Zitromax 250mg Capsules
Out of date information, search anotherZITROMAX 250mg CAPSULES (azithromycin dihydrate)
Patient Information Leaflet
This product is known by the above name but will usually be referred to as Zitromax throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Zitromax is and what it is used for
2. Before you take Zitromax
3. How to take Zitromax
4. Possible side effects
5. How to store Zitromax
6. Further information
1. What Zitromax is and what it is used for
Zitromax 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 an organism called chlamydia
2. Before you take Zitromax
Do not
take Zitromax if:
you are allergic to Zitromax or any other macrolide antibiotic such as erythromycin or clarithromycin or any of the ingredients listed in section 6. An allergic reaction may cause skin rash or wheezing
you are taking any ergot derivatives such as ergotamine (used to treat migraine) as these medicines should not be taken together with Zitromax.
Take special care with Zitromax
Your doctor needs to know before you take Zitromax 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
• and if you are taking any ergot derivatives such as ergotamine (used to treat migraine) as these medicines should not be taken together with Zitromax.
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 Zitromax.
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.
Taking other medicines
Tell your doctor before taking Zitromax, if you are taking any of the medicines listed below:
• ergot or ergotamine - see ‘Take special care' 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)
You should always tell your doctor if you are taking or have recently taken any other medicines including those obtained without a prescription.
Taking Zitromax with food and drink
You should take Zitromax either 1 hour before a meal or 2 hours after a meal.
Pregnancy and breast-feeding
If you are pregnant, trying to get pregnant or are breast-feeding you should not take Zitromax without discussing it with your doctor first.
Driving and using machines
Zitromax is not expected to affect your ability to drive or use machines.
Important information about some of the ingredients of Zitromax
Zitromax contains lactose, a type of sugar. If you have an intolerance to some sugars contact your doctor before taking Zitromax.
3. How to take Zitromax
Always take Zitromax exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The capsules should be swallowed whole.
The usual dose in adults and children over 7 stones (45 kg) is 500mg (2 capsules) taken together, once a day, for 3 days. For some diseases such as Chlamydia the dose is 1g (4 capsules) taken all together on one day only.
Zitromax 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 these. 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 Zitromax than you should
If you take too much Zitromax you may feel unwell. Tell your doctor or contact your nearest hospital casualty department immediately.
If you forget to take Zitromax
If you forget to take Zitromax 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 Zitromax
If you stop taking Zitromax 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 product, ask your doctor or pharmacist for advice.
4. Possible side effects
"\
Like all medicines Zitromax 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 Zitromax as this may be a sign of serious bowel inflammation
• severe skin rash causing redness and flaking
• rapid or irregular heartbeat
• low blood pressure
The most common side effects that occur when taking Zitromax 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 side effects (occurring in at least 1 in 10 people taking Zitromax)
• stomach cramps, feeling sick, diarrhoea, wind
Common side effects (likely to occur in less than 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 number of lymphocytes (type of white blood cells), higher number of eosinophils (types of white blood cells)
• low body bicarbonate
• tiredness or weakness
Uncommon side effects that occur in less than 1 in 100 people taking Zitromax are:
• yeast infections of the mouth and vagina (thrush)
• low number of leukocytes (type of white blood cells), low number of neutrophils (type of white blood cells)
• allergic reactions of various severity
• blistering of the skin, mouth, eyes and genitals
• 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 side effects that occur in less than 1 in 1,000 people taking Zitromax are:
• agitation
• vertigo
• changes in liver function
Other side effects have been reported, but it is not known how frequently they occur:
• 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
• blistering of the skin, severe skin reaction
• abnormal electrocardiogram (ECG)
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.
5. How to store Zitromax
• Zitromax 250mg capsules should not be stored above 30°C.
• Keep all medicines out of the sight and reach of children.
• Do not use after the expiry date printed on the carton label or blister strip after EXP. The expiry date refers to the last day of that month.
• If your doctor tells you to stop taking the capsules, please take them back to the pharmacist for safe disposal. Only keep the capsules if your doctor tells you to.
• If the capsules become discoloured or show signs of any deterioration, you should seek the advice of your pharmacist who will advise you what to do.
• 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. Further information
Your medicine is called Zitromax 250mg capsules. It contains 250mg of the active ingredient, Azithromycin (as the dihydrate) in a white oblong hard gelatin capsule marked ‘Pfizer' on the cap and ‘ZTM 250' on the body.
Zitromax 250mg capsules also contain the following:
Lactose anhydrous, magnesium stearate, maize starch, sodium lauryl sulphate, gelatin and titanium dioxide (E171).
The printing ink contains:
Shellac 45%, black iron oxide (E172), propylene glycol and ammonium hydroxide 28% or
lacquer (shellac), black iron oxide (E172), propylene glycol, strong ammonia solution and potassium hydroxide.
Zitromax 250mg capsules are available as blister packs of 6 capsules.
POM PL No: 6464/0654
This product is manufactured by Farmasierra Manufacturing, S.L. San Sebastian de los Reyes, Madrid, Spain and is procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex, SS14 3FR
Leaflet revision and issue date (Ref.) 14.3.2014