METFORMIN 500 MG TABLETS BP - patient leaflet, side effects, dosage

1. what metformin tablets are and what it is used for

The name of your Medicine is Metformin 500mg Tablets or Metformin 850mg Tablets. They contain the active ingredient called Metformin hydrochloride.

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

Metformin tablets 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 tablets for you to take on its own or in combination with other oral anti-diabetic medicines called sulphonylureas, or insulin.

2. what you need to know before you take metformin tablets

Do not take Metformin Tablets 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 sulphonylureas
• have had serious complications with your diabetes (eg.diabetic coma or ketones in your urine)
• have severely reduced kideny function
• have uncontrolled diabetes ,with,for example severe hyperglycaemia (high blood glucose),nause­a,vomiting, diarrhoea,rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below)or ketoacidosis. Ketoacidosis is a condition in which substances called ‘ketone bodies’ accumulate in the blood and which can lead to diabetic pre-coma. Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusal fruity smell.
• 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 (eg if you have suffered from diarrhoea or vomiting recently)

3. how to take metformin tablets

Always take Metformin Tablets exactly as your doctor has told you. Youshouldchec­kwithyour doctor or pharmacist if you are not sure.

If you are taking Metformin tablets continuously, you should have regular blood tests to check your blood glucose levels, kidney function and vitamin B 12levels.

Method of Administration

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

Dosage

Children 10 years and over and adlolescents usually start with 500 mg or 850 mg Metformin tablets 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 tablets two or three times a day.The maximum daily dose is 3000 mg taken as 3 divided doses.

If you have reduced kidney function, your doctor may prescribe a lower dose.

If you take insulin too, your doctor will tell you how to start Metformin tablets.

If you take more Metformin tablets 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 Tablets

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 Tablets 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.

Metformin tablets may cause a very rare (may affect up to 1 user in 10,000). but very serious side effect called lactic acidosis (see section (’warnings and precautions’).If this happens you must stop taking Metformin tablets and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.

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

• digestive problems, such as felling 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 tablets. It helps if you spread the doses over the day and if you take Metformin tablets with or straight after a meal. If symptoms continue ,stop taking Metformin tablets 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 in10,000 people)

• Lactic acidosis. This is a very rare but serious complication particullary if your kidneys are not working properly.

Symptoms of lactic acidosis are non-specific (see section ‘Warning and precautions’)

• 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 Metformin tablets and talk to your doctor.
• Skin reactions such as redness of the skin (erythema), itching or an itchy rash (hives).
• low vitamin B12 levels in the blood.

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 get serious, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:

5. how to store metformin tablets

Keep out of sight and reach of children.

Do not use Metformin Tablets after the expiry date which is stated on the pack. The expiry date refers to the last date of that month. Do not store above 25°C. Store in original package.

• 6. CONTENT OF THE PACK AND OTHER INFORMATION

What Metformin Tablets 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 Tablets look like and contents of pack: Metformin 500mg Tablets: White/off white, round, biconvex tablets marked FIL o n one side and plain on the other.

M500

Metformin 850mg Tablets: White/off white, round, biconvex tablets marked FIL o n one side and plain on the other.

500mg- 28, 84, 504 tablets in blister pack and 100, 250, 500 and 504 tablets in securitainers.

850mg- 56, 84, 308 tablets in blister pack and 100, 300 and 308 tablets in securitainers.

Not all pack sizes may be marketed.

MA Holder:

Fourrts (UK) Pharmacare Limited,

• 5 Braemore Court, Cockfosters Road, Barnet, Hertfordshire EN4 0AE, United Kingdom.