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AZITHROMYCIN 250 MG CAPSULES

Active substance(s): AZITHROMYCIN DIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Azithromycin 250 mg Capsules
(azithromycin dihydrate)
Read all of this leaflet carefully before you start using 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.
What is in this leaflet:
1. WhatAzithromycin is and what it is used for
2. What you need to know before you useAzithromycin
3. How to takeAzithromycin
4. Possible side effects
5. How to storeAzithromycin
6. Contents of the pack and other information
1.

WhatAzithromycin is and what it is used for

Azithromycin is an antibiotic. It belongs to a group of antibiotics called `macrolides`.
Azithromycin is used to treat bacterial infections caused by `micro-organisms` such as
bacteria. These infections include:
Chest, throat or nasal infections (such as bronchitis, pneumonia, tonsillitis, sore throat
(pharyngitis) and sinusitis)
ear infections
skin and soft tissue infections (such as an abscess or boil)
sexually transmitted diseases caused by an organism called chlamydia
2.

What you need to know before you useAzithromycin

Do not takeAzithromycin if
you are allergic (hypersensitive) to azithromycin dihydrate, erythromycin or any of
the other ingredients in this medicine (listed in section 6). An allergic reaction may
cause skin rash or wheezing
you are allergic (hypersensitive) to any macrolide or ketolide antibiotic
you are taking any ergot derivatives such as ergotamine (used to treat migraine) as
these medicines should not be taken together withAzithromycin
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 takingAzithromycin.
Warnings and precautions
Talk to your doctor or pharmacist before takingAzithromycin 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 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 andAzithromycin
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 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 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 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.
Azithromycin 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

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pulmonary disease (COPD)
digoxin – used to treat heart problems
astemizole – used to treat hay fever
pimozide – used to treat mental health problems

Azithromycin with food and drink
You should takeAzithromycin either 1 hour before a meal or 2 hours after a meal.
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 is not recommended if you are pregnant or planning to become pregnant or if
you are breast-feeding. Azithromycin 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.
3.

How to takeAzithromycin

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 capsules whole with a glass of water.
How much to take
Adults and young people with a body weight of 45 kg and above:
The usual dose is 500 mg (2 capsules) taken together, once a day, for 3 days.
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 (4 capsules) taken all together on one day only.
Children and adolescents under 45 kg:
The Azithromycin capsules should not be taken by children weighing less than 45 kg.
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.
Always continue with the course even if you feel better. If your infection gets worse or you
do not start to feel better within a few days or a new infection develops, go back and see
your doctor.
If you take moreAzithromycin than you should
If you take more Azithromycin 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 takeAzithromycin
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
Do not take a double dose to make up for a forgotten dose
If you have to skip a dose, still take all of your capsules. This means that you will finish
your course a day later
If you stop takingAzithromycin
Do not stop takingAzithromycin without talking to your doctor.
If you stop taking Azithromycin too soon, the infection may return. Take the capsules for
the full time of treatment, even when you begin to feel better.
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 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 (affects more than 1 user in 10)
diarrhoea
Common (affects 1 to 10 users in 100)
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 (affects 1 to 10 users in 1,000)
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 (affects 1 to 10 users in 10,000)
feeling agitated
abnormal hepatic function
jaundice cholestatic
allergic skin reactions
being sensitive to sunlight
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
low blood pressure
inflammation of the pancreas (pancreatitis)
your tongue changes colour
inflammation of the liver
allergic skin reactions
joint pain
kidney problems
rapid (ventricular tachycardia) or irregular heart beat, sometimes being lifethreatening, changes of the heart rhythm found by an electro-cardiogram (QT
prolongation and torsade de pointes)

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)
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:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this
medicine.
5.

How to storeAzithromycin

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Keep this medicine out of the sight and reach of children.
Store below 25°C. Store in the original package.

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 information

WhatAzithromycin contains
The active substance is azithromycin (as dihydrate).
Azithromycin 250 mg capsules contain azithromycin dihydrate equivalent to 250 mg of
azithromycin.
The other ingredients are:
Cellulose microcrystalline (E460), Pregelatinised starch (maize), Magnesium stearate
(E470b), Sodium laurilsulfate, gelatin, black ink (shellac, propylene glycol, black iron
oxide, potassium hydroxide).
WhatAzithromycin looks like and contents of the pack
Azithromycin 250 mg Capsules consist of a white cap and white body, size “0” hard gelatin
opaque capsuls, imprinted in black ink with “250” on cap and body, containing white to off
white granular powder.
The capsules are available in blister packages of 2, 4 or 6 capsules. Not all pack sizes may
be marketed.
MarketingAuthorisation Holder and Manufacturer
Marketing Authorisation Holder:
Jubilant Pharmaceuticals nv
Axxes Businesspark
Guldensporenpark 22 – Block C
9820 Merelbeke
Belgium
Manufacturer:
PSI supply nv
Axxes Businesspark
Guldensporenpark 22 – Block C
9820 Merelbeke
Belgium
Marketing authorisation number: PL 19156/0138
This leaflet was last revised in 02/2015.

The following side effects have been reported in prophylactic treatment against
MycobacteriumAvium complex (MAC):

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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