Azithromycin Normon 500 mg powder for oral suspension in sachet EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Azithromycin Normon 500 mg powder for oral suspension in sachet EFG

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Azithromycin Normon is and what it is used for
2. What you need to know before taking Azithromycin Normon
3. How to take Azithromycin Normon
4. Possible side effects
5. How to store Azithromycin Normon
6. Contents of the pack and other information

1. What Azitromicina Normon is and what it is used for

Azitromicina Normon contains the active substance azithromycin. Azithromycin is an antibiotic that belongs to a group of antibiotics known as macrolides, which block the growth of susceptible bacteria.

Azithromycin is indicated for the treatment of the following infections:

• Infection of the tonsils (tonsillitis) or throat (pharyngitis) caused by streptococcal bacteria
• Bacterial infection of the sinuses (sinusitis)
• Bacterial infection of the middle ear (otitis media)
• Pneumonia (community-acquired pneumonia, not contracted in a hospital)
• Bacterial infection of the skin and underlying tissues
• Infection of the urethra and cervix caused by bacteria of the species Chlamydia trachomatis
• Infection of the urethra and cervix caused by bacteria of the species Neisseria gonorrhoeae; Azithromycin Normon should be used in combination with another antibacterial agent selected by your doctor or pharmacist
• Bacterial genital infection with painful ulcers (chancroid)
• Adults with prolonged lung inflammation (chronic bronchitis)

2. What you need to know before taking Azithromycin Normon

Do not take Azithromycin Normon:

• if you are allergic to azithromycin, erythromycin, another macrolide or ketolide antibiotic, or to any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

Consult your doctor or pharmacist before taking Azithromycin Normon if you have or have had any of the following conditions:

• heart disorders (e.g., problems with heart rhythm or heart failure) or low levels of potassium or magnesium in the blood: these conditions may contribute to serious cardiac adverse effects of azithromycin;
• liver disorders: your doctor may need to monitor your liver function or discontinue treatment;
• severe diarrhoea after taking any other antibacterial agent;
• localized muscle weakness (myasthenia gravis), as symptoms of this disease may worsen during treatment;
• if you are being treated with any ergot derivative such as ergotamine (used to treat migraines), as these medicines should not be taken with Azithromycin Normon

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

• if you think you are having an allergic reaction (e.g., difficulty breathing, swelling of the face or throat, skin rash or blistering);
• if you notice any of the symptoms described in section 4 related to serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), or acute generalized exanthematous pustulosis (AGEP);
• if you think your heart rhythm is abnormal or you experience palpitations, dizziness, or fainting during treatment with Azithromycin Normon;
• if you show signs of liver disorders (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 speaking to your doctor. If your diarrhoea continues or recurs within the first few weeks after treatment, inform your doctor as well.

Superinfection

Your doctor may monitor you for signs of additional bacterial or fungal infections that cannot be treated with azithromycin (superinfection).

Sexually transmitted infections

Your doctor may perform tests to rule out possible syphilis, a sexually transmitted disease that may otherwise progress undetected and be diagnosed late. Additionally, in any case of sexually transmitted bacterial infections, your doctor will initiate follow-up laboratory tests to monitor treatment success.

Children and adolescents

Children and adolescents weighing less than 45 kg

The sachets may not be suitable for this patient group. Other pharmaceutical forms of azithromycin may be used.

Weight above 45 kg

Same dose as adults

This medicine is not recommended if:

• you are under 12 years of age and have an infection or are at risk of contracting an infection with microorganisms belonging to the Mycobacterium avium complex, which typically affect people with HIV who have weakened immune systems, as efficacy and safety have not been studied in these cases.

Other medicines and Azithromycin Normon

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

Taking Azithromycin Normon with other medicines may lead to adverse effects. Therefore, it is especially important that you inform your doctor if you are taking any of the following medicines:

• Atorvastatin and other statins (to reduce blood cholesterol levels and prevent heart diseases, including myocardial infarction and stroke)

• Cyclosporine (to prevent organ transplant rejection)

• 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 (to thin the blood [anticoagulants])

• Medicines that may prolong the time it takes for the heart muscle to contract and relax (QT interval prolongation), such as:

• Quinidine, procainamide, dofetilide, amiodarone, and sotalol (for the treatment of heart rhythm disorders, such as abnormally fast or slow heartbeats: cardiac arrhythmia)

• Pimozide (for the treatment of mental illnesses)

• Citalopram (for the treatment of depression)

• Moxifloxacin and levofloxacin (antibacterial agents)

• Cisapride (for the treatment of gastrointestinal disorders)

• Hydroxychloroquine or chloroquine (for the treatment of certain autoimmune diseases such as rheumatoid arthritis, or for the treatment or prevention of malaria)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Your doctor will assess whether you should take this medicine during pregnancy only after ensuring that the benefits of treatment outweigh the possible risks.

Breastfeeding

Azithromycin Normon is excreted in breast milk. Therefore, your doctor will decide whether you should discontinue breastfeeding or avoid treatment with azithromycin, taking into account both the benefit of breastfeeding for your child and the benefit of treatment for you.

Driving and use of machines

The effect of Azithromycin Normon on the ability to drive and use machines is moderate. Dizziness, somnolence, and seizures, as well as vision and hearing problems, have been reported with Azithromycin Normon in some individuals. These possible adverse effects may affect your ability to drive and use machines.

Azithromycin Normon contains sucrose, sodium, and benzyl alcohol.

This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Patients with diabetes mellitus should be aware that this medicine contains 4.530 g of sucrose per sachet.

This medicine contains 22.7 mg of sodium (main component of table/cooking salt) per sachet. This corresponds to 1.14% of the maximum daily sodium intake recommended for an adult.

This medicine contains approximately 1.94 mg of benzyl alcohol per sachet.

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been associated with the risk of serious adverse effects including respiratory problems ("gasping syndrome") in children.

Do not administer this medicine to your newborn (up to 4 weeks of age) unless advised by your doctor.

This medicine should not be used for more than one week in children under 3 years of age unless directed by your doctor or pharmacist.

3. How to take Azithromycin Normon

Adult patients and adolescents weighing at least 45 kg who have difficulty swallowing.

Always follow exactly the administration instructions for this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended doses and duration of treatment are as follows:

• For adult patients only.

Use in children and adolescents

The safety and efficacy of azithromycin in children under 6 months of age has not been established for any of the indications listed in section 1.

This medicine is only suitable for children and adolescents weighing more than 45 kg, for whom the same dose as for adults is recommended. For those with lower body weight, other formulations are recommended, e.g. suspensions.

Method of administration

For oral use after reconstitution.

If you take more Azitromicina Normon than you should

If you take more Azitromicina Normon than you should, you may feel unwell. Typical signs of overdose include vomiting, diarrhoea, abdominal pain, and nausea. Inform your doctor or contact immediately the Emergency Department of the nearest hospital.

If you forget to take Azitromicina Normon

If you forget to take Azitromicina Normon, take it as soon as you remember, provided that it is at least 12 hours before the next dose. If less than 12 hours remain before the next dose, skip the missed dose and take the next dose at the scheduled time. Do not take a double dose to make up for forgotten doses.

If you stop taking Azitromicina Normon

.

If you stop treatment with azithromycin too early, the infection may recur. Take azithromycin for the full duration of treatment, even if you start to feel better.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

• Serious adverse effects

• Stop taking Azithromycin Normon and seek immediate medical attention if you notice any of the following symptoms:

• sudden wheezing in the chest, difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching especially affecting the whole body (anaphylactic reaction, frequency not known).

• rapid or irregular heartbeat (cardiac arrhythmia or torsade de pointes, tachycardia, frequency not known).

• dark urine, loss of appetite, or yellowing of the skin or whites of the eyes, which are signs of liver disease (liver failure or hepatic necrosis [frequency not known], hepatitis* [uncommon: may affect up to 1 in 100 people]).

• severe diarrhoea with abdominal cramps, bloody stools or fever, which may indicate an infection in the large intestine (antibiotic-associated colitis, frequency not known). Do not take anti-diarrhoeal medicines that inhibit intestinal motility (antiperistaltics).

• flat, red, target-shaped or circular skin rashes on the trunk, often with central blisters, skin peeling, or ulcers in the mouth, throat, nose, genitals and eyes. 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 enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome, rare [may affect up to 1 in 1,000 people]).

• widespread red, scaly rash with swellings under the skin and blisters accompanied by fever. Symptoms usually occur at the beginning of treatment (acute generalized exanthematous pustulosis, rare [may affect up to 1 in 1,000 people]).

• Other adverse effects

• Very common (may affect more than 1 in 10 people)

• • diarrhoea
• • abdominal discomfort*

• Common (may affect up to 1 in 10 people)

• • headache
• • vomiting, stomach pain# , 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
• pneumonia, bacterial throat infection, inflammation of the digestive tract, respiratory disorder, inflammation of the nasal mucosa, vaginal infection
• changes in white blood cell count (leucopenia, neutropenia, eosinophilia)
• increased platelet count
• reduction in the proportion of all blood cells in total blood volume (decreased haematocrit)
• allergic reactions, swelling of the hands, feet and face (angioedema)
• loss of appetite#
• nervousness, difficulty sleeping (insomnia)
• dizziness# , numbness or drowsiness (somnolence), changes in taste sensation (dysgeusia)# , tingling or numbness sensation (paraesthesia)
• loss of vision#
• ear disorder
• sensation of spinning (vertigo)
• sensation of rapid or strong heartbeat (palpitations)
• hot flushes
• sudden wheezing in the chest, nosebleeds
• constipation, flatulence# , indigestion (dyspepsia), inflammation of the stomach lining (gastritis), difficulty swallowing (dysphagia), bloated abdomen, dry mouth, burping, mouth ulceration, increased salivation
• skin rash# , itching# , hives (urticaria)# , dermatitis, dry skin, abnormally increased sweating (hyperhidrosis)
• swelling and pain in the joints (osteoarthritis), muscle pain, back pain, neck pain
• pain when urinating (dysuria), kidney pain
• irregular menstrual bleeding (metrorrhagia), testicular disorder
• swelling due to fluid accumulation, especially in the face, ankles and feet (edema, facial edema, peripheral edema)
• weakness, fatigue# , general malaise, fever
• chest pain, pain
• abnormal laboratory test results (e.g., blood tests or liver function tests)
• post-procedural complication

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

• sensation of irritation
• liver problems, yellowing of the skin or eyes
• increased sensitivity to sunlight#

Frequency not known (cannot be estimated from available data)

• reduction in red blood cell count due to increased cell breakdown, which may cause fatigue and pale skin (haemolytic anaemia)
• reduction in the number of platelets in the blood, which may cause bleeding and bruising (thrombocytopenia)
• feeling of irritability, aggression, fear or worry (anxiety), acute state of confusion (delirium)
• hallucinations
• fainting (syncope)
• seizures (convulsions)
• reduced sensitivity to touch, pain and temperature (hypoesthesia) #
• feeling of hyperactivity
• changes in sense of smell (anosmia, parosmia)
• complete loss of taste sensation (ageusia)
• muscle weakness (myasthenia gravis)
• abnormal electrocardiogram (ECG) trace (prolongation of QT interval)
• deafness# , hearing loss# 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 kidney failure

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Azithromycin Normon

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

Do not use Azithromycin Normon after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

Before reconstitution: no special storage conditions are required. Store in the original packaging.

After reconstitution: take the suspension immediately. Discard any remaining solution.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you are in doubt, please consult your pharmacist on how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Azithromycin Normon

The active substance is azithromycin (as dihydrate). Each sachet contains 500 mg of azithromycin.

The other components (excipients) are: saccharose, hydroxypropylcellulose (E463), trisodium phosphate, xanthan gum (E415), cherry flavour (contains benzyl alcohol), vanilla flavour, and banana flavour. See section 2 Azithromycin Normon contains saccharose and sodium.

Appearance of the product and contents of the pack

Azithromycin Normon 500 mg is an off-white dry powder with a fruity odour for oral suspension in sachets. Pack containing 3 sachets. Pack containing 100 sachets (hospital pack).

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos

Madrid (SPAIN)

Date of the most recent revision of this leaflet: October 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es