Metformin 850mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
METFORMIN 850 mg TABLETS
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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
1. What METFORMIN is for
2. Before you take METFORMIN
3. How to take METFORMIN
4. Possible side effects
5. How to store METFORMIN
6. Further information
METFORMIN belongs to a group of medicines
called the biguanides. It can be used to treat Type
2 diabetes (non-insulin dependent diabetes).
How METFORMIN works
• In type 2 diabetes, there is too much sugar (glucose) in your blood. This is because your body does not make enough insulin or because it makes insulin that does not work properly.
• Insulin is a natural body chemical that helps control your blood sugar levels.
• METFORMIN helps your body make better use of the insulin it produces. METFORMIN will help reduce your blood sugar towards a normal level.
Using METFORMIN
• This medicine is given when diet and exercise alone has not been able to control your blood sugar levels.
• METFORMIN can be given on its own or in combination with other medicines for diabetes or with insulin.
• In patients who are overweight, long-term use of METFORMIN also helps to lower the risk of any problems related to diabetes.
If you are not sure why you have been prescribed
these tablets then please ask your doctor.
Do not take METFORMIN
• If you are allergic to METFORMIN or any of the other ingredients in the tablets (listed in section 6 of this leaflet)
• If you have recently had a heart attack or any other heart problems
• If you have severe circulation problems or difficulty in breathing
• If you have liver or kidney problems
• If you have had serious problems with your diabetes, which resulted in rapid weight loss, nausea or vomiting (diabetic ketoacidosis)
• If you have recently had a severe infection, injury or shock (trauma)
• If you are dehydrated
• If you are going to have an X-ray where you will be injected with a dye
• If you drink alcohol excessively (either every day or only from time to time)
• If you are pregnant, planning a pregnancy or are breast-feeding.
Take special care with METFORMIN
Tell your doctor before you take this medicine
• If you are going to have an X-ray, which involves having a dye injected. You will need to stop taking METFORMIN at the time of and for a few days after the procedure.
• If you are going to have an operation under general anaesthetic, as you may need to stop taking METFORMIN for a couple of days before and after the operation.
Tests while taking METFORMIN
• The amount of sugar in your blood or urine should be checked regularly.
• At least once a year (more often if you are elderly or have kidney problems) your doctor will check that your kidneys are working properly. Your vitamin B12 levels will also be checked.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken, any other medicines, even medicines bought without a prescription.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how METFORMIN tablets work:
• Other medicines for diabetes such as Sulphonylureas or Insulin
• Medicines for high blood pressure or heart failure such as Diazoxide, Beta-blockers or ACE inhibitors like Captopril or Ramipril
• Disopyramide to treat irregular heartbeat
• Medicines to increase urine production
• Medicines to treat depression or mental health problems such as MAO inhibitors or Phenothiazines
• Medicines to treat pain, fever and swelling such as Salicylates or Pyrazolones
• Cimetidine to treat stomach ulcers
• Lanreotide or Octreotide to treat cancer
• Steroids such as Hydrocortisone or Prednisolone to treat inflammation and allergies
• Hormones such as Testosterone,Oestrogens or Progestogens (including the contraceptive "pill" and hormone replacement therapy).
If you go into hospital or have treatment for other conditions, tell the doctor that you are taking METFORMIN.
Taking METFORMIN with food and drink
• You should eat carbohydrates regularly throughout the day. If your doctor has given you advice on your diet, you should continue to follow this.
• AVOID ALCOHOL when taking METFORMIN.
Pregnancy and breast-feeding
Do not take METFORMIN if you are pregnant, planning a pregnancy or are breast-feeding.
Driving and using machines
METFORMIN on its own should not affect your ability to drive or operate machinery, but if it is taken with other diabetic medicines you may feel faint, confused and sweaty. If this happens, do not drive or operate machinery.
Always take METFORMIN tablets exactly as your doctor has told you.
Swallow each tablet whole with a glass of water. Take with or just after food. This lowers the chance of getting an upset stomach.
Dosage
Your doctor will decide your dose, as it depends on your condition.
DO NOT STOP taking the tablets until your doctor tells you to.
Adults:
Typical dose to start with is 850 mg twice a day. If necessary, your doctor may increase your dose to a maximum of 850 mg three times a day.
Elderly:
Your doctor will decide your dose after tests have been carried out on your kidney function.
Children over 10 years and adolescents:
Typical dose to start with is 850 mg once a day. If necessary, your doctor may increase your dose to a maximum of 850 mg twice a day.
Children under 10 years: Not recommended.
If you take more METFORMIN than you should Contact your doctor or go to a hospital immediately. You may have something called lactic acidosis (see section 4 of this leaflet). The doctor may use a method called haemodialysis to remove the extra lactate and metformin from your body.
If you forget to take METFORMIN
Don't worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.
Common side effects:
• taste of metal in your mouth.
Very rare side effects:
• skin rash (including redness, itching or hives).
• low levels of vitamin B12. Over time this may lead to anaemia, a sore mouth or tongue or possibly numbness or tingling in the limbs.
• liver problems, abnormal liver function tests and hepatitis (inflammation of the liver), which may result in jaundice (yellowing of the skin or white of the eyes).
If any of the side effects become serious, or
if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not store above 25°C. Store in the original package or container and keep the container tightly closed.
Do not use these tablets after the expiry date, which is stated on the package or container. 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.
Like all medicines, METFORMIN can cause side effects, although not everybody gets them.
If you get any of the following very rare side effects, STOP TAKING METFORMIN and seek immediate medical help:
• unexpected weight loss, nausea, vomiting, very fast breathing which you cannot stop, stomach pains or feeling cold.
This may mean you have diabetic ketoacidosis or lactic acidosis.
Other side effects include:
Very common side effects:
• upset stomach causing nausea, vomiting, diarrhoea, stomach pain or loss of appetite (anorexia).
These side effects are most likely to happen at the start of the treatment. They usually last for a short time. It helps to take the tablets with or after meals.
What METFORMIN contains
The active ingredient in METFORMIN 850 mg tablets 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 looks like and contents of the pack
METFORMIN 850 mg tablets are round white film-coated tablets with the marking MP74 on one side.
The tablets come in blister packs of 28, 30, 50, 56, 60, 84, 100, 250, 300, 308, 350, 500 and 1000 tablets and in containers of 300 and 308 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Metwest Pharmaceuticals Limited,
15 Runnelfield, Harrow on the Hill,
Middlesex HA1 3NY
Manufacturer
DDSA Pharmaceuticals Limited,
310 Old Brompton Road,
London SW5 9jQ
For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was last approved in 11/2008
MET0074/0850F/LEA006