Diamicron 30 mg

Package leaflet: Information for the patient

DIAMICRON 30 mg
30 mg, modified-release tablets
Gliclazide
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Diamicron 30 mg is and what it is used for
2. What you need to know before taking Diamicron 30 mg
3. How to take Diamicron 30 mg
4. Possible side effects
5. How to store Diamicron 30 mg
6. Contents of the pack and other information

1. What Diamicron 30 mg is and what it is used for

Diamicron 30 mg is a medicine that lowers blood sugar levels (it is an oral antidiabetic agent belonging to the sulfonylurea derivatives group).
Diamicron 30 mg is used in the treatment of a certain type of diabetes (type 2 diabetes) in adults when diet, physical exercise, and weight reduction alone are not sufficient to maintain normal blood sugar levels.

2. Important information before using Diamicron 30 mg

When not to use Diamicron 30 mg:

• if the patient is allergic to gliclazide or any of the other ingredients of this medicine (listed in section 6), other medicines of the same group (sulfonylureas), or other sulfonamide derivatives with blood glucose-lowering action;
• if the patient has insulin-dependent (type 1) diabetes;
• if ketones and sugar are present in the urine (this may indicate diabetic ketoacidosis), pre-comatose or comatose states;
• if the patient has severe kidney or liver disease;
• if the patient is taking medicines used to treat fungal infections (miconazole, see section "Diamicron 30 mg and other medicines");
• if the patient is breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions
Before starting treatment with Diamicron 30 mg, discuss this with your doctor.
You must follow your doctor's recommendations for treatment to achieve proper blood glucose levels. This means that in addition to taking the tablets regularly, you should follow a diet, engage in physical exercise, and, if necessary, reduce body weight.
During treatment with gliclazide, regular monitoring of blood glucose (and possibly urine glucose) is required, as well as measurement of glycated hemoglobin (HbA1c).
The risk of low blood glucose (hypoglycemia) may be increased during the first weeks of treatment. Therefore, close medical supervision is particularly important.
Low blood glucose (hypoglycemia) 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 without adequate carbohydrate intake;
• the patient consumes alcohol, especially when skipping meals;
• the patient is taking other medicines or natural supplements at the same time;
• the patient takes too high a dose of gliclazide;
• the patient has certain hormonal disorders (thyroid, pituitary gland, or adrenal cortex dysfunction);
• kidney or liver function is severely impaired.

If the patient has low blood glucose, the following symptoms may occur:
headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, restlessness, aggression,
reduced concentration, decreased alertness and reaction time, depression, disorientation, speech or
vision disturbances, trembling, sensory disturbances, dizziness, weakness.
Other symptoms may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden, severe chest pain radiating (angina pectoris).
If blood glucose continues to drop, significant confusion (delirium), seizures, loss of self-control, shallow breathing, slow heartbeat, or loss of consciousness may occur.
In most cases, symptoms of low blood glucose disappear quickly when the patient consumes some sugar, e.g. glucose tablets, sugar cubes, sweet juice, or sweetened tea.
Therefore, it is important to always carry sugar-containing products (e.g. glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. Contact your doctor or nearest hospital if consuming sugar does not help or if symptoms recur.
Symptoms of low blood glucose may not appear, may be mild or develop slowly, or the patient may not be aware that blood glucose has dropped. This may occur in elderly patients or in patients taking certain medicines (e.g. those acting on the central nervous system or beta-blockers).
In stressful situations (accidents, surgery, fever, etc.), the doctor may temporarily switch treatment to insulin therapy.
Symptoms of high blood glucose (hyperglycemia) may occur if gliclazide has not sufficiently lowered blood glucose, if the patient has not followed the treatment plan recommended by the doctor, if the patient is taking preparations containing St. John's wort (Hypericum perforatum) (see section "Diamicron 30 mg and other medicines"), or during particularly 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.
When gliclazide is used concomitantly with antibiotics called fluoroquinolones, especially in elderly patients, disturbances in blood glucose levels (low or high blood glucose) may occur. In such cases, the doctor will remind the patient how important it is to monitor blood glucose levels.
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, hemoglobin levels may decrease and red blood cells may break down (hemolytic anemia). Before taking this medicinal product, consult your doctor.
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 derivatives.

Children and adolescents
Diamicron 30 mg is not recommended for use in children due to lack of data.

Diamicron 30 mg and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
The blood glucose-lowering effect of gliclazide may be enhanced, and symptoms of low blood glucose may occur, when any of the following medicines are taken:

• other medicines used to treat high blood glucose (oral antidiabetic agents, GLP-1 receptor agonists, or insulin);
• antibiotics (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 (H2-receptor blockers);
• medicines used to treat depression (MAO inhibitors);
• painkillers or anti-rheumatic medicines (phenylbutazone, ibuprofen);
• medicines containing alcohol.

The following medicines may reduce the effect of gliclazide and cause increased blood glucose:

• medicines used to treat central nervous system disorders (chlorpromazine);
• anti-inflammatory medicines (corticosteroids);
• medicines used to treat asthma or administered during childbirth (intravenous salbutamol, ritodrine, terbutaline);
• medicines used to treat breast disorders, severe menstrual bleeding, and endometriosis (danazol);
• preparations containing St. John's wort (Hypericum perforatum).

When Diamicron 30 mg is used concomitantly with antibiotics called fluoroquinolones, especially in elderly patients, disturbances in glucose levels (low or high blood glucose) may occur.
Diamicron 30 mg may enhance the effect of anticoagulant medicines (warfarin).
Consult your doctor before starting any other medicinal product.
If the patient is admitted to hospital, they should inform medical staff that they are taking Diamicron 30 mg.

Diamicron 30 mg with food, drink, and alcohol
Diamicron 30 mg may be taken with food and non-alcoholic beverages.
Drinking alcohol is not recommended, as it may alter diabetes control in an unpredictable way.

Pregnancy and breastfeeding
Diamicron 30 mg is not recommended during pregnancy. If the patient is pregnant, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
Diamicron 30 mg must not be used during breastfeeding.

Driving and using machines
If blood glucose is too low (hypoglycemia) or too high (hyperglycemia), or if vision disturbances occur due to abnormal blood glucose levels, the ability to concentrate or react may be impaired. Remember that the patient may pose a risk to themselves or others (e.g. when driving a car or operating machinery).
Ask your doctor whether it is safe to drive:

• if low blood glucose (hypoglycemia) occurs frequently;
• if symptoms of low blood glucose (hypoglycemia) are very mild or absent.

3. How to use Diamicron 30 mg

Dosage
Always use this medicine exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
The dosage is determined by the doctor, depending on blood and urine glucose levels.
Any changes related to external factors (weight loss, lifestyle changes, stress) or improved blood glucose control may require adjustment of gliclazide dosage.
The recommended daily dose ranges from one to four tablets (maximum 120 mg), taken orally as a single dose with breakfast. The dose depends on the body's response to treatment.
Diamicron 30 mg is intended for oral use. The tablet(s) should be taken with a glass of water at breakfast time (preferably at the same time every day). Tablets must be swallowed whole. Do not chew them.
Always eat a meal after taking the tablet(s).
In combination therapy with Diamicron 30 mg and metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-IV inhibitor, a GLP-1 receptor agonist, or insulin, the appropriate dosage of each medicine will be individually determined by the doctor.
If the patient notices high blood glucose levels despite taking the medicine as prescribed, they should consult their doctor or pharmacist.

Taking more Diamicron 30 mg than prescribed
If too many tablets have been taken, contact a doctor immediately or go to the nearest hospital.
Symptoms of overdose are those of low blood glucose (hypoglycaemia), as described in section 2. In such cases, consuming 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 action should be taken if someone, for example a child, accidentally takes this medicine. Do not give food or drink to unconscious patients.
Ensure that someone close is always informed and able to contact a doctor in case of an emergency.

Missing a dose of Diamicron 30 mg
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 Diamicron 30 mg, they should take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.

Stopping Diamicron 30 mg
Since diabetes treatment usually lasts a lifetime, consult your doctor before stopping this medicine.
Discontinuing treatment may lead to increased blood glucose levels (hyperglycaemia), increasing the risk of diabetes-related complications.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience 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 is significant or prolonged, even if temporarily controlled
by sugar intake, medical advice should be sought immediately.

Liver disorders
Isolated cases of impaired liver function have been observed, which may cause yellowing of the skin and eyes (jaundice).
In case these symptoms occur, medical advice should be sought immediately. Symptoms usually resolve after discontinuation of the medicine.
The physician will decide whether treatment should be discontinued.

Skin disorders
Skin reactions such as rash, redness, itching, urticaria (hives), and angioedema (rapid swelling of tissues such as eyelids, face, lips, oral cavity, tongue or throat, which may cause breathing difficulties) have been observed.
The rash may progress to extensive blistering or lead to skin peeling.
If a patient experiences these symptoms, Diamicron 30 mg should be discontinued immediately and the patient should urgently contact a physician, informing them about taking this medicine.

Rarely, symptoms of severe hypersensitivity reactions (DRESS, Drug Reaction with Eosinophilia and Systemic Symptoms) have been reported: initially presenting as influenza-like symptoms and facial rash, which then spreads, along with high fever.

Blood disorders
Reduced number of blood cells (e.g. platelets, red and white blood cells) may cause paleness, prolonged bleeding, bruising, sore throat and fever. These symptoms usually resolve after discontinuation of treatment.

Gastrointestinal disorders
Abdominal pain, nausea, vomiting, indigestion, diarrhoea and constipation. These symptoms may be reduced by taking Diamicron 30 mg with food, as recommended.

Eye disorders
Vision disturbances may occur, especially at the beginning of treatment. This effect is related to changes in blood glucose concentration.

As with other sulfonylurea derivatives, the following adverse events have been observed:
cases of significant blood cell count changes and allergic vasculitis, reduced sodium concentration in blood (hyponatremia), symptoms of liver damage (e.g. jaundice), which in most cases resolved after discontinuation of sulfonylurea derivatives, although in isolated cases may lead to life-threatening liver failure.

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 of Adverse Drug Reactions,
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 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 Diamicron 30 mg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the abbreviation
"EXP" (the term used to describe the expiry date). The expiry date refers to the last day of the
stated month. The abbreviation "Lot" on the packaging indicates the batch number of the medicine.
There are no special storage requirements for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help protect
the environment.

6. Contents of the pack and other information

What Diamicron 30 mg contains

• The active substance is gliclazide. Each modified-release tablet contains 30 mg of gliclazide.
• The other ingredients are: calcium hydrogen phosphate dihydrate, maltodextrin, hypromellose 100 cP, hypromellose 4000 cP, magnesium stearate, colloidal anhydrous silica.

What Diamicron 30 mg looks like and contents of the pack
Diamicron 30 mg is a white, elongated modified-release tablet,

with the imprint “DIA 30” on one side and “ ” on the other side. The tablets are available in blisters packed in cardboard boxes containing 60 or 90 tablets.

Marketing Authorisation Holder
Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex
France

Manufacturer
Les Laboratoires Servier Industrie (LSI)
905 route de Saran
45520 Gidy
France
Servier (Ireland) Industries Ltd (SII)
Gorey Road Arklow, Co. Wicklow
Ireland
ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.
Annopol Street 6 B
03-236 Warsaw
Poland

For detailed information, please contact the local representative of the Marketing Authorisation Holder:
Servier Polska Sp. z o.o.
Telephone number: (22) 594-90-00

This medicinal product is authorised in the European Economic Area under the following names:
Austria DIAMICRON MR 30 mg
Belgium UNI DIAMICRON
Cyprus DIAMICRON MR 30 mg
Czech Republic DIAPREL MR
Denmark DIAMICRON UNO 30 mg
Estonia DIAPREL MR
France DIAMICRON 30 mg
Greece DIAMICRON MR
Hungary DIAPREL MR
Iceland DIAMICRON UNO 30 mg
Ireland DIAMICRON MR 30 mg
Italy DIAMICRON 30 mg
Lithuania DIAPREL MR
Luxembourg DIAMICRON 30 mg
Netherlands DIAMICRON MR 30 mg
Poland DIAMICRON 30 mg
Portugal DIAMICRON LM 30 mg
Slovak Republic DIAPREL MR
Slovenia DIAPREL MR
Spain DIAMICRON 30 mg
United Kingdom DIAMICRON 30 mg MR