Zithromax 500 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zitromax 500 mg film-coated tablets

Azithromycin

Read all of this 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. Do not give it to others, even if they have the same symptoms as you, because it could 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 this leaflet:

1. What Zitromax 500 mg tablets are and what they are used for
2. What you need to know before taking Zitromax 500 mg tablets
3. How to take Zitromax 500 mg tablets
4. Possible side effects
5. How to store Zitromax 500 mg tablets
6. Further information

1. What Zitromax 500 mg tablets are and what they are 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 over after completing your treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via the sink or in 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 500 mg tablets

Do not take Zitromax 500 mg tablets

• 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

Talk to your doctor or pharmacist before taking this medicine

• Allergic-type reactions (itching, redness, skin rash, swelling, or difficulty breathing) or an allergic drug reaction 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 initiate appropriate therapy.
• If you have liver problems or if 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 known as ergotism.
• During treatment with this medicine, there is a possibility of superinfection by resistant organisms, including fungi. In such a case, inform your doctor.
• Diarrhea or other symptoms suggesting antibiotic-associated colitis may occur during or after treatment with Zitromax. If this occurs, 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 risk factors for developing them (certain heart conditions, electrolyte imbalances in the blood, or certain medications), inform your doctor, as this medicine may worsen or trigger these conditions.
• If you have a condition called myasthenia gravis or experience muscle weakness and fatigue during treatment, inform your doctor, as Zitromax may trigger or worsen symptoms of this disease.

Children and adolescents

Children and adolescents weighing less than 45 kg.

The tablets are not indicated for this patient group. Other pharmaceutical forms of azithromycin may be used. Should not 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 the tablets whole. Other pharmaceutical forms of azithromycin may be used.

Taking Zitromax 500 mg tablets 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 lead to ergotism (a potentially serious adverse effect with numbness or tingling 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 levels in the blood, 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 human immunodeficiency virus infections), 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 mycobacterial infections), 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, antipsychotics (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 500 mg tablets with food and drink

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 plan 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 infant, the use of azithromycin during breastfeeding is not recommended, although breastfeeding may be resumed two days after completion of treatment with Zitromax.

Driving and using machines

The effect of this medicine on the ability to drive or use machines is negligible or none.

Zitromax 500 mg tablets 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 tablet; thus, it is essentially “sodium-free”.

3. How to take Zitromax 500 mg tablets

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 is as follows:

Adults (including elderly patients) and children weighing 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 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 closely monitor them.

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:

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

Use in patients with hepatic impairment

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

Use in patients with renal impairment

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

Method of administration

Oral use.

This medicine should be taken as a single daily dose. The tablets should be swallowed whole with water and may be taken with or without food.

If you take more Zitromax 500 mg tablets 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, 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 name of the medicine and the amount ingested.

If you forget to take Zitromax 500 mg tablets

If you miss a dose, take the medicine as soon as possible and continue treatment as prescribed. However, if it is almost time for the next dose, 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 the missed dose. Continue taking Zitromax as directed by your doctor.

If you stop treatment with Zitromax 500 mg tablets

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, Zitromax 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.

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

• Fungal infection by Candida in the mouth or generalized, 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 tissue 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, burping, 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 extremities.
• Abnormal liver function tests (increased liver enzymes GOT, GPT, and alkaline phosphatase) and increased bilirubin, urea, creatinine, chloride, glucose, bicarbonate, and platelets in blood; disturbances in sodium and potassium levels; decreased hematocrit.
• Complications following surgical procedures.

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

• Agitation.
• Liver function disturbances, yellowing of the skin.
• Sensitivity to sunlight exposure (photosensitivity), drug reaction with increase in a type of white blood cells (eosinophilia) and generalized symptoms (multiorgan involvement) (DRESS syndrome).
• Skin rash characterized by sudden appearance of red skin areas with small pustules (small blisters filled with white/yellow fluid).

Frequency not known (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 sensitivity, 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 may be fatal, death of liver tissue, fulminant hepatitis.

• Appearance of raised red spots, generalized rash with blisters and peeling skin, 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 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 Zithromax 500 mg tablets

Store below 30°C. Keep in the original container. 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 container after EXP. The expiry date is the last day of the month indicated.

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

6. Additional information.

Composition of Zitromax tablets

• The active substance is azithromycin. Each tablet contains 500 mg of azithromycin (as dihydrate).
• The other components (excipients) are: tablet core: pregelatinized corn starch, anhydrous calcium hydrogen phosphate, sodium croscarmellose, 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 pack

The product is presented as film-coated, scored, white, capsule-shaped tablets, marked with "ZTM 500" on one side. The score line should not be used to divide the tablet.

It is supplied in PVC blisters packed in cardboard boxes. Each pack contains either 3 or 150 tablets (hospital pack).

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Pfizer, S.L. Avda. de Europa, 20 B
Parque Empresarial La Moraleja.
28108 Alcobendas.
Spain.

Manufacturer:

Farmasierra Manufacturing S.L.
Ctra. N-1, Km 26,200.
28709 San Sebastián de los Reyes.
Spain.

Date of the most recent revision of this leaflet: June 2023.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.