ABIANO 1000 MG EFFERVESCENT TABLETS - patient leaflet, side effects, dosage

Abiano

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 guestions, 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 signs of illness are the same as 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 Abia no is a nd what it is used for

• 2. What you need to know before you take Abiano

• 3. Howto take Abiano

• 4. Possible side effects

• 5. Howto store Abiano

• 6. Contents of the pack and other information

1. what abiano is and what it is used for

Abiano contains metformin. This is a medicine to treat diabetes. It belongs to a group of medicines called biguanides.

What Abiano is

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 leadstoa high level of glucose in your blood. Abiano helps to lower your blood glucose to as normal a level as possible.

If you arean overweight adult, taking Abiano overa long period of time also helps to lower the risk of complications associated with diabetes. Abiano is associated with either a stable body weight or modest weight loss.

What Abiano is used for

Abiano 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 Abiano 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 Abiano on its own or together with insulin.

2. what you need to know before you take abianodo not take abiano if you are allergic to metformin hydrochloride or any of the other ingredients of this medicine (listed in section 6).

• if you have severely reduced kidney function.
• if you have uncontrolled diabetes, such as severe hyperglycaemia (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 unusual fruity odour of the breath.
• 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 riskfor lactic acidosis (see Warnings and precautions').
• if you are treated for 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‘).
• ifyoudrinka lot of alcohol.

If any of the above appliesto you, talkto your doctor, before you start taking this medicine.

Warningsand precautions

Talkto yourdoctor or pharmacist before taking Abiano.

Risk of lacticacidosis

Abiano may cause a very rare, but very serious side effect called lactic acidosis, particularly if It is important to you to comply with your medication intake, dietary instructions and regular exercise program because this can reduce the risk of lactic acidosis.

Stop taking Abiano for a short time if you have a condition that may be assodated 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 Abiano and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lacticacidosis, 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.

Abiano on its own does not cause hypoglycaemia (a blood glucose level which is too low). However, if you take Abiano together with other medicinesto treat diabet esthat can cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides), there is a risk of hypoglycaemia. If you experience symptoms of hypoglycaemia such as weakness, dizziness, increased sweating, fast heart beating, visions disorders or difficulty in concentration, it usually helps to drink or eat something containing sugar.

If you need to have major surgery you must stop taking Abiano during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Abiano.

During treatment with Abiano, your doctor will check your kidney function at least once a year or more freguently if you are elderly and/or if you have worsening kidney function.

Other medidnes and Abiano

If you need to have an injection of contrast medicines that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Abiano before or at the time of the injection. Your doctor will decide when you must stop and when to restart your treatment with Abiano.

Tell your doctor if you are taking, have recently taken or might take any other medicines. You may need morefreguent blood glucose and kidney function tests, or your doctor may adjust the dosage of Abiano. 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 adrenergic 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

Abiano with alcohol

Avoid excessive alcohol intake while taking Abiano since this may increase the risk of lacticacidosis (see sect!on „Warnings and precautions“).

Pregnancy, breast-feeding and fertility

During pregnancy, you need insulin to treat your diabetes. If you are pregnant or breast-feeding, think you may be pregnant or are planning to havea baby, ask yourdoctor or pharmacist for advice before taking this medicine, 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

Abiano on its own does not cause hypoglycaemia (a blood glucose level which is too low). This meansthat it will not affect your ability to drive or use machines.

However, take special care if you take Abiano together with other medicines to treat diabetes that can cause hypoglycaemia (such as sulphonylureas, 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.

Abiano contains isomalt

This medicine contains 370 mg isomalt in each effervescent tablet. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Abiano contains sucrose

This medicine contains 2.09 mg sucrose in each effervescent tablet. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Also, Abiano may be harmful to the teeth.

3. how to take abiano

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Abiano 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 'A tablet (500 mg) or 850 mg Abiano once a day. The maximum daily dose is 2000 mg taken as 2 or 3 divided doses. Treatment of children between Wand 12 yearsof age is only recommended on specific advice from your doctor, as experience in this age group is limited.

Adults usually start with 'A tablet (500 mg) or 850 mg Abiano two or three times a day. The maximum daily dose is 3000 mg taken as 3 divided doses.

The recommended dose described above cannot always be achieved with Abiano, yet such doses can be achieved with other available drug products.

If you have reduced kidney function, your doctor may prescribea lowerdose.

If you take insulin too, your doctor will tell you howto start Abiano.

Monitoring

• Your doctor will perform regular blood glucose test and will adapt your dose of Abiano to your blood glucose levels. Make sure that you talkto yourdoctor 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 freguent checks if you are an older person or if your kidneys are not working normally.

HowtotakeAbiano

Take Abiano with or after a meal. This will avoid you having side effects affecting your digestion.

The effervescent tablets can be divided into two egual doses. The remaining part of the effervescent tablet if not used immediately, should be discarded.

The effervescent tablets must be dissolved in a glass of water and the solution should then be drunk immediately after complete dissolution of the tablets.

• 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 Abiano is too strong or too weak, talk to your doctor or pharmacist.

If you take more Abiano than you should

If you have taken more Abiano that you should have, you may experience lactic acidosis. Symptoms of lactic acidosis are nonspecific 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 Abiano immediately and contact a doctor or the nearest hospital straight away.

If you forget to take Abiano

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 furtherquestionson the use of this medicine, ask yourdoctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Lacticacidosis

Lactic acidosis is a very rare side effect (up to 1 in 10,000 people), but it is a very serious complication, especially if your kidneys are not working properly. The symptoms of lactic acidosis are nonspecific, such as vomiting, stomach pain (abdominal pain) with muscle cramps, a feeling of general malaise with intense fatigue and difficulty breathing. Other symptoms include a decrease in body temperature and heart rate. If you experience any of these symptoms, you should seek medical attention immediately as lactic acidosis can lead to coma. Stop taking Abiano immediately and contact a doctor or the nearest hospital immediately.

Liverproblems

Liver abnormalities or hepatitis (inflammation of the liver that may cause fatigue, loss of appetite, weight loss, with or without yellow coloring of the skin or whites of the eyes) are very rare side effects (may affect up to 1 in 10,000 people). If you are in this situation, stop taking Abiano and consult your doctor.

Digestive disorders

Digestive disorders, such as nausea, vomiting, diarrhea, stomach pain (abdominal pain) and loss ofappetite are very common side effects (may affect more than 1 in 10 people).These side effects occur most often at the beginning of treatment with Abiano. Spreading the doses in the day and taking Abiano during or just afterthe meal can help you. If symptoms persist, stop taking Abiano and consult your doctor.

Common side effects (may affect up to 1 in 10 people)

Changes in taste.

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

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 severityto those reported in adults.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• 5. Howto store Abiano

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

Do not use this medicine after the expiry date which is stated on the label or carton after ‚EXP‘. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture. This medicine does not reguire any special temperature storage conditions. In case of splitting of the effervescent tablet, the remaining part if not used immediately should bediscarded.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. contents of the pack and other informationwhat abiano contains- the active substance is metformin hydrochloride. each tablet contains 1000 mg of metformin hydrochloride eguivalent to 780 mg of metformin.

• -The other ingredients are:

What Abiano looks like and contents of the pack

Abiano are white, round, flat-faced, bevel-edged, bisect effervescent tablets. The effervescent tablets can be divided into two egual halves.

Each cardboard box contains 28 or 30 effervescent tablets presented in AI/PE strips, along with a Patient Information Leaflet.

Marketing Authorisation Holder and Manufacturer

Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.

14th km National Road 1,145 64 Kifissia, Greece

This medicinal product is authorised in the Member States of the EEA under the following names:

Netherlands: Glycofren 1000 mg bruistabletten

France: GLIMEZIT1000 mg Comprime effervescent

UK: Abiano 1000 mg Effervescent tablets

This leaflet was last revised in 01/2021.

Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.

14th km National Road 1

145 M Kifissia

Greece