Leaflet: information for the user

Azitromicina Normon 500 mg powder for oral suspension in a sachet EFG

azitromicina

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Azitromicina belongs to a group of antibiotics called macrolides. It eliminates bacteria that cause infections.

It is used for the treatment of infections caused by bacteria in different parts of the body, in adults, and in children with a weight of 45 kg or more.

It is used for the treatment of the following infections:

• Bronchitis and pneumonia (mild to moderate in severity).
• Throat, tonsil, ear, or sinus infections.
• Mild to moderate skin and soft tissue infections.
• Urethritis or cervicitis, see section 3.
• Chancroid, see section 3.

Do not take Azitromicina Normon:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Azitromicina Normon:

• During treatment with Azitromicina Normon, allergic reactions (itching, redness, skin rash, swelling, or difficulty breathing, or an allergic reaction to the medicine characterized by an increase in white blood cells in the blood and generalized symptoms) may occur, which could be severe. Inform your doctor, who may decide to interrupt treatment and start the appropriate treatment.
• If you have liver problems or during treatment your skin and/or the white of your eyes turns yellow, inform your doctor to confirm whether you should stop treatment or if you need to have liver function tests.
• If you are being treated with ergotamine derivatives (used to treat migraines), inform your doctor as the combined treatment with azithromycin may cause a condition called ergotism.
• During treatment with this medicine, there is a possibility of developing an overinfection by resistant germs, including fungi. In this case, inform your doctor.
• During or after treatment with Azitromicina Normon, symptoms may occur that suggest antibiotic-associated colitis (diarrhea). If this is the case, treatment should be suspended and your doctor will prescribe the treatment they consider most suitable.
• If you have severe kidney function impairment, inform your doctor.
• If you have heart rhythm disorders (arrhythmias) or factors that predispose you to them (certain heart diseases, alterations in blood electrolyte levels, or certain medications), inform your doctor, as this medicine may contribute to worsening or triggering these disorders.
• If you have a condition called myasthenia gravis or if you experience muscle weakness and fatigue during treatment, inform your doctor, as Azitromicina Normon may trigger or worsen the symptoms of this disease.

Children and adolescents

Children and adolescents with a weight of less than 45 kg

The sachets may not be indicated for this group of patients. Other forms of azithromycin may be used. Do not administer to children under 6 months.

Weight over 45 kg

The same dose as adults, so it is recommended to use other more suitable pharmaceutical forms available on the market.

Sinusitis: treatment is indicated in adults and adolescents over 16 years old.

Other medicines and Azitromicina Normon

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Especially inform your doctor or pharmacist if you are being treated with any of the following medicines:

• Antacids (medicines used for digestive problems). It is recommended to avoid simultaneous administration of both medicines at the same time of the day.
• Ergotamine derivatives (such as ergotamine, used to treat migraines), as simultaneous administration with azithromycin may cause ergotism (a potentially serious adverse effect with numbness or tingling in the extremities, muscle cramps, headaches, convulsions, or abdominal or chest pain).
• Digoxin (a medicine used to treat heart arrhythmias) as azithromycin may increase digoxin levels in the blood and levels should be monitored.
• Colchicine (used to treat gout and familial Mediterranean fever).
• Ciclosporin (a medicine used in transplant patients): as azithromycin may increase ciclosporin levels in the blood and levels should be monitored.
• Anticoagulant dicumarins (medicines used to prevent blood clotting) as azithromycin may potentiate the effect of these anticoagulants. Your doctor should control coagulation parameters (prothrombin time).
• Zidovudine, nelfinavir (medicines used to treat HIV infections), as they may increase azithromycin levels in the blood.
• Fluconazole (medicines used to treat fungal infections) as they may increase azithromycin levels in the blood.
• Terfenadine (a medicine used to treat allergies) as the combination of both may cause heart problems.
• Rifabutin (a medicine used to treat pulmonary tuberculosis and non-pulmonary infections caused by mycobacteria) as it may cause a decrease in white blood cells in the blood.
• Medicines with active substances that prolong the QT interval, such as antiarrhythmic class IA (quinidine and procainamide) and class III (dofetilide, amiodarone, and sotalol), cisapride, terfenadine, antipsychotics (such as pimozide), antidepressants (such as citalopram), and antifungals (fluoroquinolones such as moxifloxacin or levofloxacin and chloroquine and hydroxychloroquine), as they may cause severe heart rhythm disorders and even cardiac arrest.

No interactions have been observed between azithromycin and cetirizine (for treating allergic reactions); didanosine, efavirenz, indinavir (for treating HIV infections); atorvastatin (for treating high cholesterol and heart problems); carbamazepine (for treating epilepsy), cimetidine (for treating excess stomach acid); methylprednisolone (for suppressing the immune system); theophylline (for respiratory problems); midazolam, triazolam (for inducing sedation); sildenafil (for treating impotence), and trimethoprim/sulfamethoxazole (for treating infections).

Use of Azitromicina Normon with food and drinks

This medicine should be taken as a single daily dose. The contents of the sachet should be added to a glass with a little water, mixing well. The suspension should be taken immediately with or without food.

Pregnancy, breastfeeding, and fertility

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.

There is not enough information about the safety of azithromycin during pregnancy. Therefore, azithromycin should not be used during pregnancy, or if you plan to become pregnant, unless it is strictly necessary according to medical criteria.

Azithromycin is excreted in breast milk. Due to potential adverse reactions in the infant, azithromycin should not be used during breastfeeding, although breastfeeding can be continued two days after completing treatment with Azitromicina Normon.

Driving and operating machinery

The influence of this medicine on the ability to drive or operate machinery is negligible or insignificant.

Azitromicina Normon contains saccharose, sodium, glucose, and wheat starch

This medicine contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains 23 mg of sodium (main component of table salt/for cooking) in each sachet. This is equivalent to 1.15% of the maximum daily sodium intake recommended for an adult.

This medicine contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will establish the most suitable dose and treatment duration for you, according to your condition and response to treatment. As a general rule, the recommended dose of medication and administration frequency is as follows:

Adults (including elderly patients) and children with a body weight of over 45 kg:

The usual dose is 1500 mg divided over 3 or 5 days as follows:

• When taken over 3 days, 500 mg per day.

• When taken over 5 days, 500 mg on the first day and 250 mg from the 2nd to the 5th day.

Urethral or cervical infection (cervicitis):

The usual dose is 1,000 mg taken as a single dose, on a single day.

In the case of an infection caused by N. gonorrohea, your doctor will administer the same dose in combination with another antibiotic (ceftriaxone, 250 mg).

Chancroid:

The usual dose is 1,000 mg taken as a single dose, on a single day.

Sinusitis:

Treatment is indicated for adults and adolescents over 16 years old.

Use in children and adolescents weighing less than 45 kg

The sachets may not be indicated for this group of patients. Other pharmaceutical forms of azithromycin may be used. It should not be administered to children under 6 months.

Use in patients with liver insufficiency

Inform your doctor if you have severe liver problems, as the normal dose may need to be adjusted.

Use in patients with renal insufficiency

Inform your doctor if you have severe kidney problems, as the normal dose may need to be adjusted.

Administration form

Azitromicina Normon is administered orally.

The medication must be reconstituted before administration.

This medication must be taken as a single daily dose. The contents of the sachet must be added to a glass with a little water, mixing well. The suspension must be ingested immediately, with or without food.

Reconstitution instructions

Empty the contents of the sachet into a glass and add a little water, mixing well. The obtained suspension must be ingested immediately.

If you take more Azitromicina Normon than you should

In case of overdose, you may experience reversible hearing loss, intense nausea, vomiting, and diarrhea.

Information for the prescriber

In case of overdose, administration of activated charcoal is indicated, and general symptomatic and supportive measures for vital functions should be applied.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Bring this leaflet and the packaging to the hospital or to your doctor so they know how much you have taken.

If you forgot to take Azitromicina Normon

In case of forgotten dose, use the medication as soon as possible and continue treatment as prescribed. However, if the next dose is near, it is better not to take the forgotten dose and wait for the next one. Do not take a double dose to compensate for the forgotten dose. Continue using Azitromicina Normon as your doctor has indicated.

If you interrupt treatment with Azitromicina Normon

If you abandon treatment with Azitromicina Normon before your doctor has recommended, symptoms may worsen or reappear.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The side effects reported during clinical trials and after marketing, classified by frequency, are:

The very common side effects (occurring in at least 1 in 10 people):

• Diarrhea.

The common side effects (occurring in at least 1 in 100 people)

• Alteration in the number of some types of white blood cells (lymphocytes, eosinophils, basophils, monocytes, and neutrophils), decrease in bicarbonate.
• Headache.
• Vomiting, abdominal pain, nausea.

The uncommon side effects (occurring in at least 1 in 1,000 people)

• Candida fungal infection in the mouth or generalized, vaginal infection, pneumonia, fungal or bacterial infection, pharyngitis, gastroenteritis, respiratory alteration, rhinitis.

• Decrease in the number of some types of white blood cells (leukocytes, neutrophils, and eosinophils).
• Allergic reaction, including a deep skin inflammatory process (angioedema).
• Alteration in eating behavior (anorexia).
• Nervousness, insomnia.
• Drowsiness, dizziness, alteration in taste, loss of tactile sensation.
• Visual alteration.
• Auditory alteration, vertigo.
• Palpitations.
• Hot flashes.
• Respiratory alteration, nasal hemorrhage.
• Constipation, flatulence, indigestion, gastritis, difficulty swallowing, abdominal distension, dry mouth, belching, mouth ulcers, increased salivation.
• Rash, pruritus, appearance of red, elevated papules, dermatitis, dry skin, excessive sweating, erythema.
• Joint inflammation, muscle pain, back pain, neck pain.
• Difficulty urinating, kidney pain.
• Vaginal hemorrhage, alteration in testicles.
• Generalized swelling, weakness, discomfort, fatigue, facial edema, chest pain, fever, pain and swelling of the extremities.
• Alteration in liver function tests (increase in liver enzymes GOT, GPT, and alkaline phosphatase) and increase in bilirubin, urea, creatinine, chloride, glucose, bicarbonate, and platelets in blood, alteration in sodium and potassium levels, decrease in hematocrit.
• Complications after surgical intervention.

The rare side effects (occurring in at least 1 in 10,000 people)

• Agitation.
• Liver function alteration, yellow discoloration of the skin.
• Sensitivity to sunlight (photosensitivity), allergic reaction with increase in a type of white blood cell (eosinophilia) and generalized symptoms (multi-organ compromise) (DRESS syndrome).

A skin eruption characterized by the rapid appearance of red skin areas dotted with small white/yellow-filled blisters (small bubbles).

The side effectsof unknown frequency (cannot be estimated from available data)

• Diarrhea caused by Clostridium difficile.
• Decrease in platelet count in blood, anemia. Severe allergic reaction.
• Aggressive behavior, anxiety, delirium, hallucinations. Loss of consciousness, convulsions, decreased sensitivity, hyperactivity, alteration and/or loss of smell, loss of taste, muscle weakness and fatigue (myasthenia gravis).
• Auditory alteration including deafness and tinnitus.
• Torsade de pointes cardiac rhythm alterations, prolongation of the QTc interval in the electrocardiogram.
• Decrease in blood pressure.
• Pancreatitis, change in tongue color.
• Severe liver damage and liver failure that can rarely be fatal, liver tissue death, fulminant hepatitis.
• Appearance of red, elevated papules, generalized eruption with blisters and peeling skin, occurring especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), severe skin reactions such as erythema multiforme, toxic epidermal necrolysis. Joint pain.
• Acute kidney failure and interstitial nephritis.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them through the Spanish System for Pharmacovigilance of Medicines for Human Use. https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use Azithromycin Normon after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

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

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

Medicines should not be disposed of through drains or in the trash. Deposit empty containers and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

Composition of Azitromicina Normon

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

The other components (excipients) are: sucrose, hydroxypropylcellulose (E463), anhydrous trisodium phosphate, xanthan gum (E415), cherry flavor (contains wheat-derived maltodextrin and gum arabic), vanilla flavor (contains wheat-derived maltodextrin, corn-derived maltodextrin, and gum arabic), banana flavor (contains wheat-derived maltodextrin).

Appearance of the product and content of the packaging

Azitromicina Normon 500 mg is a white, powdery, fruity-smelling product for oral suspension in sachets. Packaging of 3 sachets. Packaging of 100 sachets (clinical packaging).

Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos

Madrid (SPAIN)

Last review date of this leaflet: March 2021

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es