REZAN 500 mg Film-Coated Tablets

Зміст інструкції

1. REZAN “500 mg film-coated tablets”
   1. What is REZAN and what is it used for
   2. What you need to know before taking REZAN
   3. How to take REZAN
   4. Possible side effects
   5. How to store REZAN
   6. Contents of the pack and other information

REZAN “500 mg film-coated tablets”

Azitromicina
Generic medicine

Read this leaflet carefully before taking this medicine because 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 REZAN is and what it is used for
• 2. What you need to know before you take REZAN
• 3. How to take REZAN
• 4. Possible side effects
• 5. How to store REZAN
• 6. Contents of the pack and other information

1. What is REZAN and what is it used for

REZAN contains the active substance azithromycin, which belongs to the group of antibiotics called
“macrolides”. Azithromycin blocks the growth of bacteria that are sensitive to it.
REZAN is used for the treatment of infections caused by germs sensitive to azithromycin.
These infections include:
upper respiratory tract infections including sinusitis (infections of the nasal cavities), tonsillitis and
pharyngitis (inflammation of the tonsils and throat);
lower respiratory tract infections including bronchitis and pneumonia;
ear infections (acute otitis media);
odontostomatological infections (of the mouth and esophagus);
skin and soft tissue infections;
nongonococcal urethritis (sexually transmitted infections, excluding gonorrhea) (caused by
Chlamydia trachomatis);
soft chancre (caused by Haemophilus ducreyi) (sexually transmitted infection).
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking REZAN

Do not take REZAN

• if you are allergic to azithromycin, erythromycin, any macrolide or ketolide antibiotics, or any of the other ingredients of this medicine (listed in section 6).

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

• if you have severe kidney problems (severe renal insufficiency);
• if you have liver problems or are taking or have recently taken other medicines that can cause liver problems (see section “Other medicines and Zitromax”): in these cases, caution should be exercised during treatment with Rezan;
• if you are being treated with ergotamine or its derivatives as it should not be administered at the same time as REZAN (see section “Other medicines and REZAN”);
• if you suffer from heart rhythm disorders. Rezan can also cause mild, but in some cases even fatal, changes in heart rhythm (see section 4 “Possible side effects”). Therefore, this medicine should 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 heart rhythm, such as quinidine, procainamide, dofetilide, amiodarone, sotalol (medicines for heart rhythm abnormalities), cisapride (medicine for reflux of stomach contents into the esophagus), 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 duringtreatment with Zitromax (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 Zitromax immediatelyand see your doctor;
• symptoms of liver problems such as sudden onset of weakness, yellowing of the skin or whites of the eyes, dark urine, easy bruising, brain symptoms (e.g. confusion, altered level of consciousness or coma). Stop taking Zitromax immediatelyand see your doctor who will perform medical tests to assess liver function;
• 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 Zitromax (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 Zitromax, 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 monitor you closely because Clostridium difficile infection can occur even two months after the end of treatment with this medicine;
• the onset or worsening of muscle weakness and easy fatigue, i.e. the symptoms of myasthenia gravis.

Children and adolescents
Rezan can be used in children weighing 45 kg or more and in adolescents.

Other medicines and REZAN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is important to tell your doctor or pharmacist if you are taking:

• antiarrhythmics (to treat heart problems such as quinidine, procainamide, dofetilide, amiodarone and sotalol); cisapride (used in some stomach diseases); terfenadine (an

antihistamine); antipsychotics (pimozide); antidepressants (citalopram); fluoroquinolones (antibiotics like moxifloxacin and levofloxacin), chloroquine, as they can cause prolonged QT syndrome – see section “Warnings and precautions”.

• Antacids(medicines for stomach acidity). If you are taking azithromycin and antacids, do not take the two medicines at the same time.
• Digoxin (medicine for heart problems).Digoxin levels may increase. Your doctor will check your blood levels.
• Colchicine(used for gout and familial Mediterranean fever).
• Ergotamine (medicine used for migraine).The concomitant use of azithromycin and ergotamine derivatives is not recommended as serious side effects with circulatory disturbances, especially in the fingers and hands and feet (ergotism crisis) may develop.
• Zidovudine (medicine for HIV).Zidovudine levels may increase following the simultaneous administration of azithromycin and zidovudine.
• Statins (medicines to lower blood fat levels).The simultaneous administration with azithromycin may cause muscle cell rupture (rhabdomyolysis).
• Carbamazepine (an antiepileptic medicine).
• Cyclosporine (medicine against organ rejection).If taken together, the dose of cyclosporine must be carefully monitored.
• Methylprednisolone (an anti-inflammatory).
• Midazolam, triazolam (psychotropic drugs).
• Nelfinavir, efavirenz, indinavir, didanosine (other medicines used for HIV infections).
• Rifabutin (used for the treatment of tuberculosis)
• Oral anticoagulants such as warfarin or similar medicines.If administered simultaneously with azithromycin, an increase in the anticoagulant effect of these medicines may occur.
• Theophylline (a medicine used for breathing problems).
• Trimethoprim/Sulfamethoxazole (medicine for treating infections).

Rezan should not be taken together with other medicines that can affect heart rhythm (see section “Warnings and precautions”).

Rezan with food and drink
Rezan 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 not enough information on the safety of Rezan taken during pregnancy.
Azithromycin should only be used during pregnancy if considered absolutely necessary by your doctor.
Breastfeeding
Azithromycin can pass into breast milk. Azithromycin should only be used during breastfeeding if considered absolutely necessary by your doctor.

Driving and using machines
It is not known whether azithromycin affects the ability to drive or operate machinery.

REZAN contains lactose.If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this medicine.

REZAN contains sodium.This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take REZAN

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

Adults

For the treatment of upper and lower respiratory tract infections, skin and soft tissue infections, and

dentomaxillary infections:
The recommended dose is 500 mg per day in a single administration, for three consecutive days.

For the treatment of sexually transmitted diseases, caused by strains sensitive to Chlamydia

trachomatis or Haemophilus ducreyi:
The recommended dose is 1000 mg, taken once, in a single oral administration.

Elderly
If you are an elderly patient you can use the same dosage as adults.

Patients with kidney and liver problems:
Tell your doctor if you suffer from kidney and liver problems.
In case of mild to moderate kidney and liver problems, the same dosage as
adults can be used; in case of severe kidney problems, your doctor may need to modify the dose
usual.

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 dose recommended for any pediatric therapy is 1500 mg.
The medicine must always be administered in a single daily dose.
REZAN can be taken indifferently on an empty stomach or after meals. Food intake
before administering the medicine can alleviate any undesirable effects of a
gastrointestinal type caused by azithromycin.
The tablets must be swallowed whole with a glass of water.

If you take more REZAN than you should
If you take more REZAN than you should, talk to your doctor or go to the nearest hospital.
The side effects that occurred with doses higher than those recommended were similar to those
registered with normal doses.

If you forget to take REZAN
Do not take a double dose to make up for the missed dose.

If you stop taking REZAN
Do not stop taking the medicine without first consulting your doctor, it is important that
you continue to take REZAN for the entire period established by your doctor.
If you have any doubts about 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 everyone will experience them.
The following side effects have occurred after taking Rezan.
STOP using Zitromax immediately if you/the child experiences the following side effects:

• severe allergic reaction (anaphylactic shock)
• swelling of the face, tongue and throat resulting in 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 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/the child experiences any of the following side effects:

Very common (affects more than 1 in 10 people):

• diarrhea

Common (affects 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 (affects up to 1 in 100 people):

• infection due to Candida
• Vaginal infections
• infection by microorganisms called “fungi”
• infection by microorganisms called “bacteria”
• respiratory disorders
• pneumonia
• pharyngitis
• gastroenteritis
• oral cavity infections due to candida (oral thrush)
• 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 a type of white blood cells called eosinophils (eosinophilia)
• anorexia
• nervousness
• insomnia
• dizziness
• drowsiness
• changes in sensitivity in different parts of the body
• distortion or decrease in the ability to taste flavors
• vision disorders
• ear disorders
• vertigo
• increased perception of heartbeat
• hot flashes
• difficulty breathing (dyspnea)
• nosebleeds (epistaxis)
• constipation
• production of gas in the intestine (flatulence)
• stomach discomfort (dyspepsia)
• gastritis
• difficulty or pain swallowing (dysphagia)
• abdominal bloating (abdominal distension)
• 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 (peripheral edema)
• alteration of laboratory tests to evaluate liver function (AST and ALT)
• increase in the amount of bilirubin in the blood (a substance produced by the liver)
• increase in the amount of urea in the blood (a substance produced by the liver)
• increase in the 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)
• increase in the amount of alkaline phosphatase in the blood (substance produced in various tissues of the body)
• increase in the amount of chloride in the blood (mineral salt)
• increase in the amount of glucose (a sugar) in the blood
• increase in the number of platelets in the blood
• decrease in the number of red blood cells in the blood
• increase in the amount of bicarbonate in the blood
• complications after medical or surgical procedures

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

• feeling of agitation
• yellowing of the skin and eyes (jaundice) and abnormal liver function
• photosensitivity reactions (sensitivity to sunlight)

Not known (frequency cannot be estimated based on available data):

• decrease in the number of platelets in the blood (Thrombocytopenia, hemolytic anemia)
• 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
• 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 prolongation of the QT interval) which can be ascertained by an examination called “electrocardiogram”
• decrease in blood pressure (hypotension)
• alteration of the color of the tongue pain in the joints
• joint pain
• severe kidney problems (acute renal failure, interstitial nephritis)

Side effects related to prophylaxis and treatment of Mycobacterium Avium
Very common (affects more than 1 in 10 people):

• diarrhea
• abdominal pain
• nausea
• abdominal discomfort, flatulence
• loose stools

Common (affects up to 1 in 10 people):

• anorexia
• dizziness
• migraine
• feeling of tingling or numbness (paresthesia)
• changes in taste sensation (dysgeusia)
• impaired vision
• deafness
• skin rash and itching
• joint pain (arthralgia)
• fatigue

Uncommon (affects up to 1 in 100 people):

• reduced sensitivity (hypoesthesia)
• impaired hearing, ringing in the ears (tinnitus)
• palpitations
• liver inflammation (hepatitis)
• severe allergic skin reaction (Stevens-Johnson syndrome), photosensitivity
• tiredness (asthenia)
• discomfort Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at http://www.agenziafarmaco.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 REZAN

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 Scad. The
expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
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 REZAN contains

• The active ingredient is azithromycin, as azithromycin dihydrate. Each film-coated tablet contains 524.1 mg of azithromycin dihydrate, equivalent to 500 mg of azithromycin base. The other components are: Anhydrous calcium hydrogen phosphate, pregelatinized starch, sodium lauryl sulfate, sodium croscarmellose, sodium carboxymethylcellulose, magnesium stearate Coating:Hypromellose (E464), titanium dioxide (E171), triacetin (E1518), lactose monohydrate.

Description of the appearance of REZAN 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, 1143 – 00156, Roma

Manufacturer
Special Product’s Line S.p.A.-Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR)