250 mg film-coated tablets
1. What Azithromycin Sandoz is and what it is used for
Azithromycin Sandoz is an antibiotic. It belongs to a group of antibiotics called macrolides. It is used to treat infections caused by bacteria.
This medicine is usually prescribed to treat:
- infection of the trachea and lungs such as chronic bronchitis and pneumonia
- infection of the tonsils, pharynx, or sinuses
- ear infections ( acute otitis media )
- infection in the skin and soft tissues, with the exception of infected burns
- chlamydia infections of the urinary tract and cervix.
Azithromycin contained in Azithromycin Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.
2. What you need to know before you take Azithromycin Sandoz
Do not take Azithromycin Sandoz if you are allergic to:
- second antibiotic of macrolide – or ketolide
- any other ingredient of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before taking Azithromycin Sandoz if you have:
- Liver problems: your doctor may need to check your liver function or stop treatment
- Kidney problems: If you have severe kidney problems, your doctor may need to change your dose.
- problems with the nervous system or mental problems
- a special type of muscle weakness called myasthenia gravis
- if you have had an infection caused by bacteria that are resistant to azithromycin, erythromycin, lincomycin, and/or clindamycin or by staphylococci that are resistant to methicillin (risk of cross-resistance ).
Because azithromycin may increase the risk of abnormal heart rhythms, tell your doctor if you have any of the following conditions before taking this medicine:
- Heart problems such as a weak heart ( heart failure ), very slow heart rhythm, irregular heartbeat, or something called “long QT syndrome” (diagnosed with an electrocardiogram ).
- Low levels of potassium or magnesium in the blood.
If you get diarrhea or loose stools during or after treatment, tell your doctor immediately. Do not take medicines for diarrhea without first discussing this with your doctor. If diarrhea persists, tell your doctor.
Tell your doctor
- if you are giving this medicine to an infant (younger than 6 weeks) and the baby vomits or shows irritability during feeding
- if you notice that your symptoms worsen during or shortly after treatment (risk of superinfection or resistance ).
Azithromycin is not suitable for the treatment of severe infections where a high concentration of antibiotics in the blood is required to be achieved quickly.
Other medicines and Azithromycin Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. It is especially important to mention if you are taking any of the following medicines:
- Theophylline (used in the treatment of asthma ): the effect of theophylline may increase.
- Warfarin or any other similar medicine to prevent blood clots: co-administration may increase the risk of bleeding.
- Ergotamine, dihydroergotamine (used to treat migraines ): powdery mildew (itching of the arms and legs, muscle cramps, and cold sores in the hands and feet due to poor circulation) may occur. Concomitant use is therefore not recommended.
- Ciclosporin (used to inhibit the immune system to prevent and treat organ or bone marrow rejection during transplantation): if concomitant use is necessary, your doctor will regularly check your blood counts and may adjust the dose.
- Digoxin (for heart failure ): the concentration of digoxin may increase. Your doctor will check your blood levels.
- Colchicine (used to treat gout and familial Mediterranean fever).
- Antacid a (for indigestion): see section 3.
- Cisapride (against indigestion), terfenadine (used in the treatment of hay fever), pimozide (used for certain psychiatric disorders), citalopram (depression), fluoroquinolone s ( antibiotics such as moxifloxacin and levofloxacin, used for bacterial infections): concomitant use with azithromycin can give heart problems and is therefore not recommended.
- Medications for irregular heartbeats (so-called antiarrhythmics ).
- Zidovudine (used for the treatment of HIV – infection s): concomitant use may increase the risk of side effects is.
- Nelfinavir (used in the treatment of HIV – infection s): concomitant use may increase adverse hire of azithromycin.
- Alfentanil (used in anesthesia) or astemizole (used in the treatment of hay fever): concomitant use with azithromycin may increase the effect of these medicines.
- Rifabutin (for tuberculosis ): Your doctor may want to check your blood and drug levels in your blood.
- Statins (such as atorvastatin, used to lower blood fats): concomitant use can cause muscle disorders.
Azithromycin Sandoz with food and drink
The tablets can be taken with or without food.
Pregnancy and breastfeeding
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. You should not take this medicine during pregnancy and breast-feeding unless your doctor specifically recommends it.
This medicine passes into breast milk. If you are breast-feeding, talk to your doctor before taking this medicine.
Driving and using machines
Azithromycin Sandoz is unlikely to affect your ability to drive or use machines. Impaired vision and blurred vision can affect the patient’s ability to drive and the ability to use machines.
This medication can cause side effects such as dizziness and cramps. This may make you less able to do certain things, such as driving or using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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.
Azithromycin Sandoz contains soy lecithin and sodium
If you are allergic to peanuts or soy, do not use this medicine.
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’.
3. How to take Azithromycin Sandoz
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. The doses below are for adults and children weighing more than 45 kg. Children weighing less than 45 kg should not take these tablets.
The recommended dose is:
Azithromycin Sandoz is taken as a 3‑ or 5 ‑ day regimen:
- 3-day regimen: Take 500 mg (two 250 mg or one 500 mg tablet) once daily.
- 5 ‑ day shift:
- Take 500 mg day 1 (two 250 mg tablets)
- Take 250 mg (one 250 mg tablet) on days 2, 3, 4 and 5
For chlamydia infections of the urinary tract and cervix, dose one is taken as a one-day treatment:
- One-day treatment: 1,000 mg (four 250 mg tablets or two 500 mg tablets). Take the tablets together in one day.
Patients with renal or hepatic impairment
Tell your doctor if you have impaired kidney or liver function, as your doctor may need to change your normal dosage .
Swallow these tablets with water.
- You can take them with or without food.
- Swallow the 250 mg tablet whole.
Taking Azithromycin Sandoz together with medicines for indigestion
- If you need to take medicines for indigestion, such as antacids (antacids), the tablets should be taken at least one hour before or two hours after the antacid.
If you forget to take Azithromycin Sandoz
If you forget to take a dose, take it as soon as possible. Then continue as before. Do not take more than one dose per day.
If you stop taking Azithromycin Sandoz
Always keep taking the tablets until the treatment is complete, even if you feel better. If you stop taking the tablets too soon, the infection may return. The bacteria can also become resistant to the medicine, which makes them more difficult to treat.
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.
Serious side effects:
If you get any of the following symptoms of a severe allergic reaction, stop treatment, and contact your doctor immediately or visit the emergency department at the nearest hospital:
- sudden difficulty breathing, talking, and swallowing
- swelling of the lips, tongue, face, and neck
- extreme dizziness or collapse
- severe or itchy rash, especially if blisters appear and it hurts in the eyes, mouth, or genitals.
If you experience any of the following side effects, contact your doctor as soon as possible :
- diarrhea that is severe, lasts for a long time, or contains blood, with stomach pain or fever. This may be a sign of serious intestinal inflammation. This is something that in rare cases can occur after taking antibiotics
- yellowing of the skin or whites of the eyes caused by liver problems
- inflammation of the pancreas, which causes severe pain in the abdomen and back
- increased or decreased urinary excretion, or traces of blood in the urine caused by kidney problems
- skin rash caused by sensitivity to sunlight
- easy to get bruises and bleeding
- irregular or fast pulse.
These are all serious side effects. You may need urgent medical attention. Serious side effects are uncommon (may affect up to 1 in 100 people), rare (may affect up to 1 in 1,000 people) or occur in an unknown number of users.
Other possible side effects are
Very common (may affect more than 1 user in 10):
Common (may affect up to 1 in 10 people):
- vomiting, bloating, abdominal cramps, nausea
- the low number of lymphocytes (a type of white blood cell ), the high number of eosinophils (a type of white blood cell ), low bicarbonate value in the blood, the high number of basophils, monocytes, and neutrophils (different types of white blood cells ).
Uncommon (may affect up to 1 in 100 people):
- fungal and bacterial infections especially in the oral cavity, pharynx, nose, lungs, intestines, and vagina
- the low number of leukocytes (a kind of white blood cell ), low number of neutrophils(a kind of white blood cells ), the high number of eosinophils (a kind of white blood cells )
- swelling, allergic reactions of varying severity
- loss of appetite
- nervousness, difficulty sleeping
- dizziness, drowsiness, taste disturbances, tingling or numbness in the hands or feet
- visual disturbances
- hearing loss, tingling sensation
- fast pulse
- skin rash, sweating (hot flashes)
- difficulty breathing, nosebleeds
- constipation, flatulence, indigestion, inflammation of the stomach, difficulty swallowing, bloating, dry mouth, belching, cold sores, increased salivation
- itchy skin rash, dermatitis, dry skin, sweating
- joint inflammation, pain in muscles, back and neck
- painful and troublesome urination, kidney pain
- uterine bleeding, disturbance of testicular function
- swollen skin, weakness, general malaise, fatigue, swelling of the face, chest pain, fever, ache
- abnormal results in laboratory tests (eg blood, liver, and kidney function tests)
- discomfort after treatment.
Rare (may affect up to 1 in 1,000 people):
- excitement, feeling of identitylessness
- hepatic impairment
- sensitivity to sunlight
- skin rash characterized by the rapid appearance of areas of red skin with scattered small pustules (small blisters filled with white / yellow fluid)
- a delayed allergic reaction (up to several weeks after treatment) with skin rash and other possible symptoms such as swelling of the face, swollen glands, and abnormal test results (eg in liver function tests and elevated levels of certain types of white blood cells ) (drug reaction with eosinophilia and systemic symptoms (DRESS)).
Has been reported (occurs in an unknown number of users):
- decreased platelet count, which increases the risk of bleeding and bruising
- decreased number of red blood cells, which can make the skin pale yellow and cause weakness and shortness of breath
- aggression, anxiety, severe confusion, hallucinations
- seizures, fainting, decreased sensation in the skin, hyperactivity, altered sense of smell, loss of sense of smell or taste, muscle weakness ( myasthenia gravis )
- hearing loss, deafness, or tinnitus
- aberrant ECG ( electrocardiogram )
- low blood pressure
- discolored tongue
- joint pain
- vision problems (blurred vision).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Azithromycin Sandoz
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 after EXP. The expiration date is
the last day of the specified month.
No special storage instructions.
Do not store above 30 ° C.
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
- The active substance is azithromycin.
- Other ingredients are Tablet core: microcrystalline cellulose, pregelatinized maize starch, sodium starch glycolate (type A), anhydrous colloidal silica, sodium lauryl sulfate, and magnesium stearate. Film coating: polyvinyl alcohol, titanium dioxide (E171), talc, soy lecithin, and xanthan gum.
What the medicine looks like and the contents of the pack
Azithromycin Sandoz 250 mg film-coated tablets are white or almost white, oblong, film-coated, and smooth on both sides.
The 250 mg tablet is available in the following pack sizes:
Outer carton with blister containing: 4, 6, 12, 24, 50, or 100 film-coated tablets.
HDPE jars: 30 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Sandoz SRL, Livezeni Street 7A, Targu Mures, Romania