AZITROX suspension. 200 mg. / 5 ml. 15 ml.

What AZITROX and what it is used?

AZITROX belongs to a group of antibiotics called macrolides. AZITROX is effective for the treatment of infections caused by bacteria. AZITROX used for treatment of:

- Respiratory tract infections (bronchitis, pneumonia, tonsillitis, pharyngitis and sinusitis);
- Ear infections, infections of skin and soft tissue (such as erysipelas, abscess);
- Chronic migratory erythema (first Lyme disease);
- Gastric and intestinal infections caused by Helicobacter pylori

2. What you should know before taking AZITROX
Do not take AZITROX:

If you are allergic (hypersensitive) to the active substance of AZITROX (azithromycin), or other macrolide antibiotics such as erythromycin, clarithromycin or any of the other ingredients;

- If you are taking ergot derivatives such as ergotamine (used to treat migraine)

- If you have severe liver failure. Take special care with AZITROX:

Please tell your doctor if you have health problems, especially if you have:

- A liver problem. Your doctor may monitor your liver function or to stop treatment.

- Renal Disease. AZITROX should not be used in patients with severe renal failure.

- History of offense called "syndrome of long QT 'Diarrhea

- Neurological (diseases of the nervous system such as epilepsy, schizophrenia, Alzheimer's disease and Parkinson's disease) and psychiatric disorders (affective disorders).

- Myasthenia gravis (an autoimmune disorder characterized by muscle weakness and tiredness).

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
This medicine should not be used concomitantly with ergot derivatives - ergotamine,
dihydroergotamine (used to treat migraine): ergotism may occur (ie, itching of the extremities, muscle cramps and gangrene of the hands and feet due to poor circulation).
The combination of AZITROX and the following drugs is possible only after careful consideration of a doctor:

- Antacids (indigestion) - AZITROX should be taken one hour before or two hours after antacids;

- Nelfinavir, zidovudine (medicines for the treatment of HIV);

Rifabutin (for tuberculosis);

- Ciclosporin (used to suppress the immune system, the prevention and treatment of rejection of a transplanted organ or bone marrow transplant;

- Digoxin (used to treat heart failure);

- Terfenadine (for hay fever or skin allergy);

- Warfarin and similar medicines used to prevent the formation of blood clots;

- Other antibiotics (such as erythromycin, lincomycin and clindamycin);

- Cisapride (for stomach problems), terfenadine (used to treat hay fever) concomitant intake AZITROX can cause cardiac disorders.

Taking AZITROX with food and drink

Take AZITROX fasting one hour before meals or two hours after meals.
Pregnancy and lactation

Ask your doctor or pharmacist before taking on any medicine.
Azithromycin should be used in pregnant and breastfeeding women only if no other treatment alternatives.

Driving and using machines

Azithromycin did not affect the ability to drive and use machines. Important information about some of the ingredients of AZITROX
AZITROX contains sucrose. If your doctor has told you that you have an intolerance to some sugars, contact him before taking this medicine.
No special precautions for use associated with inactive ingredients in this product.

3. AZITROX How to take?
Always take AZITROX exactly as your doctor tells you. If you are not sure, ask your doctor or pharmacist.

The usual dose for children is 1 Omg / kg of body weight in a single daily dose for 3 days. AZITROX suspension should be used in children weighing less than 45 kg. Dose in children depends on body weight.
Body weight (kg) AZITROX Dosage of 200 mg / 5 ml, using the dosing syringe
Dosage AZITROX 200 mg / 5 ml, using a dosing spoon
5 kg
1,25 ml (50mg)
 
6 kg 1,5 ml (60 mg)
7 kg 1,75 ml (70 mg)
8 kg
2 ml (80mg)
 
9 kg 2.25 ml (90mg)
10-14 2.5 ml (lOOmg) 2.5 ml (100mg)
15-24 5 ml (200mg) 5 ml (200mg)
25-34 7.5 ml (300 mg) 7.5 ml (300 mg)
34-44 10 ml (400 mg) 10 ml (400 mg)
45 kg or more adult dose (500mg)
The dose for administration can be measured using a dosing syringe or a dosing spoon.

For children under 15 kg (under 3 years):

AZITROX levels must be administered using a dosing syringe. Each of the syringe marked division by 0, 25 ml of 10 mg of azithromycin provided.

For children weighing over 15 kg: AZITROX levels must be administered using a dosing spoon.

Children weighing more than 45 kg may receive the same dose as adults. The usual dose is 500 mg as a single daily dose for 3 days.

Patients with kidney and liver problems:

You should tell your doctor if you have kidney or liver disease, and your doctor may change the normal dose.

Drug administration using syringe

1 - Make sure that the child is placed in an upright position

2. Carefully place the tip of the syringe into the mouth of the child. Aim the tip of the syringe to the inside of the cheek.

3. Slowly press the plunger: Do not squirt quickly. The medicine will trickle into the child's mouth.

4. Provide time the child to swallow medicine

5. Pull the plunger of the syringe and wash, keeping the two parts under warm running water

6. Dry the two parts. Put the plunger back into the syringe. Store in a clean safe drug.

Administration of the drug by using the spoon

1. Shake the bottle well and then remove the cap.

2. Carefully pour the medicine into the spoon to the required amount for the prescribed dose.

3. Provide time the child to swallow the medicine.

4. The spoon Wash under running warm water. Dry and store in a safe place with the drug.

Instructions for use:
Shake dry powder.
15 ml oral suspension:

To obtain an oral suspension, powder to add 7,5 ml of plain water in a container with a capacity of 15 ml, the resulting suspension contains 200 mg of azithromycin in 5 ml of suspension.

30 ml oral suspension:

To obtain an oral suspension, add 15 ml of the powder onto plain water in a container with a capacity of 30 ml, the resulting suspension contains 200 mg of azithromycin in 5 ml of suspension.

Prepared oral suspension should be stored for 5 days at 25 ° C in the original packaging.

If you take more dose AZITROX

Seek immediate medical attention if you think you have taken too much of this medicine. Symptoms of overdose azithromycin include nausea, vomiting, diarrhea, and stomach discomfort.

If you forget to take AZITROX

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your usual dosing schedule. Do not take a double dose * to make up.
Not more than one dose is to be administered in a single day. It should not take more than one dose per day.

If you stop taking AZITROX

Take this medicine for the full treatment period prescribed by your doctor. Your condition may improve before the infection is completely healed.

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

4. Possible side effects

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

Immediately stop taking the drug and seek medical attention if you experience any of these side effects:

• Swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing, low blood pressure, skin itching and hives. These symptoms may be a sign of a severe allergic reaction (angioedema or anaphylactic reaction)

• Severe skin reactions such as blistering of the skin, mouth, eyes and genital area, skin outbreaks, skin redness, rash, swelling of the skin and mucous membranes.

While taking AZITROX may occur following adverse events, stratified according to their frequency of:

Common side effects (affects 1 to 10 users in 100)

Abdominal pain, cramps, nausea, vomiting and diarrhea.

Uncommon side effects (affects 1 to 10 users in 1000):

candidiasis

headache, dizziness, drowsiness, unconsciousness, impaired sense of smell and taste fecal incontinence, bloating, indigestion, anorexia, dyspepsia

allergic skin reactions including itching and transient redness of the skin, pain in the joints.
Rare side effects affects 1 to 10 users in 10,000:

inflammation of the lining of the vagina

Increased numbers of eosinophils (eosinophilia), decreased platelet count (thrombocytopenia) and neutrophils (neutropenia) in the blood

Agitation, aggressive reactions, insomnia, anxiety, nervousness, hyperactivity,

sensation - "needles" (paresthesia)

Hearing impairment, deafness, dizziness, ringing in the ears (tinnitus)

visual disturbances

Chest pain, palpitations, abnormal or irregular heart rhythm or heart rate, palpitations ^

Abnormally low blood pressure (hypotension) fatigue, malaise

Difficulty in defecation, discoloration of the tongue, pancreas inflammation, infection of the colon

Elevated liver enzymes and bilirubin were observed infrequently,

jaundice, liver damage

photosensitivity

Inflammation of the kidneys, sudden inability of the kidneys to release and maintain electrolyte balance.

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

5. AZITROX How to store?

Keep out of reach of children.
Store at temperatures below 25 ° C in the original packaging.
Do not use after the expiry date printed on the box - The expiry date refers to the last day of the indicated month. Store below 25 ° C in the original package.
Reconstituted suspension must be stored for 5 days at 25 ° C in the original packaging.
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 Package Contents and more information
What does AZITROX?

The active ingredient is 200 mg azithromycin azithromycin dihydrate in 5 ml of oral suspension prepared.

The other ingredients are sucrose, trnnatriev phosphate (anhydrous), hydroxypropylcellulose, xanthan gum, banana flavor (powder).

What AZITROX and contents of the pack?

AZITROX is white with banana flavor, free flowing, homogeneous, fine granular, free of lumps.

Pack sizes: 15 ml for oral suspension

Bottle of powder with a child-resistant closure in 15 ml prepared oral suspension, oral syringe and a measuring spoon, measuring cap.
30 ml oral suspension

Bottle of powder with a child-resistant closure in 30 ml prepared oral suspension, oral syringe and a measuring spoon, measuring cap.