1.75 mg, 3.5 mg tablets
glibenclamide

1. What Glibenclamide Recip is and what it is used for

Glibenclamide Recip has blood sugar lowering effect by increasing the pancreas’ own insulin production and possibly making this insulin more effective.

Glibenclamide is used in adult-onset diabetes (Type II – diabetes mellitus ) where diet alone, weight reduction, and exercise alone do not provide sufficient effect.

2. What you need to know before using Glibenclamide Recip

Do not use glibenclamide:

  • if you are allergic (hypersensitive) to glibenclamide or any of the other ingredients of Glibenclamide Recip.
  • if you have type 1 diabetes mellitus (insulin-dependent diabetes ).
  • in diabetic coma and in case of 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 the diabetes disease, 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).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Glibenklamide Recip.

Blood sugar should be checked regularly.

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

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

Hypoglycaemia ( hypoglycaemia )

Hypoglycaemia ( hypoglycaemia ), 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 have no effect. 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 ( hyperglycaemia )

Signs of high blood sugar ( hyperglycaemia ) 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.

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

Glibenclamide Recip can in rare cases affect the white blood cells so that the defense of infection deteriorates. If you get an infection with symptoms such as fever with severe general condition 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 blood tests can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then inform about your medication.

Other medicines and Glibenclamide Recip

Tell your doctor or pharmacist if you have recently taken or might take any 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 Glibenclamide, which may lead to an increased risk of hypoglycemia (low blood sugar).

Drug:

  • used in diabetes treatment (such as insulin , or metformin )
  • in the treatment of pain and inflammation (phenylbutazone, azapropazone and oxyfenbutazone)
  • that promotes muscle building (anabolic steroids )
  • used in the replacement of male sex hormone
  • in the treatment of depression ( fluoxetine , MAO inhibitors )
  • in the treatment of tuberculosis (para-aminosalicylic acid)
  • used primarily in the treatment of infection your urinary tract and prostate (+ sulfamethoxazole trimethoprim)
  • which lowers high blood pressure or is used in the treatment of certain heart diseases ( ACE inhibitors )
  • that lowers high cholesterol levels (fibrates)
  • in the treatment of cancer (cyclophosphamide and ifosphosamide)
  • in the treatment of gout (probenecid and sulfinpyrazone)
  • in the treatment of nasal allergies such as hay fever (tritoqualin)
  • which increase blood circulation when given in high doses by intravenous infusion (pentoxifylline)
  • used for weight loss (fenfluramine)
  • called sympatholytic drugs such as beta-blockers and guanetidine used to treat high blood pressure , heart failure or prostate symptoms
  • used in the treatment of bacterial and fungal infections ( tetracyclines , chloramphenicol, fluconazole , miconazole , quinelone 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 Glibenclamide. This may lead to an increased risk of hyperglycaemia (high blood sugar):

Drug:

  • containing female sex hormones ( estrogens , progestogens)
  • in the treatment of increased pressure in the eye (acetazolamide)
  • in the treatment of anxiety and sleep problems ( barbiturates )
  • diuretic ( diuretic )
  • which stimulates the thyroid gland (such as levothyroxine)
  • in the treatment of seizures ( phenytoin )
  • in the treatment of allergies and inflammation ( glucocorticoids )
  • in the treatment of severe mental disorder (phentiazine derivatives)
  • in the treatment of high cholesterol levels ( nicotinic acid )
  • for long-term treatment of constipation ( laxatives )
  • in the treatment of high blood pressure or in the treatment of low blood sugar (diazoxide)
  • in the treatment of severe hypoglycaemia (glucagon)
  • used in life-threatening situations ( sympathomimetic )
  • in the treatment of infection , tuberculosis (rifampicin)

The following medicines may either enhance or weaken the blood-glucose-lowering effect of Glibenclamide:

Drug:

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

The following medicines may be affected by glibenclamide

  • Cimetidine (used to treat stomach ulcers )

Glibenclamide may either potentiate or attenuate the effects of the following medicines:

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

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 glibenclamide may be affected if glibenclamide and alcohol are taken at the same time.

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

There is a risk that the fetus is affected. Glibenclamide 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 glibenclamide passes into breast milk but other drugs in the same group (sulphonylureas) do. Glibenclamide should therefore not be used during breastfeeding. Consult a doctor as it may be necessary to switch to insulin.

Driving and using machines

When treated with Glibenclamide Recip, in some cases you can get too low blood sugar ( hypoglycemia ), which results in a reduced ability to react. At the beginning of treatment, a transient visual impairment may occur due to the change in blood sugar level.

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. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Glibenclamide Recip 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 Glibenclamide Recip

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

The recommended dose is:

Dose one is determined by your doctor, who adjusts it individually for you.

Usually, Glibenclamide recip dosed as a single dose before breakfast target but at higher daily doses maybe sometimes a dose given before breakfast and a target dose before the evening meal (supper).

The tablets should always be taken just before or at mealtime.

If you use more Glibenclamide Recip than you should 

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

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

If overdose is suspected, sugar, fruit juice, or similar should be taken immediately.

If you forget to take Glibenclamide Recip

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

If you stop taking Glibenclamide Recip

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

4. Possible side effects

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

Side effects that can occur are:

Common (affects less than 1 user in 10)

Nausea, vomiting.

Uncommon (affects less than 1 user in 100)

Low blood sugar ( hypoglycaemia ), sometimes prolonged and even life-threatening. Skin rash, hives.

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 agranulocytosis and thrombocytopenia (see Take special care with Glibenclamide Recip).

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. In case of hives, a doctor should therefore be contacted immediately.

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 glibenclamide. Conditions that can lead to life-threatening liver failure may return when glibenclamide treatment is stopped.

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

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 Glibenklamide Recip

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

Used before the expiry date which is stated on the carton. The expiration date is the last day of the specified month.

Empty packaging can be recycled via the Packaging Collection. The jar and lid are sorted as hard plastic packaging. Impression cards and single-dose packaging are sorted as soft plastic packaging.

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 tablet contains 1.75 mg and 3.5 mg respectively.
  • The other ingredients are lactose monohydrate 17.5 mg and 35 mg respectively, maize starch, povidone and magnesium stearate.

What the medicine looks like and contents of the pack

Glibenclamide Recip 1.75 mg: white with break notch, diameter 6 mm, marked “GL”

Glibenclamide Recip 3.5 mg: white with a cut notch, diameter 7.5 mm, marked “GB”

Packaging

1.75 mg: 49 × 1 single-dose pack100 pcs pressure packaging100 pcs and 250 pcs in a plastic jar
3.5 mg: 49 × 1 single-dose pack100 pcs pressure packaging100 pcs and 250 pcs print packaging

Marketing Authorization Holder

RPH Pharmaceuticals AB

Box 603

101 32 Stockholm

Manufacturer

Recipharm Stockholm AB

Lagervägen 7

136 50 Jordbro

Local representative

Astimex Pharma AB

Isafjordsgatan 36

164 40 Kista

Tel. 08-5151 1535

info@astimex.se

Muhammad Nadeem

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