Azitromicina Azevedos belongs to a group of antibiotics named macrolides. It is an antibiotic used to treat localized infections in various parts of the organism caused by bacteria.

Which infections are treated with Azitromicina Azevedos?

Azitromicina Azevedos is indicated in the treatment of severe infections or when oral treatment cannot be used. It is used to treat pneumonias (lung infections), including infections caused by Legionella pneumophila bacteria and pelvic infections.

Do not take Azitromicina Azevedos:

-        if you are allergic to Azithromycin, or other macrolide or ketolide (including erythromycin) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Azitromicina Azevedos:

- if you have ever had any problems taking another medicine.

- if you have liver problems: your doctor may need to monitor your liver function or stop treatment.

- if you have ever had kidney problems.

Tell your doctor immediately:

- if you have any signs of liver disease such as yellowing of the skin, loss/lack of energy, dark urine or any signs of bleeding or behavioural disorders, as you may need liver function tests or further diagnostic tests.

- If you experience palpitations or an altered heartbeat, or if you faint or feel dizzy or if you have any muscle weakness when taking Azitromicina Azevedos.

- If you develop diarrhea or soft stools during or after treatment, talk to your doctor immediately. Do not take any medicine to treat diarrhea without first contacting your doctor. If your diarrhea persists, tell your doctor.

- if you develop any signs of an allergic reaction, for example, a rash/papules, blisters, hard breathing, dizziness, swelling of your face or throat. Stop taking this medicine and seek emergency medical attention. Severe allergic reactions to Azitromicina Azevedos are rare.

- If your newborn child develops vomiting and irritability during feeding.

This antibiotic acts on certain bacteria, but does not act on all bacteria or on infections caused by fungi (fungal).

Azitromicina Azevedos must be reconstituted and diluted according to the instructions, being administered by intravenous infusion in a period of not less than 60 minutes.

Other medicines and Azitromicina Azevedos

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you are taking any of the following medicines, inform your doctor or pharmacist before taking Azitromicina Azevedos:

- Antacids (used for heartburn or indigestion)

- Warfarin (or other medicine that interferes with blood clotting)

- Terfenadine (used in hay fever tratment or skin allergy)

- Cyclosporine (used in immune system suppression to prevent and treat rejection in organ or bone marrow transplants)

- Digoxin (used in heart failure treatment)

- Colchicine (used for gout and family mediterranean fever)

- Nelfinavir [used for the treatment of HIV infections (AIDS)]

- Ergotamine (used to treat migraine)

- Medicines against bacterial infections (e.g. a group of medicines called macrolides including azithromycin)

- Atorvastatin (used to lower cholesterol levels)

- Antiarrhythmic drugs (used to heart disease treatment)

- Antipsychotic drugs (used to treat hallucinations or disorderly thinking)

- Antidepressant drugs (used in depression)

- Fluoroquinolones (antibiotics used to treat severe bacterial infections)

Pregnancy and breast-feeding

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

There is no evidence that Azithromycin Azevedos affects the ability to drive or use machines.

Azitromicina Azevedos contains sodium.

This medicine contains 101.5 mg of sodium (main component of cooking/table salt) in each dose unit. This is equivalent to 5.1% of the recommended maximum daily dietary intake of sodium for an adult.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will determine the appropriate dose and treatment duration in your case.

The following table describes the most commonly used doses in adult patients for the treatment of Pneumonia (pulmonary infection) and Pelvic Infections.

Mode and route of administration

Azitromicina Azevedos is intended to be administered by intravenous infusion.

Average duration of treatment

The duration of your treatment will depend on the severity of your infection. It is up to your doctor to decide.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very frequent side effects (occur in at least 1 out of 10 patients) are:

- Diarrhea

Frequent side effects (occur in at least 1 out of 100 patients) are:

- Headache

- Vomiting, abdominal pain, nausea

- Reduced number of lymphocytes (white blood cell type), higher value of eosinophils, neutrophils, basophils and monocytes (white blood cell types)

- Reduced blood bicarbonate

Less common side effects (occur in at least 1 out of 1000 patients) are:

- Fungal infections in the vagina (candidiasis) and mouth (thrush), vaginal infection, pneumonia, fungal infection, bacterial infection, sore throat, abdominal pain and cramps, respiratory disorder, runny nose and nasal irritation

- Reduction in the number of leukocytes in the blood (leukopenia), decrease in the number of neutrophils (neutropenia)

- Sudden swelling under the skin and allergic reactions of diverse severities

- Loss of appetite

- Nervousness and difficulty in falling asleep

- Dizziness, drowsiness, change in taste (dysgeusia) and tingling, cold and warm sensations in a part of the body (paresthesia)

- Changes in vision

- Hearing disorders and vertigo

- Heart palpitations

- Hot flashes (sensation of heat)

- Shortness of breath and nosebleed (epistaxis)

- Constipation, flatulence, difficulty in digestion (dyspepsia), gastritis, impaired swallowing (dysphagia), abdominal distension, dry mouth, burps, appearance of ulcers in the mouth, increased saliva in the mouth

- Skin rash, itching, hives, dermatitis, very dry skin and excessive perspiration

- Acute pain and stiffness of tendons and muscles, muscle pain, pain in the dorsal region and cervical ache

- Painful or difficult urination and kidney pain

- Abnormal bleeding outside the menstrual period and testicular disease

- Localized swelling in a part of the body, generalized loss of strength, discomfort, fatigue, swelling on the face, chest pain, fever, pain, peripheral swelling

- Alterated values of laboratory analysis (e.g. blood or liver analysis)

Rare side effects (occur in at least 1 out of 10 000 patients) are:

- Agitation

- Altered liver function, yellowish skin and white coloring of the eyes

- Severe skin reaction after exposure to light or sunlight

- Eruption in the skin that is characterized by the rapid appearance of areas of red skin with small pustules (small blisters filled with white/yellow fluid)

- Delayed allergic reaction (up to several weeks after exposure) with rash and other possible symptoms such as face swelling, swollen glands and altered laboratory results (e.g. liver markers and increased white blood cell values)

Additional side effects that have been reported during the post-marketing experiment (with unknown frequency) are:

- Colic relieved by bowel movements, low fever, profuse watery diarrhea and dehydration (pseudomembranous colitis)

- Decreased platelet count, abnormally low hemoglobin level

- Very pronounced hives

- Aggressiveness, anxiety, delusions, hallucinations

- Blackouts, seizures, motor hyperactivity, decreased sensitivity to touch, loss of smell or altered smell, loss of taste, localized muscle weakness (Myasthenia gravis)

- Hearing loss and buzzing

- Heart rhythm problems, including fast heartbeat, irregular heartbeat

- Low blood pressure (hypotension)

- Pancreas inflammation, change in tongue color, severe skin reaction

- Liver failure, liver necrosis

- Kidney failure, kidney inflammation

- Altered electrocardiogram (ECG) (torsade de pointes and prolonged QT interval)

- Stomach pain associated with diarrhea and fever

- Easy bruising and bleeding

- Joint pain

If any of the side effects get worse or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

With intravenous administration of azithromycin has been reported inflammation and pain at the site of infusion .

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. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Store at temperature below 30 ºC.

Keep the medicine in its original container.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.

After reconstitution the concentrated solution (according to instructions): Azithromycin in the form of powder for solution to infuse is chemically and physically stable for 24 hours, when stored at 30ºC.

When diluted according to instructions, it results in a chemically and physically stable solution for 24 hours at 30ºC or for 7 days if stored in the refrigerator (5ºC). However, from a microbiological point of view, the medicinal product should be used immediately. If it is not used immediately, the time and storage conditions prior to administration are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless the reconstitution and dilution has taken place in controlled and validated aseptic conditions.

The unused solution must be rejected.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.