Prospect: information for the user

Metformin Stadafarma 850 mg film-coated tablets

Metformin Stadafarma 1,000 mg film-coated tablets

hydrochloride of metformin

Read this prospect carefully before starting to take this medicine because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Metformin Stadafarma and for what it is used

2.What you need to know before starting to take Metformin Stadafarma

3.How to take Metformin Stadafarma

4.Possible adverse effects

5.Storage of Metformin Stadafarma

6.Contents of the package and additional information

Metformina Stadafarma contains metformin, a medication for treating diabetes. It belongs to a group of medications called biguanides.

Insulin is a hormone produced by the pancreas that makes your body capture glucose (sugar) from the blood. Your body uses glucose to produce energy or stores it for future use.

If you have diabetes, your pancreas does not produce enough insulin or your body cannot use the insulin it produces effectively. This causes high levels of glucose in the blood. Metformin helps to reduce your blood glucose to a normal level as possible.

If you are an adult with obesity, taking metformin for a prolonged period also helps to reduce the risk of complications associated with diabetes. Metformin is associated with maintaining body weight or a slight decrease in it.

Metformin is used to treat patients with type 2 diabetes (also known as “non-insulin-dependent diabetes”) when diet and exercise alone are not enough to control their blood glucose levels. It is used especially in patients with obesity.

Adults can take metformin alone or with other medications for treating diabetes (oral medications or insulin).

Children aged 10 years and older, and adolescents can take metformin alone or with insulin.

Do not take Metformina Stadafarma

• If you are allergic (hypersensitive) to metformin, or to any of the other components of this medication (listed in section6)
• If you have liver problems
• If you have severe kidney function reduction
• If you have uncontrolled diabetes with, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis. Ketoacidosis is a disorder 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 if your breath develops an unusual fruity odor
• If you have lost a lot of fluid from your body (dehydration), for example, due to prolonged or intense diarrhea, or if you have vomited several times in a row. Dehydration can trigger kidney problems, which can put you at risk of developing lactic acidosis (see “Warnings and precautions”)
• If you have a severe infection, for example, an infection affecting your lungs, bronchi, or kidneys. Severe infections can trigger kidney problems, which can put you at risk of developing lactic acidosis (see “Warnings and precautions”)
• If you are receiving treatment for acute heart failure or have recently had a heart attack, if you have severe circulation problems (such as shock) or if you have difficulty breathing. This can lead to tissue hypoxia, which can put you at risk of developing lactic acidosis (see below “Warnings and precautions”)
• If you drink a lot of alcohol

If any of the above circumstances apply to you, consult your doctor before starting to take this medication.

Make sure to consult your doctor if:

• You need an examination such as an X-ray or a scan that involves the injection of a contrast medium containing iodine into your bloodstream.
• You need a major surgical intervention.

You should stop taking metformin for a certain period of time before and after the examination or surgical intervention. Your doctor will decide if you need any other treatment during this time. It is essential that you follow your doctor's instructions precisely.

Warnings and precautions

Stop taking metformin and contact a doctor or the nearest hospital immediately if you experience any of the symptoms that produce lactic acidosis, as this condition can lead to coma.

The symptoms of lactic acidosis include:

• Vomiting
• Abdominal pain (stomach pain)
• Muscle cramps
• General feeling of discomfort, with intense fatigue
• Difficulty breathing
• Reduced body temperature and heart rate

Lactic acidosis is a medical emergency and should be treated in a hospital.

Stop taking metformin for a short period of time if you have a condition that may be associated with dehydration(significant loss of body fluids), such as intense vomiting, diarrhea, fever, exposure to heat, or if you drink less fluid than normal. Consult your doctor for further instructions.

Please note the following

• If you need to undergo a major surgical intervention, stop taking metformin while the procedure is being performed and for a time after it. Your doctor will decide when to interrupt metformin treatment and when to restart it.

• Metformin by itself does not cause hypoglycemia (low blood glucose levels). However, if you take metformin along with other diabetes medications that can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides), there is a risk of hypoglycemia. If you experience symptoms of hypoglycemia, such as weakness, dizziness, increased sweating, increased heart rate, visual disturbances, or difficulty concentrating, it is usually helpful to eat or drink something containing sugar.

• During metformin treatment, your doctor will check your kidney function at least once a year or more frequently if you are an older person and/or if your kidney function is deteriorating.

Other medications and Metformina Stadafarma

If you need to be administered an injection of acontrast mediumcontaining iodine into your bloodstream, for example, in the context of an X-ray or a scan, stop taking metformin before the injection or at the time of the injection. Your doctor will decide when to interrupt metformin treatment and when to restart it.

Inform your doctor if you are taking, have taken recently, or may need to take any other medication. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of metformin. It is especially important to mention the following:

• Medications that increase urine production (diuretics)
• Medications used to treat pain and inflammation (AINEsandCOX-2 inhibitors, such asibuprofenandcelecoxib)
• Certain medications used to treat high blood pressure (ACE inhibitorsandangiotensin II receptor antagonists)
• beta-2 agonists, such assalbutamolorterbutaline(used to treat asthma)
• corticosteroids(used to treat various conditions, such as intense skin inflammation or asthma)
• Medications that can alter the amount of metformin in your blood, especially if you have reduced kidney function (such asverapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib)
• Other medications used to treat diabetes

Taking Metformina Stadafarma with alcohol

Avoid excessive alcohol consumption while taking metformin, as this can increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, talk to your doctor about whether you need to make any changes to your treatment or monitor your blood glucose levels.

This medication is not recommended if you are breastfeeding or plan to breastfeed.

Driving and operating machinery

Metformin by itself does not cause hypoglycemia (low blood glucose levels). This means it will not affect your ability to drive or operate machinery.

However, be cautious if you take metformin along with other diabetes medications that can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides). The symptoms of hypoglycemia include weakness, dizziness, increased sweating, increased heart rate, visual disturbances, or difficulty concentrating. Do not drive or operate machinery if you start to experience these symptoms.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

Metformin cannot replace the benefits of a healthy lifestyle. Continue following any dietary advice given by your doctor and practice regular exercise.

Recommended dose

Children aged 10 years and above and adolescents

They usually start with 500 mg or 850 mg of metformin once a day. The maximum daily dose is 2,000 mg divided into 2 or 3 doses. Treatment of children between 10 and 12 years is only recommended under specific advice from your doctor, as clinical experience in this patient group is limited.

Adults

They usually start with 500 mg or 850 mg of metformin, taken 2 or 3 times a day. The maximum daily dose is 3,000 mg divided into 3 doses.If you have reduced renal function, your doctor may prescribe a lower dose.

If insulin is also administered, your doctor will instruct you on how to start taking metformin.

Metformin Stadafarma 1,000 mg film-coated tablets:

The tablets can be divided into equal doses.

Monitoring

• Your doctor will perform regular blood glucose tests and adjust your metformin dose according to your blood glucose levels. Be sure to speak regularly with your doctor. This is particularly important for children, adolescents, or if you are elderly.
• Your doctor will also check, at least once a year, how your kidneys are functioning. You may need more frequent check-ups if you are elderly or if your kidneys do not function normally.

How to take metformin

The tablets are for oral use.

Take metformin with meals or after meals. This will prevent you from experiencing adverse effects that affect your digestion. Do not bite or chew the tablets. Swallow each tablet with a glass of water.

• If you take a daily dose, take it in the morning (breakfast).
• If you take two doses a day, take them in the morning (breakfast) and in the evening (dinner).
• If you take three doses a day, take them in the morning (breakfast), at noon (lunch) and in the evening (dinner).

If, after some time, you believe the effect of metformin is too intense or too weak, consult your doctor or pharmacist.

If you take more Metformin Stadafarma than you should

If you have taken more metformin than you should, you may experience lactic acidosis. The symptoms of lactic acidosis are non-specific such as vomiting, stomach pain (abdominal pain) with nausea, a general feeling of discomfort with intense fatigue and difficulty breathing.Additional symptoms may be a decrease in body temperature and heart rate.If you experience any of these symptoms, you must seek immediate medical attentionas lactic acidosis can lead to coma.Stop taking metformin immediately and contact your doctor or the nearest hospital immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Metformin Stadafarma

Do not take a double dose to compensate for the missed doses. Take the next dose at the usual time.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them. The following side effects may occur:

Metformin may cause a very rare but serious side effect calledlactic acidosis(see the “Warnings and precautions” section). If this occurs,you should stop taking metformin and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

The symptoms of lactic acidosis include:

• Vomiting
• Abdominal pain (stomach pain)
• Muscle cramps
• Feeling unwell with intense fatigue
• Difficulty breathing
• Reduced body temperature and slower heart rate

Other possible side effects are listed by frequency as follows:

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

• Digestive problems, such as nausea, vomiting, diarrhea, abdominal pain (stomach pain), and loss of appetite

These side effects occur more frequently at the beginning of treatment with metformin.Taking metformin during or immediately after a meal and dividing the doses throughout the day may help reduce these side effects.If symptoms persist, stop takingmetforminand consult your doctor.

Common(may affect up to 1 in 10 people)

• Changes in taste
• Low or decreased levels of vitamin B12 in the blood (symptoms may include extreme fatigue, red and painful tongue (glossitis), tingling (paresthesia), or yellow or pale skin). Your doctor may schedule some tests to find the cause of your symptoms, as some of them may be caused by diabetes or other unrelated health problems

Very rare(may affect up to1 in 10,000 people)

• Lactic acidosis. It is a rare but serious complication, especially if your kidneys do not function properly. The symptoms of lactic acidosis are nonspecific (see the “Warnings and precautions” section)
• Abnormalities in liver function tests or hepatitis (inflammation of the liver; this may cause fatigue, loss of appetite, weight loss, with or without a yellowish tone of the skin orthe whiteof the eyes). If this occurs,stop taking metformin and talk to your doctor
• Skin reactions such as redness of the skin (erythema), itching, or a pruritic rash (urticaria)

Children and adolescents

Limited data in children and adolescents showed that side effects were similar in nature and severity to those observed in adults.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

HDPE bottles:After the first opening, the bottle can be used up to 90 days..

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Metformin Stadafarma Composition

Metformin Stadafarma 850 mg Film-Coated Tablets EFG

The active ingredient is hydrochloride of metformin. One film-coated tabletcontains850mgof hydrochloride of metformin, corresponding to663mg of metformin base. Theother ingredients are magnesium stearate, povidone (E1201), hypromellose 2910 (E464), titanium dioxide (E171) and macrogol 3350.

Metformin Stadafarma 1.000 mg Film-Coated Tablets EFG

The active ingredient is hydrochloride of metformin. One film-coated tabletcontains1.000mgof hydrochloride of metformin, corresponding to 780mg of metformin base. Theother ingredients are magnesium stearate, povidone (E1201), hypromellose 2910 (E464), titanium dioxide (E171) and macrogol 3350.

Product Appearance and Packaging Content

Description

Metformin Stadafarma 850 mg Film-Coated Tablets EFG:

Film-coated tablets, round, white to off-white, engraved with "002" on one side and "850" on the other side. The approximate dimensions of the tablets are 13 mm in diameter and 7 mm in thickness.

Metformin Stadafarma 1.000 mg Film-Coated Tablets EFG:

Film-coated tablets, white to off-white, oval, biconvex, engraved with “003” on one side and “1000” on the other side and scored on both sides. The tablet can be divided into equal doses. The approximate dimensions of the tablets are 19 mm in length and 10 mm in width.

Package Content

Metformin Stadafarma 850 mg Film-Coated Tablets EFG:

PVC-aluminium blisters with 18, 30, 40, 50, 56, 60, 90, 100, 120 and 180 film-coated tablets.

HDPE bottles with child-resistant polypropylene closures, white opaque cap, transparent inner cap and coating containing 100 film-coated tablets.

HDPE bottles with polypropylene screw cap, white opaque cap, transparent inner cap and coating containing 500 film-coated tablets.

Metformin Stadafarma 1.000 mg Film-Coated Tablets EFG:

PVC-aluminium blisters with 18, 30, 50, 60, 90, 120, 180 and 1.500 film-coated tablets.

HDPE bottles with child-resistant polypropylene closures, white opaque cap, transparent inner cap and coating containing 100 film-coated tablets.

HDPE bottles with polypropylene screw cap, white opaque cap, transparent inner cap and coating containing 500 film-coated tablets.

The packaging sizes of 500 tablets (in HDPE bottles) and 1.500 tablets (in blisters) are only for hospitals and customized dosing systems.

Only some packaging sizessmay be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel,

Germany

or

Centrafarm Services B.V.

Nieuwe Donk, 9

4879 AC Etten-Leur

Netherlands

or

Laboratori Fundació Dau

Calle Lletra C de la Zona Franca 12-14

Industrial Zone of the Zona Franca de Barcelona

08040 Barcelona

Spain

Last review date of this leaflet:March 2023

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/