Diagen

Package leaflet: Information for the patient

Diagen, 60 mg, modified-release tablets
Gliclazidum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. 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 adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Diagen is and what it is used for

The active substance in Diagen is gliclazide.
Diagen is a medicine that lowers blood glucose levels (it is an oral antidiabetic agent belonging to the sulfonylurea derivatives group).
Diagen is used in the treatment of a certain form of diabetes (type 2 diabetes) in adults, when following diet, physical exercise, and weight reduction alone are insufficient to maintain normal blood glucose levels.

2. Important information before using Diagen

When not to use Diagen:

• if the patient is allergic to gliclazide or any of the other ingredients of this medicine (listed in section 6)
• if the patient is allergic to other medicines of the same group (sulfonylurea derivatives, e.g. glipizide) or other derivatives (sulfonamides, e.g. hydrochlorothiazide)
• if the patient has insulin-dependent diabetes (type 1)
• if ketone bodies and sugar are present in the urine (this may indicate that the patient has ketoacidosis), pre-coma or diabetic coma
• if the patient has severe kidney or liver disease
• if the patient is taking miconazole used in the treatment of fungal infections (see section "Diagen with other medicines")
• if the patient is breastfeeding (see section "Pregnancy and breastfeeding")

Warnings and precautions
Before starting treatment with Diagen, discuss this with your doctor or pharmacist.
This medicine should only be taken if meals (including breakfast) are taken regularly. Regular intake of carbohydrates is important due to the increased risk of low blood sugar (hypoglycaemia) if a meal is delayed or skipped, an inadequate amount of food is consumed, or if the meal is low in carbohydrates.
You must follow the treatment plan recommended by your doctor to achieve proper blood glucose levels. This means that in addition to taking the tablets regularly, you should follow a diet, be physically active, and if necessary, reduce body weight.
During treatment with gliclazide, regular monitoring of blood glucose (and possibly urine glucose) levels is necessary, as well as measurement of glycated haemoglobin (HbA1c).
The risk of low blood sugar (hypoglycaemia) may be increased during the first weeks of treatment. Therefore, careful medical supervision, including self-monitoring of blood glucose levels if necessary, is particularly important.
Low blood sugar (hypoglycaemia) may occur if:

• the patient eats irregularly or skips meals
• the patient is fasting
• the patient is malnourished
• the patient changes their diet
• the patient increases physical activity, and carbohydrate intake is insufficient
• the patient consumes alcohol, especially when skipping meals
• the patient takes other medicines or natural products at the same time (see section "Diagen with other medicines")
• the patient takes too high a dose of gliclazide
• the patient has specific hormonal disorders (thyroid, pituitary or adrenal cortex dysfunction)
• kidney or liver function is severely impaired
• the patient has serious heart or circulatory problems (affecting blood vessel circulation, such as angina pectoris)

If the patient has low blood sugar (hypoglycaemia), the following symptoms may occur:

• headache
• intense hunger
• nausea
• vomiting
• fatigue
• sleep disturbances
• restlessness
• aggression
• impaired concentration
• reduced alertness and reaction time
• depression
• confusion
• speech or vision disturbances, which may include difficulty reading or writing
• tremor
• sensory disturbances
• muscle weakness, partial paralysis
• dizziness
• feeling of weakness

The following symptoms may also occur:

• sweating
• clammy skin
• anxiety
• rapid or irregular heartbeat
• high blood pressure
• sudden, severe chest pain radiating to adjacent areas (angina pectoris)

If the following symptoms occur, contact your doctor or nearest hospital immediately:
If blood sugar continues to decrease, severe confusion (delirium), seizures, loss of consciousness, shallow breathing, slow heartbeat, or loss of consciousness may occur, which may be life-threatening.
In most cases, symptoms of low blood sugar disappear very quickly when the patient consumes some sugar, e.g. glucose tablets, sugar lumps, sweet fruit juice, or sweetened tea.
Therefore, you should always carry some sugary products (glucose tablets, sugar lumps) with you.
Note that artificial sweeteners are not effective. Contact your doctor or nearest hospital if consuming sugar does not help, if symptoms recur, or if they persist for a long time.
Symptoms of low blood sugar may not occur, may be mild or develop very slowly, or the patient may not be aware that blood sugar has decreased. This may happen if the patient is elderly or taking certain medicines (e.g. acting on the central nervous system and beta-blockers).
In stressful situations (e.g. accidents, surgical operations, infections, fever, etc.), your doctor may temporarily switch treatment to insulin therapy.
Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide has not sufficiently lowered blood glucose, if the patient has not followed the treatment plan recommended by the doctor, if products containing St. John's wort ( Hypericum perforatum ) are taken (see section "Diagen with other medicines"), or in particular stressful situations. These may include thirst, frequent urination, dry mouth, dry, itchy skin, skin infections and reduced activity.
If these symptoms occur, the patient must contact their doctor or pharmacist.
If a congenital deficiency of glucose-6-phosphate dehydrogenase (G6PD) (abnormal red blood cells) has been diagnosed in the patient or in a family member, a decrease in haemoglobin levels and breakdown of red blood cells (haemolytic anaemia) may occur. Consult your doctor before taking this medicine.
In patients with porphyria (a hereditary genetic disorder involving accumulation of porphyrins or their precursors in the body), cases of porphyria exacerbation have been reported after using certain other sulfonylurea derivative medicines.

Children and adolescents
Diagen is not recommended for use in children and adolescents due to lack of data.

Diagen with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not use Diagen if the patient is taking miconazole for the treatment of fungal infections (see section "When not to use Diagen").
The blood glucose-lowering effect of gliclazide may be enhanced, and symptoms of low blood sugar may occur, when one of the following medicines is taken:

• other medicines used to treat high glucose levels (insulin or oral antidiabetic medicines such as acarbose, thiazolidinediones (e.g. pioglitazone), metformin, GLP-1 receptor agonists (e.g. exenatide, liraglutide, lixisenatide or albiglutide))
• antibiotics (e.g. sulfonamides, clarithromycin)
• medicines used to treat high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril or enalapril)
• medicines used to treat fungal infections (miconazole, fluconazole)
• medicines used to treat stomach or duodenal ulcers (H-receptor blockers)
• medicines used to treat depression (MAO inhibitors)
• painkillers or anti-rheumatic medicines (phenylbutazone, anti-inflammatory drugs)
• medicines containing alcohol
• medicines used to treat high cholesterol levels (fibrates)
• medicines used to treat fever or pain (salicylates)

The blood glucose-lowering effect of gliclazide may be reduced, and symptoms of high blood sugar may occur, when one of the following medicines is taken:

• medicines used to treat central nervous system disorders (chlorpromazine)
• anti-inflammatory medicines (corticosteroids). Self-monitoring of blood glucose levels is important when taking this medicine, especially at the beginning of treatment
• medicines used to treat asthma or used during childbirth (intravenous salbutamol, ritodrine, terbutaline). Self-monitoring of blood glucose levels is important when taking these medicines
• medicines used to treat breast disorders, severe menstrual bleeding and endometriosis (danazol). Self-monitoring of blood glucose and urine glucose levels is important when taking these medicines
• products containing St. John's wort ( Hypericum perforatum ) used to treat mild depression

When Diagen is taken together with medicines belonging to the group of antibiotics called fluoroquinolones, especially in elderly patients, disturbances in blood glucose levels (low and high blood sugar) may occur.
Diagen may enhance the effect of anticoagulant medicines (e.g. warfarin).
Consult your doctor before starting any other medicines. If the patient is admitted to hospital, they should inform the medical staff that they are taking Diagen.

Diagen and alcohol
Drinking alcohol while taking Diagen is not recommended, as it may disrupt diabetes control, which could lead to diabetic coma.

Pregnancy and breastfeeding
Pregnancy
Do not use Diagen during pregnancy.
Breastfeeding
Do not use Diagen during breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine. The doctor may recommend a more appropriate treatment.

Driving and using machines
Diagen has no effect or negligible effect on the ability to drive and operate machinery. However, if blood glucose is too low (hypoglycaemia) or too high (hyperglycaemia), or if vision disturbances occur as a result of abnormal blood sugar levels, the ability to concentrate or react may be impaired. Such symptoms may occur more frequently at the beginning of treatment with Diagen.
Bear in mind that the patient may pose a risk to themselves or others (e.g. while driving or operating machinery). Ask your doctor whether you may drive:

• if low blood sugar (hypoglycaemia) occurs frequently
• if symptoms of low blood sugar (hypoglycaemia) are very mild or absent.

3. How to use Diagen

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The dose is determined by the doctor, depending on blood and urine sugar levels.
Any changes related to external factors (e.g. weight loss, lifestyle changes, stress) or improved blood sugar control may require adjustment of gliclazide doses.
The recommended dose is half a tablet to 2 tablets (from 30 mg to a maximum of 120 mg) taken once daily with breakfast. The dose depends on the body's response to treatment.
The initial dose is usually 30 mg once daily. If blood glucose levels are not adequately controlled, the doctor may increase the dose in subsequent steps, usually no more frequently than once a month.
In combination therapy with Diagen and metformin, an alpha-glucosidase inhibitor, or insulin, the appropriate dose of each medicine will be individually determined by the doctor.
Consult a doctor or pharmacist if the patient feels that the effect of Diagen is too strong or too weak.
The tablet may be divided into equal doses.
Swallow half a tablet or the whole tablet(s) at once. Do not chew or crush.
The tablet(s) should be taken with a glass of water at breakfast time (preferably at the same time every day).
Always eat a meal after taking the tablet(s).

Taking more Diagen than recommended
If too many tablets are taken, the patient may develop low blood sugar (hypoglycaemia). Seek immediate medical advice or go to the nearest hospital.
Symptoms of overdose are the same as symptoms of low blood sugar (hypoglycaemia) described in section 2. In such cases, eating sugar (4 to 6 sugar cubes) or drinking a sweet beverage, followed by a snack or meal, may help. If the patient is unconscious, contact a doctor immediately and call emergency services. The same applies if someone (e.g. a child) accidentally takes this medicine. Do not give food or drink to unconscious patients.
Ensure that someone is always informed in advance who can contact a doctor in case of an emergency.

Missing a dose of Diagen
It is important to take the medicine every day, as regular use ensures better effectiveness.
However, if the patient forgets to take a dose of Diagen, the next dose should be taken at the usual time. Do not take a double dose to make up for the missed dose.

Stopping Diagen
Since diabetes treatment usually lasts a lifetime, consult a doctor before stopping this medicine. Discontinuing treatment may lead to increased blood sugar levels (hyperglycaemia).
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The most commonly observed adverse effect is low blood sugar (hypoglycaemia).
Subjective and objective symptoms are described in the section "Warnings and precautions".
If these symptoms are left untreated, they may progress to drowsiness, loss of consciousness or coma. If
the observed reduction in blood sugar concentration is significant or prolonged, even if temporarily
controlled by sugar intake, medical advice must be sought immediately.
The medicine should be discontinued and the doctor informed immediately if any of the following
adverse reactions occur:

• reduction in the number of white and red blood cells and platelets (may cause fatigue, easy bruising, fever, frequent nosebleeds, and increased risk of infection, e.g. sore throat, oral ulcers)
• liver function disorders, such as hepatitis, which may cause nausea, vomiting, loss of appetite, fever, itching, yellowing of the skin and eyes, dark urine, pale stools, potentially leading to liver failure
• purple spots and patches on the skin; skin ulcers, most commonly on the legs, buttocks or trunk; skin blisters; urticaria lasting longer than 24 hours, and open wounds with tissue necrosis
• severe skin reactions, such as Stevens-Johnson syndrome with extensive blistering of the skin and bleeding around the lips, eyes, mouth, nose and genital organs, as well as toxic epidermal necrolysis, which may cause rash, blistering or skin peeling
• drug reaction which may include red rash with palpable nodules, elevated temperature, enlarged lymph nodes (e.g. under the arms) and general malaise. Blood tests may show changes in liver function or changes in the number of certain types of blood cells
• swelling of the face, lips, tongue or throat, difficulty breathing or swallowing

Other adverse reactions
Very rare: may affect up to 1 in 10,000 people

• reduction in the number of red blood cells, which may cause pallor, fatigue, headache, dizziness
• skin reactions such as rash, redness, itching, urticaria, red raised rash, blisters
• increased activity of liver enzymes, which may be observed in blood tests.

Frequency unknown: frequency cannot be estimated from available data

• visual disturbances due to changes in blood glucose concentration
• reduction in blood sodium concentration (hyponatraemia)

These symptoms usually resolve after discontinuation of treatment.
Gastrointestinal disorders
Abdominal pain, nausea, vomiting, indigestion, diarrhoea, constipation have been observed. These effects are
less likely when Diagen is taken with breakfast, as recommended.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie
181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Diagen

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box, bottle, or
blister pack after EXP. The expiry date refers to the last day of the stated month.
Bottles: Use within 100 days of opening the container.
No special storage conditions apply.
Medicines must 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 Diagen contains
The active substance is gliclazide. Each modified-release tablet contains 60 mg of gliclazide.
Other ingredients are hypromellose, microcrystalline cellulose, magnesium stearate.

What Diagen looks like and contents of the pack
Diagen is a white to almost white, elongated, biconvex tablet with an embossed "M" to the left of the breakline on one side, and "GL" to the left and "60" to the right of the breakline on the other side. The tablet can be divided into equal doses.
Diagen is available in blisters containing 10, 30, 30 x 1 (unit dose), 60 or 90, 90 x 1 (unit dose) tablets, and in bottles containing 30, 60, 90 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturer/Importer:
Mylan Hungary Kft
H-2900 Komárom
Mylan utca 1
Hungary

For further information about this medicinal product and its names in the countries of the European Economic Area, please contact the representative of the marketing authorisation holder:
Viatris Healthcare Sp. z o.o.
Tel: +48 22 546 64 00