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METFORMIN HYDROCHLORIDE 500 MG FILM COATED TABLETS

Active substance(s): METFORMIN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Metformin Hydrochloride 500 mg Film-coated Tablets

SZ00000LT000

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

1

diabetes can
• overweight
Maintain your calorie controlled diet
• using other medicines
See “Other medicines and Metformin”.

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.

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”.

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.

2

Children under 10 years
Metformin Hydrochloride is not recommended for this age
group.

Other medicines and Metformin Hydrochloride
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.

What you need to know before you take
Metformin Hydrochloride

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”.

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.

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.

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

• 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 >>

Artwork Proof Box
Ref: V033: Addition of new pack size
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Date prepared:
03/02/2016

Colours:
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Dimensions: 165 x 360 mm

Font size:
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3

- weight loss
- yellowing of the skin or whites of the eyes.
Stop taking Metformin Hydrochloride and tell your doctor straight
away if this occurs.

How to take Metformin Hydrochloride

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.

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.

5

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.

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.

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.

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”.

6

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

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.

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.

Film coating:
hypromellose, macrogol 4000, titanium dioxide.

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.

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 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.

Not all pack sizes may be marketed.

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.

Marketing Authorisation Holder and Manufacturer:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

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

4

How to store Metformin Hydrochloride

Manufacturer:
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1,
39179 Barleben, Germany

Possible side effects

or

Salutas Pharma GmbH,
Dieselstrasse, 5,
70839 Gerlingen,
Germany

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”.

or

LEK S.A.,
Ul. Podlipie 16 C,
95 010 Strykow,
Poland
or

Other possible side effects

LEK S.A.,
Ul. Domaniewska 50 C,
02-672 Warsaw,
Poland

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.

or

Lek Pharmaceuticals d.d,
Verovskova 57,
1526 Ljubljana,
Slovenia.

This leaflet was last revised on 02/2016

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

SZ00000LT000

Artwork Proof Box
Ref: V033: Addition of new pack size
Proof no.
007.0

Date prepared:
03/02/2016

Colours:
Black
Dimensions: 165 x 360 mm

Font size:
7pt
Fonts:
Helvetica

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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