DIESMIT 50 mg/500 mg Modified-Release Tablet

Зміст інструкції

1. DIESMIT 50 mg/500 mg modified release tablets, 50 mg/1000 mg modified release tablets, 100 mg/1000 mg modified release tablets
   1. What is DIESMIT and what is it used for
   2. What you need to know before you take DIESMIT
   3. How to take DIESMIT
   4. Possible side effects
   5. How to store DIESMIT
   6. Package contents and other information

DIESMIT 50 mg/500 mg modified release tablets, 50 mg/1000 mg modified release tablets, 100 mg/1000 mg modified release tablets

sitagliptin/metformin hydrochloride

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What DIESMIT is and what it is used for
• 2. What you need to know before you take DIESMIT
• 3. How to take DIESMIT
• 4. Possible side effects
• 5. How to store DIESMIT
• 6. Contents of the pack and other information

1. What is DIESMIT and what is it used for

DIESMIT contains two different medicines called sitagliptin and metformin.

• sitagliptin belongs to a class of drugs called DPP-4 inhibitors (dipeptidyl peptidase 4 inhibitors)
• metformin belongs to a class of drugs called biguanides.

They work together to control blood sugar levels in adult patients with a form
of diabetes called “type 2 diabetes mellitus”. This medicine helps to increase the levels of
insulin produced after meals and decreases the amount of sugar produced by the body.
Along with diet and exercise, this medicine helps to lower blood sugar levels. This medicine can be used alone or with some other medicines for diabetes
(insulin, sulfonylureas or glitazones).
What is type 2 diabetes?
Type 2 diabetes is a disease in which the body does not produce enough insulin and the insulin
produced by the body does not work as well as it should. Your body may also produce
too much sugar. When this happens, sugar (glucose) builds up in the blood. This can
lead to serious medical problems such as heart disease, kidney disease, blindness and amputation.

2. What you need to know before you take DIESMIT

Do not take DIESMIT:

• if you are allergic to sitagliptin, to metformin or to any of the other ingredients of this medicine (listed in section 6)
• if you have severely reduced kidney function
• if you have uncontrolled diabetes associated with, for example, severe high blood sugar (high levels of glucose in the blood), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see below “Risk of lactic acidosis”) or ketoacidosis. Ketoacidosis is a condition in which substances

called “ketone bodies” accumulate in the blood and can lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness and breath with an unusually fruity odour.

• if you have a severe infection or are dehydrated
• if you are about to have an X-ray that involves the use of an iodine contrast agent. You will need to stop taking DIESMIT at the time of the X-ray and for 2 or more days afterwards as directed by your doctor, depending on how well your kidneys are working
• if you have recently had a heart attack or have serious problems with circulation, such as “shock” or difficulty breathing
• if you have problems with your liver
• if you drink excessive amounts of alcohol (either every day or occasionally)
• if you are breastfeeding

Do not take DIESMIT if you have any of the problems above and talk to your doctor about other ways to manage your diabetes. If you are not sure, talk to your doctor, pharmacist or nurse before taking DIESMIT.

Warnings and precautions
Cases of inflammation of the pancreas (pancreatitis) have been reported in patients treated with DIESMIT
(see section 4).
If you develop blisters on the skin, it may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop taking DIESMIT.

Risk of lactic acidosis
DIESMIT can cause a very rare but very serious side effect called lactic acidosis, particularly if your kidneys do not work properly. The risk of developing lactic acidosis is greater in the presence of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see below for more information), liver problems and any other medical condition characterised by a reduced supply of oxygen to part of the body (such as in the case of serious heart disease).
If you have any of the medical conditions described above, consult your doctor for further instructions.

Stop taking DIESMIT for a short period of time if you have a medical condition that may be associated with dehydration(significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than usual. Consult your doctor for further instructions.

If you experience any of the symptoms of lactic acidosis, stop taking DIESMIT and seek immediate medical attention or go to the nearest hospital, because lactic acidosis can lead to coma. The symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• a general feeling of unwellness with severe tiredness
• difficulty breathing
• decreased body temperature and slower heartbeat

Lactic acidosis is a medical emergency and needs to be treated in hospital.
Talk to your doctor or pharmacist before taking DIESMIT:

• if you have or have had a disease of the pancreas (such as pancreatitis)
• if you have or have had gallstones, alcohol dependence or very high levels of triglycerides (a type of fat) in your blood. These medical conditions may increase your risk of developing pancreatitis (see section 4)
• if you have type 1 diabetes. This is sometimes called insulin-dependent diabetes
• if you have or have had an allergic reaction to sitagliptin, metformin or DIESMIT (see section 4)
• if you are taking a sulfonylurea or insulin, medicines for diabetes, together with DIESMIT, as this may cause a lowering of blood sugar levels (hypoglycaemia). Your doctor may reduce the dose of sulfonylurea or insulin.

If you are going to have major surgery, you must stop taking DIESMIT during the surgery and for a certain period of time afterwards. Your doctor will decide when you should stop and when you should restart treatment with DIESMIT.
If you are not sure whether any of the above conditions apply to you, consult your doctor or pharmacist before taking DIESMIT.
During treatment with DIESMIT, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if your kidney function gets worse.

Children and adolescents
Children and adolescents under 18 years of age should not use this medicine. It is not effective in children and adolescents between 10 and 17 years of age. It is not known whether this medicine is safe and effective when used in children under 10 years of age.

Other medicines and DIESMIT
If you are going to have an iodine-containing contrast agent injected into your bloodstream, for example for an X-ray or other examination, you must stop taking DIESMIT before or during the injection. Your doctor will decide when you should stop and when you should restart treatment with DIESMIT.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. You may need to have your blood sugar and kidney function checked more often, or your doctor may decide to adjust the dose of DIESMIT. It is particularly important to mention the following:

• medicines (taken by mouth, by inhalation or by injection) used to treat inflammatory diseases, such as asthma and 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 for treating high blood pressure (ACE inhibitors and angiotensin II receptor blockers)
• specific medicines for treating asthma (beta-sympathomimetics)
• iodine 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 (for the treatment of irregular heartbeats and other heart conditions). It may be necessary to check the level of digoxin in your blood if it is taken with DIESMIT.

DIESMIT with alcohol
Avoid excessive alcohol consumption during treatment with DIESMIT as this may increase the risk of lactic acidosis (see “Warnings and precautions”).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. You should not take this medicine during pregnancy or if you are breastfeeding. See section 2, Do not take DIESMIT.

Driving and using machines
This medicine has no or negligible effect on the ability to drive and operate machinery. However, dizziness and drowsiness have been reported with sitagliptin, which may affect your ability to drive and operate machinery.
Taking this medicine with other medicines called sulfonylureas or with insulin may cause hypoglycaemia, which may affect your ability to drive, operate machinery or work without protective barriers.

DIESMIT contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take DIESMIT

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist. Your doctor will tell you how many DIESMIT tablets to take and when
to take them.
The maximum daily dose is 100 milligrams of sitagliptin and 2,000 milligrams of metformin.
The tablets are normally taken once a day with the evening meal.
In some cases, your doctor may advise you to take the tablets twice a day.
Always take the tablets with food to decrease the likelihood of stomach discomfort.
The tablets must be swallowed whole with a glass of water, without chewing.
Your doctor may need to increase the dose to control the sugar in your
blood.
If you have reduced kidney function, your doctor may prescribe a lower dose.
You must continue the diet recommended by your doctor during treatment with this medicine and
ensure that carbohydrate intake is evenly distributed throughout the day.
It is unlikely that this medicine alone will cause an abnormal lowering of blood
sugar levels (hypoglycemia). When this medicine is used with a medicine containing
sulfonylurea or with insulin, a lowering of blood sugar may occur and your doctor may
reduce the dose of sulfonylurea or insulin.

If you take more DIESMIT than you should
If you take a dose of this medicine higher than that prescribed for you, contact your
doctor immediately. Go to hospital if you have symptoms of lactic acidosis such as feeling
cold or unwell, severe nausea or vomiting, stomach pain, unexplained weight loss, muscle
cramps or rapid breathing (see section “Warnings and precautions”).

If you forget to take DIESMIT
If you miss a dose, take it as soon as you remember. If you do not remember until it is time to
take the next dose, skip the missed dose and continue with your normal dose. Do not
take a double dose to make up for a forgotten dose.

If you stop taking DIESMIT
Continue to take this medicine until your doctor prescribes it so that you can
continue to control your blood sugar level. You should not stop treatment with
this medicine without first talking to your doctor. If you stop treatment with
DIESMIT, your blood sugar level may rise again.
If you have any further questions on the use of this medicine, 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 DIESMIT and contact your doctor immediately if you notice any of the following serious
side effects:

• Severe and persistent abdominal pain (stomach area) that may spread to the back, with or without
  nausea and vomiting, as these may be signs of inflammation of the pancreas (pancreatitis).

DIESMIT can cause a very rare (may affect up to 1 in 10,000 people) but very serious side effect called
lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking
DIESMIT and immediately see your doctor or the nearest hospital, because lactic acidosis can
lead to coma.
If you have a severe allergic reaction (frequency not known as it cannot be estimated based on available
data), including skin rash, hives, blisters on the skin/skin peeling and swelling of the face, lips,
tongue and throat, which can cause difficulty breathing or swallowing, stop treatment with this medicine
and contact your doctor immediately. Your doctor may prescribe you a medicine to treat your allergic
reaction and a different medicine for your diabetes.
Some patients, while taking metformine, have experienced the following side effects after starting
therapy with sitagliptin:
Common (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting
Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness
Some patients have experienced diarrhea, nausea, flatulence, constipation, stomach pain or vomiting
when they started the combination of sitagliptin and metformine together (frequency is common).
Some patients have experienced the following side effects while taking this medicine with a
sulphonylurea such as glimepiride:
Very common (may affect more than 1 in 10 people): low blood sugar
Common: constipation
Some patients have experienced the following side effects when taking this medicine in association with
pioglitazone:
Common: swelling of the hands or legs
Some patients have experienced the following side effects when taking this medicine in association with
insulin:
Very common: low blood sugar
Uncommon: dry mouth, headache
During clinical studies, some patients have experienced the following side effects when taking
sitagliptin alone (one of the medicines contained in DIESMIT) or during the post-marketing use of
DIESMIT or sitagliptin alone or with other medicines for diabetes:
Common: low blood sugar, headache, upper respiratory tract infection, stuffy or runny nose and sore
throat, osteoarthritis, pain in the arms or legs
Uncommon: dizziness, constipation, itching
Rare: reduced number of platelets
Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain,
back pain, interstitial lung disease, bullous pemphigoid (a type of skin blistering)
Some patients, while taking metformine alone, have experienced the following side effects:
Very common: nausea, vomiting, diarrhea, stomach pain and loss of appetite. These symptoms can
occur when you start taking metformine and usually disappear
Common: metallic taste
Very rare: decreased levels of vitamin B12, hepatitis (a liver problem), hives, skin redness (rash) or
itching.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects
directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse . By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store DIESMIT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the blister and the package after
“EXP”. The expiry date refers to the last day of that month.
This medicine does not require particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What DIESMIT contains
The active ingredients are sitagliptin and metformin.
DIESMIT 50 mg/500 mg: Each tablet contains sitagliptin hydrochloride monohydrate equivalent to 50
mg of sitagliptin and 500 mg of metformin hydrochloride.
DIESMIT 50 mg/1000 mg: Each tablet contains sitagliptin hydrochloride monohydrate equivalent to
50 mg of sitagliptin and 1000 mg of metformin hydrochloride.
DIESMIT 100 mg/1000 mg: Each tablet contains sitagliptin hydrochloride monohydrate equivalent to
100 mg of sitagliptin and 1000 mg of metformin hydrochloride.
The other ingredients are:

• Layer with prolonged-release metformin: hypromellose, magnesium stearate
• Layer with immediate-release sitagliptin: calcium hydrogen phosphate, microcrystalline cellulose, sodium stearyl fumarate, sodium croscarmellose (see section 2 “DIESMIT contains sodium”).
• The film coating also contains:

o in the 100 mg/1000 mg and 50 mg/500 mg dosages: partially hydrolysed polyvinyl alcohol, titanium
dioxide (E171), macrogol 4000, talc, yellow iron oxide (E172), red iron oxide (E172).
o in the 50 mg/1000 mg dosage: poly(vinyl alcohol), titanium dioxide (E171), macrogol 4000, talc.

Description of the appearance of DIESMIT and contents of the pack
DIESMIT 50 mg/500 mg: Film-coated tablets, orange in colour, oblong, biconvex,
measuring 17.2 mm/8.4 mm.
DIESMIT 50 mg/1000 mg: Film-coated tablets, white in colour, oblong, biconvex, measuring
22.2 mm/10.8 mm, with “50” imprinted on one side and “1000” on the other side.
DIESMIT 100 mg/1000 mg: Film-coated tablets, orange in colour, oblong, biconvex,
measuring 22.2 mm/10.8 mm, with “100” imprinted on one side and “1000” on the other side.
PVC/PVDC/Aluminium blisters. Pack sizes of 10, 14, 28, 30, 56, 60, 98, 100, 112, 160, 168, 180,
196 or 200 modified-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Bruno Farmaceutici Spa
Via delle Ande 15,
00144 Roma

Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Poland

This medicinal product is authorised in the Member States of the European Economic Area under
the following denominations:
Austria, Croatia: Sitagliptin/Metformin APC
Bulgaria, Cyprus, Greece: Sitagliptin+Metformin APC
Poland: Sitagliptin + Metformin hydrochloride APC
Portugal: Mesiglic
Italy: Diesmit