PACKAGE LEAFLET: INFORMATION FOR THE USER

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Metformin Hydrochloride 500 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 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 side effects not listed in this leaflet . See section 4.

What is in this leaflet:

1.    What Metformin Hydrochloride is and what it is used for

2.    What you need to know before you take Metformin Hydrochloride

3.    How to take Metformin Hydrochloride

4.    Possible side effects

5.    How to store Metformin Hydrochloride

6.    Contents of the pack and other information

A SANDOZ

What Metformin Hydrochloride is and what it is used for

Metformin Hydrochloride is used to treat:

• people with type 2 diabetes, when diet and exercise alone cannot sufficiently control the blood sugar levels. Type 2 diabetes is where insulin production and/or its effects are gradually reduced. Metformin Hydrochloride is used particularly in overweight patients.

-    Adults can use Metformin Hydrochloride on its own or together with other medicines to treat diabetes taken by mouth, or insulin.

-    Children 10 years and over can use Metformin Hydrochloride on its own or together with insulin.

Metformin Hydrochloride belongs to a group of medicines called biguanides, which lower blood sugar levels. It also helps reduce the risk of complications associated with diabetes in overweight adults.

diabetes can

•    overweight

Maintain your calorie controlled diet

•    using other medicines

See “Other medicines and Metformin”.

It is important to do the following regularly:

•    consult your prescribing doctor particularly at the beginning of Metformin Hydrochloride treatment

•    usual blood and urine laboratory tests to manage your diabetes

•    kidney function checks by your doctor at least once a year People 65 years or older and people just within normal kidney function need these checks at least two to four times a year

•    eat meals regularly throughout the day when using Metformin Hydrochloride - See also section 3 under “Method of use”.

Children under 10 years

Metformin Hydrochloride is not recommended for this age group.

What you need to know before you take Metformin Hydrochloride

Do not take Metformin Hydrochloride

Inform your doctor if you are/have:

•    allergic (hypersensitive) to metformin hydrochloride or any of the other ingredients of this medicine (listed in section 6).

•    severe diabetes combined with a condition of too much acid in the blood called ketoacidosis, due to insulin lack. Symptoms of this condition are:

-    stomach pain

-    fast and deep breathing

-    sleepiness or unusual fruity odour to breath

-    rapid weight loss.

This can lead to the preliminary stage of coma.

•    severe diabetes combined with onset of loss of consciousness called diabetic precoma due to blood acidification.

•    kidney problems.

•    liver problems.

•    regularly drink large amounts of alcohol.

•    dehydrated, such as after

-    ongoing or severe diarrhoea, or

-    continuous vomiting.

•    treated for heart failure.

•    recently had a heart attack.

•    severe problems with your circulation.

•    breathing difficulties.

•    severe infection, such as that affecting the lung, lung airways or kidney.

Stop taking Metformin Hydrochloride and inform your doctor immediately if a serious condition called lactic acidosis occurs during therapy. This will particularly affect you if you have reduced kidney function.

Symptoms are:

•    vomiting

•    abdominal pain with muscle cramps

•    generally feeling very tired and unwell

•    difficulty breathing.

Urgent hospital treatment is required to prevent coma onset. Other illnesses, prolonged fasting, poor blood control or alcohol intake can increase the risk of this severe disorder occurring.

Warnings and precautions

Ask your doctor for advice before taking Metformin Hydrochloride if any of the following conditions apply to you:

•    undergoing surgery under general anaesthetic

Your doctor will stop Metformin Hydrochloride treatment 48 hours before. If he decides your kidney function is normal, you can continue taking Metformin Hydrochloride 48 hours after the surgery. It is important that you follow your doctor’s instructions precisely.

Your doctor will decide if you need any other treatment during this time

•    symptoms of blood sugar levels below normal are:

-    weakness

-    dizziness

-    increased sweating

-    rapid heartbeat

-    vision disorders

-    difficulty concentrating

Eat or drink something containing sugar if this occurs. Metformin Hydrochloride alone cannot cause blood sugar levels to decrease too much, however other medicines for

Other medicines and Metformin Hydrochloride

Tell your doctor or pharmacist if you are taking, have recently

taken or might take any other medicines.

The following medicines can influence or be influenced by Metformin Hydrochloride

•    iodinated contrast agents

Your doctor will stop Metformin Hydrochloride therapy

before an X-ray examination if these contrast media are used. If he decides your kidney function is normal, you can continue taking Metformin Hydrochloride 48 hours after the examination. Your doctor will decide if you need any other treatment during this time

•    alcohol containing medicines

•    glucocorticoids (medicines to prevent organ transplant rejection, reduce inflammation such as of the skin or for asthma)

•    medicines, which expand the airways, such as salbutamol, fenoterol and terbutaline

•    If there is a risk of reduced kidney function, your doctor must take particular care administering Metformin Hydrochloride. This applies for example when you are treated with:

-    medicines to treat high blood pressure

-    water pills

-    certain medicines to treat pain, fever and inflammation

Reduced kidney function more commonly occurs in elderly patients

•    medicines to treat high blood pressure, with active substance names ending in “-pril”

•    medicines to lower blood sugar levels such as insulin or those taken orally

Taking these medicines together with Metformin Hydrochloride could cause your blood sugar levels to become too low. See under “Warnings and precautions”.

Metformin Hydrochloride with alcohol

Alcohol increases the risk of the side effect lactic acidosis. It is therefore advisable that you refrain from consuming alcohol.

Pregnancy and breast-feeding

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

•    Pregnancy

If you are pregnant or wish to become pregnant you should not take Metformin Hydrochloride.

Please inform your doctor if this applies as Metformin Hydrochloride should be interrupted and replaced with insulin treatment.

•    Breast-feeding

Do not take Metformin Hydrochloride without first talking to your doctor if you are breast-feeding.

Driving and using machines

•    When Metformin Hydrochloride alone is used to treat diabetes it does not influence the ability to drive or use machines

•    If you use other medicines to treat diabetes in addition to Metformin, your blood sugar level can become too low. This could reduce your ability to drive or use machines. Discuss this with your doctor before driving or operating machinery.

Continued on the next page >>

3 How to take Metformin Hydrochloride

-    weight loss

-    yellowing of the skin or whites of the eyes.

Stop taking Metformin Hydrochloride and tell your doctor straight away if this occurs.

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

Tablets containing 850 mg active substance, metformin hydrochloride are also available for individual dose adjustment.

Adults:

•    The recommended starting dose is: 1 Metformin Hydrochloride 500 mg tablet 2 to 3 times daily.

•    After taking Metformin Hydrochloride for about 2 weeks, your doctor may measure your blood sugar and adjust the dose.

•    Maximum dose: 6 Metformin Hydrochloride 500 mg tablets daily, divided into 3 doses.

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: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How to store Metformin Hydrochloride

Keep out of the sight and reach of children.

Children 10 years and over

•    Usual starting dose: 1 Metformin Hydrochloride 500 mg tablet or 850 mg metformin hydrochloride daily.

•    After the child has taken Metformin Hydrochloride for about 2 weeks, the doctor may measure the blood sugar and adjust the dose.

•    Maximum dose: 4 Metformin Hydrochloride 500 mg tablets daily, divided into 2 or 3 doses.

Patients 65 years and over

The doctor determines the Metformin Hydrochloride dose based on your kidney function, as kidney impairment occurrence is high in this group. See also section 2 under “Warnings and precautions”.

Method of use

Swallow the tablets whole and with a glass of water with or after meals.

Duration of use

To be decided by your attending doctor.

If you take more Metformin Hydrochloride than you should

If you have taken too much Metformin Hydrochloride, contact your doctor or the nearest hospital immediately.

A Metformin Hydrochloride overdose will not cause excessively low blood sugar levels. However, it increases the risk of over-acidification with lactic acid in the blood.

Over-acidification symptoms are listed at the end of sub-chapter “Do not take Metformin Hydrochloride”. Muscle pain with cramps, deep and rapid breathing, loss of consciousness and coma can develop within hours. This requires immediate emergency admission to hospital.

If you forget to take Metformin Hydrochloride

If you forget to take a dose, skip that dose and take your next dose at the next prescribed time.

Do not take a double dose to make up for a forgotten dose.

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

This medicinal product does not require any special storage conditions.

Do not throw away 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 Hydrochloride contains

•    The active substance is metformin hydrochloride.

Each film-coated tablet contains 500 mg metformin hydrochloride equivalent to 390 mg of metformin base.

•    The other ingredients are:

Tablet core:

Povidone K90, magnesium stearate.

Film coating:

hypromellose, macrogol 4000, titanium dioxide.

What Metformin Hydrochloride looks like and contents of the pack

Metformin Hydrochloride 500 mg Film-coated Tablets are round, white, double radius film-coated tablet, embossed “M 500” on one side.

Dimension: 11 mm x 6 mm

Metformin Hydrochloride 500 mg Film-coated Tablets are available in

-    HDPE tablet container with LDPE caps with 30, 60, 100, 250, 330, 400, 500 film-coated tablets

-    PVC aluminium blisters with 28, 30, 50, 56, 60, 84, 90, 100, 120, 180, 250, 270 film-coated tablets.

If you stop taking Metformin Hydrochloride

Stopping Metformin Hydrochloride treatment without your doctor’s consent can cause your blood sugar level to rise uncontrollably. This will increase the risk of long term damage occurring e.g. to the eyes, kidney and vessels.

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

4 Possible side effects

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Sandoz Ltd,

Frimley Business Park, Frimley,

Camberley, Surrey, GU16 7SR, UK.

Manufacturer:

Salutas Pharma GmbH,

Otto-von-Guericke-Allee 1,

39179 Barleben, Germany

or

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

Stop taking Metformin immediately and tell your doctor straight away if you have the following signs of lactic acidosis:

•    vomiting

•    abdominal pain with muscle cramps

•    generally feeling very tired and unwell

•    difficulty in breathing

•    body temperature below normal

•    coma.

See chapter 2, under “Warnings and precautions”.

Other possible side effects

Very common, may affect more than 1 in 10 people:

•    nausea

•    vomiting

•    diarrhoea

•    abdominal pain

•    loss of appetite.

These complaints mainly occur when beginning therapy and spontaneously disappear in most cases. To prevent these complaints take the tablets with or after meals and in 2 to 3 doses daily.

Common, may affect up to 1 in 10 people:

•    change in taste.

Very rare, may affect up to 1 in 10,000 people:

•    reduction in the vitamin B12 uptake in the intestine when treated for a long-term period with Metformin Hydrochloride

•    skin reddening

•    itching

•    itchy rash

•    abnormalities in liver function tests or liver inflammation; this may cause:

-    tiredness

-    loss off appetite

Salutas Pharma GmbH,

Dieselstrasse, 5,

70839 Gerlingen,

Germany

or

LEK S.A.,

Ul. Podlipie 16 C,

95 010 Strykow,

Poland

or

LEK S.A.,

Ul. Domaniewska 50 C,

02-672 Warsaw,

Poland

or

Lek Pharmaceuticals d.d,

Verovskova 57,

1526 Ljubljana,

Slovenia.

This leaflet was last revised on 02/2016

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