Januvia

• Diabetes medicine
• Type 2 diabetes
• Not to be used while pregnant or breastfeeding

Januvia is a diabetes medicine. It contains the active substance sitagliptin.

Januvia is used to lower blood sugar in adult patients with type 2 diabetes. This type of diabetes is characterised by insufficient production of insulin in the pancreas, or the body’s inability to process insulin. This can lead to too high levels of glucose in the blood and cause damage to blood vessels, nerves and organs.

Januvia helps to improve the levels of insulin produced by your own body after a meal and decreases the amount of sugar made by the body.

This medicine should be used as directed by a doctor.

The tablet should be swallowed whole with some water. Januvia can be taken with or without food. Your doctor may prescribe this medicine as standalone treatment or in combination with other types of diabetes medicine.

Dosage

Dosage varies per person and is determined by a doctor for each specific patient depending on the symptoms. The general guidelines for use are listed below.

• Adults: one tablet once a day.

This medicine is not suitable for use in children and adolescents under 18 years of age.

Alcohol/driving

Januvia has no or negligible influence on the ability to drive and use machines.

When Januvia is used in combination with another type of diabetes medicine low blood sugar (hypoglycemia) can occur. This can cause symptoms such as blurred vision, tremor and concentration difficulties.

Driving when your blood sugar is low can be dangerous. Therefore, always make sure your blood sugar is stable when taking part in traffic.

Taken too much/forgot to take/stop taking Januvia

If you take more Januvia tablets than prescribed by your doctor, contact your doctor or pharmacist immediately.

If you forget to take a tablet, take it as soon as you remember unless it is time for your next scheduled dose. In this case, just skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a forgotten one.

Do not stop taking Januvia without consulting a doctor first.

Do not use Januvia if you are allergic to sitagliptin or to any of the ingredients in this medicine (see section 'What Januvia contains').

When should this medicine be used with caution?

Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving Januvia (see section 'Side effects'). Tell your doctor if you have or have had:

• A disease of the pancreas (such as pancreatitis), gallstones, alcohol dependence, or very high levels of triglycerides (a form of fat) in your blood. These medical conditions can increase your chance of getting pancreatitis.
• Type 1 diabetes, diabetic ketoacidosis, or kidney problems.
• An allergic reaction to Januvia.

This medicine is unlikely to cause low blood sugar because it does not work when your blood sugar is

low. However, when Januvia is used in combination with sulfonylurea medicine or with insulin, low blood sugar (hypoglycemia) can occur. Your doctor may reduce the dose of your medicine.

Pregnancy and breastfeeding

Do not use Januvia if you are pregnant or breastfeeding.

Other medicines and Januvia

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including herbal remedies and medicines obtained without a prescription.

Medicines can cause side effects, although some people may not experience any. The side effects that are known to be associated with Januvia include:

• Inflammation of the pancreas (pancreatitis). (Frequency cannot be estimated from the available data.) Pancreatitis is a serious, potentially life-threatening, disease. Stop using Januvia and contact a doctor immediately if you notice any of these side effects: severe and persistent pain in the abdomen (stomach area) with or without nausea and vomiting, as these could be signs of pancreatitis.
• If you have a serious allergic reaction (frequency not known), including rash, hives, blisters on the skin/peeling skin and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing, stop taking this medicine and call your doctor right away. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.

Some patients have experienced the following side effects after adding sitagliptin to metformin:

• Common (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting.
• Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhoea, constipation, drowsiness.

Some patients have experienced different types of stomach discomfort when starting the combination of sitagliptin and metformin together.

Some patients have experienced the following side effects while taking sitagliptin in combination with a sulfonylurea:

• Common: low blood sugar.

Some patients have experienced the following side effects while taking sitagliptin in combination with a sulfonylurea and metformin:

• Very common (may affect more than 1 in 10 people): low blood sugar.
• Common: constipation.

Some patients have experienced the following side effects while taking sitagliptin and pioglitazone:

• Common: low blood sugar and flatulence. Some patients have experienced swelling of the feet while taking sitagliptin in combination with pioglitazone.

Some patients have experienced the following side effects while taking sitagliptin in combination with pioglitazone and metformin:

• Common: low blood sugar, swelling of the hands or legs.

Some patients have experienced the following side effects while taking sitagliptin in combination with insulin (with or without metformin):

• Common: headache, low blood sugar and flu.
• Uncommon: dry mouth, constipation.

Some patients have experienced the following side effects while taking sitagliptin alone in clinical studies, or during post-approval use alone and/or with other diabetes medicines:

• Common: low blood sugar, headache, upper respiratory infection, stuffy or runny nose and sore throat, osteoarthritis, arm or leg pain.
• Uncommon: dizziness, constipation.
• Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Januvia tablets are available in three strengths: 25 mg, 50 mg and 100 mg. The active substance is sitagliptin. Each Januvia 25-mg, 50-mg and 100-mg film-coated tablet (tablet) contains sitagliptin phosphate monohydrate, equivalent to 25 mg, 50 mg or 100 mg sitagliptin.

The other ingredients are: microcrystalline cellulose (E460), calcium hydrogen phosphate, anhydrous

(E341), croscarmellose sodium (E468), magnesium stearate (E470b), sodium stearyl fumarate.

Film coating: poly(vinyl alcohol), macrogol 3350, talc (E553b), titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).

The manufacturers of Januvia are:

Merck Sharp & Dohme (Italia) S.p.A. Via Emilia, 21
27100 - Pavie
Italy

Merck Sharp & Dohme BV Waarderweg 39
Postbus 581
2003 PC Haarlem
The Netherlands

Read the package leaflet before use. The official package leaflets of Januvia 25 mg, Januvia 50 mg and Januvia 100 mg are available for download here.