Product Description

TENIVA M TABLET is a combination of Metformin and Teneligliptin which belongs to the group of medicines called Antidiabetic agents. It is used to treat Type II diabetes mellitus among patients when diet, exercise and treatment with other conventional medicines does not result in adequate control on blood glucose levels.

Type II diabetes mellitus is a chronic disease characterized by abnormally high levels of glucose in the blood. It is caused due to inadequate production of a hormone called insulin (produced by pancreas to metabolize glucose) in the body or due to inadequate sensitivity of body cells to the actions of insulin.

Before taking TENIVA M TABLET inform your doctor if you have any liver, kidney or heart problems. You must also inform your doctor if you have low potassium levels in blood or are severely dehydrated due to excessive vomiting or diarrhea recently.

During therapy with TENIVA M TABLET, your doctor might regularly monitor your blood sugar levels and kidney functions to avoid the risk of unwanted side effects. He/she might also ask you to make certain lifestyle changes such as following a healthy diet, regular physical exercise and quitting alcohol consumption to achieve better results.

TENIVA M TABLET is not recommended for use in patients with severe uncontrollable diabetes. It is also not suitable for use in patients with alcoholism and in patients with severe systemic infections.

Consult your doctor before taking TENIVA M TABLET if you are pregnant or breastfeeding. The most common side effects of taking TENIVA M TABLET are low blood sugar levels, stomach upset, constipation, flatulence and altered taste sensations. Consult your doctor if they bother you.

USES OF TENIVA M TABLET

• Treats Type II diabetes mellitus

HOW TENIVA M TABLET WORKS

TENIVA M TABLET is an antidiabetic medicine. It contains two medicines namely metformin and teneligliptin. Metformin makes the body more sensitive to insulin (a hormone involved in glucose metabolism). This helps our body cells to utilize more amount of the circulating blood glucose. Additionally, it can stop glucose production by the liver and reduces its absoprtion in the body.

Teneligliptin controls blood sugar levels by blocking the actions of an enzyme called dipeptidyl peptidase (DPP)-4 that reduces insulin secretion in the body. Collectively, TENIVA M TABLET controls blood sugar levels and improve glycemic control in patients with type II diabetes.

DIRECTIONS FOR USE

Take TENIVA M TABLET preferably after meals or as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine.

Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition. Do not stop taking TENIVA M TABLET unless your doctor advice you to stop.

SIDE EFFECTS OF TENIVA M TABLET

COMMON

• Hypoglycemia (low blood sugar)
• Nausea, vomiting
• Flatulence, diarrhea, constipation, stomach pain, loss of appetite
• Headache, dizziness
• Changes in taste

RARE

Stop taking TENIVA M TABLET and consult your doctor immediately if you experience any of the following side effects:

• Serious allergic reaction (such as hives, swelling of the face, lips, tongue or throat causing difficulty in breathing or swallowing)
• Severe skin rashes with redness and blistering of the skin
• Signs of lactic acidosis (cold hands or feet, dizziness or light-headedness, slow or irregular heartbeat, weakness or tiredness, unusual muscle pain, trouble breathing, sleepiness or drowsiness, stomach pains, nausea or vomiting)
• Signs of liver damage (such as tiredness, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes)

HOW TO MANAGE SIDE EFFECTS

Hypoglycemia (low blood sugar):

Have foods rich in sugars such as fruit juices, glucose drinks, candies, honey or biscuits. Check your blood sugar after 10 minutes. If not gained optimum level, take another sugary snack or a drink and check your blood sugar levels once again. Contact your doctor if there is no improvement in your condition.

Headache:

Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as water or electrolytes. Applying a pain-relieving balm on your forehead can be beneficial. Do not consume excessive alcohol, as it could aggravate your headache. Consult your doctor if your headache worsens.

Dizziness:

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Do not consume excessive alcohol, as it could aggravate your dizziness. Consult your doctor if your dizziness worsens.

Constipation:

Taking TENIVA M TABLET with meals may reduce the chances of constipation. However, if you experience constipation, eat plenty of fiber rich foods such as fresh fruits, vegetables and cereals. Drink plenty of fluids. Exercise more regularly. Consult your doctor if this side effect bothers you.

WARNING & PRECAUTIONS

PREGNANCY

TENIVA M TABLET should be used in pregnant women only if considered necessary by the physician. Your doctor will prescribe TENIVA M TABLET only if the therapeutic benefits overweigh the risk to the fetus. Therefore, inform your doctor before taking it.

BREASTFEEDING

TENIVA M TABLET is not recommended for use in breastfeeding women. However, consult your doctor before taking it.

DRIVING AND USING MACHINES

Do not drive or operate any machines if you feel dizzy after taking TENIVA M TABLET.

ALCOHOL

Avoid consumption of alcohol while taking TENIVA M TABLET as it may increase the risk of unwanted side effects.

KIDNEY

TENIVA M TABLET is not recommended for use in patients with severely reduced kidney functions. Therefore, consult your doctor before taking it.

LIVER

TENIVA M TABLET is not recommended for use in patients with severe liver problems. It should be used with caution in patients with gall stones. Therefore, consult your doctor before taking it.

ALLERGY

Do not take TENIVA M TABLET if you are allergic to Metformin or Teneligliptin.

LUNGS

TENIVA M TABLET is not recommended for use in patients with severe infections of the lungs or respiratory tract. Therefore, consult your doctor before taking it.

HEART DISEASE

TENIVA M TABLET is not recommended for use in patients with severe heart problems (such as acute heart failure, recent heart attack, arrythmia, prolonged QT interval). Therefore, consult your doctor before taking it.

OTHERS

TENIVA M TABLET is not recommended for use if you:

• Have severe, uncontrollable diabetes
• Have diabetic coma or precoma
• Have nausea, vomiting, diarrhea or rapid weight loss
• Have lactic acidosis or ketoacidosis (buildup of lactic acid or ketones in the body)
• Are dehydrated (due to drinking less fluid or had severe vomiting or diarrhea during the recent days)
• Have any severe systemic infection
• Have shock or problems in blood circulation
• Are an alcoholic
• Are scheduled for any X-rays in the upcoming days

Before taking TENIVA M TABLET, inform your doctor if you:

• Have pituitary insufficiency or adrenal insufficiency
• Are malnourished, starved, on an irregular diet or feeling weak
• Perform extreme muscle exercises
• Have a history of abdominal operation or intestinal obstruction
• Have hypokalaemia (low blood potassium levels)
• Have type I diabetes mellitus (insulin-dependent diabetes)
• Have severe traumatic conditions

Use in Pediatrics:

The safety and effectiveness of TENIVA M TABLET have not been established in infants, children and adolescents (aged below 18 years). Therefore, consult your doctor before taking it.

Use in Geriatrics:

The safety and effectiveness of TENIVA M TABLET have not been established in elderly patients (aged 65 years or above). Therefore, consult your doctor before taking it.

INTERACTIONS

A. Drug - Drug interactions:

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

• Other medicines used to treat diabetes (Ex. glimepiride, glyburide, gliclazide, rosiglitazone, pioglitazone)
• Iodine contrast medium (used during X-rays)
• Medicines used to treat asthma (Ex. salbutamol or terbutaline)
• Corticosteroids (used to treat pain and inflammation) Ex. hydrocortisone, prednisolone
• Diuretics (used to reduce edema and to treat hypertension) Ex. furosemide, hydrochlorothiazide
• Medicines used to treat pain and inflammation (such as ibuprofen and celecoxib)
• Medicines used to treat high blood pressure (such as atenolol, propranolol, captopril, enalapril, ramipril, lisinopril, losartan, valsartan, olmesartan, telmisartan)
• Cimetidine (a medicine used to treat stomach ulcer)
• Dolutegravir (a medicine used to treat HIV infection)
• Verapamil (a medicine used to treat heart problems)
• Rifampicin (a medicine used to treat tuberculosis)
• Ranolazine (a medicine used to treat chest pain)
• Trimethoprim (a medicine used to treat bacterial infection)
• Medicines used to treat cancer (Ex. vandetanib, crizotinib and Olaparib)
• Isavuconazole (a medicine used to treat fungal infections)
• Salicylic acid (a medicine used to treat skin problems like acne)
• Medicines used to treat depression (Ex. phenelzine, selegiline)
• Adrenaline (a medicine used to treat shock caused by allergic reactions or collapse)
• Thyroid hormones (used to treat thyroid deficiency) Ex. levothyroxine, liothyronine
• Medicines used to treat irregular heartbeats (Ex. quinidine, procainamide, amiodarone, sotalol, etc.)

Overdosage:

If you or anyone else accidentally took more TENIVA M TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are feeling cold or uncomfortable, severe nausea or vomiting, stomach pain, unexplained weight loss, muscular cramps and fast breathing.

SYNOPSIS

Drug	:	Metformin, Teneligliptin
Pharmacological Category	:	Biguanides, DPP-4 Inhibitors
Therapeutic Indication	:	Type II Diabetes mellitus
Dosage Forms	:	Tablet

MORE INFORMATION

• Keep TENIVA M TABLET out of the sight and reach of children
• Store TENIVA M TABLET below 30°C