Package leaflet: Information for the patient

Sitagliptin Medical Valley, 25 mg, film-coated tablets
Sitagliptin Medical Valley, 50 mg, film-coated tablets
Sitagliptin Medical Valley, 100 mg, film-coated tablets
Sitagliptinum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

What is Sitagliptin Medical Valley and what is it used for
Important information before taking Sitagliptin Medical Valley
How to take Sitagliptin Medical Valley
Possible side effects
How to store Sitagliptin Medical Valley
Contents of the pack and other information

1. What is Sitagliptin Medical Valley and what is it used for

Sitagliptin Medical Valley contains the active substance sitagliptin, which belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), which reduce blood glucose levels in adults with type 2 diabetes.
This medicine helps increase insulin levels released after meals and reduces the amount of glucose produced by the body.
Your doctor has prescribed this medicine to lower high blood glucose levels caused by type 2 diabetes. The medicine may be used alone or in combination with other glucose-lowering medicines (insulin, metformin, sulfonylureas, or glitazones) that you may already be taking, along with diet and an 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 produced does not work properly. The body may also produce too much glucose. When this occurs, sugar (glucose) accumulates in the blood. This may lead to serious health problems such as heart disease, kidney disease, vision loss, and limb amputations.

2. Information before using Sitagliptin Medical Valley

When not to take Sitagliptin Medical Valley

if the patient is allergic to sitagliptin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Cases of pancreatitis have been reported in patients taking Sitagliptin Medical Valley (see section 4).
If the patient develops blisters on the skin, this may be a symptom of a disease known as bullous pemphigoid. The doctor may advise the patient to stop taking Sitagliptin Medical Valley.
Inform the doctor if the patient has or has had:

pancreatic disease (e.g. pancreatitis);
gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood. In such cases, the risk of pancreatitis may be increased (see section 4);
type 1 diabetes;
diabetic ketoacidosis (a complication of diabetes characterized by high blood sugar levels, rapid weight loss, nausea or vomiting);
any kidney disease in the past or currently;
allergic reaction to Sitagliptin Medical Valley (see section 4).

Since this medicine does not act when blood sugar levels are low, it is unlikely to cause excessively low blood sugar levels. However, if this medicine is taken together with a sulfonylurea derivative or insulin, low blood sugar (hypoglycaemia) may occur. The doctor may reduce the dose of the sulfonylurea derivative or insulin.
Children and adolescents
Children and adolescents under 18 years of age should not take this medicine. This medicine is not effective in children and adolescents aged 10 to 17 years. It is not known whether this medicine is safe and effective in children under 10 years of age.
Sitagliptin Medical Valley and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
In particular, inform the doctor if the patient is taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). Blood levels of digoxin should be monitored when taking Sitagliptin Medical Valley together with digoxin.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy.
It is not known whether this medicine passes into human breast milk. This medicine should not be used during breastfeeding or if breastfeeding is planned.
Driving and operating machinery
This medicine has no effect or a negligible effect on the ability to drive and operate machinery. However, dizziness and drowsiness have been reported, which may affect the ability to drive and operate machinery.
Taking this medicine together with medicines called sulfonylurea derivatives or with insulin may lead to hypoglycaemia, which in turn may affect the ability to drive and operate machinery or working without secure foot support.
Sitagliptin Medical Valley contains sodium and lactose
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".
Lactose (only 25 mg tablets)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.

3. How to use Sitagliptin Medical Valley

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, you should consult your doctor or pharmacist.
The usual recommended dose is:
one 100 mg coated tablet;
once daily;
taken orally.
If the patient has impaired kidney function, the doctor may prescribe a lower dose of Sitagliptin Medical Valley (e.g. 25 mg or 50 mg).
This medicine can be taken with or without food or drink.
Your doctor may recommend taking only this medicine or this medicine together with certain other medicines that lower blood sugar levels.
Diet and physical exercise help your body use sugar in the blood more effectively.
While taking Sitagliptin Medical Valley, it is important to follow the diet and perform the physical exercises recommended by your doctor.
Taking more Sitagliptin Medical Valley than prescribed
If you take more of this medicine than prescribed, contact your doctor immediately.
Missing a dose of Sitagliptin Medical Valley
If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.
Stopping Sitagliptin Medical Valley
To maintain control of blood sugar levels, you should continue taking this medicine for as long as your doctor recommends. Do not stop taking this medicine without first consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should STOP taking Sitagliptin Medical Valley and contact your doctor immediately if you experience any of the following serious adverse effects:

Severe and persistent pain in the abdomen (around the stomach), possibly radiating to the back, with or without nausea and vomiting – these may be symptoms of pancreatitis.

In case of a severe allergic reaction (frequency unknown), including rash, hives, skin blisters or peeling of the skin, and swelling of the face, lips, tongue or throat, which may cause difficulty breathing or swallowing, you must stop taking the medicine and contact your doctor immediately. Your doctor may prescribe another medicine to treat the allergic reaction and a different medicine to treat diabetes.

In some patients, the following adverse effects occurred when sitagliptin was added to metformin:

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

Some patients experienced various gastrointestinal symptoms after starting treatment with sitagliptin in combination with metformin (common).

In some patients, the following adverse effects occurred when sitagliptin was used in combination with a sulfonylurea and metformin:

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

In some patients, the following adverse effects occurred when sitagliptin was used with pioglitazone:

Common: bloating, swelling of hands or feet

In some patients, the following adverse effects occurred when sitagliptin was used in combination with pioglitazone and metformin:

Common: swelling of hands or feet

In some patients, the following adverse effects occurred when sitagliptin was used with insulin (with or without metformin):

Common: influenza-like illness
Uncommon: dry mouth

In clinical studies, in some patients receiving sitagliptin alone or after marketing when sitagliptin was used alone or with other antidiabetic medicines, the following adverse effects were observed:

Common: low blood sugar levels, headache, upper respiratory tract infections, stuffy or runny nose and sore throat, bone and joint inflammation, pain in arms or legs
Uncommon: dizziness, constipation, itching
Rare: decreased platelet count
Frequency not known: kidney disorders (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin disorder)

Reporting of adverse effects

If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.

Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Sitagliptin Medical Valley

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after:
"EXP". The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Medicines must not be disposed of via the sewage system or in household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help protect
the environment.

6. Contents of the pack and other information

What Sitagliptin Medical Valley contains
The active substance is sitagliptin.
Sitagliptin Medical Valley 25 mg film-coated tablets: Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 25 mg of sitagliptin.
Sitagliptin Medical Valley 50 mg film-coated tablets: Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin.
Sitagliptin Medical Valley 100 mg film-coated tablets: Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 100 mg of sitagliptin.

The other ingredients are:
Tablet core: calcium hydrogen phosphate, microcrystalline cellulose, sodium croscarmellose, sodium stearyl fumarate, magnesium stearate.
Tablet coating (25 mg): lactose monohydrate, hypromellose, titanium dioxide (E 171), triacetin, and iron oxide red (E 172).
Tablet coating (50 mg): polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, iron oxide yellow (E 172), and iron oxide red (E 172).
Tablet coating (100 mg): polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, iron oxide yellow (E 172), and iron oxide red (E 172).

What Sitagliptin Medical Valley looks like and contents of the pack
Sitagliptin Medical Valley 25 mg film-coated tablets: Round, biconvex, pink film-coated tablets with a diameter of approximately 6 mm, marked with "LC" on one side and smooth on the other side.
Sitagliptin Medical Valley 50 mg film-coated tablets: Round, biconvex, orange film-coated tablets with a diameter of approximately 8 mm, marked with "C" on one side and smooth on the other side.
Sitagliptin Medical Valley 100 mg film-coated tablets: Round, biconvex, beige film-coated tablets with a diameter of approximately 9.8 mm, marked with "L" on one side and smooth on the other side.

Sitagliptin Medical Valley 25 mg film-coated tablets are packed in:
Opaque foil blisters (PVC//PVDC/Aluminium) in packs of 28 and 98 film-coated tablets.
Sitagliptin Medical Valley 50 mg film-coated tablets
Opaque foil blisters (PVC//PVDC/Aluminium) in packs of 28 and 98 film-coated tablets.
Sitagliptin Medical Valley 100 mg film-coated tablets
Opaque foil blisters (PVC//PVDC/Aluminium) in packs of 28 and 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Medical Valley Invest AB
Brädgårdsvägen 28,
Höllviken, 236 32
Sweden

Manufacturer
Laboratorios Liconsa, S.A.
Polígono Industrial Miralcampo, Avda. Miralcampo, 7
19200 Azuqueca de Henares – Guadalajara
Spain

This medicinal product is authorised in the European Economic Area under the following names:
Denmark: Sitagliptin Medical Valley
Netherlands: Sitagliptine Xiromed 25mg filmomhulde tabletten
Sitagliptine Xiromed 50mg filmomhulde tabletten
Sitagliptine Xiromed 100mg filmomhulde tabletten
Iceland: Sitagliptin Medical Valley 25 mg filmuhúðaðar töflur
Sitagliptin Medical Valley 50 mg filmuhúðaðar töflur
Sitagliptin Medical Valley 100 mg filmuhúðaðar töflur
Germany (RMS): Sitagliptin AXiromed 25 mg Filmtabletten
Sitagliptin AXiromed 50 mg Filmtabletten
Sitagliptin AXiromed 100 mg Filmtabletten
Norway: Sitagliptin Medical Valley
Poland: Sitagliptin Medical Valley
Sweden: Sitagliptin Medical Valley 25 mg filmdragerade tabletter
Sitagliptin Medical Valley 50 mg filmdragerade tabletter
Sitagliptin Medical Valley 100 mg filmdragerade tabletter