AZITHROMYCIN ARISTOGEN 500 MG FILM-COATED TABLETS

2. What you need to know before you take Azithromycin Aristogen

Do not take Azithromycin Aristogen

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine if:

• you have ever had a severe allergic reaction characterized by symptoms such as swelling of the face or throat, possibly with difficulty breathing;
• you have severe kidney problems, your doctor may need to change the dose;
• you have liver problems: your doctor may need to monitor your liver function or decide to interrupt treatment;
• you know that you have been diagnosed with a prolonged QT interval (heart problem): azithromycin is not recommended;
• you know that you have an irregular or slow heartbeat, or reduced cardiac function or existing proarrhythmias: azithromycin is not recommended;
• you know that you have low potassium or magnesium levels in your blood: azithromycin is not recommended;
• you are taking medications known as antiarrhythmics (used to treat abnormal heart rhythm), cisapride (used to treat stomach problems), or terfenadine (an antihistamine used to treat allergies), antipsychotics (e.g., pimozide), antidepressants (e.g., citalopram), or certain antibiotics (e.g., moxifloxacin, levofloxacin): azithromycin is not recommended;
• you take medications called ergot alkaloids (e.g., ergotamine) used to treat migraines: azithromycin should not be taken simultaneously (see "Other medicines and azithromycin");
• you have ever been diagnosed with a neurological disease, which is a disease of the brain or nervous system;
• you have mental, emotional, or behavioral problems;
• you suffer from a disease called myasthenia gravis, with muscle weakness and fatigue during treatment: azithromycin may worsen or trigger myasthenia symptoms;
• you suffer from a sexually transmitted disease caused by a specific pathogen (T. pallidum, including the pathogen that causes syphilis).

This medicine should not be taken in infections caused by Gram-positive bacterial strains resistant to erythromycin (cross-resistance) and most strains of methicillin-resistant staphylococci.

There have been reports of severe and severe inflammation of the intestinal lining (pseudomembranous colitis) after the use of macrolide antibiotics (a group of antibiotics to which azithromycin belongs). This should be taken into account if patients develop diarrhea after starting treatment with azithromycin.

If you have severe and persistent diarrhea during or after treatment, especially if you notice blood or mucus, inform your doctor immediately.

Secondary infections caused by another pathogen: attention should be paid to possible symptoms of secondary infections caused by non-susceptible pathogens, for example, caused by fungi of the genus B.

There is no experience with the safety and efficacy of long-term use of azithromycin in the indicated indications. If a rapid recurrence of the infection occurs, treatment with another antibiotic should be considered.

This medicine is not suitable for the treatment of severe infections in which a high concentration of the antibiotic is rapidly needed in the blood.

This medicine is not suitable as a first choice for the treatment of sinusitis, acute otitis media, pharyngitis, and tonsillitis, and as prophylaxis for acute rheumatic fever.

This medicine is not indicated for the treatment of infected burn wounds.

If the symptoms persist after finishing the treatment with this medicine, or if you notice new persistent symptoms, contact your doctor.

Children and adolescents

After the use of azithromycin in neonates (treatment in the first 42 days after birth), cases of narrowing in the gastric outlet region (hypertrophic pyloric stenosis, HPS) have been reported. Contact your doctor if your child or the child you are caring for presents with vomiting or feeding intolerance.

Other medicines and azithromycin

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines:

• Antacids, e.g., aluminum hydroxide: take azithromycin at least 1 hour before or 2 hours after taking the antacid.
• Ergot derivatives, e.g., ergotamine (used to treat migraines): azithromycin should not be taken simultaneously, as ergotism (a potentially serious adverse reaction with numbness or tingling in the limbs, muscle cramps, headaches, convulsions, chest or abdominal pain) may occur.
• Coumarin derivatives, e.g., warfarin (used to prevent blood clotting): may increase the risk of bleeding.
• Digoxin (used to treat heart failure): may increase digoxin levels in the blood.
• Colchicine (used for gout and familial Mediterranean fever).
• Zidovudine (used in the treatment of HIV): may increase zidovudine levels.
• Rifabutin (used in the treatment of HIV and bacterial infections, including tuberculosis): may lead to a decrease in the number of white blood cells.
• Cyclosporin (immunosuppressant used after organ transplantation): cyclosporin levels may be elevated. Your doctor should monitor your cyclosporin blood levels.
• Cisapride (used to treat stomach problems): may cause heart problems.
• Astemizole, terfenadine (antihistamines used to treat allergic reactions): may increase the effects.
• Alfentanil (an analgesic): the effect of alfentanil may be increased.
• Fluconazole (for fungal infections), azithromycin levels may be reduced.
• Atorvastatin (used to reduce blood lipids): concomitant use of azithromycin with atorvastatin has been associated with an increased risk of muscle tissue rupture (rhabdomyolysis) that can lead to muscle pain with dark urine.

Attention should be paid to possible parallel resistance between azithromycin and macrolide antibiotics (e.g., erythromycin), as well as lincomycin and clindamycin. Therefore, simultaneous administration of several preparations from this group of antibiotics is not recommended.

No interactions have been observed between azithromycin and cetirizine (antihistamine); didanosine, efavirenz, indinavir (for the treatment of HIV infection); carbamazepine (for the treatment of epilepsy), cimetidine (antacid); methylprednisolone (to suppress the immune system); midazolam, triazolam (sedatives); sildenafil (for the treatment of impotence), theophylline (for asthma), and trimethoprim/sulfamethoxazole (a combination of antibiotics).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

There is not enough information on the safety of azithromycin during pregnancy.

As a precautionary measure, treatment in pregnant women should only be administered in exceptional situations. Your doctor must decide if such an exceptional situation exists.

Breastfeeding

If you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether azithromycin can be used during breastfeeding. Azithromycin is excreted in breast milk. So far, no serious side effects have been observed in breastfed infants. However, hypersensitivity, alteration of intestinal flora, and fungal colonization may occur in the infant.

Driving and using machines

According to previous experience, azithromycin generally does not affect concentration and reaction. However, the occurrence of side effects (see section 4) may alter the reaction ability and impair the ability to drive and use machines.

This medicine contains sodium

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

3. How to take Azithromycin Aristogen

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is:

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

The usual dose is 1,500 mg of azithromycin divided over 3 or 5 days as follows:

• When taken for 3 days: 500 mg once daily, (2 film-coated tablets of azithromycin 250 mg or 1 film-coated tablet of azithromycin 500 mg).
• When taken for 5 days: 500 mg (2 film-coated tablets of azithromycin 250 mg) on the first day and then 250 mg (1 film-coated tablet of azithromycin 250 mg) on days 2 to 5, each once daily.

Azithromycin Aristogen 500 mg film-coated tablets cannot be divided into equal doses. If the alternative therapy is used for 5 days, you should take azithromycin 250 mg film-coated tablets.

Inflammation of the urethra or cervix caused by Chlamydia trachomatis: 1,000 mg taken as a single dose, on a single day.

Treatment of sexually transmitted diseases caused by Neisseria gonorrhoeae:

1,000 mg or 2,000 mg of azithromycin in combination with 250 mg or 500 mg of ceftriaxone.

Children and adolescents under 45 kg body weight

Film-coated tablets are not indicated for these patients. Other pharmaceutical forms of medicines containing azithromycin (e.g., suspensions) may be used.

Elderly patients

In elderly patients, the same dose as in adults can be administered. Since elderly patients with ongoing proarrhythmic conditions are at risk of developing cardiac arrhythmias and torsades de pointes (see section 2), special caution is recommended.

Patient with renal or hepatic impairment

You should inform your doctor immediately if you have kidney or liver problems, as your doctor may need to modify the usual dose.

Method of administration

Oral use.

The film-coated tablets should be taken preferably with water or another drink and should not be chewed or crushed. The film-coated tablets can be taken with or without food.

If you take more Azithromycin than you should

If you (or someone else) swallow many tablets at once, or if you think a child has swallowed some of the tablets, contact your doctor or pharmacist immediately. An overdose may cause reversible hearing loss, severe nausea (feeling of dizziness), vomiting, and diarrhea.

Bring this leaflet, the remaining film-coated tablets, and the packaging to the hospital or doctor so they know which tablets have been consumed.

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

If you forget to take Azithromycin

If you forget to take a film-coated tablet, take it as soon as possible, unless it is almost time for the next dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Azithromycin

Do not stop taking the medicine without consulting your doctor first, even if you are feeling better. It is essential that you continue taking azithromycin for the period indicated by your doctor; otherwise, the infection may recur.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

• Diarrhea.

Frequent(may affect up to 1 in 10 people)

• Headache;
• Vomiting, abdominal pain, nausea;
• Decrease in lymphocyte count (type of white blood cell), increase in eosinophil, basophil, monocyte, and neutrophil count (type of white blood cell);
• Decrease in blood bicarbonate.

Infrequent(may affect up to 1 in 100 people)

• Vaginal fungal infection (candidiasis) and oral fungal infection (thrush), vaginal infection, pneumonia, fungal infection, bacterial infection;
• Sore throat, inflammation of the stomach and intestine lining;
• Shortness of breath, chest pain, wheezing, and cough (respiratory disorders), nasal congestion;
• Blood disorders characterized by fever or chills, sore throat, ulcers in the mouth or throat;
• Allergic reactions;
• Loss of appetite;
• Nervousness, difficulty sleeping;
• Dizziness, drowsiness, taste disorders, tingling or numbness;
• Visual disturbances;
• Hearing disturbances;
• Vertigo (feeling of spinning);
• Abnormal heart rhythm or frequency and awareness of heartbeat (palpitations);
• Hot flashes;
• Difficulty breathing;
• Nosebleeds;
• Stomach inflammation, constipation, gas, indigestion, difficulty swallowing;
• Feeling of bloating, dry mouth;
• Belching, mouth ulcers, increased salivation, soft stools;
• Liver problems (such as liver inflammation, hepatitis);
• Skin rash, itching, hives (chronic hives)
• Skin inflammation, dry skin, excessive sweating
• Inflammation of bones and joints, muscle pain, back pain, neck pain;
• Difficulty urinating and painful, pain in the upper back (kidney pain)
• Irregular menstrual bleeding, alteration in the testicles
• Chest pain, swelling, discomfort, weakness, fatigue;
• Swelling of the face, hands, legs, and/or feet, fever, pain;
• Alterations in liver enzymes and blood values;
• Complications after surgery.

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

• Feeling of agitation;
• Liver function alteration, jaundice (yellowish skin pigmentation);
• Photosensitivity (redness and blistering of the skin when exposed to sunlight);
• Skin rash characterized by the rapid appearance of red skin areas with small pus-filled blisters (small blisters filled with white/yellow liquid);
• Hypersensitivity reaction with skin rash, fever, lymph node inflammation, and possible organ involvement (DRESS).

Additional adverse effects reported during post-marketing experience (frequency not known: cannot be estimated from available data)

• Cramps that are relieved by bowel movements, low-grade fever, profuse watery diarrhea, and dehydration (pseudomembranous colitis);
• Decrease in platelet count in blood, abnormally low hemoglobin level;
• Severe hives;
• Aggressive reactions, anxiety, confusion, delirium, seeing or hearing things that do not exist (hallucinations);
• Loss of consciousness, seizures, decreased sense of touch, hyperactivity, alteration or loss of smell, loss of taste, myasthenia gravis;
• Auditory disturbances, including ringing in the ears;
• Heart rhythm problems, including rapid and irregular heartbeats;
• Low blood pressure (hypotension);
• Pancreatitis, change in tongue color;
• Severe skin reaction;
• Liver failure, liver necrosis;
• Kidney failure, kidney inflammation;
• Altered electrocardiogram (ECG) (torsade de pointes and prolonged QT interval);
• Joint pain (arthralgia).

These are very serious adverse reactions. You may need urgent medical attention or hospitalization.

Adverse reactions possibly or probably related to prophylaxis and treatment with Mycobacterium Avium Complexbased on clinical trial experience and post-marketing surveillance. These adverse reactions differ from those reported with immediate-release or prolonged-release formulations, both in type and frequency:

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

• Diarrhea;
• Abdominal pain;
• Nausea;
• Flatulence;
• Abdominal discomfort;
• Soft stools.

Frequent(may affect up to 1 in 10 people)

• Anorexia;
• Dizziness;
• Headache;
• Paresthesia;
• Dysgeusia;
• Visual impairment;
• Deafness;
• Skin rash;
• Pruritus;
• Arthralgia;
• Fatigue.

Infrequent(may affect up to 1 in 100 people)

• Hypoesthesia;
• Hearing impairment, tinnitus;
• Palpitations;
• Hepatitis;
• Stevens-Johnson syndrome;
• Photosensitivity reaction;
• Asthenia;
• Malaise.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines Vigilance System, website: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Azithromycin Aristogen

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

Do not use this medicine after the expiration date that appears on the box and blister pack after "EXP". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

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

6. Package Contents and Additional Information

Azithromycin Aristogen Composition

• The active ingredient is azithromycin.

Each film-coated tablet contains 500 mg of azithromycin (as dihydrate).

• The other ingredients (excipients) are: calcium hydrogen phosphate (E341), pregelatinized corn starch, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate (E572), hypromellose (E464), titanium dioxide (E171), macrogol 400.

Product Appearance and Package Contents

Azithromycin Aristogen 500 mg film-coated tablets are white, oblong, biconvex, 6.6 mm x 17.1 mm, with the inscription "500" in relief on one side.

This medicine is available in packs of 2, 3, 6, or 30 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin,

Germany

Manufacturer

Bluepharma Indústria Farmacêutica, S.A.

Sao Martinho do Bispo

3045-016 Coimbra

Portugal

You can request more information about this medicine by contacting the local representative of the Marketing Authorization Holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany Azithromycin Aristo 500 mg Filmtabletten

Italy Azithromycin Aristo 500 mg film-coated tablets

Spain Azithromycin Aristogen 500 mg film-coated tablets EG

Date of the last revision of this leaflet:March 2023

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