Azithromycin Doc Generici

Package leaflet: Information for the patient

AZITROMICINA DOC Generici 500 mg film-coated tablets
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. Do not give it to others, even if their symptoms are the same as yours, as it could 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 AZITROMICINA DOC Generici is and what it is used for
2. What you need to know before taking AZITROMICINA DOC Generici
3. How to take AZITROMICINA DOC Generici
4. Possible side effects
5. How to store AZITROMICINA DOC Generici
6. Contents of the pack and other information

1. What AZITROMICINA DOC Generici is and what it is used for

AZITROMICINA DOC Generici contains the active substance azithromycin. Azithromycin is an antibiotic belonging to a group of antibiotics called macrolides, which inhibit the growth of susceptible bacteria.
AZITROMICINA DOC Generici is taken for the treatment of the following infections:
Adults and adolescents weighing 45 kg or more:

• Infection 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 skin and underlying tissue infections
• Bacterial gum infections (periodontitis) or gum abscess (periodontal abscess)
• Infections of the urethra and cervix caused by the bacterium Chlamydia trachomatis
• Bacterial genital infections with painful sores (chancroid)

Adults:

• Bacterial infections in patients with long-term inflammation of the bronchi (chronic bronchitis)

2. What you need to know before taking AZITROMICINA DOC Generici

Do not take AZITROMICINA DOC Generici

• 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 AZITROMICINA DOC Generici if you have or have had any of the following conditions:

• heart problems (e.g. heart rhythm disorders 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;
• or if you are taking ergot derivatives such as ergotamine (used to treat migraine), since these medicines must not be taken together with AZITROMICINA DOC Generici. 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 (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), reported in association with azithromycin treatment;
• if you experience an abnormal heartbeat or palpitations, dizziness or fainting while taking AZITROMICINA DOC Generici;
• 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 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 for symptoms of additional bacterial or fungal infections that cannot be treated with AZITROMICINA DOC Generici (superinfection).

Sexually transmitted infections
Your doctor may perform a test to rule out possible syphilis, a sexually transmitted disease that could otherwise progress undetected and be diagnosed late. Furthermore, in cases of bacterial sexually transmitted infections, your doctor will perform follow-up laboratory tests to monitor the success of therapy.

Children and adolescents
If your body weight is less than 45 kg, other azithromycin-containing medicines may be more suitable and easier for you to take.

Other medicines and AZITROMICINA DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking AZITROMICINA DOC Generici 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 belonging to the statin group (to lower blood cholesterol and prevent heart diseases, 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 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 (prolongation of the QT interval), such as:
  • 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 disorders);
  • hydroxychloroquine or chloroquine (for the treatment of autoimmune diseases, including rheumatoid arthritis, or for treating or preventing malaria).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Your doctor will decide whether you can take this medicine during pregnancy, after confirming that the benefits outweigh the potential risks.
Breastfeeding
AZITROMICINA DOC Generici passes into breast milk. Therefore, your doctor will decide whether to discontinue breastfeeding or avoid treatment with AZITROMICINA DOC Generici, taking into account both the benefit of breastfeeding for the child and the benefit of therapy for you.

Driving and using machines
AZITROMICINA DOC Generici has a moderate effect on the ability to drive and use machines. Dizziness, drowsiness, seizures, and vision or hearing problems have been reported in some people taking AZITROMICINA DOC Generici. These possible side effects may affect your ability to drive or operate machinery.

AZITROMICINA DOC Generici contains lactose and sodium

• This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her 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 AZITHROMICINA DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
The amount of AZITHROMICINA DOC Generici 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 body weight equal to or greater than 45 kg

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

Method of administration
For oral use
AZITROMICINA DOC Generici must be taken orally as a single daily dose. The tablets should be swallowed whole with water, either with or without food. Taking this medicine just before a meal may help improve gastrointestinal tolerance.

If you take more AZITROMICINA DOC Generici than you should
If you take more AZITROMICINA DOC Generici 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 DOC Generici
If you forget to take AZITROMICINA DOC Generici, 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 the missed dose.

If you stop treatment with AZITROMICINA DOC Generici
If you stop treatment with AZITROMICINA DOC Generici too early, the infection may recur. Continue taking AZITROMICINA DOC Generici for the full duration of treatment, even if you start to feel better.

If you have any doubts about how to use this medicine, consult your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Serious side effects
Stop using AZITROMICINA DOC Generici 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 unknown)

• fast or irregular heartbeat ( cardiac arrhythmia or torsades de pointes, tachycardia, frequency unknown)

• 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 unknown)

• severe diarrhoea with abdominal cramps, blood in the stools and/or fever may indicate an infection of the large intestine ( antibiotic-associated colitis, frequency unknown). Do not take medicines for diarrhoea that inhibit intestinal movements (antiperistaltics)

• red, non-elevated spots on the trunk, target-shaped or circular, often with central blisters, skin peeling, mouth, throat, nose, genital and eye ulcers. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome or toxic epidermal necrolysis, frequency unknown)

• 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 (generalized pustular eruption, 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 mucous membrane inside the nose, vaginal infection
• changes in white blood cell count (leucopenia, neutropenia, eosinophilia)
• increased platelet count
• reduction in the percentage of all blood cells in the total blood volume (reduced haematocrit)
• allergic reactions, swelling of the 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 disturbances
• ear disorder
• sensation of 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 abdomen, 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 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)

• sensation 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 cell count due to increased cellular breakdown which may cause fatigue and pale skin (haemolytic anaemia)
• reduction in platelet count which may lead to bleeding and bruising (thrombocytopenia)
• feeling angry, aggressive, feeling frightened and worried (anxiety), acute confusion (delirium)
• hallucination
• fainting (syncope)
• seizures (convulsions)
• reduced sensitivity to touch, pain and temperature (hypoesthesia)
• sensation of hyperactivity
• change in sense of smell (anosmia, parosmia)
• complete loss of sense of taste (ageusia)
• muscle weakness (myasthenia gravis)
• abnormal electrocardiogram (ECG) (prolongation of 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 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 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 AZITROMICINA DOC Generici

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 above 30 °C.
Do not use this medicine if you notice any obvious signs of deterioration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What AZITROMICINA DOC Generici contains

• The active substance is azithromycin dihydrate. Each tablet contains 524.1 mg of azithromycin dihydrate, equivalent to 500 mg of azithromycin.
• The other components are anhydrous calcium hydrogen phosphate, pregelatinized starch, sodium lauryl sulfate, sodium croscarmellose, sodium carmellose, anhydrous colloidal silica, magnesium stearate. Tablet coating: hypromellose (E464), titanium dioxide (E171), triacetin (E1518), monohydrate lactose.

Description of the appearance of AZITROMICINA DOC Generici and contents of the pack
Pack containing 3 tablets of 500 mg in blister packs.
Marketing Authorization Holder
DOC Generici S.r.l. – Via Turati 40 – 20121 Milan – Italy.
Manufacturer
Doppel Farmaceutici S.r.l. - Via Volturno 48 - 20089 Quinto De’ Stampi - Rozzano (Milan) – Italy.
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR) – Italy.