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METFORMIN HYDROCHLORIDE TABLETS 500MG

Active substance(s): METFORMIN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Metformin Hydrochloride 500mg Tablets
(Metformin Hydrochloride)
Read all of this leaflet carefully before you start taking this medicine because it contain
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 is and what it is used for
2. What you need to know before you take Metformin
3. How to take Metformin
4. Possible side effects
5. How to store Metformin
6. Contents of the pack and other information
1 What Metformin is and what it is used for
Metformin belongs to a group of medicines called biguanide anti−hyperglycaemic agents. It works by
lowering your blood−sugar level. Metformin may be used alone or in combination with other medicines
to treat diabetes (oral or insulin).
Metformin is used:
 To treat non−insulin dependent diabetes (also called type 2 diabetes) where diet and exercise
alone has failed to control blood sugar levels, particularly if overweight.
 As the only treatment or in combination with insulin, for children aged from 10 years and
adolescents.
 As an initial treatment to reduce complications associated with type 2 diabetes (non-insulin
dependent diabetes), if you are an overweight adult and diet has failed to control your blood sugar
levels.
 Insulin-dependent diabetes, where the symptoms are poorly controlled.
2 What you need to know before you take Metformin
Do not take Metformin if:
 You are allergic to Metformin or any of the other ingredients of this medicine (listed in section 6).
 You suffer from kidney or liver problems.
 You suffer from or have a history of serious diabetic complications such as loss of consciousness
caused by either very high or very low blood sugar levels (diabetic coma), a lack of insulin which
leads to high blood sugar levels, ketones in the urine and certain acids in the blood (ketoacidosis).
 You suffer from conditions which may cause a lack of oxygen supply to your body tissue (hypoxia)
such as sudden heart failure (even if the condition is under control), insufficient oxygen passes
from your lungs to your blood (respiratory failure), you have recently had a heart attack or have
severe problems with your circulation such as shock.
 You regularly drink a lot of alcohol.
 You have a severe infection.
 You suffer from a loss or lack of water in the body (dehydration).
 You have a severe disease of the blood vessels.
Warnings and precautions
Talk to your doctor before taking Metformin if:
 You are at risk of a build-up of lactic acid in the blood (lactic acidosis). Metformin may cause a
very rare, but serious complication called lactic acidosis, particularly if your kidneys are not
working properly. The risk of developing lactic acidosis is also increased with uncontrolled
diabetes, prolonged fasting, excessive alcohol intake, dehydration, liver problems and any
conditions where an area of the body is deprived of oxygen (such as heart failure or sudden heart









attack). Symptoms of lactic acidosis can include being sick (vomiting), stomach pain, muscle
cramps, a general feeling of not being well, severe tiredness, difficulty in breathing, reduced body
temperature and heartbeat. If you experience any of these symptoms, you should seek
immediately medical advice immediately as lactic acidosis may lead to coma.
You are to undergo diagnostic tests (using iodinated contrast media). You may need to stop
taking your Metformin.
You continuously use Metformin. It may reduce your vitamin B12 level and should be annually
monitored by your doctor.
You suffer from kidney problems, particularly if you are elderly.
You suffer from stable chronic heart failure.
You are due to have surgery as you must stop taking your Metformin 48 hours before having an
anaesthetic.
This medicine is intended for a child.
You are taking insulin or other oral antidiabetic medicines e.g. sulfonylureas or meglitinides (see
“Other medicines and Metformin” section) as there is a risk of low blood sugar levels
(hypoglycaemia).

Other medicines and Metformin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those obtained without prescription. This includes herbal medicines.
Other medicines which may interact with or be affected by Metformin:
 Cimetidine, for stomach ulcers and indigestion.
 Medicines to prevent clotting of the blood, such as warfarin (anticoagulants).
 Medicines for high blood pressure, such as captopril (ACE inhibitors).
 Medicines for depression, such as moclobemide (MAO inhibitors).
 Diazoxide, for high blood pressure (antihypertensives).
 Medicines for lowering high blood pressure, such as propanolol (beta−blockers).
 Medicines for inflammatory and allergic conditions, such as beclometasone (glucocorticoids).
 Medicines used to treat life-threatening allergies (anaphylaxis) such as epinephrine
(sympathomimetics).
 Oral contraceptives.
 Medicines for fluid retention, such as bumetanide (diuretics).
 Medicines for high cholesterol, such as ezetimibe (clofibrates).
 Other medicines for diabetes such as glibenclamide (sulfonylureas) or insulin (antidiabetics).
Taking Metformin with food and drink and alcohol
 These tablets should be taken with or after food.
 You should continue your diet, ensuring a regular intake of carbohydrates throughout the day. If
you are overweight, you should continue with your energy-restricted diet.
 Alcohol and alcohol-containing medicines should be avoided whilst taking Metformin .
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 for advice before taking this medicine.
Pregnancy
If you are pregnant, it is recommended that your diabetes is treated with insulin instead of Metformin.
Breast-feeding
If you are breast-feeding, the use of this medicine is not recommended as Metformin is passed into
breast milk.
Driving and using machines
Metformin should not affect your ability to drive or operate machinery. However, there is a risk of low
blood sugar levels (hypoglycaemia) when Metformin is taken in combination with other antidiabetic
medicines e.g. sulfonylureas, insulin or meglitinides (see “Other medicines and Metformin” section).
Metformin contains lactose

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor
before taking this product.
3 How to take Metformin
Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.




These tablets are to be taken orally.
These tablets should be taken with or after food.
The score line is only there to help you break the tablet if you have difficulty swallowing it whole.

Adults
 The recommended starting dose is 500mg or 850mg two or three times a day.
 After 10-15 days, your dose should be adjusted according to your blood sugar levels.
 The maximum dose is 3000mg per day, taken in 3 divided doses.
 If you are transferring from another oral medicine used to treat diabetes to Metformin, the other
medicine must be stopped before starting treatment with Metformin.
 Metformin may be taken in combination with insulin. Your dose of insulin will be adjusted
according to your blood sugar levels.
Elderly
Your doctor will monitor your condition if you have kidney problems and adjust your dose of Metformin
accordingly.
Patients with kidney problems
 The recommended starting dose is 500mg or 850mg once a day.
 The maximum dose is 1000mg per day, taken as 2 divided doses.
 Your kidney function should be monitored every 3-6 months.
Use in children
 Metformin can be used as the only treatment or in combination with insulin, for children aged from
10 years and adolescents.
 The recommended starting dose is 500mg or 850mg once a day.
 After 10-15 days, your dose should be adjusted according to your blood sugar levels.
 The maximum recommended dose is 2000mg per day, taken as 2 or 3 divided doses.
If you have taken more Metformin than you should
If you accidentally take too many tablets, contact your doctor or nearest hospital emergency
department immediately for advice. Remember to take this leaflet or any remaining tablets with you.
An overdose of Metformin may lead to a build-up of lactic acid in the blood (lactic acidosis) (see
Section 2, “Warnings and precautions”).
If you forget to take your Metformin
Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do
not take a double dose to make up for a forgotten dose.
If you stop taking Metformin
It is important that you keep taking Metformin for as long as your doctor has told you to
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4 Possible side effects
Like all medicines, Metformin can cause side effects, although not everybody gets them.
Seek medical advice immediately if you develop the following symptoms:
 Allergic reactions: swelling of the face, throat or tongue, difficulty breathing or dizziness
 A build-up of lactic acid in the blood (lactic acidosis) (see Section 2, “Warnings and precautions”)
Very common side effects (may affect more than 1 in 10 people)

 Feeling sick (nausea) or being sick (vomiting)
 Diarrhoea
 Stomach pain
 Loss of appetite
These side effects usually occur at the start of treatment and are of short duration. They may be
avoided by taking Metformin in 2 or 3 daily doses with or after food.
Common side effects (may affect up to 1 in 10 people)
 Taste disturbances
Very rare side effects (may affect less than 1 in 10,000 people)
 Decreased vitamin B12 absorption
 Abnormal liver function tests (resolves after stopping treatment with Metformin)
 Skin rashes (erythema)
 Severe itching (pruritus)
 Skin rashes with the formation of wheals (urticaria)
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 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.
5 How to store Metformin
 Keep this medicine out of the sight and reach of children.
 Do not take Metformin after the expiry date, which is stated on the carton/blister after EXP. The
expiry date refers to the last day of that month.
 Do not store above 25C.
 Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help to protect the
environment.
6 Contents of the pack and other information
What Metformin contains:
Each film-coated tablet contains 500mg of Metformin Hydrochloride.
The other ingredients are: microcrystalline cellulose, sodium starch gylcollate (type A), povidone
k−28, colloidal anhydrous silica, magnesium stearate, ethanol 96% and purified water.
Film coating is: opadry white OY−L−28900 consisting of lactose monohydrate,
methylhydroxypropylcellulose, titanium dioxide (E171), polyethylene glycol 4000 and purified water.
What Metformin looks like and content of the pack:
Metformin 500mg are white, oblong, biconvex, film−coated, tablets with a score notch on both sides
and marked M500 on one side.
Metformin is available in:
Metformin Tablets are available in packs of 28, 30, 56, 84 or 120 tablets.
Not all pack sizes may be marketed.
Product Licence Number:
PL 11311/0466
Marketing Authorisation Holder and Manufacturer:
Tillomed Laboratories Ltd
3 Howard Road
Eaton Socon,
St Neots
Cambridgeshire

PE19 8ET
United Kingdom
This leaflet was last revised in September 2016
Till-Ver.2.2s

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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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