Formetic

Patient Information Leaflet

Formetic
1000 mg, coated tablets
Metformini hydrochloridum
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet for future reference.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not share it with others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

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

1. What Formetic is and what it is used for

Formetic belongs to a group of medicines used in the treatment of non-insulin-dependent diabetes (type 2 diabetes) in adults and children above 10 years of age.
Formetic is a medicine that lowers blood glucose levels in patients with diabetes (type 2 diabetes), especially in overweight patients, in whom proper blood glucose control cannot be achieved by diet and physical activity alone.

Adults
Your doctor may prescribe Formetic as the only antidiabetic treatment (monotherapy) or in combination with other oral antidiabetic medicines or insulin.

Children and adolescents
In children above 10 years of age and adolescents, your doctor may prescribe Formetic as the only antidiabetic treatment (monotherapy) or in combination with insulin.

Reduction in diabetic complications has been demonstrated in patients with type 2 diabetes and overweight, treated with metformin as first-line therapy when dietary measures have not provided the desired results.

Formetic may also be used in a condition called prediabetes, when adequate control of blood glucose levels cannot be achieved by diet and physical activity alone.

Formetic may also be used in polycystic ovary syndrome (a hormonal disorder in women, with symptoms such as irregular menstruation, acne, weight gain, difficulty losing weight, excessive facial and body hair, and problems with becoming pregnant).

2. Important information before using Formetic

When not to use Formetic

• if the patient is allergic to metformin or any of the other ingredients of this medicine (listed in section 6),
• if the patient has a diabetic pre-coma state,
• 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 which may lead to a diabetic pre-coma state. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness or an unusual fruity odour of the breath.
• if the patient has worsening kidney function due to
  • dehydration caused by prolonged vomiting or severe diarrhoea
  • severe infection
  • shock
• if the patient has acute or chronic diseases that may cause reduced oxygen levels in tissues (tissue hypoxia), such as:
  • heart failure or respiratory failure
  • recent myocardial infarction
  • shock
• if the patient has liver failure, acute alcohol intoxication, or alcoholism.

Warnings and precautions
Before starting treatment with Formetic, discuss this with your doctor or pharmacist.
Risk of lactic acidosis
Formetic 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 detailed information 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 doctor for further instructions.
Temporarily discontinue Formetic 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 doctor for further instructions.
Stop taking Formetic and contact a doctor or the nearest hospital immediately if the patient experiences any symptoms of lactic acidosis, as this condition may lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general malaise associated with profound fatigue,
• difficulty breathing,
• decreased body temperature and slowed heart rate.

Lactic acidosis is an acute, life-threatening condition requiring immediate hospital treatment.
Contact a doctor immediately for further instructions if:

• the patient has a genetically inherited disease affecting mitochondria (cellular energy-producing structures), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• after starting metformin, the patient experiences any of the following symptoms: seizures, worsening cognitive function, difficulty moving, symptoms indicating nerve damage (e.g. pain or numbness), migraine or deafness.

If the patient is undergoing major surgery, Formetic must not be taken during the procedure and for some time afterwards. The doctor will decide when the patient should stop and restart treatment with Formetic.
During treatment with Formetic, the doctor will monitor kidney function at least once a year, or more frequently if the patient is elderly and/or has worsening kidney function.
Particular caution is required when using Formetic in situations where kidney function may be impaired (e.g. when starting treatment with a blood pressure-lowering medicine or a non-steroidal anti-inflammatory drug).
Inform the doctor of any bacterial or viral infection (e.g. influenza, respiratory or urinary tract infection).
Continue with a regular diet while taking Formetic, including regular intake of carbohydrates throughout the day (starchy foods such as rice, pasta, potatoes, fruit). Overweight patients should also follow a low-calorie diet under medical supervision.

Children and adolescents
Before using Formetic, a diagnosis of type 2 diabetes should be confirmed by a doctor.
No effect of metformin on growth and sexual maturation has been observed in annual clinical studies, but long-term data in children and adolescents are not available.
Because only a few children aged 10 to 12 years participated in clinical trials, metformin should be used with particular caution in children of this age.

Elderly patients
Since kidney function in elderly patients is often impaired, the doctor should adjust the dose of Formetic according to kidney function. Therefore, regular assessment of kidney function by the doctor is necessary in these patients.

Formetic with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
If the patient is to receive an iodine-containing contrast agent intravenously, for example during an X-ray or CT scan, the patient must stop taking Formetic before or at the latest at the time of injection. The doctor will decide when the patient should stop and restart treatment with Formetic.
Starting or stopping additional medicines during treatment with Formetic may adversely affect blood glucose control.
Tell your doctor about all medicines currently taken, recently taken, or planned to be taken. The patient may require more frequent monitoring of blood glucose levels and kidney function, or dose adjustments of Formetic. It is especially important to inform the doctor about the following medicines:

• corticosteroids (e.g. prednisolone),
• diuretics (water tablets),
• 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),
• medicines used to treat asthma (β-sympathomimetics, e.g. salbutamol).

Using Formetic with alcohol
Avoid excessive alcohol consumption while taking Formetic, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").

Pregnancy, breastfeeding and fertility
Women with diabetes who are pregnant or planning to become pregnant should not take Formetic. Insulin should be used to maintain blood glucose levels as close to normal as possible. Inform the doctor if you are pregnant or planning pregnancy, as insulin should be prescribed in such cases.
Do not use Formetic during breastfeeding.
During pregnancy, breastfeeding, if pregnancy is suspected, or when planning pregnancy, consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Taking metformin as monotherapy does not cause significant hypoglycaemia (low blood glucose levels), therefore Formetic does not affect the ability to drive or operate machinery.
However, when metformin is used in combination with sulfonylurea derivatives, insulin, or other antidiabetic medicines, the patient's ability to drive or operate machinery or perform work requiring concentration may be impaired due to low blood sugar levels (with symptoms such as sweating, fainting, dizziness or weakness).

3. How to use Formetic

This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor or pharmacist.
Treatment of type 2 diabetes
The dose of Formetic should be determined by the physician based on blood glucose levels.
For individual dose adjustment, the 1000 mg coated tablets can be divided into two equal parts,
each containing 500 mg of metformin hydrochloride. Coated tablets are also available in doses of
500 mg and 850 mg of metformin hydrochloride.
How to split a tablet:
If necessary, the coated tablet can be divided into two equal parts.
Place the tablet on a hard surface so that the thinner score line is on the bottom. Then press down
with your index finger on the deeper score line.
The tablet will break into two parts.

Unless otherwise prescribed by the physician, the medicine is usually used as described below.
Adults
Formetic 1000 mg is suitable when higher doses of the medicine are required.
The recommended initial dose is ½ coated tablet of Formetic (1000 mg) once daily (corresponding to
500 mg of metformin hydrochloride), taken during or after a meal.
The usual dose is 1 coated tablet of Formetic (1000 mg) taken twice daily (corresponding to 2000 mg
of metformin hydrochloride), during or after meals.
The maximum dose is 3 coated tablets of 1000 mg per day (corresponding to 3000 mg of metformin
hydrochloride), taken in divided doses.
If the patient has impaired kidney function, the physician may prescribe a lower dose.
Children over 10 years of age and adolescents:
Formetic used as monotherapy or in combination with insulin:
The recommended initial dose is ½ coated tablet of Formetic (1000 mg) once daily (corresponding to
500 mg of metformin hydrochloride), taken during or after a meal.
If necessary, the physician may gradually increase the dose up to the maximum dose of 2 coated
tablets of 1000 mg per day (corresponding to 2000 mg of metformin hydrochloride), administered in
divided doses.
Coated tablets should be taken during or after meals with adequate fluid. Do not chew the tablets.
When taking 2 or more coated tablets per day, they should be taken at different times of the day,
e.g., 1 coated tablet during or after breakfast and 1 coated tablet during or after lunch.
Prediabetes
The usual initial dose is 500 mg (½ coated tablet of Formetic 1000 mg) once daily.
Depending on the clinical response, the dose may be increased up to 1700 mg per day, administered
in divided doses.
Polycystic ovary syndrome
The usual dose is ½ coated tablet of Formetic 1000 mg (corresponding to 500 mg of metformin
hydrochloride) three times daily.
If you feel that the effect of Formetic is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Formetic
If a higher than recommended dose of Formetic is used, inform your doctor immediately.
Overdose with Formetic does not cause hypoglycemia (marked decrease in blood glucose levels), but
increases the risk of lactic acidosis (lactic acid build-up).
Symptoms of developing lactic acidosis may resemble gastrointestinal side effects of metformin:
nausea, vomiting, diarrhea, abdominal pain accompanied by muscle cramps and weakness. In severe
cases, muscle pain and cramps, significantly rapid breathing, lowered body temperature, acute
kidney failure, disturbances of consciousness, and coma may also occur. These symptoms may
develop within a few hours and require immediate hospital treatment.
Missed dose of Formetic
If a dose of Formetic is missed, take it at the time the next dose is due, then continue with the usual
dosing schedule. Do not take a double dose to make up for a missed dose.
Stopping treatment with Formetic
If treatment with Formetic is discontinued, remember that poorly controlled elevated blood glucose
levels may, over a prolonged period, cause damage to the eyes, kidneys, and blood vessels.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause side effects, although not everybody gets them.
Adverse reactions have been assessed according to the following frequency categories:

Very rarely, the medicine Formetic may cause (may occur in up to 1 patient in 10,000) a very serious adverse reaction known as lactic acidosis (see section "Warnings and precautions"). If this occurs in a patient, Formetic must be discontinued immediately and the patient should contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.

Very common: Nausea, vomiting, diarrhoea, abdominal pain, and loss of appetite. These symptoms occur more frequently at the beginning of treatment and usually resolve spontaneously. To avoid gastrointestinal adverse effects, it is recommended to take Formetic in 2 or 3 divided doses during or immediately after meals. If these disturbances persist for a prolonged period, Formetic should be discontinued and medical advice sought.

Common: Taste disturbances.

Very rare: Severe metabolic disturbances associated with lactic acidosis (lactic acidosis). Symptoms may include vomiting and abdominal pain, rapid breathing accompanied by muscle pain and cramps, profound fatigue, lowered body temperature, acute kidney failure, or disturbances in consciousness (see section 2 "Warnings and precautions"). Lactic acidosis requires immediate hospital treatment. If lactic acidosis (lactic acidosis) is suspected, the patient should immediately seek medical attention and discontinue use of Formetic.

Skin reactions such as rash, itching, and urticaria.

Abnormal liver function tests or hepatitis, possibly accompanied by jaundice (yellowing of the skin and eyes), which resolve after discontinuation of Formetic.

Reduced absorption of vitamin B₁₂, leading to anaemia, mouth ulcers, and sensations of pricking, burning, and tingling in the extremities.

Children and adolescents Limited data on adverse reactions observed in children aged 10 to 16 years and adolescents indicate that they are of similar nature and occur with similar frequency as in adults.

Reporting of adverse reactions If any adverse reactions occur, including those not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 reactions may also be reported to the marketing authorization holder.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Formetic

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or carton following the term "EXP". The expiry date refers to the last day of the specified month.
The label on the packaging shows the expiry date after the abbreviation "EXP", and the batch number after the abbreviation "Lot/LOT".
Storage conditions
No special storage instructions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Formetic contains

• The active substance is metformin hydrochloride. Each film-coated tablet contains 1000 mg of metformin hydrochloride, equivalent to 780 mg of metformin.
• The other ingredients are: Hypromellose (15,000 mPas), povidone (K 25), magnesium stearate, hypromellose (5 mPas), macrogol 6000, titanium dioxide (E171).

What Formetic looks like and contents of the pack
Formetic 1000 mg is a white, elongated film-coated tablet, with a score line on one side and a deep
dividing line on the other.
The tablet can be divided into two equal parts.
Formetic is available in packs containing 30, 60, 90, 120, and 180 film-coated tablets.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański, Poland
tel. + 48 22 364 61 01

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański, Poland
Dragenopharm Apotheker Püschl GmbH
Göllstraße 1, 84529 Tittmoning, Germany