Iruka

Leaflet attached to the packaging: patient information

IRUKA, 500 mg, prolonged-release tablets

IRUKA, 750 mg, prolonged-release tablets

IRUKA, 1000 mg, prolonged-release tablets

Metformin hydrochloride

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Iruka and what is it used for

Iruka contains the active substance metformin hydrochloride, which belongs to a group of medicines called biguanides and is used to treat diabetes.
Iruka is used in adults to treat type 2 diabetes, when diet and exercise alone are not enough to control blood sugar levels.
Insulin is a hormone that allows the body's tissues to take up glucose from the blood and use it to produce energy or store it for later use. In patients with type 2 diabetes, the pancreas does not produce enough insulin or the body is unable to use the insulin produced. This leads to an excessive increase in blood sugar levels, which can cause many serious, long-term health problems.
Therefore, it is essential to continue taking the medicine, even if no visible symptoms are present. Iruka makes the body more sensitive to insulin and helps restore the normal use of glucose by the body.
Taking Iruka, prolonged-release tablets is associated with maintaining or moderately reducing body weight. Iruka, prolonged-release tablets are specially designed to release the medicine slowly in the body and therefore differ from many other types of metformin tablets.

2. Important information before taking Iruka

When not to take Iruka:

• if the patient is allergic to metformin hydrochloride or any of the other ingredients of this medicine (listed in section 6)
• in case of liver function disorders
• if the patient has significantly reduced kidney function
• if the patient has uncontrolled diabetes, characterized by 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 the blood accumulates substances called "ketone bodies", which can lead to diabetic coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness or an unusual fruity odor from the mouth
• in case of excessive fluid loss from the body (dehydration). Dehydration can lead to kidney function disorders, which can put the patient at risk of lactic acidosis (see "Warnings and precautions")
• if the patient has a severe infection, such as pneumonia or bronchitis or kidney inflammation. Severe infections can lead to kidney function disorders, which can put the patient at risk of lactic acidosis (see "Warnings and precautions")
• if the patient has been treated for acute heart conditions or recently had a heart attack, severe circulatory disorders or breathing difficulties. This can lead to tissue hypoxia, which can put the patient at risk of lactic acidosis (see "Warnings and precautions")
• in case of alcohol abuse
• if the patient is under 18 years old
• if the patient is to undergo a radiographic procedure using an iodine-containing contrast medium.

Warnings and precautions

Before starting Iruka, the patient should discuss it with their doctor or pharmacist.

Risk of lactic acidosis

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

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

The patient should temporarily stop taking Iruka if they have a condition that may be associated with dehydration(significant fluid loss), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual.
To get further instructions, the patient should talk to their doctor.

The patient should stop taking Iruka and immediately contact their doctor or go to the nearest hospital if they experience any symptoms of lactic acidosis, as this condition can lead to coma.

Symptoms of lactic acidosis include:

• vomiting
• abdominal pain
• muscle cramps
• general malaise accompanied by severe fatigue
• breathing difficulties
• decreased body temperature and slowed heart rate. Lactic acidosis is a life-threatening condition that requires hospital treatment.

If the patient is to undergo major surgery, they must stop taking Iruka during and for some time after the surgery. The doctor will decide when the patient must stop and resume Iruka treatment.
During treatment with this medicine, 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.
The stool may contain remnants of the tablets. The patient should not be concerned, as this is normal when taking this type of tablet.
The patient should continue to follow any dietary recommendations given by their doctor and regularly consume carbohydrates throughout the day.
Metformin may lead to a decrease in vitamin B12 absorption. In patients at risk of vitamin B12 deficiency, it is recommended to monitor vitamin B12 blood levels.
The patient should not stop taking this medicine without consulting their doctor.

Iruka and other medicines

If it is necessary to inject an iodine-containing contrast medium into the bloodstream, for example, in connection with an X-ray examination or tomography, the patient must stop taking Iruka before or at the time of injection. The doctor will decide when the patient must stop and resume Iruka treatment.
The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. It may be necessary to have more frequent blood sugar tests and kidney function assessments, or the doctor may adjust the Iruka dosage. It is especially important to inform about the following medicines:

• Corticosteroids, such as prednisolone, mometasone, beclomethasone
• Diuretics, such as furosemide
• Medicines used to treat pain and inflammatory conditions (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)
• Sympathomimetic medicines, including epinephrine and dopamine, used to treat heart attack and low blood pressure. Epinephrine is also a component of some dental anesthetics
• Medicines that may change the level of Iruka in the blood, especially if the patient has kidney function disorders (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

Iruka and alcohol

While taking Iruka, the patient should avoid excessive alcohol consumption, as it 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 their doctor or pharmacist before taking this medicine.

Driving and using machines

Iruka taken as the only anti-diabetic medicine does not cause hypoglycemia (low blood sugar) and should not affect the ability to drive and use machines.
However, the patient should be aware that Iruka taken with other anti-diabetic medicines may cause hypoglycemia, so they should be especially careful when driving and using machines.

Iruka contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose unit, which means the medicine is considered "sodium-free".

3. How to take Iruka

This medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor or pharmacist.
The doctor may prescribe Iruka as the only anti-diabetic medicine or in combination with other oral anti-diabetic medicines or insulin.
The tablets should be swallowed whole, with a glass of water, without chewing.
Usually, the tablets should be taken once a day, during the evening meal.
In some cases, the doctor may recommend taking the tablets twice a day. The tablets should always be taken with food.

Recommended dose

Treatment usually starts with a dose of 500 mg of Iruka once a day. After about 2 weeks of taking this medicine, the doctor will order a blood sugar test and adjust the dose of Iruka. The maximum daily dose is 2000 mg of Iruka.
In case of kidney function disorders, the doctor may prescribe a lower dose.

Taking a higher dose of Iruka than recommended

Accidentally taking more tablets than recommended should not be a cause for concern, but if unusual symptoms occur, the patient should contact their doctor. In case of significant overdose, lactic acidosis may occur. Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain accompanied by muscle cramps, general malaise accompanied by severe fatigue, and breathing difficulties. Further symptoms include decreased body temperature and slowed heart rate. If any of these symptoms occur, the patient should immediately seek medical help, as lactic acidosis can lead to coma.
The patient should stop taking Iruka and immediately contact their doctor or go to the nearest hospital.
In case of overdose or accidental ingestion of this medicine by a child, the patient should always contact their doctor, hospital, or Poison Information Center to assess the risk and get further instructions.

Missing a dose of Iruka

The patient should take the next dose as soon as they remember, during a meal. They should not take a double dose to make up for the missed dose.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Iruka can cause side effects, although not everybody gets them.
The following side effects may occur:
Iruka may cause a very rare but very serious side effect called lactic acidosis (see "Warnings and precautions"). If this occurs, the patient must stop taking Iruka and immediately contact their doctor or nearest hospital, as lactic acidosis can lead to coma.
Iruka may cause abnormal liver function test results and hepatitis, which can result in jaundice. If the patient experiences yellowing of the eyes and (or) skin, they should immediately contact their doctor.
Other possible side effects are listed below by frequency:

• diarrhea, nausea, vomiting, abdominal pain, or loss of appetite. If these occur, the patient should not stop taking the tablets, as these symptoms usually resolve within about 2 weeks. It is helpful to take the tablets during or immediately after a meal.

Very common(may affect more than 1 in 10 people):

• diarrhea, nausea, vomiting, abdominal pain, or loss of appetite

Common(may affect up to 1 in 10 people):

• taste disturbance
• decreased vitamin B12 levels

Very rare(may affect up to 1 in 10,000 people):

• skin rashes, including redness, itching, and hives

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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
Phone: +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 Iruka

The medicine should be stored out of sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the blister and packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Iruka contains

What Iruka, 500 mg, prolonged-release tablets contain

• The active substance is metformin hydrochloride. Each prolonged-release tablet contains 500 mg of metformin hydrochloride (equivalent to 390 mg of metformin).
• The other ingredients are: sodium carmellose, hypromellose 100,000 cP, hypromellose 5 cP, microcrystalline cellulose, magnesium stearate.

What Iruka, 750 mg, prolonged-release tablets contain

• The active substance is metformin hydrochloride. Each prolonged-release tablet contains 750 mg of metformin hydrochloride (equivalent to 585 mg of metformin).
• The other ingredients are: sodium carmellose, hypromellose 100,000 cP, magnesium stearate.

What Iruka, 1000 mg, prolonged-release tablets contain

• The active substance is metformin hydrochloride. Each prolonged-release tablet contains 1000 mg of metformin hydrochloride (equivalent to 780 mg of metformin).
• The other ingredients are: sodium carmellose, hypromellose 100,000 cP, magnesium stearate.

What Iruka looks like and contents of the pack

Iruka, 500 mg, prolonged-release tablets:
White or almost white, uncoated, capsule-shaped tablets, approximately 19 x 9.2 mm in size, with the inscription "500" on one side and smooth on the other.
Iruka, 750 mg, prolonged-release tablets:
White or almost white, uncoated, capsule-shaped tablets, approximately 19 x 9.2 mm in size, with the inscription "750" on one side and smooth on the other.
Iruka, 1000 mg, prolonged-release tablets:
White or almost white, uncoated, capsule-shaped tablets, approximately 22 x 10.5 mm in size, with the inscription "1000" on one side and smooth on the other.
Iruka, prolonged-release tablets are available in blisters of PVC/PVDC/Aluminum, containing 30 or 60 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Farmaceutici Caber S.r.l.
Via del Mare 36
00071 Pomezia (RM)
Italy
Phone: +39 06 911801

Manufacturer

Savio Industrial S.r.l.
Via Emilia 21
27100 Pavia
Italy

Date of last revision of the leaflet: 30/04/2025