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FORZIGA ™ 10 mg film-coated tablet. Taken orally.
Active ingredient
Each film-coated tablet contains 10 mg dapagliflozin (12.3 mg as dapagliflozin propanediol monohydrate).
Excipients
Microcrystalline cellulose, lactose anhydride (derived from bovine milk), crospovidone, silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide (E171), polyethylene glycol 3350, talc, yellow iron oxide (E172)
This medication is subject to additional monitoring. This triangle will enable fast identification of new safety information. You can help by reporting any side effects that occur. You can see the end of Chapter 4 to learn how to report side effects.
2. What is FORZIGA and what is it used for?
• FORZIGA is a yellow, biconvex, about 1.1 x 0.8 cm, diamond-shaped, film-coated tablet. It has "10" on one side and "1428" on the other. FORZIGA is available in blisters of 28 or 90 tablets in cardboard boxes.
• FORZIGA contains 10 mg dapagliflozin (as Dapagliflozin propanediol monohydrate) as an active ingredient. FORZIGA containing dapagliflozin belongs to a group of medicines called oral antidiabetics.
• FORZIGA is used in the treatment of a type of diabetes mellitus called “Type 2 diabetes” in adult patients (18 years of age and above). If you have type 2 diabetes, your pancreas cannot adequately produce insulin, an enzyme that lowers the amount of sugar in your blood, or your body cannot properly use the insulin produced by the pancreas. As a result, the sugar level in your blood rises.
• FORZIGA works by removing excess sugar from your blood through your urine.
• FORZIGA is used if your diabetes cannot be controlled by other diabetes medication / drugs, diet and exercise.
• If you are intolerant to metformin, your doctor may suggest that you take FORZIGA alone or take it with other drugs used in the treatment of diabetes. FORZIGA can be used in combination with another drug administered orally and / or by injection, or with insulin or GLP-1 receptor agonist that lowers the amount of sugar in your blood.
Continue to follow the dietary and exercise recommendations of your doctor, pharmacist or nurse.
important to you.
3. How to use FORZIGA?
Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor, pharmacist or nurse.
Instructions for proper use and dose / frequency of administration
• The recommended dose is one 10 mg tablet every day.
• If you have liver problems, your doctor may start your treatment with a 5 mg dose.
• Your doctor will prescribe the dose that is right for you.
Application route and method
• The tablet should be swallowed with half a glass of water.
• You can take the tablet with or without food.
• You can take your tablet at any time of the day, but try to take it at the same time each day. This will help you remember to take your tablet.
Diet and exercise
To control your diabetes, you must stick to your diet and exercise, even while taking this drug. Therefore, it is important that you continue to follow the dietary and exercise recommendations provided by your doctor, pharmacist or nurse. In particular, if you are on a diabetic weight control diet, continue to follow this while taking FORZIGA.
Different age groups
Use in children
Use in the elderly
Use in the elderly:
FORZIGA is not recommended for elderly patients over 75 years of age.
If you have an impression that the effect of FORZIGA is too strong or too weak, talk to your doctor or pharmacist.
Special use cases
Kidney failure:
In patients with glomerular filtration rate [GFR] <60 mL / min, FORZIGA should not be started and should be stopped if the GFR is consistently below 45 mL / min.
Liver failure:
No dosage adjustment is required for patients with mild or moderate hepatic impairment. An initial dose of 5 mg is recommended in patients with severe hepatic impairment. If well tolerated, the dose can be increased to 10 mg.
If you use more FORZIGA than you should
If you have used more than you should use FORZIGA, talk to a doctor or pharmacist.
Take the medicine box with you.
If you forget to use FORZIGA
What you do if you forget to take a tablet depends on how long you have to take your next dose.
• If it is 12 hours or more before the next dose, take the FORZIGA dose as soon as you remember. Take your next dose at the usual time.
• If it is less than 12 hours before your next dose, skip the missed dose. Take your next dose at your usual time.
Do not take a double dose to make up for forgotten doses.
Effects that may occur when treatment with FORZIGA is terminated:
Do not stop using FORZIGA without consulting your doctor. Your blood sugar may rise when you are not taking this drug.