Azithromycin Accord

Package leaflet: Information for the user

Azithromycin Accord 500 mg film-coated tablets

Generic Medicine
Please read all of this leaflet carefully before you/your child take 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/your child 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 effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Azithromycin Accord is and what it is used for

This medicinal product contains the active substance azithromycin, an azalide antibiotic belonging to the group of antibiotics known as macrolides.
Azithromycin Accord is indicated in adults and children for the treatment of infections caused by bacteria sensitive to azithromycin, such as:

• Infections of the upper respiratory tract:
  • Ear infection (acute otitis media);
  • tonsil infection (tonsillitis);
  • throat infection (pharyngitis);
  • nasal cavity infection (sinusitis).
• Infections of the lower respiratory tract:
  • Infection of the bronchi and lungs (bronchitis and pneumonia)
• Infections of the mouth and oesophagus (odontostomatological infections);
• Skin and soft tissue infections;
• Genital infections caused by Chlamydia trachomatis and Haemophilus ducreyi (sexually transmitted infections).

2. What you should know before taking/giving Azithromycin Accord to a child

Do not take Azithromycin Accord
if you are allergic to azithromycin, erythromycin, other antibiotics known as "macrolides", 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/giving Azithromycin Accord to a child:

• if you have or have ever had liver problems, or if you are currently taking or have recently taken other medicines that may cause liver problems (see section “Other medicines and Azithromycin Accord”). Caution is required before starting treatment with Azithromycin Accord in these cases;
• if you are being treated with ergotamine or its derivatives (see section “Other medicines and Azithromycin Accord”);
• if you have kidney problems (renal insufficiency);
• if you suffer from heart rhythm disorders. Azithromycin Accord may cause mild changes in heart rhythm, but in some cases these may be fatal (see section 4 “Possible side effects”). Therefore, this medicine should be used with caution:
  • in patients with congenital heart rhythm disorders, very slow heart rate (bradycardia), cardiac arrhythmias, or severe heart problems (severe heart failure);
  • in patients being treated with other medicines that may affect heart rhythm, such as quinidine, procainamide, dofetilide, amiodarone, sotalol (medicines for heart rhythm disorders), cisapride (a medicine for gastric reflux), terfenadine (an antihistamine), pimozide (a medicine for mental disorders), citalopram (an antidepressant), moxifloxacin, levofloxacin (antibiotics); hydroxychloroquine, chloroquine (which may prolong the QT interval);
  • in patients with low blood levels of potassium or magnesium;
  • in elderly patients and women.

Inform your doctor if any of the following conditions occur or worsen during treatment with
Azithromycin Accord (also see section 4 “Possible side effects”):

• severe allergic reactions, including severe skin reactions that may also affect other organs and cause fever. In case of an allergic reaction, stop treatment with Azithromycin Accord immediately and contact your doctor;
• symptoms of liver problems such as sudden onset of weakness, yellowing of the skin or mucous membranes (jaundice), dark urine, easy bleeding, or neurological symptoms (e.g. confusion, altered consciousness, or coma). Stop treatment with Azithromycin Accord immediately and contact your doctor, who will perform medical tests to assess liver function;
• vomiting or irritability in your infant (if a newborn within the first 42 days of life) occurring after feeding. This medicine may cause narrowing of a part of the stomach. If these symptoms occur, contact your child’s doctor immediately;
• symptoms of new infections or persistence of current infection symptoms. This may be due to bacteria resistant to Azithromycin Accord or to non-bacterial microorganisms (e.g. fungal infection);
• onset of diarrhoea, which may be mild but in some cases may be fatal (fatal colitis). Diarrhoea may occur with almost all antibiotics, including Azithromycin Accord, due to disruption of normal intestinal bacterial flora, allowing overgrowth of a bacterium called Clostridium difficile. If diarrhoea occurs, your doctor will closely monitor you, as Clostridium difficile infection may occur up to two months after stopping this medicine;
• onset or worsening of muscle weakness and easy fatigue, i.e. symptoms of myasthenia gravis.

Children
Azithromycin Accord may be used in children and adolescents weighing 45 kg or more.

Other medicines and Azithromycin Accord
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking any of the following medicines, as caution is required:

• antacids (medicines for stomach acidity). If you are taking both antacids and Azithromycin Accord, do not take them at the same time;
• digoxin, a medicine used to treat certain heart conditions. When taken together with Azithromycin Accord, digoxin levels must be carefully monitored;
• colchicine, a medicine used for gout and familial Mediterranean fever;
• zidovudine, used in the treatment of AIDS;
• ergotamine (a medicine for migraine). Concomitant use with Azithromycin Accord is not recommended, as it may cause circulatory problems, especially in fingers and toes (ergotism crisis);
• statins (medicines to lower blood lipid levels). Concomitant use with Azithromycin Accord may cause muscle cell breakdown (rhabdomyolysis);
• cyclosporine, a medicine used to treat autoimmune diseases and in transplant patients. If co-administration of cyclosporine and Azithromycin Accord is essential, consult your doctor, as dose adjustment may be necessary;
• oral coumarin anticoagulants (e.g. warfarin). Concomitant use with Azithromycin Accord may increase the anticoagulant effect of these medicines;
• medicines known to prolong the QT interval, such as hydroxychloroquine, due to the potential risk of cardiac arrhythmia.

Azithromycin Accord must not be taken together with other medicines that may affect heart rhythm (see section “Warnings and precautions”).

Azithromycin Accord with food and drink
Tablets should be swallowed whole. Azithromycin Accord may be taken regardless of food or drink. However, to reduce gastrointestinal side effects caused by azithromycin, it is preferable to take this medicine with food.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or 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 benefits outweigh potential risks.

Breastfeeding
Azithromycin Accord passes into breast milk. Therefore, if you are breastfeeding, your doctor will prescribe this medicine only if strictly necessary.

Driving and using machines
It is unknown whether this medicine affects the ability to drive or operate machinery.

Azithromycin Accord contains lactose
Azithromycin Accord contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

Azithromycin Accord film-coated tablets contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take/give Azithromycin Accord to a child

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts,
consult your doctor or pharmacist.
ADULTS AND CHILDREN OR ADOLESCENTS WITH BODY WEIGHT EQUAL TO OR ABOVE 45 KG

• For the treatment of upper and lower respiratory tract infections (sinusitis, tonsillitis, pharyngitis, bronchitis and pneumonia), skin and soft tissue infections, and odontostomatological infections: the recommended dose is 500 mg once daily for 3 consecutive days.
• For the treatment of sexually transmitted infections caused by susceptible strains of Chlamydia trachomatis or Haemophilus ducreyi: the recommended dose is 1000 mg as a single oral dose.

This medicine must not be given to children weighing less than 45 kg.
The maximum total recommended dose for any paediatric therapy is 1500 mg.
How to take the tablets
Swallow the tablets whole. Take the tablets with a glass of water as a single daily dose.
The tablets may be taken with or without food. Taking the tablets after a meal may reduce any stomach or
intestinal side effects that this medicine may cause.
Special patients
If you are elderly or have mild to moderate liver problems or kidney problems, your doctor may prescribe the
same doses indicated above. If you are elderly, particular caution is recommended, as heart problems may
occur (see section “Warnings and precautions”).
If you take/give the child more Azithromycin Accord than you should
If you take/give the child an excessive dose of this medicine, the possible side effects will be the same as those
you might experience after taking a correct dose of the medicine.
If you have taken more medicine than you should, contact your doctor immediately.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
If you forget to take/give the child Azithromycin Accord
If you or the child forget a dose, take/give it as soon as you remember. Do not take/give a double dose to make up for the forgotten tablet.
If you/the child stops treatment with Azithromycin Accord
Do not stop treatment prematurely. Even if you/the child start to feel better, it is important to continue taking the tablets for the entire duration prescribed by your doctor.
If you have any doubts about how to use 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 have occurred after taking Azithromycin Accord.
STOP using Azithromycin Accord immediately if you/your child experience any of the following side effects:

• severe allergic reaction (anaphylactic shock)
• swelling of the face, tongue and throat leading to difficulty swallowing and breathing (angioedema), increased sensitivity of the skin and mucous membranes
• severe inflammation of the last part of the intestine called the colon, caused by excessive growth of a bacterium called Clostridium difficile (pseudomembranous colitis)
• severe skin reactions: or severe rash associated with increased number of a type of white blood cells called eosinophils, symptoms affecting one or more organs, and fever (DRESS) (rare frequency)

or red, scaly rash with formation of pustules and blisters (exanthematous pustulosis) (rare frequency)
or severe acute hypersensitivity reactions involving the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) (frequency not known)

• severe liver problems (severe hepatic failure), as this may sometimes lead to death
• sudden and massive death of liver cells (fulminant hepatitis)
• toxic liver reaction with cell death
• anaemia due to destruction of red blood cells
• sudden loss of consciousness (syncope)
• inflammation of the pancreas (pancreatitis).

Contact your doctor if you/your child experience any of the following side effects:
Very common (may affect more than 1 in 10 people)

• diarrhoea.

Common (may affect up to 1 in 10 people)

• headache;
• nausea, vomiting;
• abdominal pain;
• decrease in the amount of bicarbonate in the blood;
• decrease in the number of a type of white blood cells called lymphocytes;
• increase in the number of a type of white blood cells called eosinophils;
• increase in the number of a type of white blood cells called basophils;
• increase in the number of a type of white blood cells called monocytes;
• increase in the number of a type of white blood cells called neutrophils.

Uncommon (may affect up to 1 in 100 people)

• vaginal and/or oral infection caused by Candida (a fungus);
• infection by microorganisms called "fungi";
• infection by microorganisms called "bacteria";
• respiratory disorders;
• pneumonia;
• pharyngitis;
• gastroenteritis;
• rhinitis;
• decrease in the number of white blood cells in the blood (leucopenia);
• decrease in the number of a type of white blood cells called neutrophils (neutropenia);
• increase in a type of white blood cells called eosinophils (eosinophilia);
• decreased or absent appetite;
• nervousness;
• insomnia;
• dizziness;
• somnolence;
• altered sensation in various parts of the body;
• distortion or reduced ability to taste;
• visual disturbances;
• ear disorders;
• vertigo;
• heightened perception of heartbeat;
• hot flushes;
• difficulty breathing (dyspnoea);
• nosebleed (epistaxis);
• constipation;
• gas production in the intestine;
• stomach discomfort;
• gastritis;
• difficulty or pain when swallowing;
• abdominal swelling;
• dry mouth;
• belching;
• mouth ulcers;
• increased saliva production;
• skin rashes;
• itching;
• urticaria;
• dermatitis;
• dry skin;
• excessive sweating;
• arthralgia;
• muscle pain;
• back pain;
• neck pain;
• pain when urinating;
• kidney pain;
• abnormal, heavy and prolonged vaginal bleeding;
• testicular disorders;
• swelling;
• weakness;
• malaise;
• fatigue;
• facial swelling;
• chest pain;
• fever;
• pain;
• swelling of legs and feet;
• abnormal laboratory tests assessing liver function;
• increased amount of bilirubin in the blood (a substance produced by the liver);
• increased amount of urea in the blood (a substance produced by the liver);
• increased amount of creatinine in the blood (a substance produced by muscles);
• changes in the amount of potassium and sodium in the blood (mineral salts);
• increased amount of alkaline phosphatase in the blood (a substance produced in various body tissues);
• increased amount of chloride in the blood (mineral salt);
• increased amount of glucose (a sugar) in the blood;
• increased number of platelets in the blood;
• decreased number of red blood cells in the blood;
• increased amount of bicarbonate in the blood;
• complications following medical or surgical procedures.

Rare (may affect up to 1 in 1,000 people)

• restlessness;
• altered liver function;
• yellowish discoloration of the skin and mucous membranes (jaundice);
• increased sensitivity of the skin to sunlight (photosensitivity).

Not known (frequency cannot be estimated from the available data)

• decreased number of platelets in the blood;
• seizures;
• reduced sensitivity of any body area to stimuli;
• aggression;
• anxiety;
• delirium;
• hallucinations;
• excessive motor activity and restlessness (psychomotor agitation);
• complete or partial loss of the ability to smell;
• complete loss of the ability to taste;
• severe muscle weakness (myasthenia gravis);
• hearing disorders;
• deafness;
• ringing in the ears;
• increased heart rate due to a specific cardiac rhythm abnormality (arrhythmia) called "torsades de pointes";
• disturbances in the normal heart rhythm called arrhythmias (e.g. ventricular tachycardia, QT interval prolongation), which can be detected by a test called "electrocardiogram";
• decreased blood pressure (hypotension);
• change in tongue colour;
• joint pain;
• severe kidney problems (acute renal failure, interstitial nephritis).

Reporting of side effects
If you/your child 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 Italian Medicines Agency website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Azithromycin Accord

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.
Store below 30 °C.
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 Azithromycin Accord 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 calcium hydrogen phosphate, pregelatinized starch, sodium lauryl sulfate, sodium croscarmellose, sodium carmellose, anhydrous colloidal silica, magnesium stearate. Tablet film-coating: hypromellose, titanium dioxide, triacetin, lactose monohydrate.

Description of the appearance of Azithromycin Accord and contents of the pack
Pack containing 3 film-coated tablets of 500 mg in blisters.
Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer
Doppel Farmaceutici Srl - Via Volturno, 48 - 20089 Quinto De’ Stampi - Rozzano (Milan)