Laossian

Patient Information Leaflet: Information for the User

LAOSSIAN 50 mg/850 mg film-coated tablets, 50 mg/1000 mg film-coated tablets

sitagliptin / metformin hydrochloride
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What LAOSSIAN is and what it is used for
2. What you need to know before taking LAOSSIAN
3. How to take LAOSSIAN
4. Possible side effects
5. How to store LAOSSIAN
6. Contents of the pack and other information

1. What LAOSSIAN is and what it is used for

LAOSSIAN contains two different medicines called sitagliptin and metformin.

• sitagliptin belongs to a class of medicines known as DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors)
• metformin belongs to a class of medicines known as biguanides.

They work together to control blood sugar levels in adult patients with a form of diabetes called "type 2 diabetes mellitus". This medicine helps increase insulin levels produced after meals and reduces the amount of sugar made by the body.
Together with diet and exercise, this medicine helps lower blood sugar levels.
This medicine may be used alone or in combination with certain other diabetes medicines (insulin, sulfonylureas or glitazones).

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

2. What you need to know before taking LAOSSIAN

Do not take LAOSSIAN:

• if you are allergic to sitagliptin, metformin, or any of the excipients of this medicine (listed in section 6)

• if you have severely reduced kidney function

• if you have uncontrolled diabetes associated, for example, with severe hyperglycemia (high blood glucose levels), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see below "Risk of 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, drowsiness, and breath with an unusual fruity odor

• if you have a severe infection or are dehydrated

• if you are about to undergo radiographic imaging involving the use of a contrast agent. You will need to stop taking LAOSSIAN at the time of the imaging procedure and for 2 or more days afterwards, as directed by your doctor, depending on how well your kidneys are functioning

• if you have recently had a heart attack or have serious circulatory problems, such as "shock" or breathing difficulties

• if you have liver problems

• if you drink excessive amounts of alcohol (either regularly or occasionally)

• if you are breastfeeding

Do not take LAOSSIAN if you have any of the above conditions and speak with your doctor about alternative methods of managing diabetes. If you are unsure, consult your doctor, pharmacist, or nurse before taking LAOSSIAN.

Warnings and precautions

Cases of inflammation of the pancreas (pancreatitis) have been reported in patients treated with LAOSSIAN (see section 4).

If you develop blisters on your skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop treatment with LAOSSIAN.

Risk of lactic acidosis

LAOSSIAN may cause a very rare but serious side effect called lactic acidosis, particularly if your kidneys are not functioning properly. The risk of developing lactic acidosis is higher in the presence of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see below for further information), liver problems, or any other medical condition characterized by reduced oxygen supply to part of the body (such as severe heart disease).

If you have any of the medical conditions described above, consult your doctor for further instructions.

Seek immediate medical advice if:

• you know you have a hereditary genetic disease affecting mitochondria (the components that produce energy within cells), such as MELAS syndrome (Mitochondrial Encephalopathy, myopathy, Lactic Acidosis and Stroke-like episodes) or maternally inherited diabetes and deafness (MIDD);
• you experience any of the following symptoms after starting metformin: seizures, reduced cognitive ability, movement difficulties, symptoms indicating nerve damage (e.g., pain or numbness), headache, or hearing loss.

Temporarily stop taking LAOSSIAN if you develop a medical condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you are drinking less fluid than usual. Consult your doctor for further instructions.

If you experience any symptoms of lactic acidosis, stop taking LAOSSIAN immediately and seek urgent medical attention at the nearest hospital, as lactic acidosis can lead to coma. Symptoms of lactic acidosis include:

• vomiting
• stomach ache (abdominal pain)
• muscle cramps
• a general feeling of being unwell accompanied by severe fatigue
• difficulty breathing
• reduced body temperature and slower heart rate

Lactic acidosis is a medical emergency and must be treated in a hospital.

Consult your doctor or pharmacist before taking LAOSSIAN:

• if you have or have had a pancreatic disease (such as pancreatitis)
• if you have or have had gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood. These medical conditions may increase your risk of developing pancreatitis (see section 4)
• if you have type 1 diabetes. This is sometimes referred to as insulin-dependent diabetes
• if you have or have had an allergic reaction to sitagliptin, metformin, or LAOSSIAN (see section 4)
• if you are taking a sulfonylurea or insulin—medicines for diabetes—along with LAOSSIAN, as this may cause excessively low blood sugar levels (hypoglycemia). Your doctor may reduce the dose of sulfonylurea or insulin.

If you are scheduled for major surgery, you must stop taking LAOSSIAN during the procedure and for a certain period afterwards. Your doctor will decide when to stop and when to restart treatment with LAOSSIAN.

If you are unsure whether any of the conditions listed above apply to you, consult your doctor or pharmacist before taking LAOSSIAN.

During treatment with LAOSSIAN, your doctor will monitor your kidney function at least once a year, or more frequently if you are elderly and/or if kidney function worsens.

Children and adolescents

Children and adolescents under 18 years of age must not use this medicine. It is not effective in children and adolescents aged between 10 and 17 years. It is not known whether this medicine is safe and effective when used in children under 10 years of age.

Other medicines and LAOSSIAN

If you are scheduled to receive an injection of iodinated contrast medium into the bloodstream, for example during radiographic imaging, you must stop taking LAOSSIAN before or during the injection. Your doctor will decide when to stop and when to restart treatment with LAOSSIAN.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. You may need to monitor your blood glucose and kidney function more frequently, or your doctor may decide to adjust the dose of LAOSSIAN. It is particularly important to mention the following:

• medicines (taken orally, by inhalation, or by injection) used to treat inflammatory conditions 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 used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• specific medicines for bronchial asthma (ß-sympathomimetics)
• iodinated contrast agents or medicines containing alcohol
• 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 cancer)
• digoxin (used to treat irregular heartbeat and other heart-related problems). It may be necessary to monitor digoxin blood levels if taken together with LAOSSIAN.

LAOSSIAN and alcohol

Avoid excessive alcohol consumption while taking LAOSSIAN, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. You must not take this medicine during pregnancy or while breastfeeding. See section 2, Do not take LAOSSIAN.

Driving and using machines

This medicine has no effect or has a negligible effect 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 together with other medicines called sulfonylureas or insulin may cause hypoglycemia, which may affect your ability to drive, use machines, or work without protective barriers.

This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is essentially 'sodium-free'.

3. How to take LAOSSIAN

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

• Take one tablet:
  • twice daily by mouth,
  • with meals to reduce the likelihood of stomach upset.
• Your doctor may need to increase your dose to control the sugar level in your blood.
• If you have reduced kidney function, your doctor may prescribe you a lower dose.

You must continue the diet recommended by your doctor during treatment with this medicine and ensure that carbohydrate intake is evenly distributed throughout the day.
It is unlikely that this medicine alone will cause abnormally low blood sugar levels (hypoglycaemia). However, when this medicine is used together with a sulphonylurea medicine or insulin, low blood sugar may occur and your doctor may reduce your dose of sulphonylurea or insulin.

If you take more LAOSSIAN than you should
If you take more of this medicine than prescribed, contact your doctor immediately. Go to hospital if you experience symptoms of lactic acidosis such as feeling cold or unwell, severe nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps or rapid breathing (see section "Warnings and precautions").

If you forget to take LAOSSIAN
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 take your next dose at the usual time. Do not take a double dose of this medicine.

If you stop taking LAOSSIAN
Keep taking this medicine for as long as your doctor prescribes it, so that you can continue to control your blood sugar level. You should not stop treatment with this medicine without first talking to your doctor. If you stop treatment with LAOSSIAN, your blood sugar level may rise again.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
STOP taking LAOSSIAN and contact your doctor immediately if you notice any of the following serious side effects:

• Severe and persistent stomach (abdominal) pain that may spread to the back, with or without nausea and vomiting, as these may be signs of inflammation of the pancreas (pancreatitis).

LAOSSIAN can cause a very rare (may affect up to 1 in 10,000 people) but very serious side effect called lactic acidosis (see section "Warnings and precautions"). If this occurs, you must stop taking LAOSSIAN and seek immediate medical attention at the nearest doctor or hospital, as lactic acidosis can lead to coma.
If you experience a severe allergic reaction (frequency not known), including rash, hives, skin blistering or peeling, swelling of the face, lips, tongue or throat, which may cause difficulty breathing or swallowing, stop treatment with this medicine and contact your doctor immediately. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.
Some patients taking metformin have experienced the following side effects after starting sitagliptin therapy:
Common (may affect up to 1 in 10 people): low blood sugar level, nausea, flatulence, vomiting
Uncommon (may affect up to 1 in 100 people): stomach ache, diarrhoea, constipation, drowsiness
Some patients have experienced diarrhoea, nausea, flatulence, constipation, stomach ache or vomiting when starting combination treatment with LAOSSIAN (frequency is common).
Some patients have experienced the following side effects while taking this medicine with a sulfonylurea such as glimepiride:
Very common (may affect more than 1 in 10 people): low blood sugar level
Common: constipation
Some patients have experienced the following side effects while taking this medicine in combination with pioglitazone:
Common: swelling of the hands or legs
Some patients have experienced the following side effects while taking this medicine in combination with insulin:
Very common: low blood sugar level
Uncommon: dry mouth, headache
During clinical studies, some patients experienced the following side effects while taking sitagliptin alone (one of the medicines contained in LAOSSIAN) or during post-marketing use of LAOSSIAN, sitagliptin alone, or in combination with other diabetes medicines:
Common: low blood sugar level, headache, upper respiratory tract infection, stuffy or runny nose, sore throat, osteoarthritis, pain in arms or legs
Uncommon: dizziness, constipation, itching sensation
Rare: reduced platelet count
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 taking metformin alone have experienced the following side effects:
Very common: nausea, vomiting, diarrhoea, stomach ache and loss of appetite. These symptoms may occur when you first start taking metformin and usually go away.
Common: metallic taste, low or decreased blood levels of vitamin B12 (symptoms may include extreme tiredness (fatigue), sore and red tongue (glossitis), tingling sensations (paraesthesia), or yellowish or pale skin). Your doctor may carry out some tests to determine the cause of the symptoms, as some of these may also be caused by diabetes or other unrelated health problems.
Very rare: hepatitis (a liver problem), hives, skin redness (rash) or itching sensation.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store LAOSSIAN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What LAOSSIAN contains
The active substances are sitagliptin tartrate monohydrate and metformin hydrochloride.
LAOSSIAN 50 mg/850 mg film-coated tablets: each tablet contains 68.55 mg of sitagliptin
tartrate monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.
LAOSSIAN 50 mg/1000 mg film-coated tablets: each tablet contains 68.55 mg of sitagliptin
tartrate monohydrate equivalent to 50 mg of sitagliptin and 1000 mg of metformin hydrochloride.
The other components are: in the tablet core: microcrystalline cellulose 101, povidone,
sodium croscarmellose, sodium lauryl sulfate and sodium stearate fumarate. In addition, the tablet coating
contains: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide red (E172) and iron
oxide black (E172).
Description of the appearance of LAOSSIAN and pack contents
LAOSSIAN 50 mg/850 mg tablets are pink, film-coated, capsule-shaped, biconvex tablets, marked with “K21” on one side.
LAOSSIAN 50 mg/1000 mg tablets are red, film-coated, capsule-shaped, biconvex tablets, marked with “K22” on one side.
The tablets are available in OPA/Al/PVC/Al and aluminum blisters in packs of 56 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Errekappa Euroterapici S.p.A.
Via Ciro Menotti n. 1/A, 20129 Milan, Italy
Manufacturer
Synoptis Industrial sp. z o.o.
87-100 Toruń,
Forteczna Street No 35-37 – Poland