ADIABIN 50 mg/850 mg Film-Coated Tablets

Зміст інструкції

1. Adiabin 50 mg/850 mg film-coated tablets, 50 mg/1000 mg film-coated tablets
   1. What is Adiabin and what is it used for
   2. What you need to know before taking Adiabin
   3. How to take Adiabin
   4. Possible side effects
   5. How to store Adiabin
   6. Contents of the pack and other information

Adiabin 50 mg/850 mg film-coated tablets, 50 mg/1000 mg film-coated tablets

Sitagliptin/Metformin hydrochloride
Generic medicine

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 they have the same symptoms as you, as it may 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 Adiabin is and what it is used for
• 2. What you need to know before you take Adiabin
• 3. How to take Adiabin
• 4. Possible side effects
• 5. How to store Adiabin
• 6. Contents of the pack and other information

1. What is Adiabin and what is it used for

Adiabin 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 taking Adiabin

Do not take Adiabin:

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

Do not take Adiabin if you have any of the problems listed above and talk to your doctor about other methods of managing your diabetes. If you are unsure, talk to your doctor, pharmacist or nurse before taking Adiabin.

Warnings and precautions
Cases of inflammation of the pancreas (pancreatitis) have been reported in patients treated with Adiabin (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 treatment with Adiabin.

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

Stop taking Adiabin 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 Adiabin and seek immediate medical attention or go to the nearest hospital, as this condition can lead to coma.
Symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• a general feeling of unwellness associated with severe fatigue
• difficulty breathing
• reduced body temperature and heart rate

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

• if you have or have had a pancreatic disease (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 Adiabin (see section 4)
• if you are taking a sulfonylurea or insulin, medicines for diabetes, together with Adiabin, as this may cause a drop in 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 Adiabin during the surgery and for a certain period of time afterwards. Your doctor will decide when you should stop and when you should resume treatment with Adiabin.
If you are unsure whether any of the above conditions apply to you, consult your doctor or pharmacist before taking Adiabin.
During treatment with Adiabin, 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 worsens.

Children and adolescents
Children and adolescents under the age of 18 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 Adiabin
If you are going to have an iodine-containing contrast agent injected into your bloodstream, for example for an X-ray, you must stop taking Adiabin before or at the time of the injection. Your doctor will decide when you should stop and when you should resume treatment with Adiabin.
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 Adiabin. 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 antagonists)
• specific medicines for treating asthma (β-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 problems). It may be necessary to check the level of digoxin in your blood if it is taken with Adiabin.

Adiabin with alcohol
Avoid excessive alcohol consumption during treatment with Adiabin 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, or if you are breastfeeding, 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 Adiabin.
Driving and using machines
This medicine has no or negligible effect on the ability to drive and operate machines. However, dizziness and drowsiness have been reported with sitagliptin, which may affect your ability to drive or operate machines.
Taking this medicine with other medicines called sulfonylureas or with insulin can cause hypoglycaemia, which may affect your ability to drive, operate machines or work without protective barriers.
Adiabin contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially “sodium-free”

3. How to take Adiabin

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.

• Take one tablet: Ø twice a day by mouth, Ø with meals to decrease the probability of stomach discomfort.
• The 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 sulfonylurea-based medicine or with insulin, a lowering of blood sugar may occur and the
doctor may reduce the dose of sulfonylurea or insulin.
The score line is only to help you break the tablet if you have difficulty swallowing it whole.

If you take more Adiabin than you should
If you take a dose of this medicine higher than the one prescribed to 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
paragraph “Warnings and precautions”).

If you forget to take Adiabin
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 forgotten dose and continue with your normal dose. Do not take a double dose of this
medicine.

If you stop taking Adiabin
Continue to take this medicine until your doctor prescribes it so that you can continue
to control your blood sugar level. Do not stop treatment with this medicine without first talking to your
doctor. If you stop treatment with Adiabin, your blood sugar level may rise again.
If you have any questions about 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 Adiabin 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 your back, with or without nausea and vomiting, as these can be signs of inflammation of the pancreas (pancreatitis).

Adiabin 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 Adiabin and immediately see your doctor or the nearest hospital, because lactic
acidosis can lead to coma.
If you have a serious allergic reaction (frequency not known), 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 discomfort, diarrhoea, constipation,
drowsiness.
Some patients have experienced diarrhoea, nausea, flatulence, constipation, stomach discomfort or vomiting when
they started the combination of sitagliptin and metformine together (the frequency is common).
Some patients have experienced the following side effects while taking this medicine with
a sulfonylurea 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
combination with pioglitazone:
Common: swelling of the hands or legs
Some patients have experienced the following side effects when taking this medicine in
combination 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 Adiabin) or during post-marketing of Adiabin or sitagliptin alone or with other diabetes medicines:
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, interstitial lung disease, bullous pemphigoid (a type of skin blister)
Some patients, while taking metformine alone, have experienced the following side effects:
Very common: nausea, vomiting, diarrhoea, stomach discomfort and loss of appetite. These symptoms may
occur when you start taking metformine and generally 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 Reporting side effects can help to provide more information on the safety of
this medicine.

5. How to store Adiabin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the package after "EXP".
The expiry date refers to the last day of that month.
Opaque PVC/PE/PVDC-aluminium blister
Do not store at a temperature above 30°C.
OPA/Al/PVC-aluminium blister
This medicine does not require any 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. Contents of the pack and other information

What Adiabin contains

• The active ingredients are sitagliptin and metformin.

Adiabin 50 mg/850 mg film-coated tablets
Each film-coated tablet (tablet) contains sitagliptin hydrochloride monohydrate equivalent to 50
mg of sitagliptin and 850 mg of metformin hydrochloride.
Adiabin 50 mg/1000 mg film-coated tablets
Each film-coated tablet (tablet) contains sitagliptin hydrochloride monohydrate equivalent to 50
mg of sitagliptin and 1000 mg of metformin hydrochloride.

• The other ingredients are: in the tablet core: povidone, sodium lauryl sulfate, microcrystalline cellulose, magnesium stearate.

In addition, the tablet coating contains:
50 mg/850 mg film-coated tablets
Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, red iron oxide (E172) and black iron oxide
(E172).
50 mg/1000 mg film-coated tablets:
polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, red iron oxide (E172) and yellow iron oxide
(E172).

Description of the appearance of Adiabin and contents of the pack
Adiabin 50 mg/850 mg film-coated tablets
Pink film-coated tablet, capsule-shaped, biconvex, with “585” imprinted on one side and an incision line on the other side.
Adiabin 50 mg/1000 mg film-coated tablets
Red film-coated tablet, capsule-shaped, biconvex, with “5100” imprinted on one side and an incision line
on the other side.
Opaque PVC/PE/PVDC-aluminium blister or OPA/Al/PVC-aluminium blister.
Pack of 56 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
PHARMEXTRACTA S.P.A
Via G.Natta, 28
29010 Pontenure (PC)
Italy

Manufacturers
Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O. Box 3012 Larisa Industrial Area
Larisa 41004
Greece
PharOS MT Ltd.
HF62X, Hal Far Industrial Estate
Birzebbugia BBG3000
Malta

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
This leaflet was last updated