Batif

Patient Information Leaflet

BATIF 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 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 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. Package contents and other information

1. What BATIF 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.
BATIF is used to treat infections caused by bacteria sensitive to azithromycin, such as:

• Infections of the upper respiratory tract:
• 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)
• Infections of the mouth or teeth (odontostomatological infections);
• Skin infections and infections of other body organs (soft tissues);
• 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 BATIF

Do not take BATIF

• 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);
• 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. Contact your doctor if you think you have any of these conditions:

• Allergic 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 blistering, 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 any of these symptoms, stop treatment immediately and contact your doctor.
• New infections: as with any other antibiotic, treatment with azithromycin may lead to infections caused by other microorganisms (bacteria or fungi) to which the medicine is not effective. Be alert for any new signs of inflammation or infection.
• Clostridium difficile-associated diarrhea: this condition has been reported with the use of nearly all antibiotics, including azithromycin; its severity may 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 develop diarrhea, contact your doctor as appropriate treatment may be needed.
• A muscle disorder causing weakness (myasthenia gravis); use with 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 prescribe specific tests to monitor liver function or consider stopping treatment with this medicine:
• sudden feeling of tiredness (asthenia);
• yellowing of the skin and whites of the eyes (jaundice);
• dark urine;
• tendency to bleed;
• confusion, difficulty thinking, and problems with movement (or hepatic encephalopathy).
• you have severe kidney problems, as dose adjustment may be necessary;
• you have a sexually transmitted infection caused by the bacterium Treponema pallidum (e.g. syphilis);
• you have heart rhythm disorders, especially if you are a woman or elderly patient. Pay particular attention when taking this medicine if you or a family member have a history of heart rhythm disorders (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 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), or other antibiotics such as fluoroquinolones (moxifloxacin and levofloxacin); in these cases, the risk of 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 mainly to treat migraine (severe headache), concomitant use of BATIF is not recommended, 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.
Other medicines and BATIF
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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, 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;
• colchicine, a medicine used to treat gout and familial Mediterranean fever;
• atorvastatin, a medicine used to reduce blood cholesterol levels;
• cyclosporine, a medicine used to treat autoimmune diseases and in transplant patients; if concomitant use of cyclosporine and BATIF is essential, consult your doctor, as dose adjustment may be necessary;
• nelfinavir, a medicine used to treat AIDS;
• oral anticoagulants (coumarins), medicines used to treat circulation problems; contact your doctor as specific monitoring (prothrombin time) may be required;
• medicines used to treat heart rhythm disorders (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, 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 is no available information to determine the effect of this medicine on the ability to drive vehicles or operate machinery.
BATIF contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take BATIF

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 intestine (See section “Possible side effects”).

Use in adults and elderly
The recommended dose is 1 tablet (500 mg) as a single daily dose 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) daily as a single dose 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 BATIF than you should
In case of accidental ingestion or overdose 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 make up for the missed 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 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: frequency cannot be estimated from the available data

Very common

• Diarrhoea

Common

• Headache (cephalalgia)
• Nausea, vomiting
• Abdominal pain
• Changes in white blood cell count (lymphocytes/eosinophils, basophils, monocytes and neutrophils) and other blood test abnormalities, such as reduced bicarbonate levels

Uncommon

• Fungal infections (especially candidiasis), including oral mycosis
• Infections caused by bacteria or fungi (superinfections, see section “Warnings and precautions”)
• Lung infection (pneumonia), vaginal infection, throat infection (pharyngitis), stomach and/or intestinal infection (gastroenteritis), nasal infection (rhinitis)
• Breathing difficulties
• Decreased white blood cell count (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)
• Heart rhythm disturbances (palpitations)
• Hot flushes
• Difficulty breathing (dyspnoea)
• Nosebleed (epistaxis)
• Stomach problems (gastritis)
• Constipation
• Abdominal bloating with passage of intestinal gas (flatulence)
• Digestive problems (dyspepsia)
• Difficulty swallowing (dysphagia)
• Abdominal distension
• Eructation
• Dry mouth or increased salivation
• Appearance 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 trauma or poisoning

Rare

• Agitation
• Liver disorders and appearance of yellowing of the skin and whites of the eyes (cholestatic jaundice)
• Increased skin sensitivity to light (photosensitivity reaction)
• Red, scaly rash with pustules and blisters (exanthematous pustulosis)

Not known

• Inflammation of the intestine (pseudomembranous colitis, see section “Warnings and precautions”)
• Decreased 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 sensation (ageusia)
• Muscle disorders (myasthenia gravis, see section “Warnings and precautions”), rarely fatal
• Perception of annoying noises in the ear (tinnitus) and hearing loss (deafness)
• Changes in heart function (torsades de pointes, arrhythmia, ventricular tachycardia, QT interval prolongation on electrocardiogram)
• Drop in 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)

Below are listed the possible side effects that may occur during prevention and treatment of infections caused by the bacterium Mycobacterium Avium Complex:

Very common

• Diarrhoea
• Abdominal disorders, sometimes with pain
• Nausea
• Passage of intestinal gas (flatulence)
• Soft stools

Common

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

Uncommon

• Decreased skin sensation (hypoesthesia)
• Hearing disturbances, perception of annoying 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 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 the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Store below 30 °C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What BATIF 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 film coating: hypromellose, titanium dioxide, triacetin, monohydrate lactose.

Description of the appearance of BATIF and the contents of the pack
Pack containing 3 film-coated tablets of 500 mg in a blister pack.
Marketing Authorization 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 (Milan)