PATIENT INFORMATION LEAFLET Azithromycin 500mg Tablets

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take Azithromycin 500 mg Tablets carefully to get the best results from it.

•    Keep this leaflet. You may need to read it again.

•    If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

•    Ask your pharmacist if you need more information or advice.

•    You must contact a doctor or specialist if you develop symptoms.

In this leaflet:

1.    What Azithromycin 500mg Tablets are and what they are used for

2.    Before you take Azithromycin 500mg Tablets

3.    How to take Azithromycin 500mg Tablets

4.    Possible side effects?

5.    How to store Azithromycin 500mg Tablets

6.    Further information

7.    Important information about Chlamydia and other sexual health advice

1.    What Azithromycin 500mg Tablets are and what they are used for

The ingredient which makes this medicine work is a ‘macrolide’ antibiotic called azithromycin.

Azithromycin 500 mg Tablets are used to treat the sexually transmitted infection (STI) called Chlamydia trachomatis in people aged 16 years or over, who have tested positive but have no symptoms and in treatment of their sexual partners.

To buy Azithromycin 500 mg Tablets you must have had a positive Chlamydia test result and have no symptoms or be a sexual partner of someone who has had a positive Chlamydia test result, and have no symptoms. If you have symptoms contact your pharmacist for advice.

2.    Before you take Azithromycin 500mg Tablets

Do not take Azithromycin 500 mg Tablets but see a doctor instead if you:

•    are allergic to azithromycin, other ‘macrolide’ antibiotics or any ingredient in the product (see section 6)

•    are under 16 years of age

•    have tested positive and also have symptoms of Chlamydia such as

-    pain when urinating or having sex

-    unusual vaginal discharge (in women) or discharge from penis (in men)

-    bleeding after sex or between periods (in women)

-    pain below your belly button (in women) or in your testicles (in men)

•    symptoms suggestive of other STIs, such as unusual lumps, bumps, blisters or sores around the genital or anal area

•    are or may be pregnant or are breast feeding

•    have liver, kidney or heart problems.

Do not take Azithromycin 500 mg Tablets if you are taking any of these other medicines:

•    ergotamine or dihydroergotamine (for migraine or poor blood flow)

•    warfarin (to thin the blood)

•    disopyramide (for irregular heart beat)

•    rifabutin (for tuberculosis)

•    ciclosporin (to help prevent rejection of transplanted organs, or for use in arthritis or skin problems)

•    digoxin (for heart disorders)

•    theophylline (for asthma)

•    terfenadine (for hayfever or allergies)

•    azithromycin for any other infections e.g. chest, sinuses, ear, skin.

You can still take Azithormycin 500 mg Tablets but may need to take extra care if you are taking these medicines:

•    oral contraceptives (the ‘pill’) - if you get sickness or diarrhoea whilst taking Azithromycin 500 mg Tablets your ‘pill’ may not prevent you becoming pregnant. You will need to read the ‘pill’ instruction leaflet to take the right action. Do not have sex, even with a condom, for seven days after taking Azithromycin 500 mg Tablets (see section 3).

•    indigestion remedies - take Azithromycin 500 mg Tablets at least 1 hour before or 2 hours after the indigestion remedy. Azithromycin 500 mg Tablets will not work as well if both are taken too close together.

•    pimozide (for mental illness)

•    nelfinavir (for HIV infection)

If you are taking an regular medication and are unsure, check with your doctor or pharmacist.

Driving and operating machinery:

Azithromycin 500 mg Tablets can cause dizziness and sleepiness. Make sure you are not affected before you drive or operate machinery.

3. How to take Azithromycin 500mgTablets.

The pack contains two tablets. Take both tablets together as a single dose with a glass of water before you go to bed and at least 2 hours after food or any other drink besides water. If you are sick (vomit) within 3 hours of taking your dose, they might not work properly, so ask your pharmacist or doctor for advice.

You should not delay treatment. If you have to wait before taking them, see section 5 for storage conditions.

After treatment

•    Contact your doctor, Genito-Urinary Medicine (GUM) clinic or community sexual health clinic if you think you have come into contact with Chlamydia again or if symptoms develop.

•    Ensure any sexual partners are also tested and treated before you have sex with them, otherwise you are at risk of catching Chlamydia again.

•    If you, or your partner have been treated for Chlamydia do not have sex (oral, vaginal, anal or using sex toys), even with a condom for 7 days after taking Azithromycin 500 mg Tablets.

4. Possible Side Effects

Like many medicines, Azithromycin 500 mg Tablets may occasionally cause side effects. However, this is usually with longer courses of azithromycin treatment. Do not be alarmed by this list, you may not experience any of them. If you are worried speak to your pharmacist.

Contact your doctor or nearest casualty department immediately if you have a rare but seroius allergic reaction such as swelling of the body, face, lips or throat. Very occasionally, these effecs may be severe causing shortness of breath, shock or collapse.

Tell your doctor if you ntoice any of the following side effects or notice any other effects not listed:

•    Common (occurs in less than 1 in 10 users):

• feeling or being sick, diarrhoea or stomach ache

•    Uncommon (occurs in less than 1 in 100 users):

•    dizziness, ‘spinning’ sensation, fits, headache, fainting, changes in taste and smell, wind poor appetite, indigestion, painful joints, vaginal inflammation (you might feel soreness), drowsiness, rashes, itchy rash (pruitis).

• Rare (occurs in less than 1 in 1,000 users):

•    thrush (candidiasis), increase in nosebleeds, bruising, sore throat or infections (signs of changes in blood cells) aggression, restlessness, hyperactivity, anxiety, difficulty sleeping, nervousness, pins and needles, poor hearing, ringing in the ears, deafness, palpitations, irregular or racing heart beat, feeling faint due to a drop in blood pressure, constipation, tongue discolouration, feeling tired or unwell, weakness or loss of strength, sensitivity to sunlight, inflammation of the pancreas (pancreatitis). Inflammation of the lining of large intestine (pseudomembranous colitis, you might get diarrhoea, stomach cramps, fever, blood in the stools). Changes in liver function or jaundice (yellowing of the skin or whites of the eyes), liver damage, failure or inflammation (fatigue, weakness, loss of appetite, weight loss, abdominal pain, fever). Severe but rare skin conditions such as erythema multiforme (raised, red patches on the skin which may blister), Stevens Johnson Syndrome (more severe form of erythema multiforme) or toxic epidermal necrolysis (red painful rash that looks like a scald and may cause peeling of the skin). Kidney failure or inflammation (increased need to urinate at night, muscle twitching and cramps, loss of appetite, feeling or being sick, unpleasant taste in mouth).

You can help make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.yellowcard.gov.uk; alternatively you can call Freephone 0808 100 3352 (available between 10am to 2pm Monday to Friday) or fill in a paper form available from your local pharmacy.

5. How to store Azithromycin 500mg Tablets.

Keep in a secure place out of the reach and sight of children. Store below 25°C (room temperature) in the original package. Do not use after the expiry date shown on the pack.

6. Further information

What Azithromycin 500mg Tablets contain

o Each tablet contains 500mg of azithromycin (the active ingredient that makes the tablet work).

o The tablets also contain calcium hydrogen phosphate (anhydrous), hypromellose, maize starch, pregelatinised starch, microcrystalline cellulose, sodium laurylsulfate, magnesium stearate, polysorbate 80, talc, indigotin (E132) and titanium dioxide (E171).

7. More about Chlamydia and other important sexual health advice

What is it?

Chlamydia is an extremely common sexually transmitted infection (STI) caused by a bacteria called Chlamydia trachomatis which is found in the semen and vaginal fluids of men and women who have the infection. It infects the neck of the womb (cervix) in women, the tube that drains the bladder of urine (urethra) and the back passage (rectum) in both women and men.

Chlamydia affects between 1 in 10 and 1 in 100 people and is most common in people aged 16 to 25 years.

How do you get it?

Chlamydia is easily passed from one person to another through sexual contact.

The infection is most commonly spread through:

•    unprotected vaginal, anal or oral sex

•    sharing sex toys if you don’t wash them or cover them with a new condom each time they’re used.

It can also be passed on fingers to your eyes after touching the genital area.

A mother can also pass the infection to her baby during childbirth.

Are there any symptoms?

Chlamydia is a ‘silent’ condition; as many as 70% of infected individuals have no symptoms, so it can stay hidden for many months or years. Those who do have symptoms may have any of the following:

In women: unusual vaginal discharge, a need to pass urine more often, pain when passing urine or during sexual intercourse, pain below the belly button or bleeding between periods or after sex.

In men: pain and/or burning when passing urine, discharge from the penis, irritation at the tip of the penis or swelling and pain in the testicles.

In men and women: if the infection is in the rectum, there are rarely any symptoms but it may cause discomfort and discharge.

If you have symptoms or you think you may have another infection, consult your doctor or local GUM clinic or community sexual health clinic for further investigation and treatment.

Why is treatment important?

It is very important to get treated for Chlamydia. If left untreated the infection can spread to other parts of the body and develop into more serious problems such as:

In women:

•    pelvic inflammatory disease which can seriously affect the womb or fallopian tubes

•    scarring or damage to the fallopian tubes causing pain or infertility (problems getting pregnant)

•    increased risk of ectopic pregnancies (when pregnancy develops outside the womb)

•    infection in the liver, causing pain and inflammation.

In men:

•    painful infection in the testicles and possible reduced fertility.

In men and women:

•    rarely, inflammation of the joints (reactive arthritis). This is sometimes accompanied by inflammation of the urethra and the eye, when it is known as Reiter’s syndrome.

Each time you have Chlamydia you are at increased risk of serious problems. If you have already had Chlamydia in the last 6 months you should see a doctor.

If left untreated you can also infect your partner.

Can it be prevented?

Use a condom during sex to reduce the risk of getting or passing on not just Chlamydia, but other sexually shared infections, such as HIV, syphilis and gonorrhoea.

If you, or your partner have been treated for Chlamydia do not have sex (oral, vaginal, anal or using sex toys), even with a condom for 7 days after taking Azithromycin 500 mg Tablets, otherwise you can become re-infected. Avoid using sex toys. If you do share them, wash them or cover them with a new condom before anyone else uses them.

Other important sexual health advice

Using a condom will help reduce your risk of getting or passing on Chlamydia and other sexually shared infections (STIs).

If you have tested positive for Chlamydia, you are also at higher risk of other STIs. It is important that you visit your GUM clinic or community sexual health clinic to be tested for these. Your pharmacist can tell you how to go about this.

If you have tested positive for Chlamydia, then it is important that your current sexual partner and any previous, but recent partners are also tested and treated. They should also receive advice from a healthcare professional. There are a number of ways that partners can be contacted confidentially- your pharmacist can tell you how to go about this. You are strongly advised to tell your partner(s), but it is not compulsory.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder is:

PLIVA Pharma Ltd., Hampshire, GU32 3QB, England.

Manufacturer is:

Pliva Krakow Zaklady Farmaceutyczne S.A., ul. Mogilska 80, 31-546 Krakow, Poland

This leaflet was last revised in March 2010 PL 10622/0315