Jamesi

Patient Information Leaflet

Jamesi, 50 mg + 850 mg, film-coated tablets
Jamesi, 50 mg + 1000 mg, film-coated tablets
Sitagliptin + Metformin hydrochloride
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 or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents:

1. What Jamesi is and what it is used for
2. Important information before taking Jamesi
3. How to take Jamesi
4. Possible side effects
5. How to store Jamesi
6. Contents of the pack and other information

1. What Jamesi is and what it is used for

Jamesi 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 adults with a type of diabetes known as "type 2 diabetes." This medicine helps increase the amount of insulin released after a meal and reduces the amount of glucose produced by the body. When used together with diet and exercise, it helps lower blood glucose levels. This medicine may be used alone or in combination with certain other antidiabetic medicines (insulin, sulfonylurea derivatives, or glitazones).

What is type 2 diabetes?
In type 2 diabetes, the body does not produce enough insulin, and the insulin that is produced does not work properly. The body may also produce too much glucose. When this happens, 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. Important information before taking Jamesi

When not to take Jamesi

• 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 a diabetic pre-coma state.
Symptoms include: abdominal pain, rapid and deep breathing, drowsiness or an unusual fruity odour of the breath.

• if the patient has a severe infection or dehydration,
• if the patient is scheduled to undergo a radiological examination with intravascular administration of contrast agents. Treatment with Jamesi must be temporarily discontinued for the examination and for 2 or more days afterwards, according to the physician's instructions, depending on the patient's kidney function.
• if the patient has recently experienced 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 intermittently),
• if the patient is breastfeeding.

Do not take Jamesi if any of the above contraindications apply.
Consult a physician to determine alternative methods of diabetes control. In case of doubt, discuss this with your doctor, pharmacist, or nurse before taking Jamesi.
Warnings and precautions
Cases of pancreatitis have been reported in patients taking sitagliptin + metformin (see section 4).
If the patient develops blisters on the skin, this may be a symptom of a disease known as bullous pemphigoid. The physician may advise the patient to discontinue treatment with Jamesi.
Risk of lactic acidosis
Jamesi 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 further details below), impaired liver function, and any medical conditions in which 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.
Temporarily discontinue Jamesi if the patient develops a medical condition associated with 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 Jamesi immediately and contact a physician or the nearest hospital 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.
Contact a physician immediately for further instructions if:

• the patient has a genetically inherited mitochondrial disorder (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• the patient develops any of the following symptoms after starting metformin: seizures, worsening cognitive function, difficulty moving the body, symptoms indicating nerve damage (e.g. pain or numbness), migraine, or deafness.

Before starting Jamesi, 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 experienced allergic reactions to sitagliptin, metformin, or Jamesi (see section 4).
• if the patient is taking a sulfonylurea derivative or insulin, antidiabetic medicines together with Jamesi, 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, Jamesi must not be taken during the procedure and for some time afterwards. The physician will decide when the patient should stop and resume treatment with Jamesi.
If in doubt whether any of the above statements apply to the patient, discuss this with your doctor or pharmacist before taking Jamesi.
While being treated with Jamesi, the physician will monitor the patient's 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. The medicine is not effective in children and adolescents aged 10 to 17 years. It is unknown whether this medicine is safe and effective when used in children under 10 years of age.
Jamesi and other medicines
If the patient is to receive an intravenous iodine-containing contrast agent, for example for an X-ray or CT scan, treatment with Jamesi must be discontinued before or at the latest at the time of injection. The physician will decide when the patient should stop and resume treatment with Jamesi.
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take. The patient may require more frequent monitoring of blood glucose levels and kidney function assessments, or dose adjustments of Jamesi by the physician. It is particularly 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 asthma (β-sympathomimetics),
• iodine-containing contrast agents or medicines containing alcohol,
• certain medicines used to treat stomach problems, such as cimetidine,
• ranolazine, a medicine used to treat angina,
• 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 levels of digoxin should be monitored when taken together with Jamesi.

Jamesi and alcohol
Avoid consuming excessive amounts of alcohol while taking Jamesi, 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 plans to have a child, she should consult her doctor or pharmacist before taking this medicine. This medicine must not be used during pregnancy or while breastfeeding. See section 2, "When not to take Jamesi".
Driving and operating machinery
This medicine has no effect or negligible effect on the ability to drive and operate machinery. However, when driving and operating machinery, consider that dizziness and drowsiness have been reported with sitagliptin use, 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 may affect the ability to drive and operate machinery or work without secure foot support.
Jamesi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
3. How to take Jamesi
Always take this medicine exactly as prescribed by your doctor. In case of doubt, consult your doctor or pharmacist.

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

While taking this medicine, continue following the diet recommended by your 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 glucose levels (hypoglycaemia). Low blood glucose may occur when this medicine is taken together with a sulfonylurea derivative or insulin – in such cases, the physician may reduce the dose of the sulfonylurea derivative or insulin.
Taking more Jamesi than prescribed
If more than the prescribed dose of this medicine is taken, contact your doctor immediately. Go to 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 Jamesi
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 Jamesi
To maintain blood glucose control, continue taking the medicine for as long as directed by your doctor. Do not stop taking this medicine without consulting your doctor first.
Discontinuing Jamesi may cause increased blood glucose levels.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• 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.

Jamesi may very rarely cause (may occur in no more than 1 in 10,000 patients) a very serious side effect known as lactic acidosis (see section "Warnings and precautions"). If this occurs, you must stop taking Jamesi and contact your doctor or nearest hospital immediately, as lactic acidosis may lead to coma.
In case of a severe allergic reaction (frequency unknown), including rash, hives, skin blisters or skin peeling, and swelling of the face, lips, tongue or throat, which may cause difficulty in breathing or swallowing, you should 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 side effects have been reported in some patients taking metformin after starting treatment with sitagliptin:

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

Some patients experienced diarrhoea, nausea, bloating, constipation, stomach pain or vomiting after starting treatment with sitagliptin in combination with metformin (common).

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

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

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

• Common: swelling of hands or feet

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

• Very common: low blood sugar levels
• Uncommon: dry mouth, headache

In clinical trials and post-marketing experience, the following side effects have been reported in some patients taking sitagliptin alone (one of the active substances in Jamesi), or when taking Jamesi or sitagliptin alone or in combination with other antidiabetic medicines:

• Common: low blood sugar levels, headache, upper respiratory tract infection, nasal congestion or runny nose, sore throat, bone and joint pain, 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 skin blistering)

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

• Very common: nausea, vomiting, diarrhoea, stomach pain and loss of appetite. These symptoms may occur after starting metformin and usually resolve over time.
• Common: metallic taste, reduced or low blood levels of vitamin B12 (symptoms may include extreme tiredness (fatigue), pain and redness of the tongue (glossitis), tingling or numbness (paraesthesiae), or paleness or yellowing of the skin). Your doctor may order certain tests to determine the cause of symptoms, as some of these may also be caused by diabetes or other unrelated health problems.
• Very rare: hepatitis (liver disease), hives, skin redness (rash) or itching

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
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 directly to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Jamesi

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 mentioned month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Jamesi contains

• The active substances in Jamesi are sitagliptin and metformin.
• Jamesi, 50 mg + 850 mg: Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.
• Jamesi, 50 mg + 1000 mg: Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 1000 mg of metformin hydrochloride.
• Other ingredients are:
  Core – microcrystalline cellulose (type 102), povidone (K 29/32), sodium lauryl sulfate, and magnesium stearate;
  Coating for Jamesi, 50 mg + 850 mg film-coated tablets (Opadry QX Pink): polyethylene glycol (PEG) and polyvinyl alcohol copolymer graft (E1209), talc (E553b), titanium dioxide (E171), mono- and diglycerides of fatty acids (E471), polyvinyl alcohol (E1203), iron oxide red (E172).
  Coating for Jamesi, 50 mg + 1000 mg film-coated tablets (Opadry QX Brown): polyethylene glycol (PEG) and polyvinyl alcohol copolymer graft (E1209), talc (E553b), titanium dioxide (E171), iron oxide red (E172), mono- and diglycerides of fatty acids (E471), polyvinyl alcohol (E1203), iron oxide black (E172).

What Jamesi looks like and contents of the pack
Jamesi, 50 mg + 850 mg film-coated tablets are oval, biconvex, approximately 20.5 mm x 9.5 mm in size, pink in colour, with the imprint "S476" on one side and smooth on the other.
Jamesi, 50 mg + 1000 mg film-coated tablets are oval, biconvex, approximately 21.5 mm x 10.0 mm in size, brown in colour, with the imprint "S477" on one side and smooth on the other.
The medicinal product should be packaged in a cardboard box.
Blisters made of PVC/PVDC/Aluminium.
Pack sizes: 14, 28, 56, 60 and 196 film-coated tablets.
HDPE container with PP closure and desiccant.
Pack size: 196 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer/Importer:
Laboratorios Liconsa S.A.
Avenida Miralcampo 7
Poligono Industrial Miralcampo
Azuqueca De Henares
19200 Guadalajara
Spain

This medicinal product is authorised in the European Economic Area member states under the following names:
Czech Republic: Sitagliptin/Metformin Viatris Pharma 50 mg/850 mg potahované tablety
Sitagliptin/Metformin Viatris Pharma 50 mg/1 000 mg potahované tablety
Austria, Croatia, Estonia, Greece, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia: Jamesi
Spain: Sitagliptina/Metformina Viatris Pharmaceuticals 50 mg/850 mg comprimidos recubiertos con película EFG
Sitagliptina/Metformina Viatris Pharmaceuticals 50 mg/1.000 mg comprimidos recubiertos con película EFG
Bulgaria: Джамези/Jamesi

For more detailed information, contact the representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00