PATIENT INFORMATION LEAFLET

Zitromax 250 mg Hard Capsules

Azithromycin

Read this leaflet carefully before you start to take this medicine

• 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 personally and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you think you have suffered a side effect, you can help us by reporting it at the following website www.mhra.gov.uk/yellowcard.

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

It is used to treat 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 to treat the following infections:

• Throat, tonsil, ear, or 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 250 mg capsules

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

Warnings and precautions

Consult your doctor or pharmacist before starting this medication

• During treatment with Zitromax, allergic reactions (itching, redness, skin rash, swelling, or difficulty breathing, or an allergic reaction to the medication 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 discontinue treatment and initiate 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 discontinue treatment or undergo liver function tests.
• If you are being treated with ergotamine derivatives (used to treat migraines), inform your doctor, as concomitant treatment with azithromycin may cause a condition called ergotism.
• During treatment with this medication, there is a possibility of 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 so, treatment should be discontinued, and your doctor will prescribe the most suitable treatment.
• If you have any kidney function impairment, inform your doctor.
• If you have arrhythmias or factors that predispose you to them (certain heart diseases, alterations in blood electrolyte levels, or certain medications), inform your doctor, as this medication may exacerbate or trigger these conditions.
• If you have myasthenia gravis or if muscle weakness and fatigue occur during treatment, inform your doctor, as Zitromax may trigger or exacerbate symptoms of this disease.

Children and adolescents

Children and adolescents weighing less than 45 kg.

Hard capsules 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 medication is not suitable for children who are unable to swallow the hard capsules whole. Other forms of azithromycin may be used.

Use of Zitromax 250 mg capsules with other medications

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

You must especially inform your doctor or pharmacist if you are being treated with any of the following medications:

• Antacids (medications used for digestive problems). It is recommended to avoid simultaneous administration of both medications 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 characterized by numbness or tingling in the extremities, muscle cramps, headaches, convulsions, or abdominal or chest pain).
• Digoxin (a medication 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 medication used in transplant patients), as azithromycin may increase ciclosporin levels in the blood and levels should be monitored.
• Anticoagulant dicumarins (medications used to prevent blood clotting), as azithromycin may potentiate the effect of these anticoagulants. Your doctor should control coagulation parameters (prothrombin time).
• Nelfinavir, zidovudine (medications used to treat HIV infections), as they may increase azithromycin levels in the blood.
• Fluconazole (medications used to treat fungal infections), as they may increase azithromycin levels in the blood.
• Terfenadine (a medication used to treat allergies), as the combination may cause heart problems.
• Rifabutin (a medication used to treat pulmonary and non-pulmonary tuberculosis caused by mycobacteria), as it may cause a decrease in white blood cell count.
• Medications 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 excessive 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 250 mg capsules with food and drinks

Hard capsules should be swallowed whole with water. Administration should be made at least 1 hour before or 2 hours after meals.

Pregnancy, breastfeeding, and fertility

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

Your doctor will assess whether you should take this medication during pregnancy, whether the benefits of treatment outweigh the potential risks.

Azithromycin is excreted in breast milk. Due to 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 medication on the ability to drive or operate machinery is negligible or insignificant.

Zitromax 250 mg capsules contain lactose and sodium

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per capsule; 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 the medication and the frequency of administration 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 under 45 kg of body weight:

The chewable tablets are recommended for these patients. Other 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 hard capsules should be swallowed whole with water. Administration should be made at least 1 hour before or 2 hours after meals.

If you take more Zitromax 250 mg capsules 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 at 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Zitromax 250 mg capsules

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 missed dose and wait for the next one. Do not take a double dose to compensate for the missed dose. Continue using Zitromax as your doctor has indicated.

If you interrupt treatment with Zitromax 250 mg capsules

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 frequent (in at least 1 in 10 people)are:

• Diarrhea.

Side effectscommon (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 effectsinfrequent (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, 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

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

• 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).
• Characterized by the rapid appearance of red skin areas with small white/yellow-filled blisters (small vesicles).

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

• Diarrhea caused by Clostridium difficile.
• Decrease in platelets 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 alterations in heart rhythm, prolongation of the QTc interval in the electrocardiogram.
• Decrease in blood pressure.
• Pancreatitis, change in color of the tongue.
• Severe liver damage and hepatic failure that rarely can be fatal, liver tissue death, fulminant hepatitis.
• Appearance of red, elevated papules, generalized rash 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.

This product does not require special storage conditions. 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 the 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 Hard Capsules

• The active ingredient is azithromycin. Each hard capsule contains 250 mg of azithromycin (as dihydrate).
• The other components (excipients) are:anhydrous lactose, magnesium stearate, sodium lauryl sulfate, cornstarch, gelatin, titanium dioxide (E171), and black ink (10 A1 and 10 A2).

Appearance of the Product and Contents of the Package

Zitromax 250 mg is presented in the form of white hard capsules with the Pfizer logo and the letters “ZTM 250” printed in black.

White hard capsules with the Pfizer logo and the letters “ZTM 250” printed in black.

Holder of the Marketing Authorization and Responsible for Manufacturing

Holder of the Marketing Authorization:

Pfizer, S.L.

Avda. de Europa, 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/.