Package leaflet: Information for the user

Azithromycin Sandoz GmbH 200 mg/5 ml powder for oral suspension

azithromycin
Generic medicine
Read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
If any adverse reaction occurs, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Azithromycin Sandoz GmbH is and what it is used for
What you need to know before taking Azithromycin Sandoz GmbH
How to take Azithromycin Sandoz GmbH
Possible side effects
How to store Azithromycin Sandoz GmbH
Contents of the pack and other information

1. What Azitromicina Sandoz GmbH is and what it is used for

Azitromicina Sandoz GmbH contains the active substance azithromycin. Azithromycin is an antibiotic that
belongs to a group of antibiotics called "macrolides", which block the growth of susceptible bacteria.
Azitromicina Sandoz GmbH is taken to treat the following infections:
Children aged 6 months and above and weighing less than 45 kg

infections of the tonsils (tonsillitis) or throat (pharyngitis) caused by streptococcal bacteria
bacterial infections of the paranasal sinuses (sinusitis)
bacterial infections of the middle ear (otitis media)
lung infection (community-acquired pneumonia, not contracted in hospital)
bacterial infections of the skin and underlying tissues

Adults and adolescents weighing 45 kg or more who have difficulty swallowing:

In addition to the infections listed above, Azitromicina Sandoz GmbH can also be taken to treat the following infections:
infections of the urethra and cervix caused by the bacterium Chlamydia trachomatis
adults with chronic inflammation of the bronchi (chronic bronchitis).

2. What you should know before taking Azitromicina Sandoz GmbH

Do not take Azitromicina Sandoz GmbH if you are allergic to:
azithromycin, erythromycin, other antibiotics known as "macrolides" or "ketolides", or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Azitromicina Sandoz GmbH if you have or have previously had any of the following conditions:

heart problems (e.g. irregular heartbeat or heart failure) or low levels of potassium or magnesium in the blood: these conditions may contribute to serious cardiac side effects caused by azithromycin;
liver problems: your doctor may need to monitor liver function or discontinue treatment;
severe diarrhoea after taking other antibiotics; or muscle weakness (myasthenia gravis), as symptoms of this disease may worsen during treatment;
or if you are taking ergot derivatives such as ergotamine (used to treat migraine), since these medicines must not be taken together with Azitromicina Sandoz GmbH.

Stop taking this medicine and contact your doctor immediately (see also “Serious adverse reactions” in section 4):

if you suspect you are having an allergic reaction (e.g. difficulty breathing, swelling of the face or throat, rash, blisters);
if you notice any of the symptoms described in section 4 related to severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), which have been reported during azithromycin treatment;
if you experience an abnormal heartbeat or palpitations, dizziness or fainting while taking Azitromicina Sandoz GmbH;
if you develop signs of liver problems (e.g. dark urine, loss of appetite, or yellowing of the skin or whites of the eyes);
if you develop severe diarrhoea during or after treatment. Do not take any medicine for diarrhoea without first consulting your doctor. If diarrhoea persists or recurs within the first few weeks of treatment, inform your doctor.

Superinfection
Your doctor may monitor for symptoms of additional bacterial or fungal infections that cannot be treated with Azitromicina Sandoz GmbH (superinfection).

Sexually transmitted infections
Your doctor may perform a test to rule out possible syphilis, a sexually transmitted disease that could otherwise progress undetected and be diagnosed late. Furthermore, in cases of bacterial sexually transmitted infections, your doctor will carry out follow-up laboratory tests to monitor the success of treatment.

Children and adolescents
If the child is under 6 months of age, consult your doctor or pharmacist, as the efficacy and safety of this medicine have not been established in this age group.

Infantile hypertrophic pyloric stenosis (IHPS)
If the child is under 6 months of age and your doctor has prescribed azithromycin treatment, stop administering this medicine and contact your doctor immediately if projectile vomiting occurs or if the child becomes irritable during or immediately after feeding.

Other medicines and Azitromicina Sandoz GmbH
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking Azitromicina Sandoz GmbH together with other medicines may cause adverse effects. It is therefore particularly important that you inform your doctor if you are taking any of the following medicines:

atorvastatin and other medicines in the statin group (to lower blood cholesterol and prevent heart disease, including heart attacks and strokes);
cyclosporine (to prevent rejection of transplanted organs);
colchicine (for the treatment of gout and familial Mediterranean fever);
dabigatran (to prevent and treat blood clots (anticoagulant));
digoxin (for the treatment of heart conditions);
warfarin or similar medicines used to thin the blood (anticoagulants);
medicines that may cause the heart muscle to take longer than usual to contract and relax (QT interval prolongation), such as:
- quinidine, procainamide, dofetilide, amiodarone and sotalol (for the treatment of irregular heartbeat, including cases of heartbeat that is too fast or too slow – cardiac arrhythmia);
- pimozide (for the treatment of mental illnesses);
- citalopram (for the treatment of depression);
- moxifloxacin and levofloxacin (antibiotics);
- cisapride (for the treatment of gastrointestinal disorders);
- hydroxychloroquine or chloroquine (for the treatment of autoimmune diseases, including rheumatoid arthritis, or to treat or prevent malaria).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Your doctor will decide whether you can take this medicine during pregnancy, after ensuring that the benefits outweigh the potential risks.

Breastfeeding
Azitromicina Sandoz GmbH passes into breast milk. Therefore, your doctor will decide whether to discontinue breastfeeding or avoid treatment with Azitromicina Sandoz GmbH, taking into account both the benefit of breastfeeding for the child and the benefit of treatment for you.

Driving and using machines
Azitromicina Sandoz GmbH may moderately affect the ability to drive vehicles and use machinery.
Dizziness, drowsiness, seizures, and visual or hearing disturbances have been reported with Azitromicina Sandoz GmbH. These possible adverse effects may impair the ability to drive or operate machinery.

Azitromicina Sandoz GmbH 200 mg/5 ml contains sucrose, sodium, aspartame, benzyl alcohol, and sulfites

Sucrose
This medicine contains 3.71 grams of sucrose in each 5 ml of suspension; this should be taken into account in patients with diabetes mellitus.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Aspartame
This medicine contains 0.030 g of aspartame in each 5 ml of suspension. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.

Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially "sodium-free".

Benzyl alcohol
This medicine contains up to 410 nanograms of benzyl alcohol per 5 ml of suspension.
Benzyl alcohol may cause allergic reactions. Do not give to newborn infants (up to 4 weeks of age) unless recommended by a doctor. Do not use for more than one week in young children (under 3 years of age) unless advised by a doctor or pharmacist. Consult your doctor or pharmacist if you are pregnant or breastfeeding, or if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (called "metabolic acidosis").

Sulfites
This medicine contains up to 85 nanograms of sulfites per 5 ml of suspension.
Rarely, it may cause severe hypersensitivity reactions and bronchospasm.

3. How to take Azithromycin Sandoz GmbH

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended doses and duration of treatment are described below.
Children aged 6 months and older and weighing less than 45 kg

Infection	Azithromycin treatment regimen
Bacterial infections of the paranasal sinuses (sinusitis) Lung infection (community-acquired pneumonia, not contracted in hospital) Bacterial skin and underlying tissue infections	For these infections, a 3-day or 5-day treatment regimen is recommended 3-day treatment regimen: 10 mg/kg once daily for 3 days 5-day treatment regimen: 10 mg/kg on the first day, followed by 5 mg/kg once daily for the next 4 days
Bacterial middle ear infections (otitis media)	For this infection, a 1-day, 3-day, or 5-day treatment regimen is recommended 1-day treatment regimen: single dose of 30 mg/kg 3-day treatment regimen: 10 mg/kg once daily for 3 days 5-day treatment regimen: 10 mg/kg on the first day, followed by 5 mg/kg once daily for the next 4 days
Streptococcal bacterial infections of the tonsils (tonsillitis) or throat (pharyngitis)	For these infections, a 3-day or 5-day treatment regimen is recommended 3-day treatment regimen: 20 mg/kg once daily for 3 days 5-day treatment regimen: 12 mg/kg once daily for 5 days

It is important to ensure that you use the amount of Azithromycin Sandoz GmbH indicated in the table below, based on the patient's body weight, the infection being treated, and the specific treatment course (1 day, 3 days, 5 days) that your doctor or pharmacist has instructed you to follow.

Body weight (kg)	Maximum daily dose of azithromycin oral suspension 40 mg/mL in bottle after reconstitution (15 ml, 20 ml, 22.5 ml, 30 ml or 37.5 ml)^
Body weight (kg)	5 mg/kg+	10 mg/kg	12 mg/kg++	20 mg/kg	30 mg/kg
7	1.00 mL (40 mg) *	1.75 mL (70 mg) *	2.25 mL (90 mg)	3.50 mL (140 mg)	5.25 mL (210 mg)
8	1.00 mL (40 mg) *	2.00 mL (80 mg) *	2.50 mL (100 mg)	4.00 mL (160 mg)	6.00 mL (240 mg)
9	1.25 mL (50 mg) *	2.25 mL (90 mg)	2.75 mL (110 mg)	4.50 mL (180 mg)	6.75 mL (270 mg)
10	1.25 mL (50 mg) *	2.50 mL (100 mg)	3.00 mL (120 mg)	5.00 mL (200 mg)	7.50 mL (300 mg)
11	1.50 mL (60 mg) *	2.75 mL (110 mg)	3.25 mL (130 mg)	5.50 mL (220 mg)	8.25 mL (330 mg)
12	1.50 mL (60 mg) *	3.00 mL (120 mg)	3.75 mL (150 mg)	6.00 mL (240 mg)	9.00 mL (360 mg)
13	1.75 mL (70 mg) *	3.25 mL (130 mg)	4.00 mL (160 mg)	6.50 mL (260 mg)	9.75 mL (390 mg)
14	1.75 mL (70 mg) *	3.50 mL (140 mg)	4.25 mL (170 mg)	7.00 mL (280 mg)	10.50 mL (420 mg)
15	2.00 mL (80 mg) *	3.75 mL (150 mg)	4.50 mL (180 mg)	7.50 mL (300 mg)	11.25 mL (450 mg)
16–25	2.50 mL (100 mg)	5.00 mL (200 mg)	6.25 mL (250 mg)	10.00 mL (400 mg)	15.00 mL (600 mg)
26–35	3.75 mL (150 mg)	7.50 mL (300 mg)	8.75 mL (350 mg)	12.50 mL (500 mg)#	22.50 mL (900 mg)
36–<45	5.00 mL (200 mg)	10.00 mL (400 mg)	11.25 mL (450 mg)	12.50 mL (500 mg) #	30.00 mL (1 200 mg)

^after reconstitution, the oral suspension concentration is 40 mg/mL and the total volume of
suspension in the bottle is 15 ml (600 mg), 20 ml (800 mg), 22.5 ml (900 mg), 30 ml (1200 mg), or 37.5 ml
(1500 mg))

Doses have been rounded to obtain an appropriate dose for administration.
++ Doses have been rounded to obtain an appropriate dose for administration.
* azithromycin 20 mg/mL (100 mg/5 mL) powder for oral suspension is the most appropriate formulation
for administration to these patients.

do not exceed the adult daily dose of 500 mg

Adult and adolescent patients weighing 45 kg or more who have difficulty swallowing

Infection	Azithromycin treatment regimen
Strep throat (tonsillitis) or sore throat (pharyngitis) caused by streptococcal bacteria Bacterial infections of the paranasal sinuses (sinusitis) Bacterial infections of the middle ear (otitis media) Bacterial infections in patients with long-term bronchial inflammation (chronic bronchitis)* Lung infection (community-acquired pneumonia, not contracted in hospital)# Bacterial skin and underlying tissue infections	For these infections, a 3-day or 5-day treatment regimen is recommended, and the amount of Azithromycin Sandoz GmbH to be taken each day for these regimens is described below. 3-day treatment regimen: 12.5 mL (500 mg) taken once daily for 3 days. 5-day treatment regimen: 12.5 mL (500 mg) taken on the first day of treatment, followed by 6.25 mL (250 mg) once daily for the next 4 days
Urethral and cervical infections caused by the bacterium Chlamydia trachomatis	25 mL (1000 mg) taken as a single dose

* for adult patients only

for adult patients, oral treatment may follow an initial intravenous treatment

Use in children and adolescents
The safety and efficacy of azithromycin have not been established in children under 6 months of age
for any of the indications listed in section 1.
Method of administration
For oral use after reconstitution.
Azitromicina Sandoz GmbH must be taken orally as a single daily dose. The oral suspension can be taken regardless of meals. Taking this medicine shortly before a meal may help improve gastrointestinal tolerability.
If the bottle of Azitromicina Sandoz GmbH received from the doctor or pharmacist contains only powder and no liquid, a specific volume of water must be added to the bottle before it can be used. If the doctor or pharmacist has already dissolved the powder, you may proceed directly to the section “Instructions for taking each daily dose of Azitromicina Sandoz GmbH oral suspension” below.
How to measure a dose
This medicine comes with a 10 ml dosing syringe marked in 0.25 ml increments and a bottle adapter. To measure the medicine:

shake the bottle
insert the adapter into the bottle neck
insert the tip of the syringe into the adapter
turn the bottle upside down
pull back the plunger to draw up the required dose
return the bottle to upright position, remove the syringe, leave the adapter on the bottle and close it.

If you need help measuring this medicine, ask your doctor or pharmacist for advice.
Administration using the syringe

ensure the child is in an upright position
carefully insert the tip of the syringe into the child’s mouth, directing it towards the inside of the cheek
slowly push the syringe plunger; do not rapidly squirt the suspension. The medicine will slowly dispense into the child’s mouth
allow the child time to swallow the medicine.

How to prepare this medicine
Your doctor, nurse or pharmacist will prepare this medicine for you. To open the bottle, press down on the child-resistant cap and then turn it.
If you need to prepare the medicine yourself, shake the dry powder and add the correct amount of cold water. Use the 10 ml syringe to measure the required amount of water. The amount of water needed depends on the bottle size and is as follows:

for a 15 ml (600 mg) suspension, add 8 ml of water
for a 20 ml (800 mg) suspension, add 10.5 ml of water
for a 22.5 ml (900 mg) suspension, add 11 ml of water
for a 30 ml (1200 mg) suspension, add 15 ml of water
for a 37.5 ml (1500 mg) suspension, add 18.5 ml of water

Shake the bottle well immediately after adding the correct amount of water. The suspension should be prepared only once, at the beginning of treatment.
If you take more Azitromicina Sandoz GmbH than you should
If you take more Azitromicina Sandoz GmbH than you should, you may feel unwell. Typical signs of overdose include vomiting, diarrhoea, abdominal pain and nausea. Inform your doctor immediately or contact the emergency department of the nearest hospital.
If you forget to take Azitromicina Sandoz GmbH
If you forget to take Azitromicina Sandoz GmbH, take it as soon as possible, provided that it is at least 12 hours before the next dose. If less than 12 hours remain before the next dose, do not take the missed dose; instead, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you stop treatment with Azitromicina Sandoz GmbH
If you stop treatment with Azitromicina Sandoz GmbH too early, the infection may recur. Take Azitromicina Sandoz GmbH for the full duration of treatment, even if you start to feel better.
If you have any questions about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible side effects

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

Serious side effects
Stop taking Azithromycin Sandoz GmbH and contact your doctor immediately if you notice any of the following symptoms:

Sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching mainly affecting the whole body (anaphylactic reaction, frequency not known)
Fast or irregular heartbeat (cardiac arrhythmia or torsades de pointes tachycardia, frequency not known)
Dark urine, loss of appetite, or yellowing of the skin or whites of the eyes, signs of liver problems (liver failure or hepatic necrosis, frequency not known)
Severe diarrhoea with abdominal cramps, blood in the stools and/or fever, which may indicate an infection of the large intestine (antibiotic-associated colitis, frequency not known). Do not take anti-diarrhoeal medicines that inhibit intestinal motility (antiperistaltics)
Reddish, non-elevated spots on the trunk, target-shaped or circular rashes, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome or toxic epidermal necrolysis, frequency not known)
Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome, rare (may affect up to 1 in 1,000 people))
Widespread, red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis, rare (may affect up to 1 in 1,000 people)).

Other side effects
Very common (may affect more than 1 in 10 people)

Diarrhoea

Common (may affect up to 1 in 10 people)

Headache
Vomiting, stomach pain, feeling unwell (nausea)
Changes in blood test results (decreased lymphocyte count, increased eosinophil count, increased basophil count, increased monocyte count, increased neutrophil count, decreased blood bicarbonate)

Uncommon (may affect up to 1 in 100 people)

Candidiasis (fungal infection of the mouth and vagina), other fungal infections
Lung infection, bacterial throat infection, gastrointestinal tract inflammation, respiratory disorder, inflammation of the nasal mucosa, vaginal infection
Changes in white blood cell count (leucopenia, neutropenia, eosinophilia)
Increased platelet count
Reduced percentage of all blood cells in total blood volume (reduced haematocrit)
Allergic reactions, swelling of hands, feet and face (angioedema), loss of appetite
Nervousness, difficulty sleeping (insomnia)
Dizziness, drowsiness (somnolence), altered sense of taste (dysgeusia), numbness sensation (paraesthesia), visual disturbances
Ear disorder
Dizziness (vertigo)
Awareness of heartbeat (palpitations)
Hot flush
Sudden wheezing, nosebleed
Constipation, intestinal gas, impaired digestion (dyspepsia), inflammation of the stomach lining (gastritis), difficulty swallowing (dysphagia), bloated abdomen, dry mouth, burping, mouth ulcers, increased salivation
Rash, itching, hives (urticaria), dermatitis, dry skin, abnormally increased sweating (hyperhidrosis)
Swelling and pain in joints (osteoarthritis), muscle pain, back pain, neck pain
Painful urination (dysuria), kidney pain
Irregular menstrual bleeding (metrorrhagia), testicular disorder
Swelling due to fluid retention, especially in the face, ankles and feet (oedema, facial oedema, peripheral oedema)
Weakness, fatigue, general malaise, fever
Chest pain, pain
Abnormal laboratory test results (e.g. blood or liver tests)
Post-procedural complication

Rare (may affect up to 1 in 1,000 people)

Irritation sensation
Liver problems, increased sensitivity to sunlight

Not known (frequency cannot be estimated from the available data)

Decreased number of red blood cells due to increased cell breakdown, which may cause fatigue and pale skin (haemolytic anaemia)
Reduced number of platelets in the blood, which may lead to bleeding and bruising (thrombocytopenia)
Feeling angry, aggressive, fearful or worried (anxiety), acute state of confusion (delirium)
Hallucination
Fainting (syncope)
Seizures (convulsions)
Reduced sensitivity to touch, pain and temperature (hypoesthesia)
Feeling overactive
Changes in sense of smell (anosmia, parosmia)
Complete loss of taste (ageusia)
Muscle weakness (myasthenia gravis)
Abnormal electrocardiogram (ECG) (prolongation of QT interval)
Deafness, reduced hearing or ringing in the ears (tinnitus)
Low blood pressure
Inflammation of the pancreas causing severe abdominal and back pain (pancreatitis)
Change in tongue colour
Joint pain (arthralgia)
Kidney inflammation (interstitial nephritis) and impaired kidney function

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Azithromycin Sandoz GmbH

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton/bottle after "Exp".
The expiry date refers to the last day of that month.
Vial closed with dry powder: do not store above 30°C.
Reconstituted suspension: do not store above 25°C.
Do not use the reconstituted suspension for more than 10 days.
If you purchased the suspension from the pharmacy, use it no later than 10 days after the date of issue. The date of issue is stated on the pharmacy label.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Azitromicina Sandoz GmbH contains

The active substance is azithromycin. Each 5 ml of reconstituted suspension contains 209.6 mg of azithromycin dihydrate, equivalent to 200 mg of azithromycin.
The other components are: sucrose, xanthan gum (E415), hydroxypropylcellulose, anhydrous trisodium phosphate, anhydrous colloidal silica (E551), aspartame (E951), banana flavour (containing sulphites), vanilla cream flavour (containing benzyl alcohol), and cherry flavour (containing sulphites).

Description of the appearance of Azitromicina Sandoz GmbH and contents of the pack
Azitromicina Sandoz GmbH is a crystalline powder, white to off-white in colour.
After reconstitution, Azitromicina Sandoz GmbH is a homogeneous suspension, white to off-white in colour.
Pack sizes: HDPE bottles of 15 ml (600 mg), 20 ml (800 mg), 22.5 ml (900 mg), 30 ml (1200 mg) and 37.5 ml (1500 mg).
An oral dosing syringe (10 ml) with 0.25 ml graduations is also included.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Sandoz GmbH – Biochemiestrasse, 10 – 6250 Kundl (Austria)
Legal Representative: Sandoz S.p.A – Viale Luigi Sturzo, 43 - 20154, Milan, Italy

Manufacturers:
LEK Pharmaceuticals d.d, Verovskova 57, Ljubljana, Slovenia
Salutas Pharma GmbH – Otto von Guericke Allee 1 – 39179 Barleben – Germany
Novartis Pharmaceuticals S.R.L, Str. Livezeni nr. 7A, 540472 Târgu-Mureș, Romania

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria: Azithromycin Sandoz 200 mg/5 ml - Powder for the preparation of an oral suspension
Belgium: Azithromycine Sandoz 200mg/5ml powder for oral suspension
Finland: Azithromycin Sandoz 40 mg/ml powder for oral suspension
Hungary: Azithromycin Sandoz 200 mg/5 ml por sziruphoz belsőleges szuszpenzióhoz
Italy: AZITROMICINA Sandoz GmbH
Netherlands: Azitromycine Sandoz 200 mg/5 ml, powder for oral suspension
Poland: AzitroLEK
Romania: AZITROMICINÃ SANDOZ 200 mg/5 ml powder for oral suspension
Slovak Republic: Azithromycin Sandoz 200mg/5ml powder for oral suspension
Spain: Azitromicina Sandoz 200 mg/5 ml powder for oral suspension EFG
United Kingdom (Northern Ireland): Azithromycin 200mg/5ml Powder for Oral Suspension