Metplitin Co

METPLITIN CO contains two different prescription medicines, sitagliptin hydrochloride monohydrate and metformin hydrochloride.

• Sitagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors).

• Metformin belongs to a class called biguanides. They work together to control blood sugar levels in adult patients with a form of diabetes called “Type 2 diabetes mellitus”. Type 2 diabetes is also called non-insulin-dependent diabetes mellitus or NIDDM. This medicine helps to increase the levels of insulin produced after a meal and lowers the amount of sugar made by your body. Along with diet and exercise, METPLITIN CO helps lower your blood sugar. METPLITIN CO can be used alone or with certain other medicines for diabetes (sulphonylureas).

What is Type 2 diabetes?

Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems like heart disease, kidney disease, blindness, and amputation.

Do not take METPLITIN CO if you:

• are allergic (hypersensitive) to sitagliptin or metformin or any of the other ingredients of METPLITIN CO (see “What METPLITIN CO contains”).
• have severely reduced kidney function.
• have uncontrolled diabetes, with e.g., high blood glucose, nausea, vomiting, diarrhoea, rapid weight loss, lactic 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.
• have a severe infection or are dehydrated.
• are going to have an X-ray where you will be injected with a dye. You will need to stop taking METPLITIN CO at the time of the X-ray and for 2 or more days after as directed by your doctor, depending on how your kidneys are working.
• have recently had a heart attack or have severe circulatory problems, such as ‘shock’ or breathing difficulties.
• have liver problems.
• drink alcohol to excess (either every day or only from time to time).
• are breastfeeding.

Warnings and precautions

Special care should be taken with METPLITIN CO: Before you start taking METPLITIN CO, tell your doctor if you suffer from any of the following:

• if you have pancreas problems. Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving METPLITIN CO (see section 4).
• if you have or have had an allergic reaction to sitagliptin, metformin, or METPLITIN CO (see section 4).
• if you are elderly.
• if you are taking a sulphonylurea, diabetes medicines, together with METPLITIN CO, as you may experience low blood sugar levels (hypoglycaemia). Your doctor may reduce the dose of your sulphonylurea or insulin.
• if you have skin problems.
• if you encounter blistering of the skin, it may be a sign for a condition called bullous pemphigoid. Your doctor may ask you to stop METPLITIN CO.
• Risk of lactic acidosis: METPLITIN CO 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 METPLITIN CO 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 METPLITIN CO and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma. 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 have high blood sugar (characterised by symptoms such as excessive thirst, passing of large amounts of urine, increase in appetite and feeling weak), or a family history of diabetes.
• if you need to have major surgery you must stop taking METPLITIN CO during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with METPLITIN CO.
• during treatment with METPLITIN CO your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.

Children and adolescents

Children and adolescents below 18 years should not use this medicine.

Use in the elderly

METPLITIN CO should be used with caution as age increases. Care should be taken in dose selection and should be based on careful and regular monitoring of kidney function.

Do not share medicines prescribed for you with any other person. Always take METPLITIN CO exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Do not change the dose or stop taking METPLITIN CO without talking with your doctor or pharmacist. Talk with your doctor about how long you should keep on taking METPLITIN CO.

METPLITIN CO is for oral use. You should swallow your tablet whole with a glass of water. METPLITIN CO can be taken with food.

Take the dose prescribed to you by your doctor twice daily, with meals. Your doctor may need to increase your dose to control your blood sugar. If you have reduced kidney function, your doctor may prescribe a lower dose. You should continue the diet recommended by your doctor during treatment with this medicine and take care that your carbohydrate intake is equally distributed over the day. METPLITIN CO alone is unlikely to cause abnormally low blood sugar (hypoglycaemia). When this medicine is used with a sulphonylurea medicine, low blood sugar can occur and your doctor may reduce the dose of your sulphonylurea or insulin.

If you have the impression that the effect of METPLITIN CO is too strong or too weak, talk to your doctor or pharmacist.

If you take more METPLITIN CO than you should

If you take more than the prescribed dosage of this medicine, contact your doctor immediately. Go to the hospital if you have symptoms of lactic acidosis such as feeling cold or uncomfortable, severe nausea or vomiting, stomach ache, unexplained weight loss, muscular cramps, or rapid breathing (see section “Warnings and precautions”).

If you forget to take METPLITIN CO

If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose of this medicine.

If you stop taking METPLITIN CO

Continue to take this medicine as long as your doctor prescribes it so you can continue to help control your blood sugar. You should not stop taking this medicine without talking to your doctor first. If you stop taking METPLITIN CO, your blood sugar may rise again. If you have any further questions on the use of this product, ask your doctor, pharmacist or other healthcare provider.

METPLITIN CO can have side effects. Not all side effects reported for METPLITIN CO are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking METPLITIN CO, please consult your doctor, pharmacist or other health care professional for advice.

If any of the following happens, stop taking METPLITIN CO and tell your doctor, pharmacist or healthcare provider immediately or go to the casualty department at your nearest hospital:

• rash, hives, blisters on the skin/peeling skin and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing, throat tightness, shortness of breath and wheezing. Allergic reactions, including death, can happen in patients taking METPLITIN CO even after only one dose.
• severe and persistent pain in the abdomen (stomach area) which might reach through to your back with or without nausea and vomiting, as these could be signs of an inflamed pancreas (pancreatitis).
• METPLITIN CO may cause a very rare, but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this happens, you must stop taking METPLITIN CO and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to METPLITIN CO. You may need urgent medical attention or hospitalisation.

Tell your doctor, pharmacist or healthcare provider if you notice any of the following:

Frequent side effects

• low blood sugar levels.
• feeling sick (nausea), throwing up (vomiting), passing gas (flatulence).

Less frequent

• decrease in platelets which causes nosebleeds, bleeding gums, blood in urine, heavy menstrual periods, and bruising.
• feeling sleepy.
• loose stools (diarrhoea), hard stools (constipation), stomach pain.
• itching.

Side effects with unknown frequencies

• allergic reactions.
• lung disease.
• inflammation of the pancreas.
• swelling, rash, hives.
• joint, muscle, back and leg and arm pains.
• kidney problems.

If you notice any other side effects not on this leaflet, please inform your doctor, pharmacist or other healthcare provider.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist or health care professional. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of Metplitin Co.

Store at or below 25 °C. Protect from light and moisture. Keep the tablets in the blisters and the blisters in the outer carton until required for use. Keep all medicines out of reach and sight of children. Do not dispose medicines in drains or sewerage systems (e.g. toilets). Do not store in bathrooms. Do not use after the expiry date stated on the carton/blister.