Patient leaflet - AZITHROMYCIN 250 MG CAPSULES, ZITHROMAX 250 MG CAPSULES
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 microorganisms, 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)
- colchicine (used for gout and familial Mediterranean fever)
- terfenadine (for hay fever or a skin allergy).
- Hydroxychloroquine or chloroquine (used to treat conditions including rheumatoid arthritis, or to treat or prevent malaria): Taking these medicines at the same time as azithromycin may increase the chance of you getting side effects that affect your heart.
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, 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.
Information on sodium content
Zithromax contains less than 1mmol sodium (23mg) per capsule, that is to say essentially ‘sodium free’.
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 (45kg) is 500mg (2 capsules) taken together, once a day, for 3 days. For some diseases such as Chlamydia the recommended dose is 1g (4 capsules) taken all together on one day only. For gonorrhoea the recommended dose is 1g or 2g of azithromycin in combination with 250 or 500mg of ceftriaxone.
Zithromax capsules should not be taken by children weighing less than 45kg.
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 Generalised 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: 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 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 the capsules after the expiry date which is stated on the carton and blister labels after ‘Exp’. The expiry date refers to the last day of that month.
If the capsule becomes discoloured or shows any signs of deterioration, seek the advice of your pharmacist.
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.
6. contents of the pack and other information
What Zithromax contains
The active ingredient in the Zithromax is azithromycin.
Each capsule contains 250mg azithromycin (as dihydrate).
The other ingredients are: anhydrous lactose, magnesium stearate, sodium lauryl sulfate, corn starch (gluten free).
The components of the capsule shell are: gelatin, titanium dioxide (E171) and black printing ink composed of soy lecithin, black iron oxide (E172), antifoam DC 1510, N-butyl alcohol, industrial methylated alcohol 74 OP and special lacquer for inks (Shellac).
What Zithromax looks like and contents of the pack
Zithromax is white, hard gelatin capsule marked with ‘Pfizer’ on the cap and ‘ZTM 250’ on the body in black.
Zithromax comes in blister packs of 6 capsules.
Manufactured by: Farmasierra Manufacturing S.L. Ctra. N-1, Km 26, 200. 28700 San Sebastian de los Reyes, Madrid, Spain.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Zithromax® 250mg capsules; PL 18799/2210
Leaflet date: 09.11.2021 I POM I
Zithromax is a trademark of Pfizer Products Inc.
Blind or partially sighted? Is this leaflet hard to see or read?
Call 0208 515 3763 to obtain the leaflet in a format suitable for you.
Package leaflet: Information for the patient
Azithromycin 250mg capsules
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.
The name of your medicine is Azithromycin 250mg capsules but will be referred to as Azithromycin throughout 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
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 microorganisms, 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 azithromycin
Do not take Azithromycin:
- 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 Azithromycin 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 derive atives such as ergotamine (used to treat migraine) as these medicines should not be taken together with Azithromycin.
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 Azithromycin.
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 Azithromycin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, Azithromycin 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)
- colchicine (used for gout and familial Mediterranean fever)
- terfenadine (for hay fever or a skin allergy).
- Hydroxychloroquine or chloroquine (used to treat conditions including rheumatoid arthritis, or to treat or prevent malaria): Taking these medicines at the same time as azithromycin may increase the chance of you getting side effects that affect your heart.
Azithromycin with food and drink
You should take Azithromycin 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
Azithromycin is not expected to affect your ability to drive or use machines.
Azithromycin contains lactose, 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.
Information on sodium content
Azithromycin contains less than 1mmol sodium (23mg) per capsule, that is to say essentially ‘sodium free’.
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. The capsules should be swallowed whole.
The recommended dose in adults and children over 7 stones (45kg) is 500mg (2 capsules) taken together, once a day, for 3 days. For some diseases such as Chlamydia the recommended dose is 1g (4 capsules) taken all together on one day only. For gonorrhoea the recommended dose is 1g or 2g of azithromycin in combination with 250 or 500mg of ceftriaxone.
Azithromycin capsules should not be taken by children weighing less than 45kg.
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 Azithromycin than you should
If you take too much Azithromycin you may feel unwell. Tell your doctor or contact your nearest hospital casualty department immediately.
If you forget to take Azithromycin
If you forget to take Azithromycin 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 Azithromycin
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 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 Azithromycin 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 Generalised 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 Azithromycin 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.
5. how to store azithromycin
Keep 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 the capsules after the expiry date which is stated on the carton and blister labels after ‘Exp’. The expiry date refers to the last day of that month.
If the capsule becomes discoloured or shows any signs of deterioration, seek the advice of your pharmacist.
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.
6. contents of the pack and other information
What Azithromycin contains
The active ingredient in the Azithromycin is azithromycin.
Each capsule contains 250mg azithromycin (as dihydrate).
The other ingredients are: anhydrous lactose, magnesium stearate, sodium lauryl sulfate, corn starch (gluten free).
The components of the capsule shell are: gelatin, titanium dioxide (E171) and black printing ink composed of soy lecithin, black iron oxide (E172), antifoam DC 1510, N-butyl alcohol, industrial methylated alcohol 74 OP and special lacquer for inks (Shellac).
What Azithromycin looks like and contents of the pack
Azithromycin is white, hard gelatin capsule marked with ‘Pfizer’ on the cap and ‘ZTM 250’ on the body in black.
Azithromycin comes in blister packs of 6 capsules.
Manufactured by: Farmasierra Manufacturing S.L. Ctra. N-1, Km 26, 200. 28700 San Sebastian de los Reyes, Madrid, Spain.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Azithromycin 250mg capsules;
PL 18799/2210 .-----.
| POM |
Leaflet date: 09.11.2021
Blind or partially sighted? Is this leaflet hard to see or read?
Call 0208 515 3763 to obtain the leaflet in a format suitable for you.