Macromax

Leaflet attached to the packaging: patient information

Macromax

500 mg, film-coated tablets

Azithromycin

Read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Macromax and what is it 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 is Macromax and what is it used for

Macromax contains the active substance azithromycin, which is an azalide antibiotic from the macrolide group with a broad spectrum of action. It has a bactericidal effect on 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;
• acute otitis media;
• skin and soft tissue infections - erysipelas, impetigo, secondary pyogenic skin infections, Lyme disease - the first symptom of borreliosis; moderate acne in adults only.
• sexually transmitted diseases: uncomplicated infections caused by Chlamydia trachomatis.

2. Important information before taking Macromax

When not to take Macromax

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 startingto take Macromax, the patient should discuss it with their doctor or pharmacist if:

• the patient has conditions that may lead to the development of rhythm disorders (especially in women and elderly patients):
• congenital or existing rhythm disorders (visible in the ECG - a test of heart electrical activity),
• severe heart failure,
• very slow heart rate (called bradycardia),
• electrolyte disturbances in the blood, especially low potassium and magnesium levels,
• taking other medicines that may cause prolongation of the QT interval in the ECG (see "Macromax and other medicines");
• the patient has severe kidney problems;
• the patient has severe liver problems: the doctor may monitor liver function or discontinue treatment;
• the patient has a new infection (may indicate excessive growth of resistant microorganisms or fungal infection);
• the patient has neurological (neurological) or mental (psychiatric) disorders;
• the patient has a sexually transmitted disease: the doctor should ensure that the patient does not have a co-existing syphilis infection;
• the patient is taking ergotamine derivatives (ergot preparations);
• the patient has infected burn wounds.

If during treatmentwith Macromax, the patient experiences any of the symptoms described at the beginning of section 4, they should stop taking the medicine immediately and contact their doctor.
If, despite treatment, the symptoms of the infection do not disappear or new symptoms of another infection appear, e.g. fungal, the patient should consult their doctor again.
Infections caused by streptococci
In the treatment of pharyngitis and tonsillitis caused by streptococci, the drug of choice is usually penicillin.
Pseudomembranous colitis
In case of diarrhea, the patient should immediately inform their doctor, as it may be a symptom of pseudomembranous colitis - a complication that sometimes occurs during the use of macrolide antibiotics. Such a diagnosis should be considered by the doctor in patients who develop diarrhea after starting treatment with azithromycin. In case of pseudomembranous colitis caused by azithromycin, it may be necessary to discontinue Macromax and use appropriate treatment. It is contraindicated to administer anti-peristaltic agents.
Long-term use
There is no data on the safety and efficacy of azithromycin used long-term in the above indications. In case of rapidly recurring infections, the doctor will consider treatment with another antibacterial agent.
Myasthenia
During treatment with azithromycin, exacerbation of myasthenia symptoms or the development of a myasthenic syndrome (see "Possible side effects") has been observed.

Children and adolescents

Macromax in the form of 500 mg film-coated tablets is recommended for use in children only with a body weight of not less than 45 kg. For the rest of the group of children, it is recommended to use the Macromax product in the form of orally disintegrating tablets 20 mg and 100 mg. Children under 6 years of age should not be given any tablets due to the risk of choking.

Macromax and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
If the patient is taking any of the following medicines, it is especially important to inform their doctor or pharmacist:

• antacids - Macromax should be taken 1 hour before or 2 hours after taking an antacid,
• oral anticoagulants, e.g. warfarin,
• ergotamine derivatives (used in migraine or to reduce blood flow), e.g. ergotamine used with azithromycin may cause ergotism (symptoms - spasm of peripheral blood vessels and ischemia),
• digoxin (used to treat heart rhythm disorders),
• colchicine (used to treat gout and familial Mediterranean fever),
• nelfinavir, zidovudine (used to treat HIV infections),
• cyclosporine (used to treat skin diseases, rheumatoid arthritis, or after organ transplantation),
• atorvastatin (a medicine used to lower cholesterol levels),
• rifabutin (used to treat tuberculosis or HIV),
• medicines that affect the QT interval, such as:
• quinidine, procainamide, dofetilide, amiodarone, sotalol (used to treat heart rhythm disorders),
• cisapride (used to treat stomach disorders),
• terfenadine (used to treat allergies),
• antipsychotic medicines, e.g. pimozide,
• antidepressant medicines, e.g. citalopram,
• fluoroquinolones (used to treat infections), e.g. moxifloxacin, levofloxacin.

Macromax with food and drink

Macromax in the form of 500 mg film-coated tablets can be taken regardless of meals.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The medicine may be used during pregnancy only if the doctor considers that the benefit to the mother outweighs the risk to the child.
Breastfeeding
Azithromycin passes into breast milk. Breastfeeding should be avoided during treatment with azithromycin, unless the doctor recommends otherwise.
Fertility
In fertility studies conducted in rodents, a decrease in the conception rate was observed after administration of azithromycin. The significance of these study results for humans is unknown.

Driving and using machines

There is no data on the effect of Macromax on the ability to drive and use machines. However, when performing such activities, the possibility of side effects such as dizziness or seizures should be taken into account.

Macromax contains sodium

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

3. How to take Macromax

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
The medicine is taken orally.

Dosage for adults, including the elderly, and children and adolescents with a body weight over 45 kg

Upper and lower respiratory tract infections, otitis media, skin and soft tissue infections (except for erythema migrans and moderate acne)
The total dose of azithromycin is 1.5 g over 3 days (500 mg in a single daily dose).
Erythema migrans
The total dose is 3 g and should be taken in the following scheme: 1 g (2 film-coated tablets of 500 mg) on the first day, and then 500 mg (1 film-coated tablet) from the second to the fifth day, in single daily doses.
Moderate acne - only in adults
The total dose is 6 g and is recommended to be administered in the following scheme: 1 film-coated tablet of 500 mg once a day for 3 days, and then 1 film-coated tablet of 500 mg once a week for the next 9 weeks. In the second week of treatment, the medicine should be taken 7 days after the first dose, and the next eight doses should be taken at 7-day intervals.
Due to the use of a high dose of azithromycin in the above dosage scheme in patients with moderate acne, it is necessary to monitor liver enzyme activity before and during the course of treatment with azithromycin.
The above scheme of cyclic treatment of moderate acne (3 days + 9 weeks) can be used in a given patient only once, as there are no controlled clinical trials that have shown the safety and efficacy of repeating this treatment scheme for moderate acne.
Uncomplicated infections caused by Chlamydia trachomatis
1 g (2 film-coated tablets of 500 mg) in a single dose.
Patients with kidney or liver problems
If the patient has kidney or liver problems, they should inform their doctor, as it may be necessary to reduce the usual dose of the medicine. The medicine should not be used in patients with severe liver failure.
Method of administration
Azithromycin should be taken orally, once a day.
Macromax in the form of 500 mg film-coated tablets can be taken regardless of meals.
The dividing line on the tablet is not intended for breaking the tablet. The tablets should be swallowed whole.

Using a higher dose of Macromax than recommended

In case of taking a higher dose of the medicine than recommended, the patient should inform their doctor or go to the nearest hospital as soon as possible. The side effects that occurred after taking the medicine in doses higher than recommended were similar to those described after taking the correct doses. Characteristic symptoms of overdose of macrolide antibiotics include: transient hearing loss, severe nausea, vomiting, and diarrhea.
Treatment of overdose includes administration of activated charcoal and symptomatic treatment, as well as supportive treatment if necessary.

Missing a dose of Macromax

A missed dose should be taken as soon as possible, and subsequent doses should be taken according to the recommended dosage regimen. A double dose should not be taken to make up for a missed dose.

4. Possible side effects

Like all medicines, Macromax can cause side effects, although not everybody gets them.

The patient should stop taking the medicine immediately and contact their doctor if they experience any of the following side effects

• Swelling of the hands, feet, ankles, face, lips, or throat, which may cause difficulty swallowing or breathing, a drop in blood pressure, itching of the skin, and hives. These may be symptoms of a severe allergic reaction (angioedema or anaphylactic reaction).
• Severe skin reactions, such as blistering of the skin, mouth, eyes, and genitals, peeling of the skin, rash, redness of the skin, swelling of the skin and mucous membranes, acute generalized exanthematous pustulosis (a skin rash characterized by the rapid appearance of areas of redness of the skin dotted with small pustules [blisters filled with white or yellow fluid]).
• Diarrhea, especially severe or persistent, with blood or mucus, occurring during or after treatment with Macromax. These may be symptoms of severe colitis (pseudomembranous colitis). Do notadminister anti-peristaltic agents.
• Rapid or irregular heartbeat (may occur more frequently in women and the elderly)
• 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
• vaginal bleeding.

Frequency of side effects when taking Macromax

Side effects that occur very often (may occur in more than 1 in 10 patients):

• diarrhea

Side effects that occur often (may occur in less than 1 in 10 patients):

• headache
• vomiting, abdominal pain, nausea
• change in white blood cell count
• decrease in blood bicarbonate levels

Side effects that occur uncommonly (may occur in less than 1 in 100 patients):

• fungal infections (candidiasis), vaginal infection, pneumonia, fungal infection, bacterial infection, pharyngitis, gastrointestinal upset, respiratory disorders, rhinitis, oral thrush
• changes in blood counts (decrease in leukocytes, neutrophils, increase in eosinophils)
• angioedema (swelling in the face and throat, which can cause difficulty breathing), hypersensitivity
• loss of appetite
• nervousness, insomnia, dizziness, drowsiness, taste disorders, paresthesia (sensory disturbances - tingling, numbness, or prickling of the skin)
• visual disturbances
• hearing disorders, balance disorders
• palpitations
• flushing
• shortness of breath, nosebleeds
• constipation, bloating with gas, indigestion, gastritis, swallowing disorders (dysphagia), bloated abdomen, dry mouth, belching, oral ulcers, excessive salivation
• rash, itching, hives, skin inflammation, dry skin, excessive sweating
• degenerative joint disease, muscle pain, back pain, neck pain
• painful urination, kidney pain
• vaginal bleeding, disorders of testicular function
• edema, weakness (asthenia), malaise (apathy), fatigue, facial edema, chest pain, fever, pain, peripheral edema
• abnormal laboratory test results (e.g. related to blood parameters or liver function, glucose levels, electrolytes)
• post-procedural complications

Side effects that occur rarely (may occur in less than 1 in 1000 patients):

• agitation
• liver function disorders, jaundice with bile stasis (cholestatic)
• photosensitivity
• severe skin reactions: acute generalized exanthematous pustulosis characterized by the rapid appearance of areas of redness of the skin dotted with small pustules (blisters filled with white or yellow fluid)

Side effects that occur with an unknown frequency (frequency cannot be estimated from the available data):

• anaphylactic reaction (generalized allergic reaction, rarely leading to death; may occur with symptoms such as: swelling of the lips, face, or throat, leading to severe breathing difficulties, rash on the skin or hives)
• aggressive behavior, anxiety, hallucinations, delusions
• loss of consciousness (syncope), seizures, sensory disturbances (hypoesthesia), excessive psychomotor activity, loss of smell, loss of taste, disorders of smell, rapid fatigue of muscles (myasthenia)
• hearing disorders, including deafness and/or tinnitus
• heart rhythm disorders, including significant acceleration (disorders of the torsade de pointestype, ventricular tachycardia), prolongation of the QT interval in the electrocardiogram
• decrease in blood pressure
• 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, Drug reaction with eosinophilia and systemic symptoms)
• joint pain
• liver failure, rarely leading to death, fulminant hepatitis, liver necrosis
• acute kidney failure, interstitial nephritis
• pseudomembranous colitis
• thrombocytopenia (decrease in platelet count), decrease in red blood cell count (hemolytic anemia)

Side effects probably or possibly related to the use of azithromycin in the treatment of Mycobacterium aviumcomplex infections or prevention of them, based on clinical trials and post-marketing observations

Very often(may occur in more than 1 in 10 patients):

• diarrhea
• abdominal pain
• nausea
• bloating
• abdominal discomfort
• loose stools.

Often(may occur in less than 1 in 10 patients):

• loss of appetite
• dizziness
• headache
• abnormal skin sensations, e.g. tingling and numbness of limbs (paresthesia)
• taste disorders
• visual disturbances
• deafness
• rash, itching
• joint pain
• fatigue.

Uncommonly(may occur in less than 1 in 100 patients):

• sensory disturbances (hypoesthesia)
• hearing disorders, tinnitus
• palpitations
• hepatitis
• Stevens-Johnson syndrome (severe skin reaction), photosensitivity
• weakness (asthenia), malaise.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C, 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.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Macromax

Store in a temperature below 25°C. Store in the original packaging to protect from moisture and light.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Macromax contains

• The active substance of the medicine is azithromycin (in the form of azithromycin dihydrate). 1 film-coated tablet contains 500 mg of azithromycin.
• Other ingredients are: tablet core: microcrystalline cellulose, sodium croscarmellose, povidone K25, magnesium stearate, colloidal anhydrous silica; coating: methacrylic acid - ethyl acrylate copolymer (Eudragit E PO), talc, titanium dioxide (E 171), dibutyl sebacate, sodium lauryl sulfate, polysorbate 80, indigo carmine (E 132), lacquer.

What Macromax looks like and what the pack contains

Macromax has the form of film-coated tablets, oblong, biconvex, blue, with a transverse score.
The film-coated tablets are packaged in PVC/PE/PVDC/Aluminum blisters, in a cardboard box.
The packaging contains 2, 3, or 6 film-coated tablets.

Marketing authorization holder

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

Manufacturer

ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
35-959 Rzeszów, Poland

Date of last revision of the leaflet: