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

Read all of this leaflet carefully before you start using 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 Actavis is and what it is used for
2. What you need to know before taking Glimepiride Actavis
3. How to take Glimepiride Actavis
4. Possible side effects
5. How to store Glimepiride Actavis
6. Contents of the packaging and other information

What Glimepiride Actavis is and what it is used for

Glimepiride Actavis is a blood sugar lowering medicine in tablet form. The drug belongs to the group of sufonureids that lower your blood sugar. Glimepiride Actavis works by increasing the amount of insulin secreted by the pancreas. Insulin then lowers your blood sugar level.

What Glimepiride Actavis is used for :

Glimepiride Actavis is used to treat certain types of diabetes ( type 2 diabetes mellitus ) as changing your diet, exercise and weight loss alone are not enough to control your blood sugar levels.

What you need to know before you take Glimepiride Actavis

Do not take Glimepiride Actavis:

  • 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 type 1 diabetes mellitus
  • if you have diabetic ketoacidosis (a complication of diabetes where the acid level in your body is elevated and you may have some of the following symptoms: fatigue, nausea, increased need to urinate and muscle stiffness)
  • if you suffer from severe kidney disease
  • if you suffer from a serious liver disease

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Glimepiride Actavis.

Warnings and cautions

Talk to your doctor or pharmacist before taking Glimepiride Actavis if:

  • You are recovering from an injury, surgery, fever infection or any other type of stress, it may be necessary to temporarily change the treatment
  • You have severe liver or kidney effects

If you are not sure if you have any of the above, talk to your doctor or pharmacist before taking Glimepiride Actavis.

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

Important information about hypoglycaemia (low blood sugar)

When you take Glimepiride Actavis you may get hypoglycaemia (low blood sugar). See below for more information on hypoglycaemia , its symptoms and treatment.

The following factors may increase the risk of hypoglycaemia:

  • Malnutrition, irregular mealtimes, missed or delayed food intake or periods of fasting
  • Dietary changes
  • Too high a dose Glimepiride Actavis has been taken
  • In case of impaired renal function
  • In severe liver disease
  • If you suffer from certain hormone-induced diseases (disorders of the thyroid gland, pituitary gland or adrenal cortex )
  • Alcohol consumption (especially if you skip a meal)
  • Concomitant use of certain other medicines (see section Other medicines and Glimepiride Actavis)
  • If you increase your physical activity and do not eat enough or if you eat foods with less carbohydrate content than usual

Signs of hypoglycaemia include:

  • Hunger, headache, nausea, vomiting, inertia, fatigue, sleep disturbances, restlessness, aggression, impaired concentration, decreased alertness and reactivity, depression, confusion, speech and vision disorders, slurred speech, tremors, partial paralysis, dizziness, dizziness,
  • The following signs may also occur: sweating, sticky skin, anxiety, increased heart rate, high blood pressure , palpitations, sudden severe chest pain that may radiate to nearby areas ( angina pectoris , heart rhythm disturbance)
  • If your blood sugar levels continue to drop, you may experience pronounced confusion ( delirium ), develop seizures, loss of self-control, shallow breathing and slower heart rate, and you may become unconscious. The clinical picture of a severe fall in blood sugar may be similar to that of stroke .

Treatment of hypoglycaemia

In most cases, the signs of lowered blood sugar disappear very quickly when you consume some kind of sugar, such as sugar cubes, sweet juice or sugared tea. You should therefore always carry some form of sugar with you (eg sugar cubes). Remember that artificial sweeteners are not effective. Contact your doctor or see a hospital if you do not improve your sugar intake or if your symptoms return.

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

Available information on treatment with Glimepiride Actavis in people under 18 years of age is limited. Treatment of this patient group is therefore not recommended.

Other medicines and Glimepiride Actavis

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 Actavis on your blood sugar levels. If you are taking such medicines, your doctor may want to change your dose of Glimepiride Actavis.

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 for diabetes (e.g. insulin and metformin )
  • analgesics and anti-inflammatory drugs (phenylbutazone, azapropazone, oxyfenbutazone, acetylsalicylic acid drugs ),
  • drugs for urinary tract infections (such as long- acting sulfonamides )
  • drugs used to treat bacterial and fungal infections ( tetracyclines , chloramphenicol, fluconazole , miconazole , quinolones , clarithromycin)
  • blood-thinning drugs (coumarin-type drugs, such as warfarin )
  • muscle building agents (anabolic steroids )
  • drugs for the replacement of male sex hormone.
  • antidepressants ( fluoxetine , MAO inhibitors )
  • Cholesterol-lowering drugs (fibrates)
  • medicines to lower blood pressure ( ACE inhibitors )
  • Drugs called antiarrhythmics and used to control abnormal heart rhythms ( disopyramide )
  • anti- gout drugs (allopurinol, probenecid, sulfinpyrazone).
  • anticancer drugs (cyclophosphamide, ifosfamide and trophosphamide)
  • weight loss drug (fenfluramine)
  • infusion of high- dose drugs that increase blood flow (pentoxifylline)
  • medicines for allergies such as hay fever (tritocvaline)
  • drugs called sympatholytics used to treat high blood pressure , heart failure or prostate problems

The blood sugar lowering effect of glimepiride may be attenuated by the following medicines. This can lead to hyperglycaemia (elevated blood sugar levels):

  • drugs containing female sex hormones ( estrogens and progestogens)
  • drugs that act as diuretics (thiazide diuretics)
  • thyroid hormones (eg levothyroxine)
  • medicines for allergies and inflammation ( glucocorticoids )
  • medicines for serious mental illnesses (chlorpromazine and other medicines such as fentiazine)
  • drugs used to increase heart rate, to treat asthma or nasal congestion, coughs and colds, obesity or life-threatening conditions ( adrenaline and sympathomimetics )
  • cholesterol lowering agents (nicotinic acid derivatives)
  • drugs used for long-term treatment of constipation ( laxatives )
  • medicines for seizures ( phenytoin )
  • medicines for nervousness or sleep problems ( barbiturates )
  • drug for increased pressure on the inside of the eye (acetazolamide)
  • drugs that lower blood pressure or blood sugar (diazoxide)
  • medicines for infection , tuberculosis (rifampicin),
  • drugs used to treat low blood sugar (glucagon)

The following medicines may lower or increase the blood-glucose-lowering effect of glimepiride:

  • medicines for stomach ulcers (so-called H2 antagonists )
  • Medicines for high blood pressure or heart failure such as beta-blockers , clonidine , guanethidine and reserpine. These can also mask the symptoms of hypoglycaemia , so take special care.

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

  • blood-thinning drugs (coumarin-type drugs, such as warfarin ).

Kolesevelam, a drug used to lower cholesterol, has an effect on the uptake of Glimepiride Actavis. To avoid this effect, you should take Glimepiride Actavis at least 4 hours before cholesevelam.

Glimepiride Actavis with alcohol

Alcohol can have unpredictable effects and both enhance and weaken Glimepiride Actavis’ ability to lower blood sugar levels.

Pregnancy and breastfeeding

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.

Glimepiride Actavis should not be taken during pregnancy.

Glimepiride may pass into breast milk. Glimepiride Actavis should not be taken while breastfeeding.

Driving and using machines

Both your ability to concentrate and react can be impaired if your blood sugar becomes too low ( hypoglycaemia ) or too high ( hyperglycaemia ) or if you develop vision problems as a result of these conditions. Remember that you can put yourself and others at risk (eg when driving or using machines). Ask your doctor if it is appropriate for you to drive

  • if you often have low blood sugar
  • if you have few or no warning signs that your blood sugar is too low.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. 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 Actavis contains lactose, sodium and dyes

Glimepiride Actavis contains lactose

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

Glimepiride Actavis contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free.

Glimepiride Actavis 2 mg contains dyes

Certain dyes (tartrazine, E102 and paraorange, E110) in the tablets may cause hypersensitivity reactions.

How to take Glimepiride Actavis

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

Use of this medicine

  • The medicine is taken orally, just before or in connection with the first meal of the day (usually breakfast). If you do not eat breakfast, take the medicine according to the instructions given to you by your doctor. It is important that you do not miss a meal when using Glimepiride Actavis
  • The tablets should be swallowed whole with at least half a glass of water. The tablets must not be crushed or chewed

Dosage instructions

The dosage of Glimepiride Actavis depends on your needs, conditions and results of blood and urine sugar tests and is determined by your doctor. Do not take more tablets than your doctor has prescribed.

  • The usual starting dose is one tablet of Glimepiride Actavis 1 mg daily
  • If necessary, your doctor may increase the dose one after every 1-2 weeks of treatment
  • The maximum recommended dose is 6 mg Glimepiride Actavis daily
  • Combination therapy with glimepiride plus metformin or with glimepiride plus insulin may be appropriate. In these cases, your doctor will prescribe the appropriate dose of glimepiride, metformin or insulin 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 your medicine is too weak or too strong, do not change the dosage yourself without first consulting your doctor.

If you take more Glimepiride Actavis than you should

If you have taken too much Glimepiride Actavis or an extra dose, there is a risk of hypoglycaemia (signs of hypoglycaemia see section 2 – Take special care with Glimepiride Actavis) and therefore you should get enough sugar immediately (eg sugar cubes, sweet juice, sugared tea) and immediately contact a doctor, hospital or the Poison Information Center. When treating hypoglycaemia in children who have accidentally ingested Glimepiride Actavis, it is important that the amount of sugar is carefully determined to avoid the occurrence of dangerous hyperglycaemia. People who are unconscious should not be given food or drink.

As hypoglycaemia can be persistent, it is important that the patient is closely monitored until the danger is over. Hospitalization may be necessary, if only as a precaution. Bring packing or any remaining tablets so that your doctor knows what you have taken.

Severe cases of hypoglycaemia with unconsciousness and severe effects on the nervous system require immediate medical treatment and hospitalization. It should be ensured that there is always an understanding person who can contact a doctor in an emergency.

If you forget to take Glimepiride Actavis

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

If you stop taking Glimepiride Actavis

If you stop or stop treatment, you should be aware that the desired blood sugar lowering effect will not be achieved or that the disease will worsen. Continue to use Glimepiride Actavis until your doctor tells you to stop treatment.

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.

If any of the following occur, consult a doctor immediately or go to the nearest hospital as you may need immediate care:

Very rare (may affect up to 1 in 10,000 users).

  • Allergic reactions (with inflammation of the blood vessels, often with rash) which can develop into severe reactions with difficulty breathing, drop in blood pressure and sometimes shock .
  • Impaired liver function, including yellow skin and yellow eyes (jaundice), bile flow problems (cholestasis), hepatitis ( hepatitis ) or liver failure

No known frequency (can not be calculated from available data).

  • Skin allergy (hypersensitivity) with itching , rash, hives and increased sensitivity to sunlight. Some mild conditions can develop into severe reactions with difficulty swallowing or breathing, swelling of the lips, throat or tongue.
  • Severe hypoglycaemia with unconsciousness, seizures or coma

Other possible side effects:

Rare (may affect up to 1 in 1000 people)

  • Lower than normal blood sugar level ( hypoglycaemia ) (see section 2 – warnings and precautions).
  • Reduced blood cell count
    • Platelets (which increases the risk of bleeding and bruising)
    • White blood cells (which increases the risk of infection )
    • Red blood cells (which can make the skin pale and cause weakness or shortness of breath)

These problems usually stop after you stop taking Glimepiride Actavis.

  • Weight gain
  • Hair loss
  • Changes in the taste experience

Very rare side effects are (may affect up to 1 in 10 000 users).

  • Feeling sick, diarrhea, satiety or bloated stomach and abdominal pain
  • Decreased sodium levels in the blood (shown by blood tests)

No known frequency (can not be calculated from the available data)

  • Allergic reactions with sulphonylureas, sulphonamides or similar medicines may occur
  • Problems with vision may occur at the beginning of treatment. This is due to a change in blood sugar levels and should go away soon
  • Increased levels of liver enzymes
  • Severe and unusual bleeding or bruising under the skin

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.

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 Actavis

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

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

Do not store above 30 ° C. Store in the original package.

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. Each tablet contains 1 mg, 2 mg, 3 mg or 4 mg glimepiride.
  • The other ingredients are lactose monohydrate , microcrystalline cellulose, sodium starch glycolate, povidone and magnesium stearate. 1 mg tablets (pink) also contain: red iron oxide (E172); 2 mg tablets (green): yellow iron oxide (E172), tartrazine (E102), brilliant blue (E133), para-orange (E110); 3 mg tablets (yellow): yellow iron oxide (E172); and 4 mg tablets (blue) indigo carmine (E132).

What the medicine looks like and the contents of the pack

Flat, oblong tablets marked with “G” on one side and with a breaker notch on the other side.

Glimepiride Actavis 1 mg tablets are pink with a size of 8.0 x 4.1 mm.

Glimepiride Actavis 2 mg tablets are green with a size of 10.1 x 5.1 mm.

Glimepiride Actavis 3 mg tablets are yellow with a size of 10.1 x 5.1 mm.

Glimepiride Actavis 4 mg tablets are blue with a size of 10.1 x 5.1 mm.

Pack sizes of 1 mg, 2 mg, 3 mg and 4 mg tablets: 10, 20, 30, 50, 60, 90 and 120 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis Group PTC EHF.

Reykjavíkurvegur 76-78

220 Hafnarfjörður

Iceland

Manufacturer

Balkanpharma Dupnitsa

AD 3 Samokovsko Shosse Str

Dupnitsa, 2600

Bulgaria

or

Actavis Ltd.

BLB016 Bulebel Industrial Estate

Zejtun, ZTN 3000

Malta

or

Actavis hf.

Reykjavikurvegur 78

220 Hafnarfjordur

Iceland

Agent

Box 1070

251 10 Helsingborg

Muhammad Nadeem

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