Trozamil

Package leaflet: Information for the patient

TROZAMIL 500 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 could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What TROZAMIL is and what it is used for

TROZAMIL contains the active substance azithromycin. Azithromycin is an antibiotic that belongs to a group of antibiotics called "macrolides", which block the growth of susceptible bacteria.
TROZAMIL is taken to treat the following infections:
Adults and adolescents weighing 45 kg or more

• infections of the tonsils (tonsillitis) and 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 TROZAMIL

Do not take TROZAMIL
If you are allergic to azithromycin, erythromycin, other antibiotics called "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 TROZAMIL if you have or have had any of the
following conditions:

• heart problems (e.g. heart rhythm disorders or heart failure) or low levels of potassium or magnesium in the blood: these conditions may contribute to serious cardiac 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 disease may worsen during treatment;
• if you are taking ergot derivatives such as ergotamine (used to treat migraine), as these medicines should not be taken together with Trozamil.

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, 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), reported in association with azithromycin treatment;
• if you experience abnormal heartbeat or palpitations, dizziness or fainting while taking Trozamil;
• 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 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 Trozamil (superinfection).

Sexually transmitted infections
Your doctor may perform a test to rule out a possible syphilis infection, a sexually transmitted disease
that could otherwise progress undetected and be diagnosed late.
Furthermore, in any case of sexually transmitted bacterial infections, your doctor will perform follow-up
laboratory tests to monitor the success of therapy.

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 TROZAMIL
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking Trozamil 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 statins (to lower cholesterol in the blood and prevent heart diseases, including heart attacks and strokes);
• 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 cause the heart muscle to take longer than usual to contract and relax (QT interval prolongation), such as the following:
  • quinidine, procainamide, dofetilide, amiodarone and sotalol (for treating irregular heartbeat, including cases of heartbeat that is too fast or too slow – 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, including rheumatoid arthritis, or to treat or prevent 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 ensuring that
the benefits outweigh the potential risks.

Breastfeeding
Trozamil passes into breast milk. Therefore, your doctor will decide whether to discontinue
breastfeeding or to avoid treatment with Trozamil, taking into account both the benefit of breastfeeding for the child and the benefit of the treatment for you.

Driving and using machines
Trozamil may have a moderate effect on the ability to drive and use machines. Dizziness, drowsiness,
seizures, as well as vision and hearing problems have been reported in some people taking Trozamil.
These possible side effects may impair the ability to drive and use machines.

TROZAMIL contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars,
contact them before taking this medicine. If you know you have this intolerance, remember to consult your doctor before taking Trozamil.

TROZAMIL contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take TROZAMIL

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The amount of Trozamil you need to take each day depends on the bacterial infection being treated
and the specific treatment course prescribed by your doctor or pharmacist.
Adults and adolescents with body weight equal to or greater than 45 kg

Use in children and adolescents
If your weight is less than 45 kg, consult your doctor or pharmacist, as other azithromycin-containing medicines that may be more suitable for you are available.

Method of administration
For oral use.
Trozamil must be taken orally as a single daily dose. The tablets should be swallowed whole with water, with or without food. Taking this medicine just before a meal may help improve gastrointestinal tolerance.

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

If you forget to take TROZAMIL
If you forget to take Trozamil, 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 taking TROZAMIL
If you stop treatment with Trozamil too early, the infection may recur. Take Trozamil for the entire duration of treatment, even if 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 everyone experiences them.

Serious side effects
Stop using Trozamil and consult your doctor immediately if you notice any of the following symptoms:

• sudden wheezing, difficulty breathing, 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 torsades 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, stools containing blood 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 movements (antiperistaltics)
• red, flat spots on the trunk, target-shaped or circular rashes, 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 people))
• widespread, red, scaly rash with subcutaneous bumps and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis, rare (may affect up to 1 in 1,000 people)).

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 sick (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 (fungal infection of the mouth and vagina), other fungal infections
• lung infection, bacterial throat infection, gastrointestinal tract inflammation, respiratory disorder, inflammation of the mucous membrane inside the nose, 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 the hands, feet and face (angioedema)
• loss of appetite
• nervousness, difficulty sleeping (insomnia)
• dizziness, feeling of drowsiness (somnolence), altered sense of taste (dysgeusia), sensation of numbness (paraesthesia)
• visual impairment
• ear disorder
• sensation of 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 ulceration, 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
• menstrual bleeding at irregular intervals (metrorrhagia), testicular disorder
• swelling due to fluid retention, particularly of the face, ankles and feet (oedema, facial oedema, peripheral oedema)
• weakness, fatigue, general feeling of 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)

• sensation of irritation
• liver problems, yellowing of the skin or eyes
• increased sensitivity to sunlight

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 confusional state (delirium)
• hallucination
• fainting (syncope)
• seizures (convulsions)
• reduced sensitivity to touch, pain and temperature (hypoesthesia)
• sensation of hyperactivity
• change in sense of smell (anosmia, parosmia)
• complete loss of sense of taste (ageusia)
• muscle weakness (myasthenia gravis)
• abnormal electrocardiogram (ECG) (prolonged QT interval)
• deafness, reduced hearing or ringing in the ears (tinnitus)
• low blood pressure
• inflammation of the pancreas causing severe abdominal and back pain (pancreatitis)
• change in tongue colour
• joint pain (arthralgia)
• inflammation of the kidneys (interstitial nephritis) and impaired kidney function

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://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 TROZAMIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of deterioration.
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. Package contents and other information

What TROZAMIL contains
The active substance is azithromycin. Each tablet contains azithromycin dihydrate 524.1 mg, equivalent to 500 mg of azithromycin.
The other components are:
Tablet core: Anhydrous calcium hydrogen phosphate, pregelatinized starch, sodium lauryl sulfate, sodium croscarmellose, sodium carmellose, magnesium stearate.
Coating: hypromellose (E464), titanium dioxide (E171), triacetin (E1518), lactose monohydrate.

Description of the appearance of TROZAMIL and package contents
Film-coated tablets.
Blister pack containing 3 film-coated tablets of 500 mg.

Marketing Authorization Holder and Manufacturer
MARKETING AUTHORIZATION HOLDER
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (RM) – Italy

MANUFACTURER
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo n.1
03012 Anagni (FR) - Italy