipidemia
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Concerns

Commonly asked questions

  • How long does it take for this medicine to take effect?
    The amount of time required for this medicine to show its action is not clinically established.
  • How long do the effects of this medicine last?
    The amount of time for which this medicine remains active in the body is not clinically established.
  • Is it safe to consume alcohol while taking this medicine?
    Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.
  • Is this a habit forming medicine?
    No habit-forming tendencies were reported.
  • Can this medicine be taken during pregnancy?
    This medicine is not recommended for use in pregnant women due to the increased risk of fetal harm. Your doctor may prescribe a safer alternative based on your clinical condition.
  • Can this medicine be taken while breast-feeding?
    This medicine is not recommended for use in breastfeeding women. Your doctor may prescribe a safer alternative based on your clinical condition.

Allergy

This medicine is not recommended for use in patients with a known allergy to simvastatin, ezetimibe, or any other inactive ingredients present along with these medicines.

Impaired Liver function

This medicine is not recommended for use in patients with active liver diseases or any abnormality in the liver function tests due to the increased risk of severe adverse effects. It is also not recommended for use in patients with a moderate-to-severe liver function impairment due to the increased risk of worsening of the patient's condition.
Warnings for special population

Pregnancy

This medicine is not recommended for use in pregnant women due to the increased risk of fetal harm. Your doctor may prescribe a safer alternative based on your clinical condition.

Breast-feeding

This medicine is not recommended for use in breastfeeding women. Your doctor may prescribe a safer alternative based on your clinical condition.
General warnings

Cognitive impairment

This medicine may cause forgetfulness, memory loss, confusion, etc. These side effects are reversible and usually disappear once the therapy is discontinued.

Liver enzymes

This medicine may increase the liver enzyme levels in some patients. Close monitoring of liver function is necessary while receiving this medicine. Appropriate dose adjustments or replacement with a suitable alternative may be required based on the clinical condition.

Myopathy and Rhabdomyolysis

This medicine may cause muscle breakdown and rhabdomyolysis in some patients, a condition which can be fatal. This may cause symptoms such as severe tiredness and weakness. This risk is especially higher in the elderly population and in patients with active muscle disorders. Report any unusual symptoms to the doctor immediately. Replacement with a suitable alternative may be necessary based on the clinical condition of the patient.

Alcohol consumption

This medicine may cause liver and kidney injuries in patients consuming alcohol very frequently and in large quantities. Hence, consumption of alcohol should be avoided during treatment with this medicine.

Fusidic acid

Coadministration of systemic fusidic acid and this combination medicine is not recommended due to the increased risk of rhabdomyolysis. Replacement with a suitable alternative should be considered based on the clinical condition of the patient.

Coumarin Anticoagulants

This medicine should be used with caution in patients receiving coumarin anticoagulants such as warfarin due to the increased risk of excessive bleeding. Close monitoring of International Normalized Ratio (INR) is recommended for such patients. Appropriate dose adjustments or replacement with a suitable alternative may be required based on the clinical condition.

Pediatric use

The safety and efficacy of this medicine have not been clinically established in children less than 10 years of age.

Other medicines

Many medicines interact with this combination medicine and their interaction may cause serious adverse effects. It is advised that you report to the doctor all your current medicines including any herbs and supplements before beginning treatment with this combination medicine.

Missed Dose

Take the missed dose as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose. Do not double your dose to make up for the missed one.

Overdose

Seek the emergency medical treatment or contact the doctor in case of an overdose.
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

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.

Instructions

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.
Interaction with Medicine

Carbamazepine

Ciprofloxacin

Cyclosporine

Colchicine

Cholestyramine

Fenofibrate

Ketoconazole

HIV protease inhibitors

Disease interactions

Liver Disease

This medicine should be used with caution in patients with mild liver function impairment due to the increased risk of worsening of the patient's condition. This medicine is not recommended for use in patients with a moderate-to-severe liver function impairment. Close monitoring of liver function tests is recommended during treatment with this medicine. Appropriate dose adjustments or replacement with a suitable alternative may be required based on the clinical condition of the patient.

Rhabdomyolysis

This medicine is not recommended for use in patients with rhabdomyolysis due to the increased risk of renal failure and death. Replacement with a suitable alternative should be considered under your doctor's supervision.

Diabetes

This medicine should be used with caution in patients with diabetes due to the increased risk of elevated blood glucose levels. Close monitoring of blood glucose levels is necessary while receiving this medicine. Appropriate dose adjustments or replacement with a suitable alternative may be required based on the clinical condition of the patient.
Food interactions
Consumption of grapefruit juice is not recommended during treatment with this medicine due to the increased risk of severe adverse effects such as tenderness, weakness, dark-colored urine, etc.
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 this medicine as advised by your doctor. It can be taken with or without food. Do not take in larger amounts than advised/prescribed. Consult the doctor if you experience any undesirable side effects. Ensure that the treatment course is completed. Do not stop the use of this medicine without consulting your doctor.
Miscelleneous

Can be taken with or without food, as advised by your doctor

To be taken as instructed by doctor

May cause sleepiness

How it works
Simvastatin reduces the production of cholesterol in the body. Ezetimibe works by reducing or stopping the absorption of cholesterol through the small intestine. Their combination is thus better effective than monotherapy in the treatment of primary hypercholesterolemia.
Legal Status

Approved

Approved

Unknown

Approved

Classification

Category

Antihyperlipidemic combinations

Schedule

Schedule H

[Internet]. Accessdata.fda.gov. 2018 [cited 3 September 2018]. Available from:

https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021687s022lbl.pdf

[Internet]. Hpra.ie. 2018 [cited 3 September 2018]. Available from:

https://www.hpra.ie/img/uploaded/swedocuments/2145532.PA0577_180_001.46ae12cc-663f-4190-8dcc-23bbf7a79e5c.000001Product%20Leaflet%20Approved.150522.pdf

[Internet]. Mri.cts-mrp.eu. 2018 [cited 3 September 2018]. Available from:

http://mri.cts-mrp.eu/download/DK_H_2342_001_PAR.pdf

DailyMed - Ezetimibe and simvastatin tablet [Internet]. Dailymed.nlm.nih.gov. 2018 [cited 3 September 2018]. Available from:

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c90e8c96-e130-42d7-bf0d-5833652e40d5

[Internet]. Medicines.org.uk. 2018 [cited 3 September 2018]. Available from:

https://www.medicines.org.uk/emc/product/3872
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Information on this page was last updated on 27 Sep 2018

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