PROSPECTO: INFORMATION FOR THE USER

Azitromicina ratiopharm 250mg dispersible tablets

Read this prospect carefully before starting to use this medication, as it contains important information for you

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Azitromicina ratiopharm belongs to a group of antibiotics called macrolide antibiotics.

It is used to treat bacterial infections caused by microorganisms such as bacteria that are sensitive to azitromicina. These infections include:

• Upper respiratory tract infections, for example, nasal sinuses, throat, and tonsils (see also “Warnings and precautions” in section 2).
• Acute otitis media.
• Lung infections (lower respiratory tract) such as acute bronchitis, exacerbation of chronic bronchitis, and community-acquired pneumonia of mild to moderately severe, including interstitial pneumonia.

• Mild to moderate skin and soft tissue infections, for example, hair follicle infection (folliculitis), bacterial skin infection and its deeper layers (cellulitis), skin infection with swelling and bright red color (erysipelas).
• Migratory erythema (first phase of Lyme disease), if antibiotics such as doxiciclina, amoxicilina, and cefuroxima axetil cannot be used (see section 2 “Warnings and precautions”).
• Uncomplicated infections caused by a bacterium calledChlamydia trachomatis, which can cause inflammation of the urethra or the area where the uterus joins the vagina (cervix).

Do not take Azitromicina ratiopharm

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Azitromicina ratiopharm if:

• You have an allergic reaction such as red or white patches on the skin, itching and irritation of the skin, swelling of the skin, throat, or tongue, and difficulty breathing, in which case you should stop taking Azitromicina ratiopharm.
• You have liver problems, your doctor may need to monitor your liver function or stop treatment.
• You have severe kidney problems, your doctor may need to adjust the dose.
• You are taking medications known as ergot alkaloids (such as ergotamine or dihydroergotamine), used to treat migraines: azithromycin is not recommended (see "Other medicines and Azitromicina ratiopharm")
• You develop signs of another infection
• You develop diarrhea or soft stools during or after treatment. In some cases, there is a possibility of developing a severe intestinal inflammation known as Clostridioides difficile-associated diarrhea. Do not take any medication to treat your diarrhea without consulting your doctor first.
• You have conditions that predispose you to arrhythmias (especially important in women and elderly patients)
• You have a prolonged QT interval (a heart disease)
• You are taking medications that are known to prolong the QT interval (see section "Other medicines and Azitromicina ratiopharm")
• Your potassium or magnesium levels in the blood are too low
• You have heart problems such as slow or irregular heartbeat or reduced cardiac function
• You have a type of muscle weakness known as myasthenia gravis. Azitromicina may exacerbate or trigger the symptoms of myasthenia.
• You have mental or nervous system problems
• You have a sexually transmitted disease caused by a pathogen (T. pallidum, including the pathogen that causes syphilis)

The treatment of erythema migrans with azithromycin should be carefully monitored by your doctor as failures may occur.

If symptoms persist after completing treatment with Azitromicina or if you notice any new and persistent symptoms, inform your doctor.

Other medicines and Azitromicina ratiopharm

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

Consult your doctor if you are taking or have taken recently any of the following medications:

• Medicines that are known to prolong the QT interval, such as antiarrhythmics (used to treat abnormal heart rhythms, for example quinidine, procainamide, dofetilide, amiodarone, and sotalol), hydroxychloroquine (used to treat rheumatic diseases or malaria), cisapride (used to treat stomach problems), terfenadine (used to treat allergies), pimozide, phenothiazines (used to treat certain mental disorders), citalopram (used to treat depression), and antibacterial medicines such as moxifloxacino and levofloxacino (see also section "Warnings and precautions").
• Antacids (used for heartburn and indigestion, for example aluminum hydroxide). Azitromicina ratiopharm should be taken at least 1 hour before or 2 hours after the antacid.
• Digoxin (used to treat heart failure) as it may increase digoxin levels in the blood and its levels should be monitored.
• Colchicine (used for gout and familial Mediterranean fever) as it may increase digoxin/colchicine levels in the blood.
• Zidovudine (used in the treatment of AIDS) as zidovudine levels may increase.
• Nelfinavir (used in the treatment of HIV) as azithromycin levels may increase.
• Ergotamine derivatives, for example, ergotamine, (used to treat migraines): Azitromicina should not be administered at the same time as it may cause ergotism (a potentially serious adverse effect with numbness or tingling in the extremities, muscle cramps, headaches, convulsions, or abdominal or chest pain) (see also section "Warnings and precautions").
• Astemizol (an antihistamine) as its effects may be increased.
• Alfentanil (a sedative) as its effects may be increased.
• Atorvastatin (a cholesterol-lowering medication), as there have been reports of rhabdomyolysis (an increased risk of muscle tissue breakdown) in patients who took this medication and azithromycin
• Hydroxychloroquine (used to treat rheumatic diseases or malaria): may cause heart problems.
• Cisapride (used to treat stomach problems) as it may cause heart problems.
• Coumarin derivatives, for example, warfarin (used to prevent blood clots): may increase the risk of bleeding.
• Ciclosporina (an immunosuppressant used after organ transplantation) as ciclosporina levels may increase and your doctor will need to monitor your ciclosporina levels in the blood.
• Theophylline (used to treat respiratory problems) as azithromycin may increase its levels.

Pregnancy, breastfeeding, and fertility

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

Azitromicina ratiopharm should not be used during pregnancy unless absolutely necessary. It should only be taken during pregnancy if your doctor thinks you need it.

It is not recommended to breastfeed while taking azithromycin, as it may cause side effects including diarrhea and infection in the baby. You may continue breastfeeding two days after completing treatment with azithromycin.

Driving and operating machinery

There is no information on the effect of azithromycin on the ability to drive and operate machinery. However, azithromycin may cause certain side effects such as dizziness or convulsions that may impair your reaction time and affect your ability to participate actively in road traffic or operate machinery. If these effects occur, do not drive or operate machinery.

Azitromicina ratiopharm contains aspartame

This medicine contains 19.5 mg of aspartame in each tablet. Aspartame is a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Azitromicina ratiopharm contains benzyl alcohol

This medicine contains less than 1 mg of benzyl alcohol in each dispersible tablet. Benzyl alcohol may cause allergic reactions.

This medicine should not be used for more than one week in children under 3 years of age unless instructed by your doctor or pharmacist.

Consult your doctor or pharmacist if you are pregnant or breastfeeding or if you have liver or kidney problems. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Azitromicina ratiopharm contains sodium

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

Azitromicina ratiopharm contains glucose (in maltodextrin from corn)

If your doctor has told you that you have intolerance to certain sugars, consult with him before taking this medicine.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults including elderly patients and children and adolescents with a body weight of more than 45 kg:

Treatment of upper and lower respiratory tract infections, middle ear inflammation and skin and soft tissue infections

The total dose is 1,500 mg of azithromycin, which can be taken according to the 3-day treatment period or the 5-day treatment period.

3-day treatment period

For 3 days, 500 mg of azithromycin is taken once a day.

5-day treatment period

For a 5-day treatment, 500 mg of azithromycin is taken on the first day and 250 mg of azithromycin once a day for days 2 to 5.

Treatment of uncomplicated genital infections byChlamydia trachomatis

The total dose is 1,000 mg of azithromycin, taken once.

Treatment of erythema migrans (first stage of Lyme disease)

In the treatment of erythema migrans, the total dose of azithromycin is 3,000 mg and is administered as follows: 1,000 mg on day 1 and 500 mg once a day from day 2 to day 5.

Elderly patients

Elderly patients receive the recommended adult dose. It should be noted that they may be more susceptible to severe heart rhythm disorders (torsades de pointes arrhythmia) than younger patients (see also "Warnings and precautions" in section 2).

Patients with liver or kidney impairment

Consult your doctor before taking Azitromicina ratiopharm if you have liver or kidney problems. Your doctor will then decide if the dose needs to be adjusted.

Children and adolescents weighing less than 45 kg:

• Your doctor will determine the best dose for your child based on their body weight.
• It may be possible that, based on their weight, this medication is not suitable for your child. In this case, your doctor will prescribe a different form of azithromycin, such as a suspension.
• The recommended dose is 10 mg per kilogram of body weight, administered as a single daily dose for 3 days. Alternatively, the same dose can be administered for 5 days with 10 mg/kg on the first day followed by 5 mg/kg for the remaining 4 days.
• The maximum total dose in these patients is 1,500 mg.

Method of administration

The tablet should be dispersed by shaking in a sufficient amount of liquid such as water, apple or orange juice (at least 30 ml) until a fine suspension is obtained. After the suspension has been swallowed, any residue should be resuspended in a small volume of water and swallowed. The dispersible tablet can be taken with or without food.

The groove should not be used to split the tablet.

If you take more Azitromicina ratiopharmthan you should

If you ingest many Azitromicina ratiopharm tablets, contact your doctor or pharmacist or go to the nearest hospitalimmediately. The symptoms of overdose are similar to those observed at normal doses (see section 4). Typical signs of an overdose are temporary hearing loss, intense nausea, vomiting and diarrhea.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone 91 562 04 20 indicating the medication and the amount ingested. Bring this leaflet, some of the remaining tablets and the packaging to the hospital or to your doctor so that they know what tablets you have taken.

If you forget to take Azitromicina ratiopharm

If you forget to take a tablet, take it as soon as you remember, unless it is almost time to take the next one. Do not take a double dose to make up for the missed doses.

Instead, take the next one at your usual time. If you are unsure, contact your doctor or pharmacist.

If you have forgotten a dose, still take all the tablets. This means that you will finish your treatment a day later.

If you interrupt the treatment with Azitromicinaratiopharm

Do not stop taking Azitromicina ratiopharm without consulting your doctor, even if you feel better. If the prescribed treatment is not completed, the infection may recur.

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.

If you experience any of the following, stop taking Azitromicina ratiopharm and seek medical attention immediately or visit the nearest hospital emergency room:

• Severe allergic reaction (such as anaphylaxis or angioedema) which may include sudden difficulty breathing and swallowing, swelling of the lips, tongue, face, and neck, itchy rash affecting the entire body
• Severe skin rash: Skin rash characterized by the rapid appearance of red skin patches with small white/yellow-filled blisters; severe skin rash causing redness and peeling, severe blisters and bleeding on the lips, eyes, mouth, nose, and genitals associated with high fever and joint pain. This could be "Generalized Acute Pustular Exanthema (PEGA)", "Multiform Erythema", "Stevens-Johnson Syndrome", or "Toxic Epidermal Necrolysis".
• Severe allergic reaction that may include fever, skin rash, gland inflammation, increased eosinophils, and internal organ inflammation (pharmacological reaction with eosinophilia and systemic symptoms (DRESS)).
• Severe diarrhea or prolonged diarrhea with blood and mucus. This may occur during or after treatment and may be a sign of severe intestinal inflammation.
• Severe liver problems or liver failure (rarely fatal): Signs may include fatigue associated with yellowing of the skin or white of the eyes (jaundice), dark urine, bleeding tendency.
• Renal inflammation or renal insufficiency: Signs may include increased nighttime urination, muscle spasms and cramps, loss of appetite, nausea or vomiting, unpleasant taste in the mouth.
• Unusual tendency to bruise or bleed, which may be a sign of a blood clotting disorder characterized by a reduced number of platelets (thrombocytopenia).
• Fast or irregular heartbeat or changes in the electrocardiogram (prolongation of the QT interval and torsades de pointes).

The following other side effects have been reported:

Very common(may affect more than 1 in 10 people)

• Diarrhea

Common(may affect up to 1 in 10 people)

• Headache
• Vomiting, abdominal pain, nausea
• Alteration of some types of white blood cells and bicarbonate in the blood

Uncommon(may affect up to 1 in 100 people)

• Fungal or bacterial infection
• Candidiasis, a fungal infection caused by Candida

• Vaginal infection
• Pneumonia
• Throat inflammation (pharyngitis)
• Stomach upset (gastroenteritis)

• Respiratory problems, chest pain, wheezing, and cough (respiratory disorders)
• Stuffy nose (rhinitis)
• Reduced white blood cell count
• Hypersensitivity
• Loss of appetite (anorexia)
• Nervousness, difficulty sleeping (insomnia)
• Dizziness, feeling of drowsiness, changes in taste (dysgeusia), feeling of tingling or numbness (paresthesia)
• Eye disorders
• Ear problems, feeling of vertigo
• Strong heartbeat that may be fast or irregular
• Palpitations
• Hot flashes
• Difficulty breathing (dyspnea), nosebleed (epistaxis)
• Constipation, gas, indigestion, stomach lining inflammation (gastritis), difficulty swallowing (dysphagia), stomach inflammation, dry mouth, belching, mouth ulcers, increased salivation
• Allergic reactions such as skin rash, itching, and urticaria, skin inflammation (dermatitis), dry skin, increased sweating
• Pain, swelling, and reduced movement in the joints (osteoarthritis), muscle pain (myalgia), back and neck pain
• Pain or difficulty urinating, upper back pain (renal pain)
• Irregular menstrual bleeding (metrorrhagia), testicular disorder
• Weakness (asthenia), general feeling of discomfort, fatigue, facial, arm, and leg swelling, chest pain, fever (pyrexia), pain
• Changes in liver enzymes and blood values, increased urea levels in the blood
• Complications after the procedure

Rare(may affect up to 1 in 1,000 people)

• Feeling agitated
• Abnormal liver function, yellowing of the skin or white of the eyes (jaundice)
• Sensitivity to light

Unknown(frequency cannot be estimated from available data)

• Intestinal inflammation (pseudomembranous colitis)
• Reduced platelet count (thrombocytopenia), reduced red blood cell count (hemolytic anemia)
• Anaphylactic reaction
• Aggression, anxiety, confusion (delirium), hallucinations
• Fainting (syncope), convulsions, reduced sense of touch (hypoesthesia), hyperactivity, changes in sense of smell (anosmia, parosmia), loss of sense of taste (ageusia), exacerbation or worsening of muscle weakness (myasthenia gravis)
• Loss of hearing or ringing in the ears (tinnitus)
• Fast or irregular heartbeat (ventricular tachycardia) or irregular, sometimes fatal, changes in heart rhythm detected by electrocardiogram (prolongation of the QT interval and torsades de pointes)
• Low blood pressure (hypotension)
• Pancreatitis, tongue discoloration, hepatitis
• Joint pain (arthralgia)

The following side effects have been reported in patients in prevention and treatment of Mycobacterium Avium Complex (MAC) infections:

Very common(may affect more than 1 in 10 people)

• Diarrhea, abdominal pain, nausea, gas (flatulence), soft stools

Common(may affect up to 1 in 10 people)

• Loss of appetite (anorexia)
• Dizziness, headache, feeling of tingling or numbness (paresthesia), changes in taste (dysgeusia)
• Visual impairment
• Deafness
• Skin rash and itching
• Joint pain (arthralgia)
• Fatigue

Uncommon(may affect up to 1 in 100 people)

• Reduced sensitivity (hypoesthesia)
• Loss of hearing or ringing in the ears (tinnitus)
• Strong heartbeat that may be fast or irregular
• Hepatitis
• Severe skin rash (Stevens-Johnson syndrome), sensitivity to light
• General feeling of discomfort, weakness (asthenia)

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 Medicines for Human Use Pharmacovigilance System Website:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 medications you no longer need at the SIGRE collection point at the pharmacy.If in 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 ofAzitromicina ratiopharm

• The active ingredient is: azithromycin (as dihydrate)

Each dispersible tablet contains 250mg of azithromycin (as dihydrate).

• The other components are sodium saccharin dihydrate, microcrystalline cellulose, crospovidone type A, povidone, sodium lauryl sulfate, anhydrous colloidal silica, magnesium stearate, aspartame (E951) and orange flavor (which contains flavoring agents, corn-derived maltodextrin (contains glucose),benzyl alcohol and alpha-tocopherol) (see also section 2 “Azitromicina ratiopharm contains aspartame, benzyl alcohol, glucose and sodium”).

Appearance of the product and contents of the package

Azitromicina ratiopharm 250mg dispersible tablets are white to almost white, round, smooth tablets with beveled edges, with a notch on one face and marked with “TEVA 250” on the other. Each tablet has an approximate diameter of 12.5 mm.

Lthe 250 mg tablets are available in aluminum blisters PVC/PE/PVDC/PE/PVC containing 1, 2, 3, 6, 12 or 24 dispersible tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Teva Pharma, S.L.U

C/ Anabel Segura 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid

Responsible manufacturer:

Teva Operations Poland Sp. z.o.o.

ul. Mogilska 80

31-546 Cracow

Poland

or

Pliva Croatia Ltd.(PLIVA HRVATSKA D.O.O.)

Prilaz Baruna Filipovica 25

10000 Zagreb

Croatia

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:June 2023

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es