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METFOGAMMA 500MG TBL N120

Attention: Information on this site is provided for informational purposes and is not meant to substitute for the advice provided by your own physician or other medical professional. You should not use the information contained herein for treating a health problem or disease, or prescribing any medication. iDrugs24.com is not responsible for any damage to your health as the result of self treatment.

# On 2024-Mar-28
METFOGAMMA-drug/medicine -tablets aproximate price on "METFOGAMMA 500MG TBL N120 " in Riga city, Latvia is:
  • 6.75€  7.3$  5.79£  780Rub  77.7SEK  29PLN  26.72₪ 


Maximum allowed state defined price ( from ZVA webpage) Euro:State defined maximum allowed price indicated on the picture on drug/medicine -tablets  METFOGAMMA 500MG TBL N120     Recheck

Reģ. Nr.: 02-0345

ATC codeA10BA02 

Active substances: Metformini Hydrochloridum

 


Vendor, principal: Worwag Pharma
METFOGAMMA 500MG TBL N120 is compensated medicine in Latvia. 

 Prescription drug (℞) 

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 .

METFOGAMMA 500MG N30

Package leaflet: information for the user

Metfogamma 500, 500 mg film-coated tablets

Metformin hydrochloride
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
-   Keep this leaflet. You may need to read it again.
-   If you have any further questions, ask your doctor or pharmacist.
-   This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are similar to yours.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.   What Metfogamma is and what it is used for
2.   What you need to know before you take Metfogamma
3.   How to take Metfogamma
4.   Possible side effects
5.   How to store Metfogamma
6.   Contents of the pack and other information

1. What Metfogamma is and what it is used for

Metfogamma contains metformin, which is used to treat diabetes. It belongs in the group of medicines called biguanides. Metformin has a blood sugar lowering effect.
Insulin is a hormone produced by the pancreas that helps your body absorb 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 make enough insulin or your body is not able to properly use the insulin it produces. This leads to a high level of glucose in your blood. Metfogamma helps to lower your blood glucose to as normal a level as possible.
If you are an overweight adult, taking metformin over a long period of time also helps to lower the risk of complications associated with diabetes. Metfogamma use has been linked to maintaining weight or to moderate weight loss.
Metfogamma is used to treat patients with type 2 diabetes (also called non-insulin dependent diabetes) if diet and exercise alone have not been enough to control blood glucose levels. It is used particularly in overweight patients.
Adults can take Metfogamma on its own, or together with other medicines used to treat diabetes (medicines taken orally or insulin).
Children older than 10 years and adolescents can take Metfogamma on its own, or together with insulin.

2. What you need to know before you take Metfogamma Do not take Metfogamma:

-   If you are allergic to metformin or any of the other ingredients of this medicine (listed in section 6).
-   If you have liver problems.
-   If your kidney function has decreased significantly.
-   If you have uncontrolled diabetes that is accompanied with severe hyperglycaemia (high blood sugar levels), nausea, vomiting, diarrhoea, fast weight loss, lactic acidosis (see section below “Risk of lactic acidosis”) or ketoacidosis. Ketoacidosis is a condition in which substances called “ketone bodies” accumulate in the blood, which may lead to diabetic precoma.
Symptoms include abdominal pain, fast and deep breathing, sleepiness or unusual fruity odour of the breath.
-   If you have lost too much water from your body (dehydration), for example, due to prolonged or severe diarrhoea, or if you have vomited several times in a row. Dehydration may lead to kidney problems, which can put you at risk for lactic acidosis (see section “Warnings and precautions”).
-   If you have a severe infection, such as an infection affecting your lungs, bronchial system or kidneys. Severe infections may lead to kidney problems, which can put you at risk for lactic acidosis (see section “Warnings and precautions”).
-   If you are treated for heart failure or have recently had a heart attack, have severe problems with circulation (e.g. shock) or have breathing difficulties. This may lead to a lack of oxygen supply to tissues, which can put you at risk for lactic acidosis (see section “Warnings and precautions”).
-   If you have liver problems.
-   If you drink a lot of alcohol.
If any of the above applies to you, talk to your doctor before you start taking Metfogamma.
Make sure to ask your doctor for advice:
-   If you need to have an examination involving the injection of contrast media that contain iodine into your bloodstream.
-   If you need to have major surgery. You must stop taking Metfogamma before the surgery and for a certain period of time after the procedure. Your doctor will determine when you must stop and when you can continue taking Metfogamma.
Warnings and precautions
Risk of lactic acidosis
Metfogamma may cause a very rare, but severe complication called lactic acidosis, particularly if your kidneys are not working properly. Factors that increase the risk of lactic acidosis include uncontrolled diabetes, severe infections, prolonged fasting or alcohol use, dehydration (see further information below), liver problems and any medical conditions in which there is decreased blood supply to some body part (e.g. severe heart disease).
If any of the above applies to you, ask your doctor for more information.
Stop taking Metfogamma for a while, if you have a condition that may cause dehydration
(significant loss of body fluids), such as vomiting, diarrhoea, fever, exposure to heat or reduced consumption of liquids. For more information, talk to your doctor.
Stop taking Metfogamma and contact your doctor or the emergency department of the nearest hospital if you have any of the symptoms of lactic acidosis, as this may lead to coma.
The symptoms of lactic acidosis are:
-   Vomiting.
-   Abdominal pain.
-   Muscle cramps.
-   Generally feeling unwell and very tired.
-   Breathing difficulties.
-   Decreased body temperature and heart rate.
Lactic acidosis is a severe medical condition that needs to be treated at the hospital.
Metfogamma on its own does not cause hypoglycaemia (overly low blood glucose level). However, if you take Metfogamma with other medicines for treating diabetes, which can cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides), there is a risk of hypoglycaemia. If you get symptoms of hypoglycaemia, such as weakness, dizziness, increased sweating, fast heart rate, impaired vision or difficulty concentrating, it usually helps to eat or drink something containing sugar.
During treatment, your doctor will test your kidney function at least once a year or more frequently if you are elderly and/or your kidney function is decreasing.

Other medicines and Metfogamma

If you need to have an injection of contrast media that contain iodine into your bloodstream, for example, for an X-ray or scan, you must stop taking Metfogamma before the injection or for its duration. Your doctor will determine when you must stop and when you can continue taking Metfogamma.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It may be necessary to perform more frequent blood sugar and kidney function tests or adjust the dosage of Metfogamma. It is particularly important to tell your doctor about:
-   Medicines that increase the excretion of urine (diuretics).
-   Pain and inflammation medicines (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib).
-   Certain high blood pressure medicines (ACE inhibitors and angiotensin II receptor antagonists).
-   Beta-2 agonists, such as salbutamol or terbutaline (used to treat asthma).
-   Corticosteroids (used to treat a variety of conditions, such as severe inflammation of the skin or asthma).
-   Other diabetic medicines.

Metfogamma with food and drink

Metfogamma with alcohol
Avoid excessive consumption of alcohol when taking Metfogamma, as this may increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy and breast-feeding

During pregnancy, you need insulin to treat your diabetes. If you are pregnant, think you may be pregnant or are planning to have a baby, tell you doctor so that they could change your treatment.
Do not take this medicine if you are breast-feeding or if you are planning to start breast-feeding.

Driving and using machines

Metfogamma on its own does not cause hypoglycaemia (overly low blood glucose level). This means that it will not affect your ability to drive or use machines.
However, take special care if you take Metfogamma together with other diabetes medicines that can cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides). Symptoms of hypoglycaemia include weakness, dizziness, increased sweating, fast heart rate, impaired vision or difficulty concentrating. Do not drive or use machines if you get these symptoms.

3. How to take Metfogamma

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Metfogamma cannot replace the benefits of a healthy lifestyle. Continue following any advice about diet that your doctor has given you. Get regular physical exercise.

Recommended dose

Children aged 10 years and older and adolescents usually start with 500 mg or 850 mg of Metfogamma once a day. The maximum daily dose is 2,000 mg taken in 2 or 3 divided doses. Treatment of children between ages 10...12 is only recommended upon a specific instruction from your doctor, as there is little data about this age group.
Adults usually start with 500 mg or 850 mg of Metfogamma two or three times a day. The maximum daily dose is 3,000 mg taken in 3 divided doses.
If your kidney function has deteriorated, your doctor may decrease the dose.
If you also use insulin, your doctor will tell you how to start taking Metfogamma.

Monitoring

-   Your doctor will regularly check your blood glucose levels and adjust your dose of Metfogamma accordingly. Make sure that you talk to your doctor regularly. This is particularly important for children and adolescents or if you are elderly.
-   Your doctor will also check your kidney function at least once a year. You may need more frequent checks if you are elderly or if your kidneys are not working correctly.

How to take Metfogamma

Take the tablets with or after a meal. This way you will avoid having side effects affecting your 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 (with breakfast).
-   If you take two doses a day, take them in the morning (with breakfast) and evening (with dinner).
-   If you take three doses a day, take them in the morning (with breakfast), at noon (with lunch) and in the evening (with dinner).
If, after some time, you think that the effect of Metfogamma is too strong or too weak, talk to your doctor or pharmacist.

If you take more Metfogamma than you should

If you have taken more Metfogamma than you should have, you may get lactic acidosis. Symptoms of lactic acidosis are non-specific, such as vomiting, abdominal pain with muscle cramps, generally feeling unwell and very tired, breathing difficulties, low body temperature and slow heart rate. If you
get any of these symptoms, you must seek immediate medical attention, as lactic acidosis may lead to coma. Stop taking Metfogamma at once and immediately talk to your doctor or go to your nearest hospital.

If you forget to use Metfogamma

Do not take a double dose to make up for a forgotten dose. 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, this medicine can cause side effects, although not everybody gets them.
Metfogamma may cause a very rare (affects less than 1 user in 10,000) yet very severe side effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking Metfogamma and contact your doctor or go to the emergency department of the nearest hospital, because lactic acidosis may lead to coma.
The following side effects may also occur:

Very common side effects (affect more than 1 person in 10)

-   Digestive problems, such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite. These side effects occur most often at the beginning of the treatment with Metfogamma. It helps if you spread the doses throughout the day and take the tablets with or straight after a meal. If the symptoms persist, stop taking Metfogamma tablets and talk to your doctor.

Common side effects (affect less than 1 person in 10)

-   Changes in the sense of taste.

Very rare side effects (affect less than 1 user in 10,000):

-   Abnormal results for liver function tests or hepatitis (inflammation of the liver which may cause tiredness, loss of appetite, weight loss, and which may or may not be accompanied with a yellow discoloration of the skin and the whites of the eyes). If this happens to you, stop taking Metfogamma immediately and talk to your doctor at once.
-   Skin reactions, such as redness of the skin (erythema), itching or an itchy rash (urticaria).
-   Low vitamin B12 levels in the blood.

Children and adolescents

Limited data in children and adolescents suggest that adverse events were similar in nature and
severity to those reported in adults.

Reporting of side effects

If you get any side effects, talk to a doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By
reporting side effects you can help provide more information on the safety of this medicine.

5.   How to store Metfogamma

Keep this medicine out of the sight and reach of children. If a child is treated with Metfogamma, parents and caregivers are advised to oversee the use of the medicine.
This medicine does not require any special storage conditions.
Do not use Metfogamma after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines that you no longer use. These measures will help protect the environment.

6.   Contents of the pack and other information What Metfogamma contains

-   The active substance is metformin. One film-coated tablet contains 500 mg of metformin hydrochloride, which is equivalent to 390 mg of metformin.
-   The excipients are povidone K30, sodium starch glycolate, corn starch, colloidal anhydrous silicon, hypromellose, magnesium stearate, talc, titanium dioxide (E171), propylene glycol, macrogol 6000.

What Metfogamma looks like and contents of the pack

Metfogamma is a white round tablet with a smooth glossy film-coating.
Metfogamma is available in packs containing 30 or 120 film-coated tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Queisser Pharma GmbH & Co. KG Calwer Str. 7 71034 Böblingen Germany
Manufacturer
Dragenopharm Apotheker Püschl GmbH Göllstrasse 1 84529 Tittmoning Germany

This leaflet was last revised in April 2017

6





  Instruction, annotation source for medicine: State Agency of Medicines, Estonia




[*1]

DDD. Information source: WHO Collaborating Centre for Drug Statistics Methodology. Norwegian Institute of Public Health


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