Glimepiride Kern Pharma 4 mg tablets EFG: detailed information

Brand name Glimepiride Kern Pharma 4 mg tablets EFG

Form tablets

Active substance / Dosage

GLIMEPIRIDE · 4 mg

Prescription type Prescription Only Medicine

ATC code

A10B A10BB A10BB12

Registration number 67670

Manufacturer Kern Pharma S.L.

Glimepiride Kern Pharma 4 mg tablets EFG tablets

Table of Contents

Patient Information Leaflet
Introduction
1. What Glimepiride Kern Pharma is and what it is used for
2. What you need to know before starting Glimepiride Kern Pharma
3. How to take Glimepirida Kern Pharma
4. Possible adverse effects
5. Storage of Glimepiride Kern Pharma
6. Contents of the container and additional information

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Glimepiride Kern Pharma 4 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

What Glimepiride Kern Pharma is and what it is used for
What you need to know before taking Glimepiride Kern Pharma
How to take Glimepiride Kern Pharma
Possible adverse effects
How to store Glimepiride Kern Pharma
Contents of the pack and other information

1. What Glimepiride Kern Pharma is and what it is used for

Glimepiride belongs to a group of medicines called oral antidiabetics, which lower blood glucose to normal levels in patients with adult-onset diabetes (type 2 diabetes).

This medicine is prescribed to treat adult-onset diabetes (type 2 diabetes) when diet, physical exercise, and weight reduction alone are not sufficient.

2. What you need to know before starting Glimepiride Kern Pharma

Do not take Glimepiride Kern Pharma

if you are allergic (hypersensitive) to glimepiride, other sulfonylureas or sulfonamides, or to any of the components of Glimepiride Kern Pharma (listed in section 6),
if you have type 1 diabetes (juvenile diabetes, which involves a defect in insulin production by the pancreas),
if you are experiencing diabetic coma (decreased level of consciousness due to ketoacidosis),
if you have ketoacidosis (a metabolic disorder with increased blood acidity due to accumulation of ketone bodies),
if you have severe kidney or liver impairment. In these cases, switching to insulin is required.

Warnings and precautions

Consult your doctor or pharmacist before starting this medicine:

if you do not maintain regular meal times, as treatment may excessively lower blood sugar levels (hypoglycemia),
if you are unable to take glimepiride regularly, as this may increase the risk of hypoglycemia,
if you experience symptoms of hypoglycemia (see “Important information about hypoglycemia (low blood sugar)”) despite consuming sugar. If these symptoms are severe or prolonged, seek immediate medical attention,
if you have kidney or liver impairment, as this may increase the risk of hypoglycemia. Your doctor will recommend routine monitoring of kidney and liver function,
if you have metabolic disorders (such as thyroid, parathyroid, or steroid hormone imbalances), as these may increase the risk of hypoglycemia,
if you are scheduled for surgery, as your doctor may temporarily discontinue treatment and switch you to insulin,
if you experience an accident or infection with fever. Your doctor may temporarily prescribe a switch to insulin therapy,
if you are taking glimepiride together with insulin or other antidiabetic medicines, as hypoglycemia may occur (see “Use of other medicines”).

A decrease in hemoglobin levels and rupture of red blood cells (hemolytic anemia) may occur in patients who lack an enzyme called glucose-6-phosphate dehydrogenase.

Important information about hypoglycemia (low blood sugar)

While taking glimepiride, you may experience hypoglycemia (low blood sugar). Please read below for further information about hypoglycemia, its signs, and treatment.

The following factors may increase your risk of hypoglycemia:

Malnutrition, irregular meal timing, skipping or delaying meals, fasting periods.
Changes in your diet.
Taking more glimepiride than prescribed.
Impaired kidney function.
Severe liver disease.
Other hormonal disorders (such as thyroid, pituitary, or adrenal cortex disorders).
Consuming alcohol (especially if skipping a meal).
Taking certain medications (see “Use of other medicines”).
Increasing physical exercise without adequate food intake or consuming fewer carbohydrates than usual.

Signs of hypoglycemia include:

Feeling of hunger, headache, nausea, vomiting, lethargy, drowsiness, sleep disturbances, restlessness, aggression, difficulty concentrating, reduced alertness and reaction time, depression, confusion, speech and vision disturbances, tremors, slurred speech, partial paralysis, sensory disturbances, dizziness, feeling of helplessness.
The following symptoms may also occur: sweating, moist skin, anxiety, rapid heartbeat, high blood pressure, palpitations, sudden chest pain radiating to adjacent areas (angina pectoris and cardiac arrhythmias).

If your blood sugar continues to drop, you may experience marked confusion (delirium), seizures, loss of self-control, shallow breathing, slower heart rate, and may lose consciousness. The clinical picture of severe hypoglycemia resembles that of a stroke.

Treatment of hypoglycemia

In most cases, symptoms of low blood sugar resolve quickly after consuming sugar, such as sugar cubes, sweet fruit juices, or sugared tea.

Therefore, you should always carry a source of sugar with you (e.g., sugar cubes). Remember that artificial sweeteners are ineffective. Please consult your doctor or go to the hospital if symptoms do not improve after taking sugar or if symptoms recur.

Blood tests

Your blood and urine sugar levels should be monitored regularly. Your doctor may request blood tests to monitor blood cell counts and assess liver function.

Use of other medicines

Inform your doctor or pharmacist if you are currently using or have recently used any other medicines, including those obtained without a prescription, as it may be necessary to interrupt treatment or adjust the dose of one or more medicines.

If you take glimepiride together with the following substances, hypoglycemia (low blood sugar) may occur:

other medicines for treating diabetes mellitus (such as insulin or metformin),
medicines for pain and inflammation (phenylbutazone, azapropazone, oxyphenbutazone; and aspirin derivatives),
medicines for urinary tract infections (such as certain long-acting sulfonamides),
medicines for fungal and bacterial infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin),
blood-thinning medicines (coumarin derivatives such as warfarin),
anabolic agents (used to increase muscle mass),
medicines used in male hormone replacement therapy,
medicines for depression (fluoxetine, MAO inhibitors),
medicines to lower high cholesterol levels (fibrates),
medicines to lower high blood pressure (ACE inhibitors),
antiarrhythmic medicines used to control abnormal heart rhythms (disopyramide),
medicines for gout (allopurinol, sulfinpyrazone, probenecid),
medicines for cancer (cyclophosphamide, ifosfamide, trofosfamide),
weight-loss medicines (fenfluramine),
medicines used to improve circulation when administered intravenously at high doses (pentoxifylline),
medicines for nasal allergies such as hay fever (tritoqualine),
sympatholytic medicines used to treat high blood pressure, heart failure, or prostate symptoms.

If you take glimepiride together with the following substances, hyperglycemia (high blood sugar) may occur:

medicines containing female sex hormones (estrogens, progestogens),
medicines used to increase urine production (thiazide diuretics),
medicines used to stimulate the thyroid gland (such as levothyroxine),
medicines for allergies and inflammation (glucocorticoids),
medicines for severe mental disorders (chlorpromazine and other phenothiazine derivatives),
medicines to increase heart rate, treat asthma or nasal congestion, cough and colds, or used for weight reduction, or used in life-threatening emergencies (adrenaline and sympathomimetics),
medicines for high cholesterol (nicotinic acid),
medicines for constipation when used long-term (laxatives),
medicines for seizures (phenytoin),
medicines for anxiety and sleep disorders (barbiturates),
medicines to increase intraocular pressure (acetazolamide),
medicines used to treat high blood pressure or severe low blood sugar (diazoxide),
medicines for infections, tuberculosis (rifampicin),
medicines for treating severe low blood sugar (glucagon).

If you take glimepiride together with the following substances, either hypoglycemia or hyperglycemia may occur:

medicines for stomach ulcers (H2 antagonists),
medicines for high cardiac pressure or heart failure such as beta-blockers, clonidine, guanethidine, and reserpine. These may even mask the signs of hypoglycemia, so special caution is required when taking these medicines.

Glimepiride may also increase or decrease the effects of the following medicines:

medicines that inhibit blood coagulation (coumarin derivatives such as warfarin).

Taking Glimepiride Kern Pharma with food and drinks

Alcohol consumption may unpredictably increase or decrease the hypoglycemic effect of this medicine.

Glimepiride should be taken just before or during a meal.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Glimepiride must not be taken during pregnancy. Consult your doctor if you are pregnant, think you may be pregnant, or are planning a pregnancy.

Breastfeeding

Glimepiride may pass into breast milk. Glimepiride must not be used during breastfeeding.

Driving and using machines:

Consult your doctor or pharmacist before using any medicine.

Your ability to concentrate and react may be impaired due to symptoms caused by hypoglycemia or hyperglycemia, such as vision problems.

This may be dangerous in situations where these skills are critical (e.g., driving or operating machinery). Therefore, consult your doctor to determine whether it is advisable to drive or operate machinery.

Important information about some of the components of Glimepiride Kern Pharma

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.

3. How to take Glimepirida Kern Pharma

Follow exactly the instructions given by your doctor for taking this medicine. If you have any doubts, consult your doctor or pharmacist.

Remember to take your medicine.

The foundation of satisfactory diabetes treatment lies in a proper diet, regular physical activity, and regular blood and urine monitoring. The adverse effects resulting from failure to maintain the diet cannot be compensated for by tablets or insulin.

The dosage is based on the results of metabolic testing (blood and urine glucose measurements).

The initial dose is 1 mg of glimepiride daily, taken orally. If good control is achieved, this same dose may be used as maintenance treatment.

If blood glucose control is not satisfactory, your doctor will instruct you to gradually increase the dose to 2, 3, or 4 mg of glimepiride per day.

Only in exceptional cases is it recommended to take more than 4 mg of glimepiride per day, with the maximum recommended dose being 6 mg of glimepiride per day.

If you experience a hypoglycemic reaction after taking a single dose of 1 mg of glimepiride, inform your doctor, as you may likely be managed with diet alone.

During treatment with glimepiride, your required dose may decrease. Therefore, your doctor may need to adjust your daily dose according to your needs, and may even discontinue treatment.

If you are being treated with metformin and adequate metabolic control is not achieved, your doctor may add glimepiride to your treatment. In such a case, your doctor will indicate the necessary dose of glimepiride to be used in combination with metformin.

Your doctor will decide whether you need to combine glimepiride treatment with insulin. If so, your doctor will indicate the insulin dose to be used together with glimepiride tablets.

If you think that the effect of glimepiride is too strong or too weak, inform your doctor or pharmacist.

Glimepiride tablets should be swallowed whole, without chewing, with a little liquid.

Usually, a single daily dose of glimepiride is sufficient. It is recommended to take this dose shortly before or during a substantial breakfast, or, if breakfast is not taken, shortly before or during the first meal of the day.

Your doctor will determine how long your treatment with Glimepirida Kern Pharma should last. Do not stop treatment prematurely, as your blood sugar levels may become uncontrolled again.

Use in children

Glimepirida Kern Pharma has not been studied in children.

Elderly patients

No specific studies have been conducted in elderly patients.

Because biological functions may be reduced, your doctor will adjust the dose more cautiously and closer monitoring will be necessary.

If you take more Glimepirida Kern Pharma than you should

This may cause an excessive reduction in blood sugar (see “Warnings and precautions”), which can last from 12 to 72 hours and may even recur after initial recovery. Symptoms may appear even 24 hours after ingestion. If this occurs, go immediately to a doctor or the nearest hospital emergency department, taking this leaflet with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Glimepirida Kern Pharma

Do not take a double dose to make up for a missed dose.

If you stop taking Glimepirida Kern Pharma

If you interrupt or stop treatment, bear in mind that the desired effect of lowering blood sugar will not be achieved, or your condition may worsen again. Continue taking glimepiride until your doctor tells you to stop.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Consult your doctor immediately if you experience any of the following symptoms:

Allergic reactions (including inflammation of blood vessels, frequently with skin rash), which may lead to severe reactions with breathing difficulties, low blood pressure, and sometimes result in shock.
Abnormal liver function, including yellowing of the skin and eyes (jaundice), problems with bile flow (cholestasis), inflammation of the liver (hepatitis), or liver failure.
Skin allergy (hypersensitivity), such as itching, skin rash, hives, and light sensitivity. Some mild allergic reactions may progress to severe reactions.
Severe hypoglycaemia (reduction in blood sugar levels), including loss of consciousness, seizures, or coma.

Some patients have experienced the following adverse effects while taking glimepiride:

Rare adverse effects (affect up to 1 in 1,000 people)

Blood sugar levels lower than normal (hypoglycaemia) (see section 2).
Reduction in the number of blood cells:
- Platelets (which increases the risk of bleeding or bruising).
- White blood cells (which makes infections more likely).
- Red blood cells (which may cause paleness of the skin and lead to weakness or difficulty breathing).

In general, these changes resolve when treatment with glimepiride is stopped.

Very rare adverse effects (affect up to 1 in 10,000 people)

Allergic reactions (including inflammation of blood vessels, frequently with skin rash), which may trigger severe reactions with breathing difficulties, low blood pressure, and sometimes result in shock. If you experience any of these symptoms, inform your doctor immediately.
Abnormal liver function, including yellowing of the skin and eyes (jaundice), problems with bile flow (cholestasis), inflammation of the liver, or liver failure. If you experience any of these symptoms, inform your doctor immediately.
Nausea, vomiting, diarrhoea, a feeling of heaviness or bloating in the stomach, and stomach pain.
Decreased levels of sodium in the blood (detectable in blood tests).

Other adverse effects include:

Skin allergy (hypersensitivity), such as itching, skin rash, hives, and light sensitivity. Some mild allergic reactions may progress to severe reactions with difficulty swallowing or breathing, or swelling of the lips, throat, or tongue. Therefore, if you experience any of these adverse effects, inform your doctor immediately.
Allergic reactions to sulfonylureas, sulfonamides, or related medicines.
You may experience vision disturbances when starting treatment with glimepiride. These are due to changes in blood sugar levels and should improve quickly.
Increased liver enzymes.
Unusual severe bleeding or bruising under the skin.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Glimepiride Kern Pharma

No special storage conditions are required.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and additional information

Composition of Glimepiride Kern Pharma

The active substance is glimepiride. Each tablet contains 4 mg of glimepiride.
The other components (excipients) are: monohydrate lactose, microcrystalline cellulose, sodium carboxymethyl starch type A (from potato), povidone, magnesium stearate and indigo carmine aluminium lake (E132).

Appearance of the product and contents of the container

Glimepiride Kern Pharma 4 mg is presented as blue, oblong tablets, scored on both sides. Each pack contains 30 or 120 tablets (regular pack), or 500 tablets (hospital pack).