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Azithromycin 250mg Capsules

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Patient Information 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.

The name of your medicine is Zithromax

250mg Capsules but it will be referred to

as Zithromax throughout this leaflet.

In this leaflet:

1. What Zithromax is and what it is used for

2. Before you take Zithromax

3. How to take Zithromax

4. Possible side effects

5. How to store Zithromax

6. Further information

Zithromax® 250mg Capsules

(azithromycin)

1. What Zithromax is and what it is used for

Zithromax 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 Zithromax

Do not take Zithromax if:

• you are allergic to Zithromax 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 Zithromax.

Take special care with Zithromax

Your doctor needs to know before you take 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

• and 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.

Taking other medicines

Tell your doctor before taking Zithromax, 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 Zithromax with food and drink

You should take Zithromax 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 Zithromax without discussing it with your doctor first.

Driving and using machines

Zithromax is not expected to affect your ability to drive or use machines.

Important information about some of the ingredients of Zithromax

Zithromax contains lactose, a type of sugar. If you have an intolerance to some sugars contact your doctor before taking Zithromax. Zithromax contains sulphur dioxide which may rarely cause severe allergic (hypersensitivity) reactions and wheezing (bronchospasm).

Always take Zithromax 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 1 g (4 capsules) taken all together on one day only.

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 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 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 product, ask your doctor or pharmacist for advice.

4. Possible side effects

Like all medicines Zithromax 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

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 side effects (occurring in at least 1 in 10 people taking Zithromax):

• 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 numbers of lymphocytes (type of white blood cells), higher number of eosinophils (type of white blood cells)

• low blood bicarbonate

• tiredness or weakness

Uncommon side effects that occur in

less than 1 in 100 people taking

Zithromax are:

• yeast infections of the mouth and vagina (thrush)

• low numbers 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 Zithromax are:

• agitation

• vertigo

• changes in liver function

Other side effects that 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 (EEG)

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 Zithromax

blister label after ‘Exp’. The 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.

6. Further information

What Zithromax contains

The active substance is azithromycin. Each capsule contains 250mg of azithromycin (as dihydrate)

The other components are: lactose anhydrous, magnesium stearate, maize starch (gluten free), sodium lauryl sulphate.

The capsule components are: gelatin, titanium dioxide (E171) and black ink composed of soy lecithin, black iron oxide (E172), antifoam DC 1510, n-butyl alcohol, industrial methylated spirit 74 OP and shellac.

What Zithromax looks like and contents of the pack

White, hard gelatin capsules marked with ‘Pfizer’ on the cap and ‘ZTM 250’ on the body in black.

They come 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.

POM

Keep out of the sight and reach of children.

Do not store above 30°C.

Store in the original package.

Do not take Zithromax after the expiry date which is stated on the carton and

Zithromax 250mg Capsules PL No: 18799/2210

Leaflet date: 06.10.2014

Zithromax is a registered trademark of Pfizer group of companies.

Azithromycin 250mg Capsules

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.

The name of your medicine is Azithromycin 250mg Capsules but it will be referred to as Azithromycin throughout this leaflet.

In this leaflet:

1. What Azithromycin is and what it is used for

2. Before you take Azithromycin

3. How to take Azithromycin

4. Possible side effects

5. How to store Azithromycin

6. Further information

1. What Azithromycin is and what it is used for

Azithromycin 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 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 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 Azithromycin.

Take special care with Azithromycin

Your doctor needs to know before you take 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

• and if you are taking any ergot derivatives 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.

Taking other medicines

Tell your doctor before taking Azithromycin, 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 Azithromycin with food and drink

You should take Azithromycin 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 Azithromycin without discussing it with your doctor first.

Driving and using machines

Azithromycin is not expected to affect your ability to drive or use machines.

Important information about some of the ingredients of Azithromycin

Azithromycin contains lactose, a type of sugar. If you have an intolerance to some sugars contact your doctor before taking Azithromycin. Azithromycin contains sulphur dioxide which may rarely cause severe allergic (hypersensitivity) reactions and wheezing (bronchospasm).

Always take Azithromycin 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.

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 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 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 product, ask your doctor or pharmacist for advice.

4. Possible side effects

Like all medicines Azithromycin 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

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 side effects (occurring in at least 1 in 10 people taking Azithromycin):

• 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 numbers of lymphocytes (type of white blood cells), higher number of eosinophils (type of white blood cells)

• low blood bicarbonate

• tiredness or weakness

Uncommon side effects that occur in

less than 1 in 100 people taking

Azithromycin are:

• yeast infections of the mouth and vagina (thrush)

• low numbers 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).

PL No: 18799/2210

Rare side effects that occur in less than 1 in 1,000 people taking Azithromycin are:

• agitation

• vertigo

• changes in liver function

Other side effects that 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 (EEG)

Reporting of side effects

5. How to store Azithromycin

Keep out of the sight and reach of children.

Do not store above 30°C.

Store in the original package.

Do not take Azithromycin after the expiry date which is stated on the carton and blister label after ‘Exp’. The 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.

6. Further information

What Azithromycin contains

The active substance is azithromycin. Each capsule contains 250mg of azithromycin (as dihydrate)

The other components are: lactose anhydrous, magnesium stearate, maize starch (gluten free), sodium lauryl sulphate.

What Azithromycin looks like and contents of the pack

White, hard gelatin capsules marked with ‘Pfizer’ on the cap and ‘ZTM 250’ on the body in black.

They come 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

POM

Leaflet date: 06.10.2014.