FRONT    I

140 mm    i

...........................................................................................................................................................►!

PHARMA CODE

w	l	m
MercuryPharma	1
Package leaflet: Information for the patient	o
Situka SR 500 mg, 750 mg and 1000 mg	u m

Metformin hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    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 only. 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 of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1.    What Situka SR is and what it is used for

2.    What you need to know before you take Situka SR

3.    How to take Situka SR

4.    Possible side effects

5.    How to store Situka SR

6.    Contents of the pack and other information

1. What Situka SR is and what it is used for

Situka SR prolonged release tablets contain the active ingredient metformin hydrochloride and belong to a group of medicines called ‘biguanides’, used in the treatment of diabetes.

Situka SR is used for the treatment of Type 2 (non-insulin dependent) diabetes mellitus when diet and exercise changes alone have not been	ID
enough to control blood glucose (sugar). Insulin is a hormone that enables	> 7J
body tissues to take glucose from the blood and to use it for energy or for	<: >
storage for future use. People with Type 2 diabetes do not make enough	o o
insulin in their pancreas or their body does not respond properly to the insulin	o m
it does make. This causes a build-up of glucose in the blood which can cause

a number of serious long-term problems. This is why it is important that you continue to take your medicine, even though you may not have any obvious symptoms. Situka SR makes the body more sensitive to insulin and helps return to normal the way your body uses glucose.

Situka SR is associated with either a stable body weight or modest weight loss. Situka SR prolonged release tablets are specially made to release the medicine slowly in your body and therefore they are different than many other types of tablet containing metformin.

2. What you need to know before you take Situka SR

Do not take Situka SR:

•    if you are allergic to metformin or to any of the other ingredients of this medicine (listed in section 6)

•    if you have ketosis (this is a symptom of uncontrolled diabetes in which substances called ‘ketone bodies’ accumulate in the blood - you may notice that your breath has an unusual, fruity odour)

•    if you have long-term kidney or liver problems

•    if you have had serious complications with your diabetes or other serious conditions which resulted in rapid weight loss, nausea, vomiting or dehydration

•    if you have a severe infection or have recently suffered a severe injury

•    if you have been treated for heart problems or have recently had a heart attack or have severe circulatory problems or breathing difficulties

•    if you are a heavy alcohol drinker

•    if you are under 18 years of age.

Warnings and precautions

After you have started taking this medicine

If you have diabetes you should have your blood or urine tested for sugar regularly. You should go to your doctor at least once a year to check how your kidneys work (more often if you are elderly or if you already have kidney problems).

If you start to lose weight unexpectedly or suffer severe nausea or vomiting, uncontrolled rapid breathing or abdominal pains, stop taking the medicine and tell your doctor straight away. This can be a sign of a rare, but serious, complication with your diabetes called ‘lactic acidosis’ which means there is too much acid in your blood (see also section ‘4. Possible side effects’).

You may see some remains of the tablets in your stools. Do not worry - this is normal for this type of tablet.

If you need to have an X-ray examination involving the injection of a dye, tell the doctor that you take Situka SR as you may need to stop taking it for a few days before and after the examination.

Tell your doctor if you are going to have an operation under general anaesthetic, as you may need to stop taking Situka SR for a couple of days before and after the procedure.

Continue to follow any dietary advice that your doctor has given you and make sure that you eat carbohydrates regularly throughout the day.

Do not stop taking this medicine without speaking to your doctor first.

Other medicines and Situka SR:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you are taking any of the following medicines, your blood sugar levels may need to be checked more often and your dose adjusted:

•    Steroids such as prednisolone, mometasone, beclometasone

•    Diuretics (water tablets) such as furosemide

•    Sympathomimetic medicines including epinephrine and dopamine used to treat heart attacks and low blood pressure. Epinephrine is also included in some dental anaesthetics

•    Certain medicines used to treat stomach problems such as cimetidine. Avoid drinking alcohol and using alcohol-containing medicines while taking Situka SR as you could be at a greater risk of developing lactic acidosis (see above, ‘Warnings and precautions’ and section ‘4. Possible side effects’).

Situka SR with food, drink and alcohol:

Take Situka SR with or immediately after food. Your doctor may suggest that you stop drinking alcohol or reduce the amount of alcohol you drink. Alcohol can affect the control of your diabetes. Drinking excessive amounts of alcohol while you are being treated with Situka SR may also lead to serious side effects.

Pregnancy and breast-feeding:

Do not take Situka SR if you are pregnant, planning to become pregnant or breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines:

Situka SR taken on its own does not cause ‘hypos’ (symptoms of low blood sugar or hypoglycaemia, such as faintness, confusion and increased sweating) and therefore should not affect your ability to drive or use machinery.

You should be aware, however, that Situka SR taken with other antidiabetic medicines can cause hypos, so in this case you should take extra care when driving or operating machinery.