Skip to Content

AZITHROMYCIN 250MG TABLETS

Active substance(s): AZITHROMYCIN MONOHYDRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

SZ00000LT000

Azithromycin 250 mg Tablets

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

1

What Azithromycin is and what it is
used for

Azithromycin is an antibiotic. It belongs to a group of
antibiotics called macrolides. It is used to treat
infections caused by bacteria.



This medicine is usually prescribed to treat:
• chest infections such as chronic bronchitis,
pneumonia.
• infections of the tonsils, throat (pharyngitis) and
sinuses.
• ear infections (acute otitis media).
• skin and soft tissue infections, with exception of
infected burn wounds.
• urethra and cervix infections caused by Chlamydia.

2

What you need to know before you
take Azithromycin





(used in some mental diseases), citalopram (used
in depression), fluoroquinolones (antibiotics such
as moxifloxacin and levofloxacin, used in bacterial
infections): concomitant use with azithromycin may
cause heart disorders, therefore is not recommended.
Certain medicines for irregular heart beat
(called anti-arrythmics, such as quinidine,
amiodarone, sotalol). Concomitant use is not
recommended.
Nelfinavir (used to treat HIV infections):
concomitant use may increase the risk of side
effects.
Rifabutin (used to treat tuberculosis): Your doctor
may check your blood and blood levels of the
medicines.
Statins (such as atorvastatin, used to lower lipids
in blood): concomitant use may cause muscle
disorders.

Azithromycin with food and drink
The tablets may 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 or
any other medicine.

Do not take Azithromycin if you are allergic
(hypersensitive) to:
• azithromycin.
• erythromycin.
• other macrolide or ketolide antibiotic.
• any of the other ingredients of this medicine (listed
in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking
Azithromycin if you have:
• Liver problems: your doctor may need to monitor
your liver function or stop the treatment.
• Kidney problems: if you have severe kidney
problems, the dose may have to be adjusted.
• Nervous (neurological) or mental (psychiatric)
problems.
• Heart problems such as a
- weak heart (heart failure),
- very slow heart rate,
- irregular heart beat, or
- a condition called “long QT syndrome” (found by
an electrocardiogram) since azithromycin may
increase the risk of abnormal heart rhythm.
• Low potassium or magnesium levels in your blood.
• Myasthenia gravis, a certain type of muscle weakness.
Other medicines and Azithromycin
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
This includes any medicines obtained without a
prescription.

You should not use this medicine during pregnancy
and when you are breast-feeding unless your doctor
has specifically recommended it.

This medicine is excreted into human breast milk.
So, you should stop breast-feeding until 2 days after
you have finished taking this medicine.
Driving and using machines
Azithromycin is unlikely to impair the ability to drive
and operate machinery.

However, if side effects like dizziness, sleepiness or
convulsions occur, be careful when driving or
operating machinery.

Azithromycin contains lactose.
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicinal product.

3

How to take Azithromycin

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

It is especially important to mention that you take:
• Blood-thinning medicines, such as warfarin,
phenprocoumon: concomitant use may increase
the risk of bleeding. Your doctor may need to
monitor more often the blood clotting parameters
when Azithromycin is also being used.
• Ergotamine, dihydroergotamine (used to treat
migraine): ergotism (i.e. itching in the limbs,
muscle cramps and gangrene of hands and feet
due to poor blood circulation) may occur.
Concomitant use is therefore not recommended.
• Cyclosporin (used to suppress the immune
system to prevent and treat rejection of an organ
or bone marrow transplant): if concomitant use is
required, your doctor will check cyclosporine levels
in your blood and may adapt the dose.
• Digoxin (used for heart failure): concomitant use
may increase digoxin levels. Your doctor will check
its levels in your blood.
• Antacids (used for indigestion): may make
azithromycin less effective when used
concomitantly see section 3.
• Cisapride (used for stomach problems),
terfenadine (used to treat hay fever), pimozide

The recommended dose is:
Adults and children weighing more than 45 kg:
Azithromycin is taken as a 3 day course.

Azithromycin 250 mg
• 3 day course: Take 2 tablets once each day.

For urethra and cervix infections caused by
Chlamydia, it is taken as a 1 day course:
• 1 single dose of 4 tablets (1,000 mg azithromycin).

Use in children
Children weighing less than 45 kg should not take
these tablets. Azithromycin in other pharmaceutical
forms, e.g. oral suspensions, are preferred for these
patients.

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.

Continued on the next page >>

00000000

draft: 44032699
laetus code: 0000
mat.no.: 00000000

Artwork Proof Box
Ref: V015 - Update SPC & PIL in line with CSP
Proof no.
007.0

Date prepared:
27/06/2013

Colours:
Black
Dimensions: 165 x 420 mm

Font size:
8.5 pt
Fonts:
Helvetica

Dosage for elderly
For elderly the same dosage as for adults applies.

• Pounding heart beat
• Feeling of intense heat with sweating and rapid
heartbeat (hot flush)
• Difficulty breathing, nose bleeds
• Constipation, wind, indigestion, inflammation of
the stomach, difficulty in swallowing, bloating, dry
mouth, eructation, mouth sores, increased
formation of saliva
• Skin rash, itching, hives, skin inflammation, dry
skin, sweating
• Bones and joint inflammation, muscle, back and
neck pains
• Difficulty and pain when passing urine, kidney pain
• Uterine bleeding, testis disorder
• Skin swelling, weakness, generally feeling unwell,
tiredness, swelling of the face, chest pain, fever,
pain, swelling of extremities
• Abnormal laboratory test values (e.g. blood, liver
and kidney function test results).
• post procedural complications

Method of administration
Swallow these tablets whole once daily with a drink of
water. You can take the tablets with or without food.
Taking Azithromycin with medicines for indigestion
If you need to take a medicine for indigestion, such
as an antacid, take Azithromycin at least one hour
before or two hours after the antacid.
If you take more Azithromycin than you should
If you take too many tablets you may feel unwell or
be sick. You also may experience other side effects
such as deafness and diarrhoea. Tell your doctor or
talk to your nearest hospital casualty department
immediately. If possible, take your tablets or the box
with you to show the doctor what you have taken.
If you forget to take Azithromycin
If you forgot to take a dose, take it as soon as
possible. Then go on as before. Do not take more
than one dose in a single day.

Rare side effects (may affect up to 1 in 1,000 people):
• Agitation
• Abnormal liver function
• Sensitivity to sunlight.

If you stop taking Azithromycin
Always keep taking the tablets until the course is
finished, even if you feel better. If you stop taking the
tablets too soon, the infection may come back. Also,
the bacteria may become resistant to the medicine
and will then be more difficult to treat.

Not known (frequency cannot be estimated from
the available data):
• Low level of red blood cells which can make the
skin pale yellow and cause weakness or
breathlessness
• Reduction in blood platelets, which increases risk
of bleeding or bruising
• Severe allergic reaction
• Aggression, anxiety, severe confusion,
hallucination
• Fainting, fits, decreased skin sensitivity, feeling
hyperactive, disturbed sense of smell, loss of
sense of smell or taste, muscle weakness
(myasthenia)
• Poor hearing, deafness or ringing in the ears
• Arrhythmia, abnormal electrocardiogram (ECG)
• Low blood pressure
• Tongue discoloration
• Hepatic failure, serious liver inflammation
• Joint pain
• Renal failure, renal inflammation.

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.
Serious side effects:

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.

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. You can also report side
effects directly via the Yellow Card Scheme
(www.mhra.gov.uk/yellowcard). By reporting side
effects you can help provide more information on the
safety of this medicine.

5

If you experience any of the following side effects,
contact your doctor as soon as possible:
• Diarrhoea that is serious, lasts a long time or has
blood in it, with stomach pain or fever. This can be
a sign of a serious bowel inflammation, 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
• Increased or reduced urine output, or traces of
blood in your urine
• Skin rash caused by sensitivity to sunlight
• Unusual bruising or bleeding
• Irregular heart beat.

How to store Azithromycin

Keep this medicine out of the sight and reach of
children.

Do not use this medicine after the expiry date which
is stated on the carton and the blister pack. The
expiry date refers to the last day of that month.
Do not store above 25°C.

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), rare
(may affect up to 1 in 1,000 people), or the frequency
cannot be estimated from the available data.
Other possible side effects:

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
information

What Azithromycin contains
• The active substance is azithromycin.
Each film-coated tablet contains 250 mg
azithromycin (as azithromycin monohydrate).
• The other ingredients are: microcristalline
cellulose, maize starch, sodium starch glycollate,
silicium dioxide, magnesium stearate, sodium
laurylsulphate, lactose monohydrate,
hypromellose, macrogol 4000, titanium dioxide.

Very common side effects (may affect more than 1
in 10 people):
• Diarrhoea.

Common side effects (may affect up to 1 in 10
people):
• Headache
• Nausea, vomiting, abdominal pain
• Loss of appetite, taste disturbance
• Changes in number of white blood cells (low
numbers of lymphocytes, higher number of
eosinophils, higher number of basophils,
monocytes and neutrophils
• Decreased blood bicarbonate (what indicates too
much acidic substances in blood).

What Azithromycin looks like and contents of the
pack
White, oblong film-coated tablets with a breaking
notch on both sides and embossed: “A 250”.

Packs with 2, 3, 4, 6, 9, 12 and 24 film-coated
tablets. Not all pack sizes may be marketed.

Uncommon side effects (may affect up to 1 in 100
people):
• Yeast and bacterial infections especially of the mouth,
throat, nose, lung, stomach, bowel and vagina
• Changes in number of white blood cells (low
numbers of leukocytes, low number of neutrophils,
higher number of eosinophils)
• Swelling, allergic reactions of various severity
• Loss of apetite (anorexia)
• Nervousness, insomnia, drowsiness, sleeplessness,
dizziness, taste disturbance, tingling or numbness
of the hands and/or feet
• Visual disturbances
• Impaired hearing, spinning sensation (vertigo)

Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder:
Sandoz Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer:
Salutas Pharma GmbH, Otto-von-Geuricke-Allee 1,
39179 Barleben, Germany.
This leaflet was last revised in 12/2013.

draft: 44032699
laetus code: 0000
mat.no.: 00000000

Artwork Proof Box
Ref: V015 - Update SPC & PIL in line with CSP
Proof no.
007.0

Date prepared:
27/06/2013

Colours:
Black
Dimensions: 165 x 420 mm

Font size:
8.5 pt
Fonts:
Helvetica

00000000
SZ00000LT000

Expand view ⇕

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.

Hide