Jamesi novum

Package leaflet: Information for the patient

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

Leaflet contents:

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

1. What Jamesi Novum is and what it is used for

Jamesi Novum 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 the amount of insulin released after a meal 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 sole 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, and the insulin that is 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. Important information before taking Jamesi Novum

When not to take Jamesi Novum

• 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 for a radiological examination with intravascular administration of contrast agents. The use of Jamesi Novum should be temporarily discontinued during the radiological 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 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 Jamesi Novum if any of the above contraindications apply. Consult your doctor to determine alternative methods of diabetes control. If in doubt, discuss this with your doctor, pharmacist or nurse before taking Jamesi Novum.

Warnings and precautions

Pancreatitis has been reported in patients taking sitagliptin + metformin (see section 4).
If the patient develops skin blisters, this may be a symptom of a disease known as bullous pemphigoid. The doctor may advise the patient to discontinue taking Jamesi Novum.

Risk of lactic acidosis
Jamesi Novum 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 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 doctor for further instructions.

Temporarily discontinue the use of Jamesi Novum if the patient develops a medical condition that may lead to 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 doctor for further instructions.

Discontinue the use of Jamesi Novum and contact a doctor or the nearest hospital immediately if any symptoms of lactic acidosis occur, as this condition may lead to coma.

Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general malaise accompanied by 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 Jamesi Novum, 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 be increased (see section 4).
• if the patient has type 1 diabetes. This is sometimes referred to as insulin-dependent diabetes.
• if the patient currently has or has had allergic reactions to sitagliptin, metformin, or Jamesi Novum (see section 4).
• if the patient is taking a sulfonylurea derivative or insulin, antidiabetic drugs, together with Jamesi Novum, as this may lead to excessively low blood sugar levels (hypoglycaemia). The doctor may reduce the dose of the sulfonylurea derivative or insulin.

Contact your doctor immediately for further instructions if:

• the patient has a genetically inherited disorder affecting mitochondria (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, symptoms indicating nerve damage (e.g. pain or numbness), migraine, or deafness.

If the patient is scheduled for major surgery, Jamesi Novum must not be taken during the procedure and for some time afterwards. The doctor will decide when the patient should stop and resume treatment with Jamesi Novum.

If in doubt whether any of the above statements apply to the patient, discuss this with a doctor or pharmacist before taking Jamesi Novum.

During treatment with Jamesi Novum, the doctor 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
Jamesi Novum should not be used in children and adolescents under 18 years of age. 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 for use in children under 10 years of age.

Jamesi Novum and other medicines
If the patient is to receive an iodine-containing contrast agent injected into the bloodstream, for example for an X-ray or CT scan, the patient must stop taking Jamesi Novum before or at the latest at the time of injection. The doctor will decide when the patient should stop and resume treatment with Jamesi Novum.

Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken. The patient may require more frequent monitoring of blood glucose levels and kidney function assessments, or dose adjustments of Jamesi Novum by the doctor. 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 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 Jamesi Novum with digoxin.

Jamesi Novum and alcohol
Avoid consuming excessive amounts of alcohol while taking Jamesi Novum, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before taking this medicine.
Do not use this medicine during pregnancy. Do not use this medicine during breastfeeding; see section 2, "When not to take Jamesi Novum".

Driving and operating machinery
This medicine has no effect or a negligible effect on the ability to drive and operate machinery. However, when driving and operating machinery, consider 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 insulin may lead to hypoglycaemia, which may affect the ability to drive and operate machinery or work without secure foot support.

Jamesi Novum contains sodium and sulphites
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
Sulphites
May rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take Jamesi Novum
This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult your doctor or pharmacist.

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

While taking this medicine, continue following the diet recommended by your doctor and maintain consistent 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 levels may occur when this medicine is taken together with a sulfonylurea derivative or insulin – in such cases, the doctor may reduce the dose of the sulfonylurea derivative or insulin.

Taking more than the recommended dose of Jamesi Novum
If more than the recommended 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").

Missed dose of Jamesi Novum
If a dose is missed, take it as soon as possible. If the next dose is due soon, skip the missed dose and continue with the regular dosing schedule. Do not take a double dose of this medicine.

Stopping Jamesi Novum
To maintain blood glucose control, continue taking the medicine for as long as directed by the doctor. Do not stop taking this medicine without first consulting your doctor.
Discontinuing Jamesi Novum may lead to increased blood glucose levels.
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 Jamesi Novum and contact your doctor immediately
if you experience any of the following serious adverse 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 Novum may very rarely (occurring not more frequently than in 1 patient in 10,000) cause a very serious adverse effect known as lactic acidosis (see section “Warnings and precautions”). If this occurs in a patient, treatment with Jamesi Novum must be discontinued and immediate contact must be made with a doctor or the nearest hospital, as lactic acidosis may lead to coma.
In case of a severe allergic reaction (frequency not known), including rash, urticaria, skin blisters or skin peeling, and swelling of the face, lips, tongue or throat, which may cause difficulty in breathing or swallowing, treatment with the medicine must be stopped and immediate medical advice sought. The doctor may prescribe medication to treat the allergic reaction and another medicine (a different medicine) for the treatment of diabetes.
In some patients taking metformin, the following adverse effects occurred after starting treatment with sitagliptin:
Common (may occur in up to 1 in 10 patients): low blood sugar levels, nausea, bloating, vomiting
Uncommon (may occur in up to 1 in 100 patients): stomach pain, diarrhoea, constipation, drowsiness
Diarrhoea, nausea, bloating, constipation, stomach pain or vomiting occurred in some patients after starting treatment with sitagliptin in combination with metformin (common).
In some patients taking this medicine in combination with a sulfonylurea derivative, such as glimepiride, the following adverse effects occurred:
Very common (may occur in more than 1 in 10 patients): low blood sugar levels
Common: constipation
In some patients taking this medicine in combination with pioglitazone, the following adverse effects occurred:
Common: swelling of hands or feet
In some patients taking this medicine in combination with insulin, the following adverse effects occurred:
Very common: low blood sugar levels
Uncommon: dry mouth, headache
In clinical trials, in some patients taking sitagliptin alone (one of the active substances in Jamesi Novum) or after marketing authorization during treatment with Jamesi Novum or sitagliptin alone or in combination with other antidiabetic medicines, the following adverse effects were observed:
Common: low blood sugar levels, headache, upper respiratory tract infection, nasal congestion 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 skin blister)
In some patients taking metformin alone, the following adverse effects occurred:
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 levels of vitamin B12 in the blood (symptoms may include extreme tiredness (fatigue), pain and redness of the tongue (glossitis), tingling or numbness sensations (paresthesia), or pallor or yellowing of the skin). Your doctor may order certain tests to determine the cause of symptoms, as some of them may also be caused by diabetes or other unrelated health problems.
Very rare: hepatitis (liver disease), urticaria, skin redness (rash) or itching

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Jamesi Novum

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 the outer cardboard box following 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. Such measures help protect the environment.

6. Contents of the pack and other information

What Jamesi Novum contains

• Jamesi Novum, 50 mg + 850 mg: The active substances are sitagliptin and metformin. Each film-coated tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.
• Jamesi Novum, 50 mg + 1000 mg: The active substances are sitagliptin and metformin. Each film-coated tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 1000 mg of metformin hydrochloride.
• Other ingredients are: Core – microcrystalline cellulose type 102, povidone 30, sodium sulfite, sodium lauryl sulfate, and sodium stearyl fumarate. Coating – polyvinyl alcohol, titanium dioxide (E171), macrogol 4000, talc. Additionally, for Jamesi Novum, 50 mg + 1000 mg film-coated tablets: yellow iron oxide (E172), red iron oxide (E172).

What Jamesi Novum looks like and contents of the pack
Jamesi Novum, 50 mg + 850 mg, film-coated tablets are white to almost white, elongated, approximately 21 mm x 10 mm in size, with a breakline on both sides. The breakline on the tablet facilitates only breaking the tablet for easier swallowing and does not allow for division into equal doses.
Jamesi Novum, 50 mg + 1000 mg, film-coated tablets are light pink, elongated, approximately 21 mm x 10.0 mm in size, with a breakline on both sides. The breakline on the tablet facilitates only breaking the tablet for easier swallowing and does not allow for division into equal doses.
PVC/PVDC/Aluminium foil blisters in a cardboard box.
Pack sizes:
28, 56, 60 and 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:
Zentiva S.A.
B-dul Theodor Pallady no. 50, sector 3
032266 Bucharest
Romania

This medicinal product is authorised in the European Economic Area member states under the following names:
Bulgaria, Czech Republic, Poland, Romania, Slovakia: Jamesi Novum

For further 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