500 mg, 800 mg film-coated tablets
metformin hydrochloride
What Metformin Sandoz is and what it is used for
Metformin Sandoz contains metformin, a medicine used to treat diabetes. It belongs to a group of drugs called biguanides. Insulin is a hormone produced in the pancreas that helps the body absorb glucose (sugar) from the blood. The body uses glucose to produce energy or stores it for future needs. If you have diabetes, the pancreas does not produce enough insulin or the body cannot use the insulin that is produced well enough. This leads to high blood glucose levels. Metformin Sandoz helps lower blood glucose levels to a level that is as close to normal as possible.
If you are an adult and overweight, taking Metformin Sandoz for a long time can also help reduce the risk of complications associated with diabetes. Metformin Sandoz is associated with either stable body weight or a slight weight loss. Metformin Sandoz is used to treat patients with type 2 diabetes (also known as ‘non-insulin-dependent diabetes’) when diet and exercise alone are not sufficient to control blood glucose levels. It is especially used in obese patients.
Adults can take Metformin Sandoz as the only treatment or with other medicines to treat diabetes (medicines taken by mouth or insulin ). Children 10 years of age or older and adolescents can take Metformin Sandoz as their only treatment or with insulin.
Metformin hydrochloride contained in Metformin Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Metformin Sandoz
Do not take Metformin Sandoz:
- if you are allergic to metformin or any of the other ingredients of this medicine (listed in section 6)
- if you have severe renal impairment
- if you have uncontrolled diabetes with, for example, severe hyperglycaemia (high blood sugar), nausea, vomiting, diarrhea, rapid 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, which can lead to diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness or your breath getting a different, fruity odor.
- if you have liver problems
- if you regularly drink large amounts of alcohol
- if the body has lost too much water ( dehydration ), such as after
- prolonged or severe diarrhea or
- if you have vomited several times in a row
- if you are being treated for acute heart failure or have recently had oneheart attack, if you have severe circulatory problems (such as shock ) or difficulty breathing. This can lead to a lack of oxygen in tissue one, which can cause lactic acidosis (see “Warnings and Precautions”).
- if you have a severe infection , for example if it affects the lungs, respiratory tract or kidneys. Severe infections can lead to kidney problems which can cause lactic acidosis (See “Warnings and Precautions”).
If any of these apply to you, do not take this medicine but talk to a doctor.
You need to consult a doctor about
- you need to undergo an examination, such as an X-ray or computed tomography , which means that you are given contrast agents that contain iodine injected into the blood.
- you will undergo major surgery
You must stop taking Metformin Sandoz for some time before and after the examination or operation. Your doctor will decide when you need to stop taking Metformin Sandoz and when you should start taking it again.
Warnings and cautions
Risk of lactic acidosis
Metformin Sandoz can cause the very rare, but very serious side effect of lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased in uncontrolled diabetes, severe infections, prolonged fasting or alcohol intake, dehydration (see more information below), liver problems, and conditions where part of the body has reduced oxygen supply (including acute severe heart disease).
If any of the above apply to you, talk to your doctor for further information.
Stop taking Metformin Sandoz for a short time if you have a condition that may be associated with dehydration, such as severe vomiting, diarrhea, fever, exposure to heat, or if you drink less fluid than normal. Talk to a doctor for further instructions.
Stop taking Metformin Sandoz and contact your doctor or nearest hospital immediately if you experience any of the symptoms of lactic acidosis as the condition may lead to coma.
The symptoms of lactic acidosis include:
- vomiting
- abdominal pain (stomach pain)
- muscle cramps
- a general feeling of not feeling well and pronounced fatigue
- hard to breathe
- lowered body temperature and heart rate .
Lactic acidosis is an acute medical condition that must be treated in a hospital
Talk to your doctor before taking Metformin Sandoz if any of the following conditions apply to you:
- If you have symptoms of too low blood sugar levels such as:
– weakness
– dizziness
– increased sweating
– rapid heartbeat
– visual disturbances
– difficulty concentrating
Eat or drink something that contains sugar if this occurs. Metformin Sandoz alone may not cause your blood sugar levels to drop too much, but other diabetes medicines can. - If you are overweight.
Stick to your diet with controlled calorie intake. - Use of other medicines.
See “Other medicines and Metformin Sandoz”.
During treatment with Metformin Sandoz, your doctor will check your kidney function at least once a year or more often if you are older and/or if your kidney function is deteriorating.
Children under 10 years
Metformin Sandoz is not recommended for this age group.
Other medicines and Metformin Sandoz
If you need to get an injection in the blood with contrast media that contain iodine, for example in connection with X-rays or computed tomography, you must stop taking Metformin Sandoz before or at the time of injection. Your doctor will decide when you need to stop taking Metformin Sandoz and when you should start taking it again.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. You may need to do more blood sugar and kidney function tests, or your doctor may need to adjust the dose of one of Metformin Sandoz. You must mention the following:
- medicines containing alcohol
- glucocorticoid s , drugs that prevent the body sloughs off after transplantation, reduces inflammation example the skin or asthma
- medications that dilate the airways , such as salbutamol , fenoterol and terbutaline
- drugs that increase urine production ( diuretics )
- drugs used to treat pain and inflammation ( NSAIDs and COX 2 inhibitors, such as ibuprofen and celecoxib)
- certain medicines for high blood pressure ( ACE inhibitors and angiotensin II receptor antagonists)
- medicines that may affect the amount of Metformin Sandoz in your blood , especially if you have impaired kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).
- medicines that lower blood sugar levels such as insulin or medicines that are taken orally.
If you take these medicines together with Metformin Sandoz, your blood sugar levels may become too low. See section “Warnings and Precautions”.
Metformin Sandoz with alcohol
Avoid high alcohol intake while taking Metformin Sandoz as alcohol may increase the risk of lactic acidosis (see section “Warnings and Precautions”).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
- PregnancyIf you are pregnant or planning to become pregnant , you should not take Metformin Sandoz. Tell your doctor if this applies to you as treatment with Metformin Sandoz should be stopped and replaced with insulin therapy.
- Breast-feedingDo not take Metformin Sandoz without first talking to your doctor if you are breast-feeding.
Driving and using machines
Metformin Sandoz alone does not cause hypoglycemia ( too low a blood glucose level). This means that it does not affect your ability to drive or use machines.
However, you should be especially careful if you are taking Metformin Sandoz with other antidiabetic medicines that can cause hypoglycemia (eg sulphonylureas, insulin, meglitinides). Symptoms of hypoglycemia include weakness, dizziness, sweating, rapid heartbeat, visual disturbances, or difficulty concentrating. Do not drive or use machines if you experience such symptoms.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. The description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to take Metformin Sandoz
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. If you have impaired kidney function, your doctor may prescribe a lower dose.
Metformin Sandoz cannot replace the beneficial effects of a healthy lifestyle. Continue to follow any dietary advice your doctor has given you and exercise
regularly.
* tablets are containing 500, 850, and 1000 mg metformin hydrochloride, for individual dose adjustment.
Adults
- Recommended starting dose: 1 Metformin Sandoz 500 mg tablet or 1 Metformin Sandoz 850 mg tablet 2 to 3 times daily.
- After taking Metformin Sandoz for about 2 weeks, your doctor may want to measure your blood sugar and adjust your dose .
- The highest dose is 3000 mg metformin hydrochloride daily, equivalent to 6 Metformin Sandoz 500 mg tablets * daily, divided into 3 divided doses.
Children from 10 years of age
- Usual starting dose: 1 Metformin Sandoz 500 mg tablet or 1 Metformin Sandoz 850 mg tablet daily.
- After taking Metformin Sandoz for about 2 weeks, your doctor may want to measure your blood sugar and adjust your dose .
- The highest dose is 2000 mg metformin hydrochloride daily, equivalent to 4 Metformin Sandoz 500 mg tablets * daily, divided into 2 or 3 doses.
Patients from the age of 65
Your doctor will decide on a dose of Metformin Sandoz based on how your kidneys are working, as it is common for you to have impaired kidney function in this patient group. See also section 2 under “Warnings and Precautions”.
How to take Metformin Sandoz 500 mg
Swallow the tablet whole with a glass of water, with or after a meal.
How to take Metformin Sandoz 850 mg
Swallow the tablet with a glass of water, before or after a meal. The notch is only for you to be able to divide the tablet if you have difficulty swallowing it whole.
Check
- Your doctor will take regular blood glucose tests and adjust your dose of Metformin Sandoz to your blood glucose level. You need to talk to your doctor regularly. This is especially important for children and adolescents or if you are older.
- Your doctor will also examine your kidney function at least once a year. You may need more frequent check-ups if you are older or if your kidneys are not working properly.
Duration of treatment
This is decided by your doctor.
If you take more Metformin Sandoz than you should
An overdose of Metformin Sandoz does not significantly reduce blood sugar levels. But it increases the risk of acid accumulation with lactic acid in the blood. Symptoms of acid buildup are listed at the end of the section “Warnings and Precautions.” Muscle pain with cramps, deep and rapid breathing, unconsciousness, and coma may develop within a few hours, requiring immediate hospitalization.
If you forget to take Metformin Sandoz
If you forget to take a dose, skip the missed dose and only continue with your usual dose at the next dose.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Metformin Sandoz
If you stop taking Metformin Sandoz without your doctor’s consent, this may cause your blood sugar level to rise uncontrollably. This increases the risk of damage in the long term, for example, injuries can affect the eyes, kidneys, and blood vessels.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Metformin Sandoz can cause the very rare (may affect up to 1 in 10,000 people) but very serious side effect of lactic acidosis (see section “Warnings and precautions”). If this happens to you, you must stop taking Metformin Sandoz and contact your doctor or nearest hospital immediately, as lactic acidosis can lead to coma.
Other possible side effects are
Very common side effects ( may affect more than 1 user in 10):
- nausea
- vomiting
- diarrhea
- stomach ache
- loss of appetite
These symptoms occur mainly at the beginning of treatment and usually disappear on their own. To prevent these problems, the tablets should be taken with or after a meal and divided into 2 to 3 doses daily.
Common side effects (may affect up to 1 in 10 people):
- taste changes
Very rare side effects ( may affect up to 1 in 10,000 people):
- reduction of vitamin B 12 uptake into the intestine during long-term treatment with Metformin Sandoz
- reddening of the skin
- itching
- itchy rash
- abnormal liver values or inflammation of the liver; this can give:
- fatigue
- loss of appetite
- weight loss
- yellowing of the skin or whites of the eyes
Stop taking Metformin Sandoz and tell your doctor immediately if this happens.
How to store Metformin Sandoz
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the blister or jar after “EXP”. The expiration date is the last day of the specified month.
This medicine does not require any special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is metformin hydrochloride.
Each film-coated tablet contains 500 mg of metformin hydrochloride equivalent to 390 mg of metformin .Each film-coated tablet contains 850 mg of metformin hydrochloride equivalent to 662.9 mg of metformin . - The other ingredients are: povidone K90, magnesium stearate, hypromellose, macrogol 4000, titanium dioxide.
What the medicine looks like and contents of the pack
500 mg film-coated tablets
Round, white, and on both sides convex film-coated tablet. The tablet is embossed “M500” on one side and smooth on the other side.
Dimensions of the tablet: 11 mm x 6 mm
Metformin Sandoz 500 mg is available in
- HDPE tablet container with LDPE lid or PP lid and desiccant container with 30, 60, 100, 250, 330, 400 and 500 film-coated tablets
- PVC aluminum pressure pack with 28, 30, 50, 56, 60, 84, 90, 100, 120, 180, 250 and 270 film-coated tablets.
850 mg film-coated tablets
Oval, white and film-coated tablet. The tablet has a score line on one side and is embossed with “M850” on the other side.
Dimensions of the tablet: 19 mm x 6.5 mm
Metformin Sandoz 850 mg is available in
- HDPE tablet container with LDPE lid or PP lid and desiccant container with 30, 60, 100, 200, 250 and 500 film-coated tablets
- PVC aluminum pressure pack with 20, 28, 30, 40, 50, 56, 60, 84, 90, 100, 120, 180, 250 and 300 film-coated tablets.
Always store the desiccant container in the jar. Do not swallow the desiccant container.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
LEK SA, Ul. Domaniewska 50 C, 02-672 Warsaw, Poland