BATIF 500 mg Film-Coated Tablets

Зміст інструкції

1. BATIF 500 mg film-coated tablets
   1. What BATIF is and what it is used for
   2. What you need to know before taking BATIF
   3. How to take BATIF
   4. Possible side effects
   5. How to store BATIF
   6. Contents of the pack and other information

BATIF 500 mg film-coated tablets

Azithromycin
Generic Medicine

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

1. What BATIF is and what it is used for

This medicine contains the active substance azithromycin, belonging to the group of medicines called
antibiotics (macrolide antibiotics) which are used for the treatment of infections caused by bacteria.
BATIF 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);
• sore throat infection (pharyngitis);
• nasal cavity infection (sinusitis).
• Lower respiratory tract infections:
• Infection of the bronchi and lungs (bronchitis and pneumonia)
• Infections of the mouth or teeth (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 BATIF

Do not take BATIF

• 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);
• if you have severe liver problems (severe hepatic insufficiency).

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

• allergic 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, stop treatment and 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 more than 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 disease 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 whites 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 have a sexually transmitted infection caused by the bacterium Treponema pallidum(e.g. syphilis);
• you have heart rhythm disturbances, especially if you are a woman or an elderly patient. Be particularly careful when taking this medicine if a family member of yours or you yourself were born with a heart rhythm disturbance (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 BATIF”) 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 very serious heart rhythm disturbances (cardiac arrhythmia, torsades de pointes) may increase;
• you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

If you are taking ergotamine or ergotamine derivatives, medicines used especially for the treatment of
migraine (severe headache), it is not recommended to take BATIF at the same time 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.

Other medicines and BATIF
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
BATIF is not recommended if you are already taking:

• ergotamine, a medicine used to treat migraine (see section “Warnings and precautions”), 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;
• colchicine, a medicine used to treat gout and familial Mediterranean fever
• 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 use of cyclosporine and BATIF is strictly necessary, see your doctor as it may be necessary to adjust the dose;
• nelfinavir, a medicine used to treat AIDS;
• oral anticoagulants (coumarins), medicines used to treat circulation problems; see your doctor because specific checks (prothrombin time) are needed;
• 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, are planning to become pregnant, or are breastfeeding
with breast milk, 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.

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

3. How to take BATIF

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Take the tablets whole and always in a single daily dose, independently of meals; however if
you take the tablets after meals, you may decrease the occurrence of undesirable effects on the stomach and
intestines (See paragraph “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 paragraph “Warnings and precautions”).
Treatment of sexually transmitted diseases (caused by sensitive strains of Chlamydia trachomatisor of

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 weighing less than 45 Kg.
For children weighing 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 BATIF than you should
In case of accidental ingestion/taking of an excessive dose of this medicine, consult
your doctor immediately or go to the nearest hospital.

If you forget to take BATIF
If you forget a dose, take it as soon as you remember. Do not take a double dose to compensate for
forgetting the tablet.
If you have any doubts 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 gets them.
The following side effects may occur as listed below.
The frequencies of side effects are defined as follows:
Very common: affects more than 1 in 10 people
Common: affects 1 to 10 people in 100
Uncommon: affects 1 to 10 people in 1,000
Rare: affects 1 to 10 people in 10,000
Very rare: affects less than 1 in 10,000
Not known: the frequency cannot be estimated from the available data

Very common

• diarrhoea.

Common

• headache;
• nausea, vomiting;
• abdominal pain;
• alteration of the number of white blood cells (lymphocytes/eosinophils, basophils, monocytes and neutrophils) and other changes in blood tests, such as reduced bicarbonate levels.

Uncommon

• 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 intestine (gastroenteritis), nose (rhinitis);
• breathing difficulties;
• decrease in the levels of white blood cells (leukopenia, 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 disturbances (dysgeusia);
• vision and hearing disturbances;
• altered skin sensitivity (paresthesia);
• heartbeat disturbances (palpitations);
• hot flushes;
• difficulty breathing (dyspnea);
• nosebleeds (epistaxis);
• stomach disorders (gastritis);
• constipation;
• feeling of abdominal bloating accompanied by the release 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 accumulation 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

• agitation;
• liver disorders and appearance of yellowing of the skin and the whites of the eyes (cholestatic jaundice);
• increased skin sensitivity to light (photosensitivity reaction);
• red and scaly skin rash with the formation of pustules and blisters (pustular exanthematous).

Not known

• 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”);
• aggression, 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, prolongation of the QT interval on the electrocardiogram);
• lowering of blood pressure (hypotension);
• inflammation of the pancreas (pancreatitis);
• alteration of the color of the tongue;
• serious 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 the bacterium Mycobacterium Avium Complex:

Very common

• diarrhoea;
• abdominal discomfort including pain;
• nausea;
• release of gas from the intestine (flatulence);
• soft stools.

Common

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

Uncommon

• 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store BATIF

Keep this medicine out of 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.
Store at a temperature below 30 °C.
Do not dispose of any medicine in wastewater 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 BATIF 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, anhydrous colloidal silica, magnesium stearate. Tablet coating: hypromellose, titanium dioxide, triacetin, lactose monohydrate.

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

Marketing Authorisation Holder
Laboratorio Farmaceutico CT S.r.l. – Via Dante Alighieri, 71 - 18038 Sanremo (IM)

Manufacturer
Doppel Farmaceutici Srl - Via Volturno,48 - 20089 Quinto De’ Stampi - Rozzano (Milano)