TROZOCINA 200 mg /5 Ml Oral Suspension Powder

Зміст інструкції

1. Trozocina 500 mg film-coated tablets, 200 mg/5 ml powder for oral suspension
   1. What is Trozocina and what is it used for
   2. What you need to know before taking Trozocina
   3. How to take Trozocina
   4. graduated dropper “double spoon”,
   5. graduated dropper “syringe”,
   6. Possible side effects
   7. How to store Trozocina
   8. Contents of the pack and other information
2. Trozocina Avium 600 mg film-coated tablets
   1. What is Trozocina Avium and what is it used for
   2. What you need to know before taking Trozocina Avium
   3. How to take Trozocina Avium
   4. Possible side effects
   5. How to store Trozocina Avium
   6. Contents of the pack and other information
3. Trozocina 200 mg/5 ml powder for oral suspension
   1. What is Trozocina and what is it used for
   2. What you need to know before taking Trozocina
   3. How to take Trozocina
   4. graduated “double spoon” measuring device,
   5. graduated dropper “syringe”,
   6. Possible side effects
   7. How to store Trozocina
   8. Contents of the pack and other information
4. Trozocina 2 g granules for prolonged-release oral suspension
   1. What is Trozocina and what is it used for
   2. What you need to know before you take Trozocina
   3. How to take Trozocina
   4. Possible side effects
   5. How to store Trozocina
   6. Contents of the pack and other information
5. Trozocina 500 mg powder for solution for infusion
   1. What is Trozocina and what is it used for
   2. What you need to know before you take Trozocina
   3. How to take Trozocina
   4. Possible side effects
   5. How to store Trozocina
   6. Package Contents and Other Information
6. Trozocina 250 mg hard capsules
   1. What is Trozocina and what is it used for
   2. What you need to know before taking Trozocina
   3. How to take Trozocina
   4. Possible side effects
   5. How to store Trozocina
   6. Contents of the pack and other information

Trozocina 500 mg film-coated tablets, 200 mg/5 ml powder for oral suspension

azithromycin

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

1. What is Trozocina and what is it used for

Trozocina contains the active ingredient azithromycin, an antibiotic of the macrolide class
indicated for treating infections caused by bacteria, including:

• upper respiratory tract infections (including sinusitis, tonsillitis, pharyngitis and middle ear infections);
• lower respiratory tract infections (including bronchitis and pneumonia);
• infections of the mouth and teeth;
• infections of the skin and soft tissues (muscles, tendons, blood vessels, nerves, fat and fascia);
• urethral infections (the tube that connects the urinary bladder to the outside), caused by a bacterium called Chlamydia trachomatis;
• soft chancre, a sexually transmitted disease caused by the bacterium Haemophilus ducreyi.

2. What you need to know before taking Trozocina

Do not take Trozocina
if you are allergic to azithromycin or any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Talk to your doctor before taking Trozocina:

• if you have liver disease or impaired liver function;
• if you have severe kidney problems (severe renal insufficiency);
• if you are taking a medicine containing ergotamine or its derivatives (medicines used for example for migraine);
• if you have a sexually transmitted infection because your doctor must rule out syphilis;
• if you have heart problems, rhythm or electrical conduction disorders of the heart, for example: congenital heart rhythm abnormalities or very slow heart rate (bradycardia) or heart rhythm disorders (arrhythmias) or severe heart problems (severe heart failure);
• if you are being treated with other medicines that can affect the heart rhythm, such as: quinidine, procainamide, dofetilide, amiodarone, sotalol (medicines for heart rhythm abnormalities) or cisapride (medicine used for stomach disorders) or terfenadine (medicine for allergies) or pimozide (medicine for mental disorders) or citalopram (medicine for depression) or moxifloxacin, levofloxacin (antibiotics);
• if you have low levels of potassium and magnesium in your blood. If any of the above applies to you, your doctor will monitor you closely during treatment with Trozocina. Tell your doctor if any of the following conditions occur or worsen duringtreatment with Trozocina:
• severe allergic reactionsincluding severe skin reactions. If you experience an allergic reaction, stop taking Trozocina immediatelyand see your doctor;
• signs and symptoms of impaired liver functionsuch as sudden onset of weakness (asthenia), yellowing of the skin and whites of the eyes (jaundice), dark urine, a tendency to bleed, brain damage (e.g. confusion and altered state of consciousness). If you notice these symptoms, see your doctor immediatelywho will perform tests to assess your liver condition and assess whether to stop treatment with Trozocina;
• vomiting or irritability in your baby (if it is 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 infectionsor persistence of the symptoms of the current infection. This situation may be caused by bacteria that are not sensitive to Trozocina (resistant bacteria) or by microorganisms other than bacteria (fungal infection);
• onset of diarrhea, the severity of which varies from mild to fatal colitis (which can be life-threatening). Antibiotics, by altering the normal bacterial flora of the intestine, can allow the overgrowth of a bacterium called Clostridium difficilewhich may not respond to antibiotic therapy and may require surgery. Diarrhea may occur during treatment and up to 2 months after its completion;
• onset or worsening of muscle weakness and fatigue, i.e. symptoms of a disease called myasthenia gravis.

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

• antacids (medicines for stomach acidity). Tell your doctor if you are taking any of the following medicines because caution is necessary:
• digoxin (medicine for the treatment of heart failure);
• colchicine (medicine used for gout and familial Mediterranean fever);
• zidovudine and nelfinavir (medicines used in the treatment of HIV);
• ergotamine (medicine for migraine);
• statins (medicines to lower blood fat levels);
• cyclosporine (medicine against rejection in case of organ transplantation);
• anticoagulants and in particular oral coumarin anticoagulants (e.g. warfarin);
• terfenadine (medicine for allergies);
• rifabutin (antibiotic used in tuberculosis).

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.
Studies in animals have shown that azithromycin crosses the placenta and passes into
breast milk, but there are no clinical data on the risk in pregnant women and during
breastfeeding.
Your doctor will prescribe Trozocina only if absolutely necessary.

Driving and using machines
Studies have not been conducted on the effects of azithromycin on the ability to drive or
operate machines.
However, if you experience visual disturbances or side effects that
may impair attention, it is recommended to refrain from driving vehicles
and operating machinery (see Possible side effects).

Trozocina 200 mg/5 ml powder for oral suspension contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before
taking this medicine.
It contains 3.87 g of sucrose (sugar) per 5 ml of suspension. To be taken into
consideration in people with diabetes mellitus.
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e.
essentially “sodium-free”.

Trozocina 500 mg tablets contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before
taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e.
essentially “sodium-free”.

3. How to take Trozocina

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

Adults
Treatment of infections of the upper and lower respiratory tract, skin, soft tissues
(muscles, tendons, blood vessels, nerves, fat and fascia), mouth and teeth
The recommended dose is 500 mg (1 tablet) per day, in a single dose, for 3 consecutive days.
Treatment of sexually transmitted diseases (caused by germs and bacteria sensitive to the
species Chlamydia trachomatisor Haemophilus ducreyi)
The recommended dose is 1000 mg (2 tablets of 500 mg), in a single dose and for one
day only.

Elderly
The recommended dose is that of the adult.
If you are elderly, you may have risk factors that promote heart rhythm disturbances,
therefore your doctor will prescribe Trozocina with caution (see “Warnings and precautions”).

Impairment of kidney function
If you have severe kidney problems, your doctor may need to adjust the dose.

Children
Children weighing 45 kg or more
The recommended doses are the same as for adults (see “Adults”).
Children weighing less than 45 kg
The recommended dose is 10 mg per kilogram (kg) of body weight per day, for 3 consecutive days
according to the following scheme:
The maximum recommended dose of the treatment cycle for any treatment in children is
1500 mg.

Treatment of acute middle ear infections
The recommended dose is 10 mg per kg of weight per day, for 3 consecutive days, or 30
mg per kg of weight in a single administration per day. Your doctor will tell you which dose to use.

Treatment of streptococcal pharyngitis
The recommended dose is 10 mg per kg of weight or 20 mg per kg of weight, both in one
dose and for 3 consecutive days. Your doctor will tell you which dose to use.
Trozocina should be taken once a day, regardless of whether it is on an empty stomach or after
meals.
The tablets must be swallowed whole.

PREPARATION AND ADMINISTRATION OF THE SUSPENSION

• Shake the bottle containing the powder before adding water. -
• Use the special measuring device positioned on the closing cap of the package and fill it with water up to the line (corresponding to 19 ml), once only.
• Pour the water from the measuring device into the bottle.
• Shake well so that all the powder goes into suspension. 1 ml of the reconstituted suspension contains 40 mg of azithromycin (equivalent to 200 mg for a dose of 5 ml).

Always shake the suspension before use.
The reconstituted suspension must be administered using one of the two
graduated measuring devices attached to the package:

1. graduated dropper “double spoon”,

To be used for children weighing between 15 kg and 45 kg. The dropper consists of a small spoon (capacity 5 ml) on one side, and a large spoon (capacity 10 ml) on the other side

2. graduated dropper “syringe”,

To be used for children weighing less than 15 kg

• 1) INSTRUCTIONS FOR USE OF THE GRADUATED DROPPER “DOUBLE SPOON”

CHILD'S WEIGHT	and ONCE A DAY FOR 3 DAYS	AMOUNT OF DRUG
from 15 kg to 25 kg	d Full small spoon up to the edge	200 mg
from 26 kg to 35 kg	n Large spoon up to the mark	300 mg
from 36 kg to 45 kg	a i Full large spoon l up to the edge	400 mg

• 2) INSTRUCTIONS FOR USE OF THE GRADUATED DROPPER “SYRINGE”

• 1. The syringe is calibrated in mg and ml of drug and kg of the child's weight
• 2. Unscrew the plastic cap and insert the syringe, with the adapter, into the bottle
• 3. Draw up the prescribed amount of suspension
• 4. Detach the syringe from the adapter
• 5. Administer the suspension with the syringe directly into the child's mouth

Close the bottle tightly with the appropriate cap. Rinse the graduated dropper used thoroughly.

WARNING

• For the treatment of acute otitis media in children, a dosage of 30 mg/kg can also be administered in a single dose, filling the graduated dropper “syringe” the necessary number of times until the prescribed dose is reached.

If you take more Trozocina than you should
In case of accidental ingestion of an excessive dose of Trozocina, immediately inform your doctor or go to the nearest hospital.
The effects due to the ingestion of an excessive dose of Trozocina have been similar to those observed at normal doses (see section 4).

If you forget to take Trozocina
Do not take and do not administer to the child a double dose to compensate for the missed dose.

If you stop taking Trozocina
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Trozocina can cause side effects, although not everyone will experience them.

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

• Diarrhea. Common side effects (may affect up to 1 in 10 people)
• Headache;
• Vomiting;
• Nausea;
• Abdominal pain;
• Decreased lymphocytes (a type of white blood cells) in the blood;
• Increased levels of certain types of white blood cells (eosinophils, basophils, monocytes, neutrophils) in the blood;
• Decreased bicarbonate in the blood. Uncommon side effects (may affect up to 1 in 100 people)
• Fungal infections, particularly of the Candidagenus (candidiasis);
• Vaginal infections;
• Pneumonia;
• Infections caused by bacteria;
• Throat infections (pharyngitis);
• Inflammation of the stomach and/or intestines (gastroenteritis);
• Respiratory disorders;
• Common cold (rhinitis);
• Reduction in the number of white blood cells in the blood (leukopenia);
• Reduction in the number of neutrophils (a type of white blood cells) in the blood (neutropenia);
• Increased number of eosinophils (a type of white blood cells) in the blood;
• Swelling of the skin or mucous membranes (angioedema);
• Allergic reactions;
• Loss of appetite (anorexia);
• Nervousness;
• Insomnia;
• Dizziness;
• Drowsiness;
• Alteration of taste;
• Tingling (paresthesia);
• Vision disorders;
• Ear disorders;
• Vertigo;
• Fast heartbeat;
• Hot flushes;
• Difficulty breathing;
• Nosebleeds;
• Constipation;
• Intestinal gas;
• Difficulty digesting food;
• Inflammation of the stomach (gastritis);
• Difficulty swallowing;
• Abdominal bloating;
• Dry mouth;
• Belching;
• Mouth ulcers;
• Excessive saliva production;
• Skin rash;
• Itching;
• Hives;
• Skin inflammation (dermatitis);
• Dry skin;
• Excessive sweating;
• Degenerative joint disease (osteoarthritis);
• Muscle pain (myalgia);
• Back pain;
• Neck pain;
• Difficulty urinating;
• Kidney pain;
• Heavy menstrual bleeding;
• Testicular disorders;
• Swelling due to fluid retention;
• Weakness;
• Feeling unwell;
• Fatigue;
• Facial swelling;
• Chest pain;
• Fever;
• Pain;
• Fluid accumulation in the limbs (peripheral edema);
• Increased levels of certain substances in the blood: aspartate aminotransferase, alanine aminotransferase, bilirubin, urea, creatinine, alkaline phosphatase, chlorine, glucose, bicarbonate;
• Alteration of potassium and sodium levels in the blood;
• Increased platelets in the blood;
• Decreased red blood cell content in the blood (hematocrit);
• Complications after surgery. Rare side effects (may affect up to 1 in 1,000 people)
• Severe skin reactions: red and scaly rash with the formation of pustules and blisters (pustular exanthematous rash).
• Agitation;
• Impaired liver function;
• Yellowing of the skin, mucous membranes and eyes due to bile stagnation (cholestatic jaundice);
• Sensitivity to sunlight (photosensitivity reactions);
• Drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially appears as flu-like symptoms, with a rash on the face and then with widespread rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes observed in blood tests and an increase in a type of white blood cells (eosinophilia). Side effects with unknown frequency (frequency cannot be estimated based onavailable data)
• Severe infection of the intestine with diarrhea and possible blood loss (pseudomembranous colitis);
• Low number of platelets in the blood (thrombocytopenia);
• Reduction in the number of red blood cells in the blood due to their destruction (hemolytic anemia);
• Severe and sudden allergic reaction, which may be fatal;
• Agitation;
• Aggressiveness;
• Anxiety;
• Confused or disturbed thinking (delirium);
• Seeing or hearing things that are not there (hallucinations);
• Fainting;
• Convulsions;
• Decreased skin sensitivity;
• Psychomotor agitation;
• Alterations or loss of smell;
• Loss of taste;
• Disease of the nerves and muscles that causes muscle weakness (myasthenia gravis);
• Alterations in hearing, including deafness and ringing or buzzing in the ears;
• Severe disturbances of the heart's electrical activity (torsades de pointes);
• Heart rhythm disturbances, including ventricular tachycardia;
• Alteration of the heart's electrical conduction detected through an electrocardiogram (prolongation of the QT interval);
• Low blood pressure;
• Inflammation of the pancreas (pancreatitis);
• Discoloration of the tongue;
• Liver failure (fatal in rare cases);
• Fulminant hepatitis (severe inflammation of the liver that develops very rapidly and is often fatal);
• Death of liver tissue (hepatic necrosis);
• Severe allergic reaction involving the skin and mucous membranes that may also be fatal (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• Allergic reaction involving the skin and mucous membranes (multiforme erythema);
• Joint pain;
• Acute kidney failure;
• Acute inflammation of the kidney (interstitial nephritis). The following side effects have been reported in patients treated with azithromycin for the prevention and treatment of infections caused by Mycobacterium avium: Very common side effects (may affect more than 1 in 10 people)
• Diarrhea;
• Nausea;
• Abdominal pain and discomfort;
• Flatulence;
• Loose stools. Common side effects (may affect up to 1 in 10 people)
• Loss of appetite (anorexia);
• Dizziness;
• Headache;
• Changes in the sense of taste;
• Tingling (paresthesia);
• Impaired vision;
• Hearing loss;
• Skin rash;
• Itching;
• Joint pain;
• Fatigue. Uncommon side effects (may affect up to 1 in 100 people)
• Decreased skin sensitivity;
• Hearing loss or ringing in the ear;
• Fast heartbeat (palpitations);
• Liver inflammation (hepatitis);
• Severe allergic reaction involving the skin and mucous membranes (Stevens-Johnson syndrome);
• Allergic reactions on the skin such as sensitivity to sunlight;
• Fatigue;
• Feeling unwell.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
please inform your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
http://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 Trozocina

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the packaging after
“Exp.”. The expiry date refers to the last day of that month.
Trozocina 500 mg film-coated tablets
This medicine does not require any special storage conditions.
Trozocina 200 mg/5 ml powder for oral suspension
After reconstitution, the oral suspension is stable for 10 days at room temperature.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist
how to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What contains Trozocina
Trozocina 500 mg film-coated tablets

• The active ingredient is azithromycin dihydrate. Each film-coated tablet contains 524.110 mg of azithromycin dihydrate, equivalent to 500 mg of azithromycin base.
• The other ingredients are pregelatinized starch, anhydrous dibasic calcium phosphate, sodium carboxymethylcellulose, magnesium stearate, sodium lauryl sulfate, deionized water.
• The coating contains titanium dioxide, lactose, hypromellose, triacetin, deionized water. Trozocina 200 mg/5 ml oral suspension powder
• The active ingredient is azithromycin dihydrate. The reconstituted suspension contains 40 mg of azithromycin per ml (200 mg per a 5 ml dose). The composition per 100 grams of powder is 5.01 g of azithromycin dihydrate, equivalent to 4.78 g of azithromycin base.
• The other ingredients are anhydrous tribasic sodium phosphate, hydroxypropylcellulose, xanthan gum, cherry flavour, vanilla cream, banana flavour, sucrose.

Description of the appearance of Trozocina and contents of the pack
Trozocina 500 mg film-coated tablets
Each pack contains 1 blister with 3 divisible 500 mg film-coated tablets.
Trozocina 200 mg/5 ml oral suspension powder
Each pack contains 1 bottle with 1500 mg of azithromycin with child-resistant closure and appropriate graduated dosing device (syringe) and specific adapter to be applied to the bottle for pediatric administration.
Once reconstituted, the suspension will contain 200 mg/5 ml.

Marketing Authorisation Holder
Alfasigma S.p.A. via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)

Manufacturer
HAUPT PHARMA LATINA S.r.l.
S.S. 156 km 50
04010 Borgo San Michele (Latina)

Trozocina Avium 600 mg film-coated tablets

azithromycin

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

1. What is Trozocina Avium and what is it used for

Trozocina Avium contains the active ingredient azithromycin, an antibiotic of the macrolide class.
Trozocina Avium is indicated:

• in the prevention of infections caused by Mycobacterium avium complex(MAC) alone or in association with rifabutin, particularly in patients with advanced stage AIDS;
• in the treatment of infections caused by Mycobacterium avium complex(MAC) in association with ethambutol in patients with advanced stage AIDS.

2. What you need to know before taking Trozocina Avium

Do not take Trozocina Avium
if you are allergic to azithromycin or any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Talk to your doctor before taking Trozocina Avium:

• if you have liver disease or impaired liver function;
• if you suffer from severe kidney problems (severe renal insufficiency);
• if you are taking a medicine containing ergotamine or its derivatives (medicines used for example against migraine);
• if you have a sexually transmitted infection because the doctor must rule out syphilis;
• if you suffer from heart problems, rhythm or electrical conduction disorders of the heart, for example: or congenital heart rhythm abnormalities or very slow heart rate (bradycardia) or heart rhythm disorders (arrhythmias) or severe heart problems (severe heart failure);
• if you are being treated with other medicines that can affect the heart rhythm, such as: or quinidine, procainamide, dofetilide, amiodarone, sotalol (medicines against heart rhythm abnormalities) or cisapride (medicine used for stomach disorders) or terfenadine (medicine against allergies) or pimozide (medicine against mental disorders) or citalopram (medicine against depression) or moxifloxacin, levofloxacin (antibiotics);
• if you have low levels of potassium and magnesium in the blood. If any of the above applies to you, your doctor will monitor you closely during treatment with Trozocina Avium. Tell your doctor if any of the following conditions occur or worsen duringtreatment with Trozocina Avium:
• severe allergic reactionsincluding severe skin reactions. If an allergic reaction occurs, stop immediatelytreatment with Trozocina Avium and see your doctor;
• signs and symptoms of impaired liver functionsuch as sudden onset of weakness (asthenia), yellowing of the skin and whites of the eyes (jaundice), dark urine, a tendency to bleed, brain damage (e.g. confusion and altered consciousness). If you notice these symptoms, see your doctor immediatelywho will perform tests to assess liver function and assess whether to discontinue treatment with Trozocina Avium;
• vomiting or irritability in your baby (if he/she is 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 infectionsor persistence of symptoms of the ongoing infection. This situation may be caused by bacteria that are not sensitive to Trozocina Avium (resistant bacteria) or by microorganisms other than bacteria (fungal infection);
• onset of diarrhea, the severity of which ranges from mild to fatal colitis (which can be fatal). Antibiotics, by altering the normal intestinal bacterial flora, can allow the overgrowth of a bacterium called Clostridium difficilewhich may not respond to antibiotic therapy and may require surgery. Diarrhea may occur during treatment and up to 2 months after its completion;
• onset or worsening of muscle weakness and fatigue, i.e. symptoms of a disease called myasthenia gravis. ChildrenThe safety and efficacy of TROZOCINA Avium in the prevention or treatment of MAC infections in children have not been established.

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

• antacids (medicines for stomach acidity) Tell your doctor if you are taking any of the following medicines because caution is required:
• digoxin (medicine used for the treatment of heart failure)
• colchicine (medicine used for gout and familial Mediterranean fever)
• zidovudine and nelfinavir (medicines used in the treatment of HIV)
• ergotamine (medicine against migraine)
• statins (medicines to lower blood fat levels)
• cyclosporine (medicine against organ rejection in case of organ transplantation)
• anticoagulants and in particular oral coumarin anticoagulants (e.g. warfarin)
• terfenadine (medicine against allergies)
• rifabutin (antibiotic used in tuberculosis)

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
Studies in animals have shown that azithromycin crosses the placenta and passes into
breast milk, but no clinical data are available on the risk in pregnant women and during
breastfeeding.
Your doctor will prescribe Trozocina only if absolutely necessary.

Driving and operating machinery
No studies have been conducted on the effects of azithromycin on the ability to drive or
operate machinery.
However, if visual disturbances or side effects occur that
may impair attention, it is recommended to refrain from driving vehicles
and operating machinery (see Possible side effects).

Trozocina Avium contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him/her before
taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e.
essentially “sodium-free”.

3. How to take Trozocina Avium

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

Adults
Prevention of infections from Mycobacterium avium complex(MAC)
The recommended dose is 1200 mg (2 tablets) in a single administration 1 time a
week.
Treatment of infections from Mycobacterium avium complex(MAC)
The recommended dose is 600 mg (1 tablet) 1 time a day.

Elderly
The recommended dose is that of the adult.
If you are elderly you may have risk factors that promote heart rhythm disturbances,
therefore your doctor will prescribe Trozocina with caution (see “Warnings and precautions”).

Impaired renal function
If you have severe kidney problems, your doctor may need to adjust the dose.

Children
The safety and efficacy of TROZOCINA Avium in the prevention or treatment of
MAC infections in children have not been established.

If you take more Trozocina Avium than you should
In case of accidental ingestion of an excessive dose of Trozocina Avium, immediately notify
your doctor or go to the nearest hospital.
The effects due to the ingestion of an excessive dose of Trozocina Avium have been similar to
those observed at normal doses (see paragraph 4).

If you forget to take Trozocina Avium
Do not take a double dose to make up for a missed dose.

If you stop taking Trozocina Avium
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Trozocina Avium can cause side effects, although not everybody gets them.

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

• Diarrhoea Common side effects (may affect up to 1 in 10 people)
• Headache
• Vomiting
• Nausea
• Abdominal pain
• Decreased lymphocytes (a type of white blood cells) in the blood
• Increased of some types of white blood cells (eosinophils, basophils, monocytes, neutrophils) in the blood
• Decreased bicarbonate in the blood Uncommon side effects (may affect up to 1 in 100 people)
• Fungal infections, particularly of the Candidagenus (candidiasis)
• Vaginal infections
• Pneumonia
• Infections caused by bacteria
• Throat infections (pharyngitis)
• Inflammation of the stomach and/or intestines (gastroenteritis)
• Respiratory disorders
• Common cold (rhinitis)
• Reduced number of white blood cells in the blood (leukopenia)
• Reduced number of neutrophils (a type of white blood cells) in the blood (neutropenia)
• Increased number of eosinophils (a type of white blood cells) in the blood
• Swelling of the skin or mucous membranes (angioedema)
• Allergic reactions
• Loss of appetite (anorexia)
• Nervousness
• Insomnia
• Dizziness
• Drowsiness
• Alteration of taste
• Tingling (paresthesia)
• Vision disorders
• Ear disorders
• Vertigo
• Fast heartbeat
• Hot flushes
• Difficulty breathing
• Nosebleeds
• Constipation
• Intestinal gas
• Indigestion
• Inflammation of the stomach (gastritis)
• Difficulty swallowing
• Abdominal bloating
• Dry mouth
• Belching
• Mouth ulcers
• Excessive saliva production
• Skin rash
• Itching
• Urticaria
• Skin inflammation (dermatitis)
• Dry skin
• Excessive sweating
• Degenerative joint disease (osteoarthritis)
• Muscle pain (myalgia)
• Back pain
• Neck pain
• Difficulty urinating
• Kidney pain
• Heavy menstrual bleeding
• Testicular disorders
• Fluid retention swelling
• Weakness
• Malaise
• Fatigue
• Facial swelling
• Chest pain
• Fever
• Pain
• Fluid accumulation in the extremities (peripheral edema)
• Increased levels of certain substances in the blood: aspartate aminotransferase, alanine aminotransferase, bilirubin, urea, creatinine, alkaline phosphatase, chloride, glucose, bicarbonate
• Alteration of potassium and sodium levels in the blood
• Increased platelets in the blood
• Decreased red blood cell content in the blood (hematocrit)
• Complications after surgery

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

• Severe skin reactions: red and scaly rash with the formation of pustules and blisters (pustulosis exanthematica)
• Agitation
• Impaired liver function
• Yellowing of the skin, mucous membranes and eyes due to bile stagnation (cholestatic jaundice)
• Sensitivity to sunlight (photosensitivity reactions)
• Drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially appears as flu-like symptoms, with a rash on the face and then with widespread rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes observed in blood tests and an increase in a type of white blood cells (eosinophilia). Side effects with unknown frequency (frequency cannot be estimated based onavailable data)
• Severe infection of the intestine with diarrhea and possible blood loss (pseudomembranous colitis)
• Low number of platelets in the blood (thrombocytopenia)
• Reduced number of red blood cells in the blood due to their destruction (hemolytic anemia)
• Severe and sudden allergic reaction, which can be fatal
• Agitation
• Aggressiveness
• Anxiety
• Confused or disturbed thinking (delirium)
• Seeing or hearing things that are not there (hallucinations)
• Fainting
• Convulsions
• Decreased skin sensitivity
• Psychomotor agitation
• Alterations or loss of smell
• Loss of taste
• Nerve and muscle disease causing muscle weakness (myasthenia gravis)
• Hearing alterations, including deafness and ringing or buzzing in the ears
• Severe alterations in the electrical activity of the heart (torsades de pointes)
• Heart rhythm disorders, including ventricular tachycardia
• Alteration of the electrical conduction of the heart detected through an electrocardiogram (QT prolongation)
• Low blood pressure
• Inflammation of the pancreas (pancreatitis)
• Discoloration of the tongue
• Liver failure (fatal in rare cases)
• Fulminant hepatitis (severe liver inflammation that develops very rapidly and is often fatal)
• Death of liver tissue (hepatic necrosis)
• Severe allergic reaction involving the skin and mucous membranes that can also be fatal (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• Allergic reaction involving the skin and mucous membranes (erythema multiforme)
• Joint pain
• Acute kidney failure
• Acute kidney inflammation (interstitial nephritis) The following side effects have been reported in patients treated with azithromycin for the prevention and treatment of infections caused by Mycobacterium avium: Very common side effects (may affect more than 1 in 10 people)
• Diarrhoea
• Nausea
• Pain and abdominal discomfort
• Flatulence
• Stool loss Common side effects (may affect up to 1 in 10 people)
• Loss of appetite (anorexia)
• Dizziness
• Headache
• Changes in the sense of taste
• Tingling (paresthesia)
• Impaired vision
• Hearing loss
• Skin rash
• Itching
• Joint pain
• Fatigue Uncommon side effects (may affect up to 1 in 100 people)
• Decreased skin sensitivity
• Hearing loss or ringing in the ear
• Fast heartbeat (palpitations)
• Liver inflammation (hepatitis)
• Severe allergic reaction involving the skin and mucous membranes (Stevens-Johnson Syndrome)
• Allergic reactions on the skin such as sensitivity to sunlight
• Fatigue
• Feeling unwell

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
http://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 Trozocina Avium

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.
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 Trozocina Avium contains

• The active substance is azithromycin dihydrate. Each film-coated tablet contains 628.93 mg of azithromycin dihydrate, equivalent to 600 mg of azithromycin base.
• The other ingredients are pregelatinized starch, anhydrous calcium phosphate acid, sodium carboxymethylcellulose, magnesium stearate, sodium lauryl sulfate. The coating contains titanium dioxide, lactose, hypromellose, triacetin.

Description of the appearance of Trozocina Avium and contents of the pack
Each pack contains 1 blister with 8 film-coated tablets of 600 mg.

Marketing Authorisation Holder
Alfasigma S.p.A. via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)

Manufacturer
HAUPT PHARMA LATINA S.r.l.
S.S. 156 km 50
04010 Borgo San Michele (Latina)

Trozocina 200 mg/5 ml powder for oral suspension

azithromycin

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

1. What is Trozocina and what is it used for

Trozocina contains the active ingredient azithromycin, an antibiotic of the macrolide class
indicated for treating infections caused by bacteria, including:

• upper respiratory tract infections (including sinusitis, tonsillitis, pharyngitis and middle ear infections);
• lower respiratory tract infections (including bronchitis and pneumonia);
• oral and dental infections;
• skin and soft tissue infections (muscles, tendons, blood vessels, nerves, fat and fascia).

2. What you need to know before taking Trozocina

Do not take Trozocina
if you are allergic to azithromycin or any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Talk to your doctor before taking Trozocina:

• if you have liver disease or impaired liver function;
• if you suffer from severe kidney problems (severe renal insufficiency);
• if you are taking a medicine containing ergotamine or its derivatives (medicines used for example against migraine);
• if you suffer from heart problems, rhythm or electrical conduction disorders of the heart, for example: or congenital heart rhythm alterations or very slow heart rate (bradycardia) or heart rhythm disorders (arrhythmias) or severe heart problems (severe heart failure);
• if you are being treated with other medicines that can affect the heart rhythm, such as: o quinidine, procainamide, dofetilide, amiodarone, sotalol (medicines for heart rhythm abnormalities) o cisapride (medicine used for stomach disorders) o terfenadine (medicine for allergies) o pimozide (medicine for mental disorders) o citalopram (medicine for depression) o moxifloxacin, levofloxacin (antibiotics);
• if you have low levels of potassium and magnesium in the blood. If any of the above applies to you, your doctor will monitor you closely during treatment with Trozocina. Tell your doctor if any of the following conditions occur or worsen duringtreatment with Trozocina:
• severe allergic reactionsincluding severe skin reactions. If an allergic reaction occurs, stop immediatelytaking Trozocina and see your doctor;
• signs and symptoms of impaired liver functionsuch as sudden onset of weakness (asthenia), yellowing of the skin and whites of the eyes (jaundice), dark urine, a tendency to bleed, brain damage (e.g. confusion and altered state of consciousness). If you notice these symptoms, see your doctor immediatelywho will perform tests to assess liver function and assess whether to stop treatment with Trozocina;
• vomiting or irritability in your baby (if he/she is a newborn in the first 42 days of life) that occur 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 infectionsor persistence of symptoms of the current infection. This situation may be caused by bacteria that are not sensitive to Trozocina (resistant bacteria) or by microorganisms other than bacteria (fungal infection);
• onset of diarrhea, the severity of which varies from mild to fatal colitis (which can cause death). Antibiotics, by altering the normal intestinal bacterial flora, can allow the overgrowth of a bacterium called Clostridium difficilewhich may not respond to antibiotic therapy and may require surgery. Diarrhea may occur during treatment and up to 2 months after its completion;
• onset or worsening of muscle weakness and fatigue, i.e. symptoms of a disease called myasthenia gravis.

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

• antacids (medicines for stomach acidity) Tell your doctor if you are taking any of the following medicines because caution is necessary:
• digoxin (medicine for the treatment of heart failure)
• colchicine (medicine used for gout and familial Mediterranean fever)
• zidovudine and nelfinavir (medicines used in the treatment of HIV)
• ergotamine (medicine for migraine)
• statins (medicines to lower blood fat levels)
• cyclosporine (medicine against organ rejection in case of organ transplantation)
• anticoagulants and in particular oral coumarin anticoagulants (e.g. warfarin)
• terfenadine (medicine for allergies)
• rifabutin (antibiotic used in tuberculosis)

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you
are breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
Studies in animals have shown that azithromycin crosses the placenta and passes into
breast milk, but there are no clinical data on the risk in pregnant women and during
breastfeeding.
The doctor will prescribe Trozocina to you only if it is absolutely necessary.

Driving and using machines
No studies have been conducted on the effects of azithromycin on the ability to drive or
use machines.
However, if visual disturbances or side effects occur that
may impair attention, it is recommended to refrain from driving vehicles
and using machines (see Possible side effects).

Trozocina 200 mg/5 ml powder for oral suspension contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before
taking this medicine.
It contains 3.9 g of sucrose (sugar) per 5 ml of suspension. This should be taken into
account in people with diabetes mellitus.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e.
essentially “sodium-free”.

3. How to take Trozocina

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

Adults
The recommended dose is 500 mg per day in a single dose, for 3 consecutive days.

Elderly
The recommended dose is that of the adult.
If you are elderly, you may have risk factors that promote heart rhythm disturbances, therefore your doctor will prescribe Trozocina with caution (see “Warnings and precautions”).

Impaired renal function
If you have severe kidney problems, your doctor may need to adjust the dose.

Children
Children weighing 45 kilograms (kg) or more
The recommended doses are the same as for adults (see “Adults”).
Children weighing less than 45 kg
The recommended dose is 10 milligrams (mg) per kilogram (kg) of body weight per day, for 3 consecutive days as per the following scheme:
The maximum recommended dose for any treatment cycle in children is 1500 mg.

Treatment of acute middle ear infections
The recommended dose is 10 mg per kg of weight per day, for 3 consecutive days, or 30 mg per kg of weight in a single daily dose. Your doctor will tell you which dose to use.

Treatment of pharyngitis due to streptococcus
The recommended dose is 10 mg per kg of weight or 20 mg per kg of weight, both administered once daily for 3 consecutive days. Your doctor will tell you which dose to use.
Trozocina should be administered once a day, regardless of whether taken on an empty stomach or after meals.

PREPARATION AND ADMINISTRATION OF THE SUSPENSION

• Shake the bottle containing the powder before adding water. -
• Use the special dropper located on the cap of the package and fill it with water up to the line (corresponding to 19 ml), only once.
• Pour the water from the dropper into the bottle.
• Shake well so that all the powder goes into suspension.

One ml of the reconstituted suspension contains 40 mg of azithromycin (equivalent to 200 mg for a 5 ml dose).
Always shake the suspension before use.
The reconstituted suspension must be administered using one of the two graduated droppers attached to the package:

3. graduated “double spoon” measuring device,

To be used for children weighing between 15 kg and 45 kg. The measuring device is
composed of a small spoon (capacity 5 ml) on one side, and a
large spoon (capacity 10 ml) on the other side

4. graduated dropper “syringe”,

To be used for children weighing less than 15 kg

• 1) INSTRUCTIONS FOR USE OF THE GRADUATED DROPPER “DOUBLE SPOON”

CHILD'S WEIGHT	ONCE A DAY FOR 3 DAYS	m AMOUNT OF DRUG
from 15 kg to 25 kg	r a Small spoon full to the brim	200 mg
from 26 kg to 35 kg	F Large spoon up to the mark	300 mg
from 36 kg to 45 kg	l e Large spoon full to the brim	400 mg

• 2) INSTRUCTIONS FOR USE OF THE GRADUATED DROPPER “SYRINGE”

• 1. The syringe is calibrated in mg and ml of drug and kg of the child's weight
• 2. Unscrew the plastic cap and insert the syringe, with the adapter, into the bottle
• 3. Draw up the prescribed amount of suspension
• 4. Detach the syringe from the adapter
• 5. Administer the suspension with the syringe directly into the child's mouth

Close the bottle with the appropriate cap. Rinse the graduated dropper used thoroughly.

WARNING

• For the treatment of acute otitis media in children, a dosage of 30 mg/kg can also be given in a single administration, filling the graduated dropper “syringe” for the number of times necessary to reach the prescribed dose.

If you take more Trozocina than you should
In case of accidental ingestion of an excessive dose of Trozocina, inform
your doctor immediately or go to the nearest hospital.
The effects due to the ingestion of an excessive dose of Trozocina were similar to those
observed at normal doses (see section 4).

If you forget to take Trozocina
Do not take and do not give the child a double dose to make up for the missed dose.

If you stop taking Trozocina
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Trozocina can cause side effects, although not everyone will experience them.

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

• Diarrhea Common side effects (may affect up to 1 in 10 people)
• Headache
• Vomiting
• Nausea
• Abdominal pain
• Decreased lymphocytes (a type of white blood cells) in the blood
• Increased levels of some types of white blood cells (eosinophils, basophils, monocytes, neutrophils) in the blood
• Decreased bicarbonate in the blood Uncommon side effects (may affect up to 1 in 100 people)
• Fungal infections, particularly of the genus Candida (candidiasis)
• Vaginal infections
• Pneumonia
• Infections caused by bacteria
• Throat infections (pharyngitis)
• Inflammation of the stomach and/or intestines (gastroenteritis)
• Respiratory disorders
• Common cold (rhinitis)
• Reduced number of white blood cells in the blood (leukopenia)
• Reduced number of neutrophils (a type of white blood cells) in the blood (neutropenia)
• Increased number of eosinophils (a type of white blood cells) in the blood
• Swelling of the skin or mucous membranes (angioedema)
• Allergic reactions
• Loss of appetite (anorexia)
• Nervousness
• Insomnia
• Dizziness
• Drowsiness
• Altered taste
• Tingling (paresthesia)
• Vision disorders
• Ear disorders
• Vertigo
• Fast heartbeat
• Hot flashes
• Difficulty breathing
• Nosebleeds
• Constipation
• Intestinal gas
• Difficulty digesting
• Inflammation of the stomach (gastritis)
• Difficulty swallowing
• Abdominal bloating
• Dry mouth
• Belching
• Mouth ulcers
• Excessive saliva production
• Skin rash
• Itching
• Hives
• Skin inflammation (dermatitis)
• Dry skin
• Excessive sweating
• Degenerative joint disease (osteoarthritis)
• Muscle pain (myalgia)
• Back pain
• Neck pain
• Difficulty urinating
• Kidney pain
• Heavy menstrual bleeding
• Testicular disorders
• Fluid retention swelling
• Weakness
• General feeling of discomfort
• Fatigue
• Facial swelling
• Chest pain
• Fever
• Pain
• Fluid accumulation in the extremities (peripheral edema)
• Increased levels of certain substances in the blood: aspartate aminotransferase, alanine aminotransferase, bilirubin, urea, creatinine, alkaline phosphatase, chloride, glucose, bicarbonate
• Changes in potassium and sodium levels in the blood
• Increased platelets in the blood
• Decreased red blood cell count (hematocrit)
• Complications after surgery Rare side effects (may affect up to 1 in 1000 people)
• Severe skin reactions: red and scaly rash with the formation of pustules and blisters (pustular exanthematous rash).
• Agitation
• Impaired liver function
• Yellowing of the skin, mucous membranes and eyes due to bile stagnation (cholestatic jaundice)
• Sensitivity to sunlight (photosensitivity reactions)
• Drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially appears as flu-like symptoms, with a rash on the face and then with widespread rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes observed in blood tests and an increase in a type of white blood cells (eosinophilia). Side effects with unknown frequency (frequency cannot be estimated based onavailable data)
• Severe infection of the intestine with diarrhea and possible blood loss (pseudomembranous colitis)
• Low number of platelets in the blood (thrombocytopenia)
• Reduced number of red blood cells in the blood due to their destruction (hemolytic anemia)
• Severe and sudden allergic reaction, which may be fatal
• Agitation
• Aggressiveness
• Anxiety
• Confused or disturbed thinking (delirium)
• Seeing or hearing things that are not there (hallucinations)
• Fainting
• Convulsions
• Decreased skin sensitivity
• Psychomotor agitation
• Changes or loss of smell
• Loss of taste
• Nerve and muscle disease causing muscle weakness (myasthenia gravis)
• Hearing disorders, including deafness and ringing or buzzing in the ears
• Severe disturbances of the heart's electrical activity (torsades de pointes)
• Heart rhythm disturbances, including ventricular tachycardia
• Alteration of the heart's electrical conduction detected by electrocardiogram (QT prolongation)
• Low blood pressure
• Inflammation of the pancreas (pancreatitis)
• Discoloration of the tongue
• Liver failure (fatal in rare cases)
• Fulminant hepatitis (severe liver inflammation that develops very rapidly and is often fatal)
• Death of liver tissue (hepatic necrosis)
• Severe allergic reaction involving the skin and mucous membranes that can also be fatal (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• Allergic reaction involving the skin and mucous membranes (erythema multiforme)
• Joint pain
• Acute kidney failure
• Acute inflammation of the kidney (interstitial nephritis)

The following side effects have been reported in patients treated with azithromycin for the
prevention and treatment of infections caused by Mycobacterium avium:

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

• Diarrhea
• Nausea
• Abdominal pain and discomfort
• Flatulence
• Loose stools Common side effects (may affect up to 1 in 10 people)
• Loss of appetite (anorexia)
• Dizziness
• Headache
• Changes in taste
• Tingling (paresthesia)
• Impaired vision
• Hearing loss
• Skin rash
• Itching
• Joint pain
• Fatigue

Uncommon side effects (may affect up to 1 in 100 people)

• Decreased skin sensitivity
• Hearing loss or ringing in the ear
• Fast heartbeat (palpitations)
• Inflammation of the liver (hepatitis)
• Severe allergic reaction involving the skin and mucous membranes (Stevens-Johnson syndrome)
• Allergic reactions on the skin such as sensitivity to sunlight
• Fatigue
• Feeling unwell

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
http://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 Trozocina

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.
After reconstitution, the oral suspension is stable for 10 days at room temperature.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Trozocina contains

• The active ingredient is azithromycin dihydrate. The reconstituted suspension contains 40 mg of azithromycin per mL (200 mg per a 5 ml dose). The composition per 100 grams of powder is 5.00 g of azithromycin dihydrate, equivalent to 4.78 g of azithromycin base.
• The other ingredients are trisodium phosphate anhydrous, hydroxypropylcellulose, xanthan gum, cherry flavour, vanilla cream, banana flavour, sucrose.

Description of the appearance of Trozocina and contents of the pack
Each pack contains 1 bottle with 600 mg of azithromycin with child-resistant closure and an appropriate graduated dispenser (syringe) and a specific adapter to be applied to the bottle for paediatric administration.
Once reconstituted, the suspension will contain 200 mg/5 ml.

Marketing Authorisation Holder
Alfasigma S.p.A. via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)

Manufacturer
HAUPT PHARMA LATINA S.r.l.
S.S. 156 km 50
04010 Borgo San Michele (Latina)

Trozocina 2 g granules for prolonged-release oral suspension

azitromicina

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

1. What is Trozocina and what is it used for

Trozocina contains the active ingredient azithromycin, an antibiotic of the macrolide class
indicated for treating mild to moderate respiratory tract infections caused by
bacteria, including:

• worsening of chronic bronchitis;
• acute sinusitis;
• community-acquired pneumonia;
• upper respiratory tract infections, tonsillitis, pharyngitis.

2. What you need to know before you take Trozocina

Do not take Trozocina
if you are allergic to azithromycin or to any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Talk to your doctor before taking Trozocina:

• if you have a liver disease or impaired liver function;
• if you suffer from severe kidney problems (severe renal insufficiency);
• if you are taking a medicine containing ergotamine or its derivatives (medicines used for example against migraine);
• if you suffer from heart problems, rhythm or electrical conduction disorders of the heart, for example: or congenital rhythm alterations or very slow heart rate (bradycardia) or heart rhythm diseases (arrhythmias) or severe heart problems (severe heart failure);
• if you are being treated with other medicines that can affect the heart rhythm, such as: or quinidine, procainamide, dofetilide, amiodarone, sotalol (medicines against heart rhythm anomalies) or cisapride (medicine used for stomach disorders) or terfenadine (medicine against allergies) or pimozide (medicine against mental disorders) or citalopram (medicine against depression) or moxifloxacin, levofloxacin (antibiotics);
• if you have low levels of potassium and magnesium in the blood. If any of the above applies to you, your doctor will monitor you closely during treatment with Trozocina. Tell your doctor if any of the following conditions occur or worsen duringtreatment with Trozocina:
• severe allergic reactionsincluding severe skin reactions. If an allergic reaction occurs, stop immediatelytaking Trozocina and see your doctor;
• signs and symptoms of impaired liver functionsuch as sudden onset of weakness (asthenia), yellowing of the skin and whites of the eyes (jaundice), dark urine, tendency to bleed, brain damage (e.g. confusion and altered state of consciousness). If you notice these symptoms, see your doctor immediatelywho will perform tests to assess liver condition and evaluate whether to stop treatment with Trozocina;
• vomiting or irritability in your baby (if it is a newborn in the first 42 days of life) that occur 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 infectionsor persistence of the symptoms of the current infection. This situation may be caused by bacteria that are not sensitive to Trozocina (resistant bacteria) or by microorganisms other than bacteria (fungal infection);
• onset of diarrhea, the severity of which varies from mild to fatal colitis (which can cause death). Antibiotics, by altering the normal bacterial flora of the intestine, can allow the overgrowth of a bacterium called Clostridium difficilewhich may not respond to antibiotic therapy and require surgical intervention.

Diarrhea may occur during treatment and up to 2 months after its
completion;

• onset or worsening of muscle weakness and fatigue, i.e. symptoms of a disease called myasthenia gravis. ChildrenTrozocina is not recommended in adolescents under 12 years of age.

Other medicines and Trozocina
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 required:

• digoxin (medicine for the treatment of heart failure)
• colchicine (medicine used for gout and familial Mediterranean fever);
• zidovudine and nelfinavir (medicines used in the treatment of HIV)
• ergotamine (medicine against migraine)
• statins (medicines to lower blood fat levels)
• cyclosporine (medicine against rejection in case of organ transplantation)
• anticoagulants and in particular coumarin oral anticoagulants (e.g. warfarin)
• terfenadine (medicine against allergies)
• rifabutin (antibiotic used in tuberculosis)

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. Studies in animals have shown that azithromycin crosses the placenta and
passes into breast milk, but there are no clinical data on the risk in pregnant women
and during breastfeeding.
Your doctor will prescribe Trozocina only if it is absolutely necessary.

Driving and operating machinery
No studies have been conducted on the effects of azithromycin on the ability to drive or
operate machinery.
However, if you experience visual disturbances or side effects that
may impair attention, it is recommended to refrain from driving vehicles
and operating machinery (see Possible side effects).

Trozocina contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before
taking this medicine.
This medicine contains 19.36 g of sucrose per dose. This should be taken into account in
people with diabetes mellitus.

Trozocina contains sodium
This medicine contains 148 mg (or 6.44 mmol) of sodium (the main component of table
salt) per dose. This is equivalent to 7.4% of the recommended maximum daily intake
of sodium with the diet of an adult.

3. How to take Trozocina

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

Adults and adolescents
The recommended dose is 2 g per day, in a single dose.
In case of vomiting within 5 minutes of taking Trozocina, take a second dose.

Elderly
The recommended dose is that of the adult.
If you are elderly you may have risk factors that favor heart rhythm disturbances, therefore your doctor will prescribe Trozocina with caution (see “Warnings and precautions”).

Impaired kidney function
If you have severe kidney problems, your doctor may need to adjust the dose.

Children
Trozocina is not recommended in adolescents under 12 years of age.
Take Trozocina on an empty stomach (at least 1 hour before or 2 hours after meals).

How to prepare the oral suspension of Trozocina

• Open the container by pushing and rotating the child-resistant cap.
• Use the measuring cap provided in the package to measure the amount of water needed for reconstitution: you must use a total of 60 ml of water.
• Close the container with the original cap and shake well before use.
• Take all of the reconstituted suspension.
• The reconstituted oral suspension must be taken immediately after preparation.

If you take more Trozocina than you should
In case of accidental ingestion of an excessive dose of Trozocina, immediately inform your doctor or go to the nearest hospital.
The effects due to the ingestion of an excessive dose of Trozocina have been similar to those observed at normal doses (see section 4).

If you forget to take Trozocina
Do not take and do not administer to the child a double dose to compensate for the forgotten dose.

If you stop taking Trozocina
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Trozocina can cause side effects, although not everybody gets them.

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

• Diarrhea Common side effects (may affect up to 1 in 10 people)
• Headache
• Vomiting
• Nausea
• Abdominal pain
• Decreased lymphocytes (a type of white blood cells) in the blood
• Increased levels of some types of white blood cells (eosinophils, basophils, monocytes, neutrophils) in the blood
• Decreased bicarbonate in the blood Uncommon side effects (may affect up to 1 in 100 people)
• Fungal infections, particularly of the Candidagenus (candidiasis)
• Vaginal infections
• Pneumonia
• Infections caused by bacteria
• Throat infections (pharyngitis)
• Inflammation of the stomach and/or intestines (gastroenteritis)
• Respiratory disorders
• Common cold (rhinitis)
• Reduced number of white blood cells in the blood (leukopenia)
• Reduced number of neutrophils (a type of white blood cells) in the blood (neutropenia)
• Increased number of eosinophils (a type of white blood cells) in the blood
• Swelling of the skin or mucous membranes (angioedema)
• Allergic reactions
• Loss of appetite (anorexia)
• Nervousness
• Insomnia
• Dizziness
• Drowsiness
• Alteration of taste
• Tingling (paresthesia)
• Vision disorders
• Ear disorders
• Vertigo
• Fast heartbeat
• Hot flushes
• Difficulty breathing
• Nosebleed
• Constipation
• Intestinal gas
• Difficult digestion
• Inflammation of the stomach (gastritis)
• Difficulty swallowing
• Abdominal bloating
• Dry mouth
• Belching
• Mouth ulcers
• Excessive saliva production
• Skin rash
• Itching
• Urticaria
• Skin inflammation (dermatitis)
• Dry skin
• Excessive sweating
• Degenerative joint disease (osteoarthritis)
• Muscle pain (myalgia)
• Back pain
• Neck pain
• Difficulty urinating
• Kidney pain
• Heavy menstrual bleeding
• Testicular disorders
• Fluid retention swelling
• Weakness
• Malaise
• Fatigue
• Facial swelling
• Chest pain
• Fever
• Pain
• Fluid accumulation in the extremities (peripheral edema)
• Increased levels of certain substances in the blood: aspartate aminotransferase, alanine
• Changes in potassium and sodium levels in the blood
• Increased platelets in the blood
• Decreased red blood cell content in the blood (hematocrit)
• Complications after surgery Rare side effects (may affect up to 1 in 1,000 people)
• Severe skin reactions: red and scaly rash with the formation of pustules and blisters (pustulosis exanthematica).
• Agitation
• Impaired liver function
• Yellowing of the skin, mucous membranes and eyes due to bile stagnation (cholestatic jaundice)
• Sensitivity to sunlight (photosensitivity reactions)
• Drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially appears as flu-like symptoms, with a rash on the face and then with widespread rash, high temperature, swollen lymph nodes, increased levels of liver enzymes observed in blood tests and an increase in a type of white blood cells (eosinophilia). Side effects with unknown frequency (frequency cannot be estimated based onavailable data)
• Severe infection of the intestine with diarrhea and possible blood loss (pseudomembranous colitis)
• Low number of platelets in the blood (thrombocytopenia)
• Reduced number of red blood cells in the blood due to their destruction (hemolytic anemia)
• Severe and sudden allergic reaction, which can be fatal
• Agitation
• Aggressiveness
• Anxiety
• Confused or disturbed thinking (delirium)
• Seeing or hearing things that are not there (hallucinations)
• Fainting
• Convulsions
• Decreased skin sensitivity
• Psychomotor agitation
• Changes or loss of smell
• Loss of taste
• Disease of the nerves and muscles that causes muscle weakness (myasthenia gravis)
• Changes in hearing, including deafness and ringing or buzzing in the ears
• Severe disturbances of the heart's electrical activity (torsades de pointes)
• Heart rhythm disturbances, including ventricular tachycardia
• Alteration of the heart's electrical conduction detected through an electrocardiogram (prolongation of the QT interval)
• Low blood pressure
• Inflammation of the pancreas (pancreatitis)
• Discoloration of the tongue
• Liver failure (fatal in rare cases)
• Fulminant hepatitis (severe liver inflammation that develops very rapidly and is often fatal)
• Death of liver tissue (hepatic necrosis)
• Severe allergic reaction involving the skin and mucous membranes that can also be fatal (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• Allergic reaction involving the skin and mucous membranes (multiforme erythema)
• Joint pain
• Acute kidney failure
• Acute kidney inflammation (interstitial nephritis) The following side effects have been reported in patients treated with azithromycin for the prevention and treatment of infections caused by Mycobacterium avium: Very common side effects (may affect more than 1 in 10 people)
• Diarrhea
• Nausea
• Abdominal pain and discomfort
• Flatulence
• Stool loss Common side effects (may affect up to 1 in 10 people)
• Loss of appetite (anorexia)
• Dizziness
• Headache
• Changes in the sense of taste
• Tingling (paresthesia)
• Impaired vision
• Hearing loss
• Skin rash
• Itching
• Joint pain
• Fatigue Uncommon side effects (may affect up to 1 in 100 people)
• Decreased skin sensitivity
• Hearing loss or ringing in the ear
• Fast heartbeat (palpitations)
• Liver inflammation (hepatitis)
• Severe allergic reaction involving the skin and mucous membranes (Stevens-Johnson syndrome)
• Allergic reactions on the skin such as sensitivity to sunlight
• Fatigue
• Feeling unwell

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
http://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 Trozocina

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.
Do not store at a temperature above 30°C. Store in the original packaging.
Keep the container tightly closed.
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 Trozocina contains

• The active ingredient is azithromycin dihydrate. Each vial contains azithromycin dihydrate equivalent to 2.0 g of azithromycin base. The other ingredients are dibeenoyl glycerol, poloxamer 407, sucrose, anhydrous tribasic sodium phosphate, magnesium hydroxide, hydroxypropylcellulose, xanthan gum, anhydrous colloidal silica, titanium dioxide, cherry flavour, banana flavour.

Description of the appearance of Trozocina and contents of the pack
Each pack contains 1 vial containing 2.0 g of azithromycin dihydrate to be reconstituted
with 60 ml of water. A measuring cap is included in the pack to measure the water
needed for reconstitution.

Marketing Authorisation Holder
Alfasigma S.p.A. via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)

Manufacturer
HAUPT PHARMA LATINA S.r.l.
S.S. 156 km 50
04010 Borgo San Michele (Latina)

Trozocina 500 mg powder for solution for infusion

azithromycin

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

1. What is Trozocina and what is it used for

Trozocina contains the active substance azithromycin, an antibiotic of the macrolide class.
Trozocina is indicated to treat:

• community-acquired pneumonia caused by susceptible bacteria, including Legionellapneumophila, in patients who require initial therapy by injection into a vein (intravenous therapy);
• pelvic inflammatory disease caused by susceptible organisms, in patients who require intravenous therapy.

2. What you need to know before you take Trozocina

Do not take Trozocina
if you are allergic to azithromycin or any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Talk to your doctor before taking Trozocina:

• if you have liver disease or impaired liver function;
• if you suffer from severe kidney problems (severe renal insufficiency);
• if you are taking a medicine containing ergotamine or its derivatives (medicines used for example against migraine);
• if you suffer from heart problems, rhythm disturbances or electrical conduction disturbances of the heart, for example: or congenital rhythm alterations or very slow heart rate (bradycardia) or heart rhythm disorders (arrhythmias) or severe heart problems (severe heart failure);
• if you are being treated with other medicines that can affect the heart rhythm, such as: o quinidine, procainamide, dofetilide, amiodarone, sotalol (medicines against heart rhythm anomalies) o cisapride (medicine used for stomach disorders) o terfenadine (medicine against allergies) o pimozide (medicine against mental disorders) o citalopram (medicine against depression) o moxifloxacin, levofloxacin (antibiotics);
• if you have low levels of potassium and magnesium in the blood. If any of the above applies to you, your doctor will monitor you closely during treatment with Trozocina. Tell your doctor if any of the following conditions occur or worsen duringtreatment with Trozocina:
• severe allergic reactionsincluding severe skin reactions. If an allergic reaction occurs, stop immediatelytreatment with Trozocina and consult your doctor;
• signs and symptoms of impaired liver functionsuch as sudden onset of weakness (asthenia), yellowing of the skin and whites of the eyes (jaundice), dark urine, tendency to bleed, brain damage (e.g. confusion and altered state of consciousness). If you notice these symptoms, consult your doctor immediatelywho will perform tests to assess liver conditions and assess whether to discontinue treatment with Trozocina;
• vomiting or irritability in your baby (if he/she is 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, consult your baby's doctor immediately;
• symptoms of new infectionsor persistence of the symptoms of the current infection. This situation may be caused by bacteria that are not sensitive to Trozocina (resistant bacteria) or by microorganisms other than bacteria (fungal infection);
• onset of diarrhea, the severity of which varies from mild to fatal colitis (which can cause death). Antibiotics, by altering the normal bacterial flora of the intestine, can allow the overgrowth of a bacterium called Clostridium difficilewhich can

not respond to antibiotic therapy and require surgical intervention.
Diarrhea may occur during treatment and up to 2 months after its
completion;

• onset or worsening of muscle weakness and fatigue, i.e. symptoms of a disease called myasthenia gravis. Children and adolescentsThe safety and efficacy of TROZOCINA powder for solution for infusion in children and adolescents under 16 years of age have not been established.

Other medicines and Trozocina
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 required:

• antacids (medicines against stomach acidity)
• digoxin (medicine for the treatment of heart failure)
• colchicine (medicine used for gout and familial Mediterranean fever);
• zidovudine and nelfinavir (medicines used in the treatment of HIV)
• ergotamine (medicine against migraine)
• statins (medicines to lower blood fat levels)
• cyclosporine (medicine against rejection in organ transplantation)
• anticoagulants and in particular coumarin-type oral anticoagulants (e.g. warfarin)
• terfenadine (medicine against allergies)
• rifabutin (antibiotic used in tuberculosis)

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
Studies in animals have shown that azithromycin crosses the placenta and passes into
breast milk, but there are no clinical data on the risk in pregnant women and during
breastfeeding.
Your doctor will prescribe Trozocina only if absolutely necessary.

Driving and using machines
No studies have been conducted on the effects of azithromycin on the ability to drive or
use machines.
However, if visual disturbances or side effects occur that
may impair attention, it is recommended to refrain from driving
and using machinery (see Possible side effects).

Trozocina contains sodium
This medicine contains 114 mg (or 4.9 mmol) of sodium (the main component of table
salt) per vial. This is equivalent to 5.7% of the maximum recommended daily intake
with the diet of an adult.
To be taken into consideration in people with impaired renal function or who are following
a low-sodium diet.

3. How to take Trozocina

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Trozocina will be administered by intravenous infusion.

Adults
Treatment of community-acquired pneumonia
The recommended dose is 500 mg in a single daily dose for at least 2 days.
After intravenous administration, your doctor will then prescribe azithromycin orally in
a single daily dose for 7-10 days.
Treatment of pelvic inflammatory disease
The recommended dose is 500 mg in a single daily dose for 1 or 2 days.
After intravenous administration, your doctor will then prescribe 250 mg of azithromycin
orally in a single daily dose for 7 days.

Elderly
The recommended dose is that of the adult.
If you are elderly, you may have risk factors that promote heart rhythm disturbances,
therefore your doctor will prescribe Trozocina with caution (see “Warnings and precautions”).

Renal impairment
If you have severe kidney problems, your doctor may need to adjust the dose.

Children
The safety and efficacy of TROZOCINA powder for solution for infusion in children and
adolescents under 16 years of age have not been established

If you take more Trozocina than you should
In case of accidental ingestion or use of an excessive dose of Trozocina, immediately inform
your doctor or go to the nearest hospital.
The effects due to an excessive dose of Trozocina have been similar to those observed at normal doses (see section 4).

If you stop taking Trozocina
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Trozocina can cause side effects, although not everybody gets them.
Following administration of azithromycin, by intravenous and oral route, in the
treatment of community-acquired pneumonia, the most frequently reported side effects were:

• diarrhoea, soft stools
• nausea, abdominal pain and vomiting With intravenous administration of azithromycin the following have been reported:
• local inflammations, pain at the infusion site Following administration of azithromycin, by intravenous and oral route, in the treatment of pelvic inflammatory disease in adult women, the most frequently reported side effects were:
• diarrhoea
• nausea
• vaginal inflammation (vaginitis)
• abdominal pain
• decreased or loss of appetite
• skin irritation and itching When azithromycin was administered in combination with metronidazole, a higher number of women reported the following side effects:
• nausea, abdominal pain, vomiting
• reactions at the site of administration
• inflammation of the mouth mucosa (stomatitis)
• dizziness
• difficulty breathing (dyspnoea) Very common side effects (may affect more than 1 in 10 people)
• Diarrhoea Common side effects (may affect up to 1 in 10 people)
• Headache
• Vomiting
• Nausea
• Pain and inflammation at the site of administration
• Abdominal pain
• Decreased lymphocytes (a type of white blood cells) in the blood
• Increased of some types of white blood cells (eosinophils, basophils, monocytes, neutrophils) in the blood
• Decreased bicarbonate in the blood Uncommon side effects (may affect up to 1 in 100 people)
• Fungal infections, particularly of the genus Candida (candidiasis)
• Vaginal infections
• Pneumonia
• Infections caused by bacteria
• Throat infections (pharyngitis)
• Inflammation of the stomach and/or intestines (gastroenteritis)
• Breathing disorders
• Common cold (rhinitis)
• Decreased number of white blood cells in the blood (leucopenia)
• Decreased number of neutrophils (a type of white blood cells) in the blood (neutropenia)
• Increased number of eosinophils (a type of white blood cells) in the blood
• Swelling of the skin or mucous membranes (angioedema)
• Allergic reactions
• Loss of appetite (anorexia)
• Nervousness
• Insomnia
• Dizziness
• Drowsiness
• Alteration of taste
• Tingling (paresthesia)
• Vision disorders
• Ear disorders
• Vertigo
• Fast heartbeat
• Hot flushes
• Difficulty breathing
• Nosebleeds
• Constipation
• Intestinal gas
• Difficult digestion
• Inflammation of the stomach (gastritis)
• Difficulty swallowing
• Abdominal bloating
• Dry mouth
• Belching
• Mouth ulcers
• Excessive saliva production
• Skin rash
• Itching
• Hives
• Skin inflammation (dermatitis)
• Dry skin
• Excessive sweating
• Degenerative joint disease (osteoarthritis)
• Muscle pain (myalgia)
• Back pain
• Neck pain
• Difficulty urinating
• Kidney pain
• Heavy menstrual bleeding
• Testicular disorders
• Swelling due to fluid retention
• Weakness
• Malaise
• Fatigue
• Facial swelling
• Chest pain
• Fever
• Pain
• Fluid accumulation in the limbs (peripheral edema)
• Increased values of some substances in the blood: aspartate aminotransferase, alanine aminotransferase, bilirubin, urea, creatinine, alkaline phosphatase, chlorine, glucose, bicarbonate
• Alteration of potassium and sodium levels in the blood
• Increased platelets in the blood
• Decreased red blood cells in the blood (hematocrit)
• Complications after surgeries Rare side effects (may affect up to 1 in 1000 people)
• Severe skin reactions: red and scaly rash with formation of pustules and blisters (pustular exanthematous).
• Agitation
• Impaired liver function
• Yellowing of the skin, mucous membranes and eyes due to bile stagnation (cholestatic jaundice)
• Sensitivity to sunlight (reactions of photosensitivity)
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially appears as flu-like symptoms, with a rash on the face and then with widespread rash, high temperature, swollen lymph nodes, increased levels of liver enzymes observed in blood tests and an increase in a type of white blood cells (eosinophilia). Side effects with unknown frequency (frequency cannot be estimated based onavailable data)
• Severe infection of the intestine with diarrhoea and possible blood loss (pseudomembranous colitis)
• Low number of platelets in the blood (thrombocytopenia)
• Decreased number of red blood cells in the blood due to their destruction (hemolytic anemia)
• Severe and sudden allergic reaction, which can be fatal
• Agitation
• Aggressiveness
• Anxiety
• Confused or disturbed thinking (delirium)
• Seeing or hearing things that are not there (hallucinations)
• Fainting
• Convulsions
• Decreased skin sensitivity
• Psychomotor agitation
• Alterations or loss of smell
• Loss of taste
• Nerve and muscle disease that causes muscle weakness (myasthenia gravis)
• Hearing alterations, including deafness and ringing or buzzing in the ears
• Severe disturbances of the heart's electrical activity (torsades de pointes)
• Heart rhythm disturbances, including ventricular tachycardia
• Alteration of the electrical conduction of the heart detected through the electrocardiogram (prolongation of the QT interval)
• Low blood pressure
• Inflammation of the pancreas (pancreatitis)
• Discoloration of the tongue
• Liver failure (fatal in rare cases)
• Fulminant hepatitis (severe liver inflammation that develops very rapidly and is often fatal)
• Death of liver tissue (hepatic necrosis)
• Severe allergic reaction involving the skin and mucous membranes that can also be fatal (Stevens-Johnson syndrome, and toxic epidermal necrolysis)
• Allergic reaction involving the skin and mucous membranes (erythema multiforme)
• Joint pain
• Acute kidney failure
• Acute inflammation of the kidney (interstitial nephritis) The following side effects have been reported in patients treated with azithromycin for the prevention and treatment of infections caused by Mycobacterium avium: Very common side effects (may affect more than 1 in 10 people)
• Diarrhoea
• Nausea
• Pain and abdominal discomfort
• Flatulence
• Stool loss Common side effects (may affect up to 1 in 10 people)
• Loss of appetite (anorexia)
• Dizziness
• Headache
• Changes in the sense of taste
• Tingling (paresthesia)
• Impaired vision
• Hearing loss
• Skin rash
• Itching
• Joint pain
• Fatigue

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
You can also report side effects directly through the national reporting system at
http://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 Trozocina

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.
The reconstituted solution is stable for 24 hours if stored at temperatures not exceeding
30°C.
However, the product must be used immediately. If the suspension is not used
immediately, it is the responsibility of the user to verify the storage times and conditions.
It is recommended not to exceed 24 hours at temperatures between 2 and 8°C, except in the
case where reconstitution/dilution has taken place under validated and controlled aseptic
conditions.
Do not dispose of any medicine in the wastewater and 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 Trozocina Contains

• The active ingredient is azithromycin dihydrate. Each vial contains 524.1 mg of azithromycin dihydrate, equivalent to 500 mg of azithromycin base.
• The other ingredients are anhydrous citric acid, sodium hydroxide.

Description of the appearance of Trozocina and package contents
Each package contains 1 vial of 10 ml powder for solution for infusion.

Marketing Authorisation Holder
Alfasigma S.p.A. via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)

Manufacturer
Pfizer PGM
Zone Industrielle-29
Route des Industries-37530
Pocé-Sur-Cisse, France
---------------------------------------------------------------------------------------------------------------------------

The following information is intended exclusively for healthcare professionals

Route of administration
TROZOCINA powder for solution for infusion must not be administered as a bolus
intravenously or intramuscularly (see sections 4.4 and 6.6).
The concentration of the solution and the duration of the infusion must be equal to: 1 mg/ml for
3 hours or 2 mg/ml for 1 hour.
The intravenous administration of a dose of 500 mg of azithromycin, diluted according to the
instructions, must be carried out over a period of no less than 60 minutes.

Instructions for reconstitution and dilution
TROZOCINA powder for solution for infusion is contained in a single-dose vial. The
contents of the vial must be reconstituted with 4.8 ml of sterile water for injections
(100 mg/ml of azithromycin). For administration, the required volume of reconstituted solution
is added to the compatible infusion solution in order to obtain a
solution of azithromycin with a concentration of 1.0-2.0 mg/ml.
Final concentration of the infusion solution Volume of solvent
1.0 mg/ml 500 ml
2.0 mg/ml 250 ml
Carefully check the prepared solution to exclude the presence of particulate matter.
If particles in suspension are evident, the solution must be discarded.
Chemical and physical stability after reconstitution has been demonstrated for 24 hours at 30 °C. Once
diluted according to the instructions, the solution is chemically and physically stable
for 24 hours at temperatures equal to or less than 30 °C or for 7 days if stored in
refrigerator (5 °C).
However, from a microbiological point of view, the product must be used immediately.
If the suspension is not used immediately, it is the responsibility of the user to verify the
storage times and conditions, which should normally not exceed 24 hours
at temperatures between 2 and 8°C, except in the case where reconstitution/dilution
has taken place under validated and controlled aseptic conditions.
The reconstituted solution must be diluted with one of the following infusion solutions:
Sodium chloride 0.9 % solution
Sodium chloride 0.45 % solution
Ringer's Lactate
Glucose 5 % in water
Glucose 5 % in sodium chloride 0.45 % solution with 20 mEq KCl
Glucose 5 % in sodium chloride 0.45 % solution
Glucose 5 % in sodium chloride 0.30 % solution
Glucose 5 % in Ringer's Lactate
The reconstituted solution is chemically and physically stable for 24 hours if stored at
temperatures not exceeding 30 °C. However, from a microbiological point of view, the product
must be used immediately. If the suspension is not used immediately, it is
the responsibility of the user to verify the storage times and conditions. However, it is
recommended not to exceed 24 hours at temperatures between 2 and 8 °C, except in the
case where reconstitution/dilution has taken place under validated and controlled aseptic
conditions.

Trozocina 250 mg hard capsules

azithromycin

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

1. What is Trozocina and what is it used for

Trozocina contains the active substance azithromycin, an antibiotic of the macrolide class
indicated for treating infections caused by bacteria, including:

• upper respiratory tract infections (including sinusitis, tonsillitis, pharyngitis and middle ear infections);
• lower respiratory tract infections (including bronchitis and pneumonia);
• infections of the mouth and teeth;
• skin and soft tissue infections (muscles, tendons, blood vessels, nerves, fat and fascia);
• urethral infections (the tube that connects the urinary bladder to the outside), caused by a bacterium called Chlamydia trachomatis;
• soft chancre, a sexually transmitted disease caused by the bacterium Haemophilus ducreyi.

2. What you need to know before taking Trozocina

Do not take Trozocina
if you are allergic to azithromycin or any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Talk to your doctor before taking Trozocina:

• if you have liver disease or impaired liver function;
• if you suffer from severe kidney problems (severe renal insufficiency);
• if you are taking a medicine containing ergotamine or its derivatives (medicines used for example for migraine);
• if you have a sexually transmitted infection because the doctor must exclude syphilis;
• if you suffer from heart problems, rhythm or electrical conduction disorders of the heart, for example: congenital heart rhythm alterations or very slow heart rate (bradycardia) or heart rhythm disorders (arrhythmias) or severe heart problems (severe heart failure);
• if you are being treated with other medicines that can affect the heart rhythm, such as: quinidine, procainamide, dofetilide, amiodarone, sotalol (medicines for heart rhythm abnormalities) or cisapride (medicine used for stomach disorders) or terfenadine (medicine for allergies) or pimozide (medicine for mental disorders) or citalopram (medicine for depression) or moxifloxacin, levofloxacin (antibiotics);
• if you have low levels of potassium and magnesium in the blood. If any of the above applies to you, your doctor will monitor you closely during treatment with Trozocina. Tell your doctor if any of the following conditions occur or worsen duringtreatment with Trozocina:
• severe allergic reactionsincluding severe skin reactions. If an allergic reaction occurs, stop immediatelytaking Trozocina and see your doctor;
• signs and symptoms of impaired liver functionsuch as sudden onset of weakness (asthenia), yellowing of the skin and whites of the eyes (jaundice), dark urine, a tendency to bleed, brain damage (e.g. confusion

mental and altered state of consciousness). If you notice these symptoms, see your doctor immediatelywho will perform tests to assess liver conditions and assess whether to stop treatment with Trozocina;

• vomiting or irritability in your baby (if he/she is a newborn in the first 42 days of life) that occur 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 infectionsor persistence of the symptoms of the current infection. This situation may be caused by bacteria that are not sensitive to Trozocina (resistant bacteria) or by microorganisms other than bacteria (fungal infection);
• onset of diarrhea, the severity of which varies from mild to fatal colitis (which can cause death). Antibiotics, by altering the normal bacterial flora of the intestine, can allow the overgrowth of a bacterium called Clostridium difficilewhich may not respond to antibiotic therapy and may require surgery. Diarrhea may occur during treatment and up to 2 months after its completion;
• onset or worsening of muscle weakness and fatigue, i.e. symptoms of a disease called myasthenia gravis.

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

• antacids (medicines for stomach acidity) Tell your doctor if you are taking any of the following medicines because caution is necessary:
• digoxin (medicine for the treatment of heart failure)
• colchicine (medicine used for gout and familial Mediterranean fever);
• zidovudine and nelfinavir (medicines used in the treatment of HIV)
• ergotamine (medicine for migraine)
• statins (medicines to lower blood fat levels)
• cyclosporine (medicine against rejection in case of organ transplantation)
• anticoagulants and in particular coumarin oral anticoagulants (e.g. warfarin)
• terfenadine (medicine for allergies)
• rifabutin (antibiotic used in tuberculosis)

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
Studies in animals have shown that azithromycin crosses the placenta and passes into
breast milk, but there are no clinical data on the risk in pregnant women and during
breastfeeding.
The doctor will prescribe Trozocina to you only if it is really necessary.

Driving and operating machinery
No studies have been conducted on the effects of azithromycin on the ability to drive or
operate machinery.
However, if visual disturbances or side effects occur that
may impair attention, it is recommended to refrain from driving vehicles
and operating machinery (see Possible side effects).

Trozocina contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him/her before
taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e.
essentially “sodium-free”.

3. How to take Trozocina

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

Adults
Treatment of infections of the upper and lower respiratory tract, skin, soft tissues
(muscles, tendons, blood vessels, nerves, fat and fascia), mouth and teeth
The recommended dose is 500 mg (1 tablet) per day, in a single dose, for 3 consecutive days.
Treatment of sexually transmitted diseases (caused by germs and bacteria sensitive of the
species Chlamydia trachomatisor Haemophilus ducreyi)
The recommended dose is 1000 mg (2 500 mg tablets), in a single dose and for
only one day.

Elderly
The recommended dose is that of the adult.
If you are elderly, you may have risk factors that favor heart rhythm disturbances,
therefore your doctor will prescribe Trozocina with caution (see “Warnings and precautions”).

Impaired kidney function
If you have severe kidney problems, your doctor may need to adjust the dose.
Take Trozocina on an empty stomach (at least 1 hour before or 2 hours after meals).
The capsules must be swallowed whole.

If you take more Trozocina than you should
In case of accidental ingestion of an excessive dose of Trozocina, immediately notify
your doctor or go to the nearest hospital.
The effects due to the ingestion of an excessive dose of Trozocina have been similar to those
observed at normal doses (see section 4).

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

If you stop taking Trozocina
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Trozocina can cause side effects, although not everybody gets them.

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

• Diarrhea Common side effects (may affect up to 1 in 10 people)
• Headache
• Vomiting
• Nausea
• Abdominal pain
• Decreased lymphocytes (a type of white blood cells) in the blood
• Increased of some types of white blood cells (eosinophils, basophils, monocytes, neutrophils) in the blood
• Decreased bicarbonate in the blood Uncommon side effects (may affect up to 1 in 100 people)
• Fungal infections, particularly of the Candidagenus (candidiasis)
• Vaginal infections
• Pneumonia
• Infections caused by bacteria
• Throat infections (pharyngitis)
• Inflammation of the stomach and/or intestines (gastroenteritis)
• Respiratory disorders
• Common cold (rhinitis)
• Reduction in the number of white blood cells in the blood (leukopenia)
• Reduction in the number of neutrophils (a type of white blood cells) in the blood (neutropenia)
• Increased number of eosinophils (a type of white blood cells) in the blood
• Swelling of the skin or mucous membranes (angioedema)
• Allergic reactions
• Loss of appetite (anorexia)
• Nervousness
• Insomnia
• Dizziness
• Drowsiness
• Alteration of taste
• Tingling (paresthesia)
• Vision disorders
• Ear disorders
• Vertigo
• Fast heartbeat
• Hot flushes
• Difficulty breathing
• Nosebleeds
• Constipation
• Intestinal gas
• Indigestion
• Inflammation of the stomach (gastritis)
• Difficulty swallowing
• Abdominal bloating
• Dry mouth
• Belching
• Mouth ulcers
• Excessive saliva production
• Skin rash
• Itching
• Urticaria
• Skin inflammation (dermatitis)
• Dry skin
• Excessive sweating
• Degenerative joint disease (osteoarthritis)
• Muscle pain (myalgia)
• Back pain
• Neck pain
• Difficulty urinating
• Kidney pain
• Heavy menstrual bleeding
• Testicular disorders
• Fluid retention swelling
• Weakness
• Malaise
• Fatigue
• Facial swelling
• Chest pain
• Fever
• Pain
• Fluid accumulation in the extremities (peripheral edema)
• Increased values of some substances in the blood: aspartate aminotransferase, alanine aminotransferase, bilirubin, urea, creatinine, alkaline phosphatase, chlorine, glucose, bicarbonate
• Alteration of potassium and sodium levels in the blood
• Increased platelets in the blood
• Decreased red blood cell content in the blood (hematocrit)
• Complications after surgeries Rare side effects (may affect up to 1 in 1000 people)
• Severe skin reactions: red and scaly rash with the formation of pustules and blisters (pustular exanthematous rash).
• Agitation
• Impaired liver function
• Yellowing of the skin, mucous membranes and eyes due to bile stagnation (cholestatic jaundice)
• Sensitivity to sunlight (photosensitivity reactions)
• Drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially appears as flu-like symptoms, with a rash on the face and then with widespread rash, high temperature, swollen lymph nodes, increased levels of liver enzymes observed in blood tests and an increase in a type of white blood cells (eosinophilia).

Side effects with unknown frequency (frequency cannot be estimated based on
available data)

• Severe infection of the intestine with diarrhea and possible blood loss (pseudomembranous colitis)
• Low number of platelets in the blood (thrombocytopenia)
• Reduction in the number of red blood cells in the blood due to their destruction (hemolytic anemia)
• Severe and sudden allergic reaction, which may be fatal
• Agitation
• Aggressiveness
• Anxiety
• Confused or disturbed thinking (delirium)
• Seeing or hearing things that are not there (hallucinations)
• Fainting
• Convulsions
• Decreased skin sensitivity
• Psychomotor agitation
• Alterations or loss of smell
• Loss of taste
• Nerve and muscle disease causing muscle weakness (myasthenia gravis)
• Hearing alterations, including deafness and ringing or buzzing in the ears
• Severe alterations in the electrical activity of the heart (torsades de pointes)
• Heart rhythm disturbances, including ventricular tachycardia
• Alteration of the electrical conduction of the heart detected through an electrocardiogram (QT prolongation)
• Low blood pressure
• Inflammation of the pancreas (pancreatitis)
• Discoloration of the tongue
• Liver failure (fatal in rare cases)
• Fulminant hepatitis (severe liver inflammation that develops very rapidly and is often fatal)
• Death of liver tissue (hepatic necrosis)
• Severe allergic reaction involving the skin and mucous membranes that may also be fatal (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• Allergic reaction involving the skin and mucous membranes (erythema multiforme)
• Joint pain
• Acute kidney failure
• Acute inflammation of the kidney (interstitial nephritis) The following side effects have been reported in patients treated with azithromycin for the prevention and treatment of infections caused by Mycobacterium avium: Very common side effects (may affect more than 1 in 10 people)
• Diarrhea
• Nausea
• Pain and abdominal discomfort
• Flatulence
• Stool loss Common side effects (may affect up to 1 in 10 people)
• Loss of appetite (anorexia)
• Dizziness
• Headache
• Changes in taste
• Tingling (paresthesia)
• Impaired vision
• Hearing loss
• Skin rash
• Itching
• Joint pain
• Fatigue Uncommon side effects (may affect up to 1 in 100 people)
• Decreased skin sensitivity
• Hearing loss or ringing in the ear
• Fast heartbeat (palpitations)
• Liver inflammation (hepatitis)
• Severe allergic reaction involving the skin and mucous membranes (Stevens-Johnson Syndrome)
• Allergic reactions on the skin such as sensitivity to sunlight
• Fatigue
• Feeling unwell

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, speak to your doctor or
pharmacist. You can also report side effects directly through the national reporting system at
http://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 Trozocina

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.
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 Trozocina contains

• The active ingredient is azithromycin dihydrate. Each film-coated tablet contains 262.05 mg of azithromycin dihydrate, equivalent to 250 mg of azithromycin base.
• The other ingredients are anhydrous lactose, corn starch, magnesium stearate, sodium lauryl sulfate.
• The capsules contain gelatin, titanium dioxide.

Description of the appearance of Trozocina and contents of the pack
Each pack contains 1 blister with 6 hard capsules of 250 mg.

Marketing Authorisation Holder
Alfasigma S.p.A. via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)

Manufacturer
HAUPT PHARMA LATINA S.r.l.
S.S. 156 km 50
04010 Borgo San Michele (Latina)