ZITROMAX 250MG CAPSULES
Active substance(s): AZITHROMYCIN
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZITHROMAX® 250mg CAPSULES
ZITROMAX® 250mg CAPSULES
AZITHROMYCIN 250mg CAPSULES
(azithromycin)
This product is available as any of the above names but will be referred to as Zithromax throughout the
remainder of this leaflet.
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 Zithromax is and what it is used for
2. What you need to know before you take Zithromax
3. How to take Zithromax
4. Possible side effects
5. How to store Zithromax
6. Contents of the pack and other information
1. WHAT ZITHROMAX IS AND WHAT IT IS USED FOR
This medicine contains azithromycin, which is one of a group of antibiotics called macrolides. It is used to
treat infections caused by certain bacteria and other micro-organisms, which 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 organisms called Chlamydia trachomatis and Neisseria
gonorrhoea.
You must talk to a doctor if you do not feel better or if you feel worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZITHROMAX
Do not take Zithromax:
• if you are allergic to azithromycin or any other macrolide antibiotic such as erythromycin or clarithromycin
or any of the ingredients of this medicine (listed in section 6). An allergic reaction may cause skin rash or
wheezing.
Warnings and precautions
Talk to your doctor or pharmacist before taking Zithromax if you have or have had any of the following
conditions:
• kidney problems
• heart conditions
• liver problems: your doctor may need to monitor your liver function or stop the treatment
• myasthenia gravis (a condition that causes certain muscles to become weak)
• or if you are taking any ergot derivatives such as ergotamine (used to treat migraine) as these medicines
should not be taken together with Zithromax.
Tell your doctor immediately if you feel your heart beating in your chest or have an abnormal heartbeat, or
get dizzy or faint or suffer from any muscle weakness when taking Zithromax.
If you develop diarrhoea or loose stools during or after treatment, tell your doctor at once. Do not take any
medicine to treat your diarrhoea without first checking with your doctor. If your diarrhoea continues, please
inform your doctor.
Other medicines and Zithromax
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, Zithromax may interact with the medicines listed below:
• ergot or ergotamine – see ‘Warnings and precautions’ section
• warfarin or any similar medicine to prevent blood clots
• ciclosporin (used to suppress the immune system to prevent and treat rejection of a transplanted organ
or bone marrow)
• antacids (for indigestion)
• digoxin (used to treat heart failure)
• terfenadine (for hay fever or a skin allergy).
Zithromax with food and drink
You should take Zithromax either 1 hour before a meal or 2 hours after a meal.
Pregnancy, breast-feeding and fertility
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.
Driving and using machines
Zithromax is not expected to affect your ability to drive or use machines.
Zithromax contains lactose anhydrous, a type of sugar. 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 ZITHROMAX
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you
are not sure. The capsules should be swallowed whole.
The recommended dose in adults and children over 7 stones (45 kg) is 500 mg (2 capsules) taken together,
once a day, for 3 days. For some diseases such as Chlamydia the recommended dose is 1 g (4 capsules)
taken all together on one day only. For gonorrhoea the recommended dose is 1 g or 2 g of azithromycin in
combination with 250 or 500 mg of ceftriaxone.
Zithromax capsules should not be taken by children weighing less than 45 kg.
You should tell your doctor if you have kidney or liver problems as your doctor may need to alter the normal
dose.
Doctors sometimes prescribe different doses to the recommended dose. The label on the pack will tell you
which dose you should take. If you are still not sure, ask your doctor or pharmacist.
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 more Zithromax than you should
If you take too much Zithromax you may feel unwell. Tell your doctor or contact your nearest hospital
casualty department immediately.
If you forget to take Zithromax
If you forget to take Zithromax take it as soon as you can. Take your next dose at the right time. Do not take
a double dose to make up for a forgotten dose.
If you stop taking Zithromax
If you stop taking Zithromax 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 about 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.
Tell your doctor immediately if you experience any of the following symptoms after taking this
medicine as the symptoms can be severe.
• sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially
affecting the whole body)
• severe or prolonged diarrhoea, which may have blood or mucus in it, during or after treatment with
Zithromax as this may be a sign of serious bowel inflammation
• severe skin rash causing redness and flaking
• rapid or irregular heartbeat
• low blood pressure
• serious skin reactions:
• blistering of the skin, mouth, eyes and genitals (Stevens-Johnson Syndrome (SJS))
• blistering of the skin, severe skin reaction (Toxic Epidermal Necrosis (TEN))
• skin rash accompanied by other symptoms such as fever, swollen glands and an increase of
eosinophils (a type of white blood cell). A rash appears as small, itchy red bumps (Drug Reaction with
Eosinophilia and Systemic Symptoms (DRESS))
• 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) (Acute Generalized Exanthematous Pustulosis
(AGEP)).
Stop taking azithromycin if you develop these skin symptoms and contact your doctor or seek medical
attention immediately.
The most common side effects that occur when taking Zithromax are listed below. These may go away
during treatment as your body adjusts to the medicine. Tell your doctor if any of these side effects continue
to bother you.
Very common: may affect more than 1 in 10 people
• stomach cramps, feeling sick, diarrhoea, wind
Common: may affect up to 1 in 10 people
• dizziness, headache
• numbness or pins and needles
• being sick, indigestion
• loss of appetite, taste disturbance
• visual disturbances, deafness
• skin rash and /or itching
• joint pain
• low numbers of lymphocytes (a type of white blood cell), higher number of eosinophils (a type of white
blood cell)
• low blood bicarbonate
• tiredness or weakness
Uncommon: may affect up to 1 in 100 people
• yeast infections of the mouth and vagina (thrush)
• low numbers of leukocytes (a type of white blood cell), low number of neutrophils (a type of white blood
cell)
• allergic reactions of various severity
• skin more sensitive to sunlight than normal
• feeling nervous
• reduced sense of touch or sensation (hypoesthesia)
• sleepiness or sleeplessness (insomnia)
• poor hearing or ringing in the ears
• heart palpitations, chest pain
• constipation, stomach pain associated with diarrhoea and fever
• inflammation of the liver (hepatitis), changes in liver enzymes
• general loss of strength
• swelling
• general discomfort
• abnormal laboratory test values (e.g. blood or liver tests).
Rare: may affect up to 1 in 1,000 people
• agitation
• vertigo
• changes in liver function
Not known: frequency cannot be estimated from the available data
• fits or fainting
• aggression or anxiety
• feeling hyperactive
• localised muscle weakness
• loss of smell or altered sense of smell, loss of taste
• tongue discolouration
• inflammation of the pancreas (pancreatitis)
• inflammation of the kidney or kidney failure
• yellowing of the skin or eyes (jaundice) or liver failure (rarely life-threatening)
• bruising or prolonged bleeding after injury
• abnormal electrocardiogram (ECG)
• reduction in red blood cells which can make the skin pale and cause weakness or breathlessness.
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 at:
www.mhra.gov.uk/yellowcard 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 ZITHROMAX
• Keep all medicines out of the sight and reach of children
• Do not store above 30°C. Do not refrigerate. Store in the original package.
• Do not take this medicine after the expiry date stamped on the pack after EXP. The expiry date refers to
the last day of that month.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
• If the capsules become discoloured or show any other signs of deterioration, you should ask your doctor
or pharmacist who will advise you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Zithromax contains
Each capsule contains 250mg azithromycin (as dihydrate).
The other ingredients are lactose anhydrous, magnesium stearate, sodium lauryl sulphate and maize starch.
Capsule components are: gelatin, titanium dioxide (E171) and black ink.
What Zithromax looks like and contents of the pack
Zithromax is a white, hard gelatin capsules marked with 'Pfizer' on the cap and 'ZTM 250' on the body in
black ink.
Zithromax is available as blister packs of 6 capsules.
POM
PL No: 15814/1077
Zithromax is manufactured by Farmasierra Manufacturing S.L., Madrid, Spain.
Procured from within the EU and repackaged by the Product Licence holder: O.P.D. Laboratories Ltd., Unit
6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.) 19.12.2017.
Zithromax and Zitromax are registered trademarks of Pfizer Products Inc.
To request a copy of this leaflet in Braille, large print or
audio please call 01923 332 796.
ZITHROMAX® 250mg CAPSULES
ZITROMAX® 250mg CAPSULES
AZITHROMYCIN 250mg CAPSULES
(azithromycin)
This product is available as any of the above names but will be referred to as Zithromax throughout the
remainder of this leaflet.
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 Zithromax is and what it is used for
2. What you need to know before you take Zithromax
3. How to take Zithromax
4. Possible side effects
5. How to store Zithromax
6. Contents of the pack and other information
1. WHAT ZITHROMAX IS AND WHAT IT IS USED FOR
This medicine contains azithromycin, which is one of a group of antibiotics called macrolides. It is used to
treat infections caused by certain bacteria and other micro-organisms, which 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 organisms called Chlamydia trachomatis and Neisseria
gonorrhoea.
You must talk to a doctor if you do not feel better or if you feel worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZITHROMAX
Do not take Zithromax:
• if you are allergic to azithromycin or any other macrolide antibiotic such as erythromycin or clarithromycin
or any of the ingredients of this medicine (listed in section 6). An allergic reaction may cause skin rash or
wheezing.
Warnings and precautions
Talk to your doctor or pharmacist before taking Zithromax if you have or have had any of the following
conditions:
• kidney problems
• heart conditions
• liver problems: your doctor may need to monitor your liver function or stop the treatment
• myasthenia gravis (a condition that causes certain muscles to become weak)
• or if you are taking any ergot derivatives such as ergotamine (used to treat migraine) as these medicines
should not be taken together with Zithromax.
Tell your doctor immediately if you feel your heart beating in your chest or have an abnormal heartbeat, or
get dizzy or faint or suffer from any muscle weakness when taking Zithromax.
If you develop diarrhoea or loose stools during or after treatment, tell your doctor at once. Do not take any
medicine to treat your diarrhoea without first checking with your doctor. If your diarrhoea continues, please
inform your doctor.
Other medicines and Zithromax
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, Zithromax may interact with the medicines listed below:
• ergot or ergotamine – see ‘Warnings and precautions’ section
• warfarin or any similar medicine to prevent blood clots
• ciclosporin (used to suppress the immune system to prevent and treat rejection of a transplanted organ
or bone marrow)
• antacids (for indigestion)
• digoxin (used to treat heart failure)
• terfenadine (for hay fever or a skin allergy).
Zithromax with food and drink
You should take Zithromax either 1 hour before a meal or 2 hours after a meal.
Pregnancy, breast-feeding and fertility
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.
Driving and using machines
Zithromax is not expected to affect your ability to drive or use machines.
Zithromax contains lactose anhydrous, a type of sugar. 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 ZITHROMAX
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you
are not sure. The capsules should be swallowed whole.
The recommended dose in adults and children over 7 stones (45 kg) is 500 mg (2 capsules) taken together,
once a day, for 3 days. For some diseases such as Chlamydia the recommended dose is 1 g (4 capsules)
taken all together on one day only. For gonorrhoea the recommended dose is 1 g or 2 g of azithromycin in
combination with 250 or 500 mg of ceftriaxone.
Zithromax capsules should not be taken by children weighing less than 45 kg.
You should tell your doctor if you have kidney or liver problems as your doctor may need to alter the normal
dose.
Doctors sometimes prescribe different doses to the recommended dose. The label on the pack will tell you
which dose you should take. If you are still not sure, ask your doctor or pharmacist.
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 more Zithromax than you should
If you take too much Zithromax you may feel unwell. Tell your doctor or contact your nearest hospital
casualty department immediately.
If you forget to take Zithromax
If you forget to take Zithromax take it as soon as you can. Take your next dose at the right time. Do not take
a double dose to make up for a forgotten dose.
If you stop taking Zithromax
If you stop taking Zithromax 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 about 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.
Tell your doctor immediately if you experience any of the following symptoms after taking this
medicine as the symptoms can be severe.
• sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially
affecting the whole body)
• severe or prolonged diarrhoea, which may have blood or mucus in it, during or after treatment with
Zithromax as this may be a sign of serious bowel inflammation
• severe skin rash causing redness and flaking
• rapid or irregular heartbeat
• low blood pressure
• serious skin reactions:
• blistering of the skin, mouth, eyes and genitals (Stevens-Johnson Syndrome (SJS))
• blistering of the skin, severe skin reaction (Toxic Epidermal Necrosis (TEN))
• skin rash accompanied by other symptoms such as fever, swollen glands and an increase of
eosinophils (a type of white blood cell). A rash appears as small, itchy red bumps (Drug Reaction with
Eosinophilia and Systemic Symptoms (DRESS))
• 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) (Acute Generalized Exanthematous Pustulosis
(AGEP)).
Stop taking azithromycin if you develop these skin symptoms and contact your doctor or seek medical
attention immediately.
The most common side effects that occur when taking Zithromax are listed below. These may go away
during treatment as your body adjusts to the medicine. Tell your doctor if any of these side effects continue
to bother you.
Very common: may affect more than 1 in 10 people
• stomach cramps, feeling sick, diarrhoea, wind
Common: may affect up to 1 in 10 people
• dizziness, headache
• numbness or pins and needles
• being sick, indigestion
• loss of appetite, taste disturbance
• visual disturbances, deafness
• skin rash and /or itching
• joint pain
• low numbers of lymphocytes (a type of white blood cell), higher number of eosinophils (a type of white
blood cell)
• low blood bicarbonate
• tiredness or weakness
Uncommon: may affect up to 1 in 100 people
• yeast infections of the mouth and vagina (thrush)
• low numbers of leukocytes (a type of white blood cell), low number of neutrophils (a type of white blood
cell)
• allergic reactions of various severity
• skin more sensitive to sunlight than normal
• feeling nervous
• reduced sense of touch or sensation (hypoesthesia)
• sleepiness or sleeplessness (insomnia)
• poor hearing or ringing in the ears
• heart palpitations, chest pain
• constipation, stomach pain associated with diarrhoea and fever
• inflammation of the liver (hepatitis), changes in liver enzymes
• general loss of strength
• swelling
• general discomfort
• abnormal laboratory test values (e.g. blood or liver tests).
Rare: may affect up to 1 in 1,000 people
• agitation
• vertigo
• changes in liver function
Not known: frequency cannot be estimated from the available data
• fits or fainting
• aggression or anxiety
• feeling hyperactive
• localised muscle weakness
• loss of smell or altered sense of smell, loss of taste
• tongue discolouration
• inflammation of the pancreas (pancreatitis)
• inflammation of the kidney or kidney failure
• yellowing of the skin or eyes (jaundice) or liver failure (rarely life-threatening)
• bruising or prolonged bleeding after injury
• abnormal electrocardiogram (ECG)
• reduction in red blood cells which can make the skin pale and cause weakness or breathlessness.
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 at:
www.mhra.gov.uk/yellowcard 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 ZITHROMAX
• Keep all medicines out of the sight and reach of children
• Do not store above 30°C. Do not refrigerate. Store in the original package.
• Do not take this medicine after the expiry date stamped on the pack after EXP. The expiry date refers to
the last day of that month.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
• If the capsules become discoloured or show any other signs of deterioration, you should ask your doctor
or pharmacist who will advise you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Zithromax contains
Each capsule contains 250mg azithromycin (as dihydrate).
The other ingredients are lactose anhydrous, magnesium stearate, sodium lauryl sulphate and maize starch.
Capsule components are: gelatin, titanium dioxide (E171) and black ink.
What Zithromax looks like and contents of the pack
Zithromax is a white, hard gelatin capsules marked with 'Pfizer' on the cap and 'ZTM 250' on the body in
black ink.
Zithromax is available as blister packs of 6 capsules.
POM
PL No: 15814/1077
Zithromax is manufactured by Farmasierra Manufacturing S.L., Madrid, Spain.
Procured from within the EU and repackaged by the Product Licence holder: O.P.D. Laboratories Ltd., Unit
6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.) 19.12.2017.
Zithromax and Zitromax are registered trademarks of Pfizer Products Inc.
To request a copy of this leaflet in Braille, large print or
audio please call 01923 332 796.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
