Zitromax 500 mg comprimidos recubiertos con pelicula

Package Insert: Information for the User

Zitromax 500 mg Film-Coated Tablets

Azithromycin

Read this package insert carefully before starting to take the medication.

• Keep this package insert as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you personally and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist.

1. What Zitromax 500 mg Film-Coated Tablets are and for what they are used

2. What you need to know before starting to take Zitromax 500 mg Film-Coated Tablets

3. How to take Zitromax 500 mg Film-Coated Tablets

4. Possible adverse effects

5. Storage of Zitromax 500 mg Film-Coated Tablets

6. Additional information

Azithromycin belongs to a group of antibiotics called macrolides. It eliminates bacteria causing 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:

• Throat, tonsil, ear, or nasal sinus infections.
• Mild to moderate bronchitis and pneumonia.
• Mild to moderate skin and soft tissue infections.
• Urethritis or cervicitis, see section 3.
• Chancroid, see section 3.

Do not take Zitromax 500 mg tablets

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine

• During treatment with Zitromax, 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 general symptoms) may occur, which could be severe. Inform your doctor, who may decide to stop treatment and start 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 Zitromax, symptoms may appear that suggest antibiotic-associated colitis (diarrhea). If this is the case, treatment should be suspended, and your doctor will prescribe the most suitable treatment.
• If you have any kidney function alterations, inform your doctor.
• If you have heart rhythm alterations 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 alterations.
• If you have a condition called myasthenia gravis or if muscle weakness and fatigue appear during treatment, inform your doctor, as Zitromax may trigger or worsen the symptoms of this disease.

Children and adolescents

Children and adolescents weighing less than 45 kg.

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

Children and adolescents weighing more than 45 kg.

This medicine is not suitable for children who are unable to swallow the tablets whole. Other forms of azithromycin may be used.

Use of Zitromax 500 mg tablets with other medicines

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

You must 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 day.
• Ergotamine derivatives (such as ergotamine, used to treat migraines), as simultaneous administration with azithromycin may cause ergotism (a potentially severe 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).
• Nelfinavir, zidovudine (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 and non-pulmonary tuberculosis caused by mycobacteria) as it may cause a decrease in white blood cell count 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) medications, cisapride, antipsychotics (such as pimozide), antidepressants (such as citalopram), and antifungals (fluoroquinolones such as moxifloxacin or levofloxacin and chloroquine), as they may cause severe heart rhythm alterations and even cardiac arrest.

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

Taking Zitromax 500 mg tablets with food and drinks

The tablets should be swallowed whole with water and may be taken with or without food.

Pregnancy, breastfeeding, and fertility

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

Your doctor will assess whether you should take this medicine during pregnancy, whether the benefits of treatment outweigh the potential risksAzithromycin is excreted in breast milk. Due to the potential adverse reactions in the infant, it is not recommended to use azithromycin during breastfeeding, although breastfeeding may be continued two days after completing treatment with Zitromax.

Driving and operating machinery

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

Zitromax 500 mg tablets contain lactose and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

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

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.

In elderly patients, the same dose as for adults may be administered. However, in the case of patients with cardiac rhythm disorders, your doctor will closely monitor you.

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.gonorrhoea, 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.

Children and adolescents weighing less than 45 kg:

The tablets are not recommended for these patients. Other pharmaceutical forms of Zitromax may be used.

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 kidney problems, as the normal dose may need to be adjusted.

Administration form

Oral route.

This medication should be taken as a single daily dose. The tabletsshould be swallowed whole with water andcan be taken with or without food.

If you take more Zitromax 500 mg tabletsthan 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 function should be applied.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service at 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Zitromax 500 mg tablets

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 Zitromax as your doctor has indicated.

If you interrupt treatment with Zitromax 500 mg tablets

If you stop treatment with Zitromax 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, Zitromax can cause side effects, although not everyone will experience them.

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

Side effectsvery common (occurring in at least 1 in 10 people)are:

• Diarrhea.

Side effectscommon (occurring in at least 1 in 100 people)are:

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

Side effectsuncommon (occurring in at least 1 in 1,000 people)are:

• Candida fungal infection in the mouth or generalized, vaginal infection, pneumonia, fungal or bacterial infection, pharyngitis, gastroenteritis, alteration of breathing, 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 of eating behavior (anorexia).
• Nervousness, insomnia.
• Drowsiness, dizziness, alteration of taste, loss of tactile sensation.
• Alteration of vision.
• Alteration of hearing, vertigo.
• Palpitations.
• Hot flashes.
• Alteration of breathing, nasal hemorrhage.
• Constipation, flatulence, indigestion, gastritis, difficulty swallowing, abdominal distension, dry mouth, belching, mouth ulcers, increased salivation.
• Rash, itching, appearance of red, elevated patches, dermatitis, dry skin, excessive sweating, redness.
• 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 of 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 of sodium and potassium levels, decrease in hematocrit.
• Complications after surgical intervention

Side effectsrare (occurring in at least 1 in 10,000 people)are:

• Agitation.
• Alteration of liver function, yellow discoloration of the skin.
• Sensitivity to sunlight (photosensitivity), allergic reaction with increase of a type of white blood cell (eosinophilia) and generalized symptoms (multi-organ compromise) (DRESS syndrome).
• Skin eruption characterized by rapid appearance of red skin patches with small white/yellow-filled blisters.

Side effectsof unknown frequency(cannot be estimated from available data) are:

• Diarrhea caused byClostridium difficile.
• Decrease in platelet count in blood, anemia.
• Severe allergic reaction
• Aggressive behavior, anxiety, delirium, hallucinations.

• Loss of consciousness, convulsions, decrease in sensitivity, hyperactivity, alteration and/or loss of smell, loss of taste, muscle weakness and fatigue (myasthenia gravis).
• Alteration of hearing including deafness and tinnitus.
• Torsade de pointes alterations of heart rhythm, prolongation of QTc interval in electrocardiogram.
• Decrease in blood pressure.
• Pancreatitis, change in color of the tongue.
• Severe liver damage and liver failure that can rarely be fatal, liver tissue death, fulminant hepatitis.
• Appearance of red, elevated patches, generalized eruption with blisters and peeling skin, 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 inflammation of the tissue between kidney tubules (interstitial nephritis).

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Store below 30°C. Store in the original packaging. Do not refrigerate.

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

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

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE point of your pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Zitromax Tablets

• The active ingredient is azithromycin. Each tablet contains 500 mg of azithromycin (as dihydrate).
• The other components (excipients) are: tablet core: pregelatinized cornstarch, anhydrous calcium phosphate, croscarmellose sodium, magnesium stearate, and sodium lauryl sulfate; tablet coating: Opadry white: lactose monohydrate, hydroxypropyl methylcellulose, titanium dioxide (E171), and triacetin.

Appearance of the Product and Contents of the Package

It is presented in the form of coated tablets with a film coating, scored, white in color, and capsule-shaped, bearing the imprint "ZTM 500" on one face. The score should not be used to divide the tablet.

It is presented in PVC blisters packaged in a cardboard box. Each package contains 3 or 150 tablets (clinical package).

Holder of the Marketing Authorization and Responsible for Manufacturing

Holder of the Marketing Authorization:

Pfizer, S.L. Avda. of Europe, 20 B

Parque Empresarial La Moraleja.

28108 Alcobendas.

Spain.

Responsible for Manufacturing:

Farmasierra Manufacturing S.L.

Ctra. N-1, Km26,200.

28709 San Sebastián de los Reyes.

Spain.

Last Review Date of this Leaflet:June 2023.

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