AZITROMICINA 500 mg Film-Coated Tablets

Зміст інструкції

1. AZITROMICINA ABC 500 mg film-coated tablets
   1. What is AZITROMICINA ABC and what is it used for
   2. What you need to know before taking AZITROMICINA ABC
   3. How to take AZITROMICINA ABC
   4. Possible side effects
   5. How to store AZITROMICINA ABC
   6. Package contents and other information

AZITROMICINA ABC 500 mg film-coated tablets

Equivalent Medicinal Product

Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What AZITROMICINA ABC is and what it is used for
• 2. What you need to know before you take AZITROMICINA ABC
• 3. How to take AZITROMICINA ABC
• 4. Possible side effects
• 5. How to store AZITROMICINA ABC
• 6. Contents of the pack and other information

1. What is AZITROMICINA ABC and what is it used for

AZITROMICINA ABC contains the active ingredient azithromycin, an azalide antibiotic that belongs to the
group of antibiotics called “macrolides”. Azithromycin blocks the growth of bacteria that are susceptible to it.
AZITROMICINA ABC is indicated in adultsand in children(weighing 45 kg or more) for the
treatment of the following infections (caused by germs sensitive to azithromycin):

• Upper respiratory tract infections, including inflammation of the sinuses (sinusitis), inflammation of the tonsils (tonsillitis) and inflammation of the throat (pharyngitis),
• Lower respiratory tract infections, including bronchitis and pneumonia,
• Ear infections (acute otitis media),
• I nfections of the mouth and esophagus (odontostomatological infections),
• I nfections of the skin and soft tissues,
• I nfections of the genital tract caused by Chlamydia trachomatisand by Haemophilus ducreyi(sexually transmitted infections).

2. What you need to know before taking AZITROMICINA ABC

Do not take AZITROMICINA ABC

• if you are allergic to azithromycin, erythromycin, other antibiotics called “macrolides” or to any of the other ingredients of this medicine (listed in section 6).
• if you have severe liver problems (severe hepatic insufficiency).

Warnings and precautions
Talk to your doctor or pharmacist before taking AZITROMICINA ABC.

• if you have or have ever had liver problems or if you are taking or have recently taken other medicines that can cause liver problems (see section “Other medicines and AZITROMICINA ABC”). Caution is necessary before starting treatment with AZITROMICINA ABC in these cases;
• if you have a sexually transmitted infection caused by the bacterium Treponema pallidum(e.g. syphilis);
• if you are being treated with ergotamine or its derivatives (see section “Other medicines and AZITROMICINA ABC”);
• if you have severe kidney problems (severe renal insufficiency);
• if you suffer from heart rhythm disorders. Even AZITROMICINA ABC can cause mild, but in some cases also fatal, alterations in heart rhythm (see section 4 “Possible side effects”). Therefore, this medicine must be used with caution:
• in patients with congenital heart rhythm alterations, with a very slow heart rate (bradycardia), with heart rhythm diseases (arrhythmias) or with severe heart problems (severe heart failure);
• in patients being treated with other medicines that can affect heart rhythm, such as quinidine, procainamide, dofetilide, amiodarone, sotalol (medicines for heart rhythm anomalies), cisapride (medicine for gastroesophageal reflux), terfenadine (medicine for allergies), pimozide (medicine for mental disorders), citalopram (medicine for depression), moxifloxacin, levofloxacin, chloroquine (antibiotics);
• if you have low levels of potassium and magnesium in your blood;
• in the elderly and in women.

Tell your doctor if any of the following conditions occur or worsen during treatment
with AZITROMICINA ABC (see also section 4 “Possible side effects”):

• severe allergic reactions including severe skin reactions that can also affect other organs and cause fever. If an allergic reaction occurs, stop taking AZITROMICINA ABC immediately and see your doctor;
• symptoms of liver problems such as sudden onset of weakness, yellowing of the skin or mucous membranes, dark urine, easy bleeding, brain symptoms (e.g. confusion, altered level of consciousness or coma). Stop immediatelytaking AZITROMICINA ABC and see your doctor who will perform medical examinations to assess liver condition;
• symptoms of new infections or persistence of the symptoms of the current infection. This situation may be caused by bacteria that are not sensitive to AZITROMICINA ABC (resistant bacteria) or by microorganisms other than bacteria (fungal infection);
• onset of diarrhea, which may be mild, but in some cases can be fatal (fatal colitis). Diarrhea can occur with the use of almost all antibiotics, including AZITROMICINA ABC, and is due to the alteration of the normal bacterial flora of the intestine which allows the excessive growth of a bacterium called Clostridium difficile. If you experience diarrhea, your doctor will subject you to careful monitoring because Clostridium difficileinfection can occur even two months after the end of treatment with this medicine;
• onset or worsening of muscle weakness and easy fatigue, i.e. symptoms of myasthenia gravis.

Children
The safety and efficacy of this medicine for the prevention and treatment of infections caused by the
bacterium Mycobacterium avium complexin children have not been demonstrated.

Other medicines and AZITROMICINA ABC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Tell your doctor if you are taking any of the following medicines because caution is necessary:

• antacids (medicines for stomach acidity). If you are being treated with both antacids and AZITROMICINA ABC, you should not take these two medicines at the same time;
• digoxin (used for the treatment of heart failure). In case of concomitant use with AZITROMICINA ABC, the dose of digoxin must be carefully monitored;
• colchicine (used for gout and familial Mediterranean fever);
• zidovudine (medicine for HIV infections);
• ergotamine (medicine for migraine). Concomitant use with AZITROMICINA ABC is not recommended because circulatory disturbances may occur, especially in the fingers of the hands and feet (ergotism crises);
• statins (medicines to lower blood lipid levels). Concomitant use with AZITROMICINA ABC may cause muscle cell rupture (rhabdomyolysis);
• cyclosporine (medicine against organ rejection in case of organ transplantation). In case of concomitant use with AZITROMICINA ABC, the dose of cyclosporine must be carefully monitored;
• nelfinavir, a medicine used to treat AIDS;
• oral coumarin anticoagulants (e.g. warfarin). Concomitant use with AZITROMICINA ABC may cause an increase in the anticoagulant effect of these medicines; see your doctor because specific monitoring (prothrombin time) is necessary;

AZITROMICINA ABC should not be taken in conjunction with other medicines that can affect
heart rhythm (see section “Warnings and precautions”).

AZITROMICINA ABC with food and drink
AZITROMICINA ABC can be taken with or without food. It is preferable to take
this medicine with food.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
There is insufficient information on the safety of AZITROMICINA ABC taken during
pregnancy. Therefore, if you are pregnant, your doctor will prescribe this medicine only if strictly
necessary.

Breastfeeding
AZITROMICINA ABC passes into breast milk. Therefore, if you are breastfeeding, your doctor will prescribe
this medicine only if strictly necessary.

Driving and operating machinery
It is not known whether this medicine affects the ability to drive or operate machinery.

AZITROMICINA ABC contains lactose and sodium
This medicine contains lactose. If you have been diagnosed with intolerance to some sugars, contact
your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially sodium-free.

3. How to take AZITROMICINA ABC

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.

Adults and children weighing 45 kg or more

• For the treatment of upper and lower respiratory tract infections (sinusitis, tonsillitis, pharyngitis, bronchitis and pneumonia), skin and soft tissue infections and odontostomatological infections: the recommended dose is 1 tablet (500 mg) per day, in a single administration, for 3 consecutive days.
• For the treatment of sexually transmitted infections caused by susceptible strains of Chlamydia trachomatisor Haemophilus ducreyi: the recommended dose is 2 tablets (1000 mg), taken as a single dose, in a single oral administration.

Special patients
If you are elderly, have mild or moderate liver problems or have mild or moderate kidney problems, your doctor
may prescribe you the same dosages as above.

Use in children
This medicine should not be given to children weighing less than 45 kg.
The maximum total dose recommended for any pediatric therapy is 1500 mg.

How to take this medicine
Swallow the tablets whole. Take the tablets with a glass of water in a single daily dose.
The tablets can be taken regardless of whether the stomach is empty or after meals. Food intake
before taking the tablet may reduce any undesirable effects on the stomach and
intestine caused by this medicine (See section “Possible side effects”).

If you take more AZITROMICINA ABC than you should
In case of accidental ingestion/ intake of an excessive dose of this medicine, consult
your doctor immediately or go to the nearest hospital.

If you forget to take AZITROMICINA ABC
If you forget a dose, take it as soon as you remember. Do not take a double dose to make up for the
forgotten tablet.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported after taking AZITROMICINA ABC.

• STOPusing AZITROMICINA ABC immediately if you experience the following side effects: severe allergic reaction (anaphylactic shock)
• swelling of the face, tongue and throat leading to difficulty swallowing and breathing (angioedema), increased sensitivity of the skin and mucous membranes
• severe inflammation of the last part of the intestine called the colon, caused by the excessive growth of a bacterium called Clostridium difficile(pseudomembranous colitis)
• severe skin reactions:
• severe rash associated with an increase in the number of a type of white blood cells, called eosinophils, symptoms that can affect one or more organs and fever (DRESS) (rare frequency)
• red and scaly rash with the formation of pustules and blisters (pustular exanthematous rash) (rare frequency)
• severe acute hypersensitivity reactions involving the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) (frequency not known)
• severe liver problems (severe hepatic failure), as it can sometimes lead to death
• sudden and massive death of liver cells (fulminant hepatitis)
• toxic liver reaction with cell death
• anemia due to destruction of red blood cells
• sudden loss of consciousness (syncope)
• inflammation of the pancreas (pancreatitis)

Contact your doctor if you experience any of the following side effects:

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

• diarrhoea.

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

• headache
• vomiting
• abdominal pain
• nausea
• decrease in the amount of bicarbonate in the blood
• decrease in the number of a type of white blood cells called lymphocytes
• increase in the number of a type of white blood cells called eosinophils
• increase in the number of a type of white blood cells called basophils
• increase in the number of a type of white blood cells called monocytes
• increase in the number of a type of white blood cells called neutrophils

Uncommon(may affect up to 1 in 100 people):

• vaginal and/or oral infection by Candida(a fungus)
• infection by microorganisms called “fungi”
• infection by microorganisms called “bacteria” respiratory disorders
• pneumonia
• pharyngitis
• gastroenteritis
• rhinitis
• decrease in the number of white blood cells in the blood (leukopenia)
• decrease in the number of a type of white blood cells called neutrophils (neutropenia)
• increase in the number of a type of white blood cells called eosinophils (eosinophilia)
• loss of appetite or decreased appetite
• nervousness
• insomnia
• dizziness
• drowsiness
• changes in sensitivity in different parts of the body
• distortion or decreased ability to taste flavors
• vision disorders
• ear disorders
• vertigo
• increased awareness of heartbeat (palpitations)
• hot flashes
• difficulty breathing (dyspnea)
• nosebleeds (epistaxis)
• constipation
• production of gas in the intestine
• stomach discomfort
• gastritis
• difficulty or pain swallowing
• abdominal bloating
• dry mouth
• belching
• mouth ulcers
• increased saliva production
• skin rashes
• itching
• urticaria
• dermatitis
• dry skin
• excessive sweating
• arthrosis
• muscle pain
• back pain
• neck pain
• pain when urinating
• kidney pain
• atypical, heavy and prolonged vaginal bleeding
• testicular disorders
• swelling
• weakness
• discomfort
• fatigue
• facial swelling
• chest pain
• fever
• pain
• swelling of the legs and feet
• changes in laboratory tests to assess liver function
• increased amount of bilirubin in the blood (a substance produced by the liver)
• increased amount of urea in the blood (a substance produced by the liver)
• increased amount of creatinine in the blood (a substance produced by the muscles)
• changes in the amount of potassium and sodium in the blood (mineral salts)
• increased amount of alkaline phosphatase in the blood (substance produced in various tissues of the body)
• increased amount of chloride in the blood (mineral salt)
• increased amount of glucose (a sugar) in the blood
• increased number of platelets in the blood
• decreased number of red blood cells in the blood
• increased amount of bicarbonate in the blood
• complications after medical or surgical procedures.

Rare(may affect up to 1 in 1,000 people):

• agitation
• altered liver function
• yellowing of the skin and mucous membranes (jaundice)
• increased sensitivity of the skin to sunlight (photosensitivity)

Frequency not known(the frequency cannot be estimated from the available data):

• decreased number of platelets in the blood
• convulsions
• decreased sensitivity of any area of the body to a stimulus
• aggression
• anxiety
• delirium
• hallucinations
• excessive motor activity and agitation (psychomotor agitation)
• total or partial loss of the ability to smell odors
• total loss of the ability to taste flavors
• severe muscle weakness (myasthenia gravis)
• hearing disorders
• deafness
• ringing in the ears
• increased heart rate, caused by a particular abnormality of the heart rhythm (arrhythmia) called “torsades de pointes”
• disorders of the normal heart rhythm called arrhythmias (e.g., ventricular tachycardia, prolonged QT interval) which can be ascertained by an examination called “electrocardiogram”
• decreased blood pressure (hypotension)
• altered color of the tongue
• joint pain
• severe kidney problems (acute renal failure, interstitial nephritis).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-
avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store AZITROMICINA ABC

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 packaging after “Exp.”. The expiry date refers to the last day of that month.
Store at a temperature below 30 °C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What AZITROMICINA ABC contains

• The active ingredient is azithromycin dihydrate. Each tablet contains 524.1 mg of azithromycin dihydrate corresponding to 500 mg of azithromycin.
• The other ingredients are anhydrous calcium hydrogen phosphate, pregelatinized starch, sodium lauryl sulfate, sodium croscarmellose, sodium carboxymethylcellulose, anhydrous colloidal silica, magnesium stearate. Tablet coating: hypromellose, titanium dioxide, triacetin, lactose monohydrate.

Description of the appearance of AZITROMICINA ABC and package contents
Pack containing 3 film-coated tablets of 500 mg in blisters.

Marketing authorization holder and manufacturer
Marketing authorization holder
Ipso Pharma S.r.l. - Via San Rocco, 6 - 85033 Episcopia (PZ)

Manufacturer
Doppel Farmaceutici S.r.l. - Via Volturno, 48 - 20089 Quinto De’ Stampi - Rozzano (Milano)