Patient leaflet - SITUKA SR 750 MG PROLONGED-RELEASE TABLETS
Package leaflet: Information for the patient
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, pharmacist or nurse.
-
– 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
This product will be referred to as Situka SR from here on.
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 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■ if you are allergic to metformin or any of the other ingredients of this medicine (listed in section 6)
-
■ if you have long-term kidney problems or if you have severely reduced kidney function or liver problems
-
■ if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactate acidosis (see “Risk of lactic acidosis” below) or ketoacidosis. Ketoacidosis is a condition in which substances called ‚ketone bodies‘ accumulate in the blood and which can lead to diabetic pre-coma. Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity smell. In rare instances this could lead to unconsciousness.
-
■ 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.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Situka SR.
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).
You may see some remains of the tablets in your stools. Do not worry – this is normal for this type of tablet.
Continue to follow any dietary advice that your doctor has given you and make sure that you eat carbohydrates regularly throughout the day.
Risk of lactic acidosis
Situka SR may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease).
If any of the above apply to you, talk to your doctor for further instructions.
Stop taking Situka SR for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. Talk to your doctor for further instructions.
Stop taking Situka SR and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis
Symptoms of lactic acidosis include:
-
■ vomiting
-
■ stomach ache (abdominal pain)
-
■ muscle cramps
-
■ a general feeling of not being well with severe tiredness
-
■ difficulty in breathing
-
■ reduced body temperature and heartbeat.
Lactic acidosis is a medical emergency and must be treated in a hospital.
If you need to have major surgery you must stop taking Situka SR during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Situka SR.
During treatment with Situka SR, your doctor will check your kidney function at least once a year and more frequently if you are elderly and/or if you have worsening kidney function.
Other medicines and Situka SR
If you need to have an injection of contrast medium that contains iodine into your bloodstream, for example for in the context of an X-ray or scan, you must stop taking Situka SR before or at the time of the injection. Your doctor will decide when you must stop and when to restart your treatment with Situka SR.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dosage of Situka SR. It is especially important to mention the following:
- Steroids such as prednisolone, mometasone, beclometasone used to treat a variety of conditions, such as severe inflammation of the skin or in asthma
- medicines which increase urine production (Diuretics)
- 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
- medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib)
- certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists, verapamil).
- medicines used to treat infections (rifampicin, trimethoprim, isavuconazole)
- medicines used to treat HIV/AIDS (dolutegravir)
- medicines used to treat heart conditions such as angina (ranolazine)
- medicines used to treat different types of cancers (vandetanib, crizotinib, olaparib)
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.
Avoid excessive alcohol while taking Situka SR since this may increase the risk of lactic acidosis (see section “Warnings and precautions”).
Pregnancy and breast-feeding
Pregnancy
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. So that he or she may change your treatment.
During pregnancy, you need insulin to treat your diabetes.
Breast-feeding
It is not recommended to take Situka SR during breast-feeding. Your doctor will decide whether you should stop breast-feeding whilst you are treated with Situka SR.
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
.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor may only prescribe you this medicine or in combination with other oral antidiabetic medicines or insulin.
Swallow whole with a glass of water. Do not chew or crush the tablets. You should always take the tablets with food.
If you have reduced kidney function, your doctor may prescribe a lower dose.
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, pharmacist or nurse.
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).
Situka SR may cause a very rare (may affect up to 1 user in 10,000), but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this happens you should stop taking Situka SR and contact a doctor or the nearest hospital immediately , as lactic acidosis may lead to coma.
- 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.
- severe allergic reaction (very rare). Symptoms include red rash, swollen throat, trouble breathing.
Other possible side effects are listed by frequency as follows:
Very common (may affect more than 1 in 10 people):
- 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, 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: Website: or search for MHRA Yellow Card in the Google Play or Apple App Store.
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 stated on the carton 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 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 and Manufacturer
Mercury Pharmaceuticals Ltd,
Capital House,
85 King William Street,
London EC4N 7BL,
UK
This leaflet was last revised in February 2019.