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 experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Autnami and what is it 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 is Autnami and what is it 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 produced by the body. This medicine can be used alone or with other anti-diabetic medicines, such as sulfonylureas or insulin.

What is type 2 diabetes?

Type 2 diabetes is a condition where 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. 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

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 produce insulin). Do not use Autnami to treat this condition.
• you are taking insulin or a sulfonylurea, your doctor may want to reduce the dose of insulin or sulfonylurea when taking one of these medicines with Autnami to avoid hypoglycemia (low blood sugar).
• you have or have had pancreatitis. If you experience symptoms of acute pancreatitis, such as persistent, severe abdominal pain, contact your doctor.

If you develop blisters on your skin, it may be a sign of a condition called pemphigoid. Your doctor may advise 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 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 (see below), liver problems, or any condition that affects the oxygen supply to the tissues (such as acute, severe heart disease). If any of the above conditions apply to you, talk to your doctor for further instructions. 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 are going to have a major surgical operation, you should not take Autnami during or for a certain period 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 when used in children under 10 years of age.

Autnami with other medicines

If you are going to have an injection of a contrast agent containing iodine, for example, for an X-ray or computed tomography (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, as well as any medicines you plan to take. You may need more frequent blood glucose monitoring, kidney function testing, or dose adjustment of Autnami by your doctor. It is especially important to tell your doctor if you are taking:

• 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 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 diseases, such as asthma and arthritis (corticosteroids).
• medicines that widen the airways (beta-sympathomimetics) used to treat asthma.
• medicines containing alcohol.

Taking Autnami with alcohol

Avoid excessive alcohol intake while taking Autnami, as it 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. Autnami should not be used during pregnancy. It is not known if this medicine is harmful to the unborn child. 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, it may cause low blood sugar (hypoglycemia), which can affect your ability to drive and use machines or work without a safe 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.

What dose 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 what dose to take.

How to take this medicine

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

Do not exceed the maximum recommended daily dose: 5 mg of linagliptin and 2000 mg of metformin hydrochloride. You should take Autnami for as long as your doctor recommends to achieve long-term control of blood sugar levels. Your doctor may recommend taking this medicine with another oral anti-diabetic medicine or insulin. Take all medicines as directed by your doctor to get the best results from treatment. While taking Autnami, continue to follow the diet and exercise advice given to you by your doctor. If you have overweight, continue to follow the low-calorie diet recommended to you. It is unlikely that taking Autnami alone will cause low blood sugar (hypoglycemia). However, when taking Autnami with a sulfonylurea or insulin, it may cause low blood sugar. Your doctor may reduce the dose of sulfonylurea or insulin. The score line on the tablet is only to help you break the tablet if you have difficulty swallowing it whole.

What to do 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 are 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 are 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 immediately (see section 2). Take the medicine pack with you.

What to do 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 your next dose, do not take 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 or evening).

What to do 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. 5

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, as well as 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, 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). Stop taking Autnami and contact your 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, 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 your 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: nasal or throat inflammation, cough, loss of appetite (decreased appetite), vomiting, increased activity of the enzyme amylase in the blood, itching (pruritus).
• Rare: blistering of the skin (pemphigoid).

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

• Uncommon: liver problems, constipation.

Side effects that have been reported with metformin alone, which are not listed for Autnami, include:

• Very common: abdominal pain.
• Common (affects less than 1 in 10 people): metallic taste in the mouth (taste disturbance), low levels of vitamin B12 in the blood (symptoms may include extreme tiredness (fatigue), painful and red tongue (glossitis), tingling (paresthesia), or pale or yellowish skin). 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 (affects less than 1 in 10,000 people): liver inflammation (liver disease), skin reactions such as redness of the skin (erythema).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the national reporting system via the contact details listed below. By reporting side effects, you can help provide more information on the safety of this medicine.

• Department of Drug Safety, 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 You can also report side effects 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). 7
• 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 help you break the tablet if you have difficulty swallowing it whole, 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 help you break the tablet if you have difficulty swallowing it whole, and not to divide it 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 perforated unit dose blisters in a carton. Autnami is 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 perforated unit dose blisters 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 Warsaw, 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 tabletės, Autnami 2.5 mg/1 000 mg plevele dengtos tabletės, Latvia: Autnami 2.5 mg/850 mg apvalkotas tabletes, Autnami 2.5 mg/1000 mg apvalkotas tabletes, 8