Elzanor 12.5/1000mg Tablet 14 ‘S

Description

Indications

Elzanor 12.5/1000mg Tablet 14 ‘S is prescribed to adults between the age of 18-84.

It is used in the treatment of type 2 diabetes mellitus, (high blood sugar levels) as an adjunct to diet and exercise in patients inadequately controlled by empagliflozin or metformin alone, or metformin in combination with other antidiabetics or insulin. 

 

How does Elzanor 12.5/1000mg Tablet 14 ‘S work?

Metformin is an anti diabetic medication (biguanide) that works by decreasing the amount of sugar released into the blood by the liver, delaying sugar absorption from the intestines and increasing the body’s responsiveness to insulin. Whereas, empagliflozin  is an anti-diabetic medication (sodium glucose co-transporter 2 (SGLT2) inhibitors) that works by increasing insulin (a natural substance required in breaking down sugar) production by the pancreas and the ability of the body to utilise it effectively.

 

How to use Elzanor 12.5/1000mg Tablet 14 ‘S?

It comes in tablet form that needs to be swallowed whole with a glass of water.

It is better to take Elzanor 12.5/1000mg Tablet 14 ‘S with meals to avoid side effects like having an upset stomach.

 

Dosage 

Dosage needs to be personalized keeping in mind the patients current regime, effectiveness and tolerability towards the treatment.

• 5/850mg – 5/1000mg taken twice daily, increased if necessary to 12.5/850mg – 12.5/1000mg taken twice daily.

IMMEDIATE RELEASE TABLETS

• Patients on metformin:
  • Initial dose – Empagliflozin 10 mg plus similar total daily dose of metformin, divided into twice a day
• Patients on empagliflozin:
  • Initial dose – Empagliflozin at the same total daily dose plus metformin 1000 mg divided into twice a day
• Patients on empagliflozin and metformin as separate tablets:
  • Initial dose – same total daily dose of each constituent of Elzanor 12.5/1000mg Tablet 14 ‘S (or nearest appropriate dose of metformin) divided into twice a day
  • Maintenance – Dose is adjusted based on efficacy and tolerability; a gradual rise in dose of metformin reduces gastrointestinal side effects.
  • Maximum daily dose – Empagliflozin: 25 mg/day; metformin: 2000 mg/day

 EXTENDED RELEASE TABLETS

• Patients on metformin:
  • Initial dose – Empagliflozin 10 mg plus similar total daily dose of metformin taken once a day:
• Patients on empagliflozin:
  • Initial dose – Empagliflozin at the same total daily dose plus metformin 1000 mg taken once a day
• Patients on empagliflozin and metformin as separate tablets:
  • Initial dose – same total daily dose of each constituent of Elzanor 12.5/1000mg Tablet 14 ‘S (or nearest appropriate dose of metformin) taken once a day
  • Maintenance – Dose is adjusted based on efficacy and tolerability; a gradual rise in dose of metformin reduces gastrointestinal side effects.
  • Maximum daily dose – Empagliflozin: 25 mg/day; metformin: 2000 mg/day

–  To achieve optimal glycemic control, titrate the doses accordingly.

–  To reduce the risk of hypoglycemia, a lower dose of insulin or insulin secretagogue should be considered when used in combination with Elzanor 12.5/1000mg Tablet 14 ‘S. 

 

Pregnancy use and lactation

If you are pregnant, think you may be pregnant or are planning to have a baby, please consult your doctor before using Elzanor 12.5/1000mg Tablet 14 ‘S. If you are breastfeeding, please consult your doctor before taking Elzanor 12.5/1000mg Tablet 14 ‘S.

 

Contraindications

Please inform your doctor if you have a history of any before using Elzanor 12.5/1000mg Tablet 14 ‘S:

• Hypersensitivity to any of the constituents of Elzanor 12.5/1000mg Tablet 14 ‘S
• Type I diabetes mellitus also known as insulin dependent diabetes
• Metabolic acidosis (electrolyte disorder characterized by acid-base imbalance in the body) including diabetic ketoacidosis (abnormally fast breakdown of fat into blood acids called ketones)with or without coma.
• Renal impairment (serum creatinine level = 1.5 mg/dL for males or 1.4 mg/dL for females, or eGFR <45 mL/min/1.73 m2)
• History of UTI (urinary tract infection)
• Problems with the pancreas
• When on a low salt diet 
• Alcohol intoxication 
• Administration of iodinated contrast mediums
• Pregnancy and lactation 

 

Precautions

Please tell your doctor about any of the following conditions while using Elzanor 12.5/1000mg Tablet 14 ‘S:

• Children or adults above the age of 85
• Hypoglycemia 
• Monitor renal function to prevent lactic acidosis (excessive lactic acid accumulation in the blood) 
• Renal insufficiency – regular renal monitoring before and during treatment. 
• Hepatic (liver) impairment
• Surgical procedures (product should be temporarily discontinued 48 hours pre and post surgery)
• Volume depletion
• Administration of iodinated contrast mediums
• Alcohol intake
• Concomitant antihypertensive therapy or use of diuretics 
• Dose of insulin may be reduced when used in combination with Elzanor 12.5/1000mg Tablet 14 ‘S

 

Interaction with other medications

Certain medications could interact with Elzanor 12.5/1000mg Tablet 14 ‘S, hence, in that case your doctor might alter your dosage and make sure to monitor blood sugar levels more closely.

Please inform your doctor about the use of the following before taking Elzanor 12.5/1000mg Tablet 14 ‘S:

• Ranolazine
• selegiline
• tranylcypromine
• topiramate 
• other carbonic anhydrase inhibitors
• thiazides and other diuretics
• Antihypertensives
• UGT enzyme inducers
• Alcohol
• Agents affecting renal function
• Iodinated contrast agents 
• Corticosteroids
• ACE inhibitors
• NSAIDs
• OCT1 and OCT2 inhibitors 

Make sure to inform your doctor that you are taking Elzanor 12.5/1000mg Tablet 14 ‘S before you start or stop any other medicine.

 

Adverse effects

Like most medicines, Elzanor 12.5/1000mg Tablet 14 ‘S has some side effects which include:

COMMON:

• Nausea
• Vomiting 
• Diarrhea
• Stomach pain
• Loss of appetite
• Dizziness 
• Headache 
• Upper respiratory tract infection
• Hypoglycemia (low blood glucose level)
• Change in taste

SERIOUS:

• Hypoglycemia (low blood sugar) manifested as dizziness, weakness, drowsiness, headache and sweating
• Liver impairment
• Lactic acidosis (excess lactic acid in the blood)
• Elevated levels of serum urea and creatinine 
• Genital mycotic infections
• Urinary tract infections
• Reduced B12 absorptions
• Increased LDL-C (low density lipoprotein cholesterol)
• Hypersensitivity (allergic) reactions including anaphylaxis indicated by itching, difficulty breathing, swelling of your throat or tongue, hives, or difficulty swallowing.

How to cope with some of the adverse effects

• Nausea (feeling sick) – Take Elzanor 12.5/1000mg Tablet 14 ‘S with meals and avoid having spicy food

• Vomiting and Diarrhoea – Keep yourself hydrated by having lots of fluids as it may result in dehydration. If the problem persists, consult your doctor before taking any medication for vomiting and diarrhoea.

• Stomach ache – Try to rest as much as possible and have smaller and more frequent meals. Using a heat pack or hot water bottle over the area in pain might help in giving some relief. If the pain still persists and is severe, speak to your doctor.

• Loss of appetite – Have smaller meals than usual at times that you would normally eat.

• Dizziness – Try and rest until you feel better and refrain from driving or using any tools or machinery

• Metallic taste in the mouth – Have something that would change the taste of your mouth for example, sugar-free gum

• Hypoglycemia – Carry fast acting carbohydrates (like sweets and juice) to prevent your body from going into a state of hypoglycemia (low blood sugar)

Inform your doctor immediately if you experience any of the serious side effects.

 

Key facts about Elzanor 12.5/1000mg Tablet 14 ‘S

• Elzanor 12.5/1000mg Tablet 14 ‘S is used for the treatment of type 2 diabetes mellitus (a condition resulting in elevated levels of sugar in the blood) as an adjunct to diet and exercise, in patients inadequately controlled by empagliflozin or metformin alone, or metformin in combination with other antidiabetics or insulin
• It is prescribed to adults between 18-84 years of age.
• When using Elzanor 12.5/1000mg Tablet 14 ‘S with other medicines it can cause hypoglycemia, (low blood sugar) hence, carry something sweet in case that happens.
• Inform your doctor about your treatment if you are to undergo surgery.
• Matter of concern arises when you experience deep or rapid breathing, persistent nausea, vomiting, and stomach pain, as Elzanor 12.5/1000mg Tablet 14 ‘S may cause a rare but serious condition called lactic acidosis.
• Long term use can cause vitamin B12 deficiency. 
• Maintain a good genital hygiene to prevent yeast or urinary tract infections
• Elzanor 12.5/1000mg Tablet 14 ‘S reduces the risk of heart attack, heart failure or other cardiovascular events.
• Drink plenty of water and stay hydrated as it may cause your body to lose too much fluid (dehydration) or you to urinate frequently. 
• It is important for your doctor to monitor your blood sugar levels regularly, along with repeated kidney and liver function tests to prevent you from any complications
• Keep this medicine tightly closed in the container or the pack it came in, at room temperature, away from extreme temperatures, moisture and direct light. Dispose of the unused medicine. 

FAQs

1. WHAT EXACTLY DOES Elzanor 12.5/1000mg Tablet 14 ‘S DO?

Metformin is an anti diabetic medication (biguanide) that works by decreasing the amount of sugar released into the blood by the liver, delaying sugar absorption from the intestines and increasing the body’s responsiveness to insulin. Whereas, empagliflozin  is an anti-diabetic medication (sodium glucose co-transporter 2 (SGLT2) inhibitors) that works by increasing insulin (a natural substance required in breaking down sugar) production by the pancreas and the ability of the body to utilise it effectively.

2. HOW LONG DOES IT TAKE FOR Elzanor 12.5/1000mg Tablet 14 ‘S TO START WORKING?

Elzanor 12.5/1000mg Tablet 14 ‘S starts working in around 48 hours and reaches its maximum efficacy in 4-5 days. Initially, you might not feel that it is effective, but that does not mean you stop taking the medicine thinking it is not working. Make sure to continue taking Elzanor 12.5/1000mg Tablet 14 ‘S as directed by your doctor.

3. HOW LONG WILL I HAVE TO TAKE Elzanor 12.5/1000mg Tablet 14 ‘S FOR?

Elzanor 12.5/1000mg Tablet 14 ‘S is usually prescribed for long term use, possibly life long. Your dosage and time period is decided by your doctor after knowing the severity of your condition.

4. CAN I STOP TAKING Elzanor 12.5/1000mg Tablet 14 ‘S?

This medicine largely controls your blood sugar levels, but does not cure your condition. Hence, do not just stop taking the medicine without consulting your doctor, otherwise your condition could possibly get worse.

5. WHAT IF Elzanor 12.5/1000mg Tablet 14 ‘S STOPS WORKING?

If it stops working, then your doctor will either give it to you with a combination of other medicines or recommend a different treatment to you by switching it with other anti-diabetics.

6. WILL Elzanor 12.5/1000mg Tablet 14 ‘S AFFECT MY KIDNEYS?

It does not affect those with normal kidney function and hence, is safe to use for them. However, if you have a history of kidney disease, inform your doctor as you might need to alter your daily dose.

7. DOES Elzanor 12.5/1000mg Tablet 14 ‘S CAUSE WEIGHT GAIN?

Unlike most hypoglycemics it doesn’t cause weight gain but some individuals have shown to lose weight while taking Elzanor 12.5/1000mg Tablet 14 ‘S.

8. CAN Elzanor 12.5/1000mg Tablet 14 ‘S CAUSE VITAMIN B12 DEFICIENCY?

Long term use of Elzanor 12.5/1000mg Tablet 14 ‘S is known to cause vitamin B12 deficiency as it interferes with its absorption. If left untreated, it may cause anemia and nerve problems indicated by tingling sensation and numbness in hands and feet, weakness, urinary problems, change in mental status and difficulty in maintaining balance (ataxia). To prevent this condition, it is advised to have vitamin b12 supplements when taking Elzanor 12.5/1000mg Tablet 14 ‘S.

9. WHAT IF I TAKE TOO MUCH OF Elzanor 12.5/1000mg Tablet 14 ‘S?

An overdose of Elzanor 12.5/1000mg Tablet 14 ‘S alone usually does not cause hypoglycemia (low blood sugar) indicated by feeling hungry, trembling or shaking, sweating, feeling confused and having problems concentrating. However, it could occur if a good diet is not maintained. Contact your doctor immediately if you experience any of these signs or experience stomach pain, nausea/vomiting and dizziness.

10. WHAT IF I FORGET TO TAKE Elzanor 12.5/1000mg Tablet 14 ‘S?

Incase you miss a dose, take your next dose on time and do not try making up for the missed dose by doubling it up. If it helps to remind you, set an alarm so you do not miss any dose.

11. CAN I DRINK ALCOHOL WHILE TAKING Elzanor 12.5/1000mg Tablet 14 ‘S?

Avoid drinking alcohol while you are on Elzanor 12.5/1000mg Tablet 14 ‘S as it can interfere with your treatment causing low blood sugar levels especially in aged patients and on occasions where you have skipped a meal.

12. CAN I TAKE Elzanor 12.5/1000mg Tablet 14 ‘S BEFORE SURGERY ?

Inform your doctor that you are using Elzanor 12.5/1000mg Tablet 14 ‘S before surgery as he/she might ask you to stop taking the medicine before your operation.

13. CAN I DRIVE OR RIDE A BIKE AFTER TAKING Elzanor 12.5/1000mg Tablet 14 ‘S?

Elzanor 12.5/1000mg Tablet 14 ‘S alone might not affect your ability to drive or ride a bike, but when given in combination with other medicines, it could result in low blood sugar levels resulting in loss of concentration vision impairment (your eyesight is affected). To be on the safe side, always carry fast acting carbohydrates (like sweets and juice) to prevent your body from going into a state of hypoglycemia (low blood sugar)

14. HOW SHOULD Elzanor 12.5/1000mg Tablet 14 ‘S BE STORED?

Keep the medicine at room temperature in a cool, dry place, away from direct sunlight. Make sure to keep away from pets, children and other people.