NORMAGLYC 500 mg. 90 tablets

What is Normaglyc and what it is used
What is Normaglyc
Normaglyc contains metformin, a drug for treatment of diabetes. It belongs to a group of medicines called biguanides.
Insulin is a hormone secreted by the pancreas, which causes your body to make glucose (sugar) from the blood. Your body uses glucose to produce energy or store it for later use.
If you have diabetes, your pancreas does not release enough insulin or your body can not make full use of insulin units. This leads to high levels of glucose in your blood. Normaglik helps lower blood sugar levels as low as possible.
If you are overweight adult, taking Normaglik for an extended period also helps to reduce the risk of complications due to diabetes.
Normaglik is connected to either maintain a constant body weight or with moderate weight loss.

What is Normaglyc
Normaglik be used to treat patients with type 2 diabetes (also referred to as "non-insulin dependent diabetes") when only diet and physical activity are not sufficient to control the levels of blood sugar. It is used particularly in overweight patients.
Adults can take Normaglik alone or with other medicines to treat diabetes (medicines taken by mouth or insulin).
Children aged 10 and over and adolescents can take Normaglik alone or together with insulin.
If you do not feel well or your condition deteriorates, you should seek medical attention.

2. What you need to know before taking Normaglik
Do not take Normaglyc
if you are allergic to metformin or any of the other ingredients of this medicine (listed in section 6);
If you have kidney or liver problems;
if you have uncontrolled diabetes, such as severe hypoglycemia (high blood glucose), nausea, vomiting, dehydration, rapid weight loss or ketoacidosis. Ketoacidosis is a condition in which substances called "ketone bodies" accumulate in the blood and which can lead to diabetic pre-coma. Symptoms include stomach pain, fast and deep breathing, sleepiness or unnatural fruity breath odor;
if you lose too much water (dehydration) caused by prolonged or severe diarrhea or if you have vomited several times. Dehydration can lead to kidney problems, which can put you at risk for lactic acidosis (see "Warnings and Precautions" section below);
if you have a severe infection, such as an infection affecting your lung or bronchial system or your kidneys. Severe infections can lead to kidney problems, which can put you at risk for lactic acidosis (see "Warnings and Precautions" section below);
if you are being treated for heart failure or have recently had a heart attack, you have severe circulatory problems (such as shock) or have difficulty breathing. This can lead to a shortage of oxygen in the tissues, which can put you at risk for lactic acidosis (see "Warnings and Precautions" section below);
if you abuse alcohol.
If any of the above conditions is true for you, tell your doctor before using this medicine.

Ask your doctor for advice if:
it is necessary to conduct research as X-ray or scan involving injection into the bloodstream of a dye containing iodine;
yet your major surgical intervention (operation).
You should stop taking Normaglik for a period of time before and after the examination or surgery. Your doctor will decide if you need any other treatment in this period. It is important to follow your doctor's instructions precisely.

Warnings and Precautions
Very rarely Normaglik can cause severe complication called lactic acidosis, particularly if your kidneys are not working properly. The risk of lactic acidosis increases also in uncontrolled diabetes, prolonged fasting or alcohol intake. Symptoms of lactic acidosis are vomiting, stomach pain with muscle cramps, a general feeling that nothing is wrong with severe fatigue and difficulty breathing. If this happens to you, you may not need immediate treatment. Stop taking Normaglik and tell your doctor immediately.
Normaglik alone does not cause hypoglycaemia (too low blood sugar). However if you take Normaglik together with other medicines for the treatment of diabetes, which can cause hypoglycaemia (such as sulfonylureas, insulin, meglitinides) there is a risk of hypoglycemia. If you experience symptoms of hypoglycaemia such as weakness, dizziness, sweating, fast heartbeat, visual disturbances or difficulty concentrating, usually it helps if you eat or drink something containing sugar.

Other medicines and Normaglyc
If you need to be put directly into the bloodstream injection of contrast dye containing iodine, for example to study x-ray or scan, you must stop taking Normaglik for a period of time before and after the study (see "Talk to your doctor for advice 'above).

Tell your doctor if you are taking any of the following medicines and Normaglik simultaneously. You may need more often than blood glucose or your doctor may adjust your dose of Normaglik:
diuretics (used to remove water from the body through formation of more urine);
beta-2 agonists such as salbutamol or terbutaline (used to treat asthma);
corticosteroids (used to treat various conditions, such as severe infections of skin or in asthma);
other medicines to treat diabetes.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Normaglyc with food, drink and alcohol
Do not drink alcohol while taking this medicine. Alcohol can increase the risk of lactic acidosis especially if you have liver problems or not eating regularly. This also applies to medicines containing alcohol.

Pregnancy and lactation
During pregnancy, you need insulin to treat your diabetes.
Tell your doctor if you are, if you think you may be pregnant or planning to become pregnant, so that he / she can change your treatment.
Metformin is excreted in human milk. You should discuss with your doctor whether there are alternative treatments while you are planning to breast-feed your baby.
This medicine is not recommended if you are breastfeeding or plan to breastfeed your baby.

Driving and using machines
Normaglyc alone does not cause hypoglycaemia (too low blood sugar). This means it will not affect your ability to drive and use machines.
However, pay special attention if you are taking Normaglik together with other medicines to treat diabetes that can cause hypoglycaemia (such as sulfonylureas, insulin, meglitinides). Symptoms of hypoglycaemia include weakness, dizziness, sweating, fast heartbeat, visual disturbances or difficulty concentrating. Do not drive or operate machinery if these symptoms occur.

3. How to take Normaglyc
Always take this medicine exactly as your doctor tells you. If you're not sure, ask your doctor or pharmacist.
Normaglik can not replace the benefits of a healthy lifestyle. Continue to follow advice on diet, given to you by your doctor and do regular exercise.

Usual dose
Children aged 10 years and over and adolescents usually start with 500 mg or 850 mg once daily Normaglik. The maximum daily dose of 2000 mg taken in 2 or 3 divided doses. Treatment of children between 10 and 12 years is recommended only if explicitly suggested by your doctor, as experience in this age group is limited.
Adults usually start with 500 mg or 850 mg Normaglik two or three times daily. The maximum daily dose is 3,000 mg, given as 3 doses.
• If you take insulin, your doctor will explain how to start treatment with Normaglik.

Surveillance
Your doctor will adjust the dose of Normaglyc Your blood sugar levels. Regularly check with your doctor. This is especially important for children and adolescents, if you are older;
Your doctor will also check at least once a year how your kidneys are working. You may need more frequent checks if you are elderly or your kidneys are not functioning normally.
How to take Normaglik
Take the tablets with or after a meal. This will protect you from unwanted effects affecting digestion. Do not crush or chew the tablets. Swallow each tablet with a glass of water.
If you take one dose a day, take it in the morning (at breakfast);
If you are taking two doses a day, take them in the morning (breakfast) and evening (during dinner);
If you take three divided doses, take them in the morning (breakfast), noon (during lunch) and evening (during dinner).
If after a while you feel that the effect of Normaglik is too weak or too strong for you, tell your doctor.

If you take more dose Normaglyc
If you take more than the amount Normaglik could this lead to lactic acidosis. Symptoms of lactic acidosis are vomiting, stomach pain with muscle cramps, a general feeling of poor condition with severe fatigue and difficulty breathing. If this happens, you need immediate hospital treatment, as lactic acidosis may lead to coma. Tell your doctor immediately.

If you forget to take Normaglyc
Do not take a double dose to make up for missed. Take the next dose at the usual time.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Normaglyc can cause side effects, although not everybody gets them. The following adverse reactions may occur:

Very common side effects (more than 1 in 10 patients):
Digestive problems such as nausea, vomiting, diarrhea, abdominal pain and loss of appetite. These side effects most often occur at the start of treatment with Normaglik. Their manifestations may be limited, if spread evenly throughout the day dose and take the tablets during or immediately after a meal. If symptoms persist, stop taking Normaglik and consult your doctor.
Common side effects (in less than 1 in 10):
Taste disorders.
Rare side effects (in less than 1 in 10,000 patients):
Lactic acidosis. This is a very rare but serious complication, especially if you have kidney problems. If this complication occur, immediate treatment is necessary. Symptoms of lactic acidosis are vomiting, stomach pain with muscle cramps, a general feeling of poor condition with severe fatigue and difficulty breathing. If this happens to you, stop taking Normaglik and immediately contact your doctor;
Skin reactions such as skin redness (erythema), itching or rash and itching (hives);
Low levels of vitamin B12 in the blood;
Abnormal liver function tests or hepatitis (inflammation of the liver that can cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If this happens, stop taking this medicine and talk to your doctor.
Children and adolescents
Limited data in children and adolescents showed similar nature and severity of side effects as those observed in adults.

If you get any side effects, contact your doctor or pharmacist. This includes all listed in this leaflet.

5. How to store Normaglyc
Keep out of reach of children. If Normaglyc treated with kid advise parents and those who care for him to follow on how to use this medicine.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of that month.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and further information
What Normaglyc 500 mg of
The active substance is metformin, where he attended as metformin hydrochloride.
Each film-coated tablet contains 500 mg metformin hydrochloride corresponding to 390 mg of metformin.

Other ingredients are:
Core: Povidone, magnesium stearate.
Film-coating: Hypromellose, macrogol.

Normaglik looks like and contents of the pack
Tablets
Normaglyc 500 mg:
White, round, biconvex film-coated tablets, engraved with "A" on one side and "60" on the other side.
Normaglyc 500 mg packaged in blisters.