Fordiab

Package leaflet: Information for the user

Fordiab, 50 mg + 850 mg, film-coated tablets
Fordiab, 50 mg + 1000 mg, film-coated tablets
Sitagliptin + Metformin hydrochloride
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Leaflet contents

1. What Fordiab is and what it is 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 pack and other information

1. What Fordiab is and what it is used for

Fordiab 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 adults with diabetes known as "type 2 diabetes". This medicine helps increase insulin release after meals and reduces the amount of glucose produced by the body. When used together with diet and exercise, it helps lower blood glucose levels. This medicine may be used as the only antidiabetic treatment or in combination with certain other antidiabetic 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, the insulin produced does not work properly, or the body produces 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 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 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 may lead to a diabetic pre-coma state. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness, or unusual fruity odour of the breath.

• if the patient has severe infection or dehydration;

• if the patient is scheduled for a radiological examination with intravascular administration of contrast medium. The intake of Fordiab must be 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 Fordiab if any of the above contraindications apply.
Consult a physician to determine alternative methods of diabetes management. In case of
doubt, discuss this with a physician, pharmacist, or nurse before taking Fordiab.
Warnings and precautions
Cases of pancreatitis have been reported in patients taking Fordiab (see section 4).
If the patient develops skin blisters, this may be a symptom of a disease known as bullous pemphigoid.
The physician may advise the patient to discontinue taking Fordiab.
Risk of lactic acidosis
Fordiab 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 more details 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 physician for further instructions.
Temporarily discontinue Fordiab if the patient develops a medical condition
that may involve 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 physician for further instructions.
Discontinue taking Fordiab and immediately contact a physician or go to the nearest hospital 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 Fordiab, discuss the following with a physician 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 previously had allergic reactions to sitagliptin, metformin, or Fordiab (see section 4);
• if the patient is taking a sulfonylurea derivative or insulin, antidiabetic medicines together with Fordiab, as this may cause excessive lowering of blood glucose levels (hypoglycaemia). The physician may reduce the dose of the sulfonylurea derivative or insulin.

If the patient is undergoing major surgery, Fordiab must not be taken during the procedure and for a certain period afterwards. The physician will decide when the patient should stop and resume treatment with Fordiab.
If the patient is unsure whether any of the above statements apply, discuss this with a physician or pharmacist before taking Fordiab.
During treatment with Fordiab, the physician will monitor kidney function at least once a year, or more frequently if the patient is elderly and/or has declining 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 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.
Fordiab and other medicines
If the patient is to receive an iodine-containing contrast medium injected into the bloodstream, for example for an X-ray or CT scan, the intake of Fordiab must be stopped before or at the time of injection. The physician will decide when the patient should stop and resume treatment with Fordiab.
Inform the physician or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take. The patient may require more frequent monitoring of blood glucose levels and kidney function assessments, or dose adjustments of Fordiab by the physician. It is particularly important to inform about the following medicines:

• medicines used to treat inflammatory conditions 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 bronchial 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 Fordiab with digoxin.

Taking Fordiab with alcohol
Avoid consuming excessive amounts of alcohol (both regularly and occasionally) while taking Fordiab, 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 have a child, she should consult a physician or pharmacist before taking this medicine.
Do not take this medicine during pregnancy or while breastfeeding. See section 2, When not to take Fordiab.
Driving and operating machinery
This medicine has no effect or has a negligible effect on the ability to drive and operate machinery. However, 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 with insulin may lead to reduced blood glucose levels (hypoglycaemia), which in turn may affect the ability to drive and operate machinery or work without secure foot support.
Fordiab 50 mg + 850 mg contains lactose monohydrate and sodium.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a physician before taking this medicine.
The medicine contains 27.6 mg of sodium (the main component of table salt) in each tablet. This corresponds to 1.38% of the maximum recommended daily dietary sodium intake for adults.
Fordiab 50 mg + 1000 mg contains sodium.
The medicine contains 32.5 mg of sodium (the main component of table salt) in each tablet. This corresponds to 1.63% of the maximum recommended daily dietary sodium intake for adults.

3. How to take Fordiab

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
Dosage
The recommended dose is one tablet taken twice daily.
To control blood sugar levels, your doctor may increase the dose of this medicine.
Method of administration
Take orally with meals to reduce the likelihood of gastrointestinal upset.
Renal impairment
If the patient has impaired kidney function, the doctor may recommend a lower dose of the medicine.
Other medicines and advice
While taking this medicine, continue to follow the diet recommended by your doctor and ensure
even distribution of carbohydrates throughout the day.
It is unlikely that taking this medicine alone will lead to abnormally low blood sugar levels
(hypoglycaemia). Low blood sugar may occur when this medicine is taken together with a sulfonylurea
derivative or insulin; in such cases, your doctor may reduce the dose of the sulfonylurea derivative or
insulin.
Taking more Fordiab than recommended
If you take more than the recommended dose of this medicine, contact your doctor immediately.
Proceed 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”).
Missing a dose of Fordiab
If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed
dose and continue with your regular dosing schedule. Do not take a double dose.
Stopping Fordiab
To maintain control of blood sugar levels, take this medicine for as long as your doctor recommends.
Do not stop taking this medicine without first consulting your doctor. Discontinuing Fordiab may
result in increased blood sugar 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 must stop taking Fordiab and immediately contact a doctor or go to the nearest hospital if the following serious adverse effect occurs:
Very rare (may occur in no more than 1 in 10,000)

• Lactic acidosis (see section "Warnings and precautions"). Lactic acidosis may lead to coma.

You must stop taking Fordiab and immediately contact a doctor if any of the following serious adverse effects occur:
Frequency unknown (frequency cannot be estimated from the available data)

• 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
• Severe allergic reaction, including rash, urticaria, skin blisters or skin peeling, and swelling of the face, lips, tongue and throat, which may cause difficulty in breathing or swallowing. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes.

The following adverse effects have occurred in some patients taking metformin after starting treatment with sitagliptin:
Common (may occur in no more than 1 in 10)

• Low blood sugar level
• Nausea
• Flatulence
• Vomiting

Uncommon (may occur in no more than 1 in 100)

• Stomach pain
• Diarrhoea
• Constipation
• Drowsiness

The following adverse effects have occurred in some patients after starting treatment with sitagliptin in combination with metformin:
Common

• Diarrhoea
• Nausea
• Flatulence
• Constipation
• Stomach pain
• Vomiting

The following adverse effects have occurred in some patients taking this medicine in combination with a sulfonylurea derivative such as glimepiride:
Very common (may occur in more than 1 in 10)

• Low blood sugar level

Common

• Constipation

The following adverse effects have occurred in some patients taking this medicine in combination with pioglitazone:
Common

• Swelling of hands or feet

The following adverse effects have occurred in some patients taking this medicine in combination with insulin:
Very common

• Low blood sugar level

Uncommon

• Dry mouth
• Headache

The following adverse effects have occurred in some patients during clinical trials or after marketing authorization of sitagliptin alone (one of the active substances in Fordiab), sitagliptin with metformin, sitagliptin alone or with other antidiabetic medicines:
Common

• Low blood sugar level
• Headache
• Upper respiratory tract infections
• Stuffy or runny nose and sore throat
• Bone and joint inflammation
• Pain in arm or leg

Uncommon

• Dizziness
• Constipation
• Itching

Rare

• Decreased platelet count

Frequency unknown

• Kidney disorders (sometimes requiring dialysis)
• Vomiting
• Joint pain
• Muscle pain
• Back pain
• Interstitial lung disease
• Bullous pemphigoid (a type of blistering skin condition)

The following adverse effects have occurred in some patients taking metformin alone:
Very common

• Nausea
• Vomiting
• Diarrhoea
• Stomach pain
• Loss of appetite
  These symptoms may occur after starting metformin and usually resolve.

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 and 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
• Redness of the skin (rash)
• Itching

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, you should inform your doctor, pharmacist or nurse. 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 the medicine Fordiab

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard box
after: EXP. The expiry date refers to the last day of the specified 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. This will help protect the environment.

6. Contents of the pack and other information

What Fordiab contains
Fordiab 50 mg + 850 mg

• The active substances are sitagliptin and metformin. Each film-coated tablet (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: monohydrate lactose, hypromellose, titanium dioxide (E 171), triacetin, red iron oxide (E 172)

Fordiab 50 mg + 1000 mg

• The active substances are sitagliptin and metformin. Each film-coated tablet (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), red iron oxide (E 172), black iron oxide (E 172)

What Fordiab looks like and contents of the pack
Fordiab 50 mg + 850 mg
Oval, biconvex, pink film-coated tablets, approximately 20.5 mm x 9.5 mm in size, with the engraved code "S476" on one side.
Fordiab 50 mg + 1000 mg
Oval, biconvex, brown film-coated tablets, approximately 21.5 mm x 10 mm in size, with the engraved code "S477" on one side.
Opaque blisters made of PVC/PVDC/Aluminium in cardboard packaging.
Pack sizes: 14, 28, 30, 56, 60, 196, 210 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries 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