Document: leaflet MAH GENERIC_PL 11311-0096 change

• leaflet MAH GENERIC_PL 11311-0096
• leaflet MAH GENERIC_PL 11311-0467

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PATIENT INFORMATION LEAFLET

Metformin Hydrochloride 850mg Tablets

(Metformin Hydrochloride)_

H What Metformin Hydrochloride is and what it is used for

Metformin Hydrochloride 850mg Tablets (also referred to as Metformin Hydrochloride throughout this leaflet) belong to a group of medicines called biguanide oral anti-hyperglycaemic agents. It works by lowering your blood-sugar level.

If your blood sugar levels are not controlled, it can lead to serious problems such as kidney damage, amputations and blindness. Metformin Hydrochloride is thought to work by decreasing the amount of sugar absorbed from food through the stomach, by helping the body respond better to the insulin it makes naturally and by decreasing the amount of sugar produced by the liver and kidneys.

Metformin Hydrochloride is used to treat non-insulin dependent diabetes (also called type 2 diabetes) when an improvement in diet and exercise has failed to reduce blood sugar levels, particularly if overweight.

It may be used alone as initial therapy or along with other oral antidiabetic drugs or with insulin.

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

Sometimes Metformin Hydrochloride is also used to treat patients suffering from insulin dependent diabetes, who are overweight (obese) and whose symptoms are poorly controlled.

Do not take Metformin Hydrochloride 850mg

Tablets if:

■    you are allergic to Metformin Hydrochloride or any of the other ingredients of this medicine (listed in section 6'Contents of the pack and other information').

■    you have very high blood sugar levels (hyperglycaemia) or ketoacidosis, which can lead to diabetic pre-coma. Diabetic ketoacidosis is a condition in which substances called 'ketone bodies' accumulate in the blood, due to consistently high blood glucose levels.

Symptoms include stomach pain, fast and deep breathing, sleepiness or unusual fruity odour of the breath

■    you have kidney or liver disease

■    you have heart complications such as heart failure (even if the condition is under control) or recently had a heart attack, have severe problems with your circulation (such as shock) 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 'Warnings and precautions' below).

■    you regularly consume excess alcohol.

■    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 'Warnings and precautions' below).

■    you suffer from a loss or lack of water in the 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 'Warnings and precautions' below).

Warnings and precautions

Talk to your doctor before taking Metformin

Hydrochloride:

■    if you have diabetes and kidney problems as you are more at risk of developing a rare but serious side effect known as 'lactic acidosis'. The risk of lactic acidosis is also increased with uncontrolled diabetes, an increased level of ketones in your blood (ketosis), prolonged fasting, drinking an excessive amount of alcohol or liver problems. 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 (see Section 4 'Possible side effects')

If this happens to you, you may need immediate hospital treatment, as lactic acidosis may lead to coma. Stop taking Metformin Hydrochloride immediately and contact a doctor or the nearest hospital straight away

■    if you are to undergo diagnostic tests (using iodinated contrast media) or you need to have major surgery, you must tell your doctor. You will need to stop taking Metformin Hydrochloride for a certain period of time before and after the diagnostic tests or surgery

■    if you continuously use Metformin Hydrochloride. It may reduce your vitamin B12 level and should be annually monitored by your doctor

■    if you suffer from kidney problems, particularly if elderly

■    if you are taking Metformin Hydrochloride together with other medicines used to treat diabetes, such as insulin, sulphonylureas or meglitinides

Monitoring kidney function and diabetes

■    Kidney function: As Metformin Hydrochloride is excreted by the kidney your doctor will test your kidney function This should be done before starting treatment and regularly thereafter: once a year for normal kidney function and two to four times a year if you have kidney problems or you are elderly

■    Diabetes: Usual laboratory tests for diabetes monitoring should be performed regularly

Other medicines and Metformin Hydrochloride

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

If you are to undergo diagnostic tests (using iodinated contrast media) or you need to have major surgery, you must tell your doctor. You will need to stop taking Metformin Hydrochloride for a certain period of time before and after the diagnostic tests or surgery (see 'Warnings and precautions' above)

Other medicines may interfere with the actions of Metformin Hydrochloride. You should tell your doctor if you are taking any of the following medicines and Metformin Hydrochloride at the same time. You may need more frequent blood glucose tests or your doctor may adjust the dosage of Metformin Hydrochloride:

■    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

■    medicines for lowering high blood pressure, such as propanolol (beta-blockers)

■    medicines for inflammatory and allergic conditions, such as beclometasone (corticosteroids)

■    Oral contraceptives

■    medicines called 'diuretics' that are used to treat fluid retention or high blood pressure such as furosemide

■    medicines for high cholesterol, such as ezetimibe (clofibrates)

■    other medicines used to treat diabetes such as glibenclamide (sulphonylureas) or insulin

Metformin Hydrochloride and alcohol

You should not drink alcohol whilst taking Metformin Hydrochloride. Alcohol may increase the risk of lactic acidosis especially if you have liver problems, you are undernourished or you are fasting. This also applies to medicines that contain 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 for advice before taking this medicine. Pregnancy

If you are pregnant, think you may be pregnant or you are planning to become pregnant as you should not take Metformin Hydrochloride. However, your diabetes needs to be controlled during pregnancy and this should be done by taking insulin.

Breast-feeding

You should not take Metformin Hydrochloride whilst breast-feeding unless your doctor thinks the benefits outweigh the risks.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

If you are taking Metformin Hydrochloride on its own it should not affect your ability to drive or operate machinery.

However, if you are taking Metformin Hydrochloride together with other medicines to treat diabetes (such as sulphonylureas, insulin or meglitinides) it may cause hypoglycaemia (low blood glucose level). Symptoms of hypoglycaemia include weakness, dizziness, increased sweating, fast heart beat, vision disorders or difficulty in concentrating. If you have any of these symptoms do not drive or use machinery.

continued....

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Important information about some of the ingredients

This medicine contains lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this product.

How to take Metformin Hydrochloride

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Do not take more than the doctor has told you to. Read and follow the instructions on the pharmacist's label.

■    These tablets are for oral administration

■    Metformin Hydrochloride 850mg 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

The recommended dose is:

Adults

The usual dose is one 850mg tablet twice a day. This medicine may take a few days to 2 weeks to control your condition. Your doctor may increase the dosage to a maximum of 3000mg per day taken as 3 divided doses, until your condition is under control.

Older people

Your doctor will monitor your condition if you have kidney problems, and will need to have regular checkups to monitor your kidney function.

Use in children (10 years and above) and adolescents:

The normal dose is 500mg or 850mg, once a day.

The maximum dose is 2000mg a day 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 If you take insulin too, your doctor will tell you how to start Metformin Hydrochloride.

If you have taken more Metformin Hydrochloride than you should

If you accidentally take too many tablets, contact your doctor immediately or go to the nearest accident and emergency department.

Remember to take this leaflet or any remaining tablets with you.

An overdose of Metformin Hydrochloride may lead to lactic acidosis (for symptoms see section 4 'Possible side effects')

If you forget to take Metformin Hydrochloride

Take as soon as you remember. Do not take a double dose to make up for the forgotten individual dose.

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.

Serious side effect:

Although very rare, some people have developed a condition known as lactic acidosis whilst taking Metformin Hydrochloride.

Lactic acidosis is caused by a build up of lactic acid in the blood (produced when glucose is turned into energy without oxygen).

Possible symptoms of lactic acidosis:

■    unexplained weight loss

■    feeling sick (nausea

■    being sick (vomiting)

■    general feeling of being unwell

■    pain in the belly region

■    difficulty breathing

■    muscle cramp

■    severe weakness or loss of strength

■    feeling cold

If you have or think you may have lactic acidosis, you should go to the hospital immediately as it is a medical emergency.

effects directly via the internet at (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 H Hydrochloride_

Keep this medicine out of the sight and reach of children.

Store in the original package.

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

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 Hydrochloride 850mg Tablets contain:

■    The active ingredient is: Metformin Hydrochloride. Each tablet contains 850mg of Metformin Hydrochloride.

■    The other ingredients are: microcrystalline cellulose, copovidone, colloidal anhydrous silica and magnesium stearate.

■    The film coating is: talc, opadry white OY-L-28900 consisting of lactose monohydrate, hypromellose, titanium dioxide (E171) and macrogol 4000.

■    This medicine contains lactose (see important information about some of the ingredients at the end of section 2)

What Metformin Hydrochloride 850mg Tablets look like and the contents of the pack:

Metformin Hydrochloride 850mg Tablets are approximately 22mm x 8.7mm, white, oblong, film-coated tablets with a score notch on one side and marked M850 on the other.

They are available in pack sizes of 28, 30, 56, 84 or 120 tablets.

Not all pack sizes may be marketed.

REMEMBER

This medicine is only for YOU. Do not offer it to anybody else. It may harm them even if their symptoms seem to be the same as yours.

This information applies only to Metformin Hydrochloride 850mg Tablets.

Marketing Authorisation Holder and Manufacturer:

Tillomed Laboratories Ltd 3 Howard Road.

Eaton Socon, St Neots Cambridgeshire,

PE198ET United Kingdom.

Product Licence Number:

Metformin Hydrochloride 850mg Tablets:

PL 11311/0096

Date of approval May 2014

Very common side effects (may affect more than 1 in 10 people)

■    feeling sick (nausea)

■    being sick (vomiting)

■    diarrhoea

■    weight loss

■    abdominal pain

■    loss of appetite

These side effects usually occur at the start of treatment. You should continue to take your medicine as they normally disappear after a short time. They may be avoided by taking your medicine with or after food and in 2 or 3 divided doses.

Common side effects (may affect up to 1 in 10

people)

■    change in taste

Very rare side effects (may affect up to 1 in 10,000 people)

■    skin reactions such as flushing of the skin, itching or itchy rash

■    decreased vitamin B12 absorption

■    abnormal liver function test (detected through blood test) or inflammation of the liver (hepatitis), which may cause tiredness, loss of appetite, weight loss or yellowing of the skin or whites of the eyes. If this happens to you, stop taking Metformin and talk to your doctor

Children and adolescents

Limited data in children and adolescents showed that adverse events 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

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