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Januvia 100 Mg 28 Tablets


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JANUVIA® 100 mg film-coated tablet is

taken by mouth.

Active ingredient: 100 mg sitagliptin (128.5 mg sitagliptin phosphate monohydrate) in each film-coated tablet.

Excipients: Microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, sodium stearyl fumarate, polyvinyl alcohol, polyethylene glycol (macrogol), talc, titanium dioxide, red iron oxide, yellow iron oxide.

In this leaflet:

1. What is JANUVIA and what is it used for?

2. Things to consider before using JANUVIA

3. How to use JANUVIA?

4. What are the possible side effects?

5. The titles of Hiding of JANUVIA are


1. What is JANUVIA and what is it used for?

The active ingredient of JANUVIA is sitagliptin and is a member of a class of drugs called DPP-4 (dipeptidyl peptidase-4) inhibitor, which lowers blood sugar in adult patients with Type II Diabetes (Adult type diabetes).

JANUVIA helps to increase the level of insulin produced by the body after eating and reduces the amount of sugar made by the body.

JANUVIA is available in packages of 28 tablets. Each tablet contains 100 mg of active ingredient (sitagliptin).

Januvia'yiDo you have doctors prescribe to help decrease your blood sugar is high due to Type II Diabetes. JANUVIA can be used alone or in combination with other drugs that lower blood sugar (insulin, metformin, sulfonylurea, glitazones) and in combination with the recommended diet and exercise program.

What is Type 2 Diabetes (Type 2 diabetes)?

Type 2 Diabetes (Type 2 diabetes) is a condition where your body cannot secrete enough insulin and the insulin produced cannot be used properly in your body. Your body can also produce a lot of sugar (glucose). This can lead to serious health problems such as heart disease, kidney disease, blindness, amputation (cutting out an organ).

2. Things to consider before using

JANUVIA DO NOT use JANUVIA in the following situations:

If you

are allergic (hypersensitive) to Sitagliptine or any component of the drug.

USECAREFULLY in the following cases:

JANUVIAPancreatic inflammation (pancreatitis) has been reported in patients receiving JANUVA (see Chapter 4 "What are the possible side effects?").

Tell your doctor if the following applies to you in the past or now.

If you have

pancreatic disease (eg pancreatitis), if you have

gallstones, alcohol dependence, or increased blood levels of triglyceride (a type of fat). These medical conditions increase your chances of developing pancreatic inflammation (see Chapter 4 'What are the possible side effects?').

If you have Type I Diabetes, If you have

diabetic ketoacidosis (a condition with high blood sugar, rapid weight loss, nausea or vomiting)

,from the past or still persistent

If you have an allergic reaction to JANUVIA,

JANUVIA is unlikely to cause low blood sugar because JANUVIA has no effect when your blood sugar is low. If you are taking another sugar medicine or insulin that contains an active substance called sulfonylurea with JANUVIA, your blood sugar may drop. Your doctor may reduce the dose of your sulfonylurea or insulin treatment.

Some people who use medicines called DPP-4 inhibitors, including JANUVIA, may experience severe joint pain. If you have severe joint pain, consult your doctor.

It should not be used in children under 18 years of age. The use of JANUVIA in children under 18 has not been studied.

If these warnings are valid for you, even at any time in the past, please consult your doctor.

Using JANUVIA with food and drink:

JANUVIA can be taken with or without food and drink.


Consult your doctor or pharmacist before using the medicine.

If you are pregnant, think you are pregnant or plan to become pregnant, consult your doctor or pharmacist before using JANUVIA. You should not use JANUVIA during pregnancy.

If you notice that you are pregnant during your treatment, consult your doctor immediately.


Consult your doctor or pharmacist before using the medicine.

It is not known whether JANUVIA passes into breast milk. You should not use JANUVIA if you plan or are breastfeeding.

Driving and using machines

JANUVIA has no effect on the ability to drive or use machines or is negligible. However, dizziness and drowsiness have been reported, which may affect the ability to drive and use machines.

Using JANUVIA with drugs called sulfonylureas or insulin can cause your blood sugar to drop, which can affect your ability to drive or use machines.

Important information about some of the ingredients of JANUVIA

This medicinal product contains less than 1 mmol (23 mg) sodium (8.00 mg croscarmellose sodium and 12.00 mg sodium stearyl fumarate) in each tablet; that is, it contains an amount of sodium that can be neglected in a controlled sodium diet. No warning related to sodium is required.

Use with other medicinesyou are using

Tell your doctor, especially ifdigoxin (a medicine used to treat irregular heart rhythm or other heart problems). If used together with Januvia, it may be necessary to check the level of digoxin in your blood.

Drugs with strong CYP3A4 suppressors (e.g., ketoconazole (used to treat internal fungal infections)), itraconazole (used to treat fungal infections), ritonavir (used to treat HIV / AIDS), and clarithromycin (used to treat bacterial infections) in patients with kidney failure or end-stage kidney disease. )) sitagliptin is likely to change blood levels.

If you are currently using any prescription or non-prescription medicine, or if you have used it recently, please inform your doctor or pharmacist about them.

3. How to use JANUVIA?

Instructions for proper use and dose / frequency of application:

Always use JANUVIA exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

Recommended dose to use:

100 mg tablet once a day.administration

Method and method of: You

should take it orally.

You can take it on an empty stomach or with food.

If you have kidney problems, your doctor may prescribe lower doses (eg 25 mg or 50 mg).

Keep taking JANUVIA as long as your doctor prescribes you to help control your blood sugar.

Your doctor may prescribe JANUVIA alone or in combination with other certain medications that lower blood sugar.

Diet and exercise can help your body use blood sugar more efficiently. It is important that you adhere to the diet and exercise program recommended by your doctor while you are taking Januvia.

Different age groups::

Use in childrenShould

not be used in children under 18 years of age. The use of JANUVIA in children under 18 has not been studied.

Use in the elderly:

Studies have shown that JANUVIA is well tolerated in the elderly. Depending on the age, no special dosage adjustment is required.

Do not forget to take your medicine.

Special use cases:

Kidney failure:

While the combined use of JANUVIA with another antidiabetic product is considered, the conditions of use of the other product in patients with kidney disease should be reviewed.

No dosage adjustment is required in patients with mild renal impairment.

The dose of Januvia is 50 mg once daily in patients with moderate renal impairment.

The dose of Januvia is 25 mg once daily in patients with severe kidney impairment or end-stage kidney disease (SEBH) requiring hemodialysis or peritoneal dialysis. JANUVIA can be applied regardless of the time entered on dialysis.

It is recommended to periodically evaluate the kidney function before and after starting JANUVIA, as the kidney function needs dose adjustment.

Liver failure:

Dose adjustment is not required in patients with mild to moderate hepatic impairment.

There are no clinical studies with patients with severe hepatic impairment.

If Januvia'Doyou have the impression that the effect of a very strong or weak Talk to your doctor or pharmacist if you are. Your doctor or pharmacist will decide whether any treatment is required.

If you have used more JANUVIA than you should use:

If you have used more than you should use from JANUVIA, talk to a doctor or pharmacist immediately.

Januvia'tyou forget to use:

If you forget to take Januvia take a dose soon as you remember. If you do not remember until the next dose, skip the forgotten dose and continue using the drug according to your old calendar.

Do not take a double dose to make up for a forgotten dose.

Effects that may occur when treatment with JANUVIA is terminated: To

help control your blood sugar, continue taking the medicine as long as your doctor prescribes it. Do not stop treatment unless indicated by your doctor.

If you have any further questions on the use of JANUVIA, ask your doctor or pharmacist.

4. What are the possible side effects?

Like all medicines, side effects can occur in people sensitive to the ingredients of JANUVIA. Studies generally had mild side effects and did not cause patients to stop taking JANUVIA. The side effects reported in patients treated with Januvia are similar to those seen in patients treated with a drug-free tablet (placebo).

Very common side effects (more than 1 in 10 patients)

Common side effects (Less than 1 in 10 patients but more than 1 in 100 patients)

Uncommon side effects (less than 1 in 100 patients but more than 1 in 1000 patients )

rare (more than 1,000 patients to one of the least but 10,000 patients 1)

Very rare (10000 least patient 1)

Frequency unknown (can not be estimated from the data available)

if one of the following, please stop using the januvıa and tell your doctor immediately orto the emergency department of the hospital closest to you:

applySevere and persistent pain in your abdomen that can also hit your back with or without vomiting and nausea; these may be symptoms of pancreatic inflammation (pancreatitis).

If you experience serious allergic reactions (unknown frequency), including rash, hives, blisters on the skin / skin peeling, swelling of the face, lips, tongue, and throat (unknown frequency), stop taking JANUVIA immediately and call your doctor. Your doctor may give you a medicine to treat your allergic reaction and prescribe you a different medicine for your diabetes.

When you start together on metformin with Januvia have been reported following side effects:


low blood sugar (hypoglycemia)

Nausea and

stomach, intestinal gas



Abdominal pain




Some patients sitagliptin and metformin have experienced stomach discomfort when starting the combination (frequency is common).

When a sulfonylurea and metformin used in combination with Januvia have been reported following side effects:


common:low blood sugar



when starting together pioglitazone withJanuvia following side effects have been reported:


stomach, intestinal gas

in the hand,feet swelling

the following is withJanuvia to metformin and pioglitazone used Side effects have been reported:


Swelling in the hands or legs.

When using JANUVIA with insulin (with or without metformin), the following side effects have been reported:




Dry mouth

The following side effects When using JANUVIA alone and / or in combination with other diabetes medications Reported:


Low blood sugar

Upper respiratory tract infection

Nasal congestion or discharge and sore throat

Osteoarthritis (joint disease)

Arm or leg pain


Common not:




Frequency unknown:

Kidney problems (sometimes requiring dialysis)


Joint pain

Muscle pain

Back pain

Interstitial lung disease (Difficulty breathing in the lungs)

Cutaneous vasculitis (Inflammation of the blood vessels in the skin))

Bullous pemphigoid (Multiple and enlarged blisters on the skin)

reporting of side effects,

your doctor in case of occurrence of any side effects not listed or located in the Operating Instructions, please talk with your pharmacist or nurse. In addition, the side effects you are experiencing www.titck.gov.t is located in the sites "Drug Side Impact Statement" by clicking on the icon or 0800314 00 08 number one side effect reporting line by calling Turkey Farmaokovijilans Center (TÜFAM) 'What do you notice. By reporting side effects, you will contribute to obtaining more information about the safety of the drug you are using.

If you encounter any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

5. How to store januvia

Januvia'schildren will see Keep out of the reach and in its package.

It should be stored at room temperature below 30 ° C.

Use in accordance with the expiration date.

Do not use JANUVIA after the expiration date on the outer box.