Azithromycin Mylan

Package leaflet: Information for the patient

Azithromycin Mylan 500 mg film-coated tablets

azithromycin
Generic medicine
Read 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. Never give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

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

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

Azithromycin Mylan 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 Mylan is taken to treat the following infections:
Adults and adolescents weighing 45 kg or more

• 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 infections of the skin and underlying tissues
• infections of the urethra and cervix caused by the bacterium Chlamydia trachomatis
  Adults:
• bacterial infections in patients with long-term inflammation of the bronchi (chronic bronchitis)

2. What you need to know before taking Azithromycin Mylan

Do not take Azithromycin Mylan:

• if you are allergic to azithromycin, erythromycin, 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 if you have or have had any of the following conditions:
heart problems (e.g. heart rhythm problems 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;
if you are taking ergot derivatives such as ergotamine (used to treat migraine), as these medicines must not be taken in combination with Azithromycin Mylan.
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, 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 Mylan;
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 to treat 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 you for symptoms of additional bacterial or fungal infections that cannot be treated with Azithromycin Mylan (superinfection).
Sexually transmitted infections
Your doctor may perform a test to rule out possible syphilis infection, a sexually transmitted disease that could otherwise progress undetected and be diagnosed late.
Furthermore, in cases of bacterial sexually transmitted infections, your doctor will carry out follow-up laboratory tests to monitor the success of treatment.
Children and adolescents
If your body weight is less than 45 kg, there are other azithromycin-containing medicines that may be more convenient for you to take.
Other medicines and Azithromycin Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking Azithromycin Mylan together with other medicines may cause side 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 cholesterol in the blood and prevent heart disease, including heart attacks and strokes);
cyclosporine (to prevent rejection of transplanted organs by the body);
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 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 tract disorders);
• hydroxychloroquine or chloroquine (for the treatment of autoimmune diseases, including rheumatoid arthritis, or to treat or prevent malaria).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Your doctor will decide whether you can take this medicine during pregnancy, after ensuring that the benefits outweigh the potential risks.
Breastfeeding
Azithromycin Mylan passes into breast milk. Therefore, your doctor will decide whether to discontinue breastfeeding or to avoid treatment with Azithromycin Mylan, taking into account both the benefit of breastfeeding for the child and the benefit of therapy for you.
Driving and using machines
Azithromycin Mylan has a moderate effect on the ability to drive and use machines. Dizziness, drowsiness and seizures, as well as vision and hearing problems, have been reported with Azithromycin Mylan in some people. These possible side effects may affect your ability to drive and use machinery.
Azithromycin Mylan contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Azithromycin 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 Azithromycin Mylan

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The amount of Azithromycin Mylan you should take each day depends on the bacterial infection
being treated and the specific treatment regimen prescribed by your doctor or pharmacist.
Adults and adolescents with a body weight of 45 kg or more

Use in children and adolescents
If your weight is less than 45 kg or you are unable to swallow this medicine, consult your
doctor or pharmacist, as other azithromycin-containing medicines are also available that
may be more suitable for you.

Method of administration
For oral use.
Azithromycin Mylan should be taken orally as a single daily dose. The tablets
may be taken regardless of meals. Taking this medicine just before a meal may help improve gastrointestinal tolerability.
The tablets can be divided into two equal halves, which may be used to adjust the dose according to the instructions of the doctor or pharmacist.

If you take more Azithromycin Mylan than you should
If you take more Azithromycin Mylan than you should, you may feel unwell. Typical signs of overdose are vomiting, diarrhoea, abdominal pain and nausea. Inform your doctor immediately or contact the emergency department of the nearest hospital.

If you forget to take Azithromycin Mylan
If you forget to take Azithromycin Mylan, take it as soon as possible, provided that at least 12 hours remain 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 forgotten dose.

If you stop treatment with Azithromycin Mylan
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Stop taking Azithromycin Mylan and contact your doctor immediately if you notice any of the
following symptoms:
sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching mainly affecting the whole body (anaphylactic reaction, frequency not known)
rapid 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 the stools and/or fever, which may indicate an infection of the large intestine (antibiotic-associated colitis, frequency not known). Do not take medicines for diarrhoea that inhibit intestinal motility (antiperistaltic agents)
red, flat spots on the trunk, target-shaped or circular in appearance, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin rashes 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, bloating, indigestion (dyspepsia), inflammation of the stomach lining (gastritis), difficulty swallowing (dysphagia), abdominal distension, dry mouth, belching, mouth ulceration, increased salivation
• rash, itching, urticaria, dermatitis, dry skin, abnormally increased sweating (hyperhidrosis)
• swelling and pain in joints (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)

• feeling 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 cell breakdown, which may cause fatigue and pale skin (haemolytic anaemia)
• reduction in platelets which may lead to bleeding and bruising (thrombocytopenia)
• feeling angry, aggressive, fearful or worried (anxiety), acute confusional state (delirium)
• hallucination
• fainting (syncope)
• seizures (convulsions)
• reduced sensitivity to touch, pain and temperature (hypoesthesia)
• feeling of hyperactivity
• change in sense of smell (anosmia, parosmia)
• complete loss of sense of taste (ageusia)
• muscle weakness (myasthenia gravis)
• abnormal electrocardiogram (ECG) (prolonged 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 or pharmacist. 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 Mylan

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions. Do not transfer the tablets to another container. Do not use this medicine after the expiry date stated on the packaging and on the blister after EXP. The expiry date refers to the last day of that month.
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 film-coated tablets contain

• The active substance is azithromycin. Each tablet contains 500 mg of the active substance 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 coating film are: hypromellose, lactose monohydrate, titanium dioxide (E171) and macrogol.

Description of the appearance of Azitromicina Mylan film-coated tablets and pack sizes

Azitromicina Mylan 500 mg: oblong, film-coated tablets, white to almost white in colour, with a deep break line on one side and a score line on the other.
The 500 mg tablets are available in blister packs containing 2, 3, 6, 12, 24, 30, 50 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy

Manufacturers
Sandoz GmbH, Biochemiestraße 10, 6250 Kundl, Austria
Novartis Pharmaceuticals 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

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