3.5 mg Tablets 
Glibenclamide

1. What Daonil is and what it is used for

Daniel seems to lower blood sugar, partly by increasing insulin production and possibly partly by making the body’s own insulin et more efficiently.

Daonil is used for type 2 diabetes mellitus (adult diabetes), like diet, exercise, and weight reduction alone do not have a sufficient effect.

2. What you need to know before using Daonil

Do not use Daonil

  • if you are allergic (hypersensitive) to glibenclamide or any of the other ingredients of Daonil.
  • if you have type 1 diabetes mellitus (insulin-dependent diabetes ).
  • in diabetic coma and case of the too high content of acidic substances in the body ( ketoacidosis ).
  • in case of malnutrition.
  • in severe renal or hepatic impairment.
  • in acute conditions that complicate diabetes, such as infection or cold sores.
  • when co-administered with medicines containing bosentan (used to treat high blood pressure in the blood vessels of the lungs).

Take special care with Daonil:

Blood sugar should be checked regularly.

The risk of low blood sugar (hypoglycemia) is increased during the first weeks of treatment.

Elderly patients may be more sensitive to low blood sugar, so your doctor will adjust the dose to as low a dose as possible.

With impaired renal or hepatic function and after prolonged fasting, the blood sugar lowering effect may become too strong.

Hypoglycemia (hypoglycemia)

Hypoglycemia (hypoglycemia), a so-called “feeling”, can occur with the concomitant use of other drugs, overdose, irregular meals, decreased food or fluid intake, stress, and increased physical activity.

Mild symptoms of low blood sugar can range from hunger, lethargy, drowsiness, visual disturbances, irritability, emotional disturbances, confusion, sweating, anxiety, tremors, coordination problems, pallor, and headaches. In most cases, the symptoms disappear fairly quickly after consuming sugar. You should therefore always carry some form of sugar with you, such as grape sugar, chocolate, or the like. Note that sweeteners do not affect. If sugar intake does not help or if symptoms return, contact your doctor or hospital. More serious symptoms of low blood sugar can be seizures and if the blood sugar does not rise, unconsciousness can occur. Doctors should be contacted immediately in case of more severe symptoms.

In case of severe overdose, there is a risk of affecting the brain, heart, blood, liver, and respiration.

Elevated blood sugar (hyperglycemia)

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

Talk to your doctor before taking Daonil if you have heart disease, as it may increase the risk of serious heart problems.

People who are hypersensitive to other medicines in the same group (sulphonylureas and sulphonamides ) may also develop allergic reactions to Daonil.

Daonil can in rare cases affect the white blood cells so that the defense against infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/pharynx / mouth or urination problems, you should see a doctor as soon as possible so that a lack of white blood cells ( agranulocytosis ) can be ruled out via blood tests. . It is important that you then information about your medication.

Use of other medicines:

The following combination with glibenclamide should not be used:

  • Medicines for the treatment of high blood pressure in the lungs ( bosentan )

The following medicines may increase the blood-glucose-lowering effect of Daonil which may lead to an increased risk of hypoglycemia (low blood sugar):

  • Other medicines used to treat diabetes (such as insulin, or metformin )
  • Medicines for the treatment of pain and inflammation (phenylbutazone, azapropazone, and oxyphenbutazone)
  • Drugs that promote muscle building (anabolic steroids )
  • Drugs used in the replacement of male sex hormone
  • Drugs used to treat depression ( fluoxetine, MAO inhibitors )
  • Drugs used to treat tuberculosis (para-aminosalicylic acid)
  • Drugs primarily used in the treatment of infection your urinary tract and prostate(+ sulfamethoxazole-trimethoprim)
  • Medicines that lower high blood pressure or are used in the treatment of certain heart diseases ( ACE inhibitors )
  • Drugs that lower high cholesterol levels (fibrates)
  • Drugs used to treat cancer (cyclophosphamide and ifosfamide)
  • Medicines for the treatment of gout (probenecid and sulfinpyrazone)
  • Medicines for the treatment of nasal allergies such as hay fever (tritoqualin)
  • Drugs that increase blood circulation when given in high doses by intravenous infusion (pentoxifylline)
  • Medicines used for weight loss (fenfluramine)
  • Drugs called sympatholytic drugs such as beta-blockers and guanethidine used to treat high blood pressure, heart failure, or prostate symptoms
  • Medicines for the treatment of cardiac arrhythmias ( amiodarone )
  • Medicines used to treat bacterial and fungal infections ( tetracyclines, chloramphenicol, fluconazole, miconazole, quinolone antibiotics, clarithromycin)
  • Salicylic acid derivatives (used to remove dry and scaly skin, eg in psoriasis )

The following medicines may lower the blood sugar lowering effect of Daonil. This may lead to an increased risk of hyperglycemia (high blood sugar):

  • Medicines containing female sex hormones ( estrogens, progestogens)
  • Medicines for the treatment of increased pressure in the eye (acetazolamide)
  • Medicines for the treatment of anxiety and sleep problems ( barbiturates )
  • Drugs that act as diuretics ( diuretics )
  • Drugs that stimulate the thyroid gland (such as levothyroxine)
  • Medicines for the treatment of seizures ( phenytoin )
  • Medicines for the treatment of allergies and inflammation ( glucocorticoids )
  • Medicines for the treatment of severe mental disorders (phenazine derivatives)
  • Medicines for the treatment of high cholesterol levels ( nicotinic acid )
  • Medicines for long-term treatment of constipation ( laxatives )
  • Medicines for the treatment of high blood pressure or the treatment of low blood sugar (diazoxide)
  • Medicines for the treatment of severe low blood sugar (glucagon)
  • Medicines used in life-threatening situations ( sympathomimetic )
  • Drugs used to treat infections, tuberculosis (rifampicin)

The following medicines may either enhance or weaken Daonil’s blood sugar lowering effect:

  • Medicines for the treatment of stomach ulcers (so-called H2 antagonists )
  • Medicines for the treatment of high blood pressure or heart failures such as beta-blockers, clonidine, and reserpine. These medicines can also hide the signs of hypoglycemia, so special precautions should be taken when using them.

The following medicines may be affected by Daonil:

  • Cimetidine (used to treat stomach ulcers )

Daonil may either potentiate or weaken the effect of the following medicines:

  • Drugs that inhibit blood coagulation (coumarin derivatives such as warfarin )
  • Ciclosporin (used to block the body’s natural immune system)

Daniel should be taken at least 4 hours before medicines containing colesevelam (medicines used to treat high cholesterol levels).

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

The effect of Daonil may be affected if Daonil and alcohol are taken at the same time.

Intake of Daonil with food and drink

The tablets should always be taken just before or at mealtime. At doses above 7 mg, take 7 mg in the morning for breakfast and the rest in connection with the evening meal.

Alcohol may enhance or weaken the blood sugar unpredictably lowering the effect of Daonil.

Pregnancy and breastfeeding

Pregnancy

There is a risk that the fetus is affected. Daonil should therefore not be used during pregnancy but should be replaced by insulin. If you are planning to become pregnant, tell your doctor.

Breast-feeding

It is not known if Daonil passes into breast milk but other medicines in the same group (sulphonylureas) do. Daonil should therefore not be used during breast-feeding. Consult a doctor as it may be necessary to switch to insulin.

Driving and using machines

During the first weeks of treatment, care should be taken when driving and handling machines. Too low or too high blood sugar can impair reactivity and visual acuity.

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.

Important information about some of the ingredients of Daonil

Daonil 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.

3. How to use Daonil

Dose one is determined by the doctor who adapts it for you. Always use Daonil exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist. The usual dose for adults varies between 1.75 mg and 10.5 mg daily depending on your blood sugar level. The tablets should always be taken just before or at mealtime.

The tablets have a score line and can be divided into two equal parts.

If you take more Daonil than you should:

If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, always contact a doctor, hospital, or the Poisons Information Center immediately for assessment of the risk and advice.

If you take more doses of Daonil may be symptoms associated with low blood sugar may occur.

If overdose is suspected, sugar, fruit juice, or the like should be taken immediately. See also section “Take special care with Daonil”.

If you forget to take Daonil:

DO NOT take a double dose to make up for a forgotten dose.

If you stop taking Daonil:

Modification or termination of treatment should only be done in consultation with a physician.

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

4. Possible side effects

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

Daonil can in rare cases affect the white blood cells so that the defense against infection deteriorates. If you get an infection with symptoms such as fever with severe deterioration in general condition or fever with local infection symptoms such as sore throat/throat / mouth or difficulty urinating, you should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then information about your medication.

Mild forms of hives have in some cases developed into more serious and even life-threatening conditions with respiratory arrest and drop in blood pressure. Therefore, contact a doctor immediately if you get hives.

Other side effects that may occur are:

Common (affects less than 1 user in 10)

Nausea, vomiting

Uncommon (affects less than 1 user in 100)

Low blood sugar (hypoglycemia) is sometimes prolonged and even life-threatening. Rash.

Rare (affects less than 1 user in 1,000):

Elevated liver values, impaired liver function, or jaundice. Increased sensitivity to sunlight. Allergic vasculitis can be life-threatening. Hematological changes such as thrombocytopenia (lack of platelets ).

No known frequency (cannot be calculated from the available data)

Hypersensitivity reaction, allergic reactions, for example in the form of skin rash.

Skin reactions, even severe with eg blisters and skin detachment

Weight gain

Decreased sodium content in blood serum

The feeling of pressure or satiety, abdominal pain, and diarrhea

Liver effects

Transient visual disturbances

Isolated cases of pressure or satiety, abdominal pain, and diarrhea have been reported. These symptoms often subside with continued use, which rarely makes it necessary to discontinue treatment.

Hepatic impairment has been reported in isolated patients treated with Daonil. Conditions that can lead to life-threatening liver failure may return when treatment with Daonil is stopped.

Transient visual disturbances may occur especially at the beginning of treatment due to changes in blood sugar levels.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Daonil

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

The medicine should not be disposed of via wastewater or household waste. Ask at the pharmacy how to deal with medicines that are no longer used. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is glibenclamide. One Daonil film-coated tablet contains 3.5 mg glibenclamide.
  • The other ingredients are lactose monohydrate 123.2 mg, magnesium stearate, microcrystalline cellulose, macrogol stearate, crospovidone, povidone.

What the medicine looks like and the contents of the pack

Appearance

The tablets are white, round (8.0 mm * 8.0 mm), scored, and marked with LAF.

3.5 mg: Blister 100 tablets.
  Glass jar 100 and 500 (for hospital use) tablets.

Marketing Authorisation Holder

Sanofi AB, Box 30052, 104 25 Stockholm

Muhammad Nadeem

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