Mac Zmax

Read all of this leaﬂet carefully before you start taking this medicine because it contains important information for
you.
– Keep this leaﬂet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

What is in this leaflet

1. What Mac Zmax is and what it is used for
2. What you need to know before you take Mac Zmax
3. How to take Mac Zmax
4. Possible side eﬀects
5. How to store Mac Zmax
6. Contents of the pack and other Information

1. What Mac Zmax is and what it is used for
Mac Zmax belongs to a group of medicines called macrolide antibiotics. Antibiotics are used to treat infections caused
by micro-organisms like bacteria. Mac Zmax is used for the treatment of certain infections caused by bacteria that are
sensitive to it, such as:

chest, throat or nasal infections (such as bronchitis, pneumonia, tonsillitis, sore throat (pharyngitis) and
sinusitis)
ear infections
skin and soft tissue infections
infection of the tube that carries urine from the bladder (urethra) or the neck of the womb (cervix) caused by
Chlamidia trachomatis (bacteria).

2. What you need to know before you take Mac Zmax
Do not take Mac Zmax:

if you are allergic to Azithromycin dihydrate, erythromycin or any macrolide or ketolide antibiotic Warnings and
precautions
Talk with your doctor or pharmacist before taking Mac Zmax if:
you have severe liver or kidney problems
you have severe heart problems or problems with your heart beat such as long QT syndrome (shown on an
electro-cardiogram or ECG machine)
your blood levels of potassium or magnesium are too low
you develop signs of another infection
you are taking any ergot derivatives such as ergotamine (to treat migraine) as these medicines should not be
taken together with Mac Zmax (see section “Taking other medicines”)
you have a certain type of muscle weakness called myasthenia gravis
you have nervous (neurological) or mental (psychiatric) problems.
Other medicines and Mac Zmax
Tell your doctor or pharmacist if you are taking, have recently taken or might take any of the following
medicines:
antacids – used for heartburn and indigestion. Mac Zmax should be taken at least 1 hour before or 2
hours antacid
ergotamine – (used for migraine) should not be taken at the same time as serious side effects may
develop (with numbness or tingling sensations in the limbs, muscle cramps, headaches, convulsions abdominal or
chest pain )
cholesterol lowering medicines (statins)
warfarin or similar medicines – used to thin the blood. Mac Zmax can thin the blood even more
cisapride – (used to treat stomach problems) should not be taken at the same time as this may cause severe heart
problems (shown on an electro-cardiogram or ECG machine)
terfenadine – (used to treat hay fever) should not be taken at the same time as this may cause severe heart
problems (shown on an electrocardiogram or ECG machine)
zidovudine or nelfinavir – used to treat HIV infections Taking nelfinavir with Mac Zmax may mean that you get
more of the side effects listed in this leaflet
rifabutin – used to treat tuberculosis (TB)
quinidine – used to treat heart rhythm problems
cyclosporin – used to stop your body rejecting an organ transplant. Your doctor will regularly check your
blood levels of cyclosporin and may change your dose.

Tell your doctor or pharmacist if you are taking any of the following medicines. Mac Zmax can make the
effects of these other medicines stronger. Your doctor may change your dose:
theophylline – used for breathing problems such as asthma and chronic obstructive pulmonary disease (COPD)
Increased or reduced urine output, or traces of blood in your urine
Skin rash caused
Unusual bruising or bleeding
Irregular heart beat.

These are all serious side eﬀects. You may need urgent medical attention. Serious side eﬀects are uncommon (may
aﬀect up to 1 in 100 people) or the frequency cannot be estimated from the available data. Other side eﬀects
include
Very common (may aﬀect more than 1 in 10 people)

diarrhoea
Common (may affect up to 1 in 10 people)
headache, being sick (vomiting ), stomach pain or cramps, loss of appetite, change in the quantity of the white
blood cells and the concentration of bicarbonate in the blood.
Uncommon (may affect up to 1 in 100 people)

thrush (candidiasis) – a fungal infection , fungal infectionn, inflammation of the throat (pharyngitis)
breathlessness, chest pain, wheeze and cough (respiratory disorder), inflammation of the mucous membrane inside
the nose (rhinitis), stomach ﬂu (gastroenteritis), inﬂammation inside your vagina (vaginitis), pneumonia,
changes in the number of white blood cells, angioedema, hypersensitivity, lack of appetite (anorexia),
nervousness, feeling drowsy (somnolence), changes in your sense of taste, sensation of pins and needles or
numbness (paraesthesia), visual impairment, having difficulty sleeping (insomnia), ear disorder, dizziness,
spinning sensation (vertigo), palpitations, hot ﬂushes, shortness of breath, nosebleed, inﬂammation of the
lining of the stomach (gastritis), constipation, loose wind (ﬂatulence), difficulty swallowing, swollen abdomen,
dry mouth, belching, mouth ulcer, increased salivary ﬂow, skin rash, itching, inﬂammation of the skin
(dermatitis), dry skin, increased sweating, pain, swelling and reduced motion in your joints (osteoarthritis),
muscle pain, back pain, neck pain, increase in blood urea levels, painful or difficult urination, pain in the
upper back (renal pain), spotting, testicular disorder, urticaria, chest pain, face swelling, fever, pain,
swelling of extremities (peripheral edema), swelling (oedema), general feeling of being unwell (malaise),
fatigue, weakness (asthenia), change in liver enzyme levels and blood levels, post procedural complications Rare
(may aﬀect up to 1 in 1,000 people)
feeling agitated, abnormal hepatic function, yellowing of the skin and whites of the eyes, dark urine, pale
stool, allergic skin reactions such as being sensitive to sunlight, skin eruption that is characterized by the
rapid appearance of areas of red skin studded with small pustules (small blisters filled with white/yellow
ﬂuid).
Not known (frequency cannot be estimated from the available data) gut (colon) infection (pseudomembranous
colitis), reduced number of red blood cells due to destruction (haemolytic anaemia); reduction in number of
platelets (thrombocytopenia), anaphylactic reaction, feeling angry, aggressive, anxiety, confusion,
hallucination, fainting (syncope), fits (convulsions), reduced sense of touch (hypoaesthesia), feeling
hyperactive, change in your sense of smell (anosmia, parosmia), change in your sense of taste (ageusia),
exacerbation or aggravation of muscle weakness (myasthenia gravis), impaired hearing including loss of hearing,
ringing in your ears, rapid (ventricular tachycardia) or irregular heart beat, sometimes being life-threatening,
changes of the heart rhythm found by an electrocardiogram (QT prolongation and torsade de pointed), low blood
pressure, inﬂammation of the pancreas (pancreatitis), digoxin – used to treat heart problems, pimozide – used to
treat mental health problems. Mac Zmax with food and drink This medicine can be taken with or without food.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.
There is insufficient information available about the use of Mac Zmax during pregnancy. Therefore you should not
use Mac Zmax during pregnancy, unless explicitly advised by your doctor.
Mac Zmax is partially passed through the mother’s milk, therefore Mac Zmax should not be used if you are
breastfeeding.
Driving and using machines There are no data available about the inﬂuence of Mac Zmax on the ability to drive or
operate machines. However, Mac Zmax may cause dizziness and seizures so make sure you are not aﬀected before
driving or operating machinery.
Mac Zmax contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking medicinal product.

3. How to take Mac Zmax
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you
are not sure.
The recommended dose: For adults and young people with a body weight of 45 kg or over
500 mg once daily for three days with a total dose of 1500 mg. Alternatively your doctor may decide to prescribe the
total dose of 1500 mg over a period of 5 days, with 500 mg the first day and 250 mg on days 2 to 5.
For infections of the neck of the womb and urethra caused by Chlamydia trachomatis One dose of 1000 mg, to be taken one
time.
Children and adolescents under 45 kg The tablets are not recommended. Young people with a body weight of less than 45 kg
should use other forms of this medicine.
Patients with kidney or liver problems
You should tell your doctor if you have kidney or liver problems as your doctor may need to alter the normal dose.
Dosage for elderly For elderly the same dosage as for adults applies. The tablet can be divided into equal doses. Method
of administration The tablets should be taken with ½ glass of water. The tablets can be taken with or without food. If
you take more Mac Zmax than you should If you have taken too much Mac Zmax, contact your doctor, pharmacist or go to
your nearest hospital at once.
Symptoms of overdose are loss of hearing, feeling sick or being sick and diarrhoea. In case of overdosage admission into
hospital may be necessary.
If you forget to take Mac Zmax If you forget to take Mac Zmax, take your dose as soon as possible. If it is almost time
for the next dose, just skip that dose and take the next one when it is due. If in doubt, please contact your doctor or
pharmacist. If you have to skip a dose, still take all of your tablets. This means that you will finish your course a
day later.
Do not take a double dose to make up for a forgotten dose. If you stop taking Mac Zmax
Never stop the treatment with Mac Zmax on your own, but first discuss this with your doctor. If the prescribed treatment
is not completely finished, the infection may come back again.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side eﬀects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you have any of the following symptoms of a severe allergic reaction stop taking this medicine and tell
your doctor immediately or go to the casualty department at your nearest hospital

Sudden difficulty in breathing, speaking and swallowing, Swelling of the lips, tongue, face and neck,
Extreme dizziness or collapse, Severe or itchy skin rash, especially if this shows blistering and there is
soreness of the eyes, mouth or genital organs.
If you experience any of the following side effects contact your doctor as soon as possible
Diarrhea that is serious, lasts a longtime e or has blood in it, with stomach pain or fever. This can be a
sign of a serious bowel inflammation. This is something that can rarely happen after taking antibiotics,
Yellowing of
the skin or whites of the eyes caused by liver problems, Inflammation of the pancreas, which
causes severe pain in the abdomen and back, your tongue changes colour, liver failure, severe allergic
skin reaction, joint pain (arthralgia), kidney failure, inflammation within the kidneys.

The following side eﬀects have been reported in prophylactic treatment against Mycobacterium Avium complex
(MAC):
Very common (may aﬀect more than 1 in 10 people)
diarrhea, abdominal pain, feeling sick (nausea), loose wind (ﬂatulence), abdominal discomfort, loose stools

Common (may aﬀect up to 1 in 10 people):
lack of appetite (anorexia), feeling dizzy, headache, sensation of pins and needles or numbness (paraesthesia),
changes in your sense of taste, visual impairment, deafness, being sick (vomiting), stomach pain or cramps, loss
of appetite, problems digesting your food, skin rashes and itching, joint
pain (arthralgia), fatigue

Uncommon (may aﬀect up to 1 in 100 people):
reduced sense of touch (hypoaesthesia), hearing loss or ringing in your ears, palpitations,liver problems such
as hepatitis, severe form of skin ﬂushing, allergic skin reactions such as being sensitive to sunlight, red,
ﬂaking and swollen skin, general feeling of being unwell (malaise), weakness (asthenia) Reporting of side eﬀects
If you get any side eﬀects, talk to your doctor or pharmacist. This includes any possible side eﬀects not listed
in this leaﬂet.

5. How to store Mac Zmax
Store below 30°C.
Protect from light and moisture.
Keep the medicines out of reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the
last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help protect the environment.

6. Contents of the pack and other informa
What Mac Zmax contains

– The active substance is azithromycin dihydrate.
Each film-coated tablet contains 500 mg of azithromycin dihydrate.

Presentation :

3 tablets in a pack