Azithromycin Mylan Generics Italia

Patient Information Leaflet

Azithromycin Mylan Generics Italia 200 mg/5 ml powder for oral suspension

azithromycin
Generic medicine
Read this entire leaflet carefully before taking this medicine, as it contains
important information for you.

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

Contents of this leaflet:

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

1. What Azithromycin Mylan Generics Italia is and what it is used for

Azithromycin is an antibiotic. It belongs to a group of antibiotics called macrolides. It is used to treat infections caused by bacteria.
This medicine is usually prescribed to treat:

• chest infections, such as bronchitis and pneumonia
• tonsil, throat (pharyngitis) and sinus infections
• ear infections
• skin and soft tissue infections, except infected burn wounds
• urethral and cervical infections caused by chlamydia.

2. What you need to know before taking Azithromycin Mylan Generics Italia

Do not take Azithromycin Mylan Generics Italia

• if you are allergic to azithromycin, erythromycin, or any other macrolide or ketolide antibiotic, 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 Mylan Generics Italia if you have
any of the following conditions:

• liver problems: your doctor may need to monitor your liver function or discontinue treatment.
• kidney problems: if you have severe kidney problems, your dose may need to be adjusted.
• neurological or psychiatric disorders
• a certain type of muscle weakness called myasthenia gravis.

Since azithromycin may increase the risk of irregular heartbeat, inform your doctor if you have
any of the following conditions before taking this medicine:

• heart problems, such as a weak heart (heart failure), very slow heartbeat, irregular heartbeat, or a condition known as "long QT syndrome" (detected by electrocardiogram)
• low levels of potassium or magnesium in the blood.

If this medicine is administered to a newborn (up to 42 days of age) and causes vomiting and
irritability during feeding, you must inform the doctor immediately.
Other medicines and Azithromycin Mylan Generics Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, including those obtained without a prescription. Before taking this medicine, it is
particularly important to mention the following medicines:

• theophylline (used to treat asthma): the effect of theophylline may be increased.
• warfarin or another similar medicine used to prevent blood clotting: concomitant use of these medicines may increase the risk of bleeding.
• ergotamine, dihydroergotamine (used to treat migraine): may cause ergotism (e.g. itching of limbs, muscle cramps, and gangrene of hands and feet due to poor blood circulation). Concomitant use is therefore not recommended.
• cyclosporine (used to suppress the immune system to prevent and treat rejection after organ or bone marrow transplantation): if concomitant use is necessary, your doctor will regularly monitor your blood tests and may adjust the dose.
• digoxin (used to treat heart failure): digoxin levels may increase. Your doctor will regularly monitor your blood tests.
• colchicine (used for gout and familial Mediterranean fever)
• antacids (for indigestion) – see section 3.
• cisapride (for stomach problems), terfenadine (used to treat hay fever): concomitant use with azithromycin may cause heart problems.
• medicines used to treat irregular heartbeat (called antiarrhythmics).
• alfentanil (used as a narcotic) or astemizole (for hay fever): concomitant use with azithromycin may increase the effects of these medicines.
• pimozide: an antipsychotic medicine
• antidepressants such as citalopram, also known as SSRIs: for treatment of depression
• fluoroquinolones (moxifloxacin and levofloxacin): antibacterial agents
• atorvastatin or other statins (used to lower cholesterol)
• Hydroxychloroquine (used for rheumatoid arthritis, lupus, and malaria prevention).

Azithromycin Mylan Generics Italia with food and drink
Azithromycin Mylan Generics Italia can be taken independently of food or drink.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking any medicine.
Azithromycin should be used during pregnancy only if clinically necessary and if the expected
benefit of treatment outweighs any small potential increase in risk.
Do not take this medicine during pregnancy unless specifically prescribed by your doctor.
This medicine passes into breast milk. You should consult your doctor before taking this medicine
if you are breastfeeding.

Driving and using machines
This medicine may cause side effects such as dizziness or seizures. This may impair your ability
to perform certain activities, such as driving or operating machinery.
Azithromycin Mylan Generics Italia contains sucrose and aspartame
This medicine contains 3.7 g of sucrose in every 5 ml of suspension. This should be taken into
account in patients with diabetes mellitus.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before
taking this medicine.
This medicine contains 30 mg of aspartame per 5 ml of suspension. Aspartame is a source of
phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing
phenylalanine to accumulate because the body cannot eliminate it properly.
This medicine contains less than 1 mmol of sodium (23 mg) per 5 ml, i.e. essentially "sodium-free".

3. How to take Azithromycin Mylan Generics Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults and children with body weight above 45 kg
Azithromycin Mylan Generics Italia should be taken over a period of 3 or 5 days:

• 3-day regimen: take 12.5 ml (500 mg) once daily
• 5-day regimen: on day 1, take 12.5 ml (500 mg); on days 2, 3, 4 and 5, take 6.25 ml (250 mg) daily.

For urethral and cervical infections caused by Chlamydia, it should be taken as a single dose on one day:

• 1-day regimen: 25 ml (1,000 mg).

Children with body weight equal to or below 45 kg
Azithromycin Mylan Generics Italia is not recommended for children under 1 year of age.
Azithromycin Mylan Generics Italia should be taken over a period of 3 or 5 days.
The daily dose is calculated based on the child's body weight.
The following table provides guidance for the recommended doses:
3-day therapy

5-day treatment

The dosage for the treatment of sore throat constitutes an exception. Therefore, your doctor may
prescribe a different dosage.
Patients with kidney or liver problems:
Inform your doctor if you have kidney or liver problems, as your doctor may need to adjust the
usual dose.
Take this medicine once daily. You may take it with or without food.
The bitter aftertaste can be avoided by drinking fruit juice immediately after swallowing.
Taking Azitromicina Mylan Generics Italia with medicines for indigestion
If you need to take a medicine for indigestion, for example an antacid, take
Azitromicina Mylan Generics Italia at least one hour before or two hours after the antacid.
How to measure a dose
This medicine comes with a 10 ml dosing syringe marked in 0.25 ml increments. It is supplied with an adapter to attach to the bottle. To measure the medicine:

• shake the bottle
• insert the adapter into the neck of the bottle
• insert the tip of the syringe into the adapter
• turn the bottle upside down
• pull back the plunger to draw up the required dose
• return the bottle to an upright position, remove the syringe, leave the adapter on the bottle and close it.

If you need help measuring this medicine, ask your doctor or pharmacist for advice.
Administration using the syringe

• Ensure the child is in an upright position.
• Carefully insert the tip of the syringe into the child’s mouth, directing it towards the inside of the cheek.
• Slowly push the syringe plunger: do not squirt the suspension quickly. The medicine will slowly drip into the child’s mouth.
• Allow the child time to swallow the medicine.

How to prepare this medicine
Your doctor, nurse or pharmacist may prepare this medicine. To open the medicine bottle, press down on the child-resistant cap and then turn it.
If you need to prepare the medicine yourself, fill the bottle with cold water. Use the provided dosing syringe to measure the required amount of water. The correct amount of water to add depends on the size of the bottle:

• for a 15 ml bottle (600 mg), add 8 ml of water
• for a 20 ml bottle (800 mg), add 10.5 ml of water
• for a 22.5 ml bottle (900 mg), add 11 ml of water
• for a 30 ml bottle (1200 mg), add 15 ml of water
• for a 37.5 ml bottle (1500 mg), add 18.5 ml of water

Shake the bottle well immediately after adding water. The suspension should be prepared only once, at the beginning of treatment.
If you take more Azitromicina Mylan Generics Italia than you should
If you take too high a dose, you may experience discomfort (nausea) or feel unwell (vomiting). You may also experience other side effects such as temporary hearing loss and diarrhoea. Contact your doctor immediately or go to the nearest hospital emergency department. If possible, bring the medicine with you so you can show the doctor what you have taken.
If you forget to take Azitromicina Mylan Generics Italia
If you forget to take a dose, take it as soon as possible. Then continue as usual.
Do not take a double dose to make up for a forgotten dose, or more than one dose in a single day.
If you stop treatment with Azitromicina Mylan Generics Italia
Continue taking the oral suspension for the full duration of treatment, even if you feel better. If you stop treatment too early, the infection may return. In addition, bacteria may develop resistance to the medicine, making them harder to treat.
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.
If you experience any of the following symptoms, stop taking this medicine immediately
and contact your doctor or go to the nearest hospital emergency department:
Uncommon (may affect up to 1 in 100 people):

• severe or itchy skin rash, especially if blisters or peeling occur, along with pain in the eyes, mouth or genital organs (Stevens-Johnson syndrome)
• liver problems, which may lead to liver failure, with symptoms such as nausea, vomiting, loss of appetite, general feeling of being unwell, fever, itching, pale stools, dark urine.

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

• yellowing of the skin or whites of the eyes due to liver problems
• skin rash characterized by rapidly appearing red spots with small pustules (small blisters containing white/yellow fluid)

Very rare (may affect up to 1 in 10,000 people):

• skin rash accompanied by other symptoms such as fever, swollen lymph nodes, and an increase in eosinophils (a type of white blood cells).

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

• severe allergic reaction. Symptoms may include: sudden difficulty in breathing, speaking or swallowing; swelling of lips, tongue, face and neck; severe dizziness or collapse
• severe peeling of the skin or itchy skin rash with pink-red edges and pale center (toxic epidermal necrolysis, erythema multiforme)
• irregular heartbeat or heart rhythm disturbances known as QT interval prolongation (a delay in electrical signal conduction detected by ECG, an electrical recording of the heart). Some people may consequently develop a potentially serious heart condition known as torsade de pointes. This may lead to a rapid heartbeat causing sudden loss of consciousness.
• severe or prolonged diarrhoea, or diarrhoea with blood in the stool, associated with stomach pain or fever. This may be a sign of a serious intestinal inflammation. This may occur after taking antibiotics.
• inflammation of the pancreas, causing severe abdominal and back pain.
• kidney disease with symptoms such as: reduced or no urine production, drowsiness, nausea, vomiting, shortness of breath, increased or decreased frequency of urination, or blood in the urine.
• epileptic seizures or convulsions.
• destruction of red blood cells with symptoms such as fatigue, headache, paleness, and yellowing of the skin and/or eyes.

These are all serious side effects and you may need immediate medical attention.
If you notice any of the following symptoms, consult your doctor as soon as possible:
Common (may affect up to 1 in 10 people):

• reduced vision
• deafness

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

• severe lung infection with symptoms such as fever, chills, shortness of breath, cough and mucus.
• severe reduction in white blood cells, which may be detected by blood tests. You may also experience an increased number of infections, manifesting as sore throat, mouth ulcers and fever.
• general swelling.

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

• muscle weakness or worsening of muscle weakness (myasthenia gravis)

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

• diarrhoea, loose stools, stomach cramps or pain, feeling unwell, flatulence.

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

• headache
• drowsiness
• dizziness
• altered taste
• indigestion
• tingling in hands or feet
• skin rash, itching, vomiting
• changes in white blood cell count and decreased bicarbonate levels in the blood, which may be detected by blood tests
• joint pain
• fatigue.

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

• yeast infections, particularly of the mouth, vaginal infections
• fungal infection
• bacterial infection
• nervousness
• sleep disorders
• ear problems which may include ringing in the ears, impaired hearing
• pounding heartbeat
• inflammation of stomach and intestine, which may be caused by a bacterial or viral infection (gastroenteritis), constipation
• hypersensitivity (allergic reactions)
• hives, skin inflammation, dry skin
• increased sweating
• chest pain, skin swelling, general feeling of being unwell, weakness
• sensation of dizziness
• loss of appetite
• shortness of breath, tightness in the chest
• fever or high temperature
• inflamed throat
• runny nose, sneezing
• hot flushes
• difficulty swallowing
• stomach discomfort or bloating, relieved by burping or vomiting, flatulence, burping
• dry mouth, mouth ulcers, excessive salivation
• pain, swelling, instability and stiffness in one or more joints
• muscle pain, back pain, neck pain
• pain during urination
• kidney pain
• light menstrual bleeding at irregular intervals
• pain and swelling of the testicles
• abnormal blood sugar levels
• nosebleeds
• sensitivity to sunlight
• abnormal laboratory test results (e.g. blood tests, kidney or liver function tests).

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

• irritability.

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

• anxiety, fainting, feeling hyperactive, feelings of aggression, severe confusion
• changes in smell, loss of smell or taste, reduced skin sensitivity to touch
• low blood pressure
• spots on tongue or teeth
• seeing, hearing or feeling things that are not real (hallucinations)
• low platelet count in the blood, which may cause bleeding or bruising more easily than normal.

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

5. How to store Azithromycin Mylan Generics Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp.
The expiry date refers to the last day of that month.
Do not store the closed vial containing the dry powder at a temperature above 30°C.
Do not store the reconstituted Azithromycin Mylan Generics Italia suspension at a temperature above 30°C.
Do not use the reconstituted suspension of Azithromycin Mylan Generics Italia for longer than 10 days.
If the suspension was prepared for you by the pharmacy, use it no later than 10 days after the preparation date. The preparation date will be indicated on the pharmacy label.
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 Azitromicina Mylan Generics Italia contains

• The active substance is azithromycin dihydrate, equivalent to 200 mg of azithromycin per 5 ml.

The other components are: sucrose, see section 2 "Azitromicina Mylan Generics Italia contains sucrose", xanthan gum (E415), hydroxypropylcellulose, anhydrous trisodium phosphate, anhydrous colloidal silica, aspartame (E951), see section 2 "Azitromicina Mylan Generics Italia contains aspartame", banana flavour, vanilla cream flavour, cherry flavour.

Description of the appearance of Azitromicina Mylan Generics Italia and contents of the pack
Azitromicina Mylan Generics Italia is a white or off-white crystalline powder.
After reconstitution, Azitromicina Mylan Generics Italia is a homogeneous white or off-white suspension.
Azitromicina Mylan Generics Italia 200 mg/5 ml powder for oral suspension is available in plastic bottles with a cap, containing 15, 20, 22.5, 30 and 37.5 ml after reconstitution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy

Manufacturers
Mc Dermott Laboratories T/A Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Novartis Pharmaceuticals S.R.L., Livezeni Street n. 7A, Targu Mures, Romania
Mylan Hungary Kft., Mylan utca 1., Komárom, 2900, Hungary

This medicinal product has been authorised in the European Economic Area countries under the following names:
Italy: Azitromicina Mylan Generics Italia 200 mg/5 ml powder for oral suspension
Netherlands: Azitromycine 200 mg/5 ml, poeder voor orale suspensie