PACKAGE LEAFLET: INFORMATION FOR THE USER Metformin 100mg/ml Oral Solution

Metformin hydrochloride

BACK    FRONT

Read all of this leaflet carefully before you start taking this

medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have further questions, ask your doctor or your pharmacist.

•    This medicine has been prescribed only for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours

•    If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet

1.    What Metformin is and what is it used for

2.    Before you take Metformin

3.    How to take Metformin

4.    Possible side effects

5.    How to store Metformin

6.    Further information

1. WHAT METFORMIN IS AND WHAT IT IS USED FOR What Metformin Is

Metformin contains metformin, a medicine to treat diabetes. It belongs to a group of medicines called biguanides.

Insulin is a hormone produced by the pancreasthat 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. Metformin 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. Metformin is associated with either a stable body weight or modest weight loss.

What Metformin is used for

Metformin 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 Metformin 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 Metformin on its own or together with insulin.

2. BEFORE YOU TAKE METFORMIN Do not take Metformin:

•    If you are allergic (hypersensitive) to metformin or any of the other ingredients in this liquid (see section 6: Further information).

•    if you have kidney or liver problems

•    if you have uncontrolled diabetes, with e.g. severe hyperglycaemia

(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. 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 'Take special care with Metformin below).

•    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 Take special care with Metformin below).

•    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 Take special care with Metformin Alapis below)

•    if you drink a lot of alcohol

If any of the above applies to you, talk to your doctor, before you start 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 Metformin Alapis for a certain period of time before and after the examination or the surgery. Your doctor will decide whether you need any other treatment for this time. It is important that you follow your doctor’s instructions precisely

Take special care with Metformin

Please note the following particular risk of lactic acidosis Metformin may cause a very rare, but serious complication called lactic acidosis, particularly if your kidneys are not working properly. The risk of lactic acidosis is also increased with uncontrolled diabetes, prolonged fasting or alcohol intake.Symptoms of lactic acidosis are vomiting, bellyache (abdominal pain) with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. If this happens to you, you may need Immediate treatment in hospital. Stop taking Metformin immediately and contact your doctor or the nearest hospital straight away.

Metformin on its own does not cause hypoglycaemia (a blood glucose level which is too low). However, if you take Metformin together with other medicines to treat diabetes that 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 eat or drink something containing sugar.

Taking other medicines

If you need to have an injection of contrast medicines that contain iodine into your bloodstream, for example for examinations such as X-ray or scan, you must stop taking Metformin for a certain period of time before and after the examination (see 'Make sure you ask your doctor for advice’ above).

Tell your doctor if you take any of the following medicines and Metformin at the same time. You may need more frequent blood glucose tests or your doctor may adjust the dosage of Metformin:

•    diuretics (used to remove water from the body by making more urine).

•    sympathomimetics 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 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.

Taking Metformin with food and drink

Do not drink alcohol when you take this medicine. Alcohol may increase the risk of lactic acidosis especially if you have liver problems or if you are undernourished. This also applies to medicines that contain alcohol

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.

It is not recommended to take Metformin during breast-feeding. Your doctor will decide whether you should stop breast-feeding while you are treated with Metformin.

Driving and using machines

Metformin 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 Metformin 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.

Important information about some of the ingredients of Metformin

This medicine contains:

■    Liquid maltitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

■    Sodium methyl and propyl parahydroxybenzoates. These may cause allergic reactions (possibly delayed).

•    Sodium (7.0 mg in a 5ml dose). To be taken into consideration for patients on a controlled sodium diet.

•    Potassium (14.5mg in a 5ml dose). To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

3. HOWTO TAKE METFORMIN

Always take Metformin exactly as your doctor has told you. You

should check with your doctor or pharmacist if you are not sure.

Metformin 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.

How to take this medicine

•    This solution contains 500mg of metformin in 5ml.

•    Taking this medicine with or just after food will avoid you having side effects affecting your digestion.

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

Usual dose

Adults

•    The usual starting dose is 500mg (5 ml) or 850 mg (8.5 ml) two or three times a day.

•    The maximum daily dose is 3000mg (30 ml) of Metformin taken as 3 divided doses.

If you take insulin too, your doctor will tell you how to start Metformin.

Elderly: Your doctor may prescribe a different dose.

Children over 10 years and adolescents

•    The usual dose of metformin is 500mg (5ml) or 850 mg (8.5ml) once a day.

•    The maximium daily dose is 2000mg (20 ml) of Metformin 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 age group is limited.

Monitoring

•    Your doctor will adapt your dose of Metformin 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.

Directions for opening the bottle and using the syringe

Close the bottle with the plastic screw cap.

Wash the syringe with water after every use and leave it to airdry.

If you take more Metformin than you should

If you have taken more Metformin than you should have, you may experience lactic acidosis. Symptoms of lactic acidosis are vomiting, bellyache (abdominal pain) with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. Contact your doctor or the nearest hospital straight away.

If you forget to take Metformin

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.

If you stop taking Metformin

Keep taking this medicine until your doctor tells you to stop.

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

5. HOWTO STORE METFORMIN

Keep out of the reach and sight of children. If a child is treated with Metformin parents and caregivers are advised to oversee how this medicine is used.

Do not store above 25°C.

Once the medicine is opened, use within 28 days.

Do not use after the expiry date which is stated on the label and carton EXP. The expiry date refers to the last day of that month.

Do not use Metformin if you notice that the appearance or smell of your medicine has changed. Talk to your pharmacist.

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.

Open the bottle by pressing the cap and turn it anticlockwise (figure 1).

Insert the syringe into the bottle.

While holding the bottom ring, pull the piston upward

to the graduation mark corresponding to the quantity in milliliters (ml)

prescribed by the doctor (figure 2).

Remove the oral syringe from the bottle and wipe the body of the syringe with a tissue to remove excess solution (figure 3).

Empty the contents of the syringe onto a spoon or directly into the mouth by pressing the plunger down.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Metformin can cause side effects, although not everybody gets them.

The following side effects may occur:

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

•    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 Metformin. It helps if you spread the doses over the day and if you take the doses with or straight after a meal. If symptoms continue, stop taking Metformin and talk to your doctor.

Common side effects (In less than 1 In 10 users)

•    changes in taste.

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

•    lactic acidosis. This is a very rare but serious complication particularly if your kidneys are not working properly.

Symptoms of lactic acidosis are vomiting, bellyache (abdominal pain) with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. If this happens to you, you may need immediate hospital treatment, as lactic acidosis may lead to coma. Stop taking Metformin immediately and contact your doctor or the nearest hospital straight away.

•    skin reactions such as redness of the skin (erythema), itching or an itchy rash (urticaria).

•    low vitamin B12 levels in the blood.

•    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 this medicine and inform you doctor immediately.

Children and adolescents

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

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

6. FURTHER INFORMATION What Metformin contains

-    The active substance is metformin hydrochloride.

Each 5 ml of solution contain 500 mg of metformin hydrochloride.

-    The other ingredients are: Sodium methyl parahydroxybenzoate (E219), Sodium propyl parahydroxybenzoate (E217), Sodium dihydrogen phosphate dihydrate, Di-sodium hydrogen phosphate anhydrous (E339), Liquid Maltitol (75%) (E965), Acesulfame potassium (E950), Caramel colour (E150b), Peppermint flavour, Peach flavour and Purified Water

What Metformin looks like and contents of the pack

Metformin is a clear brown solution with characteristic odour.

It comes in a brown glass bottle, holding 150 ml of solution, with child resistant screw-cap, along with a 10ml oral syringe.

Marketing Authorisation Holder

Alapis S.A.

2, Aftokratoros Nikolaou str.

17671, Athens, Greece

Manufacturer

PNG Gerolymatos S.A.

Production Site (Plant B’)

4, Asklipiou str., 145 68 Kryoneri,

Athens, Greece

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

Malta:    Metformin Alapis 100 mg/ml Oral solution

G reece:    Metform in/Alapis100mg/miri6oipo 6i6Au pa

Cyprus:    Metformin Alapis 100 mg/ml Oral solution

United Kingdom: Metformin 100 mg/ml Oral solution Bulgaria:    Metformin Alapis 100 mg/ml nepopaneH pasTBOp

Romania:    Metformin Alapis 100 mg/ml Solu(ie orala

Portugal:    Metformina Alapis

Belgium:    Metformin Alapis 100 mg/ml Solution buvable

Metformin Alapis 100 mg/ml Drank

Germany:    Metformin Alapis 100 mg/ml Losung zum Einnehmen

This leaflet was last approved in    00000

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