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
Metformini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Iruka is and what it is used for
2. What you need to know 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 Iruka is and what it is used for

Iruka contains the active substance metformini hydrochloridum (metformin hydrochloride), which belongs to a group of medicines called biguanides and is used in the treatment of diabetes.
Iruka is used in adults for the treatment of type 2 diabetes when diet and exercise alone are insufficient to control blood glucose (sugar) levels.
Insulin is a hormone that enables body tissues to take up glucose from the blood and use it to produce energy or store it for later use. In people with type 2 diabetes, the pancreas does not produce enough insulin or the body cannot properly use the insulin that is produced. This leads to excessively high blood glucose levels, which can cause many serious, long-term health problems. Therefore, it is important to continue taking the medicine, even if no symptoms are apparent. Iruka increases the body's sensitivity to insulin and helps restore normal utilization of glucose by the body.
Treatment with Iruka prolonged-release tablets is associated with weight maintenance or moderate weight reduction. Iruka prolonged-release tablets have been specially designed to slowly release the medicine in the body and therefore differ from many other types of tablets containing metformin.

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 dysfunction
• if the patient has significantly reduced kidney function
• if the patient has uncontrolled diabetes, manifesting for example by severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, sudden weight loss, lactic acidosis (see below "Risk of lactic acidosis") or ketoacidosis. Diabetic ketoacidosis is a medical condition in which substances called "ketone bodies" accumulate in the blood, potentially leading to diabetic pre-coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness or unusual fruity odour from the mouth
• in case of excessive loss of body fluids (dehydration). Dehydration may lead to impaired kidney function, which may increase the patient's risk of lactic acidosis (see "Warnings and precautions")
• if the patient has a severe infection, such as lung or bronchial infection or kidney inflammation. Severe infections may lead to impaired kidney function, increasing the risk of lactic acidosis (see "Warnings and precautions")
• if the patient has been treated for acute heart disease or recent heart attack, severe circulatory disorders or breathing difficulties. These conditions may lead to tissue hypoxia, increasing the risk of lactic acidosis (see "Warnings and precautions")
• in case of alcohol abuse
• if the patient is under 18 years of age
• if the patient is scheduled for an imaging procedure involving intravascular administration of an iodine-containing contrast agent.

Warnings and precautions
Before starting treatment with Iruka, discuss this with your doctor or pharmacist.
Risk of lactic acidosis
Iruka may cause a very rare but serious adverse effect called lactic acidosis, especially if the patient has impaired kidney function. The risk of lactic acidosis is also increased in cases of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more information below), impaired liver function, and any medical conditions in which part of the body is inadequately supplied with oxygen (e.g. 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 (cellular energy-producing structures), 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 Iruka if the patient develops a medical condition that may lead to dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. Consult a doctor for further instructions.
Stop taking Iruka and contact a doctor immediately or go to the nearest hospital 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 malaise associated with severe fatigue
• difficulty breathing
• decreased body temperature and slowed heart rate

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

If the patient is undergoing major surgery, Iruka must be discontinued during and for some time after the procedure. The doctor will decide when to stop and restart Iruka treatment.
During treatment with this medicine, 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.
Undigested tablet residues may appear in the stool. This is normal with this type of tablet and should not be a cause for concern.
Continue to follow all dietary recommendations provided by the doctor and regularly consume carbohydrates throughout the day.
Metformin may lead to reduced absorption of vitamin B_. Patients at risk of vitamin B_ deficiency should have their blood vitamin B_ levels monitored.
Do not discontinue this medicine without consulting a doctor.

Iruka and other medicines
If an iodine-containing contrast agent needs to be injected into the bloodstream, for example during X-ray imaging or CT scan, the patient must stop taking Iruka before or at the time of injection. The doctor will decide when to stop and restart Iruka treatment.
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take. More frequent blood glucose monitoring and kidney function assessment may be necessary, or the doctor may adjust the dose of Iruka. It is especially important to inform about the following medicines:

• Corticosteroids, such as prednisolone, mometasone, beclomethasone
• Diuretics (water pills), such as furosemide
• Medicines used to treat pain and inflammation (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 present in certain dental anaesthetics
• Medicines that may alter Iruka blood levels, especially if the patient has impaired kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

Iruka and alcohol
While taking Iruka, avoid excessive alcohol consumption, as it may increase the risk of lactic acidosis (see section "Warnings and precautions").

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

Driving and operating machinery
Iruka, when used alone as an antidiabetic medicine, does not cause hypoglycaemia (low blood sugar) and therefore should not affect the ability to drive or operate machinery.
However, be aware that Iruka taken in combination with other antidiabetic medicines may cause hypoglycaemia. In such cases, exercise particular caution when driving or operating machinery.

Iruka contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dosage unit, meaning the medicine is considered "sodium-free".

3. How to take Iruka
Always take this medicine exactly as prescribed by the doctor. In case of doubt, consult the doctor or pharmacist.
The doctor may prescribe Iruka as the sole antidiabetic medicine or in combination with other oral antidiabetic medicines or insulin.
Swallow the tablets whole with a glass of water, do not chew.
Tablets are usually taken once daily with the evening meal.
In some cases, the doctor may recommend taking the tablets twice daily. Always take the tablets with food.

Recommended dose
Treatment usually starts with a dose of 500 mg of Iruka once daily. After approximately 2 weeks of treatment, the doctor will order a blood glucose test and adjust the dose accordingly. The maximum daily dose is 2000 mg of Iruka.
In cases of impaired kidney function, the doctor may prescribe a lower dose.

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

Missed dose of Iruka
Take the next dose as soon as remembered, with a meal. Do not take a double dose to make up for a missed dose.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur:
Iruka may cause a very rare but serious adverse reaction called lactic acidosis (see section "Warnings and precautions"). If this occurs in a patient, the patient must stop taking Iruka immediately and contact a doctor or the nearest hospital immediately, since lactic acidosis may lead to coma.
Iruka may cause abnormal liver function test results and hepatitis, which may result in jaundice. If a patient develops yellowing of the eyes and/or skin, immediate medical advice must be sought.
Other possible adverse reactions, listed by frequency:
Very common (may affect more than 1 in 10 people):

• diarrhoea, nausea, vomiting, abdominal pain or loss of appetite. If these occur, do not stop taking the tablets, as these symptoms usually resolve within about 2 weeks. Taking the tablets with or immediately after a meal may help.

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

• taste disturbance
• decreased vitamin B concentration

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

• skin rash, including redness, itching and urticaria

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions may also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Iruka
Keep the medicine out of the sight and reach of children.
No special storage conditions apply.
Do not use this medicine after the expiry date stated on the blister pack and outer packaging. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via the sewage system or household waste. Ask a pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Iruka contains
What Iruka 500 mg, prolonged-release tablets contains

• 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 000cP, hypromellose 5cP, microcrystalline cellulose, magnesium stearate.

What Iruka 750 mg, prolonged-release tablets contains

• 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 000cP, magnesium stearate.

What Iruka 1000 mg, prolonged-release tablets contains

• 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 000cP, 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 measuring approximately 19 x 9.2 mm, with the engraved mark “500” on one side and smooth on the other side.
Iruka 750 mg prolonged-release tablets:
White or almost white, uncoated, capsule-shaped tablets measuring approximately 19 x 9.2 mm, with the engraved mark “750” on one side and smooth on the other side.
Iruka 1000 mg prolonged-release tablets:
White or almost white, uncoated, capsule-shaped tablets measuring approximately 22 x 10.5 mm, with the engraved mark “1000” on one side and smooth on the other side.
Iruka prolonged-release tablets are supplied in blisters made of PVC/PVDC/Aluminium foil containing 30 or 60 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Farmaceutici Caber S.r.l.
Via del Mare 36
00071 Pomezia (RM)
Italy
Tel. +39 06 911801

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