Azithromicin Genoptim

Package Leaflet: Information for the Patient

Azithromycin Genoptim, 500 mg, Film-Coated Tablets

Azithromycin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Azithromycin Genoptim and what is it used for
• 2. Important information before taking Azithromycin Genoptim
• 3. How to take Azithromycin Genoptim
• 4. Possible side effects
• 5. How to store Azithromycin Genoptim
• 6. Contents of the pack and other information

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

Azithromycin Genoptim is an antibiotic belonging to the macrolide group.
It is used to treat infections caused by bacteria sensitive to azithromycin. These infections
include:

• exacerbation of chronic bronchitis and pneumonia,
• sinusitis, pharyngitis, tonsillitis,
• acute otitis media,
• skin and soft tissue infections of mild to moderate severity, such as folliculitis (inflammation of the hair follicles), bacterial skin infection and its deeper layers (cellulitis), skin infections with shiny red rash (erysipelas),
• uncomplicated urethritis or cervicitis caused by Chlamydia trachomatisbacteria.

2. Important information before taking Azithromycin Genoptim

When not to take Azithromycin Genoptim

• If you are allergic to azithromycin, erythromycin, or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic (hypersensitive) to any other macrolide or ketolide antibiotic.

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Azithromycin Genoptim.

Warnings and precautions

Before starting to take this medicine, discuss it with your doctor or pharmacist if:

• you have severe liver or kidney disease,
• you have severe heart rhythm disturbances (visible on an ECG or heart monitor),
• you have low levels of potassium or magnesium in your blood,
• you have symptoms of another infection,
• you have neurological (neurological) or psychiatric (psychiatric) disorders.

Stop taking Azithromycin Genoptim and immediately inform your doctor if you experience any of the following severe side effects while taking this medicine:

• swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing, rash, itching, large blisters on the skin, or ulcers on the lips, eyes, nose, mouth, and genitals. These may be signs of a severe allergic reaction, angioedema, or anaphylaxis.
• prolonged diarrhea with blood or mucus in the stool. This may be a sign of a serious intestinal disease called pseudomembranous colitis.

Azithromycin Genoptim and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as about the medicines you plan to take and those that are available without a prescription.
Tell your doctor or pharmacist about taking any of the following medicines:

• antacids - used to treat heartburn and indigestion. Azithromycin Genoptim should be taken at least one hour before and two hours after taking an antacid;
• ergotamine - used to treat migraines;
• warfarin or similar medicines - used to thin the blood. Azithromycin Genoptim may increase the thinning of the blood;
• cisapride - used to treat stomach disorders. Severe heart rhythm disturbances (visible on an ECG or heart monitor) may occur;
• terfenadine - used to treat hay fever. Severe heart rhythm disturbances (visible on an ECG or heart monitor) may occur;
• zidovudine or nelfinavir - used to treat HIV infections. Taking nelfinavir with Azithromycin Genoptim may cause more side effects listed in the leaflet;
• rifabutin - used to treat tuberculosis;
• quinidine - used to treat heart rhythm disturbances;
• cyclosporin - a medicine used to prevent the rejection of a transplanted organ by the body. Your doctor may recommend regular monitoring of cyclosporin levels in your blood and may change the dose.

Tell your doctor or pharmacist about taking any of the following medicines, as Azithromycin Genoptim may enhance their effects. Your doctor may change the dose:

• alfentanil - a sedative used during surgical procedures,
• digoxin - used to treat heart rhythm disturbances,
• colchicine - used to treat gout and familial Mediterranean fever,
• astemizole - used to treat hay fever,
• pimozide - used to treat psychiatric disorders.

Pregnancy, breastfeeding, and fertility

Azithromycin can be used during pregnancy and breastfeeding when the administration of this medicine is absolutely necessary.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

If taking the medicine causes dizziness and other symptoms that reduce concentration, do not drive or operate machinery.

Azithromycin Genoptim contains lactose (in the form of lactose monohydrate)

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

Azithromycin Genoptim contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Azithromycin Genoptim

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist, or nurse.
How to take the medicine

• Swallow the tablet whole with water.
• Do not crush or chew the tablets.
• The 500 mg tablet can be divided into two halves.
• The tablet can be taken with or without food.

Dosage
Adults, adolescents with a body weight of at least 45 kg, and elderly patients:
The recommended total dose is 1500 mg. It can be taken in two ways. Your doctor will inform you about the way of taking:

• for 3 days: one 500 mg tablet once a day, or
• for 5 days: one 500 mg tablet on day 1, and then one 250 mg tablet on days 2, 3, 4, and 5.

The dose may be different if you have urethritis (inflammation of the urethra) or cervicitis (inflammation of the cervix) caused by Chlamydia trachomatisbacteria. In this case, your doctor will recommend a single dose of 1000 mg.
Children and adolescents with a body weight below 45 kg:
The use of this medicine in the form of tablets is not recommended. In children and adolescents with a body weight below 45 kg, the medicine should be used in a different form, e.g., suspension.
Patients with kidney or liver function disorders:
If you have kidney or liver function disorders, inform your doctor.

Taking more than the recommended dose of Azithromycin Genoptim

If you have taken more than the recommended dose of Azithromycin Genoptim, contact your doctor or go to the hospital emergency department immediately. Take the medicine package with you. The following effects may occur:

• temporary hearing impairment,
• severe nausea, vomiting, and diarrhea.

Missing a dose of Azithromycin Genoptim

• If you miss a dose, take it as soon as you remember.
• However, do not take the missed dose if it is almost time for the next dose.
• Do not take a double dose to make up for the missed dose.
• Take all the prescribed tablets, which means that the treatment will end one day later.

Stopping Azithromycin Genoptim

Do not stop taking Azithromycin Genoptim without consulting your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Azithromycin Genoptim can cause side effects, although not everybody gets them.
Stop taking Azithromycin Genoptim and immediately inform your doctor if you notice any of the following serious side effects:

• swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing (occurs in 1 to 10 users per 1000), rash, itching, large blisters on the skin, or ulcers on the lips, eyes, nose, mouth, and genitals (occurs in less than 1 user per 10,000). These may be signs of a severe allergic reaction, angioedema, or anaphylaxis.
• severe, prolonged diarrhea with blood or mucus in the stool. This may be a sign of a serious intestinal disease called pseudomembranous colitis (occurs with an unknown frequency).
• fever, red spots on the skin, blisters, or peeling of the skin, joint pain, swollen eyes. This may be caused by severe diseases such as Stevens-Johnson syndrome (occurs in 1 to 10 users per 1000) or toxic epidermal necrolysis (occurs with an unknown frequency).

Other side effects that may occur:
Very common (affects more than 1 user in 10):

• -nausea
• diarrhea, abdominal pain, bloating.

Common (affects 1 to 10 users in 100):

• -loss of appetite
• dizziness
• headache
• tingling or numbness (paresthesia)
• changes in taste and smell
• vision disturbances
• deafness
• vomiting, abdominal pain or cramps, loss of appetite, digestion problems
• rash and itching
• joint pain
• fatigue
• changes in white blood cell count and bicarbonate levels in the blood.

Uncommon (affects 1 to 10 users in 1000):

• candidiasis (thrush) - fungal infection
• vaginitis
• decreased white blood cell count
• nervousness
• hypesthesia (increased sensitivity)
• drowsiness
• insomnia
• hearing impairment or ringing in the ears
• palpitations
• gastritis
• constipation
• hepatitis
• photosensitivity, redness, peeling, and swelling of the skin
• urticaria
• chest pain
• edema
• malaise
• weakness
• changes in liver enzyme levels and abnormal blood test results.

Rare (affects 1 to 10 users in 10,000):

• agitation
• dizziness
• abnormal liver function
• skin rash characterized by rapid onset of red skin areas with small blisters (pustules) filled with white or yellow fluid.

Frequency not known (cannot be estimated from the available data):

• decreased red blood cell count due to their destruction (hemolytic anemia); decreased platelet count
• anaphylactic reaction
• irritability, aggression
• fainting
• seizures
• hyperactivity
• smell disorders (anosmia, parosmia)
• taste disorders (ageusia)
• worsening or exacerbation of myasthenia symptoms
• rapid or irregular heartbeat, sometimes life-threatening, changes in heart rhythm detected on an electrocardiogram
• low blood pressure
• pancreatitis
• change in tongue color
• erythema multiforme,
• kidney function disorders.

If any of the side effects gets worse or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Your doctor may then decide to change the dose or stop the treatment.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw,
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Azithromycin Genoptim

• Keep out of the sight and reach of children.
• No special precautions for storage are necessary.

Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month.
The batch number on the packaging is indicated by the abbreviation Lot.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Azithromycin Genoptim contains

The active substance of the medicine is azithromycin.
One film-coated tablet of Azithromycin Genoptim, 500 mg, contains azithromycin dihydrate equivalent to 500 mg of azithromycin.
The other ingredients are:
Core:
calcium phosphate anhydrous, croscarmellose sodium, pregelatinized starch, hypromellose, sodium lauryl sulfate, magnesium stearate.
Coating Opadry White 31K58902:
hypromellose 15cP, lactose monohydrate, titanium dioxide (E 171), triacetin.

What Azithromycin Genoptim looks like and contents of the pack

Azithromycin Genoptim, 500 mg, are white or almost white, capsule-shaped, film-coated tablets with the inscription "AZ" and "500" on one side and no inscription on the other side.
The film-coated tablets are available in blisters of 2, 3, 6, or 30 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw

Manufacturer:

PSI Supply nv
Axxes Business Park
Guldensporenpark 22 – Block C
9820 Merelbeke
Belgium

Manufacturer/Importer:

Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz

Date of last revision of the leaflet: 03.2023