Zithromax

Zithromax is an antibiotic that inhibits many bacteria responsible for infections.

For the treatment of the following infections:

• Respiratory tract infections including pneumonia, acute worsening of chronic bronchitis, sinusitis, pharyngeal infections and angina.
• Otitis media.
• Skin and wound infections.
• Certain urinary tract and genital infections caused by Chlamydia.

For the prevention of the following infection:

• MAC (Mycobacterium Avium-intracellulare Complex) infection, which can occur in people with weakened immune defences.

What Does Zithromax Contain?

1 sachet of Zithromax contains:

• Active substance: azithromycin 100, 300 or 500 mg in the form of azithromycin dihydrate;
• Excipients: sucrose (1.9 g, 5.8 g or 4.8 g, respectively), anhydrous sodium phosphate tribasic, hydroxypropyl cellulose, xanthan gum; flavourings: artificial cherry flavouring, artificial vanilla flavouring (containing vanillin and ethylvanillin), artificial banana flavouring.

Uses

For Zithromax to be as effective as possible, it is essential that the dosage and duration of treatment prescribed by your doctor are strictly adhered to. Unless otherwise prescribed by your doctor, the following dosage recommendations apply:

• Zithromax should be taken once a day for all indications, except for the prevention of MAC infection.
• Zithromax sachets may be taken with or without food.

Adults

a) Infections of the urinary tract or genital organs due to Chlamydiae

A single dose of 1 g of Zithromax (2 sachets of 500 mg).

b) Prevention of MAC (Mycobacterium Avium-intracellulare Complex) infection

The dosage for the prevention of MAC infection in immunodeficient AIDS patients is 1200 mg (4 x 300 mg sachets) once weekly.

c) All other indications

Day 1 to Day 3: a dose of 500 mg (1 sachet of 500 mg) once daily.

Children

a) For all indications except prevention of MAC infection

Administer 10 mg/kg PC once daily for 3 days to children over 6 months of age.

b) Prophylaxis of MAC infection

The dose to be administered once a week to children aged between 12 and 18 years for the prevention of MAC infection will be calculated by the doctor and prescribed accordingly.

Taking Zithromax sachets

Dissolve the contents of the sachet in a one-third full glass of water shortly before taking.

Do not change the prescribed dose or duration of treatment on your own initiative. Contact your doctor or pharmacist if you feel that the efficacy of the medicine is too low or too high.

Side Effects

Taking Zithromax may cause the following side effects.

Common (in 1-10% of patients): disorders of the gastrointestinal tract such as inappetence, nausea, vomiting, diarrhoea, loose stools, abdominal pain and cramps, digestive disorders and constipation.

Please inform your doctor immediately if severe and persistent diarrhoea occurs during or after treatment with Zithromax.

Occasional to frequent (0.1 to 10% of patients): Following the use of azithromycin, the active ingredient in Zithromax, in neonates (treatment occurring within the first 42 days of life), cases of narrowing of the pylorus (infantile hypertrophic pyloric stenosis, IHPS) have been reported. Contact your doctor if you experience vomiting or irritation when feeding your child.

Occasional (in 0.1 - 1% of patients): flatulence, mycoses, vaginal inflammation, allergic reactions with rash, pruritus and urticaria, nervousness, obnubilation, drowsiness, headache, abnormal perceptions (paresthesia) and fatigue.

Rare (in 0.01-0.1% of patients): fainting, dizziness, cramps, convulsions, hyperactivity, aggressive reactions, malaise, weakness, restlessness, anxiety, fall in blood pressure, heart palpitations, heart rhythm disturbances, severe and persistent diarrhoea, photosensitivity (skin reactions have been associated with sunlight), severe skin rash, muscle disease (myasthenia gravis) (see "What precautions should be taken when taking Zithromax?"), joint and neck pain, headache, dizziness, nausea and vomiting. "), joint pain and discolouration of the tongue. Taste/smell disorders and reduced sensitivity to touch.

Severe allergic reactions have been observed rarely. Please inform your doctor immediately if any of the above side effects or allergic symptoms such as skin rash, itching, redness, blisters, facial swelling or breathing difficulties occur.

Hearing problems, including ringing in the ears, deafness and complete/partial loss of hearing, have been observed, particularly with higher doses of Zithromax taken over a prolonged period. Most of these symptoms subsequently subsided. Consult your doctor if you experience any of these symptoms.

Abnormal kidney, pancreas or liver function (including inflammation of the pancreas, inflammation of the liver and jaundice, liver failure, acute kidney failure) has been observed rarely. Consult your doctor if you experience abdominal pain, loss of appetite, tiredness or yellowing of the skin.

Precautions

Light sensitivity reactions may occur during treatment with Zithromax (skin rashes). Consequently, please avoid direct sunlight and solariums when taking Zithromax and for at least 7 days afterwards.

During treatment with Zithromax, rare serious allergic reactions such as swelling of the skin and mucous membranes, face, tongue and larynx, palpitations, fall in blood pressure (leading to fainting and shock) and respiratory distress and disorders, as well as serious skin reactions (reddish swellings with numerous small pustules (acute generalised exanthematous pustulosis), Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome) have been observed. These serious clinical symptoms, accompanied by the formation of bullae and ulcers, mainly affect mucous membranes. In addition, typical lesions also appear on the skin (redness of the skin the size of a coin with elevation of the skin or bullae in the centre). This is often accompanied by high fever and physical depression. Zithromax should be stopped at the first sign of such allergic reactions and a doctor contacted.

Zithromax should be used with caution if you suffer from heart disease, if you are taking other medicines that can cause rhythm disorders or if you suffer from electrolyte disorders.

Tell your doctor or pharmacist if:

• you know that you have heart muscle disease or irregular or slow heartbeats, or that you have a peculiarity on the electrocardiogram (ECG) known as "long QT".
• if you are taking antiarrhythmics, antidepressants, antibiotics or antipsychotics.
• if you are taking hydroxychloroquine or chloroquine (for the treatment of diseases such as rheumatoid arthritis or for the treatment or prevention of malaria). Taking these medicines at the same time as azithromycin may increase the risk of adverse reactions affecting the heart.
• if you suffer from electrolyte disorders.

Zithromax should be administered with caution to elderly patients, who may be more sensitive to drug-induced effects on the heart (cardiac rhythm disorders).

If you suffer from liver failure, you should only take Zithromax under the strict supervision of your doctor. If you experience symptoms of hepatitis (inflammation of the liver), such as weakness, malaise, loss of appetite, nausea or vomiting, tiredness, yellowing of the eyes (conjunctiva) and skin, or discoloured stools, you should contact your doctor immediately.

Please inform your doctor if you suffer from impaired kidney function.

Please inform your doctor if you suffer from persistent severe diarrhoea during or after treatment with Zithromax. In this case, stop the product and do not take medicines that inhibit intestinal peristalsis (the movement of the intestine).

During treatment with Zithromax, the appearance or worsening of symptoms of muscle disease (myasthenia gravis) has been reported.

Following the use of azithromycin, the active ingredient in Zithromax, in neonates (treatment during the first 42 days of life), cases of narrowing of the pylorus (hypertrophic stenosis of the infantile pylorus, IHPS) have been reported. Contact your doctor in the event of vomiting or irritation when feeding your child.

During treatment with Zithromax, do not take any medicine containing ergotamine or an ergotamine derivative (e.g. Dihydergot, Cafergot, Bellergal).

Do not take Zithromax at the same time as antacids.

Please tell your doctor if you are taking medicines that suppress the immune system (immunosuppressants), anticoagulants (medicines to thin the blood), cardiac glycosides (e.g. digoxin and colchicine) or medicines for migraine, allergies, HIV infection or tuberculosis.

After marketing, muscle disease (rhabdomyolysis) has been reported in patients taking Zithromax and cholesterol-lowering drugs (statins) at the same time.

This product contains sucrose and is therefore not indicated for patients with fructose intolerance, sucrose isomaltase deficiency or glucose-galactose malabsorption (rare metabolic disorders).

This medicine may affect reactions, driving ability and the ability to use tools or machines.

The antibiotic substance in Zithromax, azithromycin, is not effective against all the micro-organisms that cause infectious diseases. The use of an inappropriate or incorrectly dosed antibiotic can lead to complications. So never use it on your own initiative to treat another illness or another person. Similarly, you should not use Zithromax at a later date for a new infection or to repeat a preventive treatment without consulting a doctor again.

Note for diabetics

If you are diabetic and are taking Zithromax in sachets, you should take into account the sugar (sucrose) content.

• 1 100 mg sachet of azithromycin contains 1.9 g of assimilable carbohydrates.
• 1 300 mg sachet of azithromycin contains 5.8 g of available carbohydrates.
• 1 500 mg sachet of azithromycin contains 4.8 g of available carbohydrates.

When Should Zithromax Not Be Used?

Patients with a known or suspected hypersensitivity (allergy) to azithromycin, erythromycin or other macrolide or ketolide antibiotics and other components of Zithromax should not take Zithromax.

Alcohol

Avoid regular alcohol consumption, which can damage your liver, especially if you have hepatitis. A reasonable amount of alcohol should not harm your health. However, avoid 'skipping' a dose of medication because you drink alcohol or take drugs.

Pregnancy and Breastfeeding

Please inform your doctor if you are pregnant or breast-feeding. Animal studies have not shown any harm to the foetus. However, there is insufficient experience of the treatment of pregnant women with azithromycin, the active substance in Zithromax. Antibiotic should be used during pregnancy only if clinically necessary and if the expected benefits outweigh the potential risks.

The drug passes into breast milk. Consequently, Zithromax should not be used during breast-feeding or breast-feeding should be discontinued.

What Else Do We Need To Watch Out For?

Stability

The medicine must not be used after the date shown on the container after the words "EXP".

Storage

Store at room temperature (15-25°C), in the original packaging and out of the reach of children. At the end of treatment, please return the packaging of Zithromax, together with any remaining medicine, to the person who gave it to you (doctor or pharmacist) for proper disposal.

For further information about Zithromax, consult your doctor or pharmacist, who have detailed information for professionals.

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