Sademlip

Leaflet accompanying the packaging: patient information

Sademlip, 50 mg + 850 mg, film-coated tablets

Sademlip, 50 mg + 1000 mg, film-coated tablets

Sitagliptin + Metformin hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet, so you can read it again if you need to.
In case of any doubts, consult a doctor, pharmacist, or nurse.
This medicine has been prescribed to a specific person. Do not pass it on to others.
The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor, pharmacist, or nurse.
See section 4.

Table of contents of the leaflet:

• 1. What is Sademlip and what is it used for
• 2. Important information before taking Sademlip
• 3. How to take Sademlip
• 4. Possible side effects
• 5. How to store Sademlip
• 6. Contents of the packaging and other information

1. What is Sademlip and what is it used for

Sademlip contains two different active substances called sitagliptin and metformin.
Sitagliptin belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors)
Metformin belongs to a group of medicines called biguanides.
The combined action of these medicines leads to the normalization of blood sugar levels in adult patients with diabetes known as "type 2 diabetes". This medicine helps to increase the amount of insulin released after a meal and reduce the amount of sugar produced by the body.
The medicine is used in combination with diet and physical exercise to reduce blood sugar levels.
This medicine may be used as the only anti-diabetic medicine or in combination with certain other anti-diabetic medicines (insulin, sulfonylurea derivatives, or glitazones).
What is type 2 diabetes?
In type 2 diabetes, the body does not produce enough insulin, and the insulin produced does not work as it should. The body may also produce too much sugar. If this happens, sugar (glucose) builds up in the blood. This can lead to serious health problems, such as heart disease, kidney disease, vision loss, and limb amputation.

2. Important information before taking Sademlip

When not to take Sademlip

if the patient is allergic to sitagliptin or metformin or to any of the other ingredients of this medicine (listed in section 6);
if the patient has significantly reduced kidney function,
if the patient has uncontrolled diabetes, such as severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or diabetic ketoacidosis. Diabetic ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and can lead to a diabetic pre-coma. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness or an unusual fruity odor from the mouth.
if the patient has a severe infection or dehydration,
if the patient is scheduled to undergo a radiological examination with intravascular administration of a contrast agent. The patient should stop taking Sademlip during the radiological examination and for 2 or more days, according to the doctor's instructions, depending on the patient's kidney function.
if the patient has recently had a heart attack or has had severe circulatory disorders, such as shock or breathing difficulties,
if the patient has liver disease,
if the patient consumes excessive amounts of alcohol (either daily or from time to time),
if the patient is breastfeeding.
Do not take Sademlip if any of the above contraindications apply. Consult a doctor to determine other methods of controlling diabetes. In case of doubt, before taking Sademlip, discuss it with a doctor, pharmacist, or nurse.

Warnings and precautions

Patients taking Sademlip have reported cases of pancreatitis (see section 4).
If the patient develops blisters on the skin, it may be a sign of a disease called pemphigoid blisters. The doctor may advise the patient to stop taking Sademlip.

Risk of lactic acidosis

Sademlip may cause a very rare but very serious side effect called lactic acidosis, especially if the patient has kidney problems. The risk of lactic acidosis also increases in case of uncontrolled diabetes, severe infections, prolonged fasting, or alcohol consumption, dehydration (see below), liver problems, or any conditions in which a part of the body is not sufficiently supplied with oxygen (e.g., acute severe heart disease). If any of these situations apply to the patient, they should consult a doctor for more detailed instructions.

Temporarily stop taking Sademlip if the patient has a condition

that may be associated with dehydration(significant loss of body water), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. The patient should consult a doctor for more detailed instructions.

Stop taking Sademlip and immediately contact a doctor or the nearest hospital if the patient experiences

any symptoms of lactic acidosis, as this condition can lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell, combined with severe fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires hospital treatment.
Before starting to take Sademlip, discuss the following with a doctor or pharmacist:

• if the patient has or has had pancreatitis (e.g., pancreatitis).
• if the patient has or has had gallstones, alcohol dependence, or very high triglyceride levels in the blood. In such cases, the risk of pancreatitis (see section 4) may increase.
• if the patient has type 1 diabetes. It is sometimes called insulin-dependent diabetes.
• if the patient has currently or has had allergic reactions to sitagliptin, metformin, or Sademlip (see section 4).
• if the patient is taking a sulfonylurea derivative or insulin, anti-diabetic medicines, at the same time as Sademlip, as this may lead to excessive reduction of blood sugar levels (hypoglycemia). The doctor may reduce the dose of the sulfonylurea derivative or insulin.

If the patient is to undergo major surgery, they should not take Sademlip during the surgery and for some time after it. The doctor will decide when the patient should stop and resume treatment with Sademlip.
In case of doubt, whether any of the above situations apply to the patient, before taking Sademlip, discuss it with a doctor or pharmacist.
During treatment with Sademlip, the doctor will monitor the patient's kidney function at least once a year or more often if the patient is elderly and (or) has worsening kidney function.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age. This medicine is not effective in children and adolescents aged 10 to 17 years. It is not known whether this medicine is safe and effective when used in children under 10 years of age.

Sademlip and other medicines

If the patient is to be injected with a contrast agent containing iodine, for example, for an X-ray examination or computed tomography, they should stop taking Sademlip before or at the latest at the time of injection. The doctor will decide when the patient should stop and resume treatment with Sademlip.
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. The patient may need more frequent blood sugar checks and kidney function tests or dose adjustments of Sademlip by the doctor. It is especially important to inform about the following medicines:
medicines (taken orally, by inhalation, or by injection) used to treat inflammatory diseases, such as asthma or 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 used to treat asthma (β-sympathomimetics),
contrast agents containing iodine or medicines containing alcohol,
certain medicines used to treat stomach disorders, such as cimetidine,
ranolazine, a medicine used to treat angina pectoris,
dolutegravir, a medicine used to treat HIV infection,
vandetanib, a medicine used to treat a certain type of thyroid cancer (medullary thyroid cancer),
digoxin (used to treat heart rhythm disorders and other heart diseases). When taking Sademlip with digoxin, the digoxin level in the blood should be monitored.

Sademlip with alcohol

Avoid consuming excessive amounts of alcohol while taking Sademlip, as this may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine. Do not take this medicine during pregnancy or breastfeeding. See section 2, When not to take Sademlip.

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 during treatment with sitagliptin, which may affect the ability to drive or use machines.
Taking this medicine at the same time as sulfonylurea derivatives or insulin may lead to hypoglycemia, which may affect the ability to drive or use machines or work without safe support for the feet.

Sademlip contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is considered "sodium-free".

3. How to take Sademlip

Always take this medicine exactly as the doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Take one tablet:
twice a day, orally;
with meals to reduce the likelihood of stomach upset.
To control blood sugar levels, the doctor may increase the dose of Sademlip.
If the patient has kidney problems, the doctor may prescribe a lower dose.
During treatment with this medicine, continue to follow the diet and pay attention to the uniform intake of carbohydrates throughout the day.
It is unlikely that taking this medicine alone will lead to abnormally low blood sugar levels (hypoglycemia). Hypoglycemia may occur when taking this medicine with a sulfonylurea derivative or insulin – in such cases, the doctor may reduce the dose of the sulfonylurea derivative or insulin.

Taking a higher dose of Sademlip than recommended

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

Missing a dose of Sademlip

If you miss a dose, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and continue taking the medicine as usual. Do not take a double dose to make up for the missed dose.

Stopping treatment with Sademlip

To maintain control of blood sugar levels, take the medicine for as long as the doctor recommends. Do not stop taking this medicine without consulting a doctor first.
Stopping treatment with Sademlip may cause blood sugar levels to rise again.
If you have any further questions about taking 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.
STOP taking Sademlip and contact a doctor immediatelyif you experience any of the following serious side effects:
Severe and persistent abdominal pain (in the stomach area), which may radiate to the back, with or without nausea and vomiting, as these may be symptoms of pancreatitis.
Sademlip may very rarely cause (may occur in less than 1 in 10,000 people) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this happens to you, stop taking Sademlip and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.
In case of a severe allergic reaction (frequency not known), including rash, hives, blisters on the skin, and (or) peeling of the skin, as well as swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing, stop taking the medicine and contact a doctor immediately. The doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes.
In some patients taking metformin after starting to take sitagliptin, the following side effects have occurred:
Common(may occur in less than 1 in 10 people): low blood sugar, nausea, bloating, vomiting
Uncommon(may occur in less than 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness
Some patients have experienced diarrhea, nausea, bloating, constipation, stomach pain, or vomiting after starting treatment with sitagliptin in combination with metformin (common).
In some patients taking this medicine at the same time as a sulfonylurea derivative, such as glimepiride, the following side effects have occurred:
Very common(may occur in more than 1 in 10 people): low blood sugar
Common(may occur in less than 1 in 10 people): constipation
In some patients taking this medicine in combination with pioglitazone, the following side effects have occurred:
Common(may occur in less than 1 in 10 people): swelling of the hands or feet
In some patients taking this medicine in combination with insulin, the following side effects have occurred:
Very common: low blood sugar
Uncommon: dry mouth, headache
In clinical trials, some patients taking only sitagliptin (one of the active substances of Sademlip) or after marketing authorization during treatment with Sademlip or sitagliptin alone or with other anti-diabetic medicines, the following side effects have occurred:
Common: low blood sugar, headache, upper respiratory tract infection, stuffy nose or sore throat, and joint or muscle pain
Uncommon: dizziness, constipation, itching
Rare: reduced platelet count
Frequency not known: kidney disease (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, pemphigoid blisters (a type of blisters on the skin
In some patients taking only metformin, the following side effects have occurred:
Very common: nausea, vomiting, diarrhea, stomach pain, and loss of appetite. These symptoms may occur after starting to take metformin and usually disappear.
Common: metallic taste
Very rare: reduced vitamin B12 levels, liver inflammation (liver disease), hives, skin rash, or itching

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Sademlip

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton, after "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Sademlip contains

The active substancesare sitagliptin and metformin hydrochloride.

Sademlip, 50 mg + 850 mg, film-coated tablets

Each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.

Sademlip, 50 mg + 1000 mg, film-coated tablets

Each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg of sitagliptin and 1000 mg of metformin hydrochloride.
The other ingredients are:
Tablet core:povidence (K30), sodium lauryl sulfate, microcrystalline cellulose, sodium carmellose, sodium stearyl fumarate.
Coating: hypromellose (type 2910), hydroxypropylcellulose, triethyl citrate, titanium dioxide (E 171), talc, yellow iron oxide (E 172), red iron oxide (E 172).

What Sademlip looks like and contents of the pack

Sademlip, 50 mg + 850 mg, film-coated tablets

Light orange, oval, biconvex film-coated tablet (approximately 10x20 mm)
with "SM 2" embossed on one side.

Sademlip, 50 mg + 1000 mg, film-coated tablets

Light red, oval, biconvex film-coated tablet (approximately 10.5x21 mm) with
"SM 3" embossed on one side.
The medicine is available in blisters of OPA/Aluminum/PVC/Aluminum or PVC/PE/PVDC/Aluminum and single-dose blisters of OPA/Aluminum/PVC/Aluminum or PVC/PE/PVDC/Aluminum, placed in a carton box.
Packaging containing 56 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria
Manufacturer
Lek d.d., PE PROIZVODNJA LENDAVA
Trimlini 2D
9220 Lendava
Slovenia

For more information about this medicine, contact the local representative of the marketing authorization holder:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands
Sademlip 50/850 mg, film-coated tablets
Sademlip 50/1000 mg, film-coated tablets
Poland
Sademlip
Romania
Sademlip 50 mg/1000 mg film-coated tablets

Date of last revision of the leaflet:

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