Zitromax 250 mg hard capsules

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Zitromax 250 mg hard capsules

Azithromycin

Read the entire leaflet carefully before you start taking 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 must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet:

1. What Zitromax 250 mg capsules are and what they are used for
2. What you need to know before taking Zitromax 250 mg capsules
3. How to take Zitromax 250 mg capsules
4. Possible side effects
5. How to store Zitromax 250 mg capsules
6. Further information

1. What Zitromax 250 mg capsules is and what it is used for

Azithromycin belongs to a group of antibiotics known as macrolide antibiotics. It kills bacteria that cause infections.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left after completing your treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

It is used to treat bacterial infections in different parts of the body in adults and children weighing over 45 kg.

It is used to treat the following infections:

• Infections of the throat, tonsils, ears, or sinuses.
• Bronchitis and pneumonia (mild to moderate severity).
• Skin and soft tissue infections (mild to moderate severity).
• Infections of the urethra (urethritis) or cervix (cervicitis), see section 3.
• Sexually transmitted infections (chancroid), see section 3.

2. What you need to know before taking Zitromax 250 mg capsules

Do not take Zitromax 250 mg capsules

• if you are allergic to azithromycin, erythromycin, any other macrolide or ketolide antibiotic, 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 this medicine

• Allergic-type reactions (itching, redness, skin rash, swelling, or difficulty breathing, or a drug allergy characterized by increased white blood cells in the blood and generalized symptoms) may occur during treatment with Zitromax and could be serious. Inform your doctor, who may decide to stop treatment and start appropriate therapy.
• If you have liver problems, or during treatment your skin and/or the whites of your eyes turn yellow, tell your doctor so they can determine whether you should stop treatment or need liver function tests.
• If you are being treated with ergot derivatives (used to treat migraine), inform your doctor, as concomitant treatment with azithromycin may cause an adverse reaction called ergotism.
• During treatment with this medicine, there is a possibility of superinfection by resistant organisms, including fungi. In such a case, inform your doctor.
• Colitis (diarrhea) associated with antibiotics may occur during or after treatment with Zitromax. If this happens, treatment should be stopped and your doctor will prescribe the most appropriate treatment.
• If you have any kidney function impairment, inform your doctor.
• If you have heart rhythm disorders (arrhythmias) or factors that predispose you to them (certain heart diseases, blood electrolyte imbalances, or certain medications), inform your doctor, as this medicine may worsen or trigger such conditions.
• If you have a disease called myasthenia gravis or experience muscle weakness and fatigue during treatment, inform your doctor, as Zitromax may trigger or worsen symptoms of this condition.

Children and adolescents

Children and adolescents weighing less than 45 kg.

Hard capsules are not indicated for this patient group. Other pharmaceutical forms of azithromycin may be used. Not to be administered to children under 6 months of age.

Children and adolescents weighing more than 45 kg.

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

Taking Zitromax 250 mg capsules with other medicines

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

You should especially inform your doctor or pharmacist if you are taking any of the following medicines:

• Antacids (medicines used for digestive problems). It is recommended to avoid administering both medicines at the same time of day.
• Ergot derivatives (such as ergotamine, used to treat migraine), as concomitant administration with azithromycin may cause ergotism (a potentially serious adverse effect with numbness or tingling sensations in the limbs, muscle cramps, headaches, seizures, or abdominal or chest pain).
• Digoxin (a medicine used to treat heart arrhythmias), as azithromycin may increase digoxin blood levels, which should be monitored.
• Colchicine (used for gout and familial Mediterranean fever).
• Cyclosporine (a medicine used in transplant patients), as azithromycin may increase cyclosporine blood levels, which should be monitored.
• Dicoumarol anticoagulants (medicines used to prevent blood clots), as azithromycin may enhance the effect of these anticoagulants. Your doctor should monitor coagulation parameters (prothrombin time).
• Nelfinavir, zidovudine (medicines for treating infections caused by human immunodeficiency virus), as azithromycin blood levels may be increased.
• Fluconazole (medicines for treating fungal infections), as azithromycin blood levels may be increased.
• Terfenadine (a medicine used to treat allergies), as the combination may cause heart problems.
• Rifabutin (a medicine for treating pulmonary tuberculosis and non-pulmonary infections caused by mycobacteria), as it may cause a decrease in white blood cell count.
• Medicines containing active substances that prolong the QT interval, such as class IA antiarrhythmics (quinidine and procainamide) and class III (dofetilide, amiodarone, and sotalol), cisapride, terfenadine, antipsychotic agents (such as pimozide), antidepressants (such as citalopram), and anti-infectives (fluoroquinolones such as moxifloxacin or levofloxacin and chloroquine), as they may cause serious heart rhythm disturbances and even cardiac arrest.

No interactions have been observed between azithromycin and cetirizine (for treating allergic reactions); didanosine, efavirenz, indinavir (for treating HIV infection); 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 sedation); sildenafil (for treating impotence); and trimethoprim/sulfamethoxazole (for treating infections).

Taking Zitromax 250 mg capsules with food and drinks

The hard capsules must be taken whole with water. Administration should be done 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, intend to become pregnant, or are breastfeeding, inform your doctor or pharmacist before using this medicine.

Your doctor will assess whether you should take this medicine during pregnancy, if the benefit of treatment outweighs the potential risks.

Azithromycin is excreted in breast milk. Due to the potential for adverse reactions in the nursing infant, the use of azithromycin during breastfeeding is not recommended, although breastfeeding may be resumed two days after completing treatment with Zitromax.

Driving and use of machines

The effect of this medicine on the ability to drive or operate machinery is none or negligible.

Zitromax 250 mg capsules contain lactose and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Zitromax 250 mg capsules

Follow exactly the instructions for use provided in this leaflet or those given by your doctor. In case of doubt, consult your doctor or pharmacist.

Your doctor will determine the most appropriate dose and duration of treatment for you, based on your condition and response to treatment. As a general rule, the recommended dose and dosing frequency are as follows:

Adults (including elderly patients) and children weighing over 45 kg:

The usual dose is 1500 mg administered 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 day 2 to day 5.

In elderly patients, the same dose as in adults may be administered. However, if the patient has cardiac rhythm disorders, your doctor will monitor you closely.

Urethral or cervical infection (cervicitis):

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

If the infection is caused by N. gonorrhoeae, 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 one day.

Sinusitis:

Treatment is indicated in adults and adolescents over 16 years of age.

Children and adolescents weighing less than 45 kg:

The peach-colored capsules are recommended for these patients. Other pharmaceutical forms of Zitromax may be used.

Use in patients with hepatic impairment

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

Use in patients with renal impairment

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

Method of administration

Oral use.

This medicine should be taken as a single daily dose. The hard capsules must be swallowed whole with water. Administration should be performed 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, severe nausea, vomiting, and diarrhea.

Information for the prescriber

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

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

If you forget to take Zitromax 250 mg capsules

If you miss a dose, take the medicine as soon as possible and continue treatment as prescribed. However, if the next dose is due soon, it is better not to take the missed dose and wait for the next scheduled dose. Do not take a double dose to make up for a missed dose. Continue using Zitromax as directed by your doctor.

If you stop taking Zitromax 250 mg capsules

If you stop treatment with Zitromax before the time recommended by your doctor, your symptoms may worsen or reappear.

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

4. Possible adverse effects

Like all medicines, Zithromax may cause adverse effects, although not everyone experiences them.

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

Very common (affects at least 1 in 10 people):

• Diarrhea.

Common (affects at least 1 in 100 people):

• Headache.
• Vomiting, abdominal pain, nausea.
• Changes in the number of certain types of white blood cells (lymphocytes, eosinophils, basophils, monocytes, and neutrophils), decreased bicarbonate levels.

Uncommon (affects at least 1 in 1,000 people):

• Fungal infection caused by Candida in the mouth or systemic, vaginal infection, pneumonia, fungal or bacterial infection, pharyngitis, gastroenteritis, breathing difficulties, rhinitis.
• Decrease in the number of certain types of white blood cells (leukocytes, neutrophils, and eosinophils).
• Allergic reaction, including deep skin inflammation (angioedema).
• Changes in eating behavior (anorexia).
• Nervousness, insomnia.
• Drowsiness, dizziness, taste disturbances, loss of tactile sensation.
• Vision disturbances.
• Hearing disturbances, vertigo.
• Palpitations.
• Hot flushes.
• Breathing difficulties, nosebleeds.
• Constipation, flatulence, indigestion, gastritis, difficulty swallowing, abdominal distension, dry mouth, belching, mouth ulcers, increased salivation.
• Rash, pruritus, appearance of raised red spots, dermatitis, dry skin, excessive sweating, redness.
• Joint swelling, muscle pain, back pain, neck pain.
• Difficulty urinating, kidney pain.
• Vaginal bleeding, testicular disorders.
• Generalized swelling, weakness, malaise, fatigue, facial edema, chest pain, fever, pain and swelling of the extremities.
• Abnormal liver function tests (increased liver enzymes GOT, GPT, and alkaline phosphatase), increased bilirubin, urea, creatinine, chloride, glucose, bicarbonate, and platelets in blood; changes in sodium and potassium levels; decreased hematocrit.
• Complications following surgical procedures.

Rare (affects at least 1 in 10,000 people):

• Agitation.
• Impaired liver function, yellowing of the skin (jaundice).
• Sensitivity to sunlight (photosensitivity), drug reaction with increased eosinophils and generalized symptoms (multiorgan involvement) (DRESS syndrome).
• Skin rash characterized by the rapid appearance of red skin areas with small pustules (small blisters filled with white/yellow fluid).

Adverse effects with unknown frequency (cannot be estimated from available data):

• Diarrhea caused by Clostridium difficile.

• Decreased platelet count in blood, anemia.

• Severe allergic reaction.

• Aggression, anxiety, delirium, hallucinations.

• Loss of consciousness, seizures, decreased sensation, hyperactivity, disturbances and/or loss of smell, loss of taste, muscle weakness and fatigue (myasthenia gravis).

• Hearing disturbances including deafness and tinnitus.

• Torsade de pointes, cardiac rhythm disturbances, QTc interval prolongation on electrocardiogram.

• Decreased blood pressure.

• Pancreatitis, change in tongue color.

• Severe liver injury and liver failure, which rarely can be fatal, death of liver tissue, fulminant hepatitis.

• Appearance of raised red rashes, widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), serious skin reactions such as erythema multiforme, toxic epidermal necrolysis.

• Joint pain.

• Acute kidney failure and inflammation of the tissue between the renal tubules (interstitial nephritis).

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zitromax 250 mg capsules

No special storage conditions required. Keep in the original packaging. Do not refrigerate.

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Additional information

Composition of Zitromax hard capsules

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

Appearance of the product and contents of the pack

Zitromax 250 mg is presented as 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.

Marketing Authorization Holder and Manufacturing Responsible

Marketing Authorization Holder:

Pfizer, S.L.

Avda. de Europa, 20 B.

Parque Empresarial La Moraleja.

28108 Alcobendas.

Spain.

Manufacturing Responsible:

Farmasierra Manufacturing S.L.

Ctra. N-1, Km 26,200.

28709 San Sebastián de los Reyes.

Spain.

Date of the most recent review of this leaflet: June 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.