Ryzodeg 100IU Penfill Cartridge

INTRODUCTION

RYZODEG PENFILL 100IU CARTRIDGE is a combination of Insulin Aspart and Insulin Degludec which belongs to the group of medicines called Antidiabetic agents. It is used to treat diabetes mellitus (both Type I and Type II). Diabetes mellitus is a chronic disease characterized by abnormally high levels of glucose in the blood. It is caused either 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. RYZODEG PENFILL 100IU CARTRIDGE is suitable for use both in adults and in children (aged 6 years or older). It must be injected beneath the skin (such as on the thigh, upper arm or abdomen). Avoid sharing needles, as it may increase the risk of infections. Along with the treatment, avoid smoking and alcohol consumption, and diet with regular physical activity as advised by your doctor. Talk to your doctor before starting therapy with RYZODEG PENFILL 100IU CARTRIDGE if you have any liver, kidney or heart problems. You must also inform your doctor if you have any hormonal problems, made sudden changes to your diet or perform intense exercise as a precaution. Do not use this medicine if you have hypoglycemia (low blood sugar levels). Consult your doctor before using this medicine if you are pregnant or breastfeeding. The most common side effects of receiving RYZODEG PENFILL 100IU CARTRIDGE are low blood sugar levels, pain, redness, itching, swelling or thickening at the injection site, lump formation under the skin and swelling of body parts. Consult your doctor if any of these side effect troubles you.

• Treats diabetes mellitus (both type I and type II)

RYZODEG PENFILL 100IU CARTRIDGE helps your body to make utilize of the circulating blood glucose. It helps in the transport of glucose from the blood into the muscles and fat tissues. It also stops the production of glucose by the liver. As a result, it controls blood sugar levels and improves sugar control in patients with diabetes mellitus.

DIRECTIONS FOR USE

Always inject this medicine into your thighs, buttocks, upper arm, or abdomen (i.e., subcutaneously). Do not administer this medicine into the vein or muscle directly. It should be administered 30 minutes before meals. Eat a meal or snack containing carbohydrates within 30 minutes of the injection to avoid low blood sugar. Before administration, roll the vial/cartridge between your hands until the liquid becomes uniformly white and cloudy. While injecting, keep the needle under the skin for at least 6 seconds to make sure that the entire dose is injected. Prior to the administration, visualize the cartridge/vial for any visible particulate matter and discoloration. Discard the needle and syringe after use and do not share your needles with others to avoid the risk of transmission of infections. Avoid repeatedly injecting the medicine at the same site to prevent skin damage. Instead, rotate the injection site. Make sure to consult your doctor before changing the injection site as a precaution. RYZODEG PENFILL 100IU CARTRIDGE should not be mixed with any other insulins before use. Do not stop therapy with RYZODEG PENFILL 100IU CARTRIDGE without consulting your doctor. Your doctor will decide correct dose and frequency of administration depending upon your age, body weight and health condition.

SIDE EFFECTS OF RYZODEG PENFILL 100IU CARTRIDGE

HOW TO MANAGE SIDE EFFECTS

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions: Before RYZODEG PENFILL 100IU CARTRIDGE is administered, inform your doctor if you are taking any of the following medicines such as:

• Other medicines used to treat diabetes such as sulfonylureas (Ex. tolbutamide, glibenclamide, glipizide), biguanides (Ex. metformin, phenformin), thiazolidinediones (Ex. pioglitazone), DPP-4 inhibitors (Ex. sitagliptin, vildagliptin) or SGLT-2 inhibitors (Ex. remogliflozin)
• Medicines used to treat depression such as monoamine oxidase inhibitors (Ex. rasagiline, selegiline, phenelzine)
• Medicines used to treat high blood pressure and other heart problems such as beta-blockers (Ex. propranolol, atenolol, nebivolol) or ACE inhibitors (Ex. captopril, enalapril, lisinopril)
• Salicylates (used to relieve pain or fever) Ex. aspirin
• Anabolic steroids (used to build muscle and improve athlete performance) Ex. testosterone, nandrolone, oxandrolone
• Sulfonamide antibiotics (used to treat bacterial infections) Ex. sulfasalazine, sulfadiazine, sulfamethoxazole
• Oral contraceptives (birth control pills) Ex. mifepristone,
• Thiazide diuretics (used to increase urine output and reduce blood pressure) Ex. chlorothiazide, hydrochlorothiazide
• Glucocorticoids (used to treat inflammation) Ex. cortisone, betamethasone, beclomethasone, dexamethasone, budesonide, prednisone
• Thyroid hormone (used to treat thyroid disorders) Ex. thyroxine, triiodothyronine
• Sympathomimetic agents (used to treat asthma or other circulatory disorders) Ex. ephedrine, adrenaline, salbutamol, or terbutaline
• Growth hormone (a hormone used to increase skeletal and somatic growth in the body)
• Danazol (a medicine used to treat endometriosis)
• Octreotide (used to treat diarrhea)
• Lanreotide (a medicine used to treat abnormal body growth)

B. Interaction with food or drink: RYZODEG PENFILL 100IU CARTRIDGE should be administered 30 minutes before a meal. Overdosage: If you or anyone else took too much of this medicine, contact your doctor immediately or go to a hospital straight away as it may cause severe hypoglycemia. Symptoms of hypoglycemia might include fainting, feel unwell, sweating, vomiting, difficulty in breathing, fast heartbeat, and dizziness.

SYNOPSIS

Drug	:	Insulin Aspart, Insulin Degludec
Pharmacological Category	:	Insulin Analogs
Therapeutic Indication	:	Diabetes mellitus
Dosage Forms	:	Injection, Flex pen

MORE INFORMATION

• Keep out of reach of children
• Store the unopened pack in the refrigerator at 2-8°C. Do not freeze
• During use or when carried as a spare, keep it at room temperature
• Always place the vial/cartridge in the outer carton to protect from light
• Do not use the medicine after 28 days of opening