Diaril

Leaflet attached to the packaging: information for the user

DIARIL

1 mg, 2 mg, 3 mg or 4 mg, tablets

Glimepiride

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should 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 Diaril and what is it used for
• 2. Important information before using Diaril
• 3. How to use Diaril
• 4. Possible side effects
• 5. How to store Diaril
• 6. Contents of the pack and other information

1. What is Diaril and what is it used for

Diaril is an oral medicine that reduces blood sugar levels. It belongs to a group of medicines called sulfonylurea derivatives.
The action of Diaril is to increase the amount of insulin produced by the pancreas. Insulin lowers blood sugar levels.

What Diaril is used for:

Diaril is used to treat a certain type of diabetes (type 2 diabetes), when diet, physical exercise, and weight loss alone cannot control blood sugar levels.
Diaril can be used in combination with metformin or insulin.

2. Important information before using Diaril

You should not use Diaril and should inform your doctor:

• if you are allergic to glimepiride or other sulfonylurea derivatives (medicines used to lower blood sugar levels, e.g. glibenclamide) or sulfonamides (medicines used to treat bacterial infections, e.g. sulfamethoxazole) or any of the other ingredients of this medicine (listed in section 6);
• if you have insulin-dependent diabetes (type 1 diabetes);
• if you have diabetic ketoacidosis (a complication of diabetes that causes an increase in acid levels in the body; symptoms may include fatigue, nausea, frequent urination, and muscle stiffness);
• if you have diabetic coma;
• if you have severe kidney disease;
• if you have severe liver disease.

You should not use Diaril if you have any of the above conditions.
In case of doubts, before using Diaril, you should consult a doctor or pharmacist.

Warnings and precautions

Before starting to take Diaril, you should discuss it with your doctor or pharmacist:

• if you have had an injury, surgery, infection with fever, or other stressful situation; you should inform your doctor, as a temporary change in treatment may be necessary;
• if you have liver or kidney problems.

In case of doubts, before using Diaril, you should consult a doctor or pharmacist.
In patients with a deficiency of the enzyme glucose-6-phosphate dehydrogenase, a decrease in hemoglobin levels and breakdown of red blood cells (hemolytic anemia) may occur.

Children and adolescents

Information on the use of Diaril in patients under 18 years of age is limited. The use of this medicine is not recommended in this patient group.

Important information about hypoglycemia (low blood sugar)

During treatment with Diaril, hypoglycemia (low blood sugar) may occur in the patient.
Below are additional information about hypoglycemia, its symptoms, and treatment.

The following factors may increase the risk of hypoglycemia:

• undernutrition, irregular meals, skipping or delaying meals;
• changes in diet;
• using a higher dose of Diaril than necessary;
• kidney problems;
• severe liver disease;
• certain hormonal disorders (e.g. thyroid, pituitary, or adrenal gland disorders);
• alcohol consumption (especially if a meal is skipped);
• taking certain medicines (see below "Diaril and other medicines");
• performing more physical exercise than usual, if the meal was not sufficient or the food contained less carbohydrates than usual.

The symptoms of hypoglycemia include:

• uncontrolled hunger, headache, nausea, vomiting, fatigue, drowsiness, sleep disturbances, restlessness, aggression, concentration and attention disorders, depression, disorientation, speech and vision disorders, speech disorders, tremors, weakness, sensory disturbances, dizziness, helplessness;
• the following symptoms may also occur: sweating, moist skin, anxiety, rapid heartbeat, high blood pressure, palpitations, sudden severe chest pain that may radiate to adjacent parts of the body (angina pectoris or irregular heartbeat).

If blood sugar levels continue to decrease, the following may occur: confusion (delirium), seizures, loss of self-control, shallow breathing, and slow pulse, and may lead to loss of consciousness. The clinical picture of significant hypoglycemia may be similar to a stroke.

Treatment of hypoglycemia:

In many cases, the symptoms of low blood sugar disappear very quickly after consuming some types of sugar, e.g. sugar cubes, sweet juice, sweetened tea.
You should always carry sugar with you (e.g. sugar cubes). You should remember that artificial sweeteners are not effective in treating hypoglycemia. You should consult a doctor or go to the hospital if sugar consumption does not relieve the symptoms of hypoglycemia.

Laboratory tests

You should regularly check your blood or urine sugar levels. Your doctor may also perform regular blood tests. This is necessary to check liver function and blood cell count.

Diaril and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those that are available without a prescription.
Your doctor may decide to change the dose of Diaril if you are taking other medicines that may weaken or enhance the effect of Diaril on blood sugar levels.
The following medicines may increase the effect of Diaril on lowering blood sugar levels, which may lead to the risk of hypoglycemia (low blood sugar):

• other medicines used to treat diabetes (e.g. insulin or metformin);
• medicines used to treat pain and inflammation (phenylbutazone, azapropazone, oxyphenbutazone, medicines with a similar effect to acetylsalicylic acid);
• medicines used to treat urinary tract infections (e.g. certain long-acting sulfonamides);
• medicines used to treat bacterial and fungal infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin);
• medicines that prevent blood clotting (coumarin derivatives, e.g. warfarin);
• anti-arrhythmic medicines used to prevent heart rhythm disturbances (disopyramide);
• medicines that promote muscle growth (anabolic steroids);
• medicines used to treat male hormone deficiencies;
• medicines used to treat depression (fluoxetine, MAO inhibitors);
• medicines that lower high cholesterol levels (fibrates);
• medicines that lower high blood pressure (ACE inhibitors);
• medicines used to treat gout (allopurinol, probenecid, sulfinpyrazone);
• medicines used to treat cancer (cyclophosphamide, ifosfamide, trofosfamide);
• medicines used to reduce weight (fenfluramine);
• medicines used to improve circulation, administered intravenously in high doses (pentoxifylline);
• medicines used to treat nasal allergies, e.g. hay fever (tritoqualine);
• medicines called sympathomimetics used to treat high blood pressure, heart failure, or prostate symptoms.

The following medicines may decrease the effect of Diaril on blood sugar levels, which may lead to the risk of hyperglycemia (high blood sugar):

• medicines containing female sex hormones (estrogens, progestogens);
• medicines used to treat high blood pressure, called thiazide diuretics (diuretics);
• medicines used to stimulate the thyroid gland (thyroid hormones, e.g. levothyroxine);
• medicines used to treat allergies and inflammation (glucocorticosteroids);
• medicines used to treat severe mental disorders (chlorpromazine and other phenothiazine derivatives);
• medicines used to accelerate heart rate, treat asthma, or relieve nasal congestion, cough, and cold, or to reduce weight or used in emergency situations (adrenaline and sympathomimetics);
• medicines used to lower high cholesterol levels (nicotinic acid);
• medicines used to treat constipation, used for a long time (laxatives);
• medicines used to treat epilepsy (phenytoin);
• medicines used to treat nervousness and sleep disorders (barbiturates);
• medicines used to treat increased eye pressure (acetazolamide);
• medicines used to treat high blood pressure or low blood sugar (diazoxide);
• medicines used to treat infections, tuberculosis (rifampicin);
• medicines used to treat life-threatening low blood sugar (glucagon).

The following medicines may increase or decrease the effect of Diaril on blood sugar levels:

• medicines used to treat stomach ulcers (called H2 antagonists);
• medicines used to treat high blood pressure or heart failure, e.g. beta-blockers, clonidine, guanethidine, and reserpine. These medicines may also weaken (mask) the symptoms of hypoglycemia, so caution should be exercised when using them.

Diaril may increase or decrease the effect of the following medicines:

• medicines that prevent blood clotting (coumarin derivatives, e.g. warfarin).

You should always consult a doctor before using Diaril with other medicines.

Diaril with food, drink, and alcohol

Diaril should be taken in a single dose, immediately before or during breakfast or the first meal of the day.
Diaril tablets should be swallowed, washed down with at least half a glass of water.
Consuming alcohol may enhance or weaken the effect of Diaril in an unpredictable way.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult a doctor or pharmacist before using this medicine.
Pregnancy
You should not use Diaril during pregnancy.
Breastfeeding
Diaril may pass into breast milk. You should not use Diaril during breastfeeding.

Driving and using machines

Your ability to concentrate or react quickly may be impaired due to low blood sugar levels (hypoglycemia), high blood sugar levels (hyperglycemia), or if your vision is impaired due to changes in blood sugar levels. You should be aware that you may pose a risk to yourself or others (e.g. when driving a car or operating machinery in motion). Patients should ask their doctor for advice on whether it is advisable to drive or operate machinery in motion if:

• hypoglycemia occurs frequently,
• warning signs of hypoglycemia are weakened or do not occur.

Diaril contains lactose.

If you have been diagnosed with an intolerance to some sugars, you should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per recommended dose unit, which means that the medicine is considered "sodium-free".

3. How to use Diaril

This medicine should always be used exactly as prescribed by your doctor. In case of doubts, you should consult a doctor or pharmacist.

Using the medicine

• The medicine should be taken orally, immediately before or during the first meal of the day (usually breakfast). If you do not eat breakfast, you should take the medicine as advised by your doctor. If you are taking Diaril, you should follow the recommended diet.
• The tablet should be swallowed, washed down with at least half a glass of water.
• You should not crush or chew the tablets.
• The tablet can be divided into two equal doses.

What dose of Diaril to use

The dose of Diaril depends on your needs, your condition, and the results of your blood and urine sugar tests, and is determined by your doctor. You should not take more tablets than recommended by your doctor.

• The initial dose is usually one Diaril 1 mg tablet per day.
• Your doctor may increase the dose after 1-2 weeks of treatment if necessary.
• The maximum recommended dose is 6 mg of Diaril per day.
• Combination therapy with glimepiride and metformin or glimepiride and insulin may be initiated. In this case, your doctor will recommend the appropriate, individually determined doses of glimepiride, metformin, and insulin.
• If you experience changes in weight, lifestyle, or are under stress, you should inform your doctor so that they can adjust the dose of the medicine if necessary.
• If you think the effect of the medicine is too weak or too strong, you should not change the dose yourself, but consult a doctor.

Taking a higher dose of Diaril than recommended

Taking too many Diaril tablets or taking an additional dose is dangerous, as there is a risk of hypoglycemia (see section 2 - "Warnings and precautions"), so you should immediately consume a sufficient amount of sugar (e.g. small sugar cubes, sweet juice, sweetened tea) and inform your doctor as soon as possible.
Treatment of hypoglycemia in children who have accidentally taken the medicine, the amount of sugar given to them should be controlled to avoid the risk of hyperglycemia. Unconscious persons should not be given food or drink.
In case of prolonged hypoglycemia, it is very important that the patient is under supervision until the danger has passed. Hospitalization may be necessary as a precaution. You should show your doctor the packaging or remaining tablets so that they know what medicine has been taken.
Severe cases of hypoglycemia with loss of consciousness and severe neurological disorders require immediate medical attention, usually in a hospital. You should make sure that someone who is aware of the situation is always nearby to call a doctor in case of an emergency.

Missing a dose of Diaril

You should not take a double dose to make up for a missed dose.
Treatment should be continued, following the recommended dosing schedule of Diaril.

Stopping Diaril treatment

After stopping Diaril treatment, the achieved reduction in blood sugar levels will not be maintained, and the disease may worsen. You should use Diaril for as long as your doctor recommends.
In case of any further doubts about using this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Diaril can cause side effects, although not everybody gets them.

You should immediately tell your doctor if you experience any of the following symptoms:

• Allergic reactions (including vasculitis, often with rash), which can develop into severe reactions with difficulty breathing, low blood pressure, and even lead to shock.
• Impaired liver function, including yellowing of the skin and eyes (jaundice), bile flow problems (cholestasis), liver inflammation (hepatitis), or liver failure.
• Skin allergy (hypersensitivity) with itching, rash, hives, and increased sensitivity to sunlight. Some mild allergic reactions may develop into severe reactions.
• Severe hypoglycemia, including loss of consciousness, seizures, or coma.

In some patients, the following side effects have occurred during treatment with Diaril:
Rare side effects(occurring in 1 to 10 patients per 10,000):

• Lower than usual blood sugar levels (hypoglycemia) - see section 2 - "Warnings and precautions".
• Decreased blood cell count: platelets (which increases the risk of bleeding or bruising), white blood cells (which increases the risk of infection), red blood cells (which can cause pale skin and weakness or shortness of breath). These disorders usually disappear after stopping Diaril treatment.

Very rare side effects(occurring in less than 1 patient per 10,000):

• Allergic reactions (including vasculitis, often with rash), which can develop into severe reactions with difficulty breathing, low blood pressure, and even lead to shock. If you experience any of these symptoms, you should immediately inform your doctor.
• Impaired liver function, including yellowing of the skin and eyes (jaundice), bile flow problems (cholestasis), liver inflammation (hepatitis), or liver failure. If you experience any of these symptoms, you should immediately inform your doctor.
• Nausea or vomiting, diarrhea, feeling of fullness in the stomach or bloating, abdominal pain.
• Decreased sodium levels in the blood (shown in blood tests).

Other side effects:

• Skin allergy (hypersensitivity) with itching, rash, hives, and increased sensitivity to sunlight. Some mild allergic reactions may develop into severe reactions with difficulty swallowing and breathing, swelling of the lips, throat, or tongue. If you experience any of these symptoms, you should immediately inform your doctor.
• Allergic reactions to sulfonylurea derivatives, sulfonamides, or related medicines may occur.
• At the beginning of Diaril treatment, vision disturbances may occur. This is due to changes in blood sugar levels, and these symptoms should disappear quickly.
• Increased liver enzyme levels.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your 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:
Jerozolimskie Avenue 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 Diaril

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the medicine.
You should not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the month.
You should not use this medicine if there are visible changes in the appearance of the tablet.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Diaril contains

• The active substance of Diaril is glimepiride. Each Diaril tablet contains 1 mg, 2 mg, 3 mg, or 4 mg of glimepiride, depending on the strength indicated on the carton and blister.
• The other ingredients are lactose monohydrate, sodium carboxymethylcellulose (type A), microcrystalline cellulose, povidone K-30, magnesium stearate.
• The tablets also contain dyes: 1 mg tablets: iron oxide red (E 172); 2 mg tablets: iron oxide yellow (E 172), indigo carmine (E 132); 3 mg tablets: iron oxide yellow (E 172); 4 mg tablets: indigo carmine (E 132).

What Diaril looks like and what the pack contains

Diaril tablets of all strengths are oblong and scored on both sides. They differ in color:

• 1 mg tablets are pink, oblong, and scored on both sides.
• 2 mg tablets are green, oblong, and scored on both sides.
• 3 mg tablets are light yellow, oblong, and scored on both sides.
• 4 mg tablets are light blue, oblong, and scored on both sides.

The tablets are packaged in PVC/Aluminum blisters, placed in a cardboard box.
Pack size: 30 or 60 tablets
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Biofarm Sp. z o.o.
Wałbrzyska Street 13
60-198 Poznań
phone: +48 61 66 51 500
fax: +48 61 66 51 505
Manufacturer
Biofarm Sp. z o.o.
Wałbrzyska Street 13
60-198 Poznań
Specifar S.A.
1, 28 Octovriou str.
Ag. Varvara
12351 Athens
Greece
Date of last revision of the leaflet:12.01.2021