Fordiab

Leaflet accompanying the packaging: information for the user

Fordiab, 50 mg + 850 mg, film-coated tablets
Fordiab, 50 mg + 1000 mg, film-coated tablets
Sitagliptin + Metformin hydrochloride

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Fordiab and what is it used for

Fordiab contains two different active substances called 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 medicines leads to the normalization of blood sugar levels in adult patients with diabetes known as "type 2 diabetes". This medicine helps to increase the amount of insulin released after a meal and reduce the amount of sugar produced by the body.
The medicine is used in combination with diet and exercise to reduce blood sugar levels.
This medicine may be used as the only anti-diabetic medicine or in combination with certain other anti-diabetic medicines (insulin, sulfonylurea derivatives, 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 does not work as it should. The body may also produce too much sugar. If this happens, sugar (glucose) accumulates in the blood. This can lead to serious health problems, such as heart disease, kidney disease, vision loss, and limb amputation.

2. Important information before taking Fordiab

When not to take Fordiab

• if the patient is allergic to sitagliptin, metformin, or 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 hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or ketoacidosis. Ketoacidosis is a disease in which substances called ketone bodies accumulate in the blood and can lead to a diabetic pre-coma state. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness or an unusual fruity odor from the mouth.

in the blood and which can lead to a diabetic pre-coma state. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness or an unusual fruity odor from the mouth.

• if the patient has a severe infection or dehydration,
• if the patient is scheduled to undergo a radiological examination with intravenous administration of a contrast agent. The patient should stop taking Fordiab during the radiological examination and for a period of 2 or more days, according to the doctor's instructions, depending on the patient's kidney function.
• if the patient has recently had 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 from time to time),
• if the patient is breastfeeding.

You should not take Fordiab if any of the above contraindications occur.
You should consult a doctor to determine other methods of controlling diabetes. In case of doubts, before taking Fordiab, you should discuss it with your doctor, pharmacist, or nurse.

Warnings and precautions

In patients taking Fordiab, cases of pancreatitis (see section 4) have been reported.
If the patient develops blisters on the skin, it may be a sign of a disease called pemphigoid.
The doctor may recommend that the patient stop taking Fordiab.

Risk of lactic acidosis

Fordiab may cause a very rare but very serious side effect called lactic acidosis, especially if the patient has kidney problems. The risk of lactic acidosis increases in cases of uncontrolled diabetes, severe infection, prolonged fasting, or alcohol consumption, dehydration (see more information below), liver disease, and any conditions in which a part of the body is not sufficiently supplied with oxygen (e.g., acute severe heart disease).
If any of the above situations apply to the patient, they should consult their doctor for more detailed instructions.

You should temporarily stop taking Fordiab if you have a condition that may lead to dehydration

(significant loss of water from the body), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. You should consult your doctor for more detailed instructions.

You should stop taking Fordiab and immediately contact your doctor or go to the nearest hospital if you experience any symptoms of lactic acidosis

, as this condition can lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell, accompanied by severe fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires immediate treatment in a hospital.
Before starting to take Fordiab, you should discuss it 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 levels of triglycerides (a type of fat) in the blood. In such cases, the risk of pancreatitis (see section 4) may increase.
• if the patient has type 1 diabetes. It is sometimes called insulin-dependent diabetes.
• if the patient has currently or has had allergic reactions to sitagliptin, metformin, or Fordiab (see section 4).
• if the patient is taking a sulfonylurea derivative or insulin, anti-diabetic medicines, at the same time as Fordiab, as this may lead to an excessive reduction in blood sugar levels (hypoglycemia). The doctor may reduce the dose of the sulfonylurea derivative or insulin.

If the patient is to undergo major surgery, they should not take Fordiab during the surgery and for a certain period after it. The doctor will decide when the patient should stop and resume treatment with Fordiab.
In case of doubts, the patient should consult their doctor or pharmacist before taking Fordiab.
During treatment with Fordiab, the doctor will monitor the patient's kidney function at least once a year or more often if the patient is elderly and/or has deteriorating kidney function.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age. This medicine 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.

Fordiab and other medicines

If the patient is to be injected with a contrast agent containing iodine, for example, for an X-ray examination or computed tomography, they should stop taking Fordiab before or at the time of the injection. The doctor will decide when the patient should stop and resume treatment with Fordiab.
The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient may need more frequent monitoring of blood sugar levels and kidney function or dose adjustment of Fordiab by the doctor. It is especially important to inform about the following medicines:

• medicines used to treat inflammatory diseases, such as asthma or arthritis, taken orally, by inhalation, or by injection (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),
• contrast agents containing iodine or medicines containing alcohol,
• certain medicines used to treat stomach 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 certain type of thyroid cancer (medullary thyroid cancer)
• digoxin (used to treat heart rhythm disorders and other heart diseases). When taking Fordiab with digoxin, the patient's digoxin levels should be monitored.

Taking Fordiab with alcohol

The patient should avoid consuming excessive amounts of alcohol (both daily and occasional) while taking Fordiab, as this may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
This medicine should not be taken during pregnancy and breastfeeding. See section 2, When not to take Fordiab.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, dizziness and drowsiness have been reported in patients taking sitagliptin, which may affect the ability to drive and use machines.
Taking this medicine in combination with sulfonylurea derivatives or insulin may lead to a reduction in blood sugar levels (hypoglycemia), which may affect the ability to drive and use machines or work without safe support for the feet.

Fordiab 50 mg + 850 mg contains lactose monohydrate and sodium.

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains 27.6 mg of sodium (the main component of common salt) per tablet. This corresponds to 1.38% of the maximum recommended daily intake of sodium in the diet for adults.

Fordiab 50 mg + 1000 mg contains sodium.

The medicine contains 32.5 mg of sodium (the main component of common salt) per tablet. This corresponds to 1.63% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Fordiab

This medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor or pharmacist.
Dosage
The recommended dose is one tablet taken twice a day.
In order to control blood sugar levels, the doctor may increase the dose of the medicine.
Method of administration
The medicine should be taken orally during meals to reduce the likelihood of stomach upset.
Kidney problems
If the patient has kidney problems, the doctor may recommend a lower dose of the medicine.
Other medicines and recommendations
During treatment with this medicine, the patient should continue to follow the diet recommended by the doctor and pay attention to the uniform intake of carbohydrates throughout the day.
It is unlikely that taking this medicine alone will lead to abnormally low blood sugar levels (hypoglycemia). Hypoglycemia may occur when taking this medicine in combination with a sulfonylurea derivative or insulin - in such cases, the doctor may reduce the dose of the sulfonylurea derivative or insulin.

Taking a higher dose of Fordiab than recommended

In case of taking a higher dose of this medicine than recommended, the patient should immediately contact their doctor. The patient should go to the hospital if symptoms of lactic acidosis occur, such as a feeling of cold or discomfort, severe nausea or vomiting, abdominal pain, unexplained weight loss, muscle cramps, or rapid breathing (see "Warnings and precautions").

Missing a dose of Fordiab

In case of missing a dose, the patient should take it as soon as possible. If it is almost time for the next dose, the patient should skip the missed dose and continue taking the medicine according to the usual schedule. The patient should not take a double dose.

Stopping treatment with Fordiab

In order to maintain control of blood sugar levels, the medicine should be taken for as long as the doctor recommends. The patient should not stop taking this medicine without consulting their doctor. Stopping treatment with Fordiab may lead to an increase in blood sugar levels.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The patient should stop taking Fordiab and immediately contact their doctor or go to the nearest hospital in case of the following serious side effect:

Very rare(may occur in less than 1 in 10,000 people)

• lactic acidosis (see "Warnings and precautions"). Lactic acidosis can lead to coma.

The patient should stop taking Fordiab and immediately contact their doctor in case of any of the following serious side effects:

Frequency not known(frequency cannot be estimated from the available data)

• severe and persistent abdominal pain (in the stomach area), which may radiate to the back, with or without nausea and vomiting - these may be symptoms of pancreatitis
• severe allergic reaction, including rash, urticaria, blisters on the skin, or peeling of the skin, as well as swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing. The doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes.

In some patients taking metformin, the following side effects have occurred after starting sitagliptin:

Common(may occur in less than 1 in 10 people)

• low blood sugar
• nausea
• bloating
• vomiting

Uncommon(may occur in less than 1 in 100 people)

• stomach pain
• diarrhea
• constipation
• drowsiness

In some patients, the following side effects have occurred after starting treatment with sitagliptin in combination with metformin:

Common

• diarrhea
• nausea
• bloating
• constipation
• stomach pain
• vomiting

In some patients taking this medicine in combination with a sulfonylurea derivative, such as glimepiride, the following side effects have occurred:

Very common(may occur in more than 1 in 10 people)

• low blood sugar

Common

• constipation

In some patients taking this medicine in combination with pioglitazone, the following side effects have occurred:

Common

• swelling of the hands or feet

In some patients taking this medicine in combination with insulin, the following side effects have occurred:

Very common

• low blood sugar

Uncommon

• dry mouth
• headache

In some patients taking sitagliptin alone (one of the active substances of Fordiab) in clinical trials or during post-marketing use of sitagliptin with metformin, sitagliptin alone, or with other anti-diabetic medicines, the following side effects have occurred:

Common

• low blood sugar
• headache
• upper respiratory tract infections
• nasal congestion or sore throat
• arthralgia
• arm or leg pain

Uncommon

• dizziness
• constipation
• itching

Rare

• reduced platelet count

Frequency not known

• kidney disease (sometimes requiring dialysis)
• vomiting
• joint pain
• muscle pain
• back pain
• interstitial lung disease
• pemphigoid (a type of blistering skin disease)

In some patients taking metformin alone, the following side effects have occurred:

Very common

• nausea
• vomiting
• diarrhea
• stomach pain
• loss of appetite These symptoms may occur after starting metformin and usually disappear.

Common

• metallic taste
• reduced or low levels of vitamin B12 in the blood (symptoms may include extreme fatigue, pain, and redness of the tongue, numbness or tingling, or pallor or jaundice of the skin). The doctor may order certain tests to find the cause of the symptoms, as some of them may also be caused by diabetes or other unrelated health problems.

Very rare

• hepatitis (liver disease)
• hives
• skin rash
• itching

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Fordiab

The medicine should be stored out of 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 month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Fordiab contains

Fordiab 50 mg + 850 mg

• The active substances of the medicine are sitagliptin and metformin. Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.
• Other ingredients are: Tablet core: microcrystalline cellulose, povidone (K29/32), sodium lauryl sulfate, sodium stearyl fumarate Coating: lactose monohydrate, hypromellose, titanium dioxide (E 171), triacetin, iron oxide red (E 172)

Fordiab 50 mg + 1000 mg

• The active substances of the medicine are sitagliptin and metformin. Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 1000 mg of metformin hydrochloride.
• Other ingredients are: Tablet core: microcrystalline cellulose, povidone (K29/32), sodium lauryl sulfate, sodium stearyl fumarate Coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171), iron oxide red (E 172), iron oxide black (E 172)

What Fordiab looks like and contents of the pack

Fordiab 50 mg + 850 mg

Oval, biconvex, pink film-coated tablets with dimensions of approximately 20.5 mm x 9.5 mm, with the inscription "S476" on one side.

Fordiab 50 mg + 1000 mg

Oval, biconvex, brown film-coated tablets with dimensions of approximately 21.5 mm x 10 mm, with the inscription "S477" on one side.
Non-transparent blisters of PVC/PVDC/Aluminum in a carton box.
Pack sizes: 14, 28, 30, 56, 60, 196, 210 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Manufacturer/Importer:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
LABORATORIOS LICONSA S.A.
Avenida Miralcampo 7
Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands:
Fordiab 50 mg + 850 mg, filmomhulde tabletten
Fordiab 50 mg + 1000 mg, filmomhulde tabletten
Greece:
Fordiab 50 mg + 850 mg
Fordiab 50 mg + 1000 mg
Croatia
Fordiab 50 mg + 1000 mg
Poland
Fordiab
Date of last revision of the leaflet:03/2024