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AZITHROMYCIN 200MG/5ML POWDER FOR SUSPENSION

Active substance(s): AZITHROMYCIN DIHYDRATE

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cimetidine (an antacid); methylprednisolone (to
suppress the immune system); midazolam,
triazolam (sedatives); sildenafil (for impotence),
theophylline (for asthma) and
PACKAGE LEAFLET: INFORMATION FOR THE USER trimethoprim/sulphamethoxazole (an antibiotic
combination).
Read all of this leaflet carefully before you start
AZITHROMYCIN with food and drink:
using this medicine because it contains
Oral suspension can be taken with or without
important information for you.
food and drink.
• Keep this leaflet. You may need to read it
again.
Pregnancy, breast-feeding and fertility
• If you have any further questions, ask your
If you are pregnant or breast-feeding, think you
doctor or pharmacist.
may be pregnant or are planning to have a
• This medicine has been prescribed for you
baby, ask your doctor for advice before taking
only. Do not pass it on to others. It may
this medicine.
harm them, even if their signs of illness are
There is insufficient information regarding the
the same as yours.
safety of azithromycin during pregnancy and
• If you get any side effects, talk to your doctor.
breast-feeding. Consequently, Azithromycin is
This includes any possible side effects not
not recommended if you are pregnant or
listed in this leaflet. See section 4.
planning to become pregnant or breast-feeding.
However, your doctor may prescribe it under
WHAT IS IN THIS LEAFLET:
serious circumstances.
1. What Azithromycin is and what it is used for
Driving and using machines
2. What you need to know before you use
Azithromycin is not expected to affect your
Azithromycin
ability to drive or use machines.
3. How to use Azithromycin
4. Possible side effects
Azithromycin powder for oral suspension
5. How to store Azithromycin
contains 3.75 g of sucrose per 5 ml.
6. Contents of the pack and other information
If you have been told by your doctor that you
WHAT AZITHROMYCIN IS AND WHAT IT have an intolerance to some sugars, contact
your doctor before taking this medicine.
IS USED FOR
The sucrose content should be taken into
Azithromycin is one of a group of antibiotics
account in patients with diabetes mellitus.
called macrolides. It is used to treat bacterial
infections caused by microorganisms such as
HOW TO USE AZITHROMYCIN
bacteria. These infections include:
Always
use Azithromycin exactly as your doctor
• Chest infections such as acute bronchitis and
has told you. You should check with your doctor
pneumonia
or pharmacist if you are not sure.
• Infections in your sinuses, throat, tonsils or
ears
Preparation of the suspension
• Mild to moderate skin and soft tissue
By the pharmacist: your pharmacist should
infections, e.g. infection of the hair follicles
prepare the suspension. If you notice that this
(folliculitis), bacterial infection of the skin
was not done, then you should go back to the
and its deeper layers (cellulitis), skin
infection with shiny red swelling (erysipelas) pharmacy to have the suspension prepared.
By yourself: follow the instructions in the blue
• Infections caused by a bacterium called
box of this leaflet. See blue box information.
Chlamydia trachomatis. They can cause
inflammations of the tube that carries urine
Dosage
from your bladder (urethra) or where your
Azithromycin suspension should be
womb joins your vagina (cervix).
administered in one single daily dose, with or
without food.
WHAT YOU NEED TO KNOW BEFORE
Shake the bottle well before you use the
YOU USE AZITHROMYCIN
suspension.
Do NOT use Azithromycin:
The usual dose is:
• If you are allergic (hypersensitive) to
Use in children and adolescents with a
azithromycin or any other macrolide or
body weight above 45 kg, adults and older
ketolide antibiotic, e.g. erythromycin or
people
telithromycin or any of the other ingredients The total dose of azithromycin is 37.5 ml
of this medicine (listed in section 6).
(1500 mg) over 3 days (12.5 ml (500 mg) once
daily). As an alternative, the dose can be
Warnings and precautions:
Talk to your doctor before taking azithromycin if distributed over 5 days (12.5 ml (500 mg) as
one single dose on the first day and then
you:
6.25 ml (250 mg) once daily).
• have ever had a serious allergic reaction
causing swelling of the face and throat,
The dose for inflammation of the urethra or
possibly with breathing problems
cervix caused by Chlamydia is 25 ml (1000 mg)
• have severe kidney problems: your doctor
in one single dose.
may alter the dose
For sinusitis, treatment is aimed at adults and
• have liver problems: your doctor may need
adolescents over 16 years of age.
to monitor your liver function or stop the
Use in children and adolescents with a
treatment
body weight under 45 kg
• are aware of ever being diagnosed to have
The azithromycin suspension should be
prolonged QT interval (a heart condition):
measured as carefully as possible with the
azithromycin is not recommended
accompanying dosing syringe for children with
• are aware that you have a slow or irregular
a weight of 10 to 15 kg. For children who weigh
heart beat, or reduced heart function:
more than 15 kg, the azithromycin suspension
azithromycin is not recommended
• know that you have low levels of potassium should be administered with the help of the
or magnesium in your blood: azithromycin is dosing spoon according to the following plan:
not recommended
Weight 3-day course
5-day course
• are taking medicines known as
antiarrhythmics (used to treat abnormal
0.25 ml/kg
10-15 kg 0.25 ml/kg
heart rhythms), cisapride (used to treat
(10 mg/kg) once
(10 mg/kg)
stomach problems) or terfenadine (an
once daily on on day 1,
antihistamine that is used to treat allergies):
followed by
days 1 to 3
azithromycin is not recommended
0.125 ml (5 mg/kg)
• are taking medicines known as ergot
once daily on
alkaloids (such as ergotamine), which are
days 2 to 5
used to treat migraine: azithromycin is not
recommended (see ‘Other medicines and
16-25 kg 5 ml (200 mg) 5 ml (200 mg)
Azithromycin’ below)
once daily on once on day 1,
• have been diagnosed with a neurological
days 1 to 3
followed by
disease, which is a disease of the brain or
2.5 ml (100 mg)
nervous system
• have mental, emotional or behavioural
once daily on
problems
days 2 to 5
• have a condition known as myasthenia
gravis, with fatigue and exhaustion of the
26-35 kg 7.5 ml (300 mg) 7.5 ml (300 mg)
muscles: azithromycin may worsen or cause
once daily on once on day 1,
symptoms of myasthenia.
followed by
days 1 to 3
3.75 ml (150 mg)
If you develop severe and persistent diarrhoea
once daily on
during or after treatment, especially if you
notice blood or mucus, tell your doctor
days 2 to 5
immediately.
35-45 kg 10 ml (400 mg) 10 ml (400 mg)
If your symptoms persist after the end of your
once daily on once on day 1,
treatment with Azithromycin, or if you notice
days 1 to 3
followed by
any new and persistent symptoms, contact
5 ml (200 mg)
your doctor.
once daily on
Azithromycin is not recommended for patients
days 2 to 5
under 6 months of age.
>45 kg
Dose as with
Other medicines and azithromycin
adults
Tell your doctor if you are taking, have recently
taken or might take any of the following
For the treatment of tonsillitis/pharyngitis in
medicines:
children aged 2 years or more: Azithromycin in
• Antacids e.g. aluminium hydroxide: take
a single dose of 10 mg/kg or 20 mg/kg for three
Azithromycin at least 1 hour before or 2
days, in which the maximum daily dose of 500
hours after taking an antacid
mg should not be exceeded.
• Ergot derivatives, e.g. ergotamine (used to
treat migraine): Azithromycin should not be Sinusistis
taken at the same time as ergotism may
For the treatment of sinusitis, limited data is
develop (a potentially serious side effect
available for the treament of children under 16
with numbness or tingling sensations in the years of age.
limbs, muscle cramps, headaches,
Patients with kidney or liver problems:
convulsions, abdominal or chest pain)
You should tell your doctor if you have kidney
• Coumarin type oral anticoagulants, e.g.
warfarin (used to stop the blood clotting): the or liver problems as your doctor may need to
alter the normal dose.
risk of bleeding may be increased
• Digoxin (used to treat heart failure): the
A. Instructions for the syringe
levels of digoxin in your blood may increase Filling the syringe with medicine
• Zidovudine, nelfinavir (used in the treatment 1. Shake the bottle before use and remove the
of HIV): the levels of zidovudine or
child-proof cap.
azithromycin might be increased
2. While the bottle is sitting on a firm, flat
• Rifabutin (used in the treatment of HIV and
surface, hold it steady with one hand. With
bacterial infections including tuberculosis):
the other hand insert the tip of the syringe
decreases in your number of white blood
into the suspension.
cells could occur
3. Slowly pull back the plunger of the syringe
• Cyclosporin (an immunosuppressant used
so that the top edge of the black ring is level
following organ transplant): cyclosporin
with the graduation line indicated on the
levels may be elevated. Your doctor will need
syringe.
to monitor your cyclosporin blood levels
4. If large bubbles can be seen in the syringe,
• Cisapride (used to treat stomach problems):
slowly push the plunger back into the
heart problems may occur
syringe. This will force the medicine back
• Astemizole, terfenadine (antihistamines used
into the bottle. Repeat step 3 again.
to treat allergic reactions): their effect might 5. Remove syringe from bottle.
be increased
Giving the medicine using the syringe
• Alfentanil (a painkiller): the effect of
1. Make sure the child is supported in an
alfentanil might be increased
upright position.
• Fluconazole (for fungal infections): the levels
2. Put the tip of the syringe carefully into the
of azithromycin might be reduced.
child’s mouth. Point the tip of the syringe
No interactions have been observed between
towards the inside of the cheek.
azithromycin and cetirizine (an antihistamine);
3. Slowly push down the plunger of the
didanosine, efavirenz, indinavir (for HIV
syringe: Do not squirt it out quickly. The
infection); atorvastatin (for cholesterol and
medicine will trickle into the child's mouth.
heart problems); carbamazepine (for epilepsy);

1

3

BLACK

PANTONE® GREEN C

S4 (PANTONE® 151 C)2

PANTONE® PROCESS BLUE C

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

AZITHROMYCIN 200 mg/5 ml
POWDER FOR ORAL SUSPENSION
Azithromycin

2

Ref:

231-30-88303-D LEA AZITHROMYCIN 200mg/5ml SUSP 15ml TUK
203346
Child:
228642

2 October 2013

88303-D

Trackwise Parent:

PL 00289/0973

2

Preparation of the suspension
Your pharmacist should prepare the
suspension. If you notice that this has not
been done, then you should go back to the
pharmacy to have the suspension prepared.

Version:

Blue Box

PL 00289/0973. Teva UK Limited Licence, Teva Regulatory Team.
Packed at Pliva Croatia, Zagreb.
V1: Safety warning text update. V2: Addition of text in Section 4 after RFI from the MHRA.

This leaflet was last revised: September 2013

PL Number(s),
MA Holder & Packer:
Reason for revision:

Marketing Authorisation Holder and
Manufacturer
TEVA UK Limited, Eastbourne, BN22 9AG.

BLACK

Not all pack sizes may be marketed.

PANTONE® GREEN C

A dosing syringe and/or dosing spoon are
provided with the bottles.

Dimensions:

What Azithromycin contains
• The active ingredient is azithromycin. One
millilitre contains azithromycin dihydrate
equivalent to 40 mg azithromycin after
reconstitution with water (equivalent to
200 mg azithromycin per 5 ml).
• The other ingredients are silica, colloidal
anhydrous (E551), sucrose, xanthan gum
(E415), trisodium phosphate anhydrous,
hydroxypropyl cellulose, cherry flavouring
trusil, vanilla flavour, banana flavour.
What Azithromycin looks like and contents of
the pack
• The powder for the preparation of the
suspension is a white to yellowish-white
powder. The prepared suspension is a
yellowish-white suspension.
• The powder for oral suspension is packed in
bottles with 600, 900, 1200 or 1500 mg
azithromycin, which provide suspension of
600 mg/15 ml, 900 mg/22.5 ml, 1200 mg/
30 ml and 1500 mg/37.5 ml after
reconstitution with water.
Pack sizes
Azithromycin 600 mg/15 ml: 12.555 g of powder
for the preparation of 15 ml suspension
Azithromycin 900 mg/20 ml: 18.8325 g of
powder for the preparation of 22.5 ml
suspension
Azithromycin 1200 mg/30 ml: 25.110 g of
powder for the preparation of 30 ml suspension
Azithromycin 1500 mg/37.5 ml: 31.3875 g of
powder for the preparation of 37.5 ml
suspension.

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

CONTENTS OF THE PACK AND OTHER
INFORMATION

500 mm
155 mm

6

L:
W:

HOW TO STORE AZITHROMYCIN

S4 (PANTONE® 151 C)

5

Keep this medicine out of the sight and reach
of children.
Powder: Store below 25°C.
Do not use Azithromycin after the expiry date
that is stated on the carton and bottle.
After reconstitution store at a temperature
below 25°C and use within 5 days (azithromycin
suspension 15 ml and 22.5 ml) or within 10 days
(azithromycin suspension 30 ml and 37.5 ml).
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.

PANTONE® PROCESS BLUE C

Like all medicines, Azithromycin can cause side
effects, although not everybody gets them.
If the following happens, stop taking
Azithromycin and tell your doctor immediately
or go to the casualty department at your
nearest hospital:
• An allergic reaction (swelling of the lips, face
or neck leading to severe difficulty in
breathing; skin rash or hives)
• Blisters/bleeding of the lips, eyes, nose,
mouth and genitals, which may be caused by
Stevens-Johnson syndrome or toxic
epidermal necrosis, which are serious
illnesses
• An irregular heart beat
• Prolonged diarrhoea with blood and mucus.
These are very serious but rare side effects. You
may need urgent medical attention or
hospitalisation.
The following other side effects have been
reported:
Very common (may affect more than 1 in 10
people):
• Diarrhoea.
Common (may affect up to 1 in 10 people):
• Changes in the numbers of some white
blood cells and blood bicarbonate
• Headache
• Vomiting, stomach pain, feeling sick.
Uncommon (may affect up to 1 in 100 people):
• Yeast infection e.g. of the mouth (thrush),
vaginal infection, pneumonia, bacterial
infection
• Sore throat, inflammation of the lining of the
stomach and the bowel, stuffy nose
• Blood disorders characterised by fever or
chills, sore throat, ulcers in your mouth or
throat
• Allergic reactions
• Nervousness, difficulty sleeping
• Dizziness, sleepiness, taste disorders, pins
and needles or numbness
• Sight disorders
• Ear disorders
• Vertigo (spinning sensation)
• Abnormality of the rhythm or rate and
awareness of the heart beat (palpitations)
• Hot flush
• Difficulty breathing
• Nose bleed
• Inflammation of the stomach, constipation,
wind, indigestion, difficulty swallowing
• Feeling bloated, dry mouth
• Belching, ulcers in the mouth, increased
salivation, loose stools
• Hepatitis (inflammation of the liver)
• Rash, itching, hives (nettle rash)
• Skin inflammation, dry skin, increased
sweating
• Inflammation of the joint, muscle pain, back
pain, neck pain
• Painful and difficult urination
• Inflammation of the vagina, irregular
menstrual bleeding, testicle disorders
• Chest pain, swelling, feeling unwell,
lethargy, tiredness
• Swelling of the face, fever, pain
• Changes in liver enzymes and laboratory
blood values.
Rare (may affect up to 1 in 1000 people):
• Agitation
• A feeling of things being unreal
• Teeth discolouration
• Abnormal liver function, jaundice (yellowish
pigmentation of the skin)
• Reddening and blistering of the skin when
exposed to sunlight.

231-10-05599
N/A
Added by 3rd Party
N/A
TBC
Univers
8.3 Pt

POSSIBLE SIDE EFFECTS

F. P. Code:
EAN Code:
Pharma Code:
Edge Code:
Third party code:
Fonts:
Base Font Size:

4

Not known (frequency cannot be estimated
from the available data):
• Blood disorders characterised by unusual
bleeding or unexplained bruising, low blood
count causing unusual tiredness or
weakness
• Aggression, anxiety, confusion, seeing or
hearing things not really there
• Fainting, fits, loss of sensation, hyperactivity,
alteration or loss of the sense of smell, loss
of the sense of taste, myasthenia gravis
(fatigue and exhaustion of the muscle, see
‘Warnings and precautions’ above)
• Hearing disturbances including deafness
and/or ringing in the ears
• Change in heart rate
• Low blood pressure (which may be
associated with weakness, light headedness
and fainting)
• Discolouration of the tongue, inflammation
of the pancreas causing nausea, vomiting,
abdominal pain, back pain
• Liver failure (rarely life-threatening)
• Rash with spots and blisters
• Joint pain
• Kidney problems.
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 to1 in 10 people):
• Lack of appetite (anorexia)
• Feeling dizzy (dizziness)
• Headache
• Sensations of pins and needles or numbness
(paraesthesia)
• Changes in your sense of taste (dysgeusia)
• Visual impairment
• Deafness
• Skin rashes
• Itching (pruritus)
• Joint pain (arthralgia)
• Fatigue.
Uncommon (may affect up to 1 in 100 people):
• Reduced sense of touch (hypoesthesia)
• Hearing loss or ringing in your ears
• Abnormality of the rhythm or rate and
awareness of the heart beat (palpitations)
• Liver problems such as hepatitis
• Blisters/bleeding of the lips, eyes, nose,
mouth and genitals, which may be caused by
Stevens-Johnson syndrome
• Allergic skin reactions such as being
sensitive to sunlight, red, flaking and
swollen skin
• Weakness (asthenia)
• General feeling of being unwell (malaise).
Reporting of side effects
If you get 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 at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this
medicine.

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

4. Allow the child time to swallow the
medicine.
5. Replace the child-proof cap on the bottle.
Wash the syringe as instructed below.
6. Where daily doses of less than 5 ml have
been given for three days, some suspension
will remain in the bottle. This remaining
suspension should be discarded.
Cleaning and storing the syringe
Pull the plunger out of the syringe and wash
both parts by holding under warm running
water or by immersing in sterilising solution
used for baby’s feeding bottles, etc.
Dry the two parts. Push the plunger back into the
syringe. Keep it in a clean safe place with the
medicine. After you have given the child the final
dose of medicine, wrap the syringe in a sheet of
newspaper and put it in the rubbish bin.
B. Instructions for the spoon
The spoon should not be used for children less
than 3 years of age (less than 15 kg).
Giving the medicine using the plastic spoon
1. A plastic double-ended spoon is provided
with the medicine. Check which end of the
spoon and to which level gives the dose
required. If you are unsure, check with your
doctor or pharmacist. Multi-dosing spoon
delivers doses as follows:
2.5 ml (100mg) Small end brimful
3.75 ml (150mg) Large end
to
graduation
5 ml
(200mg) Large end
brimful
2. Shake the bottle well and then remove the
child-proof cap.
3. Gently pour the medicine into the spoon as
required to give the correct dose.
4. Allow the patient to swallow the medicine
slowly.
5. Wash the spoon under warm, running water.
Dry and store it with the medicine in a safe
place.
WARNING: GIVE THE MEDICINE SLOWLY TO
THE CHILD WHILE HE/SHE IS SUPPORTED IN
AN UPRIGHT POSITION. THIS WILL AVOID THE
RISK OF CHOKING.
If you use more Azithromycin than you should
If you (or someone else) have taken too much
Azithromycin, contact your doctor or
pharmacist immediately. An overdose is likely
to cause reversible hearing loss, severe nausea
(feeling sick), vomiting and diarrhoea.
Please take this leaflet, any remaining medicine
and the container with you to the hospital or
doctor so that they know which medicine was
consumed.
If you forget to use Azithromycin
If you forget to take a dose, take that dose as
soon as you remember, unless it is nearly time
to take the next one. Do not take a double dose
to make up for a forgotten dose.
If you stop taking Azithromycin
Do not stop taking your medicine without talking
to your doctor first even if you feel better. It is
very important that you keep taking Azithromycin
for as long as your doctor has told you to,
otherwise the infection may come back.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

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.

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