Sitagliptin Mylan Italia

Package leaflet: Information for the patient

Sitagliptin Mylan Italia 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Sitagliptin Mylan Italia is and what it is used for
2. What you need to know before taking Sitagliptin Mylan Italia
3. How to take Sitagliptin Mylan Italia
4. Possible side effects
5. How to store Sitagliptin Mylan Italia
6. Contents of the pack and other information

1. What Sitagliptin Mylan Italia is and what it is used for

Sitagliptin Mylan Italia contains the active substance sitagliptin, which belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lower blood sugar levels in adult patients with type 2 diabetes mellitus.
This medicine helps increase the levels of insulin released after a meal and reduces the amount of sugar produced by the body.
Your doctor has prescribed this medicine to help you lower your blood sugar level, which is too high due to type 2 diabetes. This medicine may be used alone or in combination with other blood sugar-lowering medicines (such as insulin, metformin, sulfonylureas, or glitazones) that you may already be taking to treat your diabetes, along with a diet and exercise program.

What is type 2 diabetes?
Type 2 diabetes is a condition in which the body does not produce enough insulin, and the insulin the body produces does not work as well as it should. The body may also produce too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems such as heart disease, kidney disease, blindness, and amputations.

2. What you need to know before taking Sitagliptin Mylan

Do not take Sitagliptin Mylan

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

Warnings and precautions
Cases of inflammation of the pancreas (pancreatitis) have been observed in patients treated with Sitagliptin Mylan (see section 4).
If you develop blisters on your skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop treatment with Sitagliptin Mylan.
Inform 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 type of fat) in the blood. These medical conditions may increase your risk of developing pancreatitis (see section 4).
• type 1 diabetes.
• diabetic ketoacidosis (a diabetes complication with high blood sugar levels, rapid weight loss, nausea or vomiting).
• any kidney problems, past or present.
• an allergic reaction to sitagliptin (see section 4).

It is unlikely that this medicine will cause low blood sugar levels because it does not act when blood sugar is low. However, when this medicine is taken together with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) may occur. Your doctor may reduce the dose of sulfonylurea or insulin.
Children and adolescents
Children and adolescents under 18 years of age must not use this medicine. It is not effective in children and adolescents aged between 10 and 17 years. It is not known whether this medicine is safe and effective when used in children under 10 years of age.
Other medicines and Sitagliptin Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking digoxin (a medicine used to treat irregular heartbeat and other heart-related problems). It may be necessary to monitor digoxin levels in your blood if taken together with Sitagliptin Mylan.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
You must not use this medicine during pregnancy.
It is not known whether this medicine passes into breast milk. You must not take this medicine if you are breastfeeding or think you may need to breastfeed.
Driving and using machines
This medicine has no effect or has a negligible effect on the ability to drive and use machines. However, dizziness and drowsiness have been reported, which may affect your ability to drive and use machines.
Taking this medicine together with other medicines called sulfonylureas or with insulin may cause hypoglycaemia, which may affect your ability to drive, use machines, or work without protective barriers.
Sitagliptin Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.
Sitagliptin Mylan 25 mg contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Sitagliptin Mylan Italia

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The usual recommended dose is:

• one 100 mg film-coated tablet
• once daily
• by mouth

If you have kidney problems, your doctor may prescribe a lower dose (such as 25 mg or 50 mg).
You may take this medicine with or without food and drinks.
Your doctor may prescribe this medicine alone or together with other medicines that lower blood sugar levels.
Diet and physical exercise can help your body use blood sugar more effectively.
While taking Sitagliptin Mylan Italia, it is important to continue the diet and exercise plan recommended by your doctor.

If you take more Sitagliptin Mylan Italia than you should
If you take more of this medicine than prescribed, contact your doctor immediately.

If you forget to take Sitagliptin Mylan Italia
If you forget 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 take your next dose at the regular time.
Do not take a double dose to make up for the forgotten tablet.

If you stop taking Sitagliptin Mylan Italia
Continue taking this medicine for as long as your doctor prescribes it, so that you can keep controlling your blood sugar level. Do not stop taking this medicine without first talking to your doctor.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
STOP taking Sitagliptin Mylan Italia and contact your doctor immediately if you notice any of the
following serious side effects:

• Severe and persistent pain in the abdomen (stomach area) which may spread to the back, with or without nausea and vomiting, as these may be signs of inflammation of the pancreas (pancreatitis) (frequency not known: frequency cannot be estimated from the available data).
• Severe allergic reaction, including rash, hives, skin blistering/skin peeling, and swelling of the face, lips, tongue, and throat, which may cause difficulty 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 when taking sitagliptin in combination with metformin:
Common: may affect up to 1 in 10 people

• low blood sugar level
• nausea
• flatulence
• vomiting
• various stomach disorders when starting the combination of sitagliptin and metformin

Uncommon: may affect up to 1 in 100 people

• stomach pain
• diarrhoea
• constipation
• drowsiness

Some patients have experienced the following side effects when taking sitagliptin in combination with a sulfonylurea and metformin:
Very common: may affect more than 1 in 10 people

• low blood sugar level

Common: may affect up to 1 in 10 people

• constipation

Some patients have experienced the following side effects when taking sitagliptin with pioglitazone:
Common: may affect up to 1 in 10 people

• flatulence
• swelling of the hands or legs

Some patients have experienced the following side effects when taking sitagliptin in combination with pioglitazone and metformin:
Common: may affect up to 1 in 10 people

• swelling of the hands or legs

Some patients have experienced the following side effects when taking sitagliptin in combination with insulin (with or without metformin):
Common: may affect up to 1 in 10 people

• influenza

Uncommon: may affect up to 1 in 100 people

• dry mouth

Some patients have experienced the following side effects when taking sitagliptin alone in clinical studies, or during post-approval use alone and/or with other antidiabetic medicines:
Common: may affect up to 1 in 10 people

• low blood sugar level
• headache
• upper respiratory tract infection
• stuffy or runny nose
• sore throat
• osteoarthritis
• pain in arms or legs

Uncommon: may affect up to 1 in 100 people

• dizziness
• constipation
• itching

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

• reduced platelet count

Frequency not known: frequency cannot be estimated from the available data

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sitagliptin Mylan Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and 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 dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sitagliptin Mylan Italia contains

• The active substance is sitagliptin.
• Sitagliptin Mylan Italia 25 mg film-coated tablets: each film-coated tablet contains sitagliptin monohydrochloride monohydrate, equivalent to 25 mg of sitagliptin.
• Sitagliptin Mylan Italia 50 mg film-coated tablets: each film-coated tablet contains sitagliptin monohydrochloride monohydrate, equivalent to 50 mg of sitagliptin.
• Sitagliptin Mylan Italia 100 mg film-coated tablets: each film-coated tablet contains sitagliptin monohydrochloride monohydrate, equivalent to 100 mg of sitagliptin.
• The other components are:
  Tablet core: calcium hydrogen phosphate, microcrystalline cellulose, croscarmellose sodium, sodium stearyl fumarate, magnesium stearate.
  Tablet coating for Sitagliptin Mylan Italia 25 mg: lactose monohydrate, hypromellose,
  titanium dioxide (E171), triacetin, red iron oxide (E172).
  Tablet coating for Sitagliptin Mylan Italia 50 mg and Sitagliptin Mylan Italia 100 mg:
  polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172),
  red iron oxide (E172).

Description of the appearance of Sitagliptin Mylan Italia and contents of the pack

Sitagliptin Mylan Italia 25 mg film-coated tablets are round, biconvex tablets with a diameter of approximately 6 mm, pink in colour, marked with "LC" on one side and smooth on the other.
Sitagliptin Mylan Italia 50 mg film-coated tablets are round, biconvex tablets with a diameter of approximately 8 mm, orange in colour, marked with “C” on one side and smooth on the other.
Sitagliptin Mylan Italia 100 mg film-coated tablets are round, biconvex tablets with a diameter of approximately 10 mm, beige in colour, marked with "L" on one side and smooth on the other.
Opaque blisters in PVC/PVDC-Alu.
Pack sizes: 14, 28, 30, 56, 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milano
Italy

Manufacturer
LABORATORIOS LICONSA S.A.
Avda. Miralcampo, Nº 7
Pol. Ind. Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Croatia: Sitagliptin Zentiva
Czech Republic: Sitagliptin Viatris Limited
Denmark: Sitagliptin Viatris Pharma
Finland: Sitagliptin Zentiva
France: SITAGLIPTINE VIATRIS SANTE 50 mg, 100 mg, comprimé pelliculé
Germany: Sitagliptin Viatris 25 mg, 50 mg, 100 mg Filmtabletten
Greece: Sitagliptin/Zentiva
Iceland: Sitagliptin Zentiva
Italy: Sitagliptin Mylan Italia
Norway: Sitagliptin Viatris Pharma
Portugal: Sitagliptina Viatris
Sweden: Sitagliptin Viatris Pharma
United Kingdom (Northern Ireland): Sitagliptin 25 mg, 50 mg, 100 mg Film-coated Tablets