AZATRIL 500 mg. 3 tablets
Azithromycin belongs to the group of medicines called macrolide antibiotics. Antibiotics are used to treat infections caused by microorganisms such as bacteria.
Azithromycin is used to treat certain infections caused by bacteria sensitive to azithromycin, such as:
chest infections, throat or nose (such as bronchitis, pneumonia, tonsillitis, sore throat (pharyngitis), and sinusitis);
infections of skin and soft tissues, with the exception of infected burn wounds, for example - an infection of the urethra through which urine is released from the bladder or cervix caused by Chlamidia trachomatis (bacteria).
2. What you need to know before taking Azatril
Do not take Azatril if:
you are allergic to azithromycin dihydrate, erythromycin or any macrolide or ketolide antibiotic;
you are allergic to any of the other ingredients of this medicine listed in Section 6.
Warnings and Precautions
Ask your doctor or pharmacist before taking your medicine if:
have severe liver or kidney problems;
you have severe heart problems and heart rhythm problems like syndrome of QT-interval prolongation (see electrocardiogram or ECG device);
the level of potassium or magnesium in the blood are too low;
Get signs of an infection;
taking any ergot derivatives such as ergotamine (used to treat migraine), as these medicines should not be given concurrently with azithromycin (see section "Taking other medicines");
you have a certain type of muscle weakness called myasthenia gravis;
You have problems with the nerves (neurological) or mental (psychiatric).
Other medicines and Azatril:
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.
Tell your doctor if you are taking any of the following medications:
antacids - used for heartburn and indigestion. Azatril should be taken at least 1 hour before or 2 hours after the antacid;
ergotamine - (used in migraine) should not be taken at the same time with azithromycin, as may occur serious adverse reactions (with numbness or tingling sensations in the extremities, muscle cramps, headache, seizures, pain in the abdomen or chest);
warfarin or similar drugs - used to thin the blood. Azithromycin can cause further thin the blood;
cisapride - (used to treat stomach problems) should not be taken at the same time as it can cause serious heart problems (visible on the electrocardiogram or ECG device);
terfenadine - (used to treat hay fever) should not be taken at the same time as it can cause serious heart problems (visible on the electrocardiogram or ECG device);
zidovudine, nelfinavir - used to treat HIV infections. While taking nelfinavir with azithromycin can get more side effects listed in this leaflet;
rifabutin - used to treat tuberculosis;
quinidine - used to treat heart rhythm problems;
cyclosporin - used to prevent rejection of the transplanted organ by the body, your doctor will regularly check the values of cyclosporin in your blood and may change your dose.
Tell your doctor or pharmacist if you are taking any of these medicines. Azatril may enhance the effects of these drugs. Your doctor may change your dose:
triazolam, midazolam (sedatives);
alfentanil - anesthetic used during operations;
Theophylline - used for breathing problems, such as asthma or chronic obstructive pulmonary disease (COPD);
digoxin - used for heart problems;
astemizole - used to treat hay fever;
pimozide - used to treat health problems linked with the psyche.
Azatril with food and drink
This medicine may be taken with or without food.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, you think you are pregnant or planning to have a baby, ask your doctor or pharmacist before taking this medicine.
There is insufficient information on the use of azithromycin in pregnancy, which is why you should not use azithromycin during pregnancy unless specifically indicated by your doctor. Azithromycin partially passes into breast milk, therefore, azithromycin should not be used if breast-feeding.
Driving and using machines
No data on the effect of azithromycin on the ability to drive and use machines. However, azithromycin tablets can cause dizziness and fainting, so before you drive or operate machinery have to make sure you're not affected.
Azithromycin contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before you start taking this medicine.
3. How to take Azatril
Always take this medicine exactly as you have been told by your doctor or pharmacist. If you're not sure, ask your doctor or pharmacist.
Adults and young people with a body weight of 45 kg or more:
500 mg once a day for three days with a total dose of 1500 mg. Your doctor may decide to prescribe a total dose of 1500 mg over 5 days (500 mg on the first day and 250 mg of 2 to 5 days).
For infections of the cervix and urethra caused by Chlamydia trachomatis:
Dose of 1000 mg should be taken at once.
Children and adolescents under 45 kg:
The tablets are not recommended. Young people weighing less than 45 kg should use other formulations of this drug.
Patients with kidney or liver problems
You should tell your doctor if you have liver or kidney problems as you may need it to change the usual dose.
Dosage in the elderly:
For elderly patients the dosage is the same that is used in adult patients.
The tablets should be taken with 1/2 cup water.
If you take more dose Azatril
If you take too much Azatril, immediately contact your doctor or pharmacist immediately go to the nearest hospital.
Symptoms of overdose may be hearing loss, nausea and diarrhea. In cases of overdose may require admission to hospital.
If you forget to take Azatril
If you forget to take Azatril, take your dose as if it is almost time for your next dose, skip the missed dose and as soon as possible in the allotted time. If in doubt, please contact your doctor or pharmacist. If you miss a dose, it is necessary to take all the tablets that you have written. This means that you will complete the course of treatment a day later.
Do not take a double dose to make up for a missed dose.
If you stop taking Azatril
Never stop treatment Azatril at your discretion but discuss this with your doctor. If the prescribed treatment is not fully completed, the infection may return.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you have any of the following symptoms of a serious allergic reaction, stop taking this medication and tell your doctor immediately or go to the emergency department of the nearest hospital:
Sudden obstruction of breathing, speaking and swallowing;
Swelling of the lips, tongue, face and neck;
Severe dizziness or collapse;
Severe or itchy skin rash, especially if blistering and inflammation of the eyes, mouth or genitals.
If any of these side effects, contact your doctor:
Severe or prolonged or bloody diarrhea, accompanied by stomach pain or high temperature. This may be an indication of a serious inflammatory bowel disease. This can be observed in rare cases of antibiotics;
Yellowing of the skin or eyes caused by liver problems;
Inflammation of the pancreas (pancreas), which can cause severe pain in the abdomen and back;
Increased or decreased urine or traces of blood in your urine;
Skin rash caused by sensitivity to sunlight;
Unusual bruising or bleeding;
These are serious side effects. You may need urgent medical attention. Serious side effects are uncommon (may affect up to 1 in 100 people) or their frequency can not be estimated from the available data.
Other side effects include:
Very common (may affect more than one in 10 people):
pain in the abdomen;
feeling sick (nausea);
Common (may affect up to 1 in 10 people):
loss of appetite (anorexia);
numbness, tingling or numbness (paraesthesia);
changes in taste and smell;
vomiting, stomach pain or cramps, loss of appetite, digestive problems;
skin rashes and itching;
joint pain (arthralgia);
change in the number of white blood cells and the concentration of bicarbonate in the blood.
Uncommon (may affect up to 1 in 100 people):
thrush (candidiasis) - an infection caused by fungi;
inflammation of the vagina (vaginitis);
reduce the number of white blood cells;
angioedema (severe allergic reaction that causes swelling of the face or throat);
weakened touch sensation (hypoesthesia);
hearing loss or ringing in the ears;
inflammation of the lining of the stomach (gastric);
liver problems such as hepatitis;
allergic skin reactions, such as sensitivity to sunlight, red, scaly and swollen skin;
pain in the chest;
edema, swelling (edema);
changes in liver enzymes and blood levels.
Rare (may affect up to 1 in 1000 people):
a sense of excitement, unreal feelings and sensations - dizziness (vertigo);
abnormal liver function;
allergic skin reactions;
Not known (frequency can not be estimated from available data):
intestinal infection (colon) (pseudomembranous colitis);
reduced number of red blood cells due to destruction (hemolytic anemia);
reducing the number of blood platelets;
anaphylactic reaction (a severe, life-threatening allergic reaction);
a feeling of anger, aggression;
fainting with temporary loss of consciousness (syncope);
a feeling of hyperactivity;
changes in sense of smell (anosmia, parosmia);
changes in sense of taste (ageusia);
exacerbation or worsening of muscle weakness (myasthenia gravis);
rapid (ventricular tachycardia) or irregular heart beat, sometimes life-threatening alteration in heart rhythm found on electrocardiogram (prolongation of QT-interval prolongation and torsade de pointes);
low blood pressure;
inflammation of the pancreas (pancreatitis);
discolouration of the tongue and teeth;
allergic skin reactions.
If you get any side effects, contact your doctor or pharmacist. This includes all listed in this leaflet.
5. How to store Azatril
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.
PVC / Alu blister: Do not store above 25 ° C. Store in the original package to protect from moisture.
OPA-PVC-Alu / Alu blister: This medicinal product does not require any special storage conditions.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents Mr. additional information
The active substance is azithromycin dihydrate.
Each tablet Azatril 250 mg contains 250 mg of azithromycin (as dihydrate).
Each film-coated tablet Azatril 500 mg contains 500 mg of azithromycin (as dihydrate).
Other ingredients are:
Core: croscarmellose sodium (E468), magnesium stearate (E572), cellulose, microcrystalline (E460), silicon dioxide (E551), poloxamer, povidone (E1201), talc, and lactose anhydrous.
Shell: hypromellose (E464), hydroxypropyl cellulose, macrogol and titanium dioxide (E171).