Azacid

Package leaflet: Information for the patient

Azacid 50 mg film-coated tablets

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

1. What Azacid is and what it is used for

Azacid contains the active substance azithromycin. Azithromycin is an antibiotic that
belongs to a group of antibiotics called "macrolides", which inhibit the growth of susceptible bacteria.
Azacid 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
• bacterial infections of the gums (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 Azacid

Do not take Azacid

• if you are allergic to azithromycin, erythromycin, or to 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 Azacid if you have or have had any of the following conditions:
heart problems (e.g. irregular heart rhythm or heart failure) or low levels of potassium or magnesium in the blood: these conditions may increase the risk of serious heart-related 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 condition may worsen during treatment;
or if you are taking ergot derivatives such as ergotamine (used to treat migraine), as these medicines should not be taken together with Azacid.
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, skin 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 during azithromycin treatment;
if you experience an abnormal heartbeat or palpitations, dizziness or fainting while taking Azacid;
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 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 Azacid (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 carry out follow-up laboratory tests to monitor the effectiveness 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 Azacid
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking Azacid 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 stroke);
cyclosporine (to prevent rejection of transplanted organs);
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 prolong the QT interval (i.e. cause the heart muscle to take longer than normal to contract and relax), such as:

• quinidine, procainamide, dofetilide, amiodarone and sotalol (used to treat irregular heartbeat, including cases of abnormally fast or slow heart rate - 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 such as 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 are 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 assessing that the benefits outweigh the potential risks.
Breastfeeding
Azacid passes into breast milk. Therefore, your doctor will decide whether to discontinue breastfeeding or avoid treatment with Azacid, taking into account both the benefit of breastfeeding for the infant and the benefit of the therapy for you.
Driving and using machines
Azacid may have 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 Azacid. These possible side effects may affect your ability to drive or operate machinery.
Azacid contains lactose and sodium
This medicine contains lactose, a type of sugar. If you have been diagnosed by your doctor with an intolerance to certain sugars, contact your doctor 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 Azacid

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
The amount of Azacid you need to take each day depends on the bacterial infection being treated and
the specific treatment regimen your doctor or pharmacist has prescribed for you.
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, consult your doctor or pharmacist, as other medicinal products containing azithromycin are also available which may be more suitable for you.

Method of administration
For oral use.
Azacid must be taken orally as a single daily dose.
The tablets must be swallowed whole with water. The tablets may be taken regardless of meals. Taking this medicine just before a meal may help improve gastrointestinal tolerability.

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

If you forget to take Azacid
If you forget to take Azacid, 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; instead, take the next dose at the usual time. Do not take a double dose to make up for the forgotten dose.

If you stop Azacid treatment
If you stop treatment with Azacid too early, the infection may recur. Take Azacid for the full duration of the treatment, even when 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 everybody gets them.

Serious side effects
Stop using Azacid and contact your doctor immediately if you notice any of the following symptoms:
Sudden wheezing, breathing difficulties, 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 torsade 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 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 spots on the trunk, flat or target-shaped or circular, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin reactions 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))
Widespread, red, scaly rash with subcutaneous nodules 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)).

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 inflammation, respiratory disorder, inflammation of the nasal mucosa, vaginal infection
• Changes in white blood cell count (leucopenia, neutropenia, eosinophilia)
• Increased platelet count
• Reduction in the 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
• 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, belching, mouth ulcers, increased salivation
• Rash, itching, hives, 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, especially in 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)

• Irritation sensation
• Liver problems, yellowing of the skin or eyes
• Increased sensitivity to sunlight

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

• Reduction in red blood cell count due to increased cell 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, fearful or worried (anxiety), acute confusion (delirium)
• Hallucination
• Fainting (syncope)
• Seizures (convulsions)
• Reduced sensitivity to touch, pain and temperature (hypoesthesia)
• Feeling overactive
• Changes in sense of smell (anosmia, parosmia)
• Complete loss 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
• Pancreas inflammation causing severe abdominal and back pain (pancreatitis)
• Change in tongue colour
• Joint pain (arthralgia)
• Kidney inflammation (interstitial nephritis) and impaired kidney function

Reporting of side effects
If you experience any side effects, 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 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 Azacid

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 carton and blister 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 required. This will help protect the environment.

6. Package contents and other information

What Azacid 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), lactose
monohydrate.
Description of the appearance of Azacid and pack contents
Pack containing 3 tablets of 500 mg in blister.
Marketing Authorization Holder
Genetic S.p.A. Via G. Della Monica 26 - 84083 Castel San Giorgio (SA)
Manufacturer
Genetic S.p.A. Contrada Canfora - 84084 Fisciano (SA)