METFOGAMMA 1000MG TBL N120

ATC code: A10BA02 

Active substances: Metformini Hydrochloridum

Vendor, principal: Worwag Pharma. 
METFOGAMMA 1000MG TBL N120 is compensated medicine in Latvia. 

 Prescription drug (℞) 

METFOGAMMA 1000MG N30

PACKAGE LEAFLET: INFORMATION FOR THE USER
Metfogamma 1000, 1000 mg film-coated tablets Metformin hydrochloride
Read all of this leaflet carefully before you start taking 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
-   If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1.   What Metfogamma 1000 is and what it is used for
2.   What you need to know, before you take Metfogamma 1000
3.   How to take Metfogamma 1000
4.   Possible side effects
5.   How to store Metfogamma 1000
6.   Contents of the pack and other information
1. WHAT METFOGAMMA 1000 IS AND WHAT IT IS USED FOR
Metfogamma 1000 contains metformin, a medicine to treat diabetes. It belongs to a class of medicines called biguanides. Metformin has been shown to reduce blood sugar.
Insulin is a hormone produced by the pancreas that makes your body take in 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 use properly the insulin it produces. This leads to a high level of glucose in your blood. Metfogamma 1000 helps to lower your blood glucose to as normal a level as possible.
If you are an overweight adult, taking Metfogamma 1000 over a long period of time also helps to lower the risk of complications associated with diabetes. Metfogamma 1000 is associated with either a stable bodyweight or modest weight loss.
Metfogamma 1000 is used to treat patients with type 2 diabetes (also called 'non-insulin dependent diabetes') when diet and exercise alone have not been enough to control your blood glucose levels. It is used particularly in overweight patients.
Adults can take Metfogamma 1000 on its own or together with other medicines to treat diabetes (medicines taken by mouth or insulin).
Children 10 years and over and adolescents can take Metfogamma 1000 on its own or together with insulin.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE Metfogamma 1000
Do not take Metfogamma 1000
•   if you are allergic (hypersensitive) to metformin or any of the other ingredients of this medicine (see ‘What Metfogamma 1000 contains’ in section 6),
•   if you have liver problems,
•   if you have severely reduced kidney function,
•   if you have uncontrolled diabetes, with, for example, severehyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, 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 and which can lead to diabetic pre-coma. Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity smell,if you lost too much water from your body (dehydration), such as due to long-lasting 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 ‘Warnings and precautions’),
•   if you have a severe infection, such as an infection affecting your lung or bronchial system or your kidney. Severe infections may lead to kidney problems, which can put you at risk for lactic acidosis (see ‘Warnings and precautions’),
•   if you are treated for acute heart failure or have recently had a heart attack, have severe problems with your circulation (such as shock) or have breathing difficulties. This may lead to a lack in oxygen supply to tissue which can put you at risk for lactic acidosis (see ‘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 taking this medicine.

Make sure you ask your doctor for advice, if:

•   you need to have an examination such as X-ray or scan involving the injection of contrast medicines that contain iodine into your bloodstream
•   you need to have major surgery. You must stop taking Metfogamma 1000 during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Metfogamma 1000.

Warnings and precautions

Risk of lactic acidosis

Metfogamma 1000may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease).
If any of the above apply to you, talk to your doctor for further instructions.
Stop taking Metfogamma 1000 for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. Talk to your doctor for further instructions.

Stop taking Metfogamma 1000 and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.

Symptoms of lactic acidosis include:
•   vomiting
•   stomach ache (abdominal pain)
•   muscle cramps
•   a general feeling of not being well with severe tiredness
•   difficulty in breathing
•   reduced body temperature and heartbeat
Lactic acidosis is a medical emergency and must be treated in a hospital.
Metfogamma 1000 on its own does not cause hypoglycaemia (a blood glucose level which is too low). However, if you take Metfogamma 1000 together with other medicines to treat diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides), there is a risk ofhypoglycaemia. If you experience symptoms of hypoglycaemia such as weakness, dizziness, in-creased sweating, fast heart beating, visions disorders or difficulty in concentration, it usually helps to eat or drink something containing sugar.
During treatment with Metfogamma 1000, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.

Other medicines and Metfogamma 1000

If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Metfogamma 1000 before or at the time of the injection. Your doctor will decide when you must stop and when to restart your treatment with Metfogamma 1000.
Tell your doctor if you are taking, have recently taken or might take any other medicines. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dosage of Metfogamma 1000. It is especially important to mention the following:
•   medicines which increase urine production (diuretics).
•   medicines used to treat pain and inflammation (NSAID 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).
•   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 in asthma).
•   other medicines used to treat diabetes.

Metfogamma 1000 with food and drink

Metfogamma 1000 with alcohol
Avoid excessive alcohol intake while taking Metfogamma 1000 since 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. Tell your doctor if you are, you think you might be or are planning to become pregnant, so that he or she may change your treatment.
This medicine is not recommended if you are breast-feeding or if you are planning to breast-feed your baby.

Driving and using machines

Metfogamma 1000 on its own does not cause hypoglycaemia (a blood glucose level which is too low). This means that it will not affect your ability to drive or use machines.
However, take special care if you take Metfogamma 1000 together with other medicines to treat diabetes that can cause hypoglycaemia (such as sulfonylureas, insulin, meglitinides). Symptoms of hypoglycaemia include weakness, dizziness, increased sweating, fast heart beat, vision disorders or difficulty in concentration. Do not drive or use machines if you start to feel these symptoms.

3. HOW TO TAKE METFOGAMMA 1000

Always take Metfogamma 1000 exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Metfogamma 1000 cannot replace the benefits of a healthy lifestyle. Continue to follow any advice about diet that your doctor has given you and get some regular exercise.

Recommended dose

Children 10 years and over and adolescents usually start with 500 mg or 850 mg Metfogamma 1000 once a day. The maximum daily dose is 2000 mg taken as 2 or 3 divided doses. Treatment of children between 10 and 12 years of age is only recommended on specific advice from your doctor, as experience in this agegroup is limited
Adults usually start with 500 mg or 850 mg Metfogamma 1000 two or three times a day. The maximum daily dose is 3000 mg taken as 3 divided doses.
If you have reduced kidney function, your doctor may prescribe a lower dose.
If you take insulin too, your doctor will tell you how to start Metfogamma 1000.

Monitoring

•   Your doctor will perform regular blood glucose tests and will adapt your dose of Metfogamma 1000 to your blood glucose levels. Make sure that you talk to your doctor regularly. This is particularly important for children and adolescents or if you are an older person.
•   Your doctor will also check at least once a year how well your kidneys work. You may need more frequent checks if you are an older person or if your kidneys are not working normally.

How to take Metfogamma 1000

Take the tablets with or after a meal. This will avoid you 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 (breakfast)
-   If you take    two divided doses a day, take them in the morning (breakfast) and evening (dinner)
-   If you take    three divided doses a day, take them in the morning (breakfast), at noon (lunch) and
in the evening (dinner)
If, after some time, you think that the effect of Metfogamma 1000 is too strong or too weak, talk to your doctor or pharmacist.

If you take more Metfogamma 1000 than you should

If you have taken more Metfogamma 1000 than you should have, you may experience lactic acidosis. Symptoms of lactic acidosis are non-specific such as vomiting, bellyache (abdominal pain) with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. Further symptoms are reduced body temperature and heart beat. If you experience some of these symptoms, you should seek immediately medical attention, as lactic acidosis may lead to coma. Stop taking Metfogamma 1000 immediately and contact a doctor or the nearest hospital straight away.

If you forget to take Metfogamma 1000

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, Metfogamma 1000 can cause side effects, although not everybody gets them.
Metfogamma 1000 may cause a very rare (may affect up to 1 user in 10,000), but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this happens you must stop taking Metfogamma 1000 and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
The following side effects can occur:

Very common side effects (in more than 1 in 10 people)

•   digestive problems, such as feeling sick (nausea), being sick (vomiting), diarrhoea, bellyache (abdominal pain) and loss of appetite. These side effects most often happen at the beginning of the treatment with Metfogamma 1000. It helps if you spread the doses over the day and if you take Metfogamma 1000 with or straight after a meal. If symptoms continue, stop taking Metfogamma 1000 and talk to your doctor.

Common side effects (in less than 1 in 10 people)

•   changes in taste.

Very rare side effects (in less than 1 in 10,000 people)

•   abnormalities in liver function tests or hepatitis (inflammation of the liver; this may cause tiredness, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If this happens to you, stop taking Metfogamma 1000 and talk to your doctor.
•   skin reactions such as redness of the skin (erythema), itching or an itchy rash (hives).
•   low vitamin B12 levels in the blood.

Children and adolescents

Limited data in children and adolescents showed 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 your doctor or 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 1000

Keep out of the sight and reach of children. If a child is treated with Metfogamma 1000, parents and caregivers are advised to oversee how this medicine is used.
This medicinal product does not require any special storage conditions.
Do not use Metfogamma 1000 after the expiry date which is stated on the carton/blister after {abbreviation used for expiry date}. The expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible sign of deterioration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Metfogamma 1000 contains

The active substance is metformin hydrochloride. One film-coated tablet of Metfogamma 1000 contains 1000 mg metformin hydrochloride corresponding to 780 mg metformin base.
• The other ingredients are povidone K 25, hypromellose, titanium dioxide (E171), magnesium stearate, macrogol 6000.

What Metfogamma 1000 looks like and contents of the pack

Metfogamma 1000 is a white, oblong film-coated tablet, with scoreline on one side and deep breakline on the other (snap-tab shaped).
The tablet can be divided into equal halves.
The tablets are supplied in blister packs of 15, 30, 60, 120, 180 and 600 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Wörwag Pharma GmbH & Co. KG Calwer Str. 7 71034 Böblingen Germany

Manufacturers

Dragenopharm Apotheker Püschl GmbH Göllstraße 1 84529 Tittmoning Germany
Medis International a.s.
Prumyslova 961/16 747 23 Bolatice Czech Republic
Wörwag Pharma GmbH & Co. KG Calwer Straße 7 71034 Böblingen Germany

This medicinal product is authorised in the Member States of the EEA under the following names:
Czech Republic	Metfogamma® 1000 mg potahovane tablety
Estonia	Metfogamma® 1000
Hungary	Metfogamma® 1000 mg filmtabletta
Lithuania	Metfogamma® 1000 mg plevele dengtos tabletes
Latvia	Metfogamma® 1000 mg apvalkotās tabletes
Poland	Metfogamma® 1000 mg
Slovak Republic	Metfogamma® 1000
Slovenia	Metfogamma® 1000 mg

This leaflet was last revised in May 2017.