Tresiba 100IU Flex Touch Pen(Prefilled) 1X3ml

Introduction About TRESIBA 100IU FLEX TOUCH PEN(PREFILLED)

TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) contains Insulin Degludec, which belongs
to a group of medicines called Antidiabetics. TRESIBA 100IU FLEX TOUCH
PEN(PREFILLED) is used to manage diabetes mellitus (high blood sugar) in adults,
adolescents, and children (aged 1 year and above).

TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) is also used in combination with oral or
other injectable antidiabetic medicines to manage type 2 diabetes mellitus. The
medicine is also indicated for use to manage type 1 diabetes mellitus when used
in combination with meal-related rapid-acting insulin medicines in affected
individuals.

Before administering TRESIBA 100IU FLEX TOUCH PEN(PREFILLED), inform your doctor
if you have abnormally low or high blood sugar levels, eye disorders, poor
eyesight, liver, and/or kidney problems.

TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) should be used with caution during
pregnancy and by women planning for pregnancy. It is also advised to be
administered with caution to breastfeeding women.

TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) should be used with caution in children
and adolescents (aged 1 to 18 years) and is advised to be used with caution in
elderly patients (aged 65 years and above) after consulting your doctor.

The most common side effects associated with the use of TRESIBA 100IU FLEX TOUCH
PEN(PREFILLED) are low blood sugar levels (associated with symptoms such as
sweating, tiredness, dizziness, and/or feeling increased hunger) and injection
site reactions (such as pain, redness, itchy welts, swelling, and/or itching).
Consult your doctor if any of these symptoms worsen.

Uses Of TRESIBA 100IU FLEX TOUCH PEN(PREFILLED)

• To manage diabetes mellitus

How TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) Works

TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) works by enhancing the body tissues to
rapidly uptake glucose from the blood, which results in a controlled blood
glucose level, thus managing diabetes mellitus and its associated symptoms in
affected individuals.

How to use TRESIBA 100IU FLEX TOUCH PEN(PREFILLED)

Administer TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) as advised by your physician.
It is given under the skin (subcutaneously) at specific areas such as the front
of the thighs, upper arms, or the front of the waist (abdomen). Keep changing
the site of injection each day to reduce the risk of developing lumps and skin
pitting.

Insert the needle into the skin as per your doctor’s advice. Ensure that you can
see the dose counter properly. Gently press and hold down the dose button until
the dose counter value returns to zero. Leave the needle under the skin for a
minimum of 6 seconds. Pull the pen straight up from the skin. If blood oozes out
at the injection site, press gently with a cotton swab. Do not rub the bleeding
area.

Your doctor will decide the correct dose and duration for you depending upon
your age, body weight, stress, physical activity, and disease condition.

Side Effects Of TRESIBA 100IU FLEX TOUCH PEN(PREFILLED)

Common

• Injection site reactions such as pain, redness, itchy welts, swelling, and/or itching
• Signs of a low blood sugar level, such as sweating, tiredness, dizziness, increased hunger, and/or tingling lips

Uncommon

• Swelling around your joints

Rare

• Signs of allergic reactions, such as itchy welts and swelling of the tongue and lips
• Diarrhoea, nausea
• Tiredness
• Itching

Stop using TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) and contact your doctor if
you experience any of the following side effects:

• Signs of serious hypoglycemia (a condition marked by very low blood sugar levels) such as looking pale (pallor), shakiness, dizziness or lightheadedness, sweating, and/or nausea
• Signs of a serious allergic reaction, such as local reactions (redness, itching, and rashes) spreading to other parts of your body, a sudden feeling of being unwell with sweating, vomiting, difficulty breathing, a rapid heartbeat, and/or dizziness
• Signs of heart failure such as unusual shortness of breath, rapid increase in weight, and/or localized swelling (oedema)
• Serious injection site reactions such as pain, redness, hives (red itchy skin), swelling, and itching
• Signs of ketoacidosis (a serious complication of diabetes) such as flushing, dryness of skin, sleepiness, tiredness, dry mouth, fruity breath, increased frequency of urination, increased thirst, loss of appetite, nausea, and/or vomiting

How To Manage Side Effects

!### Diarrhea

Drink plenty of water and stay hydrated. Try to avoid taking any medicine on
your own to manage diarrhea. Consult and inform your doctor if the symptom
worsens.

!### Hypoglycemia

Try to have a high-sugar snack (such as sweets, biscuits, or fruit juice).
Measure your blood sugar if possible and take rest. Wait until the signs of
too-low blood sugar disappear or when your blood sugar level has settled.

!### Nausea And Vomiting

Use TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) with or just after a meal. Stick to
simple meals. Avoid eating oil-rich or spicy foods, sugary snacks, and drinks.
Avoid drinking too much liquid along with your meals, and drink slowly in
between meals. Consult your doctor if the condition worsens.

!### Skin rash Or Itching

Try to pat or tap your skin instead of scratching it. Hold a damp towel to cool
your skin. Wear loose clothing and avoid tight clothes or clothes made from wool
or synthetic fabrics. Avoid using perfumed soaps, deodorants, or moisturizers,
and use a skin softener regularly.

!### Tiredness

Make sure you take a rest and drink plenty of fluids. Avoid or limit the
consum
time when you can sit down (or lie down) when the symptoms are at their worst.
Avoid driving or using tools or machinery until you feel well.

Warning & Precautions

!### Pregnancy

Use with CautionTRESIBA 100IU FLEX TOUCH PEN(PREFILLED) should be used with caution during
pregnancy and by women planning to become pregnant. Consult your doctor before
administering the medicine.

!### Breastfeeding

Use with CautionTRESIBA 100IU FLEX TOUCH PEN(PREFILLED) should be used with caution in
breastfeeding women. Consult your doctor before administering the medicine.

!### Driving and Using Machines

Use with CautionDo not drive or operate machines if you experience symptoms associated with too
low blood sugar (such as shaking, sweating, and nervousness) or high blood sugar
(such as increased thirst, tiredness, and blurred vision) after administering
TRESIBA 100IU FLEX TOUCH PEN(PREFILLED).

!### Alcohol

Consult your doctorAvoid consum
PEN(PREFILLED) since it may cause low blood sugar.

!### Kidney

Use with CautionTRESIBA 100IU FLEX TOUCH PEN(PREFILLED) should be used with caution in patients
with kidney problems. Consult your doctor before administering it.

!### Liver

Use with CautionTRESIBA 100IU FLEX TOUCH PEN(PREFILLED) should be used with caution in patients
with liver problems. Consult your doctor before administering it.

!### Allergy

ContraindicatedDo not use TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) if you are allergic to
insulin degludec and/or any other ingredients of this medicine.

!### Use In Pediatrics

Use with CautionTRESIBA 100IU FLEX TOUCH PEN(PREFILLED) should be used with caution in children
and adolescents (aged 1 to 18 years). Consult your doctor before administering
the medicine to the child.

!### Use In Geriatrics

Use with CautionTRESIBA 100IU FLEX TOUCH PEN(PREFILLED) should be used with caution in elderly
patients (aged 65 years and above). Consult your doctor before administering the
medicine.

Others

Before administering TRESIBA 100IU FLEX TOUCH PEN(PREFILLED), inform your doctor
if you:

• Have too low or high blood sugar
• Have eye disorders or poor eyesight

Interactions

A. Drug-Drug interactions:

Before administering TRESIBA 100IU FLEX TOUCH PEN(PREFILLED), inform your doctor
if you are taking any of the following medicines:

• Other medicines for diabetes, such as oral diabetic medicines (Ex. pioglitazone, metformin) and injectable diabetic medicines (Ex. insulin, lispro)
• Sulphonamides (medicines used to manage infections) Ex. sulfadiazine, sulfamethizole
• Anabolic steroids (medicines used to manage deficiency or malfunction of sex hormones) such as testosterone
• Beta-blockers (medicines used to manage high blood pressure) Ex. Metoprolol
• Salicylates (medicines used to manage pain and mild fever) Ex. acetylsalicylic acid or aspirin
• Monoamine oxidase (MAO) inhibitors (medicines used to manage depression) Ex. isocarboxazid
• Angiotensin-converting enzyme (ACE) inhibitors (medicines used to manage some heart problems or high blood pressure) Ex. enalapril
• Medicine used to manage endometriosis Ex. danazol
• Medicines used for contrace
• Medicines used to manage thyroid problems Ex. thyroid hormones
• Medicines used to manage growth hormone deficiency Ex. growth hormone,
• Medicines used to manage inflammation, such as glucocorticoids Ex. cortisone
• Sympathomimetics (medicines used to stimulate the sympathetic nervous system) Ex. epinephrine/adrenaline, salbutamol, terbutaline
• Thiazides (medicines used to manage high blood pressure or water retention in the body) Ex. chlorothiazide
• Medicines used to manage acromegaly (excess production of growth hormone) Ex. octreotide, lanreotide

Overdosage:

If you or anyone else accidentally administers too much of TRESIBA 100IU FLEX
TOUCH PEN(PREFILLED), consult your doctor immediately or visit the nearby
hospital. Symptoms of overdose are low blood sugar associated with symptoms such
as sweating, tiredness, dizziness, increased hunger, and/or tingling lips.

Synopsis

Drug	:	Insulin Degludec
Pharmacological Category	:	Antidiabetics
Therapeutic Indication	:	Diabetes mellitus type 1 and type 2
Dosage Forms	:	Cartridge, Injection

More Information

• Keep TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) out of reach of children
• Store TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) in a refrigerator at 2-8°C

FAQs About TRESIBA 100IU FLEX TOUCH PEN(PREFILLED)

Q: What is TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) used for?

A: TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) is used to manage diabetes mellitus
(high blood sugar) in adults, adolescents, and children (aged 1 year and above).
It is also used in combination with oral or other injectable antidiabetic
medicines to manage type 2 diabetes mellitus. The medicine is also used to
manage type 1 diabetes mellitus when used in combination with meal-related
rapid-acting insulin medicines in affected individuals.

Q: What happens if TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) is administered more than its required dose?

A: If you or anyone else accidentally administers too much of TRESIBA 100IU FLEX
TOUCH PEN(PREFILLED), consult your doctor immediately or visit the nearby
hospital. Symptoms of overdose are low blood sugar associated with symptoms such
as sweating, tiredness, dizziness, increased hunger, and/or tingling lips.

Q: What are the side effects associated with the use of TRESIBA 100IU FLEX TOUCH PEN(PREFILLED)?

A: The most common side effects associated with the use of TRESIBA 100IU FLEX
TOUCH PEN(PREFILLED) are low blood sugar levels (associated with symptoms such
as sweating, tiredness, dizziness, and/or feeling increased hunger) and
injection site reactions (such as pain, redness, itchy welts, swelling, and/or
itching). Consult your doctor if any of these symptoms worsen.

Q: How does TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) work?

A: TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) helps in lowering blood glucose
levels. Insulin degludec works by enhancing the body tissues to rapidly uptake
glucose from the blood, which results in a controlled blood glucose level,
managing diabetes mellitus and its associated symptoms in affected individuals.

Q: Can TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) be administered to pregnant women?

A: Yes, TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) can be administered, but with
caution during pregnancy and for women planning for pregnancy. Consult your
doctor before administering the medicine.

Useful Diagnostic Tests

• HbA1C, Also known as Glycated Hemoglobin, Glycosylated Hemoglobin
• Blood Glucose Fasting (FBS)
• Random Blood Sugar (RBS)
• Post Prandial Blood Sugar (PPBS)
• Insulin-Fasting
• Insulin Postprandial (PP)
• Vital Diabetes Care
• Extended Diabetes Care
• Advance Diabetes Care
• Comprehensive Diabetes Care