Azithromycin Teva Italia

Package Leaflet: Information for the User

Azithromycin Teva Italia 200 mg/5 ml powder for oral suspension

azithromycin (as dihydrate)
Equivalent medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Azithromycin Teva Italia is and what it is used for

Azithromycin Teva Italia contains the active substance azithromycin. Azithromycin is an antibiotic that belongs to a group of antibiotics called "macrolides", which block the growth of susceptible bacteria.
Azithromycin Teva Italia is used to treat the following infections:
Children aged 6 months and older with body weight below 45 kg

• infections of the tonsils (tonsillitis) or throat (pharyngitis) caused by streptococcal bacteria
• bacterial infections of the paranasal sinuses (sinusitis)
• bacterial infections of the middle ear (otitis media)
• lung infection (community-acquired pneumonia, not contracted in hospital)
• bacterial skin infections and infections of underlying tissues

Adults and adolescents weighing 45 kg or more who have difficulty swallowing:
In addition to the infections listed above, Azithromycin Teva Italia may also be used to treat the following infections:

• infections of the urethra and cervix caused by the bacterium Chlamydia trachomatis
• adults with chronic inflammation of the bronchi (chronic bronchitis).

2. What you should know before taking Azithromycin Teva Italia

Do not take Azithromycin Teva Italia:

• If you are allergic to azithromycin, erythromycin, other antibiotics known as “macrolides” or “ketolides”, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Azithromycin Teva Italia if you have or have had
any of the following conditions:

• heart problems (e.g. irregular heartbeat or heart failure) or low levels of potassium or magnesium in the blood: these conditions may contribute to serious cardiac side effects caused by azithromycin;
• liver problems: your doctor may need to monitor liver function or discontinue treatment;
• severe diarrhoea after taking other antibiotics;
• localized muscle weakness (myasthenia gravis), as symptoms of this disease may worsen during treatment;
• or if you are taking ergot derivatives such as ergotamine (used to treat migraine), since these medicines must not be taken together with Azithromycin Teva Italia.

Stop taking this medicine and contact your doctor immediately (see also “Serious unwanted effects” in section 4):

• if you suspect you are having an allergic reaction (e.g. difficulty breathing, swelling of the face or throat, skin rash, blisters);
• if you notice any of the symptoms described in section 4 related to serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), which have been reported in association with azithromycin treatment;
• if you experience an abnormal heartbeat or palpitations, dizziness or fainting while taking Azithromycin Teva Italia;
• if you develop signs of liver problems (e.g. dark urine, loss of appetite, or yellowing of the skin or whites of the eyes);
• if you develop severe diarrhoea during or after treatment. Do not take any medicine for diarrhoea without first consulting your doctor. If diarrhoea persists or recurs within the first few weeks of treatment, inform your doctor.

Superinfection
Your doctor may monitor for symptoms of additional bacterial or fungal infections that cannot be treated with Azithromycin Teva Italia (superinfection).
Sexually transmitted infections
Your doctor may perform a test to rule out possible syphilis, a sexually transmitted disease that could otherwise progress undetected and be diagnosed late. Furthermore, in cases of sexually transmitted bacterial infections, your doctor will carry out follow-up laboratory tests to monitor treatment success.
Children and adolescents
If the child is under 6 months of age, consult your doctor or pharmacist, as the efficacy and safety of this medicine have not been established in this age group.
Infantile hypertrophic pyloric stenosis (IHPS)
If the child is under 6 months of age and your doctor has prescribed azithromycin treatment, stop administering this medicine and contact your doctor immediately if projectile vomiting occurs or the child becomes irritable during or immediately after feeding.

Other medicines and Azithromycin Teva Italia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking Azithromycin Teva Italia together with other medicines may cause unwanted effects. Therefore, it is particularly important that you inform your doctor if you are taking any of the following medicines:

• Atorvastatin and other statins (to lower blood cholesterol and prevent heart disease, including heart attacks and strokes);
• Cyclosporine (to prevent rejection of transplanted organs);
• Colchicine (for the treatment of gout and familial Mediterranean fever);
• Dabigatran (to prevent and treat blood clots (anticoagulant));
• Digoxin (for the treatment of heart conditions);
• Warfarin or similar medicines used to thin the blood (anticoagulants);
• Medicines that may cause the heart muscle to take longer than usual to contract and relax (QT interval prolongation), such as the following:
• Quinidine, procainamide, dofetilide, amiodarone and sotalol (for the treatment of irregular heartbeat, including cases of heartbeat that is too fast or too slow – cardiac arrhythmia);
• Pimozide (for the treatment of mental illnesses);
• Citalopram (for the treatment of depression);
• Moxifloxacin and levofloxacin (antibiotics);
• Cisapride (for the treatment of gastrointestinal disorders);
• Hydroxychloroquine or chloroquine (for the treatment of autoimmune diseases including rheumatoid arthritis, or for treating or preventing malaria).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Your doctor will decide whether you can take this medicine during pregnancy only after confirming that the benefits outweigh the potential risks.
Breastfeeding
Azithromycin Teva Italia passes into breast milk. Therefore, your doctor will decide whether to discontinue breastfeeding or to avoid treatment with Azithromycin Teva Italia, taking into account both the benefit of breastfeeding for the child and the benefit of therapy for you.

Driving and using machines
Azithromycin Teva Italia has a moderate influence on the ability to drive and use machines. Dizziness, drowsiness and convulsions, as well as vision and hearing disturbances have been reported with Azithromycin Teva Italia. These possible side effects may impair your ability to drive or operate machinery.

Azithromycin Teva Italia contains benzyl alcohol, sodium, sucrose, sulphites and sulphur dioxide
This medicine contains 0.65 micrograms of benzyl alcohol per 5 ml of suspension.
Benzyl alcohol may cause allergic reactions.
Benzyl alcohol has been associated with the risk of serious adverse effects, including breathing problems (gasping syndrome), in young children.
Do not use for more than one week in young children (under 3 years of age) unless otherwise recommended by your doctor or pharmacist.
This medicine contains 35.2 mg of sodium per 5 ml of reconstituted suspension. This corresponds to 1.8% of the maximum daily dietary intake recommended for an adult.
This medicine contains 3.75 g of sucrose per 5 ml of suspension. This should be taken into account in patients with diabetes mellitus. If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains sulphites and sulphur dioxide. These may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take Azithromicina Teva Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended doses and duration of treatment are listed below.
Children aged 6 months and older, weighing less than 45 kg

It is important to ensure that you use the amount of Azithromycin Teva Italia indicated in the table below, based on the patient's body weight, the infection being treated, and the specific treatment regimen (1 day, 3 days, 5 days) your doctor or pharmacist has instructed you to follow.

Body weight Maximum daily dose of azithromycin
(kg) 40 mg/ml oral suspension in bottle after reconstitution (15 ml, 22.5 ml, 30 ml or 37.5 ml)
5 mg/kg 10 mg/kg 12 mg/kg 20 mg/kg 30 mg/kg
7 1.00 ml (40 mg)* 1.75 ml (70 mg)* 2.25 ml (90 mg) 3.50 ml (140 mg) 5.25 ml (210 mg)
8 1.00 ml (40 mg)* 2.00 ml (80 mg)* 2.50 ml (100 mg) 4.00 ml (160 mg) 6.00 ml (240 mg)
9 1.25 ml (50 mg)* 2.25 ml (90 mg) 2.75 ml (110 mg) 4.50 ml (180 mg) 6.75 ml (270 mg)
10 1.25 ml (50 mg)* 2.50 ml (100 mg) 3.00 ml (120 mg) 5.00 ml (200 mg) 7.50 ml (300 mg)
11 1.50 ml (60 mg)* 2.75 ml (110 mg) 3.25 ml (130 mg) 5.50 ml (220 mg) 8.25 ml (330 mg)
12 1.50 ml (60 mg)* 3.00 ml (120 mg) 3.75 ml (150 mg) 6.00 ml (240 mg) 9.00 ml (360 mg)
13 1.75 ml (70 mg)* 3.25 ml (130 mg) 4.00 ml (160 mg) 6.50 ml (260 mg) 9.75 ml (390 mg)
14 1.75 ml (70 mg)* 3.50 ml (140 mg) 4.25 ml (170 mg) 7.00 ml (280 mg) 10.50 ml (420 mg)
15 2.00 ml (80 mg)* 3.75 ml (150 mg) 4.50 ml (180 mg) 7.50 ml (300 mg) 11.25 ml (450 mg)
16–25 2.50 ml (100 mg) 5.00 ml (200 mg) 6.25 ml (250 mg) 10.00 ml (400 mg) 15.00 ml (600 mg)
26–35 3.75 ml (150 mg) 7.50 ml (300 mg) 8.75 ml (350 mg) 12.50 ml (500 mg) 22.50 ml (900 mg)
36–<45 5.00 ml (200 mg) 10.00 ml (400 mg) 11.25 ml (450 mg) 12.50 ml (500 mg) 30.00 ml (1200 mg)

After reconstitution, the concentration of the oral suspension is 40 mg/mL, and the total volume of suspension in the bottle depends on the container size (15 ml (600 mg), 22.5 ml (900 mg), 30 ml (1,200 mg), or 37.5 ml (1,500 mg)).

Doses have been rounded to obtain an appropriate administrable dose.
Doses have been rounded to obtain an appropriate administrable dose.

Azithromycin 20 mg/mL (100 mg/5 mL) powder for oral suspension is more suitable for administration to these patients.

Do not exceed the adult maximum daily dose of 500 mg.

Adult and adolescent patients weighing 45 kg or more who have difficulty swallowing

for adult patients only
for adult patients, oral treatment may follow an initial intravenous treatment
Use in children and adolescents
The safety and efficacy of azithromycin have not been established in children under 6 months of age
for any of the indications listed in section 1.
Method of administration
For oral use after reconstitution.
Azitromicina Teva Italia must be taken orally as a single daily dose. The oral suspension may be taken
independently of meals. Taking this medicine just before a meal may help improve gastrointestinal
tolerability.
If the bottle of Azitromicina Teva Italia received from the doctor or pharmacist contains only powder and
no liquid, a specific volume of water must be added to the bottle before it can be used. If the doctor or
pharmacist has already reconstituted the powder, proceed directly to the section “Instructions for
administration of each daily dose of Azitromicina Teva Italia oral suspension” below.
Instructions for preparing the powder for oral suspension of Azitromicina Teva Italia
before first use
You can prepare the suspension yourself using the oral dosing syringe provided.

1. Shake the bottle well to loosen the powder before adding water.
2. Open the bottle by pressing down on the safety cap and simultaneously turning it counterclockwise.
3. Use the oral dosing syringe (supplied in the package) to add the appropriate volume of water to the bottle. The syringe has a total volume of 5 ml. The syringe must be used more than once to add the appropriate volume of water.
   • For the 15 ml suspension (600 mg azithromycin): add 9.5 ml of water.
   • For the 22.5 ml suspension (900 mg azithromycin): add 12.0 ml of water.
   • For the 30 ml suspension (1,200 mg azithromycin): add 16.5 ml of water.
   • For the 37.5 ml suspension (1,500 mg azithromycin): add 20.0 ml of water.
4. Close the bottle and shake thoroughly until all the powder is well mixed with the water.

The oral suspension is now ready for use.
Instructions for administration of each daily dose of Azitromicina Teva Italia oral
suspension
Fill the syringe with the medicine

1. Ensure that the plunger of the syringe is fully inserted. The syringe has a total volume of 5 ml and is graduated in divisions of 0.1 ml and 0.25 ml. 0.25 ml of azithromycin suspension provides 10 mg of azithromycin.
2. Shake the bottle well before use and remove the child-resistant cap.
3. While the bottle is standing on a flat, stable surface, hold it steady with one hand. With the other hand, insert the tip of the syringe into the suspension.
4. Slowly pull back the plunger of the syringe so that the graduation line indicated on the plunger aligns with the upper edge of the syringe.
5. If large bubbles are present inside the syringe, slowly push the plunger back into the syringe. This will return the medicine to the bottle. Repeat step 4.
6. Remove the syringe from the bottle.

Administration of the medicine using the syringe

1. Ensure the child is in an upright position.
2. Carefully insert the tip of the syringe into the child’s mouth. Direct the tip of the syringe toward the inside of the cheek.
3. Slowly push down the plunger of the syringe: Do not inject too quickly. The medicine will flow slowly into the child’s mouth.
4. Allow the child time to swallow the medicine.
5. It may be necessary to use the syringe more than once to administer the prescribed amount of oral suspension to the child.
6. Replace the child-resistant cap on the bottle. Wash the syringe as indicated in the instructions below.
7. Repeat these steps each day during the treatment course. At the end of treatment, discard any remaining suspension.

Cleaning and storage of the syringe

1. Remove the plunger from the syringe and wash both parts under warm running water or immerse them in a sterilizing solution used for baby bottles, etc.
2. Dry the two parts. Reinsert the plunger into the syringe. Store the syringe in a clean and safe place together with the medicine.

Caution: administer the medicine slowly to the child while held in an upright
position. This will avoid the risk of choking.
If you take more Azitromicina Teva Italia than you should
If you take more Azitromicina Teva Italia than you should, you may feel unwell. Typical signs of
overdose are vomiting, diarrhea, abdominal pain, and nausea. Contact your doctor immediately or
go to the nearest hospital emergency department.
If you forget to take Azitromicina Teva Italia
If you forget to take Azitromicina Teva Italia, take it as soon as possible, provided that it is at least
12 hours before the next dose. If less than 12 hours remain before the next dose, do not take the
missed dose, but take the next dose at the usual time. Do not take a double dose to make up for a
missed dose.
If you stop treatment with Azitromicina Teva Italia
If you stop treatment with Azitromicina Teva Italia too early, the infection may recur. Take
Azitromicina Teva Italia for the full duration of treatment, even if you start to feel better.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Serious side effects
Stop using Azithromycin Teva Italia and contact your doctor immediately if you experience any of the following symptoms:

• sudden wheezing, breathing difficulties, swelling of the eyelids, face or lips, rash or itching mainly affecting the whole body (anaphylactic reaction, frequency not known)
• fast or irregular heartbeat (cardiac arrhythmia or torsades de pointes tachycardia, frequency not known)
• dark urine, loss of appetite, or yellowing of the skin or whites of the eyes, signs of liver problems (hepatic failure or hepatic necrosis, frequency not known)
• severe diarrhoea with abdominal cramps, blood in stools and/or fever, which may indicate an infection of the large intestine (antibiotic-associated colitis, frequency not known). Do not take anti-diarrhoeal medicines that inhibit intestinal motility (antiperistaltics)
• red, flat spots on the trunk, target-shaped or circular rashes, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome or toxic epidermal necrolysis, frequency not known)
• widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome, rare (may affect up to 1 in 1,000 people))
• widespread, red, scaly rash, with subcutaneous bumps and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis, rare (may affect up to 1 in 1,000 people)).

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

• diarrhoea

Common (may affect up to 1 in 10 people)

• headache
• vomiting, stomach pain, feeling unwell (nausea)
• changes in blood test results (decreased lymphocyte count, increased eosinophil count, increased basophil count, increased monocyte count, increased neutrophil count, decreased blood bicarbonate)

Uncommon (may affect up to 1 in 100 people)

• candidiasis (fungal infection of the mouth and vagina), other fungal infections
• lung infection, bacterial throat infection, gastrointestinal inflammation, respiratory disorder, inflammation of the nasal mucosa, vaginal infection
• changes in white blood cell count (leucopenia, neutropenia, eosinophilia)
• increased platelet count
• reduced percentage of all blood cells in total blood volume (reduced haematocrit)
• allergic reactions, swelling of hands, feet and face (angioedema)
• loss of appetite
• nervousness, difficulty sleeping (insomnia)
• dizziness, drowsiness (somnolence), altered sense of taste (dysgeusia), tingling sensation (paraesthesia)
• visual disturbances
• ear disorder
• sensation of dizziness (vertigo)
• awareness of heartbeat (palpitations)
• hot flush
• sudden wheezing, nosebleed
• constipation, intestinal gas, impaired digestion (dyspepsia), inflammation of the stomach lining (gastritis), difficulty swallowing (dysphagia), bloated stomach, dry mouth, burping, mouth ulceration, increased salivation
• rash, itching, hives (urticaria), dermatitis, dry skin, abnormally increased sweating (hyperhidrosis)
• joint swelling and pain (osteoarthritis), muscle pain, back pain, neck pain
• painful urination (dysuria), kidney pain
• irregular menstrual bleeding (metrorrhagia), testicular disorder
• swelling due to fluid retention, particularly of the face, ankles and feet (oedema, facial oedema, peripheral oedema)
• weakness, fatigue, general malaise, fever
• chest pain, pain
• abnormal laboratory test results (e.g. blood or liver tests)
• post-procedural complication

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

• sensation of irritation
• liver problems, yellowing of the skin or eyes
• increased sensitivity to sunlight

Not known (frequency cannot be estimated from the available data)

• reduction in red blood cells due to increased cellular breakdown, which may cause fatigue and pale skin (haemolytic anaemia)
• reduction in the number of platelets in the blood, which may lead to bleeding and bruising (thrombocytopenia)
• feeling angry, aggressive, fearful or worried (anxiety), acute confusion (delirium)
• hallucination
• fainting (syncope)
• seizures (convulsions)
• reduced sensitivity to touch, pain and temperature (hypoesthesia)
• sensation of hyperactivity
• changes in the sense of smell (anosmia, parosmia)
• complete loss of taste (ageusia)
• muscle weakness (myasthenia gravis)
• abnormal electrocardiogram (ECG) (prolongation of QT interval)
• deafness, reduced hearing or ringing in the ears (tinnitus)
• low blood pressure
• inflammation of the pancreas causing severe abdominal and back pain (pancreatitis)
• change in tongue colour
• joint pain (arthralgia)
• inflammation of the kidneys (interstitial nephritis) and impaired kidney function

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

5. How to store Azithromycin Teva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging and on the vial after "Exp.". The expiry date refers to the last day of that month.
Powder: Store below 25 °C.
After reconstitution: Store below 25 °C and use within 5 days (azithromycin 15 ml and 22.5 ml suspension) or within 10 days (azithromycin 30 ml and 37.5 ml suspension).
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Azithromycin Teva Italia contains:

• The active substance is azithromycin. After reconstitution with water, each millilitre contains 40 mg of azithromycin (as dihydrate) (equivalent to 200 mg of azithromycin per 5 ml).
• The other components are anhydrous colloidal silica (E551), sucrose, xanthan gum (E415), anhydrous trisodium phosphate, hydroxypropylcellulose, cherry flavour (contains benzyl alcohol and sulphur dioxide (E220)), vanilla flavour (contains sulphites), banana flavour (contains sulphites).

Description of the appearance of Azithromycin Teva Italia and package contents:

• The powder for the preparation of suspension is white to pale yellow in colour. The reconstituted suspension is pale yellow.
• The oral suspension powder is available in bottles containing 600, 900, 1,200 or 1,500 mg of azithromycin, providing a suspension of 600 mg/15 ml, 900 mg/22.5 ml, 1,200 mg/30 ml and 1,500 mg/37.5 ml after reconstitution with water.

Pack sizes:
Azithromycin 600 mg/15 ml: 12.555 g of powder for the preparation of 15 ml of suspension
Azithromycin 900 mg/22.5 ml: 18.8325 g of powder for the preparation of 22.5 ml of suspension
Azithromycin 1,200 mg/30 ml: 25.110 g of powder for the preparation of 30 ml of suspension
Azithromycin 1,500 mg/37.5 ml: 31.3875 g of powder for the preparation of 37.5 ml of suspension

An oral dosing syringe is supplied with the bottles. The syringe has a total volume of 5 ml and is graduated in 0.1 ml and 0.25 ml increments.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy

Manufacturers:
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków, Poland
Merckle GmbH
Ludwig Merckle Straße 3,
89143 Blaubeuren, Germany
PLIVA Croatia Ltd.
Prilaz baruna Filipovića 25
10000 Zagreb
Croatia