Rezan

Patient Information Leaflet

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

1. What REZAN is and what it is used for

REZAN 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.
REZAN is taken to treat the following infections:
Adults and adolescents weighing 45 kg or more:
bacterial infections of the tonsils (tonsillitis) or 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 skin and underlying tissue infections
bacterial gum infections (periodontitis) or gingival 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 REZAN

Do not take REZAN

• if you are allergic to azithromycin, erythromycin, or to other antibiotics known as “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 REZAN if you have or have had any of the following conditions:

• heart problems (e.g. irregular heart rhythm or heart failure) or low levels of potassium or magnesium in the blood: these conditions may contribute to serious heart-related 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 must not be taken together with REZAN.

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 an abnormal heartbeat or palpitations, dizziness or fainting while taking REZAN;
• 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 few 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 REZAN (superinfection).

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

Children and adolescents
If your body weight is less than 45 kg, there are other azithromycin-containing medicines that may be more suitable and easier for you to take.

Other medicines and REZAN
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking REZAN together with other medicines may cause side effects.
Therefore, it is especially important that you inform your doctor if you are taking any of the following medicines:

• atorvastatin and other medicines belonging to the statin group (to lower cholesterol in the blood and prevent heart diseases, including heart attacks and strokes);
• cyclosporine (to prevent organ transplant rejection);
• 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:
  • quinidine, procainamide, dofetilide, amiodarone, and sotalol (for the treatment of irregular heartbeat, including cases of heartbeat 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, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist 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
REZAN passes into breast milk. Therefore, your doctor will decide whether to discontinue breastfeeding or avoid treatment with REZAN, taking into account both the benefit of breastfeeding for the child and the benefit of the treatment for you.

Driving and using machines
REZAN has a moderate effect on the ability to drive and use machines. Dizziness, drowsiness, seizures, and vision or hearing problems have been reported in some people taking REZAN.
These possible side effects may affect your ability to drive or operate machinery.

REZAN contains lactose. If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

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

3. How to take REZAN

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

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

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

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

If you forget to take REZAN
If you forget to take REZAN, take it as soon as possible, provided that at least 12 hours remain before the next scheduled 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 REZAN
If you stop treatment with REZAN too early, the infection may recur. Take REZAN for the entire duration of the 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 gets them.

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

• sudden wheezing, breathing difficulties, swelling of the eyelids, face or lips, rash or itching mainly affecting the whole body (anaphylactic reaction, frequency not known)
• fast 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 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 unwell (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 inflammation, respiratory disorder, inflammation of the nasal mucosa, 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, drowsiness (somnolence), altered sense of taste (dysgeusia), tingling sensation (paraesthesia)
• visual disturbances
• 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, urticaria, dermatitis, dry skin, abnormally increased sweating (hyperhidrosis)
• joint swelling and pain (osteoarthritis), muscle pain, back pain, neck pain
• painful urination (dysuria), kidney pain
• irregular menstrual bleeding (metrorrhagia), testicular disorder
• swelling due to fluid retention, particularly in 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 cellular 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 state of confusion (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) (prolongation of 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 get any side effects, including ones 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 http://www.agenziafarmaco.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store REZAN

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.
This medicine does not require any special storage conditions.
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 REZAN contains

• The active substance is azithromycin, as azithromycin dihydrate. Each film-coated tablet contains 524.1 mg of azithromycin dihydrate, equivalent to 500 mg of azithromycin base.
  The other components are: Anhydrous calcium hydrogen phosphate, pregelatinized starch, sodium lauryl sulfate, sodium croscarmellose, sodium carmellose, magnesium stearate.
  Coating: Hypromellose (E464), titanium dioxide (E171), triacetin (E1518), monohydrate lactose.

Description of the appearance of REZAN and pack contents
Film-coated tablets.
Blister pack containing 3 film-coated tablets of 500 mg.
Marketing Authorization Holder
S.F. Group S.r.l. – Via Tiburtina, 1143 – 00156, Rome
Manufacturer
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR)