AZITROMICINA 500 mg Tabletki Powlekane

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1. Azitromicina Aurobindo 500 mg film-coated tablets
   1. What is Azitromicina Aurobindo and what is it used for
   2. What you need to know before taking Azitromicina Aurobindo
   3. How to take Azitromicina Aurobindo
   4. Possible side effects
   5. How to store Azitromicina Aurobindo
   6. Package contents and other information

Azitromicina Aurobindo 500 mg film-coated tablets

Generic medicine

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

1. What is Azitromicina Aurobindo and what is it used for

Azitromicina Aurobindo is an antibiotic belonging to the macrolide class. Antibiotics are
used to treat infections caused by microorganisms such as bacteria.
Azitromicina Aurobindo is used in the treatment of some infections caused by bacteria
sensitive to it, such as:

• infections of the chest, throat and nose (such as bronchitis, pneumonia, tonsillitis, sore throat (pharyngitis) and sinusitis);
• ear infections;
• skin and soft tissue infections, except for infected burn wounds;
• infection of the channel that allows urine to flow from the bladder (urethra) or the cervix caused by a bacterium called Chlamydia trachomatis(bacteria).

2. What you need to know before taking Azitromicina Aurobindo

Do not take Azitromicina Aurobindo

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

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

• if you have ever suffered a severe allergic reaction with swelling of the face and throat, possible breathing problems, rash, fever, swollen glands or increased eosinophils (a particular type of white blood cells);
• if you develop severe and persistent diarrhea during or after treatment;
• if you have severe liver or kidney problems;
• if you have serious heart problems or problems with your heartbeat such as prolonged QT interval syndrome (evident on an electrocardiogram or ECG);
• if your potassium or magnesium levels in the blood are too low;
• if you develop signs of a new infection;
• if you are taking any ergot derivatives such as ergotamine (to treat migraine) as these medicines must not be taken together with Azitromicina Aurobindo (see section “Other medicines and Azitromicina Aurobindo”);
• if you suffer from a certain type of muscle weakness called myasthenia gravis;
• if you have nervous (neurological) or mental (psychiatric) problems.

Other medicines and Azitromicina Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any of the following medicines:

• antacids, used for heartburn and indigestion. Azitromicina Aurobindo must be taken at least 1 hour before or 2 hours after the antacid;
• ergotamineand dihydroergotamine, used for migraine, must not be taken at the same time as they can develop serious side effects (ergotism, i.e. itching of the limbs, muscle cramps and gangrene of the hands and feet due to poor blood circulation);
• medicines to reduce cholesterol(statins);
• warfarin or similar drugs, used to thin the blood. Concurrent use may increase the risk of bleeding;
• cisapride(used to treat stomach problems) or terfenadine(used to treat hay fever), must not be taken at the same time as they can cause serious heart problems (shown on an electrocardiogram or ECG);
• zidovudineor nelfinavir, used to treat HIV infections. Taking nelfinavir with Azitromicina Aurobindo may develop more side effects than those listed in this
• rifabutin, used to treat tuberculosis (TB);
• quinidine, used to treat heart rhythm problems;
• cyclosporine, used to suppress the immune system in order to prevent and treat organ or bone marrow rejection after transplantation. Your doctor will regularly check your cyclosporine levels in the blood and may adjust the dose.

Tell your doctor or pharmacist if you are taking any of the following medicines. Azitromicina
Aurobindo may strengthen the effects of these medicines. Your doctor may adjust the dose:

• alfentanil, a painkiller used for example during operations;
• theophylline, used for breathing problems such as asthma and chronic obstructive pulmonary disease (COPD);
• digoxin, used to treat heart problems;
• colchicine, used for gout and familial Mediterranean fever;
• astemizole, used to treat hay fever;
• pimozide, used to treat mental health problems.

Azitromicina Aurobindo with food and drink
This medicine can be taken with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Information on the use of Azitromicina Aurobindo during pregnancy is insufficient.
Therefore, you should not use Azitromicina Aurobindo during pregnancy unless explicitly
advised by your doctor.
Azitromicina Aurobindo passes partially into breast milk.
It is not known whether azithromycin can have undesirable effects on the breastfed infant.
Therefore, it is advisable to stop breastfeeding during treatment with Azitromicina
Aurobindo. Milk should then be discarded during treatment and for up to 2 days after
discontinuation. Breastfeeding can then be resumed.

Driving and operating machinery
There is no data available on the influence of Azitromicina Aurobindo on the ability to drive vehicles
or operate machinery. However, Azitromicina Aurobindo may cause dizziness and convulsions, so
make sure these cases do not affect you before driving or using machinery.

Azitromicina Aurobindo contains lactose monohydrate
If your doctor has told you that you have intolerance to some sugars, contact your doctor before
taking this medicine.

Sodium
Azitromicina Aurobindo contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is
essentially “sodium-free”.

3. How to take Azitromicina Aurobindo

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
The recommended dose is:

For adults and children with a body weight of 45 kg or more
Azitromicina Aurobindo is taken for a treatment of 3 or 5 days:

• 3-day treatment: 500 mg to be taken once a day.
• 5-day treatment:
• Take 500 mg on day 1.
• Take 250 mg on days 2, 3, 4 and 5.

For infections of the cervix and urethra caused by Chlamydia trachomatis
A 1000 mg dose, to be taken once only.

Children and adolescents with a weight less than 45 kg
Tablets are not recommended. Children with a body weight less than 45 kg must
use other forms of this medicine.

Patients with kidney or liver problems
You must inform your doctor if you have kidney or liver problems as your doctor may need to
adjust the normal dose.

Dosage for the elderly
For elderly patients, the same dosage as adults applies.
The tablet can be divided into equal parts.

Method of administration
The tablets must be swallowed with half a glass of water.
The tablets can be taken with or without food.

If you take more Azitromicina Aurobindo than you should
If you have taken too much Azitromicina Aurobindo, contact your doctor, pharmacist immediately or
go to the nearest hospital.
Symptoms of overdose are hearing loss, nausea, vomiting and diarrhea. In case of
overdose, hospitalization may be necessary.

If you forget to take Azitromicina Aurobindo
If you forget to take Azitromicina Aurobindo, take it as soon as possible. If it is almost time to
take the next dose, skip the missed dose and take the next dose directly. If
you have doubts, contact your doctor or pharmacist. If you have missed a dose, continue to take anyway
all the tablets. This means that you will finish your cycle one day later.
Do not take a double dose to make up for a missed dose.

If you stop taking Azitromicina Aurobindo
Do not decide on your own to stop treatment with Azitromicina Aurobindo, but discuss it
first with your doctor. If the treatment prescribed to you is not completely completed,
the infection may return.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any of the following symptoms of a severe allergic reaction, stop
taking this medicine and seek immediate medical attention or go to the emergency
room of the nearest hospital.
The frequency of these reactions is not known (the frequency cannot be established based on available data

):

• Sudden difficulty breathing, speaking and swallowing.
• Swelling of the lips, tongue, face and neck.
• Severe dizziness or collapse.
• Severe skin rash or with itching, especially if it appears with blisters and if there is pain in the eyes, mouth or genitals.
• Severe skin reactions:
• blisters on the skin, mouth, eyes and genitals (Stevens-Johnson syndrome);
• skin blisters, severe skin reaction (toxic epidermal necrolysis);
• rash accompanied by other symptoms such as fever, swollen glands and increased eosinophils (a type of white blood cells). A rash appears with small, itchy red spots (drug reaction with eosinophilia and systemic symptoms, DRESS)

If you experience any of the following side effects, contact your doctor as soon as possible:
Rare(may affect up to 1 in 1,000 people):

• Increased or decreased urine production, or traces of blood in the urine.
• Skin rash characterized by the rapid appearance of areas of red skin covered with small pustules (small blisters filled with white/yellow liquid).

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

• Severe diarrhea, lasting a long time and containing blood, with stomach pain or fever. These may be signs of a serious inflammation of the intestine. This can rarely occur after taking antibiotics.
• Yellowing of the skin or whites of the eyes (jaundice) caused by liver problems.
• Inflammation of the pancreas (pancreatitis), which causes severe pain in the abdomen and back.
• Increased or decreased urine production, or traces of blood in the urine.
• Skin rash caused by sensitivity to sunlight.
• Unusual bruising or bleeding.
• Irregular heartbeat.

These are all serious side effects. You may need urgent medical attention.
Other side effects include:

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

• Diarrhea
• Abdominal pain
• Feeling unwell (nausea)
• Flatulence

Common(may affect up to 1 in 10 people)

• Loss of appetite (anorexia)
• Headache
• Feeling dizzy
• Pins and needles sensation, or numbness (paresthesia)
• Changes in taste
• Impaired vision
• Deafness
• Feeling sick (vomiting), stomach pain or cramps, loss of appetite, digestive problems
• Skin rashes and itching
• Joint pain (arthralgia)
• Fatigue
• Changes in the number of white blood cells and the concentration of bicarbonate in the blood

Uncommon(may affect up to 1 in 100 people)

• Thrush (candidiasis), a fungal infection
• Bacterial infection
• Inflammation of the throat (pharyngitis)
• Shortness of breath, chest pain, wheezing and cough (respiratory disorders)
• Inflammation inside the nose (rhinitis)
• Intestinal flu (gastroenteritis)
• Inflammation inside the vagina (vaginitis)
• Pneumonia
• Reduced number of white blood cells
• Angioedema
• Hypersensitivity
• Nervousness
• Reduced sense of touch (hypoesthesia)
• Feeling drowsy (somnolence)
• Difficulty sleeping (insomnia)
• Ear disorders
• Dizziness
• Feeling faint (vertigo)
• Palpitations
• Hot flushes
• Shortness of breath
• Nosebleeds
• Inflammation of the stomach lining (gastritis)
• Constipation
• Difficulty swallowing
• Bloated abdomen
• Dry mouth
• Burping
• Mouth ulcers
• Increased saliva flow
• Severe form of skin redness
• Liver problems, such as hepatitis
• Allergic skin reactions such as sensitivity to sunlight, red, flaky and swollen skin
• Skin rash
• Itching
• Inflammation of the skin (dermatitis)
• Dry skin
• Increased sweating
• Pain, swelling and reduced mobility of the joints (osteoarthritis)
• Muscle pain
• Back pain
• Neck pain
• Increased levels of urea in the blood
• Difficulty urinating and with pain
• Pain in the upper back (kidney pain)
• Blood loss
• Testicular disorders
• Hives
• Chest pain
• Facial swelling
• Fever
• Pain
• Swelling of the extremities (peripheral edema)Swelling (edema)
• General feeling of discomfort
• Weakness (asthenia)
• Changes in liver enzyme levels and blood levels
• Post-procedural complications
• Skin more sensitive to sunlight than normal
• Abnormal test values (e.g. blood or liver tests)

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

• Feeling agitated, feeling detached from oneself and one's feelings
• Abnormal liver function
• Allergic skin reactions
• Skin rash characterized by the rapid appearance of areas of red skin covered with small pustules (small blisters filled with white/yellow liquid)
• Swelling of the hands, feet, lips, genitals or throat (angioedema)
• Kidney problems

Not known(the frequency cannot be defined based on available data)

• Infection of the colon (pseudomembranous colitis)
• Reduced number of red blood cells due to destruction (hemolytic anemia); reduced number of platelets (thrombocytopenia)
• Anaphylactic reaction
• Feeling angry, aggressive
• Anxiety
• Confusion
• Hallucinations
• Fainting (syncope)
• Convulsions
• Reduced sense of touch (hypoesthesia)
• Feeling hyperactive
• Alteration of the sense of smell (anosmia, parosmia)
• Alteration of the sense of taste (ageusia)
• Exacerbation or worsening of muscle weakness (myasthenia gravis)
• Blurred vision
• Hearing problems including hearing loss or ringing in the ears
• Fast (ventricular tachycardia) or irregular heartbeat, sometimes life-threatening, changes in heart rhythm detected on an electrocardiogram (prolongation of the QT interval and torsades de pointes)
• Low blood pressure
• Inflammation of the pancreas (pancreatitis)
• Change in the color of the tongue
• Liver failure
• Severe allergic skin reactions
• Inflammation inside the kidneys

The following side effects have been reported in the prophylactic treatment against

Mycobacterium Aviumcomplex (MAC):

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

• Diarrhea
• Abdominal pain
• Feeling sick (with nausea)
• Gas (flatulence)
• Abdominal discomfort
• Soft stools

Common(may affect up to 1 in 10 people)

• Loss of appetite (anorexia)
• Feeling dizzy
• Headache
• Pins and needles sensation or numbness (paresthesia)
• Alteration of the sense of taste
• Impaired vision
• Deafness
• Feeling sick (vomiting), stomach pain or cramps, loss of appetite, problems digesting food
• Skin rashes and itching
• Joint pain (arthralgia)
• Fatigue

Uncommon(may affect up to 1 in 100 people)

• Reduced sense of touch (hypoesthesia)
• Hearing loss or ringing in the ears
• Palpitations
• Liver problems such as hepatitis
• Severe form of skin redness
• Allergic skin reactions such as sensitivity to sunlight, red, flaky and swollen skin
• General feeling of discomfort
• Weakness (asthenia)

Reporting of side effects
If you experience any side effects, including 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
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects
you can contribute to providing more information on the safety of this medicine.

5. How to store Azitromicina Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after SCAD. The
expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Azitromicina Aurobindo contains

• The active ingredient is azithromycin dihydrate. Each film-coated tablet contains 500 mg of azithromycin (as dihydrate).
• The other ingredients are: Tablet core: anhydrous calcium hydrogen phosphate, pregelatinized starch (corn starch), sodium croscarmellose, sodium lauryl sulfate, magnesium stearate. Coating: lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin.

Description of the appearance of Azitromicina Aurobindo and package contents
Film-coated tablet.

Azitromicina Aurobindo 500 mg film-coated tablets:
Tablets from white to almost white, film-coated, biconvex, with imprinted on one side “6”
and “7” on either side of the score line and “D” on the other side.
The size of each individual tablet is 17.1 mm x 8.5 mm.
Azitromicina Aurobindo film-coated tablets are available in blister packs made of transparent PVC
-Aluminum containing 3 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
Aurobindo Pharma (Italia) S.r.l. – via San Giuseppe, 102 – 21047 Saronno (VA)

Manufacturer
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000
Malta
Milpharm Limited Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD – United
Kingdom

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Italy: Azitromicina Aurobindo
Poland: Azypronal
Portugal: Azitromicina Aurobindo
Spain: AZITROMICINA AUROBINDO 500 mg comprimidos recubiertos con película EFG