Patient leaflet - Zithromax 250 mg capsules, Azithromycin 250 mg capsules
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.
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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.
Ref: 1375/270618/1/F
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).
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 capsules contain 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.
Zithromax capsules contain sulfur dioxide, which may rarely cause severe allergic (hypersensitivity) reactions and wheezing (bronchospasm).
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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.
® Ref: 1375/270618/1/B
Patient Information Leaflet (continued)
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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.
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 on 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.
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How to store Zithromax
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. Do not store above 30°C. Protect from light.
Do not take this medicine after the expiry date shown on the carton label. If your doctor tells you to stop taking the medicine, take any remaining medicine back to the pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
If your medicine becomes discoloured or show any other signs of deterioration, ask 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.
Very common: may affect more than 1 in 10 people
* stomach cramps, feeling sick, diarrhoea, wind
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Contents of the pack and other information
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
What Zithromax contains
The active substance is azithromycin.
Each capsule contains 250mg azithromycin as azithromycin dihydrate.
The other ingredients are lactose anhydrous, magnesium stearate, sodium lauryl sulphate, corn starch, gelatin, titanium dioxide (E171), shellac, black iron oxide (E172), propylene glycol, ammonium hydroxide, potassium hydroxide and strong ammonia solution.
What Zithromax looks like and contents of the pack
Zithromax capsules are white, hard capsules with markings Pfizer and ZTM 250 printed in black ink. They come in blister packs of 6.
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
Manufacturer and Licence Holder
This medicine is manufactured by Farmasierra Manufacturing S.L. Ctra. N-1, Km 26,200. 28700 San Sebastian de los Reyes, Madrid, Spain and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
POM
PL 15184/1375 Zithromax 250mg Capsules
Zithromax is a registered trademark of Pfizer Products Inc.
Revision date: 27/06/18
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