Autnami

Package leaflet: Information for the patient

Autnami, 2.5 mg + 850 mg, film-coated tablets
Autnami, 2.5 mg + 1000 mg, film-coated tablets
Linagliptinum + Metformini hydrochloridum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• 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 Autnami is and what it is used for
2. What you need to know before taking Autnami
3. How to take Autnami
4. Possible side effects
5. How to store Autnami
6. Contents of the pack and other information

1. What Autnami is and what it is used for

The name of the tablet is Autnami. The tablet contains two different active substances: linagliptin and metformin.

• Linagliptin belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors).
• Metformin belongs to a group of medicines called biguanides.

How Autnami works
Both active substances work together to control blood glucose levels in adult patients with diabetes, known as type 2 diabetes. This medicine, used together with diet and exercise, helps increase the levels and effectiveness of insulin after meals and reduces the amount of glucose produced by the body.
This medicine may be used alone or in combination with certain other antidiabetic medicines, such as sulfonylureas or insulin.

What is type 2 diabetes?
Type 2 diabetes is a condition in which 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. As a result, glucose accumulates in the blood. This can lead to serious health problems, such as heart disease, kidney disease, blindness and limb amputation.

2. Important information before taking Autnami

When not to take Autnami

• if the patient is allergic to linagliptin 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, 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 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 ever experienced diabetic pre-coma.
• if the patient has a severe infection, such as pneumonia, bronchitis, or kidney infection. Severe infections may lead to impaired kidney function, which may increase the patient's risk of lactic acidosis (see section "Warnings and precautions").
• if the patient has lost a large amount of body water (dehydration), for example due to prolonged or severe diarrhoea, or if the patient has vomited repeatedly. Dehydration may lead to impaired kidney function, which may increase the patient's risk of lactic acidosis (see section "Warnings and precautions").
• if the patient is being treated for acute heart failure or has recently had a heart attack, has severe circulatory disorders (such as shock), or has difficulty breathing. These conditions may lead to inadequate tissue oxygenation, which may increase the patient's risk of lactic acidosis (see section "Warnings and precautions").
• if the patient has liver disease.
• if the patient abuses alcohol, either daily or occasionally (see section "Taking Autnami with alcohol").

Do not take Autnami if any of the above conditions apply to the patient. If in doubt, consult a doctor or pharmacist before taking this medicine.

Warnings and precautions

Before starting Autnami, discuss with your doctor, pharmacist, or nurse:

• if the patient has type 1 diabetes (the patient's body does not produce insulin). Autnami should not be used to treat this condition.
• if the patient is taking insulin or an antidiabetic medicine called a "sulfonylurea derivative", the doctor may wish to reduce the dose of insulin or sulfonylurea derivative when taking one of these medicines together with Autnami, to prevent low blood sugar (hypoglycaemia).
• if the patient has or has had pancreas disease. If the patient develops symptoms of acute pancreatitis, such as persistent, severe abdominal pain, contact a doctor.

If the patient develops blisters on the skin, this may be a sign of a disease called bullous pemphigoid. The doctor may advise the patient to stop taking Autnami.

If in doubt whether any of the above warnings apply to the patient, discuss with a doctor, pharmacist, or nurse before taking Autnami.

Diabetic skin problems are common complications of diabetes. Follow the skin and foot care advice provided by the doctor or nurse.

Risk of lactic acidosis

Autnami may cause a very rare but serious side effect called lactic acidosis, especially if the patient has impaired kidney function. The risk of lactic acidosis increases in cases of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see below), impaired liver function, and any medical conditions in which part of the body is inadequately supplied with oxygen (such as acute, severe heart disease).

If any of the above conditions apply to the patient, consult a doctor for further instructions.

Contact a doctor immediately for further instructions if:

• the patient has a genetically inherited mitochondrial disorder (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• the patient develops any of the following symptoms after starting metformin: seizures, worsening cognitive function, difficulty moving, symptoms indicating nerve damage (e.g. pain or numbness), migraine, or deafness.

Temporarily discontinue taking Autnami if the patient has a medical condition that may lead to dehydration (significant loss of body water), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or if the patient is drinking less fluid than usual. Consult a doctor for further instructions.

Stop taking Autnami and contact a doctor or the nearest hospital immediately 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 feeling of being unwell combined with severe fatigue,
• difficulty breathing,
• decreased body temperature and slowed heart rate.

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

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

While taking Autnami, the doctor will monitor kidney function at least once a year, or more frequently if the patient is elderly and/or has worsening kidney function.

Children and adolescents

Autnami 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 not known whether this medicine is safe and effective in children under 10 years of age.

Autnami and other medicines

If the patient is to receive an iodine-containing contrast agent injected into the bloodstream, for example for an X-ray or CT scan, the patient must stop taking Autnami before or at the latest at the time of injection. The doctor will decide when the patient should stop and restart treatment with Autnami.

Tell the doctor about all medicines the patient is currently taking, has recently taken, or plans to take. The patient may require more frequent monitoring of blood glucose levels and kidney function, or the doctor may need to adjust the dose of Autnami. It is especially important to inform the doctor about the use of the following medicines:

• diuretics (medicines that increase urine production).
• medicines used to treat pain and inflammation (non-steroidal anti-inflammatory drugs - 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).
• medicines that may alter metformin blood levels, especially in patients with reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).
• carbamazepine, phenobarbital, or phenytoin. These medicines may be used to treat seizures (epilepsy) or chronic pain.
• rifampicin. This is an antibiotic used to treat infections such as tuberculosis.
• medicines used to treat inflammatory conditions such as asthma and arthritis (corticosteroids).
• bronchodilators (beta-sympathomimetics) used to treat asthma.
• medicines containing alcohol.

Taking Autnami with alcohol

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before taking this medicine.

Autnami should not be used during pregnancy. It is not known whether this medicine is harmful to the unborn child.

Metformin passes into breast milk in small amounts. It is not known whether linagliptin passes into breast milk. Inform the doctor if the woman wishes to breastfeed while taking this medicine.

Driving and operating machinery

Autnami has no effect or a negligible effect on the ability to drive and use machines.

However, taking Autnami in combination with sulfonylurea derivatives or insulin may cause low blood sugar (hypoglycaemia), which may affect the ability to drive and operate machinery or perform work without safe support for the feet.

Autnami contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, i.e. the medicine is considered "sodium-free".

3. How to take Autnami

This medicine should always be taken as directed by the physician or pharmacist. In case of
doubt, consult the physician or pharmacist.
What dose to take
The amount of Autnami a patient will take varies depending on the patient's health condition
and the current doses of metformin and (or) separate linagliptin and metformin tablets
the patient is taking. The physician will clearly indicate what dose of this medicine the patient
should take.
How to take this medicine

• One tablet orally twice daily, as prescribed by the physician.
• With meals, to reduce the possibility of stomach irritation.

Do not exceed the maximum recommended daily dose: 5 mg of linagliptin and 2,000 mg of
metformin hydrochloride.
Autnami should be taken for as long as directed by the physician to achieve long-term control
of blood sugar levels. The physician may recommend using this medicine together with another
oral antidiabetic medicine or insulin. All medicines should be taken as directed by the physician to
achieve the best possible treatment outcome.
While taking Autnami, patients should continue to follow a diet and ensure an even intake of
carbohydrates throughout the day. Patients who are overweight should continue to follow the
recommended low-calorie diet. It is unlikely that taking this medicine alone will lead to abnormally
low blood sugar levels (hypoglycaemia). However, when Autnami is taken together with a
sulphonylurea derivative or insulin, blood sugar levels may become too low. In such cases, the
physician may reduce the dose of the sulphonylurea derivative or insulin.
The score line on the tablet is intended only to facilitate breaking the tablet in half if there is
difficulty swallowing it whole.
Taking more Autnami than prescribed
If more tablets of Autnami than prescribed are taken, the patient may develop lactic acidosis.
Symptoms of lactic acidosis may be non-specific, such as severe nausea or vomiting, abdominal
pain with muscle cramps, general malaise with severe fatigue, and difficulty breathing. Further
symptoms include lowered body temperature and slowed heart rate. If such symptoms occur,
immediate hospital treatment may be necessary, as lactic acidosis can lead to coma. The
medicine must be stopped immediately and the physician or nearest hospital must be
contacted without delay (see section 2). The medicine packaging should be brought along.
Missed dose of Autnami
If the patient forgets to take a dose, it should be taken as soon as remembered. However, if it is
almost time for the next dose, the missed dose should not be taken. Do not take a double dose to
make up for a missed dose. Never take two doses of the medicine at the same time (in the morning
or in the evening).
Stopping Autnami
Do not stop taking Autnami unless instructed by the physician. The treatment aims to control
blood sugar levels.
If there are any further doubts regarding the use of this medicine, consult the physician,
pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some symptoms require immediate medical attention.
You must stop taking Autnami and contact your doctor immediately if you experience any of the following symptoms caused by low blood sugar (hypoglycaemia): trembling, sweating, anxiety, blurred vision, tingling around the lips, paleness, mood changes or confusion. Hypoglycaemia (frequency: very common; may affect more than 1 in 10 people) is a known adverse reaction associated with combination therapy using Autnami and a sulfonylurea derivative, as well as combination therapy using Autnami and insulin.

Autnami may very rarely (may affect up to 1 in 10,000 patients) cause a very serious adverse reaction known as lactic acidosis (see section "Warnings and precautions"). If this occurs, stop taking Autnami immediately and contact your doctor or nearest hospital immediately, as lactic acidosis may lead to coma.

Pancreatitis has occurred in some patients (frequency: rare; may affect up to 1 in 1,000 people).

You must STOP taking Autnami and contact your doctor immediately if any of the following serious adverse reactions occur:

• Severe and persistent abdominal pain (in the stomach area), which may radiate to the back, along with nausea and vomiting, as these may be symptoms of pancreatitis.

Other adverse reactions with Autnami include:
In some patients, allergic reactions (frequency: rare) have occurred, which may be severe, including wheezing and shortness of breath (bronchospasm, frequency: uncommon; may affect up to 1 in 100 people). Some patients experienced rash (frequency: uncommon), urticaria (frequency: rare), and swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing (angioedema; frequency: rare). If any of the above symptoms occur, discontinue use of Autnami immediately and contact your doctor without delay. Your doctor may prescribe medication for treating allergic reactions and may switch you to another medicine for diabetes.

During treatment with Autnami, the following adverse reactions have been reported in some patients:

• Common (may affect up to 1 in 10 people): diarrhoea, increased activity of the enzyme (lipase) in blood, nausea
• Uncommon: inflammation of the nose or throat, cough, loss of appetite (decreased appetite), vomiting, increased activity of the enzyme in blood (amylase), itching (pruritus)
• Rare: formation of blisters on the skin (bullous pemphigoid)

The following adverse reactions have occurred in some patients during treatment with Autnami in combination with insulin:

• Uncommon: liver function disorders, constipation

Adverse reactions reported with metformin alone, which have not been described for Autnami:

• Very common: abdominal pain.
• Common (may affect up to 1 in 10 people): metallic taste in the mouth (dysgeusia), reduced or low levels of vitamin B12 in the blood (symptoms may include extreme tiredness (fatigue), sore and red tongue (glossitis), tingling (paraesthesiae), or paleness or yellowing of the skin). Your doctor may order certain tests to determine the cause of these symptoms, as some of them may also be caused by diabetes or other unrelated health conditions.
• Very rare (may affect up to 1 in 10,000 people): hepatitis (liver disease), skin reactions such as redness of the skin (erythema).

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 Reactions to Medicinal Products at 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 Authorisation Holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Autnami

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, bottle, and cardboard
package: Expiry date: (EXP). The expiry date refers to the last day of the stated month.
No special temperature storage requirements for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. Such practices help protect
the environment.

6. Contents of the pack and other information

What Autnami contains

• The active substances in this medicine are linagliptin and metformin hydrochloride.
• Each Autnami 2.5 mg + 850 mg film-coated tablet contains 2.5 mg of linagliptin and 850 mg of metformin hydrochloride.
• Each Autnami 2.5 mg + 1,000 mg film-coated tablet contains 2.5 mg of linagliptin and 1,000 mg of metformin hydrochloride.
• Other ingredients are:
• Tablet core: copovidone, maize starch, anhydrous sodium carbonate (E 500), crospovidone, Type A (A 1202), magnesium stearate (E 470b), anhydrous colloidal silica (E 551).
• Tablet coating: hypromellose 2910, 5 mPas (E 464), titanium dioxide (E 171), talc (E 553b), propylene glycol (E 1520), iron oxide red (E 172). Autnami 2.5 mg + 850 mg film-coated tablets additionally contain iron oxide yellow (E 172).

What Autnami looks like and contents of the pack
Autnami 2.5 mg + 850 mg film-coated tablets are oval, biconvex, beige film-coated tablets with a breakline on one side and engraved "2.5/850" on the other side.
The breakline on the tablet is intended only to facilitate breaking for easier swallowing and does not ensure division into equal doses.
Autnami 2.5 mg + 1,000 mg film-coated tablets are oval, biconvex, pink film-coated tablets with a breakline on one side and engraved "2.5/1000" on the other side.
The breakline on the tablet is intended only to facilitate breaking for easier swallowing and does not ensure division into equal doses.
Autnami is available in packs containing 10, 30, 56, 60 or 90 film-coated tablets or 180 (2 packs of 90 or 3 packs of 60) film-coated tablets in collective packs in aluminium-OPA/aluminium/PVC blisters in a cardboard carton.
Autnami is also available in packs containing 10 x 1, 30 x 1, 56 x 1, 60 x 1 or 90 x 1 film-coated tablet or 180 x 1 (2 packs of 90 x 1 or 3 packs of 60 x 1) film-coated tablets in unit dose aluminium-OPA/aluminium/PVC blisters in collective packs in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
Tel. 22 209 70 00
{logo of the marketing authorisation holder}

Manufacturer
PharOS MT Ltd.
HF62X, Hal Far Industrial Estate,
Birzebbugia BBG3000
Malta
Lek Pharmaceuticals d.d.
Verovškova ulica 57, 1526 Ljubljana
Slovenia
PharOS Pharmaceutical Oriented Services Ltd.
Lesvou Street End, Thesi Loggos
Industrial Zone, Metamorfossi, 144 52
Greece

This medicinal product is authorised in the member states of the European Economic Area under the following names:
Hungary Autnami 2.5 mg/850 mg filmtabletta
Autnami 2.5 mg/1000 mg filmtabletta
Cyprus Autnami
Estonia AUTNAMI
Greece Autnami
Croatia Autnami 2.5 mg/850 mg filmom obložene tablete
Autnami 2.5 mg/1000 mg filmom obložene tablete
Lithuania Autnami 2.5 mg/850 mg plevele dengtos tabletes
Autnami 2.5 mg/1 000 mg plevele dengtos tabletes
Latvia Autnami 2.5 mg/850 mg apvalkotas tabletes
Autnami 2.5 mg/1000 mg apvalkotas tabletes