AZITROMICINA 500 mg Tabletki Powlekane

Treść ulotki

1. What is Azitromicina Mylan and what is it used for
2. What you need to know before taking Azitromicina Mylan
3. How to take Azitromicina Mylan
4. Possible side effects
5. How to store Azitromicina Mylan
6. Package Contents and Other Information

Azitromicina Mylan 500 mg film-coated tablets
azitromicina

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if 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 Mylan is and what it is used for
• 2. What you need to know before you take Azitromicina Mylan
• 3. How to take Azitromicina Mylan
• 4. Possible side effects
• 5. How to store Azitromicina Mylan
• 6. Contents of the pack and other information

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

Azitromicina Mylan is an antibiotic belonging to the macrolide class. It is used in the
treatment of bacterial infections caused by microorganisms such as bacteria. These infections include:

• Chest infections such as bronchitis and pneumonia
• Sinusitis, infections of the throat, tonsils and ears
• Mild to moderate skin and soft tissue infections, e.g.hair follicle infection (folliculitis), bacterial infections of the skin and its deeper tissues (cellulitis), skin infection with patchy swelling and a shiny surface (erysipelas)
• Infections caused by a bacterium called Chlamydia trachomatis. These can cause inflammation of the tube that carries urine from the bladder (urethra) or in the area where the uterus connects to the vagina (cervix).

2. What you need to know before taking Azitromicina Mylan

Do not take Azitromicina Mylan:

• if you are allergic to azithromycin, to any other macrolide antibiotic (such as erythromycin or clarithromycin) or ketolide or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction can cause skin rash or shortness of breath.

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

• you have had a previous severe allergic reaction with swelling of the face and throat, and with possible difficulty breathing, skin rash, fever, swollen lymph nodes or increased eosinophils (a type of white blood cells).
• you have severe kidney problems: your doctor may adjust the dose
• you have liver problems: your doctor may need to monitor liver function or stop treatment
• you have myasthenia gravis (localized muscle weakness)
• you have been diagnosed with a neurological disease, which is a disease of the brain or nervous system
• you have mental, emotional or behavioral problems

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• you are taking medicines called ergot alkaloids (e.g. ergotamine) at the same time, which are used to treat migraine: azithromycin is not recommended (see section below Other medicines and Azitromicina Mylan).

Because azithromycin can increase the risk of abnormal heart rhythm, talk to your doctor if
you experience any of the following problems before taking this medicine (especially if you are a
woman or an elderly person):

• Diagnosis of prolonged QT interval (a heart condition, shown on an electrocardiogram or ECG machine): azithromycin is not recommended
• Low or irregular heart rate, or reduced heart function (heart failure): azithromycin is not recommended
• Low levels of potassium or magnesium in the blood: azithromycin is not recommended
• Concomitant administration of antiarrhythmic medicines (e.g. quinidine, procainamide, dofetilide, amiodarone, sotalol: used to treat abnormal heart rhythms), cisapride (used to treat stomach problems) or terfenadine (an antihistamine used to treat allergies) or antipsychotic agents (e.g. pimozide), antidepressants (e.g. citalopram), some antibiotics (e.g. moxifloxacin, levofloxacin) that can interfere with heart rhythm: azithromycin is not recommended (see section below Other medicines and Azitromicina Mylan).

Immediately inform your doctor if you develop symptoms of severe and persistent diarrhea during or after
treatment, especially if there is blood or mucus present.
If the symptoms persist after the end of treatment with azithromycin, or if you observe
any new and persistent symptoms, contact your doctor.

Other medicines and Azitromicina Mylan
Consult your doctor beforetaking Azitromicina Mylan if you are taking any of the
following medicines:

• Warfarin or other similar medicines used to prevent blood clots: concomitant use may increase the risk of bleeding.
• Ergotamine, dihydroergotamine (used to treat migraine): ergotism may occur (itching of the limbs, muscle cramps and gangrene of the 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 organ or bone marrow transplant rejection); if concomitant use is necessary, your doctor will check your blood levels and may adjust the dose.
• Digoxin (used to treat heart failure): digoxin levels may increase. Your doctor will check your blood levels.
• Colchicine (used for gout and familial Mediterranean fever)
• Antacids (for indigestion): Azitromicina Mylan should be taken at least 1 hour before or 2 hours after the antacid.
• Cisapride (for stomach problems), terfenadine (used for hay fever): concomitant use with azithromycin can cause heart problems.
• Medicines for irregular heartbeat (called anti-arrhythmics) or to lower cholesterol (called statins) such as atorvastatin.
• Alfentanil (used for anesthesia) or astemizole (used to treat hay fever): concomitant use with azithromycin may increase the effect of these medicines.
• Hydroxychloroquine (used for rheumatoid arthritis, lupus and malaria prevention).

Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

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.

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Azithromycin should be used during pregnancy only if clinically necessary and if the benefit of treatment is expected to
outweigh any small increase in risks that may exist.
Do not use this medicine during pregnancy unless your doctor has specifically
recommended it.
This medicine passes into breast milk. You should talk to your doctor before taking this
medicine if you are breastfeeding.

Driving and operating machinery
Azitromicina Mylan can cause dizziness and convulsions. If you experience these symptoms, do not drive and
do not operate machinery.

Azitromicina Mylan contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking
this medicine.

Azitromicina Mylan contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially
sodium-free.

3. How to take Azitromicina Mylan

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
Azitromicina tablets should be taken as a single daily dose. The tablets should
be swallowed preferably with water and can be taken independently of food intake.
Azitromicina 500 mg: The tablet can be divided into equal doses.
The recommended dose is:

Adults (including elderly patients), children and adolescents with a body weight over 45 kg:
The recommended dose is 1500 mg distributed over 3 or 5 days according to the following scheme:

• If taken over 3 days, 500 mg once a day.
• If taken over 5 days, 500 mg as a single dose on the first day and subsequently 250 mg once a day from the second to the fifth day. Inflammation of the urethra or cervix caused by Chlamydia: 1000 mg taken as a single daily dose for one day only.

For sinus infections, treatment is indicated for adults and adolescents aged 16 years and over.

Children and adolescents with a body weight of 45 kg or less:
The tablets are not indicated for these patients. Other pharmaceutical forms of products containing azithromycin (e.g. suspensions) may be administered.

Patients with kidney or liver problems:
Inform your doctor if you have kidney or liver problems. Your doctor may consider it appropriate to modify the
usual dosage.

If you take more Azitromicina Mylan than you should
In case of taking numerous tablets at the same time, or if you suspect that a child has
swallowed some tablets, contact your doctor or pharmacist immediately. Overdosage may
produce reversible hearing loss, severe nausea (feeling unwell), vomiting and diarrhea.
to the doctor so that it is possible to understand which tablets have been ingested.

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If you forget to take Azitromicina Mylan
If you forget to take a tablet, take it as soon as you remember unless it is
close to the time of the next dose. Do not take a double dose to make up for the forgotten
tablet.

If you stop taking Azitromicina Mylan
Do not stop taking the medicine unless after consulting your doctor even if
you feel better. It is very important to continue therapy with Azitromicina Mylan as
prescribed by your doctor; otherwise the infection may recur.
If you have any doubts about the use of Azitromicina Mylan, 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 develop any of the following side effects, stop taking the tablets and immediately contact your doctor or go to the nearest hospital emergency room:
Uncommon (may affect up to 1 in 100 people)

• A severe reaction causing sores/bleeding of the lips, eyes, nose, mouth and genitals (Stevens-Johnson syndrome)
• Yellowing of the skin and the whites of the eyes, fatigue and loss of appetite, which may be caused by liver inflammation (hepatitis) Rare (may affect up to 1 in 1,000)
• Yellowing of the skin or eyes (jaundice)
• Skin rash characterized by the rapid appearance of areas of reddened skin covered with small pustules (small blisters filled with white/yellow fluid).

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

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

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

• An allergic reaction (swelling of the lips, face or neck leading to severe breathing difficulties, skin rash or hives).
• Severe skin peeling or itchy skin rash with pink-red rings around a pale central area (toxic epidermal necrolysis, erythema multiforme).
• Heart rhythm disorders called prolongation of the QT interval (delayed conduction of electrical signals that can be observed with an electrocardiogram (ECG), an electrical recording of the heart's activity). In some individuals this can develop into a potentially serious heart condition known as “torsades de pointes”. This can cause very fast heartbeats, leading to sudden loss of consciousness.
• Irregular heartbeat
• Feeling of weakness and shortness of breath with yellowing of the skin which may be due to a reduction in red blood cells following their destruction (hemolytic anemia)
• Prolonged diarrhea with blood and mucus
• Stomach pain radiating to the back with a feeling and state of unwellness which may be caused by inflammation of the pancreas (pancreatitis)
• Pain in the central part of the back and difficulty urinating, inflammation of the kidneys or kidney failure
• Pain in the upper right side of the stomach with a feeling and state of unwellness, bloating of the stomach, yellowing of the skin and eyes which may be due to liver failure (rarely life-threatening)
• Convulsions.

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These side effects are very serious. Urgent medical attention or hospitalization
may be necessary.

The following side effects have been observed:
Very common (may affect more than 1 in 10 people)

• Diarrhea.
• Feeling unwell
• Abdominal pain
• Flatulence

Common (may affect up to 1 in 10 people)

• Headache
• Dizziness, drowsiness, altered taste, numbness or tingling (paresthesia)
• Vision disorders
• Deafness
• Feeling unwell
• Indigestion
• Skin rash
• Itching
• Joint pain (arthralgia)
• Fatigue
• Changes in white blood cell count detected in blood tests
• Reduced blood levels of bicarbonate.

Uncommon (may affect up to 1 in 100 people)

• Reduced sense of touch or sensitivity (hypoesthesia)
• Changes in liver function
• Skin more sensitive than normal to light
• Yeast infections of the mouth and vagina (candidiasis), vaginal infections, fungal infections (mycosis), bacterial infections, sore throat, inflammation of the stomach and intestines, difficulty breathing, stuffy or runny nose
• Allergic reactions of varying severity
• Loss of appetite
• Nervousness
• Insomnia
• Hearing disorders, vertigo
• Impaired hearing including hearing loss
• Tinnitus (ringing in the ears)
• Palpitations
• Hot flashes
• Recurrent frequent infections with fever, chills, sore throat, mouth ulcers, which may be caused by a decrease in the number of white blood cells in the blood
• Severe lung infection, with symptoms such as fever, chills, shortness of breath, cough and sputum (pneumonia)
• Generalized swelling
• Nosebleeds
• Constipation, inflammation of the stomach lining (gastritis), difficulty swallowing, feeling of fullness, dry mouth, belching, mouth ulcers, increased salivation
• Hives, skin inflammation (dermatitis), dry skin, increased sweating
• Bone and joint pain, muscle pain, back pain, neck pain
• Pain during urination, kidney pain
• Abnormal or unexpected vaginal bleeding,
• Problems with the testicles

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• General loss of strength, generally feeling unwell, chest pain, fever, pain, swelling of the lower limbs
• Abnormal laboratory values (e.g. blood or liver tests)
• Post-procedural complications
• Shortness of breath.

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

• Agitation
• Irritability.

Not known (frequency cannot be estimated on the basis of available data)

• Delays in blood clotting and more frequent bruising which may be due to a reduction in the number of platelets (thrombocytopenia)
• Aggression, anxiety, severe confusion (delirium), seeing, perceiving or hearing things that do not exist (hallucinations)
• Fainting, hyperactivity, loss of smell or altered sense of smell, loss of taste
• Muscle weakness or worsening of muscle weakness (myasthenia gravis)
• Low blood pressure
• Discoloration of the tongue
• Discoloration of the teeth.

The following side effects have been found in the prophylactic treatment against Mycobacterium

Aviumcomplex (MAC):

Very common (may affect more than 1 in 10)

• Diarrhea
• Abdominal pain
• Feeling unwell
• Flatulence
• Abdominal discomfort
• Loose stools.

Common (may affect up to 1 in 10)

• Loss of appetite
• Dizziness
• Headache
• Numbness or tingling (paresthesia)
• Altered taste
• Vision changes
• Deafness
• Skin rash and/or itching
• Joint pain
• Fatigue.

Uncommon (may affect up to 1 in 100):

• Decreased sense of touch and sensitivity (hypoesthesia)
• Hearing disorders or ringing in the ears
• Palpitations
• Skin more sensitive than normal to sunlight
• General loss of strength
• General feeling of unwellness.

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 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.

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5. How to store Azitromicina Mylan

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions. Do not transfer the
tablets into another container. Do not use this medicine after the expiry date indicated on the
package and on the blister 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. Package Contents and Other Information

What Azitromicina Mylan contains

• The active ingredient is azithromycin. Each tablet contains 500 mg of the active ingredient azithromycin (as azithromycin dihydrate).
• The other ingredients (excipients) are: microcrystalline cellulose (E460), pregelatinized corn starch, sodium starch glycolate (type A), anhydrous colloidal silica (E551), sodium lauryl sulfate, magnesium stearate (E470b). The ingredients of the film coating are: hypromellose, lactose monohydrate, titanium dioxide (E171) and macrogol.

Description of the appearance of Azitromicina Mylan film-coated tablets and package contents
Azitromicina Mylan 500 mg: oblong, film-coated tablets from white to almost white in color with a deep fracture line on one side and an incision line on the other.
The 500 mg tablets are available in packs of 2, 3, 6, 12, 24, 30, 50 or 100 tablets in
blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan

Manufacturers
Sandoz GmbH, Biochemiestraße 10, 6250 Kundl, Austria
Sandoz S.R.L, Livezeni Street no 7A, Targu Mures, Romania
Mylan Hungary Kft
Mylan utca 1, Komarom, H-2900
Hungary
Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

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This medicinal product is authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) with the following denominations:
Czech Republic Azitromycin Viatris 500 mg potahovane tablety
Denmark Azithromycin Viatris
Ireland Azromax 250 mg Film-coated Tablet
Italy Azitromicina Mylan
Netherlands Azitromycine Viatris250 mg & 500 mg filmomhulde tabletten
Portugal Azitromicina Mylan
Slovakia Azitromycin Viatris500 mg
Sweden Azithromycin Viatris250 mg & 500 mg’ filmdragerad tablett
United Kingdom Azithromycin 250 mg & 500 mg Film-Coated Tablets
(Northern Ireland)

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