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SITUKA SR 1000MG PROLONGED RELEASE TABLETS

Active substance(s): METFORMIN HYDROCHLORIDE

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Package leaflet: Information for the patient

Situka SR 500 mg, 750 mg and 1000 mg
prolonged release tablets
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.
2.
3.
4.
5.
6.

What Situka SR is and what it is used for
What you need to know before you take Situka SR
How to take Situka SR
Possible side effects
How to store Situka SR
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
enough to control blood glucose (sugar). Insulin is a hormone that enables
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
insulin in their pancreas or their body does not respond properly to the insulin
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.

3. How to take Situka SR
Your doctor may only prescribe you this medicine, or in combination with
other oral antidiabetic medicines or insulin.
Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
Swallow whole with a glass of water. Do not chew or crush the tablets. You
should always take the tablets with food.

The recommended dose is:
Usually you will start treatment with 500 milligrams Situka SR daily. After you
have been taking Situka SR for about 2 weeks, your doctor may measure
your blood sugar and adjust the dose. The maximum daily dose is 2000
milligrams of Situka SR.
Normally, you should take the tablets once a day, however in some cases,
your doctor may recommend that you take the tablets twice a day.
Keep taking Situka SR for as long as your doctor recommends. This medicine
will help control your diabetes, but will not cure it. Situka SR is usually taken
for long periods of time. When you start treatment it can take some weeks for
your blood glucose levels to be properly controlled.

Use in children and adolescents:
Do not give this medicine to children and adolescents under the age of 18
because efficacy and safety have not been established for this age group
(see section 2, ‘Do not take Situka SR’).

If you take more Situka SR than you should:
If you take extra tablets by mistake you need not worry, but if you have
unusual symptoms, contact your doctor. If the overdose is large, lactic
acidosis is more likely and this is a medical emergency requiring treatment in
hospital (see also section ‘4, Possible side effects’).

If you forget to take Situka SR:
If you forgot to take one dose of Situka SR, take it as soon as you remember
with some food.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor
or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.

If you notice any of the following, stop taking Situka SR and see your
doctor immediately:
• unexpected weight loss
• very severe nausea or vomiting
• very fast breathing which you cannot stop
• stomach pains or feeling cold
These can be signs of serious problems with your diabetes and may mean
you have a very rare side effect called “lactic acidosis” (too much acid in the
blood). If this happens, see a doctor as you will need treatment straight away.
• Abnormal liver function tests and hepatitis (inflammation of the liver) which
may result in jaundice. If you develop yellowing of the eyes and/or skin
contact your doctor immediately.

Other possible side effects are listed by frequency as follows:
Very common (may affect more than 1 person in 10):
• Diarrhoea, nausea, vomiting, stomach ache or loss of appetite.
If you get these, do not stop taking the tablets as these symptoms will
normally go away in about 2 weeks. It helps if you take the tablets with or
immediately after a meal.

Common (may affect up to 1 in 10 people):
• Taste disturbance

Very rare (may affect up to 1 in 10,000 people):
• Decreased vitamin B12 levels
• Skin rashes including redness, itching and hives.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also report
side effects directly via 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 Situka SR
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is printed on the pack
after “EXP:”. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help to protect the environment.

6. Contents of the pack and other information
What Situka SR contains
- The active substance is metformin hydrochloride. Each prolonged release
tablet contains 500, 750 or 1000 milligrams of metformin hydrochloride.
- The other ingredients are magnesium stearate, silica colloidal anhydrous,
povidone-K30 and hypromellose.

What Situka SR looks like and contents of the pack
500 mg: White to off white capsule shaped, 16.50 mm x 8.20 mm uncoated
tablet debossed with ‘XR500’ one side and plain on other side.
750 mg: White to off white capsule shaped 19.60 mm x 9.30 mm uncoated
tablet debossed with ‘XR750’ one side and plain on other side.
1000 mg: White to off white capsule shaped 21.10 mm x 10.10 mm uncoated
tablet debossed with ‘XR1000’ one side and plain on other side.
Situka SR 500 mg, 750 mg and 1000 mg Prolonged Release Tablets are
supplied in blister packs of 28 or 56 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mercury Pharmaceuticals Ltd,
Capital House,
85 King William Street,
London EC4N 7BL,
UK

Manufacturer
Mercury Pharmaceuticals Ltd,
Capital House,
85 King William Street,
London EC4N 7BL,
UK
This leaflet was last revised in September 2014.
102065-66-67-68-69-70/LF/1

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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