Metformin Tablets 500mg
fcj PACKAGE LEAFLET: INFORMATION FOR THE USER
§ Metformin Tablets 500 mg and 850 mg
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 signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Metformin is and what it is used for
2. What you need to know before you take Metformin
3. How to take Metformin
4. Possible side effects
5. How to store Metformin
6. Contents of the pack and other information
1. WHAT METFORMIN IS AND WHAT IT IS USED FOR
Metformin belongs to a group of medicines called oral hypoglycaemics. It works by reducing the level of sugar in the blood.
Metformin Tablets are used for the treatment of Type 2 diabetes in patients when diet and exercise have not been enough to keep their blood sugar level under control, especially when these patients are overweight.
The tablets can be used as follows:
Adults (18 or over):
• as the only medicine for the treatment of diabetes
• with other anti-diabetic medicines also taken by mouth
• in combination with insulin.
Children (10 to 17):
• as the only medicine for the treatment of diabetes
• in combination with insulin.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE METFORMIN
Tests should have been done, especially if you are elderly (65 or over) to assess the risks and benefits of you taking this medicine and to check the functioning of your kidneys.
Do not take these tablets if you:
• have ketoacidosis (a symptom of uncontrolled diabetes). You may notice an unusual, sweetish smell on your breath
• are allergic to the active substance metformin hydrochloride or to any of the other ingredients in this medicine, (see below, Section 6 for a list of these)
• have ever fainted or suffered a coma as a result of your diabetes
• have had long-term problems with your liver or your kidneys
• suffer from alcoholism or if you are intoxicated
• have been treated for heart problems or have recently had a heart attack
• have severe problems with your circulation causing, for example, frequent cramps in your calves or leg ulcers which do not heal
• have had any serious medical conditions resulting in serious dehydration or shock
• have recently suffered a serious injury or have a serious infection
• are pregnant or think you may be pregnant
• are having serious difficulties in breathing.
If you think any of these may apply to you, do not start taking these tablets. Talk to your doctor or pharmacist first and follow the advice given to you.
Warnings and Precautions
Do not drink alcohol whilst you are taking this medicine.
Take special care (after you have started taking Metformin):
• if you are taking Metformin along with insulin or with any medicine taken by mouth to control your blood sugar level. You will be supervised at the beginning of the treatment, as a hospital outpatient, until your correct dosages have been sorted out.
• if you suddenly start having muscle spasms, indigestion, stomach pain and tiredness. Contact a doctor immediately or go immediately to the emergency department of your nearest hospital, taking this leaflet with you. You may have a serious illness called lactic acidosis which can also cause breathing difficulties, feeling cold, confusion and drowsiness.
• if you need to begin taking:
- medicine for high blood pressure
- diuretic medicines.
because these treatments could affect your kidney function.
• if you are going to have surgery under general anaesthetic or an examination using injections containing iodine, you must:
- tell the doctors beforehand that you are taking Metformin
- stop taking Metformin for up to 48 hours before and after you have the surgery or examination. Tests will be done to see that it is safe for you to start taking Metformin again.
Your blood and/or urine should be checked regularly. You should see your doctor at least once a year, (more often if you are 65 or over or if you already have kidney problems), to have your kidneys checked. The level of Vitamin B12 in your body should also be checked once a year, because Metformin may reduce the amount of this vitamin.
You should continue to:
• follow any diet advice given to you by your doctor
• make sure that you get enough carbohydrates at regular intervals throughout the day
• check your own blood sugar level regularly.
Taking other medicines
Check first with your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines, including medicines obtained without a prescription while you are on Metformin. This is especially important in the case of:
- any other medicines for diabetes
- medicines to treat high blood pressure and/or heart conditions, such as
- ACE inhibitors, for example, lisinopril
- beta-blockers, for example, metoprolol
- thiazides, for example, bendroflumethiazide
- loop diuretics, for example, furosemide
- diazoxide (also used to treat diabetes)
- medicines used to treat depression or psychoses, for example, MAO inhibitors
- cimetidine, a medicine for treating stomach ulcers, heartburn and reflux conditions
- medicines containing hormones, such as the contraceptive pill
- glucocorticoids, for example prednisolone.
Check with your doctor or pharmacist if you are unsure.
Taking Metformin with food and drink
You should not drink alcohol while you are being treated with Metformin tablets.
Pregnancy and breast-feeding
You must not take Metformin if you are pregnant or think you may be pregnant. Please talk to your doctor if you plan to get pregnant, so your treatment can be adapted. This medicine is not recommended for use if you are breast-feeding.
The elderly (65 or over)
Your daily dosage will depend on the results of regular kidney tests. Metformin will be stopped if your kidney function gets worse.
Children (10 to 17)
These tablets can be used in one of two ways:
• as their only medicine for the treatment of diabetes
• in combination with insulin.
For the correct doses of Metformin, see (below) Section 3.
Driving and using machines
Taken on its own, Metformin should not affect your ability to drive or to use machinery.
If, however, you are also taking any other medicines to lower your blood sugar level, the combined effects could lead to a “hypo” (you feel faint, dizzy, weak or very nervous) so you need to take extra care.
If these situations happen, stop driving or operating machinery as soon as it is safe to do so, switch off, remove any keys and do not start again, until you have recovered.
3. HOW TO TAKE METFORMIN
Always take Metformin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Your doctor or diabetic nurse will have already told you about taking these tablets and you should always follow their instructions carefully. If you are also taking insulin, this will be adjusted on the basis of tests of your blood sugar level.
Take the tablets during or just after meals, with a glass of water. Swallow them whole. Do not chew or crush them.
Dosage:
Adults (18 or over):
The usual starting dose is either:
• one 500 mg tablet, three times a day
• or one 850 mg tablet, twice a day.
These starting dosages may be gradually increased up to a maximum of 3,000 mg per day as:
• either six 500 mg tablets daily
• or three 850 mg tablets daily.
Lower doses may be used in the elderly or in those with reduced kidney function.
Children (10 or over):
The usual starting dose is either:
• one 500 mg tablet, once a day
• or one 850 mg tablet, once a day.
The maximum recommended children's dosage is 2,000 mg per day, taken as two or three divided doses.
For both adults and children blood sugar tests may result in adjustments to the doses after 10-15 days.
If you take more Metformin Tablets than you should
If you take too many tablets or someone else accidentally takes your medicine, contact a doctor immediately, or go immediately to the emergency department of the nearest hospital
taking this leaflet with you.
If you forget to take Metformin Tablets
If you miss a dose, take your next dose at your usual time. Never take a double dose to make up for the one you’ve missed.
Don’t stop taking Metformin Tablets without first consulting your doctor.
Like all medicines, Metformin can cause side effects, although not everybody gets them.
Your body will usually accept Metformin without difficulties, but the tablets can sometimes cause side effects.
If you develop (very rare - affecting less than 1 in 10,000 patients):
* muscle spasms, indigestion, stomach pain or tiredness, contact a doctor immediately or go immediately to the nearest hospital emergency department, taking this leaflet with you. These symptoms may indicate a serious condition called lactic acidosis which can also cause breathing difficulties, feeling cold, confusion and drowsiness.
* disturbances to your liver, which may show as jaundice (yellow skin and eyes), see your doctor immediately.
Very common (affecting more than 1 in 10 patients):
stomach upsets, such as feeling sick, vomiting, abdominal pain, diarrhoea, loss of appetite.
If these side effects occur, they often get better spontaneously, so you should continue to take the tablets.
If your stomach upset is severe or shows no sign of getting better after a few days, contact your doctor as soon as possible.
Common (less than 1 in 10 patients): a metallic taste in your mouth.
Rare (less than 1 in 1,000 patients): skin reactions such as redness, itching, hives/nettle rash.
If you notice a rash, ask your doctor for advice.
Very rare (less than 1 in 10,000 patients): a decrease in the level of vitamin B12 in your body, which may lead to anaemia (for which you will have tests).
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.
5. HOW TO STORE METFORMIN
Keep this medicine out of the sight and reach of children.
Do not store the tablets above 25°C. Keep the tablets in their original blister pack.
Do not take the tablets after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Metformin Tablets contain
The active ingredient is metformin hydrochloride. Each film-coated tablet contains either 500 or 850mg of this active ingredient.
The other ingredients are: sodium starch glycollate, maize starch, povidone, colloidal anhydrous silica, magnesium stearate, hydroxypropylmethylcellulose, titanium dioxide (E171), propylene glycol, macrogol 6000 and purified talc.
What Metformin Tablets look like and contents of the pack
Metformin Tablets 500 mg are white, round, biconvex tablets engraved with “C” on one side and “323” on the other side, available in blister packs of 28, 56 or 84 tablets.
Metformin Tablets 850 mg are white, round, biconvex tablets engraved with “C” on one side and “324” on the other side, available in blister packs of 56 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Crescent Pharma Limited, Units 3 & 4 Quidhampton Business Units, Polhampton Lane,
Overton, Hampshire, RG25 3ED, UK.
Leaflet revised September 2016