U01PSJ1P pesj SpODBLUJBLjd

llllllll

i Focus Pharmaceuticals Ltd

BACK    FRONT

PACKAGE LEAFLET:

INFORMATION FOR THE USER Metformin 100mg/ml Oral Solution

Metformin Hydrochloride 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 get 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 100mg/ml Oral Solution is and what it is used for

2.    Before you take Metformin 100mg/ml Oral Solution

3.    How to take Metformin 100mg/ml Oral Solution

4.    Possible side effects

5.    How to store Metformin 100mg/ml Oral Solution

6.    Further information

What Metformin Oral Solution is used for:

Metformin Oral Solution 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 Oral Solution 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 Oral Solution on its own or together with insulin.

<D-

1. What Metformin 100mg/ml Oral Solution is and what it is used for

Your medicine is called Metformin 100mg/ml Oral Solution (called Metformin Oral Solution throughout the rest of this leaflet).

What Metformin Oral Solution is:

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

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 properly able to use the insulin that it produces. This leads to a high level of glucose in your blood. Metformin Oral Solution helps to lower your blood glucose to as normal a level as possible.

If you are an overweight adult, taking Metformin Oral Solution 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._

2. Before you take Metformin 100mg/ml Oral Solution

Do not take Metformin Oral Solution:

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

•    If you have kidney or liver problems.

•    If you have uncontrolled diabetes, with 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 have lost too much water from your body (dehydration), 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 of lactic acidosis (see 'Take special care with Metformin Oral Solution’ below).

•    If you have a severe infection, such as an infection affecting your lungs, bronchial system or your kidneys. Severe infections may lead to kidney problems, which can put you at risk of lactic acidosis (see 'Take special care with Metformin Oral Solution’ below).

•    If you are being 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 of lactic acidosis (see 'Take special care with Metformin Oral Solution’ 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 an

X-ray or scan, involving the injection of contrast medicines into your bloodstream that contain iodine;

•    you need to have major surgery.

You must stop taking Metformin Oral Solution for a certain period of time before and after the examination or the surgery. Your doctor will decide whether or not you need any other treatment during this period. It is important that you follow your doctor’s instructions precisely.

Take special care with Metformin Oral Solution Please note the following particular risk of lactic acidosis:

Metformin Oral Solution 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, stomach ache (abdominal pain) with muscle cramps, a general feeling of being unwell, with severe tiredness and difficulty in breathing. If this happens to you, you may need immediate treatment in hospital. Stop taking Metformin Oral Solution immediately and contact your doctor or go to the nearest hospital straight away.

Metformin Oral Solution on its own does not cause hypoglycaemia (a blood glucose level which is too low). However, if you take Metformin Oral Solution 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 heartbeat, vision 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 into your bloodstream, that contain iodine, for example for examinations such as an X-ray or scan, you must stop taking Metformin Oral Solution 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 Oral Solution at the same time. You may need more frequent blood glucose tests or your doctor may adjust the dosage of Metformin Oral Solution:

•    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 Oral Solution 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 Oral Solution during breast-feeding. Your doctor will decide whether you should stop breast-feeding whilst you are treated with Metformin Oral Solution.

Driving and using machines

Metformin Oral Solution 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 Oral Solution 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 heartbeat, 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 Oral Solution

This medicine contains:

•    Liquid maltitol (75%) and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Sucrose may also be harmful to teeth.

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

•    Sodium (7mg per 5ml dose). To be taken into consideration by patients on a controlled sodium diet.

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

_(continued overleaf)

m

U0(PSJ!P pBSJ SpOOBLUJBLjd

UOLPSJ1P pBSJ SpOOBLUJBLjd

Hill

Sodium sulfite. This may rarely cause severe hypersensitivity (allergic) reactions and bronchospasm.

Ethanol. This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per 10ml.

■S©~

3. How to take Metformin 100mg/ml Oral Solution

Always take Metformin Oral Solution exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Metformin Oral Solution 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 100mg of metformin in 1ml. 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 Oral Solution is too strong or too weak, talk to your doctor or pharmacist.

Usual dose Adults

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

The maximum daily dose is 3000mg (30ml) taken as 3 divided doses. f you take insulin too, your doctor will tell you how to start taking Metformin Oral Solution.

Elderly: Your doctor may prescribe a different dose. Children over 10 years and adolescents

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

The maximium daily dose is 2000mg (20ml) 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 Oral Solution 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 elderly.

•    Your doctor will also check, at least once a year, how well your kidneys work. You may need more frequent checks if you are elderly or if your kidneys are not working normally.

Directions for opening the bottle and using the syringe

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

Insert the syringe into the bottle.

Whilst holding the bottom ring, pull the piston upwards to the graduation mark corresponding to the quantity in millilitres (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.

Empty the contents of the syringe onto a spoon or directly into the mouth by pressing the plunger down. Close the bottle with the plastic screw cap.

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

If you take more Metformin Oral Solution than you should

If you have taken more Metformin Oral Solution than you should have, you may experience lactic acidosis. Symptoms of lactic acidosis are vomiting, stomach ache (abdominal pain) with muscle cramps, a general feeling of being unwell, with severe tiredness and difficulty in breathing. Contact your doctor or go to the nearest hospital straight away.

If you forget to take Metformin Oral Solution

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 Oral Solution

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.

-&r

4. Possible side effects

Like all medicines, Metformin Oral Solution 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, stomach ache (abdominal pain) and loss of appetite. These side effects most often happen at the beginning of treatment with Metformin Oral Solution. 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 Oral Solution 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, stomach ache (abdominal pain) with muscle cramps, a general feeling of being unwell, 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 Oral Solution immediately and contact your doctor or go to 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 your 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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

Once the medicine is opened, use within 28 days. Do not use after the expiry date which is stated on the bottle label and carton. The expiry date refers to the last day of that month.

Do not use Metformin Oral Solution 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.

<D-

<D-

5. How to store Metformin 100mg/ml Oral Solution

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

Do not store above 25°C.

6. Further information

What Metformin Oral Solution contains

The active substance is metformin hydrochloride. Each 1ml of solution contains 100mg 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) (containing sucrose and sodium sulfite (E221)), Peppermint flavour, Peach flavour (containing ethanol) and Purified water. What Metformin Oral Solution looks like and contents of the pack

Metformin Oral Solution is a clear brown solution with characteristic odour.

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

Marketing Authorisation Holder

Focus Pharmaceuticals Ltd., Capital House, 1st

Floor, 85 King William Street, London EC4N 7BL

United Kingdom

Tel: 00 44 (0)1283 495280

Fax: 00 44 (0)1283 495290

Email: medinfo@focuspharma.co.uk

Manufacturer

Farmasierra Manufacturing, S.L.

Ctra. de Irun, Km 26,200,

28709 San Sebastian de los Reyes (Madrid), Spain

For any information about this medicinal product please contact the Marketing Authorisation Holder details provided above.

For information in large print, audio CD or Braille please telephone 00 44 (0)1283 495 280 or email medinfo@focuspharma.co.uk.

This leaflet was last revised in 06/2015.

_

uoipajip peej epoDewjeqd