Metformin STADA – Metformin hydrochloride uses, dose and side effects

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1000 mg Film-coated tablets
metformin hydrochloride

What Metformin STADA is and what it is used for

What Metformin Stada is

Metformin Stada 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 glucose levels in the blood. Metformin Stada 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 Stada for a long time can also help reduce the risk of complications associated with diabetes.

What Metformin Stada is used for

Metformin Stada 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, especially for obese patients.

Adults can take Metformin Stada as the only treatment or with medicines to treat diabetes (medicines taken by mouth or insulin ).

Children 10 years of age or older and adolescents can take Metformin Stada as their only treatment or with insulin.

metformin hydrochloride contained in Metformin Stada 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 you use Metformin STADA

Do not use Metformin STADA

  • 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 liver problems
  • 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 that your breath has a different, fruity odor.
  • if the body has lost too much water (dehydration), e.g. due to prolonged or severe diarrhea, or if you have vomited several times in a row. Dehydration can lead to kidney problems which can cause lactic acidosis (See “Warnings and Precautions”)
  • if you have a severe infection , e.g. an infection that affects the lungs, trachea or kidneys. Severe infections can lead to kidney problems which can cause lactic acidosis (See “Warnings and Precautions”)
  • if you are being treated for acute heart failure or have recently had a heart 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 drink a lot of alcohol.

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 have an examination, such as an X-ray or a computed tomography scan , which means that you are receiving contrast media containing iodine injected into your blood
  • you will undergo major surgery.

You must stop taking Metformin Stada for some time before and after the examination or operation. Your doctor will decide if you need any other treatment during this time. You must follow your doctor’s instructions carefully.

Warnings and cautions

Talk to your doctor or pharmacist before taking Metformin Stada.

Risk of lactic acidosis

Metformin Stada can cause the very rare, but very serious, side effect of lactic acidosis, especially 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 Stada for a short time if you have a condition that may be associated with dehydration, such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. Talk to a doctor for further instructions.

Stop taking Metformin Stada 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.

If you are going to have a major operation, you must stop taking Metformin Stada during the operation and for a certain time after it. Your doctor will decide when you need to stop taking Metformin Stada and when you should start taking it again.

During treatment with Metformin Stada, 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.

Metformin Stada itself does not cause hypoglycaemia (too low blood sugar) but if you take Metformin Stada with other antidiabetic medicines that can cause hypoglycaemia (eg sulphonylureas, insulin, meglitinides) there is a risk of hypoglycaemia. If you experience symptoms of hypoglycaemia, such as weakness, dizziness, sweating, rapid heartbeat, visual disturbances or difficulty concentrating, eating or drinking something containing sugar usually helps.

Other medicines and Metformin STADA

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

If you need to get an injection into your blood with a contrast agent that contains iodine, for example in connection with an X-ray or computed tomography, you must stop taking Metformin Stada before or at the time of injection. Your doctor will decide when you need to stop taking Metformin Stada and when you should start taking it again.

Tell your doctor 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 Stada. You must mention the following:

  • beta-2 agonist as salbutamol or terbutaline (used to treat asthma )
  • corticosteroids (used to treat a variety of conditions, such as severe dermatitis or asthma )
  • 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 the treatment of high blood pressure ( ACE inhibitors and angiotensin II receptor antagonists).

Metformin STADA with food, drink and alcohol

Avoid high alcohol intake while taking Metformin Stada as alcohol may increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy, breastfeeding and fertility

During pregnancy, you need insulin to treat your diabetes. 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. He or she may change your treatment.

It is not recommended to take Metformin Stada if you are breastfeeding or if you are planning to breastfeed your baby.

Driving and using machines

Metformin Stada alone does not cause hypoglycaemia (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 take Metformin Stada with other antidiabetic medicines that can cause hypoglycaemia (eg sulphonylureas, insulin, meglitinides). Symptoms of hypoglycaemia 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. Descriptions 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 use Metformin STADA

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Metformin Stada cannot replace the beneficial effects of a healthy lifestyle. Continue to follow any dietary advice your doctor has given you and exercise regularly.

Usual dose

Children 10 years of age or older and adolescents usually start with 500 mg or 850 mg metformin hydrochloride once daily. The maximum daily dose is 2,000 mg divided into two or three doses. Treatment of children aged 10-12 years is only recommended according to your doctor’s instructions, as experience in this age group is limited.

Adults usually start with 500 mg or 850 mg metformin hydrochloride two or three times a day. The maximum daily dose is 3,000 mg divided into three doses.

If you have impaired kidney function, your doctor may prescribe a lower dose.

If you are also taking insulin, your doctor will tell you how to start treatment with Metformin Stada.

Check

  • Your doctor will take regular blood glucose tests and adjust your dose of Metformin Stada 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.

How to take Metformin Stada

Take Metformin Stada with or after a meal. This way you avoid side effects that affect digestion.

Method of administration

The film-coated tablet with breaking notch can be divided with two hands like other tablets or by placing the tablet with the smaller notch facing down on a hard, smooth surface and at the same time using thumb pressure with both thumbs on the right and left side of the notch.

The tablets must not be crushed or chewed. Swallow each tablet with a glass of water.

  • If you take one dose a day, take it in the morning (breakfast).
  • If you take two doses a day, take one dose in the morning (breakfast) and one in the evening (dinner).
  • If you take three doses a day, take one in the morning (breakfast), one in the middle of the day (lunch) and one in the evening (dinner).

If after a while you think that the effect of Metformin Stada is too strong or too weak, talk to your doctor or pharmacist.

Use for children and adolescents

Usual dose

Children 10 years of age or older and adolescents usually start with 500 mg or 850 mg metformin hydrochloride once daily. The maximum daily dose is 2,000 mg divided into two or three doses. Treatment of children aged 10-12 years is only recommended according to your doctor’s instructions, as experience in this age group is limited.

If you use more Metformin STADA than you should  

If you take more Metformin Stada than you should, lactic acidosis may occur. The symptoms of lactic acidosis are vomiting, stomach pain with muscle cramps, general malaise with great tiredness and difficulty breathing. If you experience any of these symptoms, seek medical attention immediately.

If you forget to use Metformin STADA

Do not take a double dose to make up for a forgotten dose. Take the next dose at the time you would normally take it.

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 Stada can cause it very rarely (may affect up to 1 user in 10,000), but very serious side effects include lactic acidosis (see section “Warnings and precautions”). If this happens to you, you must stop taking Metformin Stada and contact a doctor or nearest hospital immediately as lactic acidosis may lead to coma.

Symptoms of lactic acidosis include vomiting, stomach pain (abdominal pain) with muscle cramps, general malaise with severe fatigue and difficulty breathing.

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

  • Digestive problems such as nausea, vomiting, diarrhea, abdominal pain and decreased appetite. These side effects usually occur at the beginning of treatment with Metformin Stada. It helps if you distribute the doses throughout the day and if you take the tablets with or immediately after a meal. If symptoms persist, stop taking Metformin Stada and talk to your doctor.

Common (may affect up to 1 in 10 people)

  • Taste changes.

Very rare (may affect up to 1 in 10,000 people)

  • Skin reactions such as redness, itching or hives .
  • Low levels of vitamin B 12 in the blood.
  • Deviations in liver function tests or hepatitis (this may cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If this happens to you, stop taking this medicine.

Children and young people

Limited information shows that the type and severity of side effects are similar for children and adolescents as for adults.

How to store Metformin STADA

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

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

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. A film-coated tablet Metformin Stada 100 mg contains 1000 mg metformin hydrochloride equivalent to 780 mg metformin .
  • The other ingredients are hypromellose, macrogol 6000, magnesium stearate, povidone K25, titanium dioxide (E171)

What the medicine looks like and contents of the pack

Metformin Stada is white, oblong film-coated tablets with a notch on both sides.

The tablets are sold in blister packs of 15, 20, 30, 50, 60, 90, 100, 118, 120, 150, 180, 200 and 600 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Local representative

STADA Nordic ApS

Marielundvej 46 A

2730 Herlev

Denmark

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