Formetic

Package leaflet: Information for the patient

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

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, 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.

Contents of the leaflet

1. What Formetic is and what it is used for
2. What you need to know 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 mellitus (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), particularly in overweight patients in whom proper blood glucose control cannot be achieved by diet and physical activity alone.
Adults
In adults, your doctor may prescribe Formetic as the sole 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 sole antidiabetic treatment (monotherapy) or in combination with insulin.
Reduction in diabetic complications has been demonstrated in patients with type 2 diabetes and overweight who were treated with metformin as first-line therapy when dietary measures failed to achieve desired results.
Formetic may 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 pre-coma state in diabetes,
• 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), impaired liver function, and any disease states in which 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.
Discontinue 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 marked 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 drug or a non-steroidal anti-inflammatory drug).
Inform the doctor about any bacterial or viral infection (e.g. influenza, respiratory or urinary tract infection).
Continue following a diet during treatment with 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 during one-year clinical studies; however, long-term data in children and adolescents are not available.
Since 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 group.
Elderly patients
As kidney function is often impaired in elderly patients, 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 and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or might take in the future.
If the patient is to receive an iodine-containing contrast agent injected into the bloodstream, for example during an X-ray or CT scan, treatment with Formetic must be stopped before or at the latest at the time of injection. The doctor will decide when the patient should stop and restart treatment with Formetic.
During treatment with Formetic, starting or stopping additional medicines may adversely affect blood glucose control.
Inform the doctor about all medicines the patient is currently taking, has recently taken, or plans to take. The patient may require more frequent blood glucose monitoring and kidney function assessments, or dose adjustments of Formetic by the doctor. It is especially important to inform about the following medicines:

• corticosteroids (e.g. prednisolone),
• diuretics (medicines that increase urine production),
• 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 bronchial asthma (β-sympathomimetics, e.g. salbutamol).

Use of 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 to become pregnant, 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 lowering of blood glucose (hypoglycaemia); therefore, Formetic does not affect the ability to drive or operate machinery.
However, when metformin is used in combination with sulfonylureas, 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 exactly as directed by your doctor. In case of doubt, consult your doctor or pharmacist.
Treatment of type 2 diabetes
The dose of Formetic should be determined by your doctor based on blood glucose levels.
Formetic is available in various strengths. To individually adjust the dose, coated tablets containing 850 mg or 1000 mg of metformin hydrochloride may be used.
Unless otherwise prescribed by your doctor, the usual dosing is as described below.
Adults
The recommended initial dose is 1 coated tablet of Formetic (500 mg) taken 2 to 3 times daily (corresponding to 1000 mg to 1500 mg of metformin hydrochloride), taken during or after meals.
If necessary, your doctor may gradually increase the dose up to a maximum of 6 coated tablets of Formetic per day (corresponding to 3000 mg of metformin hydrochloride), taken in divided doses.
However, if a higher number of tablets is required, it is recommended to use tablets with a higher strength.
If the patient has impaired kidney function, the doctor 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 1 coated tablet of Formetic (500 mg) per day (corresponding to 500 mg of metformin hydrochloride), taken during or after a meal.
If necessary, the doctor may gradually increase the dose up to a maximum of 4 coated tablets of 500 mg per day (corresponding to 2000 mg of metformin hydrochloride), taken in 2 or 3 divided doses.
Coated tablets should be taken during or after meals with an adequate amount of liquid; do not chew them. 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 tablet during or after lunch.
Prediabetes
The usual starting dose is 500 mg (1 coated tablet of Formetic 500 mg) per day.
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 1 coated tablet of Formetic 500 mg three times daily.
If you feel the effect of Formetic is too strong or too weak, consult your doctor.
Taking more Formetic than prescribed
If you take more Formetic than prescribed, inform your doctor immediately.
Overdosing with Formetic does not cause hypoglycaemia (a significant drop in blood glucose levels), but increases the risk of lactic acidosis (lactic acid build-up).
Symptoms of developing acidosis may resemble gastrointestinal side effects of metformin: nausea, vomiting, diarrhoea, 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.
Missing a dose of Formetic
If you miss a dose of Formetic, take it as soon as you remember at the time when the next dose is due, then continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.
Stopping Formetic
If you stop taking Formetic, remember that poorly controlled high 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 adverse reactions, although not everybody experiences them.
Adverse reactions have been assessed according to the following frequency categories:

The medicine Formetic may very rarely cause (it 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 and the patient should immediately contact a doctor or the nearest hospital, 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 in most cases. 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 related to lactic acidosis (lactic acidosis). Symptoms may include vomiting and abdominal pain, shortness of breath 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 a patient suspects lactic acidosis (lactic acidosis), they should immediately seek medical attention and stop taking Formetic.

Skin reactions such as rash, itching and urticaria.

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

Reduced absorption of vitamin B_, leading to anaemia, tongue ulceration, 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, patients should inform their 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 can also be reported to the Marketing Authorisation 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 sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or carton after the word "EXP". The expiry date refers to the last day of the specified month.
The label on the packaging after "EXP" indicates the expiry date, and after "LOT" or "Lot" indicates the batch number.
Storage conditions
No special storage requirements.
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 in this medicine is metformin hydrochloride. Each film-coated tablet contains 500 mg of metformin hydrochloride, equivalent to 390 mg of metformin.
• 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 500 mg is a white, round, biconvex film-coated tablet.
Formetic is available in packs containing 30, 60, 90, 120, and 180 film-coated tablets.
Marketing Authorisation Holder
POLPHARMA Pharmaceutical Works S.A.
Pelplińska Street 19, 83-200 Starogard Gdański, Poland
tel. +48 22 364 61 01
Manufacturer
POLPHARMA Pharmaceutical Works S.A.
Pelplińska Street 19, 83-200 Starogard Gdański, Poland
Dragenopharm Apotheker Püschl GmbH
Göllstraße 1, 84529 Tittmoning, Germany