Empagliflozin 
F.C. Tablet 
Read this leaflet carefully before you start taking Empagliflozin. There may be new information. This information does not take the place of talking with your doctor about your medical condition and treatment. If you have any questions, ask your doctor or pharmacist. General guidance 
• This medicine has been prescribed for your present disease. Do not pass it on to others with same symptoms. 
• Tell your doctor before taking this medicine if you are taking any other prescription or non-prescription (over-the-counter) medicine or if you have had any unusual or allergic reaction to this medicine or any other medicines, foods, dyes, preservatives. 
• This medicine is available only with your doctor's prescription. 
• Do not take more of this medicine than is recommended on the package label unless otherwise directed by your medical doctor. 
• You need to be prepared for emergency help for a problem caused by your diabetes. It is a good idea to carry an I.D. card in your wallet or purse that says that you have diabetes and a list of all your medicines. Also keep some kind of quick acting sugar to treat low blood sugar. 
• Tell your doctor if you change your diet or the amount of exercise you do. 
Pregnancy and breastfeeding: 
Pregnancy: You should not take Empagliflozin during pregnancy unless your doctor orders you to do so. Talk to your healthcare provider if you become pregnant or think you may be pregnant during treatment with Empagliflozin. Breastfeeding: You should not take Empagliflozin during breastfeeding unless your doctor orders you to do so. Precautions: 
• 
Taking Empagliflozin especially with sulphonylureas or with insulin can cause hypoglycemia, which may cause symptoms such as shaking, sweating, and change in vision and may affect your ability to drive and use machines. Do not drive or use machines if you feel dizzy while taking this medicine. 
• Empagliflozin may increase the risk of genital mycotic and urinary tract infections. Patients with a history of these infections or uncircumcised males are at greater risk for genital mycotic infections. 
• This medicine may cause symptomatic hypotension due to intravascular volume depletion, especially in patients with renal impairment, elderly patients, patients on diuretics, or those with low systolic blood pressure. 
• Use caution in patients with elevated hematocrit at baseline. 
• 
Empagliflozin may cause low-density lipoprotein cholesterol (LDL-C) elevation; 
• Use is contraindicated in severe renal impairment (end-stage renal disease and dialysis patient) 
• Before initiating treatment consider risk factors that may predispose to ketoacidosis; if indicated, consider interruption or discontinuation of therapy. 
Patients presenting with nausea/vomiting, abdominal pain, generalized malaise, and/or shortness of breath should be assessed immediately for ketoacidosis, if indicated, consider interruption of therapy. 
• Interrupt SGLT2 inhibitor treatment in patients who are hospitalized for major surgery or acute serious illness until their condition has stabilized. 
Empagliflozin should not be used for the treatment of diabetic ketoacidosis and in patients with type 1 diabetes mellitus (insulin-dependent). 
• Talk to a doctor immediately if you experience severe pain, tenderness, redness, or swelling in the genital or perianal area with fever of feeling unwell. These symptoms could be a sign of a rare but serious infection called Fournier's 
rious infe gangrene. 
• Your urine may test positive for sugar while taking this medicine. 
Drug Interactions 
Using this medicine with any of the following medicines is not recommended. It is important that your healthcare professional know if you are taking any of the following medicines: alpha-lipoic acid; androgens; hyperglycemia associated agents; insulin; antihypertensive agents; loop diuretics; thiazide and thiazide-like diuretics; MAO inhibitors; pegvisomant, quinolone antibiotics; salicylates; SSRI's; sulfonylureas; teriflunomide. 
Other medical problems: 
Make sure you tell your doctor if you have any other medical problems especially: 
diabetic ketoacidosis, cardiovascular disease, complicated urinary tract infections, heart failure, history of hypotension, patients at increased risk of volume depletion, predisposition to fluid disturbances (e.g. gastro-intestinal illness, concomitant use of diuretics), fracture risk factors, severe liver disease, severe renal impairment, end-stage renal disease, or dialysis. How to take empagliflozin: 
The dose of this medicine will be different for different patients, and the doctor must always tell you how to use the medicine, but the usual dose is: 
• For type 2 diabetes mellitus as monotherapy (if metformin inappropriate)/ Type 2 diabetes mellitus in combination with insulin or other antidiabetic drugs (if existing treatment fails): 
- 
Adult 18-84 years: 10 mg once daily, increased to 25 mg once daily if necessary and if tolerated. 
- 
- Adult 85 years and over: Initiation is not recommended. *Administer once daily in the morning, with or without food. *Dose adjustments due to interactions: Dose of concomitant insulin or drug that stimulate insulin secretion may need to be reduced. 
*Missed dose: If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. 
Side effects 
Every medicine by the side of therapeutic effects may cause some adverse effects, although not everybody gets them. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet: hypoglycemia, urinary tract infection, dyslipidemia, increased LDL cholesterol, increased thirst, nausea, increased urine output, increased hematocrit, genitourinary fungal infection, Hypovolemia, Diabetic ketoacidosis (discontinue immediately), Fournier's gangrene (discontinue and initiate treatment promptly.), dizziness. Storage: 
• Store the medicine below 30°C, away from heat, moisture and direct light, in the original packaging. 
• Keep out of the reach of children. 
• Do not keep outdated medicine or medicine no longer needed. 
Packaging: 
Empagliflozin tablets manufactured by Karen pharmaceutical company are available as: 
•F.C. Tablets containing 10 mg Empagliflozin in a cardboard box containing 3 blisters of 10's with a leaflet. 
• Scored F.C. Tablets containing 25 mg Empagliflozin in a cardboard box containing 3 blisters of 10's with a leaflet. Revision date: December 2021 
Manufacturer: Karen pharmaceutical company, Yazd, Iran Manufacturing site: Karen pharmaceutical company, Yazd, 
Iran 
Address: Karen pharmaceutical company, 24 meters of 
Boulevard, Zeyton, Aghaghia Boulevard, Abrisham 
Khezrabad Industrial town, Yazd, Iran 
Email: info@karenpharma.com Website: www.karenpharma.com 
Karen 
Karen Pharmaceutical Co.