Macromax

Patient Information Leaflet

Macromax
500 mg, film-coated tablets
Azithromycinum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents

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

1. What Macromax is and what it is used for

Macromax contains azithromycin as the active substance, which is an azalide antibiotic belonging to the broad-spectrum macrolide group. It acts bactericidally against susceptible microorganisms.
Macromax 500 mg film-coated tablets are indicated for the treatment of the following infections caused by microorganisms susceptible to azithromycin:

• upper respiratory tract infections – bacterial pharyngitis, tonsillitis, sinusitis (see also section 2);
• lower respiratory tract infections – acute bronchitis, exacerbation of chronic bronchitis, mild to moderate pneumonia, including interstitial pneumonia;
• acute otitis media;
• skin and soft tissue infections – erysipelas, impetigo, secondary bacterial skin infections, erythema migrans – the first sign of Lyme disease; moderate acne vulgaris, in adults only;
• sexually transmitted infections: uncomplicated infections caused by Chlamydia trachomatis.

2. Important information before using Macromax

When not to use Macromax
Do not use this medicine if the patient is allergic to azithromycin, other macrolide antibiotics, or any of the
other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Macromax, consult a doctor or pharmacist if:

• the patient has conditions predisposing to cardiac rhythm disturbances (particularly relevant in women and elderly patients):
• congenital or previous history of cardiac arrhythmias (visible on ECG – electrocardiogram),
• severe heart failure,
• very slow heart rate (called bradycardia),
• electrolyte imbalances in the blood, especially low levels of potassium and magnesium,
• use of other medicines that may cause QT interval prolongation on ECG (see section "Macromax with other medicines");
• the patient has severe kidney function impairment;
• the patient has severe liver function impairment: the doctor may monitor liver function or discontinue treatment;
• the patient develops a new infection (this may indicate overgrowth of resistant microorganisms or a fungal infection);
• the patient has neurological or psychiatric disorders;
• the patient has a sexually transmitted infection: the doctor should ensure that syphilis is not present;
• the patient is using ergotamine derivatives (ergot preparations);
• the patient has infected burn wounds.

If during treatment with Macromax the patient experiences symptoms described at the beginning of section 4,
treatment should be stopped immediately and the patient should contact a doctor.
If, despite treatment, symptoms of infection persist or new infections (e.g. fungal) appear, medical advice should be sought again.

Streptococcal infections
For the treatment of streptococcal pharyngitis and tonsillitis, penicillin is usually the drug of choice.

Pseudomembranous colitis
If diarrhea occurs, it should be reported immediately to a doctor, as it may be a sign of pseudomembranous colitis—a complication that may occur occasionally during treatment with macrolide antibiotics. Physicians should consider this diagnosis in patients who develop diarrhea after starting azithromycin therapy. In cases of pseudomembranous colitis due to azithromycin use, discontinuation of Macromax and initiation of appropriate treatment may be necessary. Antiperistaltic agents are contraindicated.

Long-term use
There are no data on the safety and efficacy of long-term use of azithromycin for the indications listed above. In cases of rapidly recurring infections, the doctor may consider treatment with another antibacterial agent.

Myasthenia
Worsening of myasthenia symptoms or development of a myasthenic syndrome has been observed during azithromycin treatment (see section "Possible side effects").

Children and adolescents
Macromax 500 mg film-coated tablets are recommended for use in children only if body weight is at least 45 kg. For other pediatric groups, Macromax 20 mg and 100 mg orodispersible tablets are recommended. Tablets should not be administered to children under 6 years of age due to the risk of choking.

Macromax with other medicines
Inform the doctor about all medicines currently used, recently used, or planned for use.
It is especially important to inform the doctor or pharmacist if the patient is taking any of the following medicines:

• antacids – Macromax should be taken 1 hour before or 2 hours after antacid administration,
• oral anticoagulants, e.g. warfarin,
• ergot alkaloids (used in migraine or reducing blood flow), e.g. ergotamine: co-administration with azithromycin may lead to ergotism (symptoms: peripheral vasoconstriction and ischemia),
• digoxin (used in treating heart rhythm disorders),
• colchicine (used in treating gout and familial Mediterranean fever),
• nelfinavir, zidovudine (used in treating HIV infections),
• cyclosporine (used in skin diseases, rheumatoid arthritis, or after organ transplantation),
• atorvastatin (used to lower cholesterol levels),
• rifabutin (used in treating tuberculosis or HIV),
• drugs affecting the QT interval, such as:
• quinidine, procainamide, dofetilide, amiodarone, sotalol (used in treating cardiac arrhythmias),
• cisapride (used for gastric disorders),
• terfenadine (used in treating allergies),
• antipsychotics, e.g. pimozide,
• antidepressants, e.g. citalopram,
• fluoroquinolones (used in infections), e.g. moxifloxacin, levofloxacin.

Macromax with food and drink
Macromax 500 mg film-coated tablets can be taken independently of meals.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
This medicine may be used during pregnancy only if, in the opinion of the doctor, the benefit to the mother outweighs the risk to the fetus.

Breastfeeding
Azithromycin passes into breast milk. Breastfeeding is not recommended during azithromycin treatment unless otherwise advised by a doctor.

Fertility
In fertility studies conducted in rodents, a reduced pregnancy rate was observed after administration of azithromycin. The relevance of these findings to humans is unknown.

Driving and using machines
There are no data on the effect of Macromax on the ability to drive or operate machinery. However, when performing such activities, consider the possibility of adverse effects such as dizziness or seizures.

Macromax contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Macromax

This medicine should always be taken exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
This medicine is for oral use.
Dosage in adults, including elderly patients, and in children and adolescents with body weight
above 45 kg
Upper and lower respiratory tract infections, otitis media, skin and soft tissue infections (excluding
erythema migrans and acne vulgaris)
The total dose of azithromycin is 1.5 g over 3 days (500 mg as a single daily dose).
Erythema migrans
The total dose is 3 g, to be taken according to the following regimen: 1 g on the first day (2
500 mg film-coated tablets), followed by 500 mg (1 film-coated tablet) once daily from the second
to the fifth day.
Moderate acne vulgaris – in adults only
The total dose is 6 g, administered according to the following regimen: 1 film-coated tablet of 500 mg
once daily for 3 days, followed by 1 film-coated tablet of 500 mg once weekly for the next 9 weeks.
During the second week of treatment, the dose should be taken 7 days after the first dose, and the
next eight doses should be taken at 7-day intervals.
Due to the administration of a high dose of azithromycin in the above regimen for moderate acne
vulgaris, monitoring of liver enzyme activity is required before starting and during the course of
azithromycin treatment.
The above cyclic regimen for moderate acne vulgaris (3 days + 9 weeks) may be applied only once
in a given patient, as there are currently no controlled clinical trials demonstrating the safety and
efficacy of repeating this treatment regimen for acne vulgaris.
Uncomplicated infections caused by Chlamydia trachomatis
1 g (2 film-coated tablets of 500 mg) as a single dose.
Patients with renal or hepatic impairment
If the patient has impaired kidney or liver function, this should be reported to the physician, as a
reduction in the usual dose may be necessary. This medicine should not be used in patients with
severe hepatic insufficiency.
Method of administration
Azithromycin should be taken orally once daily.
Macromax 500 mg film-coated tablets may be taken with or without food.
The break-line on the tablet is not intended for splitting the tablet. Tablets should be swallowed whole.
Taking more Macromax than prescribed
If more medicine has been taken than prescribed, contact a doctor or go to the nearest hospital as
quickly as possible. Adverse effects observed after overdosage were similar to those reported with
correct doses. Characteristic symptoms of macrolide antibiotic overdose include transient hearing
loss, severe nausea, vomiting, and diarrhea.
Management of overdose includes administration of activated charcoal and symptomatic treatment,
and, if necessary, supportive measures to maintain vital functions.
If you forget to take Macromax
If a dose is missed, take it as soon as possible, and then continue with the next doses according to
the prescribed schedule. Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, Macromax may cause adverse effects, although not everyone experiences them.
The medicine must be discontinued immediately and a doctor should be contacted if the patient
experiences any of the following adverse effects:

• Swelling of the hands, feet, ankles, face, lips or throat, which may cause difficulty in swallowing or breathing, low blood pressure, skin itching and urticaria. These may be symptoms of a severe allergic reaction (angioedema or anaphylactic reaction).
• Severe skin reactions, such as blistering of the skin, inside the mouth, around the eyes or genitals, skin peeling, rash, redness of the skin, swelling of the skin and mucous membranes, acute generalized exanthematous pustulosis (a skin eruption characterized by rapid appearance of red skin areas covered with small pustules [vesicles filled with white or yellow fluid]).
• Diarrhoea, especially severe or persistent, with blood or mucus, occurring during or after treatment with Macromax. These may be symptoms of severe intestinal inflammation (pseudomembranous colitis). Antiperistaltic agents must not be used.
• Rapid or irregular heartbeat (may occur more frequently in women and elderly patients)
• Rapidly progressing weakness with jaundice, dark urine, tendency to bleed, which may be symptoms of liver failure (rarely leading to death), fulminant hepatitis, liver necrosis
• Uterine bleeding.

Frequency of adverse effects during treatment with Macromax
Adverse effects occurring very commonly (may affect more than 1 in 10 patients):

• Diarrhoea

Adverse effects occurring commonly (may affect less than 1 in 10 patients):

• Headache
• Vomiting, abdominal pain, nausea
• Changes in white blood cell count
• Decreased concentration of bicarbonates in blood

Adverse effects occurring uncommonly (may affect less than 1 in 100 patients):

• Fungal infections (candidiasis), vaginal infection, pneumonia, fungal infection, bacterial infection, pharyngitis, gastritis and enteritis, respiratory disorders, rhinitis, oral candidiasis
• Changes in blood counts of various types of white blood cells (decreased leukocytes, neutrophils, increased eosinophils)
• Angioedema (swelling of the face and throat, possibly causing breathing difficulties), hypersensitivity
• Anorexia (loss of appetite)
• Nervousness, insomnia, dizziness, somnolence, taste disturbances, paresthesia (sensory disturbances – tingling, pricking or numbness of the skin)
• Visual disturbances
• Ear disorders, balance disorders
• Palpitations
• Hot flushes
• Dyspnea, nosebleeds
• Constipation, bloating with flatulence, dyspepsia, gastric mucosal inflammation, swallowing difficulties (dysphagia), abdominal distension, dry mouth, regurgitation with vomiting, oral ulcers, excessive salivation
• Rash, pruritus, urticaria, dermatitis, dry skin, excessive sweating
• Arthropathy, muscle pain, back pain, neck pain
• Painful urination, kidney pain
• Uterine bleeding, testicular function disorders
• Edema, asthenia (weakness), malaise, fatigue, facial swelling, chest pain, fever, pain, peripheral edema
• Abnormal laboratory test results (e.g. blood parameters, liver function, glucose or electrolyte levels)
• Post-procedural complications

Adverse effects occurring rarely (may affect less than 1 in 1000 patients):

• Restlessness
• Liver function disorders, cholestatic jaundice
• Photosensitivity
• Severe skin reactions: acute generalized exanthematous pustulosis characterized by rapid appearance of red skin areas covered with small pustules (vesicles filled with white or yellow fluid)

Adverse effects occurring with unknown frequency (frequency cannot be estimated from available data):

• Anaphylactic reaction (generalized allergic reaction, rarely leading to death; may present with symptoms such as swelling of lips, face or neck leading to severe breathing difficulties, skin rash or urticaria)
• Aggressive behavior, anxiety, delirium, hallucinations
• Loss of consciousness (fainting), seizures, sensory disturbances (hypoesthesia), psychomotor hyperactivity, loss of smell, loss of taste, olfactory disturbances, rapid muscle fatigue (myasthenia)
• Hearing disorders, including deafness and (or) tinnitus
• Cardiac arrhythmias, including marked tachycardia (e.g. torsade de pointes, ventricular tachycardia), QT interval prolongation on electrocardiogram
• Hypotension
• Pancreatitis, tongue discoloration
• Severe skin reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), erythema multiforme, drug reaction with eosinophilia and systemic symptoms (DRESS)
• Joint pain
• Liver failure, rarely fatal, fulminant hepatitis, liver necrosis
• Acute renal failure, interstitial nephritis
• Pseudomembranous colitis
• Thrombocytopenia (reduced platelet count), reduced number of red blood cells (hemolytic anemia)

Adverse effects probably or possibly related to the use of azithromycin in the treatment of
Mycobacterium avium complex infections or prophylaxis, based on clinical trials and post-marketing
observations
Very common (may affect more than 1 in 10 patients):

• Diarrhoea
• Abdominal pain
• Nausea
• Bloating
• Abdominal discomfort
• Loose stools

Common (may affect less than 1 in 10 patients):

• Anorexia
• Dizziness
• Headache
• Unusual skin sensations, such as tingling and numbness of limbs (paresthesia)
• Taste disturbances
• Visual disturbances
• Deafness
• Rash, pruritus
• Joint pain
• Fatigue

Uncommon (may affect less than 1 in 100 patients):

• Sensory disturbances (hypoesthesia)
• Hearing disorders, tinnitus
• Palpitations
• Hepatitis
• Stevens-Johnson syndrome (severe skin reaction), photosensitivity
• Asthenia (weakness), malaise

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects may also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Macromax

Store below 25°C. Keep in the original packaging to protect from moisture and light.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Macromax contains

• The active substance is azithromycin (in the form of azithromycin dihydrate). One coated tablet contains 500 mg of azithromycin.
• Other components are: tablet core: microcrystalline cellulose, sodium croscarmellose, povidone K25, magnesium stearate, colloidal anhydrous silica; coating: basic butyl methacrylate copolymer (Eudragit E PO), talc, titanium dioxide (E 171), dibutyl sebacate, sodium lauryl sulfate, polysorbate 80, indigo carmine (E 132), lac.

What Macromax looks like and contents of the pack
Macromax is in the form of oblong, biconvex, film-coated tablets, blue in colour, with a transverse engraved line.
The film-coated tablets are packed in blisters made of PVC/PE/PVDC/Aluminium, placed in a cardboard box.
The pack contains 2, 3 or 6 film-coated tablets.

Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer
ICN Polfa Rzeszów S.A.
Przemysłowa 2 Street
35-105 Rzeszów, Poland