INSUPEN PRO+BASALOG REFIL INITIATION Kit 1's

Introduction About INSUPEN PRO+BASALOG REFIL INITIATION KIT

INSUPEN PRO+BASALOG REFIL INITIATION KIT contains Insulin glargine, which
belongs to the group of medicines called Antidiabetic. It is used to manage
Diabetes mellitus. Diabetes mellitus is a disease where the body does not
produce enough insulin to control the level of blood sugar, resulting in high
blood sugar levels. Symptoms include increased thirst, frequent urination,
extreme hunger, unexplained weight loss, fatigue, irritability, blurred vision,
slow-healing sores, frequent infections, and increased ketone levels in urine.

Your doctor might want you to make certain lifestyle changes like eating a
healthy diet, not skipping meals, maintaining your weight, quitting alcohol and
smoking, and exercising regularly. Before the management, your doctor might want
to take certain blood and urine tests to understand your existing condition.

Before receiving INSUPEN PRO+BASALOG REFIL INITIATION KIT, inform your doctor if
you have low blood sugar, kidney, liver, or heart problems, if you’re not eating
enough, are ill, or have a major injury before going abroad. Avoid drinking
alcohol while receiving INSUPEN PRO+BASALOG REFIL INITIATION KIT. Inform your
doctor if you are pregnant or breastfeeding before receiving INSUPEN PRO+BASALOG
REFIL INITIATION KIT.

INSUPEN PRO+BASALOG REFIL INITIATION KIT is not recommended for children under
the age of two. The most common side effects of receiving INSUPEN PRO+BASALOG
REFIL INITIATION KIT are skin allergies at the injection site, pain, swelling,
itching, and redness. Consult your doctor if your symptoms get worse or persist.

Uses Of INSUPEN PRO+BASALOG REFIL INITIATION KIT

• Manage diabetes mellitus

How INSUPEN PRO+BASALOG REFIL INITIATION KIT Works

INSUPEN PRO+BASALOG REFIL INITIATION KIT lowers the blood glucose facilitated by
increased protein synthesis and uptake of glucose, following the binding of
insulin to receptors on muscle and fat cells and then inhibiting glucose output
from the liver.

How to use INSUPEN PRO+BASALOG REFIL INITIATION KIT

INSUPEN PRO+BASALOG REFIL INITIATION KIT will be given to you only by a doctor
or a nurse under the skin (subcutaneously, usually thighs, upper arm or abdomen.
Your doctor will decide the right dose and duration depending on your age, body
weight and disease condition.

Side Effects Of INSUPEN PRO+BASALOG REFIL INITIATION KIT

Common

• redness, swelling or itching around the area of the injection
• injecting at the same place, the fatty tissue may thicken (lipohypertrophy)

Uncommon

• injecting at the same place, the fatty tissue may shrink (lipoatrophy)

Rare

• having proliferative retinopathy (an eye disease related to diabetes) severe hypoglycemic attacks can cause temporary loss of vision
• cause temporary build-up of water in the body, with swelling in the calves and ankles

Stop receiving INSUPEN PRO+BASALOG REFIL INITIATION KIT and contact your doctor
immediately if you experience any of the following side effects:

• widespread skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angioedema), shortness of breath, a fall in blood pressure with rapid heartbeat and sweating
• signs of heart failure such as unusual shortness of breath or rapid increase in weight or localized swelling (oedema)
• severe hypoglycemia (low blood sugar, headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances, visual disorders, trembling, paralysis, tingling sensation, dizziness, loss of self-control, convulsions, loss of consciousness
• thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heartbeat, and glucose and ketone bodies in urine. stomach pain, fast and deep breathing, sleepiness or even loss of consciousness may be signs of a serious condition (ketoacidosis)

Warning & Precautions

!### Pregnancy

Consult your doctorIf you are pregnant, think you may be pregnant or are planning to have a baby,
ask your doctor for advice before receiving INSUPEN PRO+BASALOG REFIL INITIATION
KIT. Careful control of your diabetes, particularly the management of
hypoglycemia, is important for the health of the baby. The dose will be adjusted
by your doctor.

!### Breastfeeding

Consult your doctorInform your doctor if you are breastfeeding before receiving INSUPEN PRO+BASALOG
REFIL INITIATION KITas it is not known if it is excreted in breast milk. The
dose and diet will be adjusted by your doctor.

!### Driving and Using Machines

Use with CautionDo not drive or use machines while receiving INSUPEN PRO+BASALOG REFIL
INITIATION KIT as your blood sugar can be low or high and your concentration and
ability to react might be affected. Consult your doctor if you have frequent
episodes of hypoglycemia.

!### Alcohol

Consult your doctorAvoid consum
INITIATION KIT as it can raise or lower your blood sugar levels.

!### Kidney

Use with CautionINSUPEN PRO+BASALOG REFIL INITIATION KIT should be used with caution in patients
with kidney disease. Your dose will be adjusted depending on your age, body
weight and disease condition. Consult your doctor before receiving INSUPEN
PRO+BASALOG REFIL INITIATION KIT.

!### Liver

Use with CautionINSUPEN PRO+BASALOG REFIL INITIATION KIT should be used with caution in patients
with liver disease. Your dose will be adjusted depending on your age, body
weight and disease condition. Consult your doctor before receiving it.

!### Allergy

ContraindicatedBefore receiving INSUPEN PRO+BASALOG REFIL INITIATION KIT inform your doctor if
you are allergic to Insulin glargine, or any of the other ingredients in this
medicine.

!### Heart Disease

Use with CautionINSUPEN PRO+BASALOG REFIL INITIATION KIT should be used with caution in patients
with heart disease or stroke. Consult your doctor before receiving INSUPEN
PRO+BASALOG REFIL INITIATION KIT.

!### Use In Pediatrics

ContraindicatedINSUPEN PRO+BASALOG REFIL INITIATION KIT is not recommended for use in children
below 2 years of age. Consult your doctor before receiving INSUPEN PRO+BASALOG
REFIL INITIATION KIT.

!### Use In Geriatrics

Use with CautionINSUPEN PRO+BASALOG REFIL INITIATION KIT should be used with caution in patients
above 65 years of age. The dose will be adjusted, and regular blood and kidney
tests will be conducted. Consult your doctor before receiving INSUPEN
PRO+BASALOG REFIL INITIATION KIT.

Others

INSUPEN PRO+BASALOG REFIL INITIATION KIT is not recommended for use if you:

• hypersensitivity to the contents of this medicine

Before receiving INSUPEN PRO+BASALOG REFIL INITIATION KIT, inform your doctor if
you:

• are not well or have a major injury
• are not eating enough
• are going abroad, travelling over different time zones may affect your need for insulin

Interactions

A. Drug-Drug interactions:

Before receiving INSUPEN PRO+BASALOG REFIL INITIATION KIT, inform your doctor if
you are taking any of the following medicine:

• other medicines for the management of diabetes (metformin, repaglinide etc.)
• monoamine oxidase inhibitors (MAOI) (used to manage depression) (phenelzine, selegiline)
• beta-blockers (used to manage high blood pressure) (metoprolol, atenolol, clonidine, guanethidine and reserpine)
• angiotensin-converting enzyme (ACE) inhibitors (used to manage certain heart conditions or high blood pressure) (benazepril, captopril, disopyramide)
• salicylates (used to relieve pain and lower fever) (aspirin, pentoxifylline, propoxyphene)
• sulphonamides (used to manage infections). (Bactrim, cotrim)
• oral contrace
• thiazides (used to manage high blood pressure or excessive fluid retention) (chlorothiazide, diazoxide)
• glucocorticoids (such as ‘cortisone’ used to manage inflammation)
• thyroid hormones (used to manage thyroid gland disorders)
• growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced influence on the body’s metabolic processes like somatropin)
• danazol (medicine acting on ovulation)
• pioglitazone (tablets used for the management of type 2 diabetes)
• disopyramide (used to manage certain heart conditions)
• fluoxetine (used to manage depression)
• fibrates (used to lower high levels of blood lipids)
• diuretics (used to manage high blood pressure or excessive fluid retention)
• glucagon (pancreas hormone used to manage severe hypoglycaemia)
• isoniazid (used to manage tuberculosis)
• phenothiazine derivatives, lithium salts (used to manage psychiatric disorders), atypical antipsychotic medicines (such as olanzapine and clozapine)
• sympathomimetic medicines (such as epinephrine, salbutamol, and terbutaline used to manage asthma)
• protease inhibitors (Ex. darunavir, indinavir used to manage HIV)
• pentamidine (used to manage some infections caused by parasites)

Overdosage:

INSUPEN PRO+BASALOG REFIL INITIATION KIT will be administered to you only by a
doctor or a nurse in a hospital, so it is unlikely to receive an overdose.
However, consult your doctor or nurse if you experience any unusual symptoms of
low blood sugar.

Synopsis

Drug	:	Insulin glargine
Pharmacological Category	:	Antidiabetic
Therapeutic Indication	:	Diabetes mellitus
Dosage Forms	:	Injection, Cartridge, Prefilled pen

More Information

• Keep INSUPEN PRO+BASALOG REFIL INITIATION KIT out of reach from children
• Store in a refrigerator (2°C to 8°C)

FAQs About INSUPEN PRO+BASALOG REFIL INITIATION KIT

Q: What is INSUPEN PRO+BASALOG REFIL INITIATION KIT used for?

A: INSUPEN PRO+BASALOG REFIL INITIATION KIT is used to manage diabetes mellitus.
Diabetes mellitus is a disease where the body does not produce enough insulin to
control the level of blood sugar, resulting in high blood sugar levels.

Q: What should I do if I experience low blood sugar during management with
INSUPEN PRO+BASALOG REFIL INITIATION KIT?

A: Eat glucose tablets or high-sugar snacks (sweets, biscuits, fruit juice) if
you experience low blood sugar while taking INSUPEN PRO+BASALOG REFIL INITIATION
KIT. Measure your blood sugar and rest. Carry glucose tablets or sugar snacks
with you in case of emergencies.

Q: Can I receive INSUPEN PRO+BASALOG REFIL INITIATION KIT during pregnancy?

A: If you are pregnant, think you may be pregnant, or are planning to have a
baby, ask your doctor for advice before receiving INSUPEN PRO+BASALOG REFIL
INITIATION KIT. Careful control of your diabetes, particularly the management of
hypoglycemia, is important for the health of your baby. The dose will be
adjusted by your doctor.

Q: Can INSUPEN PRO+BASALOG REFIL INITIATION KIT be used in patients with
kidney and liver problems?

A: INSUPEN PRO+BASALOG REFIL INITIATION KIT should be used with caution in
patients with liver and kidney disease. Your dose will be adjusted depending on
your age, body weight, and disease condition. Consult your doctor before
receiving INSUPEN PRO+BASALOG REFIL INITIATION KIT.

Q: How does INSUPEN PRO+BASALOG REFIL INITIATION KIT work?

A: INSUPEN PRO+BASALOG REFIL INITIATION KIT lowers blood glucose levels due to
the facilitated uptake of glucose following the binding of insulin to receptors
on muscle and fat cells, inhibiting glucose output from the liver. Your doctor
might also want you to make certain lifestyle changes, like eating a healthy
diet, not skipping meals, maintaining your weight, quitting alcohol and smoking,
and exercising regularly.

Useful Diagnostic Tests

• Blood sugar tests
• Urine tests