Sitagliptin+metformin hcl medical valley

Package leaflet: Information for the patient

Sitagliptin+Metformin HCL Medical Valley, 50 mg + 850 mg, film-coated tablets
Sitagliptin+Metformin HCL Medical Valley, 50 mg + 1000 mg, film-coated tablets
Sitagliptinum + Metformini hydrochloridum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, 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.

Contents of the leaflet

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

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

Sitagliptin+Metformin HCL Medical Valley contains two different active substances:
sitagliptin and metformin.

• Sitagliptin belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors).
• Metformin belongs to a group of medicines called biguanides.

The combined action of these two medicines helps regulate blood glucose levels in adult patients with diabetes known as "type 2 diabetes." This medicine helps increase insulin levels released after meals and reduces the amount of glucose produced by the body. When used together with diet and physical exercise, it helps lower blood glucose levels. This medicine may be used as the only antidiabetic treatment or in combination with certain other antidiabetic medicines (insulin, sulfonylureas, or glitazones).

What is type 2 diabetes?
In type 2 diabetes, the body does not produce enough insulin, the insulin produced does not work properly, or the body may produce too much glucose. When this happens, sugar (glucose) accumulates in the blood. This can lead to serious health problems, such as heart disease, kidney disease, vision loss, and limb amputations.

2. Important information before taking Sitagliptin+Metformin HCL Medical Valley

When not to take Sitagliptin+Metformin HCL Medical Valley

• if the patient is allergic to sitagliptin or metformin, or to any of the other ingredients of this medicine (listed in section 6)
• if the patient has significantly reduced kidney function
• if the patient has uncontrolled diabetes, for example severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or ketoacidosis. Ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and which may lead to diabetic pre-coma. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness or unusual fruity odour of the breath.
• if the patient has severe infection or dehydration
• if the patient is scheduled to undergo a radiological examination with intravascular administration of contrast agents. The intake of Sitagliptin+Metformin HCL Medical Valley should be discontinued during the radiological examination and for 2 or more days thereafter, according to the physician's instructions, depending on the patient's kidney function
• if the patient has recently suffered a heart attack or has had severe circulatory disorders, such as shock or breathing difficulties
• if the patient has liver disease
• if the patient consumes excessive amounts of alcohol (either daily or occasionally)
• if the patient is breastfeeding

Do not take Sitagliptin+Metformin HCL Medical Valley if any of the above contraindications apply. Consult a physician to determine alternative methods of diabetes control. If in doubt, discuss this with your doctor, pharmacist, or nurse before taking Sitagliptin+Metformin HCL Medical Valley.

Warnings and precautions

Cases of pancreatitis have been reported in patients taking Sitagliptin+Metformin HCL Medical Valley (see section 4).

If the patient develops skin blisters, this may be a symptom of a disease known as bullous pemphigoid. The physician may advise the patient to discontinue taking Sitagliptin+Metformin HCL Medical Valley.

Risk of lactic acidosis

Sitagliptin+Metformin HCL Medical Valley may cause a very rare but serious adverse effect called lactic acidosis, especially if the patient has impaired kidney function. The risk of lactic acidosis increases in cases of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more detailed information below), liver dysfunction, and any medical conditions in which a part of the body is inadequately supplied with oxygen (e.g. acute severe heart disease).

If any of the above conditions apply to the patient, consult a physician for further instructions.

Contact a physician immediately for further instructions if:

• the patient has a genetically inherited disease affecting mitochondria (cellular energy-producing structures), such as MELAS (mitochondrial encephalopathy, myopathy, lactic acidosis and stroke-like episodes), or

• maternally inherited diabetes and deafness (MIDD).

• the patient experiences any of the following symptoms after starting metformin: seizures, worsening of cognitive abilities, difficulty moving, symptoms indicating nerve damage (e.g. pain or numbness), migraine, or deafness.

Temporarily discontinue use of Sitagliptin+Metformin HCL Medical Valley if
the patient develops a medical condition that may involve dehydration (significant loss of water from the body), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. Consult a physician for further instructions.

Discontinue use of Sitagliptin+Metformin HCL Medical Valley and contact a physician or the nearest hospital immediately if
the patient experiences any symptoms of lactic acidosis, as this condition may lead to coma.
Symptoms of lactic acidosis include:

• vomiting
• abdominal pain
• muscle cramps
• general malaise combined with profound fatigue
• difficulty breathing
• decreased body temperature and slowed heart rate

Lactic acidosis is an acute, life-threatening condition requiring immediate hospital treatment.

Before starting Sitagliptin+Metformin HCL Medical Valley, discuss the following with your doctor or pharmacist:

• if the patient has or has had pancreatic disease (e.g. pancreatitis)
• if the patient has or has had gallstones, alcohol dependence, or very high blood triglyceride levels (a type of fat). In such cases, the risk of pancreatitis may increase (see section 4)
• if the patient has been diagnosed with type 1 diabetes. This is sometimes referred to as insulin-dependent diabetes
• if the patient currently has or has previously had allergic reactions to sitagliptin, metformin, or to the medicine Sitagliptin+Metformin HCL Medical Valley (see section 4)
• if the patient is taking a sulfonylurea derivative or insulin, antidiabetic medicines, together with Sitagliptin+Metformin HCL Medical Valley, as this may lead to excessively low blood sugar levels (hypoglycaemia). The physician may reduce the dose of the sulfonylurea derivative or insulin.

If the patient is undergoing major surgery, the use of Sitagliptin+Metformin HCL Medical Valley must be discontinued during and for some time after the procedure. The physician will decide when the patient should stop and resume treatment with Sitagliptin+Metformin HCL Medical Valley.

If in doubt, consult your doctor or pharmacist before taking Sitagliptin+Metformin HCL Medical Valley.

During treatment with Sitagliptin+Metformin HCL Medical Valley, the physician will monitor kidney function at least once a year, or more frequently if the patient is elderly and/or has worsening kidney function.

Children and adolescents

This medicine must not be used in children and adolescents under 18 years of age. This medicine is not effective in children and adolescents aged between 10 and 17 years. It is unknown whether this medicine is safe and effective when used in children under 10 years of age.

Sitagliptin+Metformin HCL Medical Valley and other medicines

If the patient is to receive an intravenous iodine-containing contrast agent, for example for an X-ray or CT scan, the intake of Sitagliptin+Metformin HCL Medical Valley must be stopped before or, at the latest, at the time of administration. The physician will decide when the patient should stop and resume treatment with Sitagliptin+Metformin HCL Medical Valley.

Inform your doctor or pharmacist about all medicines currently or recently taken, or which you plan to take. The patient may require more frequent monitoring of blood glucose levels and kidney function, or dose adjustments of Sitagliptin+Metformin HCL Medical Valley by the physician. It is especially important to inform about the following medicines:

• medicines (taken orally, by inhalation, or by injection) used to treat inflammatory conditions such as asthma or arthritis (corticosteroids)
• medicines that increase urine production (diuretics)
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• specific medicines used to treat bronchial asthma (β-sympathomimetics)
• iodine-containing contrast agents or medicines containing alcohol
• some medicines used to treat gastrointestinal disorders, such as cimetidine
• ranolazine, a medicine used to treat angina pectoris
• dolutegravir, a medicine used to treat HIV infection
• vandetanib, a medicine used to treat a specific type of thyroid cancer (medullary thyroid cancer)
• digoxin (used to treat heart rhythm disorders and other heart conditions). Blood digoxin levels should be monitored when taking Sitagliptin+Metformin HCL Medical Valley with digoxin.

Sitagliptin+Metformin HCL Medical Valley and alcohol

Avoid consuming excessive amounts of alcohol while taking Sitagliptin+Metformin HCL Medical Valley, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. This medicine must not be used during pregnancy or while breastfeeding. See section 2, "When not to take Sitagliptin+Metformin HCL Medical Valley".

Driving and using machines

This medicine has no effect or negligible effect on the ability to drive and use machines. However, when driving and operating machinery, take into account that dizziness and drowsiness have been reported during treatment with sitagliptin, 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 work without secure foot support.

Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Sitagliptin+Metformin HCL Medical Valley

This medicine should always be taken as directed by the doctor. If in doubt, consult the doctor or pharmacist.

• Take one tablet:
• twice daily, orally;
• with meals to reduce the likelihood of gastrointestinal upset.
• To control blood sugar levels, the doctor may increase the dose of this medicine.
• If the patient has impaired kidney function, the doctor may prescribe a lower dose.

While taking this medicine, continue with the diet recommended by the doctor and pay attention to evenly distributing carbohydrate intake throughout the day.
It is unlikely that taking this medicine alone will lead to abnormally low blood sugar (hypoglycaemia). Low blood sugar may occur when this medicine is used together with a sulphonylurea derivative or insulin – in such cases, the doctor may reduce the dose of the sulphonylurea derivative or insulin.
Taking more Sitagliptin+Metformin HCL Medical Valley than prescribed
If an overdose of this medicine is taken, contact the doctor immediately. Go to the hospital if symptoms of lactic acidosis occur, such as feeling cold or discomfort, severe nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps, or rapid breathing (see section "Warnings and precautions").
Missing a dose of Sitagliptin+Metformin HCL Medical Valley
If a dose is missed, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and continue with the regular dosing schedule. Do not take a double dose of this medicine.
Stopping Sitagliptin+Metformin HCL Medical Valley
To maintain control of blood sugar levels, continue taking this medicine for as long as directed by the doctor. Do not stop taking this medicine without first consulting the doctor.
Discontinuing Sitagliptin+Metformin HCL Medical Valley may result in increased blood sugar levels.
If there are any further doubts about the use of this medicine, consult the 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+Metformin HCL Medical Valley and contact your doctor immediately if any of the following serious adverse effects occur:

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

Sitagliptin+Metformin HCL Medical Valley may very rarely cause (may affect no more than 1 in 10,000 people) a very serious adverse effect known as lactic acidosis (see section "Warnings and precautions"). If this occurs in a patient, STOP taking Sitagliptin+Metformin HCL Medical Valley and seek immediate medical attention from a doctor or the nearest hospital, as lactic acidosis can lead to coma.
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 in breathing or swallowing, stop taking the medicine and contact your doctor immediately. Your doctor may prescribe medication to treat the allergic reaction and another medicine (a different medicine) for the treatment of diabetes.
The following adverse effects have been reported in some patients taking metformin after starting sitagliptin:

Frequent (may affect up to 1 in 10 people): low blood sugar levels, nausea, bloating, vomiting
Not frequent (may affect up to 1 in 100 people): stomach pain, diarrhoea, constipation, drowsiness

Diarrhoea, nausea, bloating, constipation, stomach pain, or vomiting may occur in some patients after starting treatment with sitagliptin in combination with metformin (frequent).

The following adverse effects have been reported in some patients taking this medicine in combination with a sulfonylurea derivative such as glimepiride:

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

The following adverse effects have been reported in some patients taking this medicine in combination with pioglitazone:

Frequent: swelling of hands or feet

The following adverse effects have been reported in some patients taking this medicine in combination with insulin:

Very frequent: low blood sugar levels
Not frequent: dry mouth, headache

In clinical trials, the following adverse effects have been reported in some patients taking sitagliptin alone (one of the active substances in Sitagliptin+Metformin HCL Medical Valley) or after marketing approval when using sitagliptin alone, in combination with metformin, or with other antidiabetic medicines:

Frequent: low blood sugar levels, headache, upper respiratory tract infection, nasal congestion or runny nose and sore throat, bone and joint pain, pain in arms or legs
Not frequent: 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 condition)

The following adverse effects have been reported in some patients taking metformin alone:

Very frequent: nausea, vomiting, diarrhoea, stomach pain, and loss of appetite. These symptoms may occur when starting metformin and usually resolve over time.
Frequent: metallic taste, reduced or low levels of vitamin B in the blood (symptoms may include extreme tiredness (fatigue), pain and redness of the tongue (glossitis), tingling sensations (paraesthesia), or pale or yellowish skin). Your doctor may order several tests to determine the cause of these symptoms, as some of them may also be caused by diabetes or other health conditions unrelated to diabetes.
Very rare: hepatitis (liver disease), urticaria, skin redness (rash), or itching

Reporting of adverse effects
If any adverse effects occur, including any 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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
Al. Jerozolimskie 181 C, 02-222 Warsaw
Phone: +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 Authorisation Holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Sitagliptin+Metformin HCL 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
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Medicines must 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 the medicine Sitagliptin+Metformin HCL Medical Valley contains

• The active substances are sitagliptin and metformin. Each coated tablet of Sitagliptin+Metformin HCL Medical Valley 50 mg + 850 mg contains sitagliptin hydrochloride equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride. Each coated tablet of Sitagliptin+Metformin HCL Medical Valley 50 mg + 1000 mg contains sitagliptin hydrochloride equivalent to 50 mg of sitagliptin and 1000 mg of metformin hydrochloride.
• The other ingredients are:
  Tablet core: microcrystalline cellulose, povidone (K29/32), sodium lauryl sulfate, and magnesium stearate.
  Tablet coating (50 mg + 850 mg): partially hydrolysed polyvinyl alcohol, polyethylene glycol-polyvinyl alcohol grafted copolymer, talc, titanium dioxide (E 171),
  mono- and diglycerides of fatty acids (GMDCC, GMCC), iron oxide red (E 172).
  Tablet coating (50 mg + 1000 mg): partially hydrolysed polyvinyl alcohol,
  polyethylene glycol-polyvinyl alcohol grafted copolymer, talc, titanium dioxide (E 171),
  mono- and diglycerides of fatty acids (GMDCC, GMCC), iron oxide red (E 172),
  and iron oxide black (E 172).

What Sitagliptin+Metformin HCL Medical Valley looks like and contents of the pack
Sitagliptin+Metformin HCL Medical Valley 50 mg + 850 mg are pink, oval, biconvex coated tablets with dimensions of approximately 20.5 mm x 9.5 mm, marked with the imprint “S476” on one side and smooth on the other.
Sitagliptin+Metformin HCL Medical Valley 50 mg + 1000 mg are brown, oval, biconvex coated tablets with dimensions of approximately 21.5 mm x 10 mm, marked with the imprint “S477” on one side and smooth on the other.
Sitagliptin+Metformin HCL Medical Valley is packed in opaque PVC/PVdC-Aluminium blisters.
The packs contain 56 coated tablets in a cardboard box.

Marketing Authorisation Holder
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
email: [email protected]

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

This medicine is authorised for marketing in the European Economic Area countries under the following names:
Denmark: Sitagliptin/Metforminhydrochlorid Medical Valley
Netherlands: Sitagliptine/Metformine Xiromed 50/850 mg filmomhulde tabletten
Sitagliptine/Metformine Xiromed 50/1000 mg filmomhulde tabletten
Iceland: Sitagliptin/Metformin Medical Valley 50 mg/850 mg filmuhúðaðar töflur
Sitagliptin/Metformin Medical Valley 50 mg/1000 mg filmuhúðaðar töflur
Germany: Sitagliptin/Metformin AXiromed 50 mg/850 mg Filmtabletten
Sitagliptin/Metformin AXiromed 50 mg/1000 mg Filmtabletten
Norway: Sitagliptin/Metformin Medical Valley
Poland: Sitagliptin+Metformin HCL Medical Valley
Sweden: Sitagliptin/Metformin Medical Valley 50 mg/850 mg filmdragerade tabletter
Sitagliptin/Metformin Medical Valley 50 mg/1000 mg filmdragerade tabletter