Eris Lifesciences Ltd

ZOMELIS SG Tablet 10's

Diabetes
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    Introduction About ZOMELIS SG TABLET

    ZOMELIS SG TABLET contains Remogliflozin and Vildagliptin which belongs to the group of medicines called Anti-diabetic agents. ZOMELIS SG TABLET is used to manage type 2 diabetes when diet and exercise alone are insufficient to provide adequate glycaemic control in adult patients.

    Along management with ZOMELIS SG TABLET, your doctor might advise you to follow the diet and/or exercise which is beneficial. Avoid consumption of alcohol while taking ZOMELIS SG TABLET because it might lead to low blood glucose levels.

    ZOMELIS SG TABLET is not recommended for use in patients allergic to Remogliflozin and Vildagliptin. It is also not recommended for use in patients with liver problems and/or kidney problems. Before taking [GBKEYWORD], inform your doctor if you have type 1 diabetes, dehydration (associated with symptoms such as nausea, vomiting, and/or loss of excessive fluid from the body), and/or low blood pressure.

    ZOMELIS SG TABLET is not recommended for use during pregnancy and in women planning for pregnancy. It is also not recommended for use in breastfeeding women since it is not known whether the medicine may pass through breast milk. The most common side effects of taking [GBKEYWORD] are constipation, diarrhoea, weakness, dizziness, fever, joint pain, chills, urinary tract infection, and headache. Consult your doctor if any of these above side effects worsens or persists for a longer duration.

    Uses Of ZOMELIS SG TABLET

    • It is used to manage type 2 diabetes

    How ZOMELIS SG TABLET Works

    [GBKEYWORD] helps in reducing blood glucose by increasing the excretion of glucose via urine. It does so by acting on certain proteins in the body which are responsible for the reabsorption of glucose from the kidney. [GBKEYWORD] inhibits the action of these proteins hence, stopping the reabsorption of glucose and increasing urinary glucose excretion thus helps to manage type 2 diabetes in affected individuals. [GBKEYWORD] controls blood glucose level by acting on the pancreas to produce more insulin and less glucagon which leads to low production of blood sugar levels resulting in controlled blood glucose levels.

    How to use ZOMELIS SG TABLET

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

    Side Effects Of ZOMELIS SG TABLET

    Common

    • constipation
    • diarrhoea
    • weakness
    • fever and chills
    • urinary tract infection
    • upper respiratory tract infection
    • signs of low blood sugar levels such as sweating, feeling tired, dizziness, and/or feeling shaky
    • headache
    • cough
    • signs of orthostatic hypotension such as low blood pressure, light-headedness/ dizziness upon standing

    Uncommon

    • anaemia
    • vertigo (spinning sensation)
    • eye pain, increased flow of tears
    • stomach pain, stomach discomfort, inflammation of the lining of the stomach, higher levels of gastric acid (heartburn)
    • gastroesophageal reflux (stomach contents move backwards towards the mouth)
    • inflammation of the mouth
    • increases in creatinine (changes in frequency of urination, itching, swelling, fatigue)
    • irregular heartbeats
    • decreased appetite
    • decreased weight
    • build-up of lactate in the body (muscle ache, burning sensation, rapid breathing)
    • inflammation or pain of joint, back pain, inflammation and swelling of the cartilage of the chest wall, musculoskeletal pain
    • reduced sense of touch
    • anxiety
    • lack of sleep
    • painful or difficult urination, frequent daytime urination, production of abnormally large volumes of urine
    • inflammation of the glans (rounded head of the penis), posthitis (inflammation of the foreskin)
    • oropharyngeal pain (persistent mouth pain), seasonal allergies
    • rash, skin lesion, red itchy welts
    • swollen hands, ankle or feet (oedema)
    • joint pain
    • signs of low blood glucose levels such as excessive hunger, sweating, tiredness

    Stop taking ZOMELIS SG TABLET and inform your doctor immediately if you experience any of the following side effects:

    • signs of diabetic ketoacidosis such as nausea, vomiting, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, fruity smelling breath, a sweet or metallic taste in mouth, a different odour in urine or sweat, rapid weight loss
    • signs of fournier’s gangrene such as fever, pain and swelling in the genitals or anal area, unpleasant odour coming from the affected skin tissue, crackling sound when touching the affected area, and/or dehydration
    • signs of dehydration such as very dry, sticky mouth, feeling very thirsty, passing little or no urine, feeling very sleepy or tired, and/or fast heartbeat
    • signs of angioedema (such as swollen face, tongue or throat, difficulty swallowing, difficulty in breathing, sudden onset rash or hives)
    • signs of liver disease (hepatitis) such as loss of appetite or dark-coloured urine, yellow skin and eyes, nausea
    • signs of inflammation of the pancreas such as severe and persistent pain in the abdomen (stomach area), nausea and vomiting

    How To Manage Side Effects

    Constipation

    Eat plenty of fiber rich foods such as fresh fruits, vegetables, and cereals and drink plenty of water. Exercise more regularly. If the symptom does not improve, consult your doctor.

    Diarrhea

    Drink a lot of fluids, such as water, fruit juice, or squash to keep yourself hydrated. Do not consume any medicine by yourself without consulting your doctor. Ask for your doctor’s advice if diarrhea does not improve.

    Dizziness Or Drowsiness

    Lie down until dizziness is gone, then get up slowly. Move slowly and carefully, do not hurry. Get adequate rest. Drink plenty of water and other fluids. Consult your doctor if the symptom gets worse.

    Headache

    Drink ample amount of water and avoid skipping meals. Get adequate rest. Try to be relaxed and stress free. Apply pain relieving balm on your forehead if necessary. Consult your doctor if the symptom does not improve.

    Warning & Precautions

    Pregnancy

    Contraindicated

    ZOMELIS SG TABLET is generally not recommended for use in pregnant women. However, consult your doctor for advice.

    Breastfeeding

    Contraindicated

    ZOMELIS SG TABLET is not recommended for use in breastfeeding women as it may pass through the breast milk. However, consult your doctor for advice.

    Driving and Using Machines

    Use with Caution

    Do not drive or operate any machines if you feel dizziness, shaking, sweating, change in vision after taking ZOMELIS SG TABLET.

    Alcohol

    Consult your doctor

    Avoid consumption of alcohol while taking ZOMELIS SG TABLET as it may increase your blood sugar levels.

    Kidney

    Contraindicated

    ZOMELIS SG TABLET is not recommended for use in patients suffering from kidney problems such as moderate to severe renal impairment. Consult your doctor before taking the medicine.

    Liver

    Contraindicated

    ZOMELIS SG TABLET is not recommended for use in patients with liver problems such as moderate to severe liver impairment. Therefore, consult your doctor for advice before taking the medicine.

    Allergy

    Contraindicated

    Do not take ZOMELIS SG TABLET if you are allergic to Remogliflozin or Vildagliptin or any other ingredients of this medicine.

    Heart Disease

    Use with Caution

    ZOMELIS SG TABLET should be used with caution in patients suffering from heart failure. Consult your doctor before taking the medicine.

    Use In Pediatrics

    Contraindicated

    ZOMELIS SG TABLET is not recommended for use in children and adolescents below18 years of age. Consult your doctor for advice.

    Use In Geriatrics

    Contraindicated

    ZOMELIS SG TABLET is not recommended for use in elderly patients (aged 65 years and above). Consult your doctor before taking it.

    Others

    Before taking ZOMELIS SG TABLET inform your doctor if you:

    • have type 1 diabetes
    • signs of dehydration such as nausea, vomiting, fever, loss of excessive fluid from the body
    • have tendency of urinary tract infections
    • have low blood pressure
    • have a condition called diabetic ketoacidosis (serious complication of diabetes)
    • have intolerance to certain sugars
    • had or have a disease of the pancreas

    Interactions

    A. Drug-Drug interactions:

    Before taking ZOMELIS SG TABLET, inform your doctor if you are taking any of the following medicines such as:

    • ketoconazole (used to manage fungal infections)
    • oral contraceptives (ex. estradiol, norethindrone)
    • medicines used to manage high blood pressure (ex. ramipril, rosuvastatin, verapamil)
    • other blood glucose lowering medicines (ex. sulphonylureas, metformin, insulin)
    • bupropion (used to manage depression)
    • medicines used to remove water from body (diuretics) ex. spironolactone, furosemide
    • digoxin (used to manage heart failure)
    • warfarin (used to manage blood clot)
    • amlodipine, ramipril, valsartan and angiotensin-converting enzyme (ACE) inhibitors (used to manage high blood pressure) such as captopril, enalapril, fosinopril
    • simvastatin (used to reduce high cholesterol levels)
    • thiazides or other diuretics (medicines used to manage high blood pressure) ex. chlorothiazide, chlorthalidone, hydrochlorothiazide
    • corticosteroids (used to manage inflammation) ex. Prednisolone
    • certain medicines affecting nervous system such as antidepressants ex. clomipramine, amitriptyline
    • thyroid medicines (used to lower thyroid levels) ex. levothyroxine

    Overdosage:

    If you or anyone else accidentally takes too much of ZOMELIS SG TABLET, consult your doctor immediately or visit the nearby hospital. Overdosage symptoms of ZOMELIS SG TABLET are muscle pain, mild and transient paraesthesia (burning and prickling sensation in hands and legs), fever, oedema (swelling in arms and legs).

    Synopsis

    Drug :   Remogliflozin, Vildagliptin
    Pharmacological Category :   Sodium Glucose Co-Transporter-2 (SGLT2) Inhibitors, Dipeptidyl peptidase-4 (DPP-4) inhibitor
    Therapeutic Indication :   Type II diabetes mellitus  
    Dosage Forms :   Tablet

    More Information

    • Keep ZOMELIS SG TABLET out of reach of children
    • Store at room temperature

    FAQs About ZOMELIS SG TABLET

    Q: What if I forget to take a dose of ZOMELIS SG TABLET?

    A: If you forgot to take a dose of ZOMELIS SG TABLET then do not take the missed dose between meals. Wait until your next scheduled dose and meal and continue taking your medicine as per normal. Do not take a double dose of ZOMELIS SG TABLET to make up for a forgotten dose. Consult your doctor.

    Q: Can ZOMELIS SG TABLET be used in children and adolescents?

    A: No. ZOMELIS SG TABLET is not recommended to use in children and adolescents (below 18 years of age). Consult your doctor before administering the medicine to the child.

    Q: What is the best time to take ZOMELIS SG TABLET?

    A: Take ZOMELIS SG TABLET as directed by your doctor. It can be taken with or without meals. Try to take ZOMELIS SG TABLET at the same time everyday which will make you remember to take it. Keep following the diet and exercises your doctor has advised you to.

    Q: Is ZOMELIS SG TABLET safe for pregnant and breast-feeding women?

    A: ZOMELIS SG TABLET is not recommended for use in pregnant and breast-feeding women. Consult your doctor before taking it.  

    Q: Does taking ZOMELIS SG TABLET cause weight gain?

    A: No, ZOMELIS SG TABLET has no effect on weight gain. Moreover, these kinds of medicines delay gastric emptying and make you feel satiety (stomach fullness). These further decreases hunger. So, basically ZOMELIS SG TABLET has no effect or it does not influence weight gain.

    Q: Does ZOMELIS SG TABLET cause dizziness?

    A: Yes, ZOMELIS SG TABLET may cause dizziness in some individuals. To manage this effect, lie down until dizziness is gone, then get up slowly. Move slowly and carefully, do not hurry. Get adequate rest. Drink plenty of water and other fluids.

    References

    1. Wiley. Remogliflozin.  Metabolic Syndrome: Underlying Mechanisms and Drug Therapies. 2011. Page – 371.

    2. Nasser Mikhail. Remogliflozin etabonate: a novel SGLT2 inhibitor for treatment of diabetes mellitus. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. August 2015. [Accessed on 22th, December 2023] https://pubmed.ncbi.nlm.nih.gov/26288025/

    3. B Ahren, A Schweizer, S Dejager, E B Villhauer, B E Dunning, J E Foley. Mechanisms of action of the dipeptidyl peptidase-4 inhibitor vildagliptin in humans. NIH National Library of Medicine. National Center for Biotechnology Information.PubMed.gov. [Revised in September 2011] [Accessed on 22th December 2023] https://pubmed.ncbi.nlm.nih.gov/21507182/

    4. Kalyan Kumar Gangopadhyay and Parminder Singh. Consensus Statement on Dose Modifications of Antidiabetic Agents in Patients with Hepatic Impairment. NIH National Library of Medicine. National Center for Biotechnology Information. PMC PubMed Central. [Revised in March 2017] [Accessed on 22th December 2023] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5367241/

    5. Torrent Pharmaceuticals Ltd. Zucator 100. [Revised in July 2020] [Accessed on 22th December 2023] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2859.pdf

    Useful Diagnostic Tests

    • HbA1C, Also known as Glycated Hemoglobin, Glycosylated Hemoglobin
    • Blood Glucose Fasting (FBS)
    • Random Blood Sugar (RBS)
    • Post Prandial Blood Sugar (PPBS)
    • Routine Diabetes Care
    • Diabetes Screening
    • Healthians Diabetic Checkup
    • Diabetes Care Package

    Author Details

    Written By Dr. Janet.C - Pharm.D
    Reviewed For Accuracy By Dr. Jaya Prabakaran - MBBS, MD (Diabetology and Family Medicine)
    Last updated on 08 Jan 2024 | 08:56 AM(IST)
    Lab updated