Diaril

Package Leaflet: Information for the User

DIARIL

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

Glimepiride

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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It 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, please inform your 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 taking Diaril
• 3. How to take 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 anti-diabetic medicine. It belongs to a group of medicines called sulfonylureas.
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 reduction alone have not been able to control blood sugar levels.
Diaril can be used with metformin or insulin.

2. Important information before taking Diaril

Do not take Diaril and inform your doctor:

• if you are allergic to glimepiride or other sulfonylureas (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 tiredness, nausea, frequent urination, and muscle stiffness);
• if you have diabetic coma;
• if you have severe kidney disease;
• if you have severe liver disease.

Do not take Diaril if you have any of the above conditions.
In case of doubt, consult your doctor or pharmacist before taking Diaril.

Warnings and precautions

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

• if you have had trauma, surgery, infection with fever, or any other stress 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 doubt, consult your doctor or pharmacist before taking Diaril.
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 children and adolescents is limited. The use of this medicine is not recommended in this age group.

Important information about hypoglycemia (low blood sugar levels)

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

The following factors may increase the risk of hypoglycemia:

• undernourishment, irregular meals, skipping or delaying meals;
• changes in diet;
• taking a higher dose of Diaril than necessary;
• kidney problems;
• severe liver disease;
• certain endocrine disorders (e.g. thyroid, pituitary, or adrenal gland disorders);
• consumption of alcohol (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, tiredness, 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), convulsions, loss of self-control, shallow breathing, and slow heartbeat, and loss of consciousness may occur. The clinical picture of severe hypoglycemia may be similar to a stroke.

Treatment of hypoglycemia:

In many cases, the symptoms of low blood sugar levels disappear very quickly after consuming some types of sugar, e.g. sugar cubes, sweet juice, sweetened tea.
Always carry sugar with you (e.g. sugar cubes). Remember that artificial sweeteners are not effective in treating hypoglycemia. Consult your doctor or go to the hospital if sugar consumption does not cause the symptoms of hypoglycemia to disappear.

Lab tests

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

Diaril and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take, including those 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 levels):

• other anti-diabetic medicines (e.g. insulin or metformin);
• medicines used to treat pain and inflammation (phenylbutazone, azapropazone, oxyphenbutazone, salicylates);
• 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 used to lower high cholesterol levels (fibrates);
• medicines used to 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 body 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 levels):

• medicines containing female sex hormones (estrogens, progestogens);
• diuretics used to treat high blood pressure (thiazide 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 speed up heart rate, treat asthma, or relieve nasal congestion, cough, and colds, or to reduce body weight or used in life-threatening 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 levels (diazoxide);
• medicines used to treat infections, tuberculosis (rifampicin);
• medicines used to treat life-threatening low blood sugar levels (glucagon).

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

• medicines used to treat stomach ulcers (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 is advised when taking them.

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

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

Always consult your doctor before taking Diaril with other medicines.

Diaril with food, drink, and alcohol

Diaril should be taken once daily, immediately before or during breakfast or the first meal of the day.
Diaril tablets should be swallowed with at least half a glass of water.
Consumption of 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Diaril during pregnancy.
Breastfeeding
Diaril may pass into breast milk. Do not take Diaril while breastfeeding.

Driving and using machines

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

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

Diaril contains lactose.

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

3. How to take Diaril

This medicine should always be taken exactly as advised by your doctor. If you are unsure, consult your doctor or pharmacist.

Administration

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

What dose to take

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. Do 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 your weight, lifestyle, or stress levels change, inform your doctor so that they can adjust the dose if necessary.
• If you think the effect of the medicine is too weak or too strong, do not change the dose yourself, but consult your doctor.

Taking a higher dose of Diaril than recommended

Taking too many Diaril tablets or taking an extra 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. 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 requires careful control of the amount of sugar given to avoid the risk of hyperglycemia. Do not give food or drink to unconscious patients.
In case of prolonged hypoglycemia, it is very important that the patient is under supervision until the danger has passed. It may be necessary to hospitalize the patient as a precaution. 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. 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

Do not take a double dose to make up for a missed dose.
Continue treatment, following the prescribed dosage regimen 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. Take Diaril for as long as your doctor recommends.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Inform your doctor immediately 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 disorders (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, convulsions, or coma.

Some patients taking Diaril have experienced the following side effects:
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 likelihood 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, inform your doctor immediately.
• Impaired liver function, including yellowing of the skin and eyes (jaundice), bile flow disorders (cholestasis), liver inflammation (hepatitis), or liver failure. If you experience any of these symptoms, inform your doctor immediately.
• Nausea or vomiting, diarrhea, feeling of fullness, 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, inform your doctor immediately.
• There may be allergic reactions to sulfonylureas, sulfonamides, or related medicines.
• 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 those not listed in this leaflet, please inform 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Diaril

Keep the medicine out of the sight and reach of children.
There are no special precautions for storing the medicine.
Do 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.
Do not use this medicine if the appearance of the tablet has changed.
Medicines should not be disposed of via wastewater or household waste. 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 colorants: 1 mg tablets: red iron oxide (E 172); 2 mg tablets: yellow iron oxide (E 172), indigo carmine (E 132); 3 mg tablets: yellow iron oxide (E 172); 4 mg tablets: indigo carmine (E 132).

What Diaril looks like and contents of the pack

The tablets of all strengths of Diaril 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.
Package size: 30 or 60 tablets
Not all package 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