MACROZIT 500 mg Film-Coated Tablets

Зміст інструкції

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

MACROZIT

“500 mg film-coated tablets”
Azithromycin dihydrate
Generic medicine
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 their symptoms are the same as yours, as it could 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 MACROZIT is and what it is used for
• 2. What you need to know before you take MACROZIT
• 3. How to take MACROZIT
• 4. Possible side effects
• 5. How to store MACROZIT
• 6. Contents of the pack and other information

1. What MACROZIT is and what it is used for

MACROZIT contains azithromycin, an antibiotic used to
treat infections caused by bacteria sensitive to it.

• infections of the sinuses (sinusitis),
• ear infections (otitis media),
• infections of the tonsils (tonsillitis) and throat (pharyngitis),
• infections of the lower respiratory tract (including bronchitis and pneumonia),
• infections of the mouth and teeth (odontostomatological),
• skin and soft tissue infections, sexually transmitted (urethritis due to Chlamydia trachomatisand soft chancre due to Haemophilusducreyi).

2. What you need to know before taking MACROZIT

Do not take MACROZIT
If you are allergic to azithromycin, erythromycin, similar antibiotics (macrolides or ketolides), or to
any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking MACROZIT:

• 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 MACROZIT”). Caution is necessary before starting treatment with MACROZIT in these cases;
• if you are being treated with ergotamine or its derivatives (see section “Other medicines and MACROZIT);
• if you suffer from kidney problems (severe renal insufficiency);
• if you suffer from heart rhythm disorders. MACROZIT can also cause mild heart rhythm changes, but in some cases also fatal ones (see section 4 “Possible side effects”).

Therefore, this medicine must be used with caution:

• in patients with congenital heart rhythm abnormalities, 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 the 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);
• in patients with low levels of potassium and magnesium in the blood;
• In the elderly and in women. Tell your doctor if any of the following conditions occur or worsen during treatment with MACROZIT (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 MACROZIT 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 taking MACROZIT immediately and see your doctor who will perform medical examinations to assess liver function;
• vomiting or irritability in your baby (if you are a newborn in the first 42 days of life) that occurs after feeding. This medicine can cause narrowing of a part of the stomach. If these symptoms occur, see your baby's doctor immediately;
• 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 MACROZIT (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 MACROZIT, 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. the symptoms of myasthenia gravis.

Other medicines and MACROZIT
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
In particular, tell your doctor if you are taking:

• Cimetidine and antacids (medicines used to treat stomach disorders). If you are being treated with both antacids and MACROZIT, you should not take these two medicines at the same time.
• Cetirizine and terfenadine (antihistamines, used to treat allergies).
• Didanosine, Zidovudine, Efavirenz, Indinavir, Nelfinavir (used in HIV therapy).
• Rifabutin (an antibiotic used to treat tuberculosis).
• Digoxin (used to treat heart problems). If taken concurrently with MACROZIT, the dose of digoxin must be carefully monitored.
• Ergotamine (used to treat headaches). Concurrent use with MACROZIT is not recommended because circulatory disorders, especially in the fingers of the hands and feet (ergotism crises), may occur;
• Statins (used to lower cholesterol levels in the blood). Concurrent use with MACROZIT is not recommended as it can cause muscle cell breakdown (rhabdomyolysis).
• Carbamazepine (used in the treatment of epilepsy).
• Oral coumarin anticoagulants (e.g. warfarin). Concurrent use with MACROZIT may increase the anticoagulant effect of these medicines. Cyclosporine (used to regulate the function of the immune system in case of transplants). If taken concurrently with MACROZIT, the dose of cyclosporine must be carefully monitored.
• Methylprednisolone (used to regulate the function of the immune system).
• Fluconazole (used in the treatment of fungal infections).
• Midazolam and Triazolam (sedatives).
• Hydroxychloroquine (used to treat some diseases such as rheumatoid arthritis and malaria).
• Sildenafil (used to treat impotence).
• Theophylline (used in the treatment of asthma).
• Trimethoprim/sulfamethoxazole (a combination of antibiotics).
• Colchicine (used for gout and familial Mediterranean fever).

MACROZIT with food and drink
MACROZIT can be taken with or without food. It is preferable to
take this medicine with a full stomach.

Fertility, pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Fertility
In fertility studies conducted in rats, a reduced number of pregnancies was observed
after the administration of azithromycin. The relevance of these findings to humans is unknown
Pregnancy
The doctor will decide whether you can take this medicine during pregnancy, after ensuring
that the benefits outweigh the potential risks.
Breastfeeding
MACROZIT passes into breast milk. Therefore, if you are breastfeeding, your doctor will prescribe
MACROZIT only if strictly necessary.

Driving and operating machinery
There are no data to demonstrate that azithromycin can affect the ability of patients to
drive vehicles or operate machinery.

MACROZIT contains lactose
This medicine contains lactose (milk sugar). If your doctor has diagnosed you with a
lactose intolerance, contact him before taking this medicine.

MACROZIT contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
“sodium-free”.

3. How to take MACROZIT

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

• oral and dental infections (odontostomatological),
• skin and soft tissue infections,
• sexually transmitted infections (urethritis caused by Chlamydia trachomatisand soft chancre caused by Haemophilus ducreyi).AdultsFor the treatment of sinus infections (sinusitis), ear infections (otitis media), tonsil infections (tonsillitis), throat infections (pharyngitis), lower respiratory tract infections (bronchitis and pneumonia), and skin and soft tissue infections: 500 mg per day in a single dose, for three consecutive days. For the treatment of sexually transmitted infections (urethritis caused by Chlamydia trachomatisand soft chancre caused by Haemophilus ducreyi): 1000 mg, taken as a single dose, in a single oral administration.

Children
For children weighing 45 kg or more, the same dosage as adults can be used
(500 mg/day for three consecutive days).
The total maximum recommended dose for any pediatric therapy is 1500 mg.
The medicine must always be administered in a single daily dose.

Special patients
If you are elderly, have mild or moderate liver problems or have kidney problems, your doctor may
prescribe the same dosages as above.
MACROZIT can be taken regardless of whether the stomach is empty or after meals. Taking
food before administering the product may reduce any undesirable gastrointestinal effects.
The tablets must be swallowed whole.

If you take more MACROZIT than you should
In case of accidental ingestion/administration of an excessive dose of MACROZIT, immediately
inform your doctor or go to the nearest hospital.
If you have any doubts about the use of MACROZIT, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, MACROZIT can cause side effects, although not everybody gets them.
The following side effects have been observed after taking MACROZIT.

STOPusing MACROZIT immediately if you experience the following side effects:

• severe allergic reaction (anaphylactic shock)
• swelling of the face, tongue and throat with resulting inability to swallow and breathe (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 skin reaction 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 skin 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), because it can sometimes cause death
• sudden and massive death of liver cells (fulminant hepatitis)
• toxic reaction of the liver 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):

• Diarrhea

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

• Headache
• Vomiting
• Abdominal pain
• Nausea
• 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
• Decrease in the amount of bicarbonate in the blood.

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

• Infections of the vagina and/or mouth by Candida(a fungus)
• Vaginal infection
• Pneumonia
• Infection by microorganisms called “fungi”
• Infection by microorganisms called “bacteria”
• Pharyngitis
• Gastroenteritis
• Respiratory disorders
• Rhinitis
• Oral candidiasis (oral thrush)
• Reduction in the number of white blood cells in the blood (leukopenia)
• Reduction in the number of a type of white blood cells called neutrophils (neutropenia)
• Reduction in the number of a type of white blood cells called eosinophils (eosinophilia)
• Swelling of the face, lips, mouth, tongue or throat that may cause difficulty in swallowing (angioedema)
• Allergy (hypersensitivity)
• Decreased or absent appetite
• Nervousness
• Insomnia
• Dizziness
• Drowsiness
• Distortion or decrease in the ability to taste flavors
• Changes in sensitivity in different parts of the body
• Visual disturbances
• Ear disorders
• Vertigo
• Increased awareness of heartbeat
• Hot flashes
• Difficulty breathing (dyspnea)
• Nosebleeds (epistaxis)
• Constipation
• Production of gas in the intestines
• 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
• Abnormal, heavy and prolonged vaginal bleeding
• Testicular disorders
• Fluid retention (edema)
• 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
• 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,
• Impaired liver function,
• Yellowing of the skin and mucous membranes (jaundice),
• Increased sensitivity of the skin to sunlight (photosensitivity),
• Severe allergic reaction (DRESS),
• Acute generalized pustular exanthematous rash (AGEP)

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

• Severe diarrhea caused by antibiotics (pseudomembranous colitis)
• Decreased number of platelets in the blood
• Destruction of red blood cells (hemolytic anemia)
• Severe allergic reaction (anaphylactic reaction)
• Aggressiveness
• Anxiety
• Delirium,
• Hallucinations
• Loss of consciousness (syncope)
• Convulsions
• Decreased sensitivity of any area of the body to a stimulus
• Excessive motor activity and agitation (psychomotor agitation)
• Loss of the ability to smell
• Total loss of the ability to taste flavors
• Alteration of smell (parosmia),
• Severe muscle weakness (myasthenia gravis)
• Hearing disorders including deafness
• Tinnitus (ringing in the ears)
• Increased heart rate caused by a particular abnormality in the heart rhythm (arrhythmia) called “torsades de pointes”
• Heart rhythm disturbances called arrhythmias (e.g., ventricular tachycardia, prolonged QT interval) that can be detected by an examination called “electrocardiogram”
• Decreased blood pressure (hypotension)
• Inflammation of the pancreas (pancreatitis)
• Alteration of the color of the tongue
• Severe allergic reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme,)
• Severe kidney problems
• Acute renal failure
• Interstitial nephritis
• Liver failure (rarely fatal)
• Severe liver disorder (fulminant hepatitis)
• Death of liver cells (hepatic necrosis)
• Joint pain (arthralgia)

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 https://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 MACROZIT

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 pack after the wording
EXP. and on the blister.
The expiry date refers to the last day of that month.
Do not use this medicine if you notice signs of deterioration.
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. Contents of the pack and other information

What MACROZIT contains
The active ingredient is azithromycin dihydrate mg 524.1 equivalent to azithromycin mg 500.
The other ingredients are:

Tablet core: anhydrous calcium hydrogen phosphate, pregelatinized starch, sodium
lauryl sulfate, croscarmellose sodium, sodium carboxymethylcellulose, magnesium stearate.

Coating: hypromellose (E464), titanium dioxide (E171), triacetin (E1518), lactose monohydrate.

Description of the appearance of MACROZIT and contents of the pack
Film-coated tablets.
Blister containing 3 film-coated tablets of 500 mg.

MARKETING AUTHORISATION HOLDER
S.F. GROUP S.r.l. Via Tiburtina, n. 1143 - 00156 Rome

MANUFACTURER
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, n° 1 -03012 Anagni (FR)
Lachifarma S.r.l. Laboratorio Chimico Farmaceutico Salentino
S.S. Industrial Area - 73010 – Zollino (Lecce)