Azitredil

Package leaflet: Information for the patient

AZITREDIL 500 mg film-coated tablets

Azithromycin
Generic Medicine
Please 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 give it to other people, 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What AZITREDIL is and what it is used for

This medicinal product contains the active substance azithromycin, which belongs to a group of
medicines called antibiotics (macrolide antibiotics) used to treat infections caused by bacteria.
AZITREDIL is used to treat infections caused by bacteria sensitive to azithromycin, such as:

• Upper respiratory tract infections:
• ear infection (otitis media);
• tonsil infection (tonsillitis);
• throat infection (pharyngitis);
• nasal cavity infection (sinusitis).
• Lower respiratory tract infections:
• infection of the bronchi and lungs (bronchitis and pneumonia)
• Mouth or dental infections (odontostomatological infections);
• Skin and other body organ infections (soft tissue infections);
• Urinary tract infections (non-gonococcal urethritis due to Chlamydia trachomatis);
• Genital infections (chancroid due to Haemophilus ducreyi).

2. What you need to know before taking AZITREDIL

Do not take AZITREDIL

• if you are allergic to azithromycin or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to erythromycin or to other similar antibiotic medicines (macrolide or ketolide antibiotics).

Warnings and precautions
Talk to your doctor or pharmacist before taking AZITREDIL.
The following conditions may occur with azithromycin. Contact your doctor if you think you have any of these conditions:

• anaphylactic reactions: (rarely severe allergic reactions, including angioedema and anaphylaxis), Stevens-Johnson syndrome and toxic epidermal necrolysis. Symptoms may include redness and irritation of the skin, sometimes severe, with blisters, swelling of lips, tongue or throat. These conditions can be life-threatening and require urgent medical attention. Allergic events may recur even after discontinuation of treatment. If you notice any of these symptoms, contact your doctor immediately.
• new infections: as with any other antibiotic, treatment with azithromycin may lead to infections caused by microorganisms (bacteria or fungi) not affected by this medicine. Be alert for any new signs of inflammation or infection.
• diarrhea associated with Clostridium difficile : this condition has been reported with the use of nearly all antibiotics, including azithromycin; its severity can range from mild diarrhea to severe inflammation of the intestine (pseudomembranous colitis), which may be fatal and can occur even more than two months after taking this medicine. If you develop diarrhea, contact your doctor as appropriate treatment may be needed.
• a muscle disorder causing weakness (myasthenia gravis); use caution if you already suffer from this condition, as it may worsen during treatment with this medicine.

Take this medicine with caution and inform your doctor if:

• you have liver problems, as these may worsen; if you experience any of the following symptoms, contact your doctor, who may order specific tests to monitor liver function or consider stopping treatment with this medicine:
  • sudden feeling of fatigue (asthenia);
  • yellowing of the skin and whites of the eyes (jaundice);
  • dark urine;
  • tendency to bleed;
  • confusion, difficulty thinking, and problems performing movements (or hepatic encephalopathy).
• you have severe kidney problems, as dose adjustment may be necessary;
• you suffer from heart rhythm disorders, especially if you are a woman or an elderly patient. Pay particular attention when taking this medicine if you or a family member were born with a heart rhythm disorder (prolonged QT interval seen on electrocardiogram), if your blood electrolyte levels are abnormal (especially low potassium or magnesium levels), if you have a slow or irregular heartbeat (bradycardia, cardiac arrhythmia), if you have a weak heart (severe heart failure), or if you are taking other medicines (see section “Other medicines and AZITREDIL”) that affect the heart (some antiarrhythmics such as quinidine, procainamide, dofetilide, amiodarone and sotalol, cisapride and terfenadine, medicines used to treat mental illnesses such as depression (antidepressants, antipsychotics), other antibiotics such as fluoroquinolones (moxifloxacin and levofloxacin)); in these cases, the risk of serious, potentially life-threatening heart rhythm disorders (cardiac arrhythmia, torsades de pointes) may increase;
• you suffer from a muscle disorder causing weakness (myasthenia gravis); this condition may worsen during treatment with this medicine.

If you are taking ergotamine or ergotamine derivatives, medicines mainly used to treat migraine (severe headache), do not take AZITREDIL, as the combination of these two medicines may cause a life-threatening condition (ergotism).
Children
The safety and efficacy of this medicine for the prevention and treatment of infections caused by the bacterium Mycobacterium avium complex in children have not been established.
Consult your doctor before administering any medicine to children.
Other medicines and AZITREDIL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take AZITREDIL if you are already taking:

• ergotamine, a medicine used to treat migraine (see section “Do not take AZITREDIL”), due to the risk of ergot poisoning;
• antacids, medicines used to reduce stomach acidity.

Take this medicine with caution and inform your doctor if you are taking any of the following medicines:

• digoxin, a medicine used to treat certain heart conditions;
• atorvastatin, a medicine used to lower blood cholesterol levels;
• cyclosporine, a medicine used to treat autoimmune diseases and in transplant patients; if concomitant use of cyclosporine and AZITREDIL is strictly necessary, consult your doctor, as dose adjustment may be required;
• nelfinavir, a medicine used to treat AIDS;
• oral anticoagulants (coumarins), medicines used to treat circulation problems; consult your doctor, as specific monitoring (prothrombin time) may be needed;
• medicines used to treat heart rhythm disorders (certain antiarrhythmics such as quinidine, procainamide, amiodarone, dofetilide, sotalol, cisapride and terfenadine);
• medicines used to treat mental illnesses such as depression (antidepressants, antipsychotics);
• other antibiotics such as fluoroquinolones (moxifloxacin and levofloxacin).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, take this medicine only if your doctor considers it strictly necessary.
Driving and using machines
There are no available data to determine the effect of this medicine on the ability to drive or operate machinery.
AZITREDIL contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take AZITREDIL

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Swallow the tablets whole, always as a single daily dose, regardless of meals; however, taking the tablets after meals may reduce the occurrence of unwanted effects on the stomach and intestines (See section “Possible side effects”).

Use in adults and elderly
The recommended dose is 1 tablet (500 mg) taken as a single dose once daily for 3 days.
If you are elderly, particular caution is advised, as heart-related problems may occur (See section “Warnings and precautions”).

Treatment of sexually transmitted diseases (caused by susceptible strains of Chlamydia trachomatis or Haemophilus ducreyi): the recommended dose is 2 tablets (1000 mg) as a single dose.

Use in children
This medicine must not be given to children with a body weight below 45 kg.
For children with a body weight equal to or above 45 kg, the recommended dose is 1 tablet (500 mg) once daily for 3 days.

Use in patients with kidney or liver problems
If you have kidney or liver problems, consult your doctor, as your dose may need to be adjusted.

If you take more AZITREDIL than you should
In case of accidental ingestion or overdose of this medicine, contact your doctor immediately or go to the nearest hospital.

If you forget to take AZITREDIL
If you forget a dose, take it as soon as you remember. Do not take a double dose to make up for the forgotten tablet.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
The following side effects may occur:
Very common (may affect more than 1 in 10 people)

• Diarrhoea

Common (may affect up to 1 in 10 people)

• Headache (cephalalgia);
• Nausea, vomiting;
• Abdominal pain;
• Changes in the number of white blood cells (lymphocytes/eosinophils, basophils, monocytes and neutrophils) and other changes in blood tests, such as reduced bicarbonate levels.

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (especially candidiasis), including fungal infection of the mouth;
• Infections caused by bacteria or fungi (superinfections, see section “Warnings and precautions”); lung infection (pneumonia), vaginal infection, throat infection (pharyngitis), stomach and/or intestine infection (gastroenteritis), nasal infection (rhinitis);
• Breathing difficulties;
• Decrease in white blood cell levels (leucopenia, neutropenia);
• Increase in certain blood cells (eosinophilia);
• Severe allergic reactions with possible swelling of lips, tongue or throat (angioedema);
• Allergic-type reactions (hypersensitivity);
• Loss of appetite (anorexia);
• Nervousness;
• Sleep disturbances (insomnia or drowsiness);
• Dizziness, vertigo;
• Taste disturbances (dysgeusia);
• Vision and hearing disturbances;
• Altered skin sensation (paraesthesia);
• Heartbeat disturbances (palpitations);
• Hot flushes;
• Difficulty breathing (dyspnoea);
• Nosebleeds (epistaxis);
• Stomach problems (gastritis);
• Constipation;
• Abdominal bloating accompanied by intestinal gas (flatulence);
• Digestive problems (dyspepsia);
• Difficulty swallowing (dysphagia);
• Abdominal distension;
• Belching;
• Dry mouth or increased salivation;
• Development of mouth lesions (ulcers);
• Skin problems with inflammation (urticaria, rash, pruritus, dermatitis, increased sweating or dry skin);
• Joint pain and stiffness (osteoarthritis), muscle pain (myalgia), back pain and neck pain, chest pain;
• Difficulty urinating (dysuria) and kidney pain;
• Testicular disorders;
• Bleeding between menstrual periods (metrorrhagia);
• Swelling in various parts of the body due to fluid accumulation (oedema), particularly in the face (facial oedema), ankles, feet or fingers (peripheral oedema);
• Feeling of tiredness (asthenia) and malaise, fatigue, fever, generalised pain;
• Abnormal blood test results (inform your doctor if you undergo blood tests);
• Complications in case of injuries or poisoning.

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

• Agitation;
• Liver disorders and development of yellowing of the skin and whites of the eyes (cholestatic jaundice);
• Increased skin sensitivity to light (photosensitivity reaction);
• Severe skin rash associated with increased number of a type of white blood cells called eosinophils; symptoms may affect one or more organs with fever (DRESS);
• Red, scaly rash with pustules and blisters (exanthematous pustulosis).

Not known (frequency cannot be estimated from the available data)

• Inflammation of the intestine (pseudomembranous colitis, see section “Warnings and precautions”);
• Decrease in platelet count (thrombocytopenia);
• Anaemia caused by abnormal destruction of red blood cells (haemolytic anaemia);
• Severe allergic reactions (anaphylaxis, see section “Warnings and precautions”);
• Aggressiveness, anxiety, delirium and hallucinations;
• Fainting with loss of consciousness (syncope);
• Seizures;
• Decreased skin sensation (hypoesthesia), physical and mental hyperactivity;
• Difficulty perceiving smells (parosmia, anosmia);
• Loss of taste (ageusia);
• Muscle disorders (myasthenia gravis, see section “Warnings and precautions”), rarely fatal;
• Perception of unpleasant noises in the ear (tinnitus) and hearing loss (deafness);
• Changes in heart function (torsades de pointes, arrhythmia, ventricular tachycardia, QT interval prolongation on electrocardiogram);
• Low blood pressure (hypotension);
• Inflammation of the pancreas (pancreatitis);
• Change in tongue colour;
• Various liver problems, rarely leading to death (liver failure, fulminant hepatitis, hepatic necrosis);
• Severe skin problems with redness and blistering (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme);
• Joint pain (arthralgia);
• Kidney problems (acute renal failure, interstitial nephritis).

Listed below are the possible side effects that may occur during prevention and treatment of infections caused by a specific bacterium ( Mycobacterium Avium Complex ):
Very common (may affect more than 1 in 10 people)

• Diarrhoea;
• Abdominal disorders, sometimes with pain;
• Nausea;
• Gas from the intestine (flatulence);
• Soft stools.

Common (may affect up to 1 in 10 people)

• Loss of appetite (anorexia);
• Dizziness, headache;
• Altered skin sensation (paraesthesia);
• Altered sense of taste (dysgeusia);
• Vision disturbances;
• Deafness;
• Skin irritation (rash), itching;
• Joint pain (arthralgia);
• Fatigue.

Uncommon (may affect up to 1 in 100 people)

• Decreased skin sensitivity (hypoesthesia);
• Hearing disturbances, perception of unpleasant noises in the ear (tinnitus);
• Sensation of irregular heartbeat (palpitations);
• Inflammation of the liver (hepatitis);
• Severe skin problems with redness and blistering (Stevens-Johnson syndrome);
• Increased skin sensitivity to light (photosensitivity reaction);
• Feeling of tiredness (asthenia), malaise.

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 the website
http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store AZITREDIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack 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. Pack contents and other information

What AZITREDIL 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, magnesium stearate. Tablet film coating: hypromellose (E464), titanium dioxide (E171), triacetin (E1518), monohydrate lactose.

Description of the appearance of AZITREDIL and pack contents
Pack containing 3 film-coated tablets of 500 mg in blisters.
Marketing Authorization Holder
PIAM Farmaceutici S.p.A. – Via Fieschi, 8 – 16121 Genova – Italy
Manufacturer
Special Product’s line S.P.A. - Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)