ZITRONOVA 500 mg Tabletki Powlekane

Treść ulotki

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

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

1. What ZITRONOVA is and what it is used for

ZITRONOVA contains the active ingredient azithromycin which belongs to a group of medicines called
antibiotics (macrolides) used for the treatment of infections caused by bacteria.
This medicine is indicated for the treatment of infections caused by bacteria sensitive
to azithromycin, such as:

• upper respiratory tract infections:
• ear infections (otitis media);
• infections of the nasal mucous membranes (sinusitis);
• tonsil infections (tonsillitis);
• throat infections (pharyngitis);
• lower respiratory tract infections:
• infections of the bronchi and lungs (bronchitis and pneumonia);
• infections of the mouth or teeth (odontostomatological infections);
• infections of the skin and other organs of the body (soft tissues);
• urinary tract infection (non-gonococcal urethritis caused by Chlamydia trachomatis);
• genital infection (soft chancre caused by Haemophilus ducreyi).

2. What you need to know before taking ZITRONOVA

Do not take ZITRONOVA

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other similar antibiotics (macrolide or ketolide antibiotics);
• if you have severe liver problems (severe hepatic insufficiency);
• if you are pregnant or breastfeeding (except in the cases listed in the “Pregnancy and breastfeeding” section);
• if you are a very young child (except in the cases listed in the “Children” section);

Warnings and precautions
Talk to your doctor or pharmacist before taking ZITRONOVA.
As with other antibiotic medicines, including those belonging to the same class as ZITRONOVA
(erythromycin and other macrolides), the following conditions may occur:

• severe allergic reactions (anaphylaxis, angioedema), whose symptoms may include redness and severe skin irritation, with swelling of the lips, tongue or throat. These conditions can be life-threatening and require urgent medical attention. Allergic events may recur even after stopping treatment. If you notice the onset of any of these symptoms, stop treatment and seek immediate medical attention.
• new infections (superinfections). Treatment with ZITRONOVA may cause infections by other bacteria or fungi to which the medicine is not effective (non-sensitive microorganisms). Therefore, pay attention to any new sign of inflammation and infection;
• diarrhea associated with Clostridium difficile; which can be from mild to severe inflammation of the intestine (pseudomembranous colitis) that can be fatal. If you should experience diarrhea, even several days or months after using this medicine, see your doctor as appropriate therapy is needed;
• the onset or worsening of symptoms of a muscle disorder that manifests with weakness (myasthenia gravis).

Take this medicine with caution and tell your doctor if any of the following conditions apply to you:

• if you have severe kidney problems (severe impairment of renal function, GFR < 10 ml/min.);
• if you suffer from liver problems (liver diseases, hepatic insufficiency). Therefore, see your doctor, who will prescribe specific tests to check liver function (liver function tests) and assess the need to stop treatment with ZITRONOVA if you experience the following symptoms:
• yellowing of the skin and the whites of the eyes (jaundice);
• dark urine;
• a tendency to bleed;
• confusion, difficulty reasoning and problems performing movements (hepatic encephalopathy);
• if you have a sexually transmitted infection. In this case, your doctor must rule out that it is an infection caused by the bacterium Treponema pallidumsuch as syphilis;
• if you are predisposed to developing heart rhythm disturbances, as this medicine may increase the risk of very serious heart problems (prolongation of cardiac repolarization and the QT interval, cardiac arrhythmia, torsades de pointes) that can lead to cardiac arrest. Therefore, pay particular attention if you have any of the following risk factors:
• if you are a woman or are elderly;
• if you or a family member was born with a heart rhythm disorder or has been diagnosed with an electrocardiogram (congenital or documented prolongation of the QT interval);
• if you are taking antiarrhythmics (quinidine, procainamide, dofetilide, amiodarone and sotalol), medicines used to treat heart rhythm disorders; cisapride, a medicine used to treat a condition characterized by heartburn and regurgitation (gastroesophageal reflux); terfenadine, medicines used to treat allergies (antihistamine); antidepressants such as citalopram, medicines used to treat depression; antipsychotics such as pimozide, medicines used to treat some mental disorders; fluoroquinolones (moxifloxacin and levofloxacin), medicines used to treat infections caused by bacteria (see the “Other medicines and ZITRONOVA” section);
• if you have an alteration in the amount of salts in the blood (electrolyte disturbance), especially low levels of potassium (hypokalemia) or magnesium (hypomagnesemia) in the blood;
• if you have a slow or irregular heartbeat (bradycardia, cardiac arrhythmia);
• if you suffer from severe heart failure.

Do not take ZITRONOVA or other macrolide antibiotics if you are taking ergotamine or ergotamine derivatives,
medicines used to treat migraine (severe headaches), as
the combination of the two medicines can cause a life-threatening disease called ergotism which
manifests with symptoms such as disturbances in blood circulation to the legs, even severe (gangrene)
or with hallucinations and involuntary muscle movements (convulsions) (See the “Other
medicines and ZITRONOVA” section).

Children
During early infancy, this medicine should only be administered in cases of actual
need and under the direct control of the doctor (See the “Do not take ZITRONOVA” section).
The safety and efficacy of ZITRONOVA for the prevention and treatment of infections caused by
the bacterium Mycobacterium avium complexin children have not been demonstrated.

Other medicines and ZITRONOVA
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not take ZITRONOVA together with the following medicines:

• ergotamine, a medicine used to treat migraine, as a life-threatening disease (ergotism) may occur (See the “Warnings and precautions” section);
• antacids, medicines used to reduce stomach acidity.

Take this medicine with cautionand tell your doctor if you are taking any of the following medicines:

• digoxin, a medicine used to treat some heart problems, as azithromycin may increase levels of digoxin in the blood;
• colchicine, a medicine used for gout and familial Mediterranean fever;
• atorvastatin, a medicine used to reduce cholesterol levels in the blood, as it may cause damage and muscle pain (rhabdomyolysis);
• cyclosporine, a medicine used after a transplant and for the treatment of immune system disorders. If your doctor deems it strictly necessary to take cyclosporine and ZITRONOVA together, he will check the levels of cyclosporine in the blood and adjust the dose;
• nelfinavir, a medicine used to treat AIDS, as it may increase the side effects of azithromycin;
• oral coumarinic anticoagulantssuch as warfarin, medicines used to thin the blood and other medicines that affect blood coagulation. In this case, your doctor will prescribe specific blood tests (prothrombin time) and monitor you;
• antiarrhythmics(quinidine, procainamide, amiodarone, dofetilide, sotalol), medicines used to treat heart rhythm problems;
• cisapride, a medicine used to treat a condition characterized by heartburn and regurgitation (gastroesophageal reflux);
• rifabutin, an antibiotic used to treat infections caused by mycobacteria, as cases of neutropenia (reduction in the number of neutrophils) have been observed in patients taking the two drugs together;
• terfenadine, medicines used to treat allergies (antihistamine);
• antidepressantssuch as citalopram, medicines used to treat depression;
• antipsychoticssuch as pimozide, medicines used to treat some mental disorders;
• fluoroquinolones(moxifloxacinand levofloxacin), medicines used to treat infections caused by bacteria (See section “Warnings and precautions”).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or breastfeeding, take this medicine only if absolutely
necessary and under the direct supervision of your doctor.

Driving and operating machinery
This medicine does not impair the ability to drive and operate machinery.

ZITRONOVA contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with
intolerance to some sugars, contact him before taking this medicine.

3. How to take ZITRONOVA

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
Swallow the tablets whole and always in a single dose per day, independently of meals.
Keep in mind that if you take the tablets after meals, you may reduce the occurrence of undesirable effects
on the stomach and intestines (See section “Possible side effects”).

Use in adults
The recommended dose is 1 tablet (500 mg) once a day, for 3 consecutive days.
For the treatment of sexually transmitted diseases (caused by sensitive strains of Chlamydia

trachomatisor Haemophilus ducreyi) the recommended dose is 2 tablets (1000 mg) to be taken
in a single administration.

Use in children weighing 45 Kg or more
The recommended dose is 1 tablet (500 mg) once a day, for 3 consecutive days.
The maximum total recommended dose in children is 1500 mg.

Use in the elderly
If you are elderly, no dose adjustments are necessary.
Take this medicine with particular caution as heart problems
(cardiac arrhythmia and torsades de pointes) may occur (See section “Warnings and precautions”).

Use in people with kidney problems (impaired renal function)
If you suffer from moderate kidney problems (GFR 10 - 80 ml/min.), no dose adjustments are
necessary.
If you suffer from severe kidney problems (GFR < 10 ml/min.), your doctor may decide to adjust the dose.

Use in people with liver problems (impaired hepatic function)
If you suffer from mild or moderate liver problems, no dose adjustments are necessary.

If you take more ZITRONOVA than you should
In case of overdose, no specific side effects are known other than those found for
a normal dosage (See section “Possible side effects”).
In case of accidental ingestion/taking of an excessive dose of this medicine, consult
your doctor immediately or go to the nearest hospital.

If you forget to take ZITRONOVA
Do not take a double dose to make up for the missed tablet.
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 everybody gets them.
The following side effects may occur:

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;
• alteration of the number of white blood cells in the blood (decreased lymphocyte count, increased eosinophil count, increased basophils, increased monocytes, increased neutrophils) and other alterations in blood tests, such as reduced bicarbonate levels in the blood.

Uncommon(may affect up to 1 in 100 people)

• fungal infections (candidiasis or other fungal infections), including fungal infection of the mouth (oral candidiasis);
• infections caused by bacteria (superinfections, See section “Warnings and precautions”), vaginal infection, lungs (pneumonia), throat (pharyngitis), stomach and intestines (gastroenteritis), nose (rhinitis), breathing difficulties;
• decreased number of white blood cells in the blood (leukopenia, neutropenia); increased number of a type of white blood cells called eosinophils in the blood (eosinophilia);
• swelling of the face, lips, mouth, tongue or throat due to fluid accumulation (angioedema), allergic reactions (hypersensitivity);
• severe loss of appetite leading to a drastic reduction of it (anorexia);
• nervousness, inability to fall asleep (insomnia);
• dizziness, drowsiness, taste disturbances (dysgeusia), tingling (paresthesia);
• vision disturbances (impaired vision);
• ear disorders, vertigo;
• increased heart rate (palpitations);
• hot flushes;
• difficulty breathing (dyspnea), nosebleeds (epistaxis);
• constipation, presence of gas in the intestines (flatulence), digestive problems (dyspepsia), inflammation of the stomach (gastritis), difficulty swallowing (dysphagia), abdominal bloating (abdominal distension), dry mouth, belching, appearance of sores in the mouth (ulcers), increased salivation (hypersecretion salivary);
• irritations (skin rash, urticaria) and skin inflammation (dermatitis), itching, dry skin, increased sweating (hyperhidrosis);
• joint pain and stiffness (osteoarthritis), muscle pain (myalgia) or neck pain, back pain;
• difficulty urinating (dysuria), kidney pain;
• bleeding even on days not corresponding to the menstrual cycle in women (metrorrhagia), diseases affecting the testicles in men (testicular pathologies);
• swelling in various parts of the body due to fluid accumulation (edema), especially on the face (facial edema), ankles, feet or toes (peripheral edema), weakness (asthenia), malaise, fatigue, chest pain, fever (pyrexia), generalized pain;
• alteration of the results of some blood tests (increased aspartate aminotransferase, alanine aminotransferase, bilirubin, creatinine and urea, abnormal concentration of potassium and sodium in the blood, increased alkaline phosphatase, increased concentration of chlorine, glucose and bicarbonate in the blood, increased platelets, increased hematocrit value). Therefore, inform your doctor if you are undergoing blood tests;
• complications in case of trauma or poisoning (post-procedural).

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

• agitation;
• yellowing of the skin and the white of the eyes (cholestatic jaundice), liver disorders (abnormal liver function);
• increased skin sensitivity to light (photosensitization reaction).
• severe skin reactions: red and scaly rash with the formation of pustules and blisters (pustulotic exanthematous).

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

• inflammation of the intestine (pseudomembranous colitis) (See section “Warnings and precautions”);
• decreased number of platelets in the blood (thrombocytopenia), destruction of red blood cells (hemolytic anemia);
• severe allergic reaction (anaphylactic reaction) (See section “Warnings and precautions”);
• agitation, aggressiveness, anxiety, delirium, hallucinations;
• fainting with temporary loss of consciousness (syncope), convulsions, decreased skin sensitivity (hypoesthesia), increased physical and mental activity (psychomotor hyperactivity), loss of sense of smell (anosmia) and taste (ageusia), difficulty perceiving odors (parosmia), muscle disorders (myasthenia gravis) (See section “Warnings and precautions”);
• hearing disorders such as hearing loss (deafness), ringing in the ears (tinnitus);
• alterations of the heart rhythm (torsades de pointes, arrhythmia, ventricular tachycardia, prolongation of the QT interval);
• lowering of blood pressure (hypotension);
• inflammation of the pancreas (pancreatitis), alteration of the color of the tongue (discoloration);
• serious liver problems that rarely lead to death (liver failure, fulminant hepatitis, hepatic necrosis);
• serious skin problems with redness and blistering (Stevens Johnson syndrome, toxic epidermal necrolysis, erythema multiforme);
• joint pain (arthralgia);
• kidney problems (acute renal failure, interstitial nephritis).

The following are possible side effects that may occur during the prevention
(prophylaxis) and treatment of infections caused by a particular bacterium ( Mycobacterium Avium

Complex):

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

• diarrhoea, abdominal pain, nausea, presence of gas in the intestines (flatulence), abdominal discomfort, passage of stools.

Common(may affect up to 1 in 10 people)

• severe loss of appetite leading to a drastic reduction of it (anorexia);
• dizziness, headache, tingling (paresthesia), altered sense of taste (dysgeusia);
• vision disturbances (impaired vision);
• hearing loss (deafness);
• skin irritation (rash), itching;
• joint pain (arthralgia);
• fatigue.

Uncommon(may affect up to 1 in 100 people)

• decreased skin sensitivity (hypoesthesia);
• hearing disorders, ringing in the ears (tinnitus);
• increased heart rate (palpitations);
• inflammation of the liver (hepatitis);
• serious skin problems with redness and blistering (Stevens Johnson syndrome);
• increased skin sensitivity to light (photosensitization reaction);
• weakness (asthenia), malaise.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting side
effects you can help provide more information on the safety of this medicine.

5. How to store ZITRONOVA

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 “Expiry”.
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 ZITRONOVA contains

• The active ingredient is azithromycin dihydrate. Each tablet contains 524.1 mg of azithromycin dihydrate (equivalent to 500 mg of azithromycin).
• The other ingredients are: o tablet core: anhydrous calcium hydrogen phosphate, pregelatinized starch, sodium lauryl sulfate, crospovidone, magnesium stearate; o coating: hypromellose, titanium dioxide, triacetin, lactose monohydrate.

Description of the appearance of ZITRONOVA and contents of the pack
Pack of 3 film-coated tablets containing 500 mg.

Marketing Authorisation Holder
LANOVA FARMACEUTICI S.R.L.
VIA CONCA D'ORO, 212

• 00141 - ROMA

Manufacturer
Bluepharma – Industria Farmaceutica S.A. – S. Martinho do Bispo – Coimbra – Portugal