Diaril

Patient Information Leaflet

DIARIL
1 mg, 2 mg, 3 mg or 4 mg, tablets
Glimepiride
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult 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 similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Diaril is and what it is 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 Diaril is and what it is used for

Diaril is an oral antidiabetic medicine. It belongs to a group of medicines called sulfonylurea derivatives.
Diaril works by increasing the amount of insulin produced by the pancreas. Insulin lowers blood glucose levels.
For what purpose is Diaril used:
Diaril is used to treat a certain type of diabetes (type 2 diabetes) when blood glucose levels cannot be controlled by diet, physical exercise, and weight reduction alone.
Diaril may be used concomitantly with metformin or insulin.

2. Information before using Diaril

Do not use Diaril and inform your doctor if:

• the patient is allergic to glimepiride or other sulfonylurea drugs (medicines used to lower blood sugar levels, e.g. glibenclamide), or sulfonamides (medicines used for bacterial infections, e.g. sulfamethoxazole), or to any of the other ingredients of this medicine (listed in section 6);
• the patient has insulin-dependent diabetes (type 1 diabetes);
• the patient has been diagnosed with ketoacidosis (a complication of diabetes causing increased acidity in the body; symptoms may include fatigue, nausea, frequent urination, and muscle stiffness);
• the patient has been diagnosed with diabetic coma;
• the patient has severe kidney disease;
• the patient has severe liver disease.

Do not use Diaril if any of the above conditions apply.
If in doubt, consult your doctor or pharmacist before using Diaril.
Warnings and precautions
Before starting Diaril, discuss with your doctor or pharmacist:

• if the patient has experienced trauma, surgery, infection with fever, or any other stressful condition; inform your doctor, as temporary changes in treatment may be necessary;
• if the patient has impaired liver or kidney function.

If you have any doubts, consult your doctor or pharmacist before using Diaril.
Patients with glucose-6-phosphate dehydrogenase deficiency may develop reduced hemoglobin levels and breakdown of red blood cells (hemolytic anemia).
Children and adolescents
Information on the use of Diaril in patients under 18 years of age is limited. Use of Diaril is not recommended in this patient group.
Important information about hypoglycemia (low blood sugar)
Diarrhea may cause hypoglycemia (low blood sugar) in patients.
Below are additional details about hypoglycemia, its symptoms, and treatment.
The following factors may increase the risk of hypoglycemia:

• undernutrition, irregular meals, skipped or delayed meals;
• changes in diet;
• taking a higher dose of Diaril than required;
• impaired kidney function;
• severe liver disease;
• certain specific disorders caused by hormonal imbalances (e.g. thyroid, pituitary, or adrenal gland disorders);
• alcohol consumption (especially when a meal is missed);
• taking certain medications (see below “Diarrhea with other medicines”);
• unusually high physical exertion, especially if meals are insufficient or contain fewer carbohydrates than usual.

Symptoms of hypoglycemia include:

• intense hunger, headache, nausea, vomiting, fatigue, drowsiness, sleep disturbances, restlessness, aggression, difficulty concentrating, impaired alertness and reaction time, depression, disorientation, speech and vision disturbances, difficulty speaking, tremors, partial paralysis, sensory disturbances, dizziness, helplessness;
• additional symptoms may include sweating, clammy skin, anxiety, rapid heartbeat, elevated blood pressure, palpitations, sudden severe chest pain radiating to adjacent body parts (angina or irregular heart rhythm).

If blood sugar continues to drop, symptoms may progress to confusion (delirium), seizures, loss of coordination, shallow breathing, slowed pulse, and may lead to loss of consciousness. The clinical picture of severe hypoglycemia may resemble a stroke.
Treatment of hypoglycemia:
In many cases, symptoms of low blood sugar resolve quickly after consuming certain types of sugar, such as sugar cubes, sweet juice, or sweetened tea. Always carry sugar (e.g. sugar cubes) with you. Remember that artificial sweeteners are not effective in treating hypoglycemia. Contact your doctor or go to a hospital if symptoms of hypoglycemia do not improve after consuming sugar.
Laboratory tests
Regular monitoring of blood or urine glucose levels is necessary. Your doctor may also perform regular blood tests to assess liver function and blood cell counts.
Diarrhea with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines planned for future use, including those available without a prescription.
Your doctor may decide to adjust the dose of Diaril if the patient is taking other medicines that may weaken or enhance Diaril’s effect on blood sugar levels.
The following medicines may enhance the blood sugar-lowering effect of Diaril, increasing the risk of hypoglycemia (low blood sugar):

• other antidiabetic medicines (e.g. insulin or metformin);
• medicines used to treat pain and inflammation (phenylbutazone, azapropazone, oxyphenbutazone, drugs similar to acetylsalicylic acid);
• medicines used to treat urinary tract infections (e.g. certain long-acting sulfonamides);
• medicines used for bacterial and fungal infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin);
• anticoagulant medicines (coumarin derivatives, e.g. warfarin);
• antiarrhythmic medicines used to prevent heart rhythm disorders (disopyramide);
• anabolic steroids (used to increase muscle mass);
• medicines used in testosterone replacement therapy;
• antidepressants (fluoxetine, MAO inhibitors);
• lipid-lowering medicines (fibrates);
• blood pressure-lowering medicines (ACE inhibitors);
• medicines used to treat gout (allopurinol, probenecid, sulfinpyrazone);
• anticancer medicines (cyclophosphamide, ifosfamide, trofosfamide);
• weight-loss medicines (fenfluramine);
• medicines used to improve circulation, administered intravenously in high doses (pentoxifylline);
• medicines used to treat nasal allergies, e.g. hay fever (tritoqualine);
• sympatholytic medicines used to treat high blood pressure, heart failure, or symptoms of prostate disease.

The following medicines may reduce the blood sugar-lowering effect of Diaril, increasing the risk of hyperglycemia (high blood sugar):

• medicines containing female sex hormones (estrogens, progestogens);
• blood pressure medicines known as thiazide diuretics (water pills);
• 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 increase heart rate, treat asthma, nasal congestion, cough, colds, for weight loss, or in life-threatening emergencies (adrenaline and sympathomimetics);
• medicines used to treat high cholesterol (nicotinic acid);
• long-term use of laxatives for constipation;
• medicines used to treat epilepsy (phenytoin);
• medicines used to treat anxiety and sleep disorders (barbiturates);
• medicines used to treat increased intraocular 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 very 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 (H₂-receptor 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; therefore, caution is required when using them.

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

• anticoagulant medicines (coumarin derivatives, e.g. warfarin).

Always consult your doctor before using Diaril together with other medicines.
Diarrhea, food, drink, and alcohol
Diarrhea should be taken as a single dose immediately before or during breakfast or the first meal of the day.
Diarrhea tablets should be swallowed with at least half a glass of water.
Alcohol consumption may unpredictably enhance or weaken the effect of Diaril.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Do not use Diaril during pregnancy.
Breastfeeding
Diarrhea may pass into breast milk. Do not use Diaril during breastfeeding.
Driving and operating machinery
The ability to concentrate or react quickly may be impaired due to low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), or vision disturbances caused by fluctuating blood sugar levels. Be aware that the patient may pose a risk to themselves or others (e.g. when driving a car or operating moving machinery). Patients should consult their doctor and seek advice on whether driving or operating machinery is advisable if:

• they frequently experience hypoglycemia;
• warning symptoms of hypoglycemia are weakened or absent.

Diarrhea contains lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per recommended dose unit, meaning the medicine is considered "sodium-free".

3. How to use Diaril

This medicine should always be taken as directed by the physician. In case of doubt, consult your
doctor or pharmacist.
How to take the medicine

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

What dose of medicine should be taken
The dose of Diaril depends on individual needs, the patient's condition, and blood and urine glucose
test results, and is determined by the physician. Do not take more tablets than prescribed by the
doctor.

• The initial dose is usually one 1 mg Diaril tablet once daily.
• The 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 such cases, the doctor will prescribe appropriate, individually adjusted doses of glimepiride, metformin, and insulin.
• If body weight changes, lifestyle changes, or the patient is under stress, inform the doctor so that the dose of the medicine can be adjusted if necessary.
• If the patient feels that the effect of the medicine is too weak or too strong, do not change the dose independently; instead, contact the doctor.

Taking more than the recommended dose of Diaril
Taking too many Diaril tablets or an additional dose is dangerous because of the risk of hypoglycaemia (hypoglycaemia symptoms, see section 2 – "Warnings and precautions"). In such a case, consume sufficient sugar immediately (e.g. sugar cubes, sweet fruit juice, sweetened tea) and contact your doctor as soon as possible.
In cases of accidental ingestion of the medicine by children, the amount of sugar administered must be carefully controlled to avoid the risk of hyperglycaemia. Do not give food or drink to unconscious individuals.
In cases of prolonged hypoglycaemia, it is very important that the patient remains under medical supervision until the danger has passed. Hospitalisation may be necessary as a precaution. Show the doctor the packaging or remaining tablets so that they know which medicine has been taken.
Severe cases of hypoglycaemia with loss of consciousness and serious neurological disturbances require immediate medical assistance, usually in a hospital setting. Ensure that someone nearby has been previously informed and can call a doctor in case of emergency.
Missed dose of Diaril
Do not take a double dose to make up for a missed dose.
Continue treatment according to the prescribed dosing schedule for Diaril.
Stopping Diaril treatment
After discontinuing the medicine, the achieved reduction in blood glucose levels will not be maintained, and the disease may worsen. Continue taking Diaril for as long as directed by your doctor.
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.
You should tell your doctor immediately if any of the following symptoms occur:

• Allergic reactions (including inflammation of blood vessels, often with rash), which may progress to severe reactions with breathing difficulties, drop in blood pressure, and even lead to shock.
• Impaired liver function, including yellowing of the skin and eyes (jaundice), impaired bile flow (cholestasis), inflammation of the liver (hepatitis), or liver failure.
• Skin allergy (hypersensitivity), manifesting as itching, rash, urticaria, and increased sensitivity to sunlight. Some mild allergic reactions may progress to severe reactions.
• Severe hypoglycaemia, including loss of consciousness, seizures, or coma.

The following adverse reactions have been reported in some patients treated with Diaril:
Uncommon adverse reactions (occurring in 1 to 10 patients per 10,000):

• Lower than usual blood glucose levels (hypoglycaemia) – see section 2. "Warnings and precautions".
• Decreased blood cell counts: platelets (increasing the risk of bleeding or bruising), white blood cells (increasing the likelihood of infections), red blood cells (which may cause paleness, weakness, or shortness of breath). These disorders usually resolve after discontinuation of Diaril.

Very rare adverse reactions (occurring in less than 1 patient per 10,000):

• Allergic reactions (including inflammation of blood vessels, often with rash), which may progress to severe reactions with breathing difficulties, drop in blood pressure, and even lead to shock. If any of these symptoms occur, you must inform your doctor immediately.
• Impaired liver function, including yellowing of the skin and eyes (jaundice), problems with bile flow (cholestasis), inflammation or failure of the liver. If any of these symptoms occur, you must inform your doctor immediately.
• Nausea or vomiting, diarrhoea, feeling of fullness or bloating, abdominal pain.
• Decreased sodium concentration in the blood (detected in blood tests).

Other adverse reactions:

• Skin allergy (hypersensitivity) with itching, rash, urticaria, and increased sensitivity to sunlight. Some mild allergic reactions may progress to severe reactions with difficulty swallowing and breathing, swelling of lips, throat, or tongue. If any of these symptoms occur, you must inform your doctor immediately.
• Allergic reactions to drugs belonging to the sulfonylurea derivatives, sulfonamides, or related medicines may occur.
• Visual disturbances may occur at the beginning of Diaril therapy. These are caused by changes in blood glucose levels and should resolve quickly.
• Increased liver enzyme levels.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your 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
Tel.: +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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Diaril

Keep the medicine out of sight and reach of children.
No special storage instructions apply to this medicine.
Do not use this medicine after the expiry date stated on the carton and blister pack.
The expiry date refers to the last day of the stated month.
Do not use this medicine if visible changes in the appearance of the tablet are observed.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Diaril contains

• The active substance is glimepiride. Each Diaril tablet contains 1 mg, 2 mg, 3 mg, or 4 mg of glimepiride, depending on the strength indicated on the box and blister pack.
• The other ingredients are lactose monohydrate, sodium carboxymethyl starch (type A), microcrystalline cellulose, povidone K-30, magnesium stearate.
• The tablets also contain colouring agents:
  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 contents of the pack
All strengths of Diaril tablets are oblong and scored on both sides. They differ in colour:

• 1 mg tablets are pink, oblong, with a score line on both sides.
• 2 mg tablets are green, oblong, with a score line on both sides.
• 3 mg tablets are light yellow, oblong, with a score line on both sides.
• 4 mg tablets are light blue, oblong, with a score line on both sides.

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505

Manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Specifar S.A.
1, 28 Octovriou str.
Ag. Varvara
12351 Athens
Greece