Azitromycine 200 mg/5 ml ratiopharm, poeder voor orale suspensie

Azithromycin is one of a group of antibiotics called macrolides. It is used to treat bacterial infections caused by micro-organisms such as bacteria. These infections include:

• Chest infections such as acute bronchitis and pneumonia
• Infections in your sinuses, throat, tonsils or ears
• Mild to moderate skin and soft tissue infections, e.g. infection of the hair follicles (folliculitis), bacterial infection of the skin and its deeper layers (cellulitis), skin infection with shiny red swelling (erysipelas)
• Infections caused by a bacterium called Chlamydia trachomatis. They can cause inflammations of the tube that carries urine from your bladder (urethra) or where your womb joins your vagina (cervix).

Do NOT use Azithromycin:

• If you are allergic (hypersensitive) to azithromycin or any of the other ingredients of this medicine or any other macrolide or ketolide antibiotic, e.g. erythromycin or telithromycin

Take special care with Azithromycin:

Talk to your doctor before you start to take this medicine if you:

• have ever had a serious allergic reaction causing swelling of the face and throat, possibly with breathing problems
• have severe kidney problems: your doctor may alter the dose
• have liver problems: your doctor may need to monitor your liver function or stop the treatment
• are aware of ever being diagnosed to have prolonged QT interval (a heart condition):

azithromycin is not recommended

• are aware that you have a slow or irregular heart beat, or reduced heart function: azithromycin is not recommended
• know that you have low levels of potassium or magnesium in your blood: azithromycin is not recommended
• are taking medicines known as antiarrhythmics (used to treat abnormal heart rhythms), cisapride (used to treat stomach problems) or terfenadine (an antihistamine that is used to treat allergies): azithromycin is not recommended
• are taking medicines known as ergot alkaloids (such as ergotamine), which are used to treat migraine: azithromycin is not recommended (see 'Taking other medicines' below)
• have been diagnosed with a neurological disease, which is a disease of the brain or nervous system
• have mental, emotional or behavioural problems
• have a condition known as myasthenia gravis, with fatigue and exhaustion of the muscles: azithromycin may worsen or cause symptoms of myasthenia.

If you develop severe and persistent diarrhoea during or after treatment, especially if you notice blood or mucus, tell your doctor immediately.

If your symptoms persist after the end of your treatment with Azithromycin, or if you notice any new and persistent symptoms, contact your doctor.

Taking other medicines

Check with your doctor if you are taking any of the following:

• Antacids e.g. aluminium hydroxide: take Azithromycin at least 1 hour before or 2 hours after taking an antacid
• Ergot derivatives, e.g. ergotamine (used to treat migraine): Azithromycin should not be taken at the same time as ergotism may develop (a potentially serious side effect with numbness or tingling sensations in the limbs, muscle cramps, headaches, convulsions, abdominal or chest pain)
• Coumarin derivatives, e.g. warfarin (used to stop the blood clotting): the risk of bleeding may be increased
• Digoxin (used to treat heart failure): the levels of digoxin in your blood may increase
• Zidovudine, nelfinavir (used in the treatment of HIV): the levels of zidovudine or azithromycin might be increased
• Rifabutin (used in the treatment of HIV and bacterial infections including tuberculosis): decreases in your number of white blood cells could occur
• Ciclosporin (an immunosuppressant used following organ transplant): your doctor will need to monitor your ciclosporin blood levels
• Cisapride (used to treat stomach problems): heart problems may occur
• Astemizole, terfenadine (antihistamines used to treat allergic reactions): their effect might be increased
• Alfentanil (a painkiller): the effect of alfentanil might be increased
• Fluconazole (for fungal infections): the levels of azithromycin might be reduced.

No interactions have been observed between azithromycin and cetirizine (an antihistamine); didanosine, efavirenz, indinavir (for HIV infection); atorvastatin (for cholesterol and heart problems); carbamazepine (for epilepsy); cimetidine (an antacid); methylprednisolone (to suppress the immune system); midazolam, triazolam (sedatives); sildenafil (for impotence) and

trimethoprim/sulphamethoxazole (an antibiotic combination).

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

There is insufficient information regarding the safety of azithromycin during pregnancy. Consequently, Azithromycin is not recommended if you are pregnant or planning to become pregnant. However, your doctor may prescribe it under serious circumstances.

You should not breast-feed whilst you are taking Azithromycin, because it may cause side effects including diarrhoea and infection in your baby. You may resume nursing two days after stopping your treatment with Azithromycin.

Ask your doctor for advice before taking any medicine.

Driving and using machines

Azithromycin may cause dizziness and fits. If affected, do not drive or operate machinery.

Important information about some of the ingredients of Azithromycin

This medicine contains 3.75 g of sucrose per 5 ml.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

The sucrose content should be taken into account in patients with diabetes mellitus

Always use Azithromycin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Preparation of the suspension

By the pharmacist: your pharmacist should prepare the suspension. If you notice that this was not done, then you should go back to the pharmacy to have the suspension prepared.

By yourself: follow the instructions in the blue box of this leaflet.

See blue box information

Dosage

Azithromycin suspension should be administered in one single daily dose, with or without food.

Shake the bottle well before you use the suspension.

The usual dose is:

Children and adolescents with a body weight above 45 kg, adults and the elderly

The total dose of azithromycin is 37.5 ml (1500 mg) over 3 days (12.5 ml (500 mg) once daily). As an alternative, the dose can be distributed over 5 days (12.5 ml (500 mg) as one single dose on the first day and then 6.25 ml (250 mg) once daily).

The dose for inflammation of the urethra or cervix caused by Chlamydia is 25 ml (1000 mg) in one single dose.

For sinusitis, treatment is aimed at adults and adolescents over 16 years of age.

Children and adolescents with a body weight under 45 kg

The azithromycin suspension should be measured as carefully as possible with the accompanying dosing syringe for children with a weight of 10 to 15 kg. For children who weigh more than 15 kg, the azithromycin suspension should be administered with the help of the dosing spoon according to the following plan:

Weight	3-day course	5-day course
10-15 kg	0.25 ml/kg (10 mg/kg) once	0.25 ml/kg (10 mg/kg) once on day 1, followed by
	daily on days 1 to 3	0.125 ml (5 mg/kg) once daily on days 2 to 5
16-25 kg	5 ml (200 mg) once daily on	5 ml (200 mg) once on day 1, followed by 2.5 ml
	days 1 to 3	(100 mg) once daily on days 2 to 5
26-35 kg	7.5 ml (300 mg) once daily on	7.5 ml (300 mg) once on day 1, followed by 3.75 ml
	days 1 to 3	(150 mg)) once daily on days 2 to 5
35-45 kg	10 ml (400 mg) once daily on	10 ml (400 mg) once on day 1, followed by 5 ml
	days 1 to 3	(200 mg) once daily on days 2 to 5
>45 kg	Dose as with adults

For the treatment of tonsillitis/pharyngitis in children aged 2 years or more: Azithromycin in a single dose of 10 mg/kg or 20 mg/kg for three days, in which the maximum daily dose of 500 mg should not be exceeded.

Sinusistis

For the treatment of sinusitis, limited data is available for the treament of children under 16 years of age.

Patients with kidney or liver problems:

You should tell your doctor if you have kidney or liver problems as your doctor may need to alter the normal dose.

A. Instructions for the syringe

Filling the syringe with medicine

1. Shake the bottle before use and remove the cap.
2. While the bottle is sitting on a firm, flat surface, hold it steady with one hand. With the other hand insert the tip of the syringe into suspension.
3. Slowly pull back the plunger of the syringe so that the top edge of the black ring is level with the graduation line indicated on the syringe.

1. If large bubbles can be seen in the syringe, slowly push the plunger back into the syringe. This will force the medicine back into the bottle. Repeat step 3 again.
2. Remove syringe from bottle.

Giving the medicine using the syringe

1. Make sure the child is supported in an upright position.
2. Put the tip of the syringe carefully into the child's mouth. Point the tip of the syringe towards the inside of the cheek.
3. Slowly push down the plunger of the syringe: Do not squirt it out quickly. The medicine will trickle into the child's mouth.
4. Allow the child time to swallow the medicine.
5. Replace the cap on the bottle. Wash the syringe as instructed below.
6. Where daily doses of less than 5 ml have been given for three days, some suspension will remain in the bottle. This remaining suspension should be discarded.

Cleaning and storing the syringe

Pull the plunger out of the syringe and wash both parts by holding under warm running water or by immersing in sterilising solution used for baby's feeding bottles, etc.

Dry the two parts. Push the plunger back into the syringe. Keep it in a clean safe place with the medicine. After you have given the child the final dose of medicine, wrap the syringe in a sheet of newspaper and put it in the rubbish bin.

B. Instructions for the spoon

The spoon should not be used for children less than 3 years of age (less than 15 kg).

Giving the medicine using the plastic spoon

1. A plastic double-ended spoon is provided with the medicine. Check which end of the spoon and to which level gives the dose required. If you are unsure, check with your doctor or pharmacist. Multi-dosing spoon delivers doses as follows:

2.5 ml	(100mg)	Small end	brimful
3.75 ml	(150mg)	Large end	to graduation
5 ml	(200mg)	Large end	brimful

1. Shake the bottle well and then remove the cap.
2. Gently pour the medicine into the spoon as required to give the correct dose.
3. Allow the patient to swallow the medicine slowly.
4. Wash the spoon under warm, running water. Dry and store it with the medicine in a safe place.

WARNING: GIVE THE MEDICINE SLOWLY TO THE CHILD WHILE HE/SHE IS SUPPORTED IN AN UPRIGHT POSITION. THIS WILL AVOID THE RISK OF CHOKING.

If you use more Azithromycin than you should

If you (or someone else) have taken too much Azithromycin, contact your doctor or pharmacist immediately. An overdose is likely to cause reversible hearing loss, severe nausea (feeling sick), vomiting and diarrhoea.

Please take this leaflet, any remaining medicine and the container with you to the hospital or doctor so that they know which medicine was consumed.

If you forget to use Azithromycin

If you forget to take a dose, take that dose as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose.

If you stop taking Azithromycin

Do not stop taking your medicine without talking to your doctor first even if you feel better. It is very important that you keep taking Azithromycin for as long as your doctor has told you to, otherwise the infection may come back.

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

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

If the following happens, stop taking Azithromycin and tell your doctor immediately or go to the casualty department at your nearest hospital:

• An allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives)
• Blisters/bleeding of the lips, eyes, nose, mouth and genitals, which may be caused by Stevens- Johnson syndrome or toxic epidermal necrosis, which are serious illnesses
• An irregular heart beat
• Prolonged diarrhoea with blood and mucus.

These are very serious but rare side effects. You may need urgent medical attention or hospitalisation.

The following other side effects have been reported:

Very common (affecting more than 1 user in 10):

• Diarrhoea, stomach pain, feeling sick, wind

Common (affecting 1 to 10 users in 100):

• Changes in the numbers of some white blood cells and blood bicarbonate
• Dizziness, headache, pins and needles or numbness
• Taste disorders
• Sight disorders
• Deafness
• Vomiting, indigestion, loss of appetite
• Rash, itching
• Joint pain
• Tiredness.

Uncommon (affecting 1 to 10 users in 1,000):

• Yeast infection e.g. of the mouth (thrush), vaginal infection
• Blood disorders characterised by fever or chills, sore throat, ulcers in your mouth or throat
• Allergic reactions
• Nervousness

• Loss of sensation, sleepiness, difficulty sleeping
• Hearing disturbances including ringing in the ears
• Abnormality of the rhythm or rate and awareness of the heart beat (palpitations)
• Inflammation of the stomach, constipation, loose stools
• Hepatitis (inflammation of the liver)
• Reddening and blistering of the skin when exposed to sunlight, hives (nettle rash)
• Inflammation of the vagina
• Chest pain, swelling, feeling unwell, lethargy
• Changes in liver enzymes and laboratory blood values.

Rare (affecting 1 to 10 users in 10,000):

• Agitation
• A feeling of things being unreal
• Confusion, especially in the elderly
• Spinning sensation
• Teeth discolouration
• Abnormal liver function
• Allergic reactions including angioneurotic oedema

The frequency of the following side effects is not known:

• Blood disorders characterised by unusual bleeding or unexplained bruising, low blood count causing unusual tiredness or weakness
• Aggression, anxiety
• Fainting, fits, hyperactivity, alteration or loss of the sense of smell, loss of the sense of taste, myasthenia gravis (fatigue and exhaustion of the muscle, see 'Take special care with Azithromycin' above)
• Change in heart rate
• Low blood pressure (which may be associated with weakness, lightheadedness and fainting)
• Discolouration of the tongue, inflammation of the pancreas causing nausea, vomiting, abdominal pain, back pain
• Liver failure (rarely life-threatening)
• Rash with spots and blisters
• Kidney problems
• Pain
• Serious bowel inflammation (pseudomembranous colitis)
• Serious allergic reaction that may lead to shock (anaphylactic reaction).

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

Keep out of the reach and sight of children.

Powder: store below 25°C

Do not use Azithromycin after the expiry date that is stated on the carton and bottle.

After reconstitution store at a temperature below 25°C and use within 5 days (azithromycin suspension 15 ml and 22.5 ml) or within10 days (azithromycin suspension 30 ml and 37.5 ml).

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.

What Azithromycin contains

• The active ingredient is azithromycin. One millilitre contains azithromycin dihydrate equivalent to 40 mg azithromycin after reconstitution with water (equivalent to 200 mg azithromycin per 5 ml).
• The other ingredients are silica, colloidal anhydrous (E551), sucrose, xanthan gum (E415), trisodium phosphate anhydrous, hydroxypropyl cellulose, chery flavouring trusil, vanilla flavour, banana flavour.

What Azithromycin looks like and contents of the pack

• The powder for the preparation of the suspension is a white to yellowish-white powder. The prepared suspension is a yellowish-white suspension.
• The powder for oral suspension is packed in bottles with 600, 900, 1200 or 1500 mg azithromycin, which provide suspension of 600 mg/15 ml, 900 mg/22.5 ml, 1200 mg/30 ml or 1500 mg/37.5 ml after reconstitution with water.

Pack sizes

Azithromycin 600 mg/15 ml: 12.555 g of powder for the preparation of 15 ml suspension Azithromycin 900 mg/22.5 ml: 18.8325 g of powder for the preparation of 22.5 ml suspension Azithromycin 1200 mg/30 ml: 25.110 g of powder for the preparation of 30 ml suspension’

Azithromycin 1500 mg/37.5 ml: 31.3875 g of powder for the preparation of 37.5 ml suspension

A dosing syringe and/or dosing spoon are provided with the bottles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Ratiopharm Nederland B.V.

Swensweg 5

2031 GA, Haarlem

Manufacturer

Teva Operations Poland Sp. z o.o. ul. Mogilska 80; 31-546 Krakow Polen

In het register ingeschreven onder:

RVG 111454

This medicinal product is authorised in the Member States of the EEA under the following

names:

Nederland	Azitromycine 200 mg/5 ml ratiopharm, poeder voor orale suspensie
Spanje	Azitromicina ratio 200 mg/5 ml, polvo para suspensión oral en frasco EFG

Deze bijsluiter is voor het laatst goedgekeurd in april 2013

Blue box

For countries where preparation of the suspension is carried out by pharmacist:

Preparation of the suspension

Your pharmacist should prepare the suspension. If you notice that this has not been done, then you should go back to the pharmacy to have the suspension prepared.

For countries where preparation of the suspension is carried out by the patient:

Preparation of the suspension

You can prepare the suspension yourself using the dosing syringe provided. First loosen the powder by tapping well.

For 15 ml (600 mg) bottle: add 9.5 ml water. For 22.5 ml (900 mg) bottle: add 12.0 ml water. For 30 ml (1200 mg) bottle: add 16.5 ml water. For 37.5 ml (1500 mg) bottle: add 20.0 ml water. Shake well.