Package leaflet: Information for the user

Metformin Colonis 1000mg/5ml Oral Solution

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 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 Metformin Oral Solution is and what it is used for

2.    What you need to know before you take Metformin Oral Solution

3.    How to take Metformin Oral Solution

4.    Possible side effects

5.    How to store Metformin Oral Solution

6.    Contents of the pack and other information

1. What Metformin Oral Solution is and what it is used for

■    Metformin Colonis 1000mg/5ml Oral Solution (referred to as Metformin Oral Solution in this leaflet) contains metformin hydrochloride, a medicine to treat diabetes. It belongs to a group of medicines called biguanides.

■    After you have eaten, your body converts the carbohydrates and sugar in your food into glucose, which travels in your blood to where it is needed. Insulin is a hormone produced in your pancreas which moves the glucose from your blood into your body’s cells where it is used as energy (fuel)

■    If you have type 2 diabetes, your pancreas does not make enough insulin or your body is not able to use properly the insulin it produces, (known as insulin resistance). This leads to

high levels of glucose in your blood. Metformin Oral Solution helps to lower your blood glucose to as normal a level as possible.

■    This medicine is used to treat patients with type 2 diabetes (also called ‘noninsulin dependent diabetes’) when diet and exercise alone have not been enough to control your blood glucose levels. It is often used in overweight patients.

■    If you are an overweight adult, taking this medicine over a long period of time can also help lower the risk

of complications associated with diabetes. This medicine is associated with either a stable body weight or modest weight loss.

■    Adults can take this medicine on its own or together with other medicines to treat diabetes or with insulin.

■    Adolescents and children aged 10 years and over can take this medicine on its own or together with insulin.

2. What you need to know before you take Metformin Oral Solution

Do not take Metformin Oral Solution

■    if you are allergic (hypersensitive) to metformin hydrochloride or any of the other ingredients of this medicine (listed in section 6)

■    if you have uncontrolled diabetes, with e.g. severe hyperglycaemia (high levels of blood glucose in your blood), nausea (feeling sick), vomiting (being sick), dehydration or rapid weight loss

■    if you have symptoms of a condition called ketoacidosis in which substances called ‘ketone bodies’ accumulate in the blood and can lead to diabetic pre-coma (unconsciousness). Symptoms include stomach pain, fast and deep breathing, sleepiness and unusual fruity odour of the breath (likened to the smell of pear drops)

■    if you have moderate or severe liver or kidney problems

■    if you become dehydrated (when ou lose too much water from your ody), due to long-lasting or severe

diarrhoea, or if you have been sick several times in a short space of time. Dehydration may lead to kidney problems, which can put you at risk of lactic acidosis (see ‘Warnings and precautions’)

■    if you have a severe infection,

such as an infection affecting your lungs, airways or your kidneys.

Severe infections may lead to kidney problems, which can put you at risk of lactic acidosis (see ‘Warnings and precautions’ and Section 4 Possible side effects)

■    if you are treated for acute heart failure or have recently had a heart attack, have severe problems with

our circulation (such as shock) or ave breathing difficulties. This may lead to a lack of oxygen in your body tissues which can put you at risk of lactic acidosis (see “Warnings and precautions”)

■    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.

Warnings and precautions

■    Metformin Oral Solution may cause a very rare, but very serious complication called lactic acidosis, particularly if your kidneys are not working properly

(kidney function may worsen when starting medication for high blood pressure, water retention and when starting treatment with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).

■    The risk of developing lactic acidosis is also increased with:

■    uncontrolled diabetes

■    prolonged fasting or alcohol intake

■    loss ofbody fluid (dehydration) due to severe diarrhoea or vomiting (being sick)

■    liver problems

■    any medical conditions in which a region of the body is deprived of oxygen (such as acute severe heart diseases).

■    It is important you take your medication as prescribed, follow dietary instructions and keep up your regular exercise program because these measures can reduce the risk of lactic acidosis.

■    The onset of lactic acidosis can be

subtle and the symptoms can be nonspecific such as:

■    being sick (vomiting)

■    stomach ache (abdominal pain) with muscle cramps

■    a general feeling of not being well with severe tiredness

■    difficulty in breathing

■    further symptoms are reduced body temperature and heartbeat.

If you experience some of these symptoms, stop taking this medicine and seek medical attention immediately.

■    Talk to your doctor or pharmacist before using Metformin Oral Solution if:

■    you need to have a diagnostic examination such as X-ray or scan involving the injection of contrast dyes that contain iodine into your bloodstream

■    you need to have surgery in which you will be given an anaesthetic (put to sleep).

You must stop taking Metformin Oral Solution for a certain period of time before and after the examination or surgery. Your doctor will tell you what you need to do and will decide whether you need any other treatments during this time. It is important that you follow your doctor’s instructions precisely.

■    On its own this medicine does not cause hypoglycaemia (a condition when your blood glucose levels become too low). However, if you take Metformin Oral Solution together with other medicines used to treat diabetes (such as sulphonylureas, insulin, meglitinides), there is a risk of hypoglycaemia. If you experience symptoms such as weakness, dizziness, increased sweating, fast heart beating, vision disorders or difficulty in concentration, it usually helps to eat or drink something containing sugar.

Children aged 10 and over and adolescents

■    This medicine may be used in children aged 10 and over either by itself or in combination with insulin.

■    Regular monitoring of children taking this medicine is recommended

Other medicines and Metformin Oral Solution

■    If you need to have an injection of a contrast dye medicine that contains iodine for a diagnostic examination such as an X-ray or scan, you will need to stop taking Metformin Oral Solution for a period of time both before and after the examination (at least 48 hours). It is important that you discuss this with your doctor beforehand.

■    Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those bought without a prescription.

■    You may need more frequent blood glucose tests or your doctor may adjust the dosage of Metformin Oral Solution if you are taking or have recently taken:

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

■    beta-2 agonists such as salbutamol or terbutaline (used to treat asthma)

■    corticosteroids such as prednisolone (used to treat a variety of conditions including asthma and inflammation)

■    other medicines used to treat diabetes

■    Non-Steroidal Anti-Inflammatories (NSAIDS) such as diclofenac (used to treat inflammation)

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

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

■    During pregnancy, you need to use insulin to treat your diabetes rather than Metformin Oral Solution. Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby, so that they can 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

■    Taken on its own this medicine does not cause hypoglycaemia (a condition where your blood glucose levels become too low). This means that it will not affect your ability to drive or use machines.

■    If this medicine is taken with insulin or other medicines used to treat diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin and meglitinides), it is possible that their combined effects may make you feel faint or dizzy. Other symptoms

of hypoglycaemia include weakness, increased sweating, fast heartbeat, vision disorders and difficulty concentrating. If you experience any of these symptoms do not drive or operate machinery until you feel better.

Important information about some of the ingredients of Metformin Oral Solution

This medicine contains Sodium propyl parahydroxybenzoate (E217) which may cause allergic reactions (possibly delayed)

3. How to take Metformin Oral Solution

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

Metformin Oral Solution cannot replace the benefits of a healthy lifestyle. You should continue to follow any advice about diet that your doctor has given you and take regular exercise.

Recommended dose

Children and adolescents aged 10 years and over

■    The recommended starting dose for children is either 500mg (2.5ml)

or 850mg (4.25ml) Metformin Oral Solution once a day.

■    The maximum daily dose is 2000mg (10ml) 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 knowledge of the effects of this medicine in this age group is limited.

Adults

■    The recommended starting dose for adults is either 500mg (2.5ml) or 850mg (4.25ml) Metformin Oral Solution two or three times a day.

■    The maximum daily dose is 3000mg (15ml) taken as 3 divided doses.

Adults with kidney problems

■    The recommended starting dose for adults with kidney impairment is 500mg (2.5ml) or 850mg (4.25ml) Metformin Oral Solution once a day.

■    The um dose is 1000mg (5ml) daily, given as 2 divided doses.

■    Kidney function should be closely monitored every 3 - 6 months

If you also take insulin your doctor will give you advice about how to take this medicine with your insulin.

Monitoring

■    Your doctor will perform regular blood glucose tests and 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 an older person.

■    Your doctor will also check how well your kidneys are working at least once a year. You may need more frequent checks if you are an older person or if your kidneys are not working normally.

Directions for use

■    Always take this medicine with or after a meal. This may help you avoid having some of the side effects

■    If you take one dose a day, take it in the morning (breakfast)

■    If you have been advised to take two doses a day, take them in the morning (breakfast) and evening (dinner)

■    If you have been advised to take three 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 this medicine is too strong or too weak, talk to your doctor or pharmacist

■    Use either the graduated 10ml dosing spoon provided or the syringe (using the instructions below) to administer the correct dose

Method of administration

Metformin Oral Solution is for oral use only. A graduated oral syringe and a Press-In Bottle Adapter (PIBA) are provided with the product. The press in bottle adapter must be used only if the product is administered by the use of the oral syringe.

1.    Open the bottle by pressing down on the child-resistant cap very firmly and turning it anti-clockwise. At first use insert the Press-In Bottle Adapter (PIBA) firmly into the neck of the bottle ensuring that it fits well enough to prevent any spillages.

2.    Insert the syringe into the PIBA opening.

3.    Turn the bottle upside down and fill the syringe with a small amount of solution by pulling the plunger down.

4.    Push the plunger back up to remove any possible bubbles.

5.    Pull the plunger down to the graduation mark corresponding to the quantity inml prescribed by your doctor.

6.    Remove the filled syringe from the bottle in the upright position.

7.    Discharge the syringe contents into the mouth. Repeat steps 2 to 7 as needed to achieve the required dose prescribed by your doctor.

8.    Rinse the syringe and replace the cap on the bottle (PIBA remains in place). Let the syringe dry before using again.

Note

If necessary, Metformin Oral Solution can be administered via a gastric, duodenal, and nasal feeding tube, that should be rinsed twice with 10ml of water immediately after administration.

If you take more Metformin Oral Solution than you should

If you have taken more Metformin Oral Solution that you should have, you may experience lactic acidosis, (see Section 4 Possible side effects). This is a very serious medical condition and you should stop taking this medicine and seek medical advice immediately because it can lead to a diabetic coma.

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 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.

Stop taking Metformin Oral Solution and see a doctor or go to a hospital straight away if you experience any of these very rare side effects (may affect up to 1 in 10,000 people)

■ Lactic acidosis: lactic acidosis is a very rare side effect (may affect up to 1 in 10,000 people) but is a very serious complication particularly if your kidneys are not working properly. Lactic acidosis can be subtle and the symptoms can be non-specific such as:

■    being sick

■    stomach ache (abdominal pain) with muscle cramps

■    a general feeling of not being well with severe tiredness

■    difficulty in breathing

■    reduced body temperature (hypothermia)

■    slower heartbeat

If you experience these symptoms, you should seek medical advice immediately, because lactic acidosis may lead to diabetic coma, even if you have not had problems with this medicine before.

■    Liver function: abnormalities in liver function tests or hepatitis (inflammation of the liver).

This may cause:

■    tiredness

■    loss of appetite

■    weight loss

■    possible yellowing of your skin or the whites of your eyes

If this happens to you, stop taking Metformin Oral Solution and talk to your doctor straight away.

Very Common Side effects

(may affect more than 1 in 10 people) These side effects happen most often at the beginning of treatment with Metformin Oral Solution. It helps if you spread the doses out over the day and if you take this medicine with or straight after a meal. If symptoms continue, stop taking Metformin Oral Solution and talk to your doctor

■    feeling or being sick

■    diarrhoea

■    stomach ache (abdominal pain)

■    loss of appetite 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 levels of vitamin B12 in the blood which may cause anaemia

Children and adolescents

Limited data in children and adolescents showed that side effects 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Metformin Oral Solution

Keep this medicine out of the sight and reach of children. If this medicine is intended for use in a child, administration of the medicine should be supervised by an adult.

■    Do not store above 25°C

■    Do not use this medicine after the expiry date which is stated on the bottle and carton after ‘EXP’.

The expiry date refers to the last day of that month.

■    Once the bottle has been opened, this medicine should be used within 2 months

■    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 protect the environment.

6. Contents of the pack and other information

What Metformin Oral Solution contains

■    The active substance is metformin hydrochloride. Each 5ml oral solution contains 1000mg of metformin hydrochloride.

■    The other ingredients are:

■    Sodium propyl parahydroxybenzoate (E217),

■    Sodium dihydrogen phosphate dihydrate (E 339)

■    Disodium phosphate anhydrous (E 339)

■    Sucralose

■    Peach flavour (contains propylene glycol and ethanol)

■    Sodium hydroxide (for pH adjustment)

■    Purified water.

What Metformin Oral Solution looks like and contents of the pack

Metformin Oral Solution is a clear, colourless solution with a peach flavour, filled into 150ml or 300ml, amber glass bottles fitted with a child-resistant, tamper-evident screw cap. (Not all pack sizes may be marketed)

A 5ml LDPE oral syringe with intermediate graduations of 0.25ml and a graduated dosing spoon of 10ml are also included in the package.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Colonis Pharma Limited Hanover Place, 8 Church Road Royal Tunbridge Wells Kent TN11JP United Kingdom

Manufacturer:

Rafarm SA Thesi Pousi-Xatzi,

Agiou Louka,

Paiania Attiki,

TK19002,

TO 37,

Greece

Or

Saneca Pharmaceuticals, a.s.

Nitrianska 100 920 27 Hlohovec Slovak Republic

Marketed and Distributed by:

Quantum Pharmaceutical Hobson Industrial Estate Burnopfield County Durham NE16 6EA United Kingdom

This leaflet was last revised in July 2016

A Quantum

Pharmaceutical

K0000    a Quantum pharma group company