Download Azithromycin 200 mg/5 ml powder for oral suspension 1.3.1.3

PIL Azithromycin NL955 Renewal
FRAR
2012-02-13/AR
2012-05-22/AR
Azithromycin
200 mg/5 ml powder for oral suspension
7215008
1.3.1.3 Package Leaflet
NL/H/0955/001/
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AzithromycinAzithromycin 200 mg/5 ml200 mg/5 ml powder for oral
suspensionpowder for oral suspension
Patient Information Leaflet
Package leaflet: Information for the user
Azithromycin 200 mg/5 ml powder for oral suspension
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.
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 bronchitis, pneumonia
infections of the tonsils, throat (pharyngitis) and sinuses
ear infections
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
DO NOT take this medicine
if you are allergic to azithromycin, to any other macrolide or ketolide antibiotics, or to
any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Azithromycin.
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AzithromycinAzithromycin 200 mg/5 ml200 mg/5 ml powder for oral
suspensionpowder for oral suspension
Patient Information Leaflet
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Tell your doctor if you have any of the following illnesses before taking this medicine:
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.
Clostridium difficile associated diarrhoea (CDAD) This condition has been reported
with the use of nearly all antibacterial agents, including azithromycin, and may range in
severity from mild diarrhoea to severe inflammation of the large intestine colitis causing
e.g. abdominal pain, loss of appetite, cramping, fever.
Nervous (neurological) or mental (psychiatric) problems.
Worsening and new onset of myasthenia gravis (muscle disease were muscles become
progressively weaker) has been reported.
Heart problems such as a weak heart (heart failure), very slow heart rate, irregular heart
beat, or something called “long QT syndrome” (found by an electro-cardiogram) since
azithromycin may increase the risk of abnormal heart rhythm.
Electrolyte problems, especially low levels of magnesium or potassium in your blood.
Tell your doctor if you are taking any ergot derivatives such as ergotamine (used to treat
migraine) as these medicines should not be taken together with Azithromycin.
Other medicines and Azithromycin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
It is especially important to mention before taking this medicine:
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Theophylline (used to treat asthma): the effect of theophylline may be increased.
Warfarin or any similar medicine to prevent blood clots: concomitant use can increase
the risk of bleeding.
Ergotamine, dihydroergotamine (used to treat migraine): ergotism (ie. 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.
Ciclosporin (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
your blood levels regularly and may adapt the dose.
Digoxin (for heart failure): digoxin levels may increase. Your doctor will check your
blood levels.
Antacids (for indigestion): see section 3.
Cisapride (for stomach problems), terfenadine (used to treat hay fever): concomitant use
with azithromycin may cause heart disorders.
Medicines for irregular heart beat (called anti-arrythmics).
Nelfinavir (used to treat HIV infections): concomitant use can increase the risk of side
effects.
Alfentanil (used for narcosis) or astemizol (used to treat hay fever): concomitant use
with azithromycin may increase the effect of these medicinal products.
Pregnancy and breast-feeding
Kommentiert [AR1]: The MAH would prefer to leave the
additional warning for ergot derivatives in this section to be in line
with our SmPC (ergotamine derivatives are mentioned in section 4.4
and 4.5) and also to be in line with the originator.
Kommentiert [AR2]: The MAH prefers not to include “Fertility”
in to the heading, because the PIL text does not contain any
information about fertility. According to the QRD template
“Fertility” is an optional feature and therefore the MAH would like to
leave “Fertility” out of the heading.
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AzithromycinAzithromycin 200 mg/5 ml200 mg/5 ml powder for oral
suspensionpowder for oral suspension
Patient Information Leaflet
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.
You should not use this medicine during pregnancy unless your doctor has specifically
recommended it.
This medicine goes into human milk. So, you should stop breastfeeding. You may discuss
with your doctor to pump and discard milk during this time or alternatively to use another
antibiotic.
Driving and using machines
This medicine may cause side effects such as dizziness or convulsions. This may make you
less able to do certain things, such as driving or using machines.
Azithromycin contains sucrose and aspartame
This medicine contains 3.7 gram sucrose per 5ml suspension. This should be taken into
account in patients with diabetes mellitus.
If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.
Aspartame is a source of phenylalanine and may be harmful for people with phenylketonuria.
3.
How to take Azithromycin
Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
Adults and children weighing more than 45 kg:
Azithromycin is taken as a 3 or 5 day course
 3 day course: Take 12.5 ml (500 mg) once each day
 5 day course:
o Take 12.5 ml (500 mg) on Day 1
o Take 6.25 ml (250 mg) on Days 2, 3, 4 and 5
For urethra and cervix infections caused by Chlamydia, it is taken as a 1 day course:
 1 day course: 25 ml (1,000 mg).
Children weighing less than 45 kg:
Azithromycin is not suitable for use in children under the age of 1 year.
Azithromycin is taken as a 3 or 5 day course. The daily amount is worked out according to the
weight of the child.
The following tables provide a guide to recommended doses:
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Patient Information Leaflet
3- day therapy
Weight
Day 1-3
10 kg
12 kg
14 kg
16 kg
17 – 25 kg
26 – 35 kg
36 – 45 kg
> 45 kg
2.5 ml
3 ml
3.5 ml
4 ml
5 ml
7.5 ml
10 ml
12.5 ml
5- day therapy
Weight
Day 1
Day 2-5
10 kg
12 kg
14 kg
16 kg
17 – 25 kg
26 – 35 kg
36 – 45 kg
> 45 kg
2.5 ml
3 ml
3.5 ml
4 ml
5 ml
7.5 ml
10 ml
12.5 ml
1.25 ml
1.5 ml
1.75 ml
2 ml
2.5 ml
3.75 ml
5 ml
6.25 ml
The dosage for the treatment of sore throat is an exception. Your doctor may prescribe a
different dosage.
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.
Take this medicine once daily. You may take it with or without food.
A bitter after-taste can be avoided by drinking fruit juice directly after swallowing.
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.
How to measure the dose
A 10 ml syringe marked at each 0.25 ml is provided with this medicine. It comes with an
adaptor which fits onto the bottle. To measure the medicine:
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Patient Information Leaflet
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Shake the bottle
Put the adaptor into the mouth of the bottle
Put the end of the syringe into the adaptor
Turn the bottle upside-down
Pull the plunger to measure the dose you need
Turn the bottle upright, remove the syringe, leave the adaptor on the bottle and close the
bottle
Ask you doctor or pharmacist if you need advice on how to measure out the medicine.
Giving the medicine using the syringe:
 Make sure the child is supported in an upright position.
 Put the tip of the syringe carefully into the child's mouth. Point the tip of the syringe
towards the inside of the cheek.
 Slowly push down the plunger of the syringe: Do not squirt it out quickly. The medicine
will trickle into the child's mouth.
 Allow the child time to swallow the medicine.
How to prepare this medicine
A doctor, nurse or pharmacist will prepare this medicine for you. To open the medicine bottle,
you need to press the childproof top down and then turn it.
If you need to prepare this medicine yourself, you should fill the bottle with cold water. With
the 10 ml syringe you can measure the right amount of water. The right amount of water
depends on the bottle size:
 For 15 ml bottle (600 mg) add 7.5 ml of water
 For 20 ml bottle (800 mg) add 10 ml of water
 For 22.5 ml bottle (900 mg) add 11 ml of water
 For 30 ml bottle (1200 mg) add 15 ml of water
 For 37.5 ml bottle (1500 mg) add 18.5 ml of water
Shake the bottle well as soon as you have filled it with waterYou only need to prepare the
suspension once, at the beginning of your course.
If you take more Azithromycin than you should
If you take too much you may feel or be sick. You also may experience other side effects such
as temporary deafness and diarrhoea. Tell your doctor or talk to your nearest hospital casualty
department immediately. If possible, take your medicine 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.
If you stop taking Azithromycin
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AzithromycinAzithromycin 200 mg/5 ml200 mg/5 ml powder for oral
suspensionpowder for oral suspension
Patient Information Leaflet
Always keep taking the oral suspension until the course is finished, even if you feel better. If
you stop taking the oral suspension too soon, the infection may come back. Also, the bacteria
may become resistant to the medicine and will then be more difficult to treat.
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
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. 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.
Skin rash caused by sensitivity to sunlight
Unusual bruising or bleeding
Irregular heart beat
Possible side effects:
Very Common: may affect more than 1 in 10 people
 feeling sick (nausea)
 diarrhoea
 abdominal discomfort (pain and cramps)
 wind (flatulence)
Common: may affect up to 1 in 10 people
 loss of appetite (anorexia)
 dizziness (vertigo)
 headache
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Patient Information Leaflet
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feeling of pins and needles (paraesthesia)
disturbances of taste
visual impairment
deafness
vomiting
indigestion (dyspepsia)
rash
itching (pruritus)
joint pain (arthralgia)
tiredness (fatigue)
altered numbers of lymphocytes/eosinophiles (white blood cells) and blood bicarbonate
decreased
Uncommon: may affect up to 1 in 100 people
 infection with the fungus Candidas (candidiasis) including fungus infection of the mouth
 inflammation of the vagina (vaginitis)
 decreased number of white blood cells (leukopenia, neutropenia)
 allergic reactions causing swelling of the lips, tongue or throat (angiooedema)
 feeling nervous
 reduced sense of touch (hypoaesthesia)
 sleepiness (somnolence)
 sleeplessness (insomnia)
 impaired hearing and/or tinnitus
 feeling the heart beats (palpitations)
 inflammation of the stomach (gastritis)
 constipation
 inflammation of the liver (hepatitis)
 Stevens-Johnson syndrome (a severe skin disorder with rash, blisters, red splotches and
wounds)
 increased sensitivity to sunlight (photosensitivity)
 hives (urticaria)
 Chest pain
 Accumulation of fluid in the body (oedema)
 feeling ill (malaise)
 general weakness (asthenia)
 blood parameter changes (tell your doctor if you have a blood test)
Rare: may affect up to 1 in 1,000 people
 restlessness (agitation)
 a feeling of dizziness or spinning (vertigo)
 abnormal liver function
Not known: frequency cannot be estimated from the available data
 bacterial infection of the large intestine (pseudomembranous colitis)
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Patient Information Leaflet
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low number of blood platelets (thrombocytopenia)
haemolytic anaemia (anaemia caused by an abnormal breakdown of red blood cells)
severe life-threatening allergic reactions (anaphylaxis), including swelling of mouth and
throat (oedema) – rarely life-threatening
aggressive reactions
anxiety
fainting (syncope)
seizures (convulsions)
feeling hyperactive
problems/inability to smell
loss of tast (ageusia)
worsening and new onset of myasthenia gravis (muscle disease were muscles become
progressively weaker)
irregular heart beat (arrhythmia), including fast heart beat (ventricular tachycardia)
increased risk of QT prolongation (which causes irregular heart beat) and torsades de
pointes (life-threatening fast heart beat)
low blood pressure
inflammation of the pancreas (pancreatitis)
discolouration of the tongue
severe, rapidly progressive loss of liver function (fulminant hepatitis)
blockage of the flow of bile from the liver to the gut which causes yellowing of the skin
and the whites of the eyes (cholestatic jaundice)
death of liver cells and liver failure, which rarely was life-threatening
toxic epidermal necrolysis (a very serious skin disorder characterised by peeling of the
skin)
erythema multiforme (a skin condition with itchy pink-red blotches)
inflammation of the kidneys (interstitial nephritis)
acute kidney failure
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects
not listed in this leaflet.
5.
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 package after “EXP.:”.
The expiry date refers to the last day of that month.
Do not store the unopened bottle with dry powder at a temperature above 30°C.
Do not store Azithromycin suspension at a temperature above 25 °C.
Do not use the reconstituted Azithromycin suspension later than 5 days.
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AzithromycinAzithromycin 200 mg/5 ml200 mg/5 ml powder for oral
suspensionpowder for oral suspension
Patient Information Leaflet
If you get the suspension from the pharmacy: do not use later than 5 days after the date of
issue. The date of issue is on the pharmacy’s label.
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
What Azithromycin contains
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The active substance is azithromycin monohydrate equivalent to 200 mg azithromycin
per 5 ml.
The other ingredients are: sucrose, xanthan gum (E415) hydroxypropylcellulose,
anhydrous trisodium phosphate, anhydrous colloidal silica, aspartame (E951), cream
caramel, titanium dioxide (E171).
What Azithromycin looks like and contents of the pack
Azithromycin is a white or off-white crystalline powder.
After reconstitution a white to off white coloured, homogenous suspension exists.
Azitromycin 200 mg/5 mL powder for oral suspension is available in plastic bottles with a
top, containing 15, 20, 22.5, 30 and 37.5 ml.
Marketing Authorisation Holder and Manufacturer
[To be completed nationally.
This medicinal product is authorised in the Member States of the EEA under the
following names:
Germany:
The Netherlands
Austria
Belgium
Denmark
Italy
Luxembourg
Azithromycin STADA fűr Kinder 200 mg/ 5 ml Pulver zur Herstellung
einer Suspension zum Einnehmen
Azitromycine CF 200 mg/5 ml, poeder voor orale suspensie
Azithromycin STADA 200 mg/5 ml Pulver zur Herstellung einer
Suspension zum Einnehmen
Azithromycine EG 200mg/5ml poeder voor orale suspensie
Azithromycin STADA
Azitromicina Eurogenerici - 200 mg/5 ml polvere per sospensi
Azithromycine EG 200mg/5ml poudre pour suspension buvable
This leaflet was last revised in MM/YYYY
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