AZITREDIL 500 mg Фильм-Coated Таблетки

Содержание инструкции

1. AZITREDIL 500 mg film-coated tablets
   1. What is AZITREDIL and what is it 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

AZITREDIL 500 mg film-coated tablets

Azithromycin
Generic Equivalent

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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even 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 you take 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 is AZITREDIL and what is it used for

This medicine contains the active ingredient azithromycin, belonging to the group of
medicines called antibiotics (macrolide antibiotics) which are used for the treatment of
infections caused by bacteria.
AZITREDIL is used for the treatment of 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:
• bronchi and lung infection (bronchitis and pneumonia)
• Oral or dental infections (odontostomatological infections);
• Skin and other body organ infections (soft tissues);
• Urinary tract infections (non-gonococcal urethritis caused by Chlamydia trachomatis);
• Genital infections (soft chancre caused by Haemophilus ducreyi).

2. What you need to know before taking AZITREDIL

Do not take AZITREDIL

• if you are allergic to azithromycin or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to erythromycin and 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. Talk to your doctor if you think
you have any of these disorders:

• anaphylactic reactions:(rarely severe allergic reactions, including angioedema and anaphylaxis), Stevens Johnson syndrome and toxic epidermal necrolysis. Symptoms may include redness and severe skin irritation, even with blisters, swelling of the lips, tongue or throat. These conditions can be life-threatening and require urgent medical attention. Allergic events may recur even after stopping treatment. If you notice the appearance of any of these symptoms, see your doctor immediately.
• new infections:as with any other antibiotic, treatment with azithromycin can cause infections by other microorganisms (bacteria or fungi) to which the medicine is not effective. Pay attention to any new signs of inflammation and infection.
• diarrhea associated withClostridium difficile: this condition has been reported with the use of almost all antibiotics, including azithromycin; its severity can range from mild diarrhea to severe inflammation of the intestine (pseudomembranous colitis) which can be fatal and may occur even two months after taking this medicine. If you experience diarrhea, see your doctor as appropriate therapy is needed.
• a muscle disorderthat manifests with 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 tell your doctor if:

• you have liver problems as these may worsen; if you experience the following symptoms, see your doctor who will prescribe specific tests to check liver function or assess the suspension of treatment with this medicine:
• sudden feeling of fatigue (asthenia);
• yellowing of the skin and the white of the eyes (jaundice);
• dark urine;
• a tendency to bleed;
• confusion, difficulty reasoning and problems performing movements (or hepatic encephalopathy).
• you have severe kidney problems, as it may be necessary to reduce the dose;
• you suffer from heart rhythm disturbances, especially if you are a woman or an elderly patient. Pay particular attention when taking this medicine if a family member or you yourself were born with a heart rhythm disorder (prolongation of the QT interval seen on an electrocardiogram), if your blood salt levels are altered (especially low levels of potassium or magnesium in the blood), 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 act on 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 very serious heart rhythm disturbances (cardiac arrhythmia, torsades de pointes) may increase;
• you suffer from a muscle disorder that manifests with weakness (myasthenia gravis); this condition may worsen during treatment with this medicine.

If you are taking ergotamine or ergotamine derivatives, medicines used especially for the
treatment of migraine (severe headache), do not take AZITREDIL as
the combination of the two medicines can cause a life-threatening illness
(ergotism).

Children
The safety and efficacy of this medicine for the prevention and treatment of
infections caused by the bacterium Mycobacterium avium complexin children have not
been demonstrated.
Consult your doctor before giving any medicine.

Other medicines and AZITREDIL
Tell 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, used to reduce stomach acidity.

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

• digoxin, a medicine used to treat some heart problems;
• atorvastatin, a medicine used to reduce cholesterol levels in the blood;
• cyclosporine, a medicine used to treat autoimmune diseases and in case of transplants; if the intake of cyclosporine and AZITREDIL is strictly necessary, consult your doctor because it may be necessary to adjust the dose;
• nelfinavir, a medicine used to treat AIDS;
• oral anticoagulants (coumarins), medicines used to treat circulation problems; consult your doctor because specific checks (prothrombin time) are necessary;
• medicines used to treat heart rhythm problems (some 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, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine.
If you are pregnant or breastfeeding, take this medicine only if your
doctor considers it strictly necessary.

Driving and operating machinery
There is no information available to establish the effect of this medicine on
the ability to drive vehicles and operate machinery.

AZITREDIL contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with
intolerance to certain sugars, contact him before taking this medicine.

3. How to take AZITREDIL

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Take the tablets whole and always in a single dose per day, independently of meals; however, if you take the tablets after meals, you may reduce the occurrence of undesirable effects on the stomach and intestines (See section “Possible side effects”).

Use in adults and the elderly
The recommended dose is 1 tablet (500 mg) in a single administration, for 3 days.
If you are an elderly person, particular caution is recommended as heart problems may occur (See section “Warnings and precautions”).
Treatment of sexually transmitted diseases (caused by strains sensitive to Chlamydia

trachomatisor Haemophilus ducreyi): the recommended dose is 2 tablets (1000 mg) in a single administration.

Use in children
This medicine should not be given to children with a body weight of less than 45 Kg.
For children with a body weight of 45 Kg or more, the recommended dose is 1 tablet (500 mg) per day in a single administration, for 3 days.

Use in patients with kidney or liver problems
If you have kidney or liver problems, consult your doctor, as it may be necessary to adjust the dose.

If you take more AZITREDIL than you should
In case of accidental ingestion/administration of an excessive dose of this medicine, consult 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 doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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;
• nausea, vomiting;
• abdominal pain;
• alteration of the number of white blood cells (lymphocytes/eosinophils, basophils, monocytes and neutrophils) and other alterations of blood tests, such as reduced bicarbonate levels.

Uncommon(may affect up to 1 in 100 people)

• fungal infections, especially candidiasis, including oral thrush;
• infections caused by bacteria or fungi (superinfections, see section “Warnings and precautions”); lung infection (pneumonia), vagina, throat (pharyngitis), stomach and/or intestines (gastroenteritis), nose (rhinitis);
• breathing difficulties;
• decrease in the levels of white blood cells (leucopenia, neutropenia);
• increase of 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 disorders (insomnia or drowsiness);
• dizziness, vertigo;
• taste disorders (dysgeusia);
• vision and hearing disorders;
• altered skin sensitivity (paresthesia);
• heartbeat disturbances (palpitations);
• hot flushes;
• difficulty breathing (dyspnea);
• nosebleeds (epistaxis);
• stomach disorders (gastritis);
• constipation;
• feeling of abdominal bloating accompanied by passage of intestinal gas (flatulence);
• digestive problems (dyspepsia);
• difficulty swallowing (dysphagia);
• abdominal distension;
• belching;
• dry mouth or increased salivation;
• appearance of sores in the mouth (ulcers);
• skin problems with inflammation (urticaria, rash, itching, 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 even on days not corresponding to the menstrual cycle (metrorrhagia);
• swelling in different parts of the body due to fluid retention in the body (edema), especially in the face (facial edema), ankles, feet or toes (peripheral edema);
• feeling of fatigue (asthenia) and malaise, tiredness, fever, generalized pain;
• alteration of blood tests (inform your doctor if you are undergoing blood tests);
• complications in case of trauma or poisoning.

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

• agitation;
• liver disorders and appearance of yellowing of the skin and whites of the eyes (cholestatic jaundice);
• increased skin sensitivity to light (photosensitivity reaction);
• severe skin rash associated with an increase in the number of a type of white blood cells in the blood, called eosinophils; symptoms may affect one or more organs with fever (DRESS);
• red and scaly skin rash with the formation of pustules and blisters (pustular exanthematous).

Not known(frequency cannot be estimated from available data)

• inflammation of the intestine (pseudomembranous colitis, see section “Warnings and precautions”);
• decrease in the number of platelets (thrombocytopenia);
• anemia caused by abnormal destruction of red blood cells (hemolytic anemia);
• severe allergic reactions (anaphylaxis, see section “Warnings and precautions”);
• aggressiveness, anxiety, delirium and hallucinations;
• fainting with loss of consciousness (syncope);
• convulsions;
• decreased skin sensitivity (hypoesthesia), hyperactivity physical and mental;
• difficulty perceiving smells (parosmia, anosmia);
• loss of the sense of taste (ageusia);
• muscle disorders (myasthenia gravis, see section “Warnings and precautions”), rarely fatal;
• perception of bothersome noises in the ear (tinnitus) and hearing loss (deafness);
• alterations in heart function (torsades de pointes, arrhythmia, ventricular tachycardia, prolonged QT interval on electrocardiogram);
• lowering of blood pressure (hypotension);
• inflammation of the pancreas (pancreatitis);
• alteration of the color of the tongue;
• various liver problems that rarely lead 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).

The following are possible side effects that may occur during the
prevention and treatment of infections caused by a particular bacterium ( Mycobacterium

Avium Complex):

Very common(may affect more than 1 in 10 people)

• diarrhoea;
• abdominal disorders also with pain;
• nausea;
• passage of gas from the intestines (flatulence);
• soft stools.

Common(may affect up to 1 in 10 people)

• loss of appetite (anorexia);
• dizziness, headache;
• altered skin sensitivity (paresthesia);
• alteration of the sense of taste (dysgeusia);
• vision disorders;
• deafness;
• skin irritation (rash), itching;
• joint pain (arthralgia);
• fatigue.

Uncommon(may affect up to 1 in 100 people)

• decreased skin sensitivity (hypoesthesia);
• hearing disorders, perception of bothersome noises in the ear (tinnitus);
• feeling of altered 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 fatigue (asthenia), malaise.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
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 which is stated on the packaging after
“Scad.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What AZITREDIL contains

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

Description of the appearance of AZITREDIL and contents of the pack
Pack containing 3 film-coated tablets of 500 mg in blisters.

Marketing Authorisation 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)