Azithromycin EG

Package leaflet: Information for the user

Azithromycin EG 500 mg film-coated tablets

Generic medicine
Please read all of 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Azithromycin EG contains the active substance azithromycin. Azithromycin is an antibiotic belonging to the group of antibiotics known as macrolides, which block the growth of susceptible bacteria.
Azithromycin EG 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 EG

DO NOT take Azithromycin EG
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 EG if you have or have had any of the following conditions:

• heart problems (for example, 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;
• 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 in combination with Azithromycin EG.

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

• if you suspect you are having an allergic reaction (for example, 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), reported in association with azithromycin treatment;
• if you experience an abnormal heartbeat or palpitations, dizziness or fainting while taking Azithromycin EG;
• if you develop signs of liver problems (for example, 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 weeks of treatment, inform your doctor.

Superinfection
Your doctor may monitor symptoms of additional bacterial or fungal infections that cannot
be treated with Azithromycin EG (superinfection).
Sexually transmitted infections
Your doctor may perform a test to rule out a possible syphilis infection, a sexually
transmitted disease that could otherwise progress undetected and be diagnosed late. Furthermore, in any case of
sexually transmitted bacterial infections, your doctor will perform follow-up laboratory tests to
monitor the success of therapy.
Children and adolescents
If your 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 EG
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.
Taking Azithromycin EG 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 medicines in the statin group (to lower cholesterol in the blood and prevent heart disease, including heart attacks and strokes);

• cyclosporine (to prevent the body rejecting transplanted organs);

• colchicine (for the treatment of gout and familial Mediterranean fever);

• dabigatran (to prevent and treat blood clot formation (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 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 a pregnancy, or breastfeeding,
ask your doctor or pharmacist for advice 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 EG passes into breast milk. Therefore, your doctor will decide whether to discontinue breastfeeding or avoid
treatment with Azithromycin EG, taking into account both the benefit of breastfeeding for the child and the benefit of the therapy for you.
Driving and using machines
Azithromycin EG 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 EG in some people. These possible side effects may affect the ability to drive and use machines.
Azithromycin EG contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this
medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Azithromycin EG

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 EG you should take each day depends on the bacterial infection being treated
and the specific treatment course your doctor or pharmacist has prescribed.
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, please consult your doctor or pharmacist, as other azithromycin-containing medicines are available which may be more suitable for you.

Use in the elderly
No dose adjustment is necessary. You should take the dose of azithromycin indicated in the table above. However, consult your doctor or pharmacist if you have heart problems (see section 2. What you should know before taking Azitromicina EG).

Use in patients with renal or hepatic impairment
Consult your doctor first if you have liver or kidney problems. Your doctor will then decide whether a dose adjustment is necessary.

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

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

If you forget to take Azitromicina EG
If you forget to take Azitromicina EG, take it as soon as possible, provided that at least 12 hours remain before the next scheduled dose. If less than 12 hours remain before the next dose, do not take the missed dose; instead, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Azitromicina EG
If you stop treatment with Azitromicina EG too early, the infection may recur. Take Azitromicina EG for the full duration of treatment, even if you start to feel better.

If you have any questions 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 everyone will experience them.

Serious side effects
Stop using Azithromycin EG and consult 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)
• 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 the 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)
• Reddish flat spots on the trunk, target-shaped or circular, often with central blisters, skin peeling, mouth, throat, nose, genital and 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 and 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 (candidiasis), a fungal infection of the mouth and vagina, other fungal infections
• Lung infection, bacterial throat infection, gastrointestinal tract inflammation, respiratory disorder, inflammation of the nasal mucosa, vaginal infection
• Changes in white blood cell count (leukopenia, 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), sensation of numbness (paraesthesia)
• Visual impairment
• Ear disorder
• 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)
• 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 feeling of 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)

• Decrease in red blood cell count due to increased cell breakdown, which may cause fatigue and pale skin (haemolytic anaemia)
• Decrease in platelet count, which may lead to bleeding and bruising (thrombocytopenia)
• Feeling angry, aggressive, frightened or worried (anxiety), acute confusion (delirium)
• Hallucination
• Fainting (syncope)
• Seizures (convulsive seizures)
• Reduced sensitivity to touch, pain and temperature (hypoesthesia)
• Feeling overactive
• Change in sense of smell (anosmia, parosmia)
• Complete loss 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 experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 EG

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the blister or packaging, following the wording EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines 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 EG contains
The active substance is azithromycin.
Each film-coated tablet of Azitromicina EG 500 mg contains azithromycin dihydrate equivalent to
500 mg of azithromycin.
The other components are:
Tablet core:
Microcrystalline cellulose
Pregelatinized corn starch
Sodium starch glycolate
Anhydrous colloidal silica
Sodium lauryl sulfate
Magnesium stearate
Coating:
Hypromellose
Lactose monohydrate
Titanium dioxide (E 171)
Macrogol 4000
Description of the appearance of Azitromicina EG and pack contents
Azitromicina EG 500 mg film-coated tablets: oblong, film-coated tablets, white to almost white, with a deep score on one side and a notch on the other side.
Azitromicina EG is available in PVC/PVdC/aluminum blisters.
Pack sizes:
2, 3, 6, 12, 24, 30, 50 and 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 - 20136 Milan, Italy
Manufacturers
Sandoz Gmbh, Biochemiestrasse, 10 – 6250 Kundl - Austria
Lek d.d. Pharmaceuticals, Verovskova, 57 Ljubljana - Slovenia
Novartis Pharmaceuticals S.R.L., Str. Livezeni n. 7a - 540472 Targu-Mures - Romania
Centrafarm Services B.V., Van de Reijtstraat 31-E, 4814 NE Breda - The Netherlands
Stada Arzneimittel AG, Stadastr. 2-18, 61118 Bad Vilbel - Germany
Clonmel Healthcare Ltd, Waterford Road - Clonmel, Co. Tipperary - Ireland
This medicinal product is authorized in the European Economic Area countries under the following
names:
Finland Azithromycin STADA 250/500 mg tabletti, kalvopäällysteinen
Germany Azithromycin STADA 250 mg und 500 mg Filmtabletten
Luxembourg Azithromycine EG 250 mg/500 mg, omhulde tabletten
Ireland Azithromycin Clonmel 250 mg film-coated tablets
Italy Azitromicina EG 500 mg compresse rivestite con film
The Netherlands Azitromycine CF 250 mg/500 mg, filmomhulde tabletten