Sitagliptin Medical Vallei

Leaflet accompanying the packaging: patient information

Sitagliptin Medical Valley, 25 mg, film-coated tablets

Sitagliptin Medical Valley, 50 mg, film-coated tablets

Sitagliptin Medical Valley, 100 mg, film-coated tablets

Sitagliptin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Sitagliptin Medical Valley and what is it used for
• 2. Important information before taking Sitagliptin Medical Valley
• 3. How to take Sitagliptin Medical Valley
• 4. Possible side effects
• 5. How to store Sitagliptin Medical Valley
• 6. 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 sugar levels in adults with type 2 diabetes.
This medicine helps to increase the amount of insulin released after a meal and decrease the amount of sugar produced by the body.
Your doctor has prescribed this medicine to reduce high blood sugar levels caused by type 2 diabetes. This medicine can be used alone or in combination with other medicines that reduce blood sugar levels (insulin, metformin, sulfonylureas, or glitazones), which you are already taking for type 2 diabetes, together with diet and exercise.

What is type 2 diabetes?

Type 2 diabetes is a condition where the body does not produce enough insulin and the insulin produced does not work as it should. The body may also produce too much sugar. If this happens, sugar (glucose) builds up in the blood. This can lead to serious diseases such as heart disease, kidney disease, loss of vision, and limb amputation.

2. Important information before taking Sitagliptin Medical Valley

When not to take Sitagliptin Medical Valley

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

Warnings and precautions

Patients taking Sitagliptin Medical Valley have reported cases of pancreatitis (see section 4).
If you experience blisters on your skin, it may be a sign of a disease called bullous pemphigoid. Your doctor may advise you to stop taking Sitagliptin Medical Valley.
Tell your doctor if you have or have had:

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

Since this medicine does not work when blood sugar levels are low, it is unlikely to cause low blood sugar levels. However, if this medicine is taken with a sulfonylurea or insulin, it may cause low blood sugar levels (hypoglycemia). Your doctor may reduce the dose of the sulfonylurea 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 when used in children under 10 years of age.

Sitagliptin Medical Valley and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, and about any medicines you plan to take.
In particular, tell your doctor if you are taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). When taking Sitagliptin Medical Valley with digoxin, your doctor may need to check your digoxin blood levels.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine during pregnancy.
It is not known whether this medicine passes into breast milk. Do not take this medicine while breastfeeding or if you plan to breastfeed.

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 the ability to drive and use machines.
Taking this medicine with sulfonylureas or insulin may cause low blood sugar levels (hypoglycemia), which can affect the ability to drive and use machines or work without safe support.

Sitagliptin Medical Valley contains sodium and lactose

Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.
Lactose (only 25 mg tablets)
If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Sitagliptin Medical Valley

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is:
one 100 mg film-coated tablet;
once a day;
taken orally.
If you have kidney problems, your 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 and drink.
Your doctor may prescribe this medicine alone or with certain other medicines that reduce blood sugar levels.
Diet and exercise help your body use sugar from your blood. While taking Sitagliptin Medical Valley, it is important to follow the diet and exercise plan recommended by your doctor.

What to do if you take more Sitagliptin Medical Valley than you should

If you take more of this medicine than you should, contact your doctor immediately.

What to do if you miss a dose of Sitagliptin Medical Valley

If you miss a dose, take it as soon as you remember. 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.

What to do if you stop taking Sitagliptin Medical Valley

To keep your blood sugar levels under control, you should keep taking this medicine for as long as your doctor tells you. Do not stop taking this medicine without talking to your doctor first.
If you have any further questions on the use of this product, 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 Medical Valley and contact your doctor immediately if you experience any of the following serious side effects:

• Severe and persistent stomach pain (in the abdomen), which may radiate to the back, with or without nausea and vomiting - these may be signs of pancreatitis.

If you experience a severe allergic reaction (frequency not known), including rash, hives, blisters on the skin, or peeling skin, and swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat your diabetes.
In some patients, when sitagliptin was added to metformin, the following side effects were reported:
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, diarrhea, constipation, drowsiness
Some patients experienced various stomach discomforts after starting sitagliptin with metformin (common).
In some patients, when sitagliptin was added to a sulfonylurea and metformin, the following side effects were reported:
Very common (may affect more than 1 in 10 people): low blood sugar levels
Common: constipation
In some patients, when sitagliptin and pioglitazone were used, the following side effects were reported:
Common: bloating, swelling of the hands or feet
In some patients, when sitagliptin, pioglitazone, and metformin were used, the following side effects were reported:
Common: swelling of the hands or feet
In some patients, when sitagliptin and insulin (with or without metformin) were used, the following side effects were reported:
Common: flu
Uncommon: dry mouth
In clinical studies, when sitagliptin was used alone or with other anti-diabetic medicines, the following side effects were reported:
Common: low blood sugar levels, headache, upper respiratory tract infections, stuffy or runny nose and sore throat, and joint or muscle pain
Uncommon: dizziness, constipation, itching
Rare: reduced number of platelets in the blood
Frequency not known: kidney disease (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin condition)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 and carton after "EXP". The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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 phosphate monohydrate, equivalent to 25 mg sitagliptin.
Sitagliptin Medical Valley, 50 mg, film-coated tablets: Each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg sitagliptin.
Sitagliptin Medical Valley, 100 mg, film-coated tablets: Each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.
The other ingredients are:
Tablet core:calcium hydrogen phosphate, microcrystalline cellulose, sodium carmellose, sodium stearyl fumarate, magnesium stearate.
25 mg tablet coating:lactose monohydrate, hypromellose, titanium dioxide (E 171), triacetin, and iron oxide red (E 172).
50 mg tablet coating:polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, iron oxide yellow (E 172), and iron oxide red (E 172).
100 mg tablet coating: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, approximately 6 mm in diameter, with "LC" marked on one side and smooth on the other side.
Sitagliptin Medical Valley, 50 mg, film-coated tablets: Round, biconvex, orange film-coated tablets, approximately 8 mm in diameter, with "C" marked on one side and smooth on the other side.
Sitagliptin Medical Valley, 100 mg, film-coated tablets: Round, biconvex, beige film-coated tablets, approximately 9.8 mm in diameter, with "L" marked on one side and smooth on the other side.
Sitagliptin Medical Valley, 25 mg, film-coated tablets are packaged in:
Opaque blisters (PVC//PVDC/Aluminum) in packs of 28 and 98 film-coated tablets.
Sitagliptin Medical Valley, 50 mg, film-coated tablets
Opaque blisters (PVC//PVDC/Aluminum) in packs of 28 and 98 film-coated tablets.
Sitagliptin Medical Valley, 100 mg, film-coated tablets
Opaque blisters (PVC//PVDC/Aluminum) in packs of 28 and 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization 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 medicine is authorized in the Member States of 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

Date of last revision of the leaflet: