Package Leaflet: Information for the User

Azithromycin Cinfa 500 mg Film-Coated Tablets

Azithromycin dihydrate

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to 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.

Azithromycin belongs to a group of antibiotics called macrolides. It eliminates the 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 sinus infections.

-Mild to moderate bronchitis and pneumonia.

-Mild to moderate skin and soft tissue infections.

-Urethritis or cervicitis, see section 3.

-Sexually transmitted infections (chancroid), see section 3

Do not take azitromicina cinfa

• If you are allergic to azitromicina, eritromicina, another macrolide antibiotic, or ketolide, or to any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take azitromicina cinfa.

• During treatment with azitromicina, 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 interrupt 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 interrupt 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 azitromicina may cause a condition called ergotism.

During treatment with this medication, 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, symptoms may appear that suggest antibiotic-associated colitis (diarrhea). If so, treatment should be suspended, and your doctor will initiate the treatment they consider most appropriate.

If you have severe 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 appear during treatment, inform your doctor, as azitromicina may trigger or exacerbate symptoms of this disease.

Children and adolescents

Children and adolescents weighing less than 45 kg.

The tablets are not indicated for this group of patients. Other forms of azitromicina 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 tablets whole. Other forms of azitromicina may be used.

Taking azitromicina cinfa with other medications

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

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 azitromicina 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 medication used to treat heart arrhythmias) as azitromicina 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 azitromicina may increase ciclosporin levels in the blood, and levels should be monitored.

-Anticoagulant dicumarins (medications used to prevent blood clotting) as azitromicina may potentiate the effect of these anticoagulants. Your doctor should control coagulation parameters (prothrombin time).

-Nelfinavir, zidovudine (medications for treating HIV infections), as they may increase azitromicina levels in the blood.

-Fluconazole (medications for treating fungal infections), as they may increase azitromicina levels in the blood.

-Terfenadine (a medication used to treat allergies) as the combination may cause heart problems.

-Rifabutin (a medication for treating pulmonary and non-pulmonary tuberculosis caused by mycobacteria) as it may cause a decrease in white blood cells in the blood.

-Medications with active substances that prolong the QT interval, such as antiarrhythmic class IA (quinidine and procainamide) and class III (dofetilide, amiodarone, and sotalol), cisapride, antipsychotics (such as pimozide), antidepressants (such as citalopram), and antibiotics (fluoroquinolones such as moxifloxacino or levofloxacino and chloroquine), as they may cause severe heart rhythm alterations and even cardiac arrest.

No interactions have been observed between azitromicina 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 excessive 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).

Taking azitromicina cinfa with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

There is not enough information about the safety of azitromicina during pregnancy. Therefore, azitromicina is not recommended for use during pregnancy, or if you wish to become pregnant, unless it is strictly necessary according to medical criteria.

Azitromicina is excreted in breast milk. Due to potential adverse reactions in the infant, azitromicina is not recommended during breastfeeding, although breastfeeding may be continued two days after completing azitromicina treatment.

Driving and operating machinery

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

Azitromicina cinfa contains lactose.

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

Azitromicina cinfa contains sodium

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

Follow exactly the administration instructions of this medication 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):500 mg of azithromycin (1 tablet) once a day for 3 consecutive days, with a total dose of 1500 mg of azithromycin (3 tablets).

Urethral or cervical infection (cervicitis):

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

If the infection is 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.

Use in children and adolescents:

The dose of 500 mg of azithromycin from this presentation is only suitable for children and adolescents over 45 kg in weight, for whom the same dose as for adults is recommended. For those weighing less, other presentations are recommended.

Use in patients with liver insufficiency

Inform your doctor if you have severe liver problems, as it may be necessary to adjust the normal dose.

Use in patients with renal insufficiency

Inform your doctor if you have severe kidney problems, as it may be necessary to adjust the normal dose.

Administration form

Oral route.

This medication should be administered as a single daily dose. Tablets should be swallowed whole with water and can be taken with or without food. The groove should not be used to break the tablet.

If you take more azithromycin cinfa 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.

If you forgot to take azithromycin cinfa

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 doses. Continue using azithromycin as your doctor has recommended.

If you interrupt the treatment with azithromycin cinfa

If you abandon the treatment with azithromycin before your doctor recommends it, 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 can 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) are:

?Diarrhea.

The common side effects (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), decreased bicarbonate.

The uncommon side effects (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, respiratory alteration, rhinitis.

?Decreased 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 of 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 of sodium and potassium levels, decrease in hematocrit.

?Complications after surgical intervention

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

?Agitation.

?Liver function alteration, yellow discoloration of the skin.

?Sensitivity to sunlight (photosensitivity), allergic reaction to the medication with increase of a type of white blood cell (eosinophilia) and generalized symptoms (multi-organ compromise) (DRESS syndrome).

?Skin rash characterized by rapid appearance of red skin patches with small white/yellow-filled blisters.

The side effects of unknown frequency (cannot be estimated from available data) are:

?Diarrhea caused by Clostridium difficile.

?Decreased number of 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.

?Torsades de pointes cardiac rhythm alterations, prolongation of the QTc interval in the electrocardiogram.

?Decreased 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 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 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 directly 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 medication.

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.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and themedications that you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask yourpharmacist how to dispose of the packaging and the medications that you no longer need. By doing so,you will help protect the environment.

Composition of azithromycin cinfa

• The active ingredient is azithromycin dihydrate. Each tablet contains 500 mg of azithromycin (as azithromycin dihydrate).
• The other components are:
• Tablet core: pregelatinized cornstarch, crospovidone (E-1202), anhydrous calcium hydrogen phosphate, sodium lauryl sulfate, and magnesium stearate.
• Tablet coating: hydroxypropylmethylcellulose (E-464), titanium dioxide (E-171), lactose monohydrate, and triacetin.

Appearance of the product and contents of the packaging

White, capsule-shaped tablets with a notch on one face.

The coated tablets are packaged in PVC-Aluminum blisters and are presented in containers of 3 or 150 (clinical container) tablets.

Only some package sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: September 2020

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/65600/P_65600.html

QR code to: https://cima.aemps.es/cima/dochtml/p/65600/P_65600.html