AZITHROMYCIN 500 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Patient leaflet - AZITHROMYCIN 500 MG FILM-COATED TABLETS

if you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects not listed in this leaflet.

What is in this leaflet

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

1. what azithromycin tablets is and what it is used for

The full name of your medicine is Azithromycin 250mg Film-coated tablets or Azithromycin 500mg Film-coated tablets, but within the leaflet it will be referred to as Azithromycin Tablets.

Azithromycin Tablets is an antibiotic. It belongs to a group of antibiotics called “macrolides”.

Azithromycin Tablets is used to treat bacterial infections caused by “micro-organisms” such as bacteria. These infections include:

chest infections such as acute exacerbation of chronic bronchitis (adequately diagnosed) and pneumonia;
infections in your sinus, throat, tonsil or ears;
mild to moderate skin and soft tissue infections e.g. infection of the hair follicles (folliculitis), bacterial infection of the skin and its deeper layers (cellulitis), skin infection with shiny red swelling (erysipelas);
infections caused by a bacteria called “Chlamydia trachomatis”. They can cause inflammation of the tube that carries urine from your bladder (urethra) or where your womb joins your vagina (cervix).

2. what you need to know before you use azithromycin tablets you are allergic (hypersensitive) to azithromycin, erythromycin or any of the other ingredients in this medicine (listed in section 6);

you are allergic (hypersensitive) to any macrolide or ketolide antibiotic.

DO NOT take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Azithromycin Tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking Azithromycin Tablets if:

you have liver problems – your doctor may need to monitor your liver function or STOP the treatment;
you have severe 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 have nervous (neurological) or mental health (psychiatric) problems.

STOP taking Azithromycin Tablets and see a doctor STRAIGHT AWAY if you notice any of the following serious side effects while taking this medicine:

swelling of your face, lips, tongue or throat, difficulty breathing or swallowing, rash which may

range from itchy skin rash to serious blistering of the skin or ulcers on your lips, eyes, nose, mouth and genitals. These could be signs of a severe allergic reaction, angioedema or anaphylaxis;

severe diarrhoea that lasts a long time or has blood and mucous in it. These could be signs of a serious gut (intestine) problem called “pseudomembranous colitis”.

Other medicines and Azithromycin Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tell your doctor or pharmacist if you are taking any of the following medicines:

antacids – used for heartburn and indigestion. Azithromycin Tablets should be taken at least 1 hour before or 2 hours after the 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);
warfarin or similar medicines – used to thin the blood. Azithromycin Tablets 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 electro-cardiogram or ECG machine);
zidovudine or nelfinavir – used to treat HIV infections. Taking nelfinavir with Azithromycin Tablets 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
Hydroxychloroquine or chloroquine (used to treat conditions including rheumatoid arthritis, or to treat or prevent malaria): Taking these medicines at the same time as azithromycin may increase the chance of you getting side effects that affect your heart.
Tell your doctor or pharmacist if you are taking any of the following medicines. Azithromycin Tablets can make the effects of these other medicines stronger. Your doctor may change your dose: triazolam, midazolam (sedatives)
alfentanil – a painkiller used e.g. during operations
theophylline – used for breathing problems such as asthma and chronic obstructive pulmonary disease (COPD)
digoxin – used to treat heart problems
colchicine (used for gout and familial Mediterranean fever)
astemizole – used to treat hay fever
pimozide – used to treat mental health problems.

Azithromycin Tablets with food and drink

This medicine can be taken with or without food.

Pregnancy and breast-feeding

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.

Azithromycin Tablets is NOT recommended if you are pregnant or planning to become pregnant or if you are breast-feeding. Azithromycin Tablets should only be used during pregnancy when clearly necessary.

This medicine goes into human milk. So, you should STOP breast-feeding until 2 days after you have finished taking this medicine. You may discuss with your doctor to pump and discard milk during this time or alternatively to use another antibiotic.

Driving and using machines

If your medicine makes you feel dizzy or you have other side effects that reduce your ability to concentrate, DO NOT drive or operate machinery.

Azithromycin Tablets contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. how to take azithromycin tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

Swallow the tablets whole with a glass of water.
DO NOT crush or chew the tablets.
The 500 mg tablet can be divided into equal doses.

How much to take

Adults and young people with a body weight of 45 kg and above:

The usual total dose is 1,500 mg. This can be taken in two ways. Your doctor will tell you which way to take it:

Over three days: one 500 mg tablet each day or
Over five days: one 500 mg tablet on day 1 and then one 250 mg tablet on days 2, 3, 4 and 5.

The dose is different if you have inflammation of the tube that carries urine from your bladder (urethra) or where your womb joins your vagina (cervix). Your doctor will ask you to take a single dose of 1000 mg.

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 such as azithromycin suspension.

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.

If you take more Azithromycin Tablets than you should

If you take more Azithromycin Tablets than you should, talk to a doctor or go to a hospital STRAIGHT AWAY. Take the medicine pack with you. The following effects may happen: temporary loss of hearing;
feeling very sick (severe nausea), being sick (vomiting) and diarrhoea.

If you forget to take Azithromycin Tablets

DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR A FORGOTTEN DOSE.

If you forget a dose, take it as soon as you remember it.
However, if it is nearly time for the next dose, skip the missed dose.
If you have to skip a dose, still take all of your tablets. This means that you will finish your

course a day later.

If you stop taking Azithromycin Tablets

DO NOT stop taking Azithromycin Tablets without talking to your doctor.

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.

STOP taking Azithromycin Tablets and see a doctor STRAIGHT AWAY if you notice any of the following serious side effects - you may need urgent medical treatment:

swelling of your face, lips, tongue, face or throat, difficulty breathing or swallowing, rash which may range from itchy skin rash to serious blistering of the skin or ulcers on your lips, eyes, nose, mouth and genitals. These could be signs of a severe allergic reaction, angioedema or anaphylaxis;
severe diarrhoea that lasts a long time or has blood or mucus in it. These could be signs of a serious gut (intestine) problem called “pseudomembranous colitis”;
fever, red spotted skin, blistering or peeling skin, joint pain, swollen eyes. These could be signs of a serious reaction such as “Steven-Johnson syndrome”, “toxic epidermal necrolysis” or “erythema multiforme”.

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), abdominal pain, feeling sick (nausea)
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) – yeast infections especially of the mouth
infections of the vagina
lung infection (pneumonia)
fungal infection
bacterial infection
inflammed throat (pharyngitis)
inflammation of the stomach and intestines (gastroenteritis)
runny nose, sneezing (rhinitis)
reduction in the number of white blood cells
hypersensitivity
anorexia
nervousness
having difficulty sleeping (insomnia)
feeling dizzy
feeling drowsy (somnolence)
sensation of pins and needles or numbness (paraesthesia)
changes in your sense of taste and smell (dysgeusia)
visual impairment
ear disorder
palpitations
hot flush
shortness of breath
nosebleeds
gastritits
constipation
loose wind (flatulence)
problems with digesting your food (dyspepsia)
difficulty swallowing (dysphagia)
abdominal distension
dry mouth
belching (eructation)
excess production of saliva
liver problems such as hepatitis or jaundice
urticaria
skin inflammation
dry skin
increased sweating
swelling, creaking and stiffness of one or more joints
muscle pain
back pain
neck pain
pain when passing urine
pain in kidneys
mild menstrual bleeding at irregual intervals
testicular pain and swelling
swelling (oedema)
malaise
weakness
fatigue
chest pain
pain
skin swelling
change in liver enzyme levels and blood levels
abnormal kidney function test results, abnormal blood potassium, abnormal sugar levels in blood
post-procedural complication

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

feeling agitated
abnormal hepatic function
jaundice cholestatic
allergic skin reactions
being sensitive to sunlight
skin eruption that is characterised 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)

reduced number of red blood cells due to destruction (haemolytic anaemia); reduction in number of platelets (thrombocytopenia)
anaphylactic reaction
feeling angry, aggressive
anxiety
delirium
seeing, feeling or hearing things that are not there (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 myasthenia gravis
hearing loss or ringing in your ears
rapid or irregular heart beat, sometimes being life-threatening, changes of the heart rhythm

found by an electro-cardiogram

low blood pressure
inflammation of the pancreas (pancreatitis)
your tongue changes colour
inflammation of the liver
allergic skin reactions
joint pain
kidney problems
disturbances in heart rhythm called QT prolongation.

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)

diarrhoea
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
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 any of the side effects gets serious, or if you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Your doctor may then decide to reduce your dose or stop treatment.

You can also report side effects directly via the Yellow Card Scheme Website:

or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store azithromycin tablets

KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.

This medicinal product does not require any special storage conditions.

DO NOT use this medicine after the expiry date which is stated on the packaging 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 to protect the environment.

6. contents of the pack and other informationthe active substance is azithromycin (as dihydrate).

The other ingredients are:

Tablet core: calcium hydrogen phosphate anhydrous, hypromellose (E464), croscarmellose sodium, magnesium stearate (E470b), pregelatinised maize starch, sodium laurilsulfate.
Tablet coat: hypromellose (E464), lactose monohydrate, titanium dioxide (E171), triacetin.

What Azithromycin Tablets looks like and contents of the pack

Azithromycin 250 mg Film-coated tablets are white to off-white, capsule shaped, film-coated tablets debossed with “AZ” and “250” on one side and plain on other side of the tablets. The film-coated tablets are available in blister packages of 4 or 6 tablets.

Azithromycin 500 mg Film-coated tablets are white to off-white, capsule shaped, film-coated tablets, debossed with “AZ” and “500” on either side of score line on one side and plain on other side of the tablets. The film-coated tablets are available in blister packages of 3 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Crescent Pharma Limited,

Units 3 & 4, Quidhampton Business Units,

Polhampton Lane, Overton,

Hampshire RG25 3ED

United Kingdom

Manufacturer:

PharmaS d.o.o.

Industrijska cesta 5

Potok

Popovaca, 44317

Croatia

This leaflet was last revised in 01/2022