1 mg, 2 mg, 3 mg and 4 mg tablets
glimepiride

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects , talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet:
1. What Glimepiride Bluefish is and what it is used for
2. What you need to know before you use Glimepiride Bluefish
3. How to take Glimepiride Bluefish
4. Possible side effects
5. How to store Glimepiride Bluefish 6. Contents of the pack
and other information

What Glimepiride Bluefish is and what it is used for

Glimepiride Bluefish is a medicine used to lower blood sugar. It belongs to a group of medicines called sulphonylureas.

Glimepiride Bluefish works by increasing the amount of insulin secreted by the pancreas. Insulin then in turn lowers blood sugar.

Glimepiride Bluefish is used to treat certain types of diabetes (type 2 diabetes ) in cases where only a change in diet, exercise and weight loss have not been able to alleviate the blood sugar problems. You need to talk to a doctor if you do not feel better or if you feel worse.

Glimepiride contained in Glimepiride Bluefish may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Glimepiride Bluefish

Do not use Glimepiride Bluefish

  • if you are allergic to glimepiride or other sulphonylureas (medicines used to lower your blood sugar, such as glibenclamide) or sulphonamides (medicines used to treat bacterial infections, such as sulphamethoxazole) 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 lost consciousness due to a very high blood sugar or low blood sugar (diabetic coma)
  • if you have diabetic ketoacidosis (a complication of diabetes where your acid levels in the body are too high and which can manifest itself as fatigue, nausea, a need to throw water often and muscle stiffness)
  • you suffer from a serious kidney disease
  • you suffer from a serious liver disease

Warnings and cautions

Talk to your doctor or pharmacist before taking Glimepiride Bluefish.

  • Blood and urine sugar should be checked regularly. The risk of low blood sugar ( hypoglycaemia ) is increased during the first weeks of treatment.
  • in case of impaired kidney or liver function and after prolonged fasting, the blood sugar lowering effect may become too strong.
  • if you are taking other medicines or natural products at the same time (see section “Other medicines and Glimepiride Bluefish”)
  • experience with glimepiride treatment in people under 18 years of age is limited. Therefore, this treatment is not recommended in these patients.

Symptoms of hypoglycemia may occur,

  • if you are taking other medicines at the same time,
  • in case of overdose,
  • if you have irregular meals,
  • if you have a fever,
  • if you have bothersome stress,
  • if you exert yourself more physically than usual,
  • if you use alcohol.
  • severe kidney and liver disease
  • if you have certain hormone- causing diseases (diseases of the thyroid gland or pituitary gland or adrenal cortex ).
  • malnutrition, irregular meals, omitted or delayed meals or fasting periods.
  • changes in your diet

Signs of low blood sugar can e.g. be voracious hunger, lethargy, sweating, anxiety, tremors and pallor, headache, nausea, vomiting, fatigue, drowsiness, sleep disturbances, restlessness, aggression, impaired concentration, decreased alertness and reaction, depression, confusion, speech and vision disorders, tremors, partial paralysis, emotional disturbance, dizziness and helplessness, seizures that can lead to unconsciousness.

The following symptoms may also occur sweating, damp skin, anxiety, increased heart rate, high blood pressure, palpitations, sudden severe chest pain that may radiate to surrounding areas (angina and irregular heartbeat).

If your blood sugar level continues to drop, you may experience significant confusion ( delirium ), develop seizures, lose self-control, have shallow breathing and a slower heart rate, and even become unconscious. The clinical picture of a sharp drop in blood sugar may be similar to that of a stroke.

The symptoms of low blood sugar disappear in most cases quite quickly after consuming sugar. You should therefore always carry some form of sugar with you, such as glucose, fruit juice, chocolate, or the like. Note that sweeteners do not give any effect. If sugar intake does not help or if symptoms return, contact your doctor or hospital.

Signs of high blood sugar (hyperglycemia) may include thirst, frequent urination, dry mouth, and dry skin. In such cases, a doctor or hospital should be contacted. In connection with accidents, operations, and febrile conditions, it may be temporarily necessary to switch to insulin treatment.

A decrease in hemoglobin levels and breakdown of red blood cells ( hemolytic anemia ) may occur in patients lacking enzyme et glucose -6-phosphate dehydrogenase.

Laboratory tests

The sugar level in your blood or urine should be checked regularly. Your doctor may also want to take blood samples to examine your blood cell levels and your liver function.

Children and young people

Glimepiride Bluefish is not recommended for the treatment of children under 18 years.

Other medicines and Glimepiride Bluefish

Tell your doctor or pharmacist if you have recently taken or might take any other medicines. Other medicines may weaken or enhance the effect of Glimepiride Bluefish on your blood sugar levels. The blood sugar lowering effect of glimepiride may be enhanced by the following medicines. This may lead to a risk of hypoglycaemia (low blood sugar):

  • other medicines to treat diabetes mellitus (such as insulin or metformin )
  • drugs for the treatment of pain and inflammation (phenylbutazone, azopropazone, oxyfenbutazone, aspirin-like drugs).
  • medicines used to treat urinary tract infections (such as long-acting sulfonamides )
  • medicines used to treat depression ( MAO inhibitors , fluoxetine )
  • drugs that promote muscle building (anabolic steroids and male sex hormone)
  • medicines used to treat bacterial and fungal infections ( tetracyclines , chloramphenicol, fluconazole , miconazole , quinolones , clarithromycin)
  • drugs that inhibit blood coagulation (coumarin derivatives)
  • drugs that lower high blood pressure ( ACE inhibitors )
  • drugs called antiarrhythmics and used to control abnormal heart rhythms ( disopyramide )
  • medicines used to treat gout (allopurinol, probenecid, sulfinpyrazone)
  • drugs used to treat cancer (cyclophosphamide, ifosfamide, trophosphamide)
  • weight loss drug (fenfluramine)
  • drugs to increase circulation when given in high doses intravenously (pentoxifylline)
  • drugs to treat allergy symptoms from the nose, e.g. hay fever (tritoqualin).
  • drugs called sympatholytics to treat high blood pressure , heart failure or prostate symptoms .

The following medicines may reduce the blood sugar lowering effect of Glimepiride Bluefish. This may lead to a risk of hyperglycaemia (high blood sugar levels):

  • drugs containing female sex hormone ( estrogen , progesterone )
  • diuretics ( saluretics , thiazide diuretics)
  • drugs that stimulate the thyroid gland (such as levothyroxine)
  • medicines used to treat allergies and inflammation ( glucocorticoids )
  • medicines for the treatment of severe mental illness (phenothiazine derivatives or chlorpromazine)
  • medicines used to increase heart rate, to treat asthma or nasal congestion, coughs and colds, for weight loss or in acute life-threatening situations ( adrenaline and sympathomimetics)
  • drugs to treat high cholesterol levels ( nicotinic acid )
  • medicines for the treatment of constipation when used for a long time ( laxatives )
  • drugs in the treatment of seizures ( phenytoin )
  • medicines used to treat high blood pressure or lower blood sugar (diazoxide)
  • medicines for the treatment of anxiety and sleep problems ( barbiturates )
  • drugs in the treatment of infections , tuberculosis (rifampicin)
  • medicines used to treat high pressure in the eyes (azetazolamide)
  • drugs for the treatment of very low blood sugar levels (glucagon)

The following medicines may increase or decrease the blood-glucose-lowering effect of Glimepiride Bluefish:

  • Medicines for the treatment of peptic ulcer (H 2 – antagonists )
  • Medicines for the treatment of high blood pressure or heart failure such as beta-blockers ( clonidine , guanetidine and reserpine).

Glimepiride Bluefish may either increase or decrease the effect of the following medicines

  • drugs that inhibit blood coagulation (coumarin derivatives such as warfarin )

Glimepiride Bluefish with food, drink and alcohol

Alcohol can potentially enhance or weaken the blood sugar lowering effect of Glimepiride Bluefish.

Pregnancy, breastfeeding and fertility

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

Glimepiride Bluefish should not be used during pregnancy. Tell your doctor if you are, think you may be, or are planning to become pregnant.

Breast-feeding

Glimepiride Bluefish may pass into breast milk. Glimepiride Bluefish should not be taken if you are breastfeeding.

Driving and using machines

Your ability to concentrate or react may be impaired if you get too low ( hypoglycaemia ) or too high blood sugar ( hyperglycaemia ) or vision problems. Always remember the risk of this in all situations where you can expose yourself and others to danger (eg when driving or handling machines). Therefore, you and your doctor should consider whether it is advisable for you to drive or use machines if you:

  • have recurring problems with hypoglycemia
  • may have few or no warning signs of hypoglycaemia

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Glimepiride Bluefish contains lactose

Glimepiride Bluefish contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Glimepiride Bluefish contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per 1 mg, 2 mg, 3 mg, and 4 mg tablets, ie essentially ‘sodium-free.

3. How to use Glimepiride Bluefish

Always use this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.

The recommended dose for adults is 1-4 mg per day depending on the blood sugar level. The maximum dose is 6 mg per day.

Use of this medicine

  • Take the medicine by mouth, just before or with the first meal of the day (usually breakfast). If you do not eat breakfast, take the medicine according to your doctor’s instructions. It is important not to skip meals when taking Glimepiride Bluefish.
  • Swallow the tablets with at least half a glass of water. Do not crush or chew the tablets.

It is important that you do not skip any meal when using Glimepiride Bluefish. Insulin can be used as a supplement to treatment with Glimepiride Bluefish. The insulin dose is determined by a doctor who will adjust it for you. If your weight changes or if your lifestyle changes or if you are in a stressful situation, you should inform your doctor as it may be necessary to adjust dose one.

If you have the impression that the effect of Glimepiride Bluefish is too strong or too weak, talk to your doctor or pharmacist.

If you take more Glimepiride Bluefish than you should

If you have ingested too much medicine or if e.g. a child ingested the medicine accidentally contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

Symptoms of overdose may include low blood sugar, nausea, vomiting, abdominal pain, anxiety, tremors, visual disturbances, coordination problems, drowsiness, unconsciousness ( coma ), and seizures.

If you suspect that you took too large a dose of Glimepiride Bluefish, sugar, fruit juice, or similar consumed immediately. However, it is forbidden to give food or drink to an unconscious patient.

As a condition with hypoglycaemia can last for some time, it is very important that the patient is monitored until the danger is over. Hospitalization may be necessary, even as a precautionary measure. Show the doctor the box with the medicine, so the doctor knows what was taken.

Severe cases of hypoglycemia accompanied by unconsciousness and severe nerve failure require urgent medical attention and hospitalization. It is important to make sure that at least one person is always informed, and can call a doctor if needed.

If you forget to take Glimepiride Bluefish

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

If you stop taking Glimepiride Bluefish

It is possible that blood sugar levels rise. Discuss with your doctor before stopping using this medicine.

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

4. Possible side effects

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

Rare side effects (may affect up to 1 in 1,000 people):

  • Lower blood sugar than normal
  • Reduction in the number of blood cells:
    • Platelets (which increases the risk of bleeding or bruising)
    • White blood cells (which increases the risk of infection)
    • Red blood cells (which may cause pale skin and weakness or shortness of breath)

These problems usually get better after you stop taking Glimepiride Bluefish.

Very rare side effects (may affect up to 1 in 10,000 people):

Nausea, vomiting, diarrhea, satiety, abdominal pain, hepatic impairment (eg bile stasis and jaundice), hepatitis, hepatic failure, severe hypersensitivity reactions (shortness of breath, decreased blood pressure, shock ), allergic vascular inflammation, decrease in serum sodium.

Other possible side effects:

  • Elevation of liver enzyme levels, hypersensitivity reactions with skin symptoms, such as photosensitivity, itching , rash and hives, unusual bleeding or bruising under the skin and cross-allergy to sulphonylureas or sulphonamides .
  • Visual disturbances can be observed at the beginning of treatment.
  • If you experience severe or bothersome symptoms such as difficulty swallowing or breathing, swelling of the lips, throat or tongue, jaundice or shortness of breath, contact a doctor immediately.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Glimepiride Bluefish

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

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton after EXP.

The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is glimepiride.
  • The other ingredients are lactose monohydrate, sodium starch glycollate, povidone K-30 and magnesium stearate.

1 mg tablets: red iron oxide (E172), 2 mg tablets: yellow iron oxide (E172), indigo carmine aluminum lacquer (E132), 3 mg tablets: yellow iron oxide (E172), 4 mg tablets: indigo carmine aluminum lacquer (E132).

What the medicine looks like and contents of the pack

The 1 mg tablet is round and scored on one side.

The 2, 3, and 4 mg tablets are oblong and scored on one side.

PVC / PVDC / aluminum blisters with 10, 30, 60, 90 and 120 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Bluefish Pharmaceuticals AB

PO Box 49013

100 28 Stockholm

Manufacturer

Bluefish Pharmaceuticals AB

Gävlegatan 22

113 30 Stockholm

Laboratori Fundació Dau

Terminal. Ind. Consorci Zona Franca. C / C, 12-14

08040, Barcelona

Spain

This medicinal product is authorized under the European Economic Area under the names:

DK (RMS) Glimepiride Bluefish
SEE Glimepiride Bluefish
IS Glimepiride Bluefish

Muhammad Nadeem

Leave a Reply