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This medicine helps to lower your blood sugar.
What is Simvia and what is it used for?
• Active substances: Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg sitagliptin and 1000 mg metformin hydrochloride.
Sitagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors).
Metformin belongs to a class of medicines called biguanides.
They work together to control blood sugar levels in adult patients with type 2 diabetes mellitus. This medicine helps to increase the levels of insulin produced after a meal and decreases the amount of sugar made by your body.
Together with diet and exercise, this medicine helps to lower your blood sugar. This medicine may be used alone or together with certain other medicines for diabetes (insulin, sulfonylureas, or glitazones).
• The other ingredients are:
Core – microcrystalline cellulose (Avicel PH 102), povidone, sodium lauryl sulfate, magnesium stearyl fumarate;
Coating for Simvia 50 mg/1000 mg (Opadry QX Brown (321A265038)) – macrogol (PEG) polyvinyl alcohol graft copolymer (E1209), talc (E553b), titanium dioxide (E171), iron oxide red (E172), GMDCC, GMCC type 1 mono/diglycerides, glycerol (E471), polyvinyl alcohol – partially hydrolyzed (E1203), ferrosoferric oxide/black iron oxide (E172)
Do not take Simvia:
- If you are allergic to sitagliptin or metformin or any of the other ingredients of this medicine.
- If you have severely reduced kidney function.
- If you have uncontrolled diabetes, for example with severe hyperglycemia (high blood glucose), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis or ketoacidosis. Ketoacidosis is a condition in which substances called “ketone bodies” accumulate in the blood and may lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, sleepiness or your breath developing an unusual fruity smell.
- If you have a severe infection or are dehydrated.
- If you are going to have an X-ray procedure in which you will be injected with a dye. You must stop taking Simvia at the time of and for 2 or more days after the X-ray, as directed by your doctor, depending on how well your kidneys are working.
- If you have recently had a heart attack or have severe circulation problems such as “shock” or difficulty breathing.
- If you have liver problems.
- If you drink alcohol excessively (every day or only from time to time).
- If you are breastfeeding.
Do not take Simvia if any of the above applies to you and talk to your doctor about other ways to control your diabetes. If you are not sure, talk to your doctor, pharmacist or nurse before taking Simvia.
Warnings and precautions:
Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving sitagliptin/metformin.
Blistering of the skin may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop Simvia.
Risk of lactic acidosis
Simvia 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, liver problems and any medical condition in which a part of the body is supplied with a reduced amount of oxygen (such as acute severe heart disease).
If any of the above applies to you, talk to your doctor for further instructions.
Stop taking Simvia for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, exposure to heat or if you drink less fluid than normal. Contact your doctor for further instructions.
Stop taking Simvia 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,
- stomachache (abdominal pain),
- muscle cramps,
- a general feeling of being unwell with severe tiredness,
- difficulty breathing,
- reduced body temperature and heartbeat.
Lactic acidosis is a medical emergency and must be treated in a hospital. Talk to your doctor or pharmacist before taking Simvia.
- If you have or have had a disease of the pancreas (such as pancreatitis).
- If you have or have had gallstones, alcohol dependence or very high levels of triglycerides (a form of fat) in your blood. These medical conditions may increase your chance of getting pancreatitis.
- If you have type 1 diabetes. This is sometimes called insulin-dependent diabetes.
- If you have or have had an allergic reaction to sitagliptin, metformin or Simvia.
- If you are taking a sulfonylurea or insulin, medicines for diabetes, together with Simvia, as you may experience low blood sugar (hypoglycemia). Your doctor may reduce your dose of sulfonylurea or insulin.
- If you need to have major surgery, you must stop taking Simvia during the procedure and for some time afterwards. Your doctor will decide when you must stop and when to restart your treatment with Simvia.
During treatment with Simvia, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or have worsening kidney function.
Children and adolescents:
Children and adolescents under 18 years should not use this medicine. It is not effective in children and adolescents between 10 and 17 years of age. It is not known whether this medicine is safe and effective when used in children under 10 years of age.
Other medicines and Simvia:
If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Simvia before or at the time of injection. Your doctor will decide when you must stop and when to restart your treatment with Simvia.
Tell your doctor or pharmacist 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 dose of Simvia. It is especially important to mention the following:
• Medicines (taken by mouth, inhalation or injection) used to treat diseases that involve inflammation, such as asthma and arthritis (corticosteroids),
• Medicines that increase urine production (diuretics),
• Medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib),
• Certain medicines for treating high blood pressure (ACE inhibitors and angiotensin II receptor antagonists),
• Specific medicines for treating bronchial asthma (β-sympathomimetics),
• Iodinated contrast agents or alcohol-containing medicines,
• Certain medicines used to treat stomach problems, such as cimetidine,
• Ranolazine, a medicine used to treat angina,
• Dolutegravir, a medicine used to treat HIV infection,
• Vandetanib, a medicine used to treat a specific type of thyroid cancer (medullary thyroid carcinoma),
• Digoxin (to treat irregular heartbeat and other heart problems). When taken with Simvia, the level of digoxin in your blood may need to be checked.
Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take this medicine during pregnancy. Do not take this medicine if you are breastfeeding.
Driving and using machines:
This medicine has no or negligible influence on the ability to drive and use machines. However, dizziness and drowsiness have been reported with sitagliptin, which may affect your ability to drive or use machines.
Taking this medicine in combination with sulfonylureas or insulin may cause hypoglycemia, which may affect your ability to drive and use machines.
Contains: less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.
Method of use:
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Take one tablet:
• twice daily by mouth,
• with meals to reduce the chance of stomach upset.
• 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.
- During treatment with this medicine you should continue the diet recommended by your doctor and take care that your carbohydrate intake is evenly distributed throughout the day.
- When this medicine is used with a sulfonylurea or insulin, low blood sugar may occur and your doctor may reduce your dose of sulfonylurea or insulin.
If you take more Simvia than you should: contact a doctor immediately. Go to the hospital if you have symptoms of lactic acidosis such as feeling cold or uncomfortable, severe nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps or rapid breathing.
If you forget to take Simvia: 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 return to your regular schedule. Do not take a double dose of this medicine.
If you stop taking Simvia: continue to take this medicine for as long as your doctor prescribes it to help control your blood sugar. You should not stop taking this medicine without first talking to your doctor. If you stop taking Simvia, your blood sugar may rise again.
Possible side effects:
Stop taking Simvia and contact a doctor immediately if you notice any of the following serious side effects:
• Severe and persistent pain in the abdomen (stomach area), which may reach through to your back, with or without nausea and vomiting, as this could be a sign of inflammation of the pancreas (pancreatitis).
• Simvia may cause a very rare but very serious side effect called lactic acidosis. If this happens, you must stop taking Simvia and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
• If you have a serious allergic reaction (frequency unknown), including 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, stop taking this medicine and call your doctor right away. Your doctor may prescribe a medicine to treat your allergic reaction and another medicine for your diabetes.
Some patients taking metformin have experienced the following side effects after starting sitagliptin:
Common: low blood sugar, nausea, flatulence, vomiting
Uncommon: stomach pain, diarrhea, constipation, drowsiness.
Some patients have experienced diarrhea, nausea, flatulence, constipation, stomach pain or vomiting when starting the combination of sitagliptin and metformin (common).
Some patients have experienced the following side effects when taking this medicine with a sulfonylurea such as glimepiride:
Very common: low blood sugar
Common: constipation
Some patients have experienced the following side effects when taking this medicine with pioglitazone:
Common: swelling of the hands or legs
Some patients have experienced the following side effects when taking this medicine with insulin:
Very common: low blood sugar
Uncommon: dry mouth, headache
Some patients have experienced the following side effects in clinical studies when taking sitagliptin alone:
Common: low blood sugar, headache, upper respiratory tract infection, runny nose and sore throat, osteoarthritis, pain in arm or leg
Uncommon: dizziness, constipation, itching
Rare: reduced platelet count
Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blistering)
Some patients have experienced the following side effects when taking metformin alone:
Very common: nausea, vomiting, diarrhea, stomach pain and loss of appetite. These symptoms may occur when you start taking metformin and usually go away over time.
Common: metallic taste, reduced or low vitamin B12 levels in the blood (symptoms may include extreme tiredness (fatigue), a sore and red tongue (glossitis), tingling or prickling sensation (paresthesia) or pale or yellow skin). Your doctor may run some tests to find out the cause of your symptoms as some of these may also be caused by diabetes or other unrelated health problems.
Very rare: hepatitis (a liver problem), hives, redness of the skin (rash) or itching.
Storage:
- 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 blister and carton after “EXP”. The expiry date refers to the last day of that month.
- Do not throw away 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.
Dispensing conditions: Pharmaceutical product group II, dispensed with prescription form №3
Shelf life:24 months
Storage conditions: Do not store above 25°C
Manufactured by
Laboratorios LICONSA, SA
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo,
19200 Azuqueca de Henares (Guadalajara), Spain
Marketing Authorisation Holder
D&FISHER CO LTD
Niriidon 5, Strovolos, 2045 Nicosia, Cyprus
