Iruka

Package Leaflet: Information for the Patient

IRUKA, 500 mg, prolonged-release tablets

IRUKA, 750 mg, prolonged-release tablets

IRUKA, 1000 mg, prolonged-release tablets

Metformin hydrochloride

Read the package 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 to you by a doctor. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your 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 high blood sugar levels, which can cause many serious, long-term health problems.
Therefore, it is essential to continue taking the medicine, even if no symptoms are visible. 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 have been 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 you are allergic to metformin hydrochloride or any of the other ingredients of this medicine (listed in section 6)
• in case of liver function disorders
• if you have significantly reduced kidney function
• if you have 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 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 you at risk of lactic acidosis (see "Warnings and precautions")
• if you have a severe infection, such as pneumonia or bronchitis or kidney inflammation. Severe infections can lead to kidney function disorders, which can put you at risk of lactic acidosis (see "Warnings and precautions")
• if you have been treated for acute heart disease or have recently had a heart attack, severe circulatory disorders or breathing difficulties. This can lead to tissue hypoxia, which can put you at risk of lactic acidosis (see "Warnings and precautions")
• in case of alcohol abuse
• if you are under 18 years old
• if you are to undergo a radiographic examination using an iodine-containing contrast agent.

Warnings and precautions

Before starting to take Iruka, discuss it with your doctor or pharmacist.

Risk of lactic acidosis

Iruka may cause a very rare but very serious side effect called lactic acidosis, especially if you have 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 disease). If any of these conditions apply to you, consult your doctor for more detailed instructions.
You should immediately contact your doctor for further instructions if:

• you have 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.
• after starting metformin, you experience any of the following symptoms: seizures, cognitive impairment, difficulty moving, signs of nerve damage (e.g. pain or numbness), migraine and hearing loss.

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

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

Symptoms of lactic acidosis include:

• vomiting
• abdominal pain
• muscle cramps
• general feeling of being unwell with severe fatigue
• breathing difficulties
• decreased body temperature and slowed heart rate. Lactic acidosis is a life-threatening condition that requires hospital treatment.

If you are to undergo major surgery, you should stop taking Iruka during and for some time after the surgery. Your doctor will decide when you should stop and resume Iruka treatment.
During treatment with this medicine, your doctor will check your kidney function at least once a year or more often if you are elderly and (or) have deteriorating kidney function.
The stool may contain remnants of the tablets. Do not worry, this is normal when taking this type of tablet.
You should continue to follow any dietary recommendations given by your doctor and regularly eat 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.
Do not stop taking this medicine without consulting your doctor.

Iruka and other medicines

If it is necessary to inject an iodine-containing contrast agent into the bloodstream, for example, in connection with an X-ray examination or tomography, you should stop taking Iruka before or at the time of injection. Your doctor will decide when you should stop and resume Iruka treatment.
Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take. It may be necessary to check your blood sugar levels more frequently or assess your kidney function, or your doctor may adjust the dose of Iruka. 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 you have kidney function disorders (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

Iruka and alcohol

While taking Iruka, you should avoid excessive alcohol consumption, 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.

Driving and using machines

Iruka taken as the only antidiabetic medicine does not cause hypoglycemia (low blood sugar) and therefore should not affect your ability to drive or use machines.
However, you should be aware that Iruka taken with other antidiabetic medicines may cause hypoglycemia, so in this case, you should be particularly careful when driving or using machines.

Iruka contains sodium

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

3. How to take Iruka

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Your doctor may prescribe Iruka as the only antidiabetic medicine or in combination with other oral antidiabetic 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, your 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, your doctor will have your blood sugar levels checked and adjust the dose of Iruka. The maximum daily dose is 2000 mg of Iruka.
In case of kidney function disorders, your 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 you experience unusual symptoms, contact your doctor. In case of significant overdose, lactic acidosis may occur. Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain with muscle cramps, general feeling of being unwell with severe fatigue, and breathing difficulties. Further symptoms include decreased body temperature and slowed heart rate. If you experience any of these symptoms, seek medical help immediately, as lactic acidosis can lead to coma.
Stop taking Iruka and immediately contact your doctor or go to the nearest hospital.
In case of overdose or accidental ingestion of this medicine by a child, always contact a doctor, hospital or Poison Information Center to assess the risk and get further instructions.

Missing a dose of Iruka

Take the next dose as soon as you remember, during a meal. Do not take a double dose to make up for a missed dose.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 happens to you, you must stop taking Iruka and immediately contact your doctor or nearest hospital, as lactic acidosis can lead to coma.
Iruka may cause abnormal liver function test results and liver inflammation, which can lead to jaundice. If you experience yellowing of the eyes and (or) skin, contact your doctor immediately.
Other possible side effects, listed by frequency:

• diarrhea, nausea, vomiting, abdominal pain or loss of appetite. If you experience these, do not stop taking the tablets, as these symptoms usually disappear 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 you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Iruka

Keep this medicine out of the 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 carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 tablets in the shape of a capsule, 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 tablets in the shape of a capsule, 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 tablets in the shape of a capsule, 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 foil, 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