Patient Information Leaflet

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.

What is in this leaflet:
1. What AZIMED 500 is and what it is used for
2. What you need to know before you take AZIMED 500
3. How to take AZIMED 500
4. Possible side effects
5. How to store AZIMED 500
6. Contents of the pack and other information

1. What AZIMED 500 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 gonorrhea.

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 AZIMED 500
Do not take AZIMED 500:

• 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 AZIMED 500 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 AZIMED 500.

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 AZIMED 500
• if you are giving this medicine to an infant (less than 6 weeks of age) and they vomit or become irritable when fed.

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 AZIMED 500
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, AZIMED 500 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 autoimmune diseases 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.

AZIMED 500 with food and drink
You should take AZIMED 500 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
AZIMED 500 is not expected to affect your ability to drive or use machines.

Azithromycin Tablets contain soya lecithin
If you are allergic to peanut or soya, do not use this medicine.

3. How to take AZIMED 500
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 (1 tablet) taken, once a day, for 3 days. For some diseases such as Chlamydia the recommended dose is 1 g (2 tablets) taken 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.

AZIMED 500 tablet 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 AZIMED 500 than you should
If you take too much AZIMED 500 you may feel unwell. Tell your doctor or contact your nearest hospital casualty department immediately.

If you forget to take AZIMED 500
If you forget to take AZIMED 500 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 AZIMED 500
If you stop taking AZIMED 500 too soon, the infection may return. Take the tablets 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 AZIMED 500 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 characterized 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 AZIMED 500 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.

  5. How to store AZIMED 500
  Keep this medicine out of the sight and reach of children. This medicine does not require any special storage conditions.
  Do not take this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
  Do not throw away any medicines via waste-water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

  6. Contents of the pack and other information
  What AZIMED 500 contains
  The active substance of AZIMED 500 is Azithromycin 500 mg USP.

  AZIMED 500
  Each film coated tablet contains:
  Azithromycin Dihydrate USP equivalent to Azithromycin 500 mg
  Colour: Titanium Dioxide

  What AZIMED 500 looks like and contents of the pack
  AZIMED 500 tablets are white coloured, oval, biconvex, film coated tablets with breakline scored on one side. Tablets are packed into Blister. The pack size is 10 x 3 tablets in a printed paper carton.

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