Microsoft word - metformine hcl pfizer common pl

PACKAGE LEAFLET: INFORMATION FOR THE USER
Metformin HCl Pfizer 500 mg film-coated tablets
Metformin HCl Pfizer 850 mg film-coated tablets
Metformin HCl Pfizer 1000 mg film-coated tablets

Read all of this leaflet carefully before you start taking this medicine.
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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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. 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.
In this leaflet:
1. What Metformin HCl Pfizer is and what it is used for
2. Before you take Metformin HCl Pfizer
3. How to take Metformin HCl Pfizer
4. Possible side effects
5. How to store Metformin HCl Pfizer
6. Further
WHAT METFORMIN HCl PFIZER IS AND WHAT IT IS USED FOR

What Metformin HCl Pfizer is
Metformin HCl Pfizer 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 able to use properly
the insulin it produces. This leads to a high level of glucose in your blood. Metformin HCl Pfizer helps to
lower your blood glucose to as normal a level as possible.
If you are an overweight adult, taking Metformin HCl Pfizer over a long period of time also helps to lower
the risk of complications associated with diabetes.
What Metformin HCl Pfizer is used for
Metformin HCl Pfizer 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 HCl Pfizer 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 HCl Pfizer on its own or together with
insulin.

2.
BEFORE YOU TAKE METFORMIN HCl PFIZER

Do not take Metformin HCl Pfizer
 if you are allergic (hypersensitive) to metformin or any of the other ingredients of this medicine (see 'What Metformin HCl Pfizer contains' in section 6)  if you have kidney or liver problems  if you have uncontrolled diabetes, such as severe hyperglycaemia 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 HCl Pfizer' 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 HCl Pfizer' below).  if you are treated for heart failure or have recently had a heart attack, have severe problems with your circulation 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 HCl Pfizer' below)  if you drink a lot of alcohol  if you are breast-feeding 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 HCl Pfizer 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 HCl Pfizer
Metformin HCl Pfizer may cause a very rare, but serious complication called lactic acidosis, 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 treatment. Stop taking Metformin HCl
Pfizer immediately and tell your doctor straight away.
Metformin HCl Pfizer on its own does not cause hypoglycaemia (a blood glucose level which is too low).
However, if you take Metformin HCl Pfizer together with other medicines to treat diabetes that can cause
hypoglycaemia (such as sulphonylureas, insulin, glinides), 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 HCl Pfizer 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 HCl Pfizer at the same time.
You may need more frequent blood glucose tests or your doctor may adjust the dosage of Metformin HCl
Pfizer:
 angiotensin-converting enzyme inhibitors (used to treat a variety of heart and blood vessel conditions,
such as high blood pressure or heart failure)  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 (used to treat a variety of conditions, such as severe inflammation of the skin or in 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 HCl Pfizer 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.
Do not take this medicine if you are breast-feeding or if you are planning to breast-feed your baby.
Driving and using machines
Metformin HCl Pfizer 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 HCl Pfizer together with other medicines to treat
diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin, glinides). 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.
3.
HOW TO TAKE METFORMIN HCl PFIZER

Always take Metformin HCl Pfizer exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
Metformin HCl Pfizer 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.
Usual dose
Children 10 years and over and adolescents usually start with 500 mg or 850 mg Metformin HCl Pfizer
once a day. The maximum daily dose is 2000 mg 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.
Adults usually start with 500 mg or 850 mg Metformin HCl Pfizer two or three times a day. The maximum
daily dose is 3000 mg taken as 3 divided doses.
If you take insulin too, your doctor will tell you how to start Metformin HCl Pfizer.
Monitoring
 Your doctor will adapt your dose of Metformin HCl Pfizer 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.
How to take Metformin HCl Pfizer
Take the tablets with or after a meal. This will avoid you having side effects affecting your digestion.
Do not crush or chew the tablets. Swallow each tablet with a glass of water.
The 1000 mg tablet has a scoreline which can help you break the tablet to make it easier to swallow. The
scoreline is not intended to divide the tablet into equal doses.
 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
If, after some time, you think that the effect of Metformin HCl Pfizer is too strong or too weak, talk to your
doctor or pharmacist.

If you take more Metformin HCl Pfizer than you should
If you have taken more Metformin HCl Pfizer that 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. Talk to your doctor or
pharmacist straight away.
If you forget to take Metformin HCl Pfizer
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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Metformin HCl Pfizer 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 people)
 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 HCl Pfizer. It helps if you spread the doses over the day and if you take the
tablets with or straight after a meal. If symptoms continue, stop taking Metformin HCl Pfizer and
talk to your doctor.

Common side effects (in less than 1 in 10 people)
 changes in taste.

Very rare side effects (in less than 1 in 10,000 people)
 lactic acidosis. This is a very rare but serious complication particularly if your kidneys are not working properly. If you get this complication, you will need immediate treatment.
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,
stop taking Metformin HCl Pfizer immediately and tell your doctor straight away.
 skin reactions such as redness of the skin (erythema), itching or an itchy rash (urticaria).
 low vitamin B12 levels in the blood.

The frequencies of the following side effects are not known:
 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.

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.
5.
HOW TO STORE METFORMIN HCl PFIZER

Keep out of the reach and sight of children. If a child is treated with Metformin HCl Pfizer, parents and
caregivers are advised to oversee how this medicine is used.
This medicinal product does not require any special storage conditions.
Do not use Metformin HCl Pfizer after the expiry date which is stated on the carton, blister or the bottle
after 'EXP'. The expiry date refers to the last day of that month.
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.
6.
FURTHER INFORMATION

What Metformin HCl Pfizer 500 mg/ 850 mg/ 1000 mg contains

- The active substance is metformin; this is present in the form of metformin hydrochloride.
Metformin HCl Pfizer 500 mg:
Each film-coated tablet contains 500 mg metformin hydrochloride corresponding to 390 mg metformin.
Metformin HCl Pfizer 850 mg:
Each film-coated tablet contains 850 mg metformin hydrochloride corresponding to 663 mg metformin.

Metformin HCl Pfizer 1000 mg:
Each film-coated tablet contains 1000 mg metformin hydrochloride corresponding to 780 mg metformin.
- The other ingredients are:
Tablet core: Povidone, magnesium stearate.
Film-coating: Hypromellose, macrogol 400 & macrogol 6000.
What Metformin HCl Pfizer 500 mg/ 850 mg/ 1000 mg looks like and contents of the pack

Film-coated tablet.

Metformin HCl Pfizer 500 mg:
White, round, biconvex, film-coated tablets with ‘A’ debossed on one side and ‘60’ debossed on the other
side.
Metformin HCl Pfizer 850 mg:
White, round, biconvex, film-coated tablets with ‘A’ debossed on one side and ‘61’ debossed on the other
side.
Metformin HCl Pfizer 1000 mg:
White, oval, biconvex, film-coated tablets with a scoreline between ‘6’ and ‘2’ on one side and ‘A’
debossed on the other. The scoreline is only to facilitate breaking for ease of swallowing and not to divide
into equal doses.

Metformin HCl Pfizer 500 mg/ 850 mg/ 1000 mg is packed in a blister pack. Metformin HCl Pfizer 500mg
is also packed in a HDPE bottle.

Metformin HCl Pfizer 500 mg:
Each box contains 20/28/30/40/42/50/56/60/70/80/84/90/98/100/120/200/300/400 film-coated tablets in
blister packs. Each HDPE bottle contains 400 film-coated tablets. The bottle also contains a sachet which
should not be eaten. It is included to help maintain the quality of the product.
Metformin HCl Pfizer 850 mg:
Each box contains 20/28/30/40/42/50/56/60/70/80/84/90/98/100/120/200/300/400 film-coated tablets in
blister packs.
Metformin HCl Pfizer 1000 mg:
Each box contains 20/30/40/50/60/70/80/90/100/120/180 film-coated tablets in blister packs.

Not all pack sizes may be marketed.
Marketing Authorisation Holder
[To be completed nationally]
Manufacturer
[To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following names:
Austria
Metformin Pfizer 500 mg, 850 mg & 1000 mg Filmtabletten Metformine Pfizer 850 mg comprimés pelliculés Metformin Pfizer 500 mg, 850 mg & 1000 mg kalvopäällysteiset tabletit Metformine Pfizer 500 mg, 850 mg & 1000 mg, comprimé pelliculé Metformin Pfizer 500 mg, 850 mg & 1000 mg Filmtabletten Metformin Pfizer 500 mg, 850 mg & 1000 mg potahované tablety Metformin Pfizer 500 mg, 850 mg & 1000 mg film-coated tablets Metformine Pfizer 850 mg comprimés pelliculés Metformine HCl Pfizer 500mg, 850 mg & 1000 mg filmomhulde tabletten Metformina Pharmacia 850 mg comprimidos recubiertos con película Metformin 500 mg, 850 mg and 1000 mg film-coated tablets
This leaflet was last approved in {MM/YYYY}.
[To be completed nationally]

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