AZEAL-500mg

Category:

AZEAL 500mg: Each film coated tablet contains: Azithromycin Dihydrate IP equivalent to Azithromycin 500mg.

It is used to treat bacterial infections caused by microorganisms such as bacteria. These infections include:

  • Chest infections such as bronchitis and pneumonia
  • Infections in your sinuses, throat, tonsils or ears
  • Mild to moderate skin and soft tissue infections, e.g. infection of the hair follicles (folliculitis), bacterial infection of the skin and its deeper layers (cellulitis), skin infection with shiny red swelling (erysipelas)
  • Infections caused by a bacterium called Chlamydia trachomatis. They can cause inflammation of the tube that carries urine from your bladder (urethra) or where your womb joins your vagina (cervix).

Description

AZEAL 500 Tablet brand name for Azithromycin comes under one of the group of antibiotics called macrolides. It works by preventing synthesis of essential proteins required by bacteria to carry out vital functions. Thus, it stops the bacteria from growing, and prevents the infection from spreading.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Azithromycin tablets should be given as a single daily dose. The tablets should be swallowed preferably with a drink of water and can be taken with or without food.

The recommended dose is:

Adults (including older patients), children and adolescents with a body weight of over 45 kg:

The recommended dose is 1500 mg divided over either 3 or 5 days as follows:

  • When taken over 3 days, 500 mg once daily.
  • When taken over 5 days, 500 mg as a single dose on the first day and then 250 mg once daily on days 2 through to 5.

Inflammation of the urethra or cervix caused by Chlamydia: 1000 mg taken as a single dose, for one day only.

For infections in your sinuses, treatment is indicated for adults and adolescents 16 years of age and over.

Children and adolescents with a body weight of 45 kg and under:

Tablets are not indicated for these patients. Other pharmaceutical forms of azithromycin-containing products (e.g. suspensions) may be used.

Patients with kidney or liver problems:

You should tell your doctor if you have kidney or liver problems as your doctor may need to alter the normal dose.

Tell your doctor before taking Azithromycin, if you are taking any of the medicines listed below:

  • Warfarin or any similar medicine to prevent blood clots: concomitant use can increase the risk of bleeding.
  • Ergotamine, dihydroergotamine: ergotism may occur. Concomitant use is therefore not recommended.
  • Cyclosporin: if concomitant use is required, your doctor will check your blood levels regularly and may adapt the dose.
  • Digoxin: digoxin levels may increase. Your doctor will check your blood levels.
  • Colchicine
  • Antacids: Azithromycin should be taken at least 1 hour before or 2 hours after the antacid
  • Cisapride, terfenadine: concomitant use with azithromycin may cause heart disorders.
  • Medicines for irregular heart-beat, or to lower cholesterol such as atorvastatin.
  • Alfentanil (used for narcosis) or astemizole (used to treat hay fever): concomitant use with azithromycin may increase the effect of these medicinal products.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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

If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:

  • A severe skin reaction causing blisters/bleeding of the lips, eyes, nose, mouth and genitals (Stevens-Johnson syndrome).
  • yellowing of the skin and whites of the eyes, tiredness and loss of appetite which may be caused by inflammation of the liver (hepatitis)
  • yellowing of the skin or eyes (jaundice).
  • skin eruption that is characterized by the rapid appearance of areas of red skin studded with small pustules (small blisters filled with white/yellow fluid).
  • skin rash accompanied by other symptoms such as fever, swollen glands and an increase of eosinophils (a type of white blood cell).

Very common (may affect more than 1 in 10 people):

  • Diarrhoea, feeling sick., abdominal pain., flatulence (wind)

Common (may affect up to 1 in 10 people):

  • headache, dizziness, feeling drowsy (somnolence), taste disturbance, numbness or pins and needles (paraesthesia), visual disturbances, deafness, being sick, indigestion, skin rash, itching, joint pain (arthralgia), tiredness, changes in white blood cell count in blood tests, low blood bicarbonate.

Uncommon side effects:

  • reduced sense of touch or sensation (hypoaesthesia), changes in liver function, skin more sensitive to light than normal, yeast infections of the mouth and vagina (thrush), vaginal infections, fungal infections, bacterial infections, inflammation of the throat, inflammation of the stomach and intestine, breathing difficulties, runny or blocked nose, allergic reactions of various severity,  loss of appetite, feeling nervous, sleeplessness (insomnia), ear disorder, vertigo, hearing impairment including hearing loss, tinnitus (ringing in your ears), heart palpitations, hot flushes, recurring frequent infections with fever, chills, sore throat, mouth ulcers, which may be caused by a decrease in the number of white cells in the blood, serious lung infection with symptoms such as fever, chills, shortness of breath, cough and phlegm (pneumonia), general swelling.

Rare side effects (may affect 1 to 10 patients in 10,000) include:

  • agitation
  • irritability

Talk to your doctor or pharmacist before taking Azithromycin if you:

  • have ever had a serious allergic reaction causing swelling of the face and throat, possibly with breathing problems, rash, fever, swollen glands or increase in eosinophils (certain type of white blood cells).
  • have severe kidney problems: your doctor may alter the dose
  • have liver problems: your doctor may need to monitor your liver function or stop the treatment
  • have myasthenia gravis (localized muscle weakness)
  • have been diagnosed with a neurological disease, which is a disease of the brain or nervous system
  • have mental, emotional or behavioural problems
  • are taking medicines known as ergot alkaloids (such as ergotamine), which are used to treat migraine: azithromycin is not recommended

Since azithromycin may increase the risk of abnormal heart rhythm, please tell your doctor if you have any of the following problems before taking this medicine (especially you are female or elderly):

  •  you are aware of ever being diagnosed to have prolonged QT interval (a heart condition, shown on an electro-cardiogram or ECG machine): azithromycin is not recommended
  • are aware that you have a slow or irregular heart-beat, or reduced heart function (heart failure): azithromycin is not recommended.
  • know that you have low levels of potassium or magnesium in your blood: azithromycin is not recommended.
  • are taking medicines known as antiarrhythmics (e.g. quinidine, procainamide, dofetilide, amiodarone, sotalol: used to treat abnormal heart rhythms), cisapride (used to treat stomach problems) or terfenadine (an antihistamine that is used to treat allergies), or antipsychotic agents (e.g. pimozide), antidepressants (e.g. citalopram), some antibiotics (e.g. moxifloxacin,levofloxacin) that can affect the heart rhythm: azithromycin is not recommended

If you develop severe and persistent diarrhoea during or after treatment, especially if you notice blood or mucus, tell your doctor immediately.

If your symptoms persist after the end of your treatment with azithromycin, or if you notice any new and persistent symptoms, contact your doctor.

Azithromycin with food: Azithromycin Tablets can be taken with or without food.

Pregnancy and breast-feeding: If you are pregnant or breast-feeding, 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 insufficient information regarding the safety of azithromycin during pregnancy. Consequently, Azithromycin is not recommended if you are pregnant or planning to become pregnant. However, your doctor may prescribe it under serious circumstances.

Breast-feeding: Azithromycin is excreted in human milk, therefore you should not breast-feed whilst you are taking Azithromycin, because it may cause side effects including diarrhoea and infection in your baby. It is recommended to discard the milk during treatment and up until 2 days after discontinuation of treatment. You may resume nursing two days after stopping your treatment with Azithromycin.

Driving and using machines: Azithromycin may cause dizziness and fits. If affected, do not drive or operate machinery.

 

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It is used to treat bacterial infections caused by microorganisms such as bacteria. These infections include:

  • Chest infections such as bronchitis and pneumonia
  • Infections in your sinuses, throat, tonsils or ears
  • Mild to moderate skin and soft tissue infections, e.g. infection of the hair follicles (folliculitis), bacterial infection of the skin and its deeper layers (cellulitis), skin infection with shiny red swelling (erysipelas)
  • Infections caused by a bacterium called Chlamydia trachomatis. They can cause inflammation of the tube that carries urine from your bladder (urethra) or where your womb joins your vagina (cervix).

Description

AZEAL 500 Tablet brand name for Azithromycin comes under one of the group of antibiotics called macrolides. It works by preventing synthesis of essential proteins required by bacteria to carry out vital functions. Thus, it stops the bacteria from growing, and prevents the infection from spreading.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Azithromycin tablets should be given as a single daily dose. The tablets should be swallowed preferably with a drink of water and can be taken with or without food.

The recommended dose is:

Adults (including older patients), children and adolescents with a body weight of over 45 kg:

The recommended dose is 1500 mg divided over either 3 or 5 days as follows:

  • When taken over 3 days, 500 mg once daily.
  • When taken over 5 days, 500 mg as a single dose on the first day and then 250 mg once daily on days 2 through to 5.

Inflammation of the urethra or cervix caused by Chlamydia: 1000 mg taken as a single dose, for one day only.

For infections in your sinuses, treatment is indicated for adults and adolescents 16 years of age and over.

Children and adolescents with a body weight of 45 kg and under:

Tablets are not indicated for these patients. Other pharmaceutical forms of azithromycin-containing products (e.g. suspensions) may be used.

Patients with kidney or liver problems:

You should tell your doctor if you have kidney or liver problems as your doctor may need to alter the normal dose.

Tell your doctor before taking Azithromycin, if you are taking any of the medicines listed below:

  • Warfarin or any similar medicine to prevent blood clots: concomitant use can increase the risk of bleeding.
  • Ergotamine, dihydroergotamine: ergotism may occur. Concomitant use is therefore not recommended.
  • Cyclosporin: if concomitant use is required, your doctor will check your blood levels regularly and may adapt the dose.
  • Digoxin: digoxin levels may increase. Your doctor will check your blood levels.
  • Colchicine
  • Antacids: Azithromycin should be taken at least 1 hour before or 2 hours after the antacid
  • Cisapride, terfenadine: concomitant use with azithromycin may cause heart disorders.
  • Medicines for irregular heart-beat, or to lower cholesterol such as atorvastatin.
  • Alfentanil (used for narcosis) or astemizole (used to treat hay fever): concomitant use with azithromycin may increase the effect of these medicinal products.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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

If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:

  • A severe skin reaction causing blisters/bleeding of the lips, eyes, nose, mouth and genitals (Stevens-Johnson syndrome).
  • yellowing of the skin and whites of the eyes, tiredness and loss of appetite which may be caused by inflammation of the liver (hepatitis)
  • yellowing of the skin or eyes (jaundice).
  • skin eruption that is characterized by the rapid appearance of areas of red skin studded with small pustules (small blisters filled with white/yellow fluid).
  • skin rash accompanied by other symptoms such as fever, swollen glands and an increase of eosinophils (a type of white blood cell).

Very common (may affect more than 1 in 10 people):

  • Diarrhoea, feeling sick., abdominal pain., flatulence (wind)

Common (may affect up to 1 in 10 people):

  • headache, dizziness, feeling drowsy (somnolence), taste disturbance, numbness or pins and needles (paraesthesia), visual disturbances, deafness, being sick, indigestion, skin rash, itching, joint pain (arthralgia), tiredness, changes in white blood cell count in blood tests, low blood bicarbonate.

Uncommon side effects:

  • reduced sense of touch or sensation (hypoaesthesia), changes in liver function, skin more sensitive to light than normal, yeast infections of the mouth and vagina (thrush), vaginal infections, fungal infections, bacterial infections, inflammation of the throat, inflammation of the stomach and intestine, breathing difficulties, runny or blocked nose, allergic reactions of various severity,  loss of appetite, feeling nervous, sleeplessness (insomnia), ear disorder, vertigo, hearing impairment including hearing loss, tinnitus (ringing in your ears), heart palpitations, hot flushes, recurring frequent infections with fever, chills, sore throat, mouth ulcers, which may be caused by a decrease in the number of white cells in the blood, serious lung infection with symptoms such as fever, chills, shortness of breath, cough and phlegm (pneumonia), general swelling.

Rare side effects (may affect 1 to 10 patients in 10,000) include:

  • agitation
  • irritability

Talk to your doctor or pharmacist before taking Azithromycin if you:

  • have ever had a serious allergic reaction causing swelling of the face and throat, possibly with breathing problems, rash, fever, swollen glands or increase in eosinophils (certain type of white blood cells).
  • have severe kidney problems: your doctor may alter the dose
  • have liver problems: your doctor may need to monitor your liver function or stop the treatment
  • have myasthenia gravis (localized muscle weakness)
  • have been diagnosed with a neurological disease, which is a disease of the brain or nervous system
  • have mental, emotional or behavioural problems
  • are taking medicines known as ergot alkaloids (such as ergotamine), which are used to treat migraine: azithromycin is not recommended

Since azithromycin may increase the risk of abnormal heart rhythm, please tell your doctor if you have any of the following problems before taking this medicine (especially you are female or elderly):

  •  you are aware of ever being diagnosed to have prolonged QT interval (a heart condition, shown on an electro-cardiogram or ECG machine): azithromycin is not recommended
  • are aware that you have a slow or irregular heart-beat, or reduced heart function (heart failure): azithromycin is not recommended.
  • know that you have low levels of potassium or magnesium in your blood: azithromycin is not recommended.
  • are taking medicines known as antiarrhythmics (e.g. quinidine, procainamide, dofetilide, amiodarone, sotalol: used to treat abnormal heart rhythms), cisapride (used to treat stomach problems) or terfenadine (an antihistamine that is used to treat allergies), or antipsychotic agents (e.g. pimozide), antidepressants (e.g. citalopram), some antibiotics (e.g. moxifloxacin,levofloxacin) that can affect the heart rhythm: azithromycin is not recommended

If you develop severe and persistent diarrhoea during or after treatment, especially if you notice blood or mucus, tell your doctor immediately.

If your symptoms persist after the end of your treatment with azithromycin, or if you notice any new and persistent symptoms, contact your doctor.

Azithromycin with food: Azithromycin Tablets can be taken with or without food.

Pregnancy and breast-feeding: If you are pregnant or breast-feeding, 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 insufficient information regarding the safety of azithromycin during pregnancy. Consequently, Azithromycin is not recommended if you are pregnant or planning to become pregnant. However, your doctor may prescribe it under serious circumstances.

Breast-feeding: Azithromycin is excreted in human milk, therefore you should not breast-feed whilst you are taking Azithromycin, because it may cause side effects including diarrhoea and infection in your baby. It is recommended to discard the milk during treatment and up until 2 days after discontinuation of treatment. You may resume nursing two days after stopping your treatment with Azithromycin.

Driving and using machines: Azithromycin may cause dizziness and fits. If affected, do not drive or operate machinery.

 

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