Zindel

Package leaflet: Information for the patient

ZINDEL 500 mg film-coated tablets

Azithromycin dihydrate
Generic medicine
Read this entire 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 other people, even if their symptoms are the same as yours, as it may 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 ZINDEL is and what it is used for
2. What you need to know before taking ZINDEL
3. How to take ZINDEL
4. Possible side effects
5. How to store ZINDEL
6. Contents of the pack and other information

1. What ZINDEL is and what it is used for

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

• 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 infections 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 ZINDEL

Do not take ZINDEL

• if you are allergic to azithromycin, erythromycin, 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 ZINDEL if you have or have previously 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;
• or if you are taking ergot derivatives such as ergotamine (used to treat migraine), since these medicines must not be taken together with ZINDEL.

Stop taking this medicine and contact your doctor immediately (see also “Serious unwanted 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 heartbeats or palpitations, dizziness or fainting while taking ZINDEL;
• 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 ZINDEL (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 cases of bacterial sexually transmitted infections, your doctor will perform laboratory follow-up tests to monitor the success of treatment.

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

• atorvastatin and other statin-group medicines (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 clot formation (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 the treatment of 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 tract 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 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
ZINDEL passes into breast milk. Therefore, your doctor will decide whether to discontinue breastfeeding or to avoid treatment with ZINDEL, taking into account both the benefit of breastfeeding for the child and the benefit of the therapy for you.

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

ZINDEL contains lactose and sodium
This medicine contains lactose. If you have been diagnosed by your doctor with an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take ZINDEL

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The amount of ZINDEL you need to take each day depends on the bacterial infection being treated
and 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 weight is less than 45 kg or you are unable to swallow this medicine, 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.
ZINDEL 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 ZINDEL than you should
If you take more ZINDEL 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 ZINDEL
If you forget to take ZINDEL, 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, but 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 ZINDEL
If you stop treatment with ZINDEL too early, the infection may recur. Continue taking ZINDEL for the full 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 everybody gets them.

Serious side effects
Stop using ZINDEL 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 affecting mainly 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, blood in the stools and/or fever may indicate an infection of the large intestine (antibiotic-associated colitis, frequency not known). Do not take medicines for diarrhoea that inhibit intestinal motility (antiperistaltics)
reddish spots on the trunk, not raised, target-shaped or circular, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, 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))
widespread, red, scaly rash, with subcutaneous bumps and blisters, accompanied by fever. Symptoms usually appear early in treatment (generalised exanthematous pustulosis, rare (may affect up to 1 in 1,000)).

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 tract 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, nosebleeds
• 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)
• swelling and pain in the joints (osteoarthritis), muscle pain, back pain, neck pain
• painful urination (dysuria), kidney pain
• irregular menstrual bleeding (metrorrhagia), testicular disorder
• swelling due to fluid retention, particularly of the face, ankles and feet (oedema, facial oedema, peripheral oedema)
• weakness, fatigue, general 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 the number of red blood cells due to increased cell breakdown, which may cause fatigue and pale skin (haemolytic anaemia)
• reduction in the number of platelets, which may lead to bleeding and bruising (thrombocytopenia)
• feeling angry, aggressive, fearful and worried (anxiety), acute confusional state (delirium)
• hallucination
• fainting (syncope)
• seizures (convulsions)
• reduced sensitivity to touch, pain and temperature (hypoesthesia)
• feeling hyperactive
• change in the sense of smell (anosmia, parosmia)
• complete loss of taste (ageusia)
• muscle weakness (myasthenia gravis)
• abnormal electrocardiogram (ECG) (prolongation of the 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 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 ZINDEL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after the word 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 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 ZINDEL contains
The active substance is azithromycin. Each tablet contains azithromycin dihydrate 524.1 mg equivalent to azithromycin 500 mg.
The other components are:
Tablet core: Anhydrous calcium hydrogen phosphate, pregelatinized starch, sodium lauryl sulfate, sodium croscarmellose, sodium carmellose, magnesium stearate.
Film coating: hypromellose (E464), titanium dioxide (E171), triacetin (E1518), lactose monohydrate.
Description of the appearance of ZINDEL and package contents
Film-coated tablets.
Blister pack containing 3 film-coated tablets of 500 mg.
Marketing Authorization Holder
Maven Pharma s.r.l. - Via Stefano Jacini, 68 - 00191 Rome – Italy
Manufacturer
Special Product’s line S.P.A. - Via Campobello, 15 - 00040 Pomezia (RM) - Italy