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It is taken orally.
Each film-coated tablet contains 25 mg of empagliflozin.
Tablet core: Lactose monohydrate (derived from cow's milk) (For warnings see "Important information about some excipients contained in JARDIANCE"), microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate
Film coating: Hypromellose, titanium dioxide (E171), talc, macrogol (400), yellow iron oxide (E 172)
Ilaç This medicine 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. See the end of Chapter 4 to learn how to report side effects.
2.What is JARDIANCE and what is it used for?
JARDIANCE 25 mg film-coated tablets are oval, light yellow, two-sided convex film-coated tablets. "S25" is printed on one side and the Boehringer Ingelheim logo on the other. Tablets are 11.1mm long and 5.6mm wide.
JARDIANCE tablets are available in unit-dose PVC / aluminum blisters and in pack sizes of 30 film-coated tablets.
JARDIANCE contains empagliflozin as an active ingredient. Empagliflozin acts by blocking a protein called sodium-glucose-co-transporter 2 (SGLT-2) found in the kidneys. SGLT-2 allows blood sugar to be absorbed and pass into the bloodstream while the blood is filtered from the kidneys and prevents its excretion with urine. This drug blocks this protein, causing the blood sugar (glucose), sodium (salt) and water to be excreted in the urine. Your blood sugar level, which is too high due to your type-2 diabetes, will thus drop. This medicine may also help prevent heart disease.
• JARDIANCE is used in adult patients (18 years of age and above) to treat type 2 diabetes (diabetes) that cannot be controlled by diet and exercise alone.
• JARDIANCE can be used alone and without other medicines in patients who are not able to take metformin (another diabetes medicine).
• JARDIANCE can be used in combination with other medicines to treat diabetes. These drugs can be taken orally or administered by injection, such as insulin.
It is extremely important that you continue with the diet and exercise program that your doctor, pharmacist or nurse has told you.
3.How to use JARDIANCE?
Always use your medicine exactly as your doctor has told you. If there is anything you are not sure about, talk to your doctor or pharmacist.
- The starting dose of JARDIANCE is 10 mg once a day. Your doctor will decide whether to increase your dose to 25 mg once a day.
If you have a kidney problem, your doctor may limit your dose to 10 mg once a day.
- Your doctor will choose the right drug unit dose for you. Do not change the dose of your medication unless your doctor tells you to.
4. What are the possible side effects?
Like all medicines, people who are sensitive to the substances contained in JARDIANCE may have side effects.
Side effects are listed as shown in the following categories:
Very common: It can be seen in at least 1 of 10 patients.
Common: It can affect up to 1 in 10 patients.
Uncommon: It can affect up to 1 in 100 patients.
Rare: It can affect up to 1 in 1,000 patients.
Very rare: May affect less than one in 10,000 patients.
Unknown: It cannot be estimated from the available data.
Allergic reactions - not known
Severe allergic reaction (may include swelling of the face, lips, mouth, tongue or throat, causing difficulty in breathing or swallowing). The frequency at which these reactions occur is unknown.
Diabetic ketoacidosis - rare
The following are signs of diabetic ketoacidosis (See Chapter 2. "Things to consider before using JARDIANCE"):
• Increased levels of "ketone bodies" in your urine or blood
Fast weight loss
Nausea or vomiting
• Stomache ache
• Fast and deep breathing
Unusual sleepiness or tiredness
A sweet smell in your breath, a sweet or metallic taste in your mouth, or a difference in the smell of your urine or sweat.
This condition can occur regardless of your blood sugar level. Your doctor may decide to temporarily or permanently stop your treatment with JARDIANCE.
These are all very serious side effects. If you have one of these, you may need urgent medical attention or hospitalization.
If any of the following occur, contact your doctor as soon as possible.
Low blood sugar (hypoglycaemia) - very common
There is a higher risk of low blood sugar levels if you take JARDIANCE with another medicine that can cause low blood sugar (such as a sulphonylurea or insulin).