Metformin 500mg Tablets
Metformin 500mg and 850mg 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.
In this leaflet
T| What Metformin tablets are and what they are used for 2| Before you take 3| How to take 4 Possible side effects |5| How to store 6| Further information
T| What Metformin tablets are and what they are used for
Metformin tablets belong to a group of medicines called biguanide hypoglycaemic agents. These work by lowering the amount of sugar in the blood.
Metformin tablets may be used for the treatment of non-insulin dependent (type 2) diabetes which cannot be controlled by diet and exercise alone. Your doctor may prescribe metformin for you to take on its own or in combination with other oral antidiabetic medicines or insulin.
4 Before you take
Do not take Metformin tablets and tell your doctor if you:
• have ever had an allergic reaction to Metformin tablets or any of the ingredients in the tablet (see section 6). An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue
• have kidney, liver, heart or breathing problems
• are a heavy drinker of alcohol (alcoholism)
• have recently had a heart attack
• have had serious complications with your diabetes (e.g. diabetic coma or ketones in your urine)
• are dehydrated (e.g. if you have suffered from diarrhoea or vomiting recently)
• have had a serious infection or recently suffered trauma (shock)
Check with your doctor or pharmacist before taking Metformin tablets if you:
• have been told that the amount of oxygen in your blood is low
• drink too much alcohol
• have fasted for a long time
• have a high level of ketones in the body (ketosis).
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Especially:
• medicines to treat high blood pressure such as ACE inhibitors
• corticosteroids (strong anti-inflammatory medicines, e.g. prednisolone)
• medicines to treat asthma (e.g. salbutamol, terbutaline, salmeterol, formoterol).
Alcohol
You are advised not to drink alcohol with this medicine. If you have any questions, discuss this with your doctor.
Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or are breast-feeding ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Make sure your blood sugar levels are under control before you drive or operate machinery.
Diet
Continue to follow any dietary advice that your doctor has given you and make sure that you eat carbohydrates regularly throughout the day. If you are overweight, you should continue with your carbohydrate restricted diet.
Surgery
If you see another doctor or go into hospital for surgery or x-rays, tell them you are taking Metformin. You may be given advice to stop Metformin tablets for a while.
Tests
If you have diabetes, you should have your blood or urine tested for sugar regularly. Your doctor should check your kidney function at least once a year (more often if you are elderly or have kidney problems). Some patients, who have been taking Metfomin for a long time have experienced reduced levels of vitamin B12 in their blood. Therefore an annual check on vitamin B12 levels may be carried out.
"3| How to take
Always take Metformin tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Swallow the tablets with or after food. Take this medicine for as long as your doctor tells you to.
Doses:
Adults: One tablet two or three times a day. Your doctor may adjust your dose depending on your blood sugar levels. The maximum daily dose is 3g.
Elderly: If you are elderly and have reduced kidney function, your doctor may prescribe a different dose.
Children: Your doctor will decide if this medicine is suitable.
If you take more Metformin tablets than you should:
If you (or someone else) swallow a lot of the tablets at the same time, or if you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose include stomach pain, low body temperature, difficulty breathing or coma.
If you forget to take the tablets
If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose. Then go on as before. Never double up on the next dose to make up for the one missed.
"4 Possible side effects
Stop taking Metformin tablets and contact your doctor at once if you experience:
• An allergic reaction: hives, skin rash affecting the whole body, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing. This is a very serious but rare
side effect. You may need urgent medical attention or hospitalisation.
• Signs of serious problem with your diabetes (diabetic ketoacidosis or lactic acidosis) such as unexpected weight loss, severe nausea or vomiting (feeling or being sick), uncontrolled rapid breathing or abdominal pains. These symptoms can be severe, quick to appear and can be signs of a serious diabetic problem.
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
• Very common (occurs in more than 1 in 10 users): diarrhoea, loss of appetite, feeling or being sick, stomach upset or pain, especially at the start of treatment.
• Common (occurs in less than 1 in 10 users): metallic or change in taste.
• Very rare (occurs in less than 1 in 10, 000 users): a mild red rash, hepatitis (yellowing of the skin or eyes), changes in liver function tests.
Some patients, who have been taking Metformin tablets for a long time, have experienced reduced levels of vitamin B12 in their blood (a type of anaemia causing breathlessness on exertion, pale skin and poor resistance to infections). This would be detected by a blood test.
Reporting of side effects
If you get any side effects, 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: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
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[5 How to store
Keep out of the reach and sight of children.
Do not store the tablets above 25°C.
Do not use Metformin tablets after the expiry date stated on the label/carton/bottle. 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.
"6 Further information
What Metformin tablets contain
• The active substance (the ingredient that makes the tablet work) is metformin hydrochloride. Each tablet contains either 500mg or 850mg of the active ingredient.
• The tablets also contain: povidone (E1201), stearic acid, colloidal anhydrous silica.
• The coating contains: methylhydroxypropylcellulose (E464), titanium dioxide (E171), polyethylene glycol.
What Metformin tablets look like and contents of the pack
Metformin tablets are white, circular, biconvex, film-coated tablets.
Metformin tablets are available in pack sizes of 28s, 56s and 84s.
Not all pack sizes may be available.
Marketing Authorisation Holder
Actavis, Barnstaple, EX32 8NS, UK
Manufacturer
Balkanpharma-Dupnitsa AD,
3 Samokovsko Shosse Str, Dupnitsa 2600, Bulgaria
This leaflet was last revised in February 2015
Actavis, Barnstaple, EX32 8NS, UK