Sitagliptin Zentiva 100 mg film-coated tablets – patient leaflet, side effects, dosage

1. What Sitagliptin is and what it is used for

Sitagliptin contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus.

This medicine helps to increase the levels of insulin produced after a meal and decreases the amount of sugar made by the body.

Your doctor has prescribed this medicine to help lower your blood sugar, which is too high because of your type 2 diabetes. This medicine can be used alone or in combination with certain other medicines (insulin, metformin, sulphonylureas, or glitazones) that lower blood sugar, which you may already be taking for your diabetes together with a food and exercise plan.

What is type 2 diabetes?

Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar.

When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems like heart disease, kidney disease, blindness, and amputation.

2. What you need to know before you take Sitagliptin

Do not take Sitagliptin

• if you are allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving sitagliptin (see section 4).

If you encounter blistering of the skin it may be a sign for a condition called bullous pemphigoid. Your doctor may ask you to stop Sitagliptin.

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 (see section 4).
• type 1 diabetes.
• diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting).
• any past or present kidney problems.
• an allergic reaction to sitagliptin (see section 4).

This medicine is unlikely to cause low blood sugar because it does not work when your blood sugar is low. However, when this medicine is used in combination with a sulphonylurea medicine or with insulin, low blood sugar (hypoglycaemia) can occur. Your doctor may reduce the dose of your sulphonylurea or insulin medicine. Children and adolescents

Children and adolescents below 18 years should not use this medicine. It is not effective in children and adolescents between the ages of 10 and 17 years. It is not known if this medicine is safe and effective when used in children younger than 10 years. Other medicines and Sitagliptin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor if you are taking digoxin (a medicine used to treat irregular heart beat and other heart problems). The level of digoxin in your blood may need to be checked if taking with Sitagliptin.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take this medicine during pregnancy.

It is not known if this medicine passes into breast milk. You should not take this medicine if you are breast-feeding or plan to breast-feed.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, dizziness and drowsiness have been reported, which may affect your ability to drive or use machines.

Taking this medicine in combination with medicines called sulphonylureas or with insulin can cause hypoglycaemia, which may affect your ability to drive and use machines or work without safe foothold.

Sitagliptin contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.

Sitagliptin 25 mg contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Sitagliptin

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual recommended dose is:

• one 100 mg film-coated tablet
• once a day
• by mouth

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

You can take this medicine with or without food and drink.

Your doctor may prescribe this medicine alone or with certain other medicines that lower blood sugar.

Diet and exercise can help your body use its blood sugar better. It is important to stay on the diet and exercise recommended by your doctor while taking Sitagliptin. If you take more Sitagliptin than you should

If you take more than the prescribed dosage of this medicine, contact your doctor immediately.

If you forget to take Sitagliptin

If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Sitagliptin

Continue to take this medicine as long as your doctor prescribes it so you can continue to help control your blood sugar. You should not stop taking this medicine without talking to your doctor first.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP taking Sitagliptin and contact a doctor immediately if you notice any of the following serious side effects:

• Severe and persistent pain in the abdomen (stomach area) which might reach through to your back with or without nausea and vomiting, as these could be signs of an inflamed pancreas (pancreatitis) (frequency not known: frequency cannot be estimated from the available data).
• Serious allergic reaction, 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. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes (frequency not known: frequency cannot be estimated from the available data).

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

• nausea
• flatulence
• vomiting
• different types of stomach discomfort when starting the combination of sitagliptin and metformin

Uncommon: may affect up to 1 in 100 people

• stomach ache
• diarrhoea
• constipation
• drowsiness

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

Very common: may affect more than 1 in 10 people

• constipation

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

• flatulence
• swelling of the hands or legs

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

• 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):

• flu

Uncommon: may affect up to 1 in 100 people

• dry mouth

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:

• headache
• upper respiratory infection
• stuffy or runny nose
• sore throat
• osteoarthritis
• arm or leg pain

Uncommon: may affect up to 1 in 100 people

• dizziness
• constipation
• itching

Rare: may affect up to 1 in 1,000 people

• reduced number of platelets

Not known: frequency cannot be estimated from the available data

• kidney problems (sometimes requiring dialysis)
• vomiting
• joint pain
• muscle pain
• back pain
• interstitial lung disease
• bullous pemphigoid (a type of skin blister)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Sitagliptin

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and the carton after ‘EXP’. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions.

Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Sitagliptin contains

• The active substance is sitagliptin.
• Sitagliptin 25 mg film-coated tablets: Each film-coated tablet contains sitagliptin hydrochloride monohydrate, equivalent to 25 mg sitagliptin.
• Sitagliptin 50 mg film-coated tablets: Each film-coated tablet contains sitagliptin hydrochloride monohydrate, equivalent to 50 mg sitagliptin.
• Sitagliptin 100 mg film-coated tablets: Each film-coated tablet contains sitagliptin hydrochloride monohydrate, equivalent to 100 mg sitagliptin.

• The other ingredients are:

  Tablet core: calcium hydrogen phosphate, cellulose microcrystalline, croscarmellose sodium, sodium stearyl fumarate, magnesium stearate.

  Tablet film coating for Sitagliptin 25 mg: lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, iron oxide red (E172).

  Tablet film coating for Sitagliptin 50 mg and Sitagliptin 100 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172), iron oxide red (E172).

What Sitagliptin looks like and contents of the pack

Sitagliptin 25 mg film-coated tablets are round-shaped, biconvex with diameter approx. 6 mm, pink, debossed with “LC” on one side and plain on the other. Sitagliptin 50 mg film-coated tablets are round-shaped, biconvex with diameter approx. 8 mm, orange, debossed with “C” on one side and plain on the other. Sitagliptin 100 mg film-coated tablets are round-shaped, biconvex with diameter approx. 10 mm, beige, debossed with “L” on one side and plain on the other. Opaque PVC/PVDC-Alu blisters.

Packs size: 14, 28, 30, 56, 98 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Zentiva Pharma UK Limited,

12 New Fetter Lane,

London,

EC4A 1JP, United Kingdom

Manufacturer

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº 7,

Polígono Industrial Miralcampo

19200 Azuqueca de Henares

Guadalajara

SPAIN

This leaflet was last revised in October 2021

Folder n°103865061