Document: leaflet MAH GENERIC_PL 41318-0024 change

• leaflet MAH GENERIC_PL 29831-0133
• leaflet MAH GENERIC_PL 41318-0024

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PACKAGE LEAFLET: INFORMATION FOR THE USER METFORMIN 500mg FILM-COATED TABLETS BP METFORMIN 850mg FILM-COATED TABLETS B P

Metformin hydrochloride

Read all of this leaflet carefully before you start taking this medicine.

•    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 effect not listed in this leaflet, please tell your doctor or pharmacist.

1. WHAT METFORMIN 500 mg / 850 mg FILM-COATED TABLETS BP ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Metformin 500mg film-coated tablets BP or Metformin 850mg film-coated tablets BP. They contain the active ingredient called Metformin hydrochloride.

Metformin is one of a group of medicines called oral hypoglycaemics, which work by reducing the level of sugar in the blood.

Metformin 500mg / 850mg film-coated tablets BP are used for the treatment of type II diabetes (a condition in which your body does not make enough insulin or where the insulin that your body produces does not work as well as it should) not controlled by diet and exercise alone. Your doctor may prescribe Metformin 500mg / 850mg film-coated tablets BP for you to take on their own or in combination with other oral anti-diabetic medicines called sulfonylureas, or insulin.

2. BEFORE YOU TAKE METFORMIN 500 mg / 850 mg FILM-COATED TABLETS BP

Do not take Metformin 500mg / 850 mg film-coated

tablets BP if you:

•    are allergic to Metformin hydrochloride or any of the ingredients in this medicine (see section 6)

•    have failed to respond to the treatment with other anti-diabetics, called sulfonylureas

•    have had serious complications with your diabetes (e.g. diabetic coma or ketones in your urine)

•    suffer from kidney disorders

•    have problems with your liver

•    have had heart failure or have recently had a heart attack

•    have problems with your circulation causing, for example, frequent cramp in your calves or leg ulcers that do not heal

•    have had a serious infection or recently suffered trauma (shock)

•    are dehydrated (e.g. if you have suffered from diarrhoea or vomiting recently)

•    are on a very low calorie diet (less than 1000 calories per day)

•    are a heavy drinker of alcohol

•    have been told that the amount of oxygen in your blood is low

Take special care with Metformin 500mg / 850mg

film-coated tablets BP:

Talk to your doctor before you start to take this medicine if

you:

•    are elderly

•    are a patient with prostatic hypertrophy or impairment of micturition

•    have low blood pressure

•    are likely to have surgery under general anaesthesia within the next few days

•    are going to have a certain type of x-ray with an injectable dye. You will need to stop taking Metformin 500mg / 850mg film-coated tablets BP at the time of and for a few days after the procedure.

If you are already on insulin you should only be started on a course of treatment with Metformin 500mg / 850mg film-coated tablets BP in hospital.

Taking other medicines

You should tell your doctor if you are taking or have taken any of the following medicines as they may interact with your Metformin 500mg / 850mg film-coated tablets BP. Examples of medicines that can affect Metformin 500mg / 850mg film-coated tablets BP are:

•    Medicines like insulin, other antidiabetics and guar

•    Monoamine-oxidase inhibitors (MAO inhibitors) used to treat depression

•    Antibiotics know as tetracyclines, such as oxytetracycline

•    Lipid regulating drugs, such as clofibrate and nicotinic acid derivatives

•    Anti-inflammatory painkillers like salicylates or pyrazolones

•    Medicine like cyclophosphamide used to treat cancer

•    Beta-blockers, such as atenolol for high blood pressure

•    Medicines like ACE inhibitors, such as lisinopril for high blood pressure

•    Other medicines used to treat high blood pressure such as clonidine, reserpine, diazoxide or guanethidine

•    Adrenaline and other sympathomimetics used to treat allergic conditions and heart attacks

•    Glucagon used to control hypoglycaemia (low blood sugar)

•    Thyroid hormones such as thyroxine sodium used for underactive thyroid glands

•    Water tablets (diuretics) like furosemide

•    H₂ blockers, such as cimetidine, used to heal stomach ulcers

•    Phenprocoumone, used to thin the blood

•    Oestrogen and progesterone (female) hormones, such as the ‘‘Pill’’, or hormone replacement therapy

•    Antipsychotic drugs, such as phenothiazines

•    Medicines such as steroids used to treat inflammatory and allergic disorders

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicine obtained without prescription.

Pregnancy and Breast Feeding

Do not take Metformin 500mg / 850mg film-coated tablets BP if you are, or planning to become pregnant. Tell your doctor if you are breast feeding before taking this medicine.

Driving and using machines

Metformin 500mg / 850 mg film-coated tablets BP on their own should not affect your ability to drive, but if you are taking any other medicines which lower the blood sugar it is possible that their combined effects could make you feel faint, dizzy, weak or jittery. If this happens you should not drive or operate any machinery until you have recovered.

Taking Metformin 500mg / 850 mg film-coated tablets BP with food and alcohol

You can take Metformin 500mg / 850mg film-coated tablets BP with or after food. Do not drink excessive alcohol or take medicines that contain alcohol whilst taking these tablets.

You should continue to follow any dietary advice that your doctor has given you and should make sure that you eat carbohydrates regularly throughout the day. If you are overweight, you should continue with your energy restricted diet.

3. HOW TO TAKE METFORMIN 500 mg / 850 mg FILM-COATED TABLETS BP

Always take Metformin 500mg / 850mg film-coated tablets BP exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

If you are taking Metformin 500mg / 850mg film-coated tablets BP continuously, you should have regular blood tests to check your blood glucose levels, kidney function and vitamin B₁₂ levels.

Method of Administration

These tablets should be taken with a glass of water during or after meals. Do not chew.

Dosage

Adults and Elderly: The usual starting dose is one 500mg film-coated tablet three times a day or one 850mg film-coated tablet twice a day, which is gradually increased until the right dose for you is found. The maximum dose is six 500mg film-coated tablets or three 850mg film-coated tablets daily taken in divided doses.

Children: Metformin tablets should not be taken by children.

If you take more Metformin 500mg / 850mg film-coated tablets BP than you should

If you or anyone else has swallowed a lot of the tablets all together, contact your nearest hospital casualty department or doctor immediately.

If you forget to take Metformin 500mg / 850mg film-coated tablets BP

If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for a forgotten tablet.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Metformin 500mg / 850mg film-coated tablets BP can cause side effects, although not everybody gets them. Stop taking Metformin tablets and tell your doctor immediately if you experience any of the following side effects.

•    Allergic reactions. An allergic reaction may include a rash, itching, swelling of throat or difficulty in breathing.

Below are the other side effects that you may experience:

Common side effects

•    Symptoms of upset stomach such as abdominal pain, nausea, vomiting, diarrhoea or loss of appetite

•    Metallic taste

Taking the tablets during or after meals usually helps to prevent these effects. When an increase in the dose is prescribed, a gradual change to the higher dose lessens the likelihood of these symptoms occurring.

Very rare side effects

•    Redness of the skin (rash) and/or itching

•    Lower blood sugar than normal (hypoglycaemia)

•    Hepatitis (a liver disorder)

•    Decrease of Vitamin B₁₂ levels

•    Decrease in the number of cells in the blood, including a lower red blood count (anaemia)

•    A condition called as lactic acidosis (excess of lactic acid in your blood), particularly in those whose kidneys are not working properly. Symptoms include: Feeling cold or uncomfortable, severe nausea or vomiting, abdominal pain, unexplained weight loss, or rapid breathing).

Some people may have side-effects when taking this medicine. If you have any unwanted side-effects or if you notice any side-effect not listed in this leaflet, please tell your doctor, pharmacist or other healthcare professional.

Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.mhra.gov.uk/yellowcard alternatively you can call Freephone 0808 100 3352 (available between 10am-2pm Monday - Friday) or fill in a paper form available from your local pharmacy.

5. HOW TO STORE METFORMIN 500 mg / 850 mg FILM-COATED TABLETS BP

Keep out of the sight and reach of children.

Do not use Metformin 500mg / 850mg film-coated tablets BP after the expiry date which is stated on the pack. The expiry date refers to the last day of that month. Do not store above 25°C. Store in the original bottle / blister pack to protect from light and moisture.

6. FURTHER INFORMATION

What Metformin 500mg / 850 mg film-coated tablets BP contain:

The active substance is Metformin hydrochloride.

The other ingredients are:

Sodium starch glycollate, maize starch, povidone, colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide E171, propylene glycol, macrogol 6000 and purified talc.

What Metformin 500mg / 850 mg film-coated tablets BP look like and contents of the pack:

Metformin 500mg film-coated tablets BP: White/off white, round, biconvex, tablets marked tablets marked -i!L on one side and plain on the other.    ^M500

Metformin 850mg film-coated tablets BP: White/off white, round, biconvex tablets marked -ilk on one side and plain on the other.    ^M850

Pack sizes

500mg - 28, 84, 504 film-coated tablets in blister packs and 504 tablets in securitainers.

850mg - 56, 84, 308 film-coated tablets in blister packs and 308 tablets in securitainers.

Not all pack sizes may be marketed.

Product MA Holder: GlobeGen Laboratories Ltd.,

1406 Coventry Road, Yardley, Birmingham, B25 8Ae, UK. Manufacturer (1): Milpharm Limited, Area,

Odyssey Business Park, West End Road, South Ruislip HA4 6QD, United Kingdom.

Manufacturer (2): Medreich PLC, Warwick House,

Plane Tree, Crescent, Feltham, TW13 1HF, UK

This leaflet was last revised in June 2016.

PL41318/0024, PL41318/0025