Adiabin: detailed information

Patient Information Leaflet

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

Sitagliptin/Metformin hydrochloride
Generic medicine
Please read this leaflet carefully before 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 give it to others, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Adiabin is and what it is used for
What you need to know before taking Adiabin
How to take Adiabin
Possible side effects
How to store Adiabin
Contents of the pack and other information

1. What Adiabin is and what it is used for

Adiabin contains two different medicines called sitagliptin and metformin.

sitagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors)
metformin belongs to a class of medicines 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 increase insulin levels produced after meals and reduces the amount of sugar produced by the body. Together with diet and exercise, this medicine helps lower blood sugar levels. This medicine can be used alone or in combination with certain other diabetes medicines (insulin, sulfonylureas or glitazones).

What is type 2 diabetes?
Type 2 diabetes is a condition in which the body does not produce enough insulin and the insulin the body produces 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, for example, with severe hyperglycaemia (high blood glucose levels), 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 may lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or breath with an unusually fruity odour.
if you have a severe infection or are dehydrated
if you are about to undergo radiographic imaging involving injection of a contrast agent. You will need to stop taking Adiabin at the time of the imaging procedure and for 2 or more days afterwards, as directed by your doctor, depending on how well your kidneys are functioning
if you have recently had a heart attack or have serious circulatory problems, such as “shock” or breathing difficulties
if you have liver problems
if you drink excessive amounts of alcohol (either regularly or occasionally)
if you are breastfeeding

Do not take Adiabin if you have any of the above conditions and speak with your doctor about other methods of managing diabetes. If you are unsure, speak with 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 your skin, this 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 may cause a very rare but serious side effect called lactic acidosis, particularly if the kidneys are not functioning properly. The risk of developing lactic acidosis is also higher in the presence of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see below for further information), liver problems, or any other medical condition characterized by reduced oxygen supply to part of the body (such as in severe acute heart conditions).

If you have any of the medical conditions listed above, consult your doctor for further instructions.

Temporarily stop taking Adiabin if you develop a medical condition that may lead to dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, heat exposure, or if you are drinking less fluid than usual. Consult your doctor for further instructions.

If you experience any of the symptoms of lactic acidosis, stop taking Adiabin immediately and contact your doctor or go to the nearest hospital, as this condition may lead to coma.

Symptoms of lactic acidosis include:

vomiting
stomach ache (abdominal pain)
muscle cramps
a general feeling of malaise associated with severe fatigue
difficulty breathing
low body temperature and slow heart rate

Lactic acidosis is a medical emergency and must be treated in hospital.

Talk to 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 the 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, diabetes medicines, together with Adiabin, as this may cause low blood sugar levels (hypoglycaemia). Your doctor may reduce the dose of sulfonylurea or insulin.

If you are scheduled to undergo major surgery, you must stop taking Adiabin during the procedure and for a certain period afterwards. Your doctor will decide when to stop and when to restart 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 kidney function worsens.

Contact your doctor immediately for further instructions if:

you know you have a hereditary genetic mitochondrial disease (components that produce energy within cells), such as MELAS (Mitochondrial Encephalopathy, myopathy, Lactic Acidosis and Stroke-like episodes) or Maternal Inherited Diabetes and Deafness (MIDD)
you experience any of the following symptoms after starting metformin: seizures, reduced cognitive ability, movement difficulties, symptoms indicating nerve damage (e.g. pain or numbness), headache, or deafness

Children and adolescents

Children and adolescents under 18 years of age must not use this medicine. It is not effective in children and adolescents aged between 10 and 17 years. 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 scheduled to receive an injection of iodinated contrast medium into the bloodstream, for example for radiographic imaging, you must stop taking Adiabin before or at the time of injection. Your doctor will decide when to stop and when to restart treatment with Adiabin.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. You may need to monitor your blood glucose and kidney function more frequently, or your doctor may decide to adjust the dose of Adiabin. It is particularly important to mention the following:

medicines (taken orally, inhaled, or injected) used to treat inflammatory conditions 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 used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
specific medicines for the treatment of bronchial asthma (β-sympathomimetics)
iodinated 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 irregularities and other heart conditions). It may be necessary to monitor digoxin blood levels when taken with Adiabin.

Adiabin and alcohol

Avoid excessive alcohol consumption while taking Adiabin, as this may increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. You must not take this medicine during pregnancy or while breastfeeding. See section 2, Do not take Adiabin.

Driving and using machines

This medicine has no effect or has a negligible effect on the ability to drive and use machines. However, dizziness and drowsiness have been reported with sitagliptin, which may affect your ability to drive or use machines.

Taking this medicine together with other medicines called sulfonylureas or with insulin may cause hypoglycaemia, which may affect your ability to drive, use 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 exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Take one tablet: ➢ twice daily by mouth, ➢ with meals to reduce the likelihood of stomach upset.
Your doctor may need to increase your dose to control the sugar level in your blood.
If you have reduced kidney function, your doctor may prescribe you 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 abnormally low blood sugar levels (hypoglycaemia). However, when this medicine is used together with a sulphonylurea medicine or with insulin, a drop in blood sugar may occur, and your doctor may reduce the dose of sulphonylurea or insulin.
The break line on the tablet is only intended to help you split the tablet if you have difficulty swallowing it whole.

If you take more Adiabin than you should
If you take more of this medicine than prescribed, contact your doctor immediately. Go to hospital if you experience 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 Adiabin
If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and take your next dose at the regular time. Do not take a double dose of this medicine.

If you stop taking Adiabin
Continue taking this medicine for as long as your doctor prescribes it, so that you can keep your blood sugar level under control. Do not stop taking 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 how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
STOP taking Adiabin and contact a doctor immediately if you notice any of the following serious side effects:

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

Adiabin may 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 seek immediate medical attention at the nearest doctor or hospital, because lactic acidosis can lead to coma.
If you experience a severe allergic reaction (frequency not known), including rash, hives, skin blistering/skin peeling, and swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing, stop treatment with this medicine and contact your doctor immediately.
Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.

Some patients, while taking metformin, experienced the following side effects after starting treatment with sitagliptin:
Common (may affect up to 1 in 10): low blood sugar level, nausea, flatulence, vomiting.
Uncommon (may affect up to 1 in 100): stomach ache, diarrhoea, constipation, drowsiness.

Some patients experienced diarrhoea, nausea, flatulence, constipation, stomach ache, or vomiting when they started taking the combination of sitagliptin and metformina together (frequency is common).

Some patients experienced the following side effects while taking this medicine with a sulfonylurea such as glimepiride:
Very common (may affect more than 1 in 10): low blood sugar level
Common: constipation

Some patients experienced the following side effects while taking this medicine in combination with pioglitazone:
Common: swelling of the hands or legs

Some patients experienced the following side effects while taking this medicine in combination with insulin:
Very common: low blood sugar level
Uncommon: dry mouth, headache

During clinical studies, some patients experienced the following side effects while taking sitagliptin alone (one of the medicines contained in Adiabin) or during post-marketing use of Adiabin or sitagliptin alone or with other diabetes medicines:
Common: low blood sugar level, headache, upper respiratory tract infection, stuffy or runny nose and sore throat, osteoarthritis, pain in arms or legs
Uncommon: dizziness, constipation, itching sensation
Rare: reduced platelet count
Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister)

Some patients, while taking metformin alone, experienced the following side effects:
Very common: nausea, vomiting, diarrhoea, stomach ache, and loss of appetite. These symptoms may occur when you first start taking metformin and usually resolve:
Common: metallic taste
Very rare: decreased levels of vitamin B12, hepatitis (a liver problem), hives, skin redness (rash), or itching sensation.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at the following website: 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 Adiabin

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 outer carton after "EXP".
The expiry date refers to the last day of that month.
PVC/PE/PVDC-aluminium opaque blister
Do not store above 30°C.
OPA/Al/PVC-aluminium blister
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Adiabin contains

The active substances are sitagliptin and metformin.

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

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

Additionally, 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 package contents
Adiabin 50 mg/850 mg film-coated tablets
Pink, capsule-shaped, biconvex film-coated tablet with "585" engraved on one side and a score line on the other side.
Adiabin 50 mg/1000 mg film-coated tablets
Red, capsule-shaped, biconvex film-coated tablet with "5100" engraved on one side and a score line on the other side.
Opaque blisters made of PVC/PE/PVDC-aluminum or OPA/Al/PVC-aluminum.
Pack size: 56 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization 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 has been authorised in the European Economic Area Member States under the following names:
Italy:
Adiabin 50 mg/850 mg, Adiabin 50 mg/1000 mg film-coated tablets

This leaflet was last updated: 09/2025