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

Linagliptin + Metformin hydrochloride

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

• Keep this leaflet, 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

• 1. What Autnami is and what it is used for
• 2. Important information 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 sugar levels in adults with type 2 diabetes. This medicine, used in combination with diet and exercise, helps increase the amount of insulin released by the body after a meal and decreases the amount of sugar made by the body. This medicine can be used alone or with other diabetes medicines, such as sulfonylureas or insulin.

What is type 2 diabetes?

Type 2 diabetes is a condition where the body does not make enough insulin, and the insulin that is made does not work properly. The body may also make too much sugar. This can lead to serious health problems, such as heart disease, kidney disease, blindness, and amputation.

2. Important information before taking Autnami

When not to take Autnami

1

• if you are allergic to linagliptin or metformin, or any of the other ingredients of this medicine (listed in section 6).
• if you have severely reduced kidney function.
• if you have uncontrolled diabetes, such as severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or diabetic ketoacidosis. Diabetic ketoacidosis is a condition where substances called ketones build up in the blood and can lead to diabetic coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness, or a fruity odor from the mouth.
• if you have ever had diabetic coma.
• if you have a severe infection, such as pneumonia, bronchitis, or pyelonephritis. Severe infections can lead to kidney problems, which can increase the risk of lactic acidosis (see "Warnings and precautions").
• if you have lost a lot of water from your body (dehydration), for example, due to prolonged or severe diarrhea, or if you have vomited several times in a row. Dehydration can lead to kidney problems, which can increase the risk of lactic acidosis (see "Warnings and precautions").
• if you are being treated for acute heart failure or have recently had a heart attack, severe circulatory problems (such as shock) or breathing difficulties. This can lead to inadequate oxygen supply to the tissues, which can increase the risk of lactic acidosis (see "Warnings and precautions").
• if you have liver disease.
• if you drink a lot of alcohol, either regularly or from time to time (see "Taking Autnami with alcohol").

Do not take Autnami if you have any of the conditions listed above. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before taking Autnami, talk to your doctor, pharmacist, or nurse if:

• you have type 1 diabetes (your body does not make insulin). Do not use Autnami to treat this condition.
• you are taking insulin or a diabetes medicine called a sulfonylurea, your doctor may want to reduce the dose of insulin or sulfonylurea when taking it with Autnami to avoid low blood sugar (hypoglycemia).
• you have or have had pancreatitis (inflammation of the pancreas). If you get symptoms of acute pancreatitis, such as persistent, severe abdominal pain, contact your doctor.

If you get blisters on your skin, it may be a sign of a condition called bullous pemphigoid. Your doctor may tell you to stop taking Autnami. If you are not sure if any of the above warnings apply to you, talk to your doctor, pharmacist, or nurse before taking Autnami. Diabetic skin problems are common complications of diabetes. Follow the skin and foot care advice given by your doctor or nurse. 2

Risk of lactic acidosis

Autnami may cause a very rare but very serious side effect called lactic acidosis, especially if you have kidney problems. The risk of lactic acidosis increases with uncontrolled diabetes, severe infection, prolonged fasting or alcohol intake, dehydration (for more information, see below), liver problems, and any conditions that affect the supply of oxygen to the tissues (such as acute, severe heart disease). If any of the above conditions apply to you, talk to your doctor for more information. You should contact your doctor immediately if you experience any of the following symptoms:

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell with severe tiredness,
• difficulty breathing,
• low body temperature and slow heart rate.

Lactic acidosis is a medical emergency that requires immediate hospital treatment. If you take more Autnami than you should, you may experience lactic acidosis. Symptoms of lactic acidosis can be non-specific, such as severe nausea or vomiting, abdominal pain with muscle cramps, general feeling of being unwell with severe tiredness, and difficulty breathing. Further symptoms include low body temperature and slow heart rate. In case of these symptoms, you may need immediate hospital treatment, as lactic acidosis can lead to coma.Stop taking this medicine and contact your doctor or the nearest hospital (see section 2). Bring the package leaflet with you.

Temporary discontinuation of Autnami

If you have a condition that may lead to dehydration (loss of body water), such assevere vomiting, diarrhea, fever, high temperature, or if you drink less fluid than normal, you should talk to your doctor for more information.

Discontinuation of Autnami and immediate contact with your doctor or the nearest hospital

If you experience any of the symptoms of lactic acidosis, you should stop taking this medicine and contact your doctor or the nearest hospital immediately, as this can lead to coma. Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell with severe tiredness,
• difficulty breathing,
• low body temperature and slow heart rate.

Lactic acidosis is a medical emergency that requires immediate hospital treatment. If you need to have a major surgical operation, you should not take Autnami during or for some time after the operation. Your doctor will decide when you should stop and restart taking Autnami. During treatment with Autnami, your doctor will check your kidney function at least once a year or more often if you are elderly and/or have 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 from 10 to 17 years of age. It is not known if this medicine is safe and effective in children under 10 years of age.

Autnami with other medicines

If you are going to have an injection of a contrast medium that contains iodine, for example, for an X-ray or CT scan, you should stop taking Autnami before or at the time of the injection. Your doctor will decide when you should stop and restart taking Autnami. Tell your doctor about all the medicines you are taking, or have recently taken, and any you plan to take. You may need more frequent blood sugar tests and kidney function tests, or your doctor may need to adjust the dose of Autnami. It is especially important to tell your doctor if you are taking:

• diuretics (water tablets),
• 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 change the levels of metformin in your blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib),
• carbamazepine, phenobarbital, or phenytoin. These medicines are used to treat 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),
• medicines used to widen the airways (beta-sympathomimetics) used to treat asthma,
• medicines containing alcohol.

Taking Autnami with alcohol

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

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 Autnami if you are pregnant. It is not known if this medicine can harm your unborn baby. Metformin passes into breast milk in small amounts. It is not known if linagliptin passes into breast milk. If you want to breastfeed during treatment with this medicine, talk to your doctor.

Driving and using machines

Autnami has no or negligible influence on the ability to drive and use machines. However, when taking Autnami with a sulfonylurea or insulin, low blood sugar (hypoglycemia) can occur, which may affect your ability to drive and use machines or work without support for your feet.

Autnami contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which is essentially "sodium-free". 4

3. How to take Autnami

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

How much to take

The amount of Autnami you take will depend on your medical condition and the doses of metformin and/or linagliptin you are already taking. Your doctor will tell you exactly how much Autnami to take.

How to take it

• one tablet twice a day by mouth, at the dose prescribed by your doctor.
• with meals to reduce the chance of stomach upset.

Do not take more than the maximum recommended dose: 5 mg of linagliptin and 2000 mg of metformin hydrochloride per day. You should take Autnami for as long as your doctor recommends to maintain long-term control of blood sugar levels. Your doctor may prescribe this medicine in combination with another oral diabetes medicine or insulin. Take all medicines as directed by your doctor to get the best results. While taking Autnami, continue to follow your diet and exercise program as recommended by your doctor. Patients with overweight should continue to follow a low-calorie diet. It is unlikely that taking this medicine alone will cause low blood sugar (hypoglycemia). However, when taking Autnami with a sulfonylurea or insulin, low blood sugar can occur. Your doctor may need to adjust the dose of sulfonylurea or insulin. The score line on the tablet is only to facilitate breaking the tablet and not to divide it into equal doses.

If you take more Autnami than you should

If you take more Autnami than you should, you may experience lactic acidosis. Symptoms of lactic acidosis can be non-specific, such as severe nausea or vomiting, abdominal pain with muscle cramps, general feeling of being unwell with severe tiredness, and difficulty breathing. Further symptoms include low body temperature and slow heart rate. In case of these symptoms, you may need immediate hospital treatment, as lactic acidosis can lead to coma.Stop taking this medicine and contact your doctor or the nearest hospital (see section 2). Bring the package leaflet with you.

If you forget to take Autnami

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose. Never take two doses at the same time (morning and evening).

If you stop taking Autnami

Do not stop taking Autnami unless your doctor tells you to. The treatment is to control your blood sugar levels. If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some symptoms require immediate medical attention

Stop taking Autnami and contact your doctor immediately if you experience any of the following symptoms of low blood sugar (hypoglycemia): shaking, sweating, anxiety, blurred vision, tingling of the mouth, paleness, mood changes, or confusion. Hypoglycemia (frequency: very common; may affect more than 1 in 10 people) is a known side effect of combination therapy with Autnami and sulfonylurea and combination therapy with Autnami and insulin. Autnami may very rarely (may affect up to 1 in 10,000 people) cause a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this happens to you, you should stop taking Autnami and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma. Some patients experienced pancreatitis (frequency: rare, may affect up to 1 in 1,000 people).

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

Other side effects of Autnami include:

Some patients experienced allergic reactions (frequency: rare), which can 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 can cause difficulty breathing or swallowing (angioedema; frequency: rare). If you experience any of these symptoms, stop taking Autnami and contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes. While taking Autnami, some patients experienced the following side effects:

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

Some patients experienced the following side effects while taking Autnami with insulin:

• Uncommon: liver problems, constipation

Side effects of metformin alone that have not been reported for Autnami:

• Very common: abdominal pain.
• Common (may affect up to 1 in 10 people): metallic taste in the mouth (taste disturbance), reduced or low levels of vitamin B12 in the blood (symptoms may include extreme tiredness, painful and red tongue, or numbness or tingling). Your doctor may order tests to find 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): liver inflammation (liver disease), skin reactions such as redness of the skin.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the national reporting system (see below). By reporting side effects, you can help provide more information on the safety of this medicine.

• Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warszawa, 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.

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 which is stated on the blister, bottle, and carton after EXP. The expiry date refers to the last day of that month. There are no special storage instructions for this medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Autnami contains

• The active substances are linagliptin and metformin hydrochloride.
• Each film-coated tablet of Autnami 2.5 mg + 850 mg contains 2.5 mg of linagliptin and 850 mg of metformin hydrochloride.
• Each film-coated tablet of Autnami 2.5 mg + 1000 mg contains 2.5 mg of linagliptin and 1000 mg of metformin hydrochloride.
• The other ingredients are:
• Tablet core: copovidone, corn starch, sodium carbonate anhydrous (E500), crospovidone, Type A (A 1202), magnesium stearate (E470b), colloidal anhydrous silica (E551).
• Tablet coating: hypromellose 2910, 5mPas (E464), titanium dioxide (E171), talc (E553b), propylene glycol (E1520), iron oxide red (E172). Autnami 2.5 mg + 850 mg film-coated tablets also contain iron oxide yellow (E172).

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 score line on one side and "2.5/850" embossed on the other side. The score line on the tablet is only to facilitate breaking the tablet and not to divide it into equal doses. Autnami 2.5 mg + 1000 mg film-coated tablets are oval, biconvex, pink film-coated tablets with a score line on one side and "2.5/1000" embossed on the other side. The score line on the tablet is only to facilitate breaking the tablet and not to divide it into equal doses. Autnami is available in packs of 10, 30, 56, 60, or 90 film-coated tablets or 180 (2 packs of 90 or 3 packs of 60) film-coated tablets in perforated unit dose blisters of Aluminium-OPA/Aluminium/PVC in a carton. Autnami is also available in packs of 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 perforated unit dose blisters of Aluminium-OPA/Aluminium/PVC in a carton. Not all pack sizes may be marketed.

Marketing authorization holder

Sandoz Polska Sp. z o.o., ul. Domaniewska 50 C, 02-672 Warszawa, Tel. 22 209 70 00, {logo of the marketing authorization 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 medicine is authorized 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, Date of last revision of the leaflet: 03/20259