Sademlip

Package leaflet: Information for the patient

Sademlip, 50 mg + 850 mg, film-coated tablets
Sademlip, 50 mg + 1000 mg, film-coated tablets
Sitagliptinum + Metformini hydrochloridum
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.
Keep this leaflet, so that you can read it again if necessary.
If you have any further questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others.
This medicine may harm another person, even if their symptoms appear identical.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
See section 4.

Contents of the leaflet:

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

1. What is Sademlip and for what is it used

Sademlip contains two different active substances: sitagliptin and metformin.
Sitagliptin belongs to a group of medicines known as DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors).
Metformin belongs to a group of medicines called biguanides.
The combined action of these two medicines helps regulate blood glucose levels in adult patients with diabetes known as "type 2 diabetes". This medicine helps increase insulin secretion after meals and reduces the amount of glucose produced by the body.
Used together with diet and physical exercise, this medicine helps lower blood glucose levels.
This medicine may be used as the sole antidiabetic treatment or in combination with certain other antidiabetic 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 that is produced does not work properly. The body may also produce too much glucose. When this occurs, sugar (glucose) accumulates in the blood. This may lead to serious health problems, such as heart disease, kidney disease, vision loss, and limb amputations.

2. Important information before using Sademlip

When not to use 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, for example severe hyperglycaemia (high
blood glucose levels), nausea, vomiting, diarrhoea, sudden 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 may lead to diabetic pre-coma. Symptoms include:
abdominal pain, rapid and deep breathing, drowsiness or an unusual fruity odour on the breath.
if the patient has severe infection or dehydration;
if the patient is scheduled to undergo a radiological examination with intravascular administration of contrast agents. Treatment with Sademlip must be discontinued during the radiological examination and for 2 or more days afterwards, according to the physician's instructions, depending on the patient's kidney function;
if the patient has recently suffered a heart attack or has 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 occasionally);
if the patient is breastfeeding.

Do not take Sademlip if any of the above contraindications apply. Consult your doctor to determine alternative methods of diabetes control. If in doubt, discuss this with your doctor, pharmacist, or nurse before taking Sademlip.

Warnings and precautions
Cases of pancreatitis have been reported in patients taking Sademlip (see section 4).
If the patient develops skin blisters, this may be a symptom of a condition known as bullous pemphigoid. The doctor may advise the patient to stop taking Sademlip.

Risk of lactic acidosis
Sademlip may cause a very rare but serious adverse reaction called lactic acidosis, especially if the patient has impaired kidney function. The risk of lactic acidosis is also increased in cases of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see further information below), liver dysfunction, and any medical conditions in which part of the body is inadequately supplied with oxygen (e.g. acute severe heart disease). If any of the above conditions apply to the patient, consult a doctor for further instructions.

Temporarily discontinue Sademlip if the patient develops any illness associated with dehydration (significant loss of water from the body), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. Consult a doctor for further instructions.

Stop taking Sademlip immediately and contact a doctor or the nearest hospital if the patient experiences any symptoms of lactic acidosis, as this condition may lead to coma.

Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general malaise accompanied by profound fatigue,
• difficulty breathing,
• decreased body temperature and slowed heart rate.

Lactic acidosis is an acute, life-threatening condition requiring hospital treatment.

Before starting Sademlip, discuss the following with your doctor or pharmacist:

• if the patient has or has had pancreatic disease (e.g. pancreatitis);
• if the patient has or has had gallstones, alcohol dependence, or very high blood triglyceride levels (a type of fat). In such cases, the risk of pancreatitis may be increased (see section 4);
• if the patient has type 1 diabetes, sometimes referred to as insulin-dependent diabetes;
• if the patient currently has or has previously experienced allergic reactions to sitagliptin, metformin, or Sademlip (see section 4);
• if the patient is taking a sulfonylurea derivative or insulin, or other antidiabetic medicines together with Sademlip, as this may lead to excessively low blood glucose levels (hypoglycaemia). The doctor may reduce the dose of the sulfonylurea derivative or insulin.

If the patient is scheduled for major surgery, Sademlip must not be taken during the procedure and for some time afterwards. The doctor will decide when the patient should stop and resume treatment with Sademlip.

If in doubt whether any of the above situations apply, discuss this with your doctor or pharmacist before taking Sademlip.

While being treated with Sademlip, the doctor will monitor the patient's kidney function at least once a year, or more frequently 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. The medicine is not effective in children and adolescents aged 10 to 17 years. It is unknown whether this medicine is safe and effective in children under 10 years of age.

Sademlip and other medicines
If the patient is to receive an intravenous iodine-containing contrast agent, for example for an X-ray or CT scan, treatment with Sademlip must be stopped before or at the latest at the time of administration. The doctor will decide when the patient should stop and resume treatment with Sademlip.

Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned for use. The patient may require more frequent monitoring of blood glucose levels and kidney function, or dose adjustments of Sademlip. It is especially important to inform about the following medicines:

• medicines (taken orally, by inhalation, or by injection) used to treat inflammatory conditions 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);
• iodine-containing contrast agents or medicines containing alcohol;
• some medicines used to treat gastrointestinal disorders, 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 (used to treat heart rhythm disorders and other heart conditions). Blood digoxin levels should be monitored when taking Sademlip with digoxin.

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

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine. This medicine should not be used during pregnancy or while breastfeeding. See section 2, When not to use Sademlip.

Driving and operating machinery
This medicine has no or negligible effect on the ability to drive and operate machinery. However, dizziness and drowsiness have been reported during treatment with sitagliptin, which may affect the ability to drive or operate machinery.

Taking this medicine together with medicines called sulfonylurea derivatives or insulin may lead to hypoglycaemia, which in turn may affect the ability to drive or operate machinery, or to work without secure foot support.

Sademlip contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning it is considered "sodium-free".

3. How to take Sademlip

This medicine should always be taken as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
Take one tablet:
twice daily, orally;
with meals to reduce the likelihood of stomach upset.
To control blood sugar levels, the physician may increase the dose of this medicine.
If the patient has impaired kidney function, the physician may prescribe a lower dose.
While taking this medicine, continue the diet recommended by the physician and ensure
carbohydrates are consumed evenly throughout the day.
It is unlikely that use of this medicine alone will lead to abnormally low blood sugar levels
(hypoglycaemia). Low blood sugar may occur if this medicine is used together with a sulfonylurea
derivative or insulin – in such a case, the physician may reduce the dose of the sulfonylurea
derivative or insulin.
Taking more Sademlip than recommended
If more of this medicine is taken than recommended, contact a physician immediately.
Go to hospital if symptoms of lactic acidosis occur, such as feeling cold or discomfort, severe
nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps or rapid breathing (see
section “Warnings and precautions”).
Missing a dose of Sademlip
If a dose is missed, take it as soon as possible. If the next dose is due soon, skip the missed dose
and continue with the regular dosing schedule. Do not take a double dose to make up for a
missed dose.
Stopping Sademlip
To maintain control of blood sugar levels, continue taking this medicine for as long as directed by
the physician. Do not stop taking this medicine without first consulting a physician.
Discontinuing use of Sademlip may lead to a recurrence of high blood sugar levels.
If there are any further questions about the use of this medicine, consult a physician or
pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
You should STOP taking Sademlip and immediately contact your doctor
if any of the following serious adverse reactions occur:
Severe and persistent abdominal pain (in the stomach area), possibly radiating to the back,
with or without nausea and vomiting, as these may be symptoms of pancreatitis.
Sademlip may very rarely cause (may occur in fewer than 1 in 10,000 people)
a very serious adverse reaction known as lactic acidosis (see section
"Warnings and precautions"). If this occurs in a patient, treatment with Sademlip must be
discontinued immediately and medical attention must be sought immediately from a doctor or the
nearest hospital, as lactic acidosis may lead to coma.
In case of a severe allergic reaction (frequency unknown), including rash, hives, skin blisters and/or
skin peeling, and swelling of the face, lips, tongue, or throat, which may cause difficulty in breathing or
swallowing, discontinue the use of this medicine and seek immediate medical attention. Your doctor
may prescribe medication to treat the allergic reaction and another medicine for diabetes.
In some patients taking metformin, the following adverse reactions occurred after starting
sitagliptin:
Common (may occur in fewer than 1 in 10 people): low blood sugar levels, nausea,
bloating, vomiting
Uncommon (may occur in fewer than 1 in 100 people): stomach pain, diarrhoea, constipation,
drowsiness
Diarrhoea, nausea, bloating, constipation, stomach pain, or vomiting occurred in some patients
after starting treatment with sitagliptin in combination with metformin (common).
In some patients taking this medicine together with a sulfonylurea derivative, such as glimepiride,
the following adverse reactions occurred:
Very common (may occur in more than 1 in 10 people): low blood sugar levels
Common (may occur in fewer than 1 in 10 people): constipation
In some patients taking this medicine in combination with pioglitazone, the following adverse
reactions occurred:
Common (may occur in fewer than 1 in 10 people): swelling of hands or feet
In some patients taking this medicine in combination with insulin, the following adverse
reactions occurred:
Very common: low blood sugar levels
Uncommon: dry mouth, headache
In clinical trials and post-marketing experience, when sitagliptin (one of the active substances in
Sademlip) was used alone or in combination with other antidiabetic medicines including Sademlip,
the following adverse reactions were observed:
Common: low blood sugar levels, headache, upper respiratory tract infection, nasal congestion or
runny nose and sore throat, bone and joint pain, pain in arms or legs
Uncommon: dizziness, constipation, itching
Rare: decreased platelet count
Frequency unknown: kidney disorders (sometimes requiring dialysis), vomiting, joint pain, muscle
pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin condition)
In some patients taking metformin alone, the following adverse reactions occurred:
Very common: nausea, vomiting, diarrhoea, stomach pain, and loss of appetite. These symptoms
may occur when starting metformin and usually resolve over time.
Common: metallic taste
Very rare: decreased vitamin B12 levels, hepatitis (liver disease), hives, skin redness (rash), or
itching
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist,
or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug
Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Sademlip

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

6. Contents of the pack and other information

What Sademlip contains
Active substances: sitagliptin and metformin hydrochloride.
Sademlip 50 mg + 850 mg, film-coated tablets
Each film-coated tablet contains sitagliptin hydrochloride 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 hydrochloride monohydrate equivalent to 50 mg
of sitagliptin and 1000 mg of metformin hydrochloride.

Other ingredients:
Tablet core: povidone (K30), sodium lauryl sulfate, microcrystalline cellulose, sodium
croscarmellose, 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 the imprint
"SM 2" on one side.
Sademlip 50 mg + 1000 mg, film-coated tablets
Light red, oval, biconvex film-coated tablet (approximately 10.5x21 mm) with the imprint
"SM 3" on one side.

The medicine is available in blisters made of OPA/Aluminium/PVC/Aluminium or
PVC/PE/PVDC/Aluminium, and in unit dose blisters made of OPA/Aluminium/PVC/Aluminium
or PVC/PE/PVDC/Aluminium, packed in a cardboard box.
Pack size: 56 film-coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria

Manufacturer
Lek d.d., PE PROIZVODNJA LENDAVA
Trimlini 2D
9220 Lendava
Slovenia

For further information about this medicinal product, contact the local representative of the
Marketing Authorisation Holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
Poland
tel. 22 209 70 00

This medicinal product is authorised for marketing in the European Economic Area countries
under the following names:
Netherlands: Sademlip 50/850 mg, filmomhulde tabletten
Sademlip 50/1000 mg, filmomhulde tabletten
Poland: Sademlip
Romania: Sademlip 50 mg/1000 mg Comprimate filmate