Metformin Tablet 500mg (Metformin Hydrochloride) Dynapharm (M) 1apr2014 Eng

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Consumer Medication Information Leaflet (RiMUP)

METFORMIN TABLET
Metformin hydrochloride (500 mg).

What is in this leaflet - you have had serious problems with In particular, tell your doctor or
1. What Meformin is used for. your diabetes in the past called pharmacist if you are taking the
2. How it works. diabetic ketoacidosis. When you have following medicine:
3. Before you take Metformin. this you lose weight quickly, feel sick - Anticoagulants - an interaction
4. How to take Metformin. (nausea) or are sick (vomiting). See between Metformin and
5. While you are using it. also the section on ‘side effects’. anticoagulants is a possibility and
6. Side Effects. - you have recently had a severe dosage of the latter may need
7. Storage and disposal of Metformin. infection, injury or trauma (shock) adjustment.
8. Product Description - you are dehydrated If the above apply to you (or you are
9. Manufacturer and Product - you are a heavy drinker of alcohol not sure), talk to your doctor or
Registration Holder - you are pregnant, planning to get pharmacist before taking metformin.
10. Date of revision pregnant or are breast-feeding (see Taking metformin with food and drink
Pregnancy and Breast-feeding). - You need to eat carbohydrates
1. What METFORMIN is used for Do not take this medicine if any of the regularly throughout the day. If your
Metformin belongs to a group of above applies to you. If you are not doctor has given you advice on your
medicines called biguanides (a type of sure, talk to your doctor or pharmacist diet, you need to continue to follow
oral hypoglycaemic). Metformin is used before taking metformin. this.
for the sort of diabetes called Type 2 - Do not drink large amounts of alcohol
diabetes or non-insulin-dependent • Before you start to take it or take medicines containing alcohol
diabetes mellitus. Take special care and check with your while taking metformin
This medicine is given when diet and doctor or pharmacist before taking
exercise alone has not been able to metformin if: Pregnancy and breast-feeding
control your blood sugar levels. - You are elderly Do not take this medicine and talk to
Metformin can be given on its own. - You are on a very low calorie diet your doctor if you are pregnant,
However, sometimes it is given with (less than 1000 calories a day) or are planning to get pregnant or are breast-
other medicines for diabetes or with fasting. This could increase the feeding
insulin. chances of you getting a very rare, but Driving and using machines
serious side effect called lactic - Metformin on its own does not
2. How METFORMIN works acidosis (See also the section on ‘side usually affect your ability to drive.
In type 2 diabetes, there is too much effects’) - However, if you also take other
sugar (glucose) in your blood. This is If any of the above apply to you (or you medicines which lower blood sugar
because your body does not make enough are not sure), talk to your doctor or you may feel faint, dizzy, weak or
insulin or because it makes insulin that pharmacist before taking metformin. shaky. If this happens, do not drive or
does not work properly. Operations and tests while taking use any tools or machines.
Insulin is a hormone that allows your Metformin
body tissue to take glucose from the - The amount of sugar in your blood or 4. How to take METFORMIN
blood and use it for energy or for storage urine should be checked regularly. Always take metformin exactly as your
for future use. Your doctor will also check your doctor has told you. You should check
Metformin works by improving the kidneys are working properly. with your doctor or pharmacist if you are
sensitivity of your body to insulin. It - If you are going to have an X-ray, tell not sure.
helps your body to use glucose in the your doctor you are taking metformin. Taking this medicine
normal way again - If you are going to have an operation • Swallow the tablets whole with a glass
that needs a general anaesthetic, tell of water.
3. Before you use METFORMIN your doctor you are taking metformin • This medicine has been prescribed for
• When you must not take it before the operation. you. Do not pass it on to others. It may
Do not take Metformin if: harm them, even if their symptoms are
- you are allergic (hypersensitive) to • Taking other medicines the same as yours.
metformin or any of the other Please tell your doctor or pharmacist if
ingredients in this tablet (see section you are taking or have recently taken
on Product description (ingredients). any other medicine. This includes
An allergic reaction can include a medicines obtained without a
rash, itching or shortness of breath. prescription, including herbal
- you have recently had a heart attack medicines. This is because metformin
or any other heart problems can affect the way some other
- you have severe circulation problems medicines work. Also, some medicines
or difficulty in breathing can affect the way metformin works.
- you have liver or kidney problems

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Consumer Medication Information Leaflet (RiMUP)

• How much to take it 5. While you are using METFORMIN 6. Side Effects
Adults • Things you must do Like all medicines metformin can cause
- The usual starting dose is one tablet 2 - Have a regular monitoring of renal side effects, although not everybody gets
or 3 times a day. Your doctor will tell function them.
you when to take this - Have an annual estimation of Vitamin Stop taking metformin and see a doctor or
- Your doctor may slowly increase your B12 levels go to a hospital straight away if you get
dose until the right dose for you is - Have a regular blood glucose level any of the following very rare side
reached. This will help lower the monitoring. effects:
chances of getting side effects such as - unexpected weight loss
feeling sick (nausea) or being sick • Things you must not do - feeling very sick (nausea) or being very
(vomiting). - Not to engage in excessive exercises sick (vomiting)
- The maximum daily dose is six or in activities that may cause - very fast breathing which you cannot
500mg tablets. dehydration. stop
Elderly - stomach pains or feeling cold
- Your doctor may give you a much • Things to be careful of This may mean you have something
lower starting dose as there is a risk of - This medication may cause changes in called “diabetic ketoacidosis” or “lactic
kidney problems. your blood sugar. You should know acidosis”. These can be signs of serious
the symptoms of low and high blood problems with your diabetes. If this
• When to take it sugar and what to do if you have these happens, see a doctor as you will need
- Take metformin with meals. This symptoms. treatment straight away.
lowers the chance of getting an upset - You may experience hypoglycemia Other side effects:
stomach. (low blood sugar) while you are - Stomach problems such as feeling sick
- Try to take your medicine at the same taking this medication. Your doctor (nausea), being sick (vomiting),
time each day so that it becomes part will tell you what you should do if diarrhoea, stomach pain and loss of
of your daily routine. you develop hypoglycemia. He or she appetite. These side effects are most
may tell you to check your blood likely to happen at the start of
• How long to take it sugar, eat or drink a food or beverage treatment.
Keep taking this medicine until your that contains sugar, such as hard - They usually last for a short time. It
doctor tells you to stop. Do not stop candy or fruit juice, or get medical helps to take the dose with or after a
taking metformin just because you feel care. meal.
better. If you stop your illness may get - Follow these directions carefully if - taste of metal in your mouth
worse. you have any of the following
If you have any further questions on the symptoms of hypoglycemia: - low levels of vitamin B12. Over time
use of this medicine, ask your doctor or Shakiness,dizziness or this may lead to anaemia, a sore mouth
pharmacist. lightheadedness, sweating, or tongue or possibly numbness or
nervousness or irritability, sudden tingling in the limbs.
• If you forget to take a dose, changes in behavior or mood, If any of the side effects gets serious, or if
- take it as soon as you remember, with headache, numbness or tingling you notice any side effects not listed in
your next meal. However, if it is time around the mouth, weakness, pale the leaflet, please tell your doctor or
for your next dose, do not take the skin, hunger, clumsy or jerky pharmacist.
missed dose. movements You may report any side effects or
Take only a single dose as usual. - If hypoglycemia is not treated, severe adverse drug reactions directly to the
- Do not take a double dose to make up symptoms may develop. Be sure that National Centre for Adverse Drug
for a forgotten dose your family, friends, and other people Reaction Monitoring by calling Tel: 03-
who spend time with you know that if 78835550, or visiting the website
• If you take too much (overdose), you have any of the following portal.bpfk.gov.my (Consumers 
Tell your doctor or go to the nearest symptoms, they should get medical Reporting)
hospital casualty department straight treatment for you immediately:
away. Remember to take the pack and Confusion, seizures, loss of
any remaining tablets with you. This is consciousness
so the doctor knows what you have
taken.
The following effects may happen if
you take too much metformin: feeling
very sick or being very sick, very fast
breathing which you cannot stop,
stomach pains or feeling cold. You may
have something called lactic acidosis.

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Consumer Medication Information Leaflet (RiMUP)

7. Storage and Disposal of


METFORMIN
Storage
- Keep your medicine in a safe place
out of the reach and sight of children.
- Do not store above 25°C. Store in the
original package.

Disposal
- Do not take this medicine after the
expiry date which is stated on the
packagings.
- Medicines should not be disposed of
via waste water or household waste.
Ask your pharmacist how to dispose
of medicines no longer required.
These measures will help to protect
the environment.

8. Product description
• What it looks like
Metformin Tablet 500mg is white, flat,
round, scored tablets with the marking
‘M’ on the surface.
Metformin Tablet 500mg is available in
blister pack of 10 tablets (in boxes of
10x10's and 100x10's) and plastic
container of 1000 tablets.
(Not all pack sizes may be marketed.)
• Your doctor may have given you this
medicine before from another company.
It may have looked slightly different.
However, either brand will have the
same effect.

• Ingredients
Each tablet contains 500mg of
metformin hydrochloride as the active
ingredient. Other ingredients are starch,
lactose, PVP K90, isopropyl alcohol
(IPA) & magnesium stearate

• MAL No.: MAL19961876A

9. Manufacturer and product


registration holder:
Dynapharm (M) Sdn Bhd (65683-V),
2497, Mk. 1, Lorong Perusahaan Baru
5, Kawasan Perusahaan Perai 3,
13600 Perai, Pulau Pinang,
MALAYSIA

10. Date of Revision:


1 April 2014

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