Leaflet: information for the user

Azitromicina Auxil 500 mg film-coated tablets EFG

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 the same symptoms as 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.

1. What isAzitromicina Auxil tabletsand what it is used for

2. What you need to know before you start takingAzitromicina Auxil tablets

3. How to takeAzitromicina Auxil tablets

4. Possible side effects

5. Storage ofAzitromicina Auxil tablets

6. Contents of the pack and additional information

Azitromicina belongs to a group of antibiotics called macrolide antibiotics.

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

• Worsening of chronic bronchitis and pneumonia (mild to moderate severity).
• Upper respiratory tract infections, throat infections, tonsillitis, or ear infections.
• Mild to moderate skin and soft tissue infections, for example, folliculitis, bacterial skin infection, or cellulitis.
• Infections caused by a bacteria called Chlamydia trachomatis, which may produce inflammation of the urethra or the cervix.

Do not take Azitromicina Auxil:

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

Warnings and precautions

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

• Have ever had a severe allergic reaction with facial and throat inflammation and possible respiratory problems.
• Have liver problems, your doctor may need to monitor your liver function or interrupt treatment.
• Are taking medicines known as ergot alkaloids (such as ergotamine), used to treat migraine: azithromycin is not recommended (see “Use of Azitromicina Auxil with other medicines”)
• Have severe kidney problems, your doctor may modify the dose.
• Know that you have or have been diagnosed with prolonged QT interval (a heart disease): azithromycin is not recommended.
• Know that you have a slow or irregular pulse or reduced cardiac function: azithromycin is not recommended.
• Know that you have low levels of potassium or magnesium in the blood: azithromycin is not recommended.
• Are taking medicines known as antiarrhythmics (used to treat abnormal heart rhythm), cisapride (used to treat stomach problems) or terfenadine (an antihistamine used to treat allergies): azithromycin is not recommended.
• Have been diagnosed with any neurological disease, brain or nervous system disease.
• Have mental, emotional, or behavioral problems.
• If you have a disease called myasthenia gravis, with muscle weakness and fatigue, as azithromycin may worsen the symptoms of this disease or trigger it.

If you experience severe and persistent diarrhea, especially with blood or mucus, during or after treatment, consult your doctor immediately.

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

Children and adolescents

The tablets are not recommended for children and adolescents weighing less than 45 kg (see section 3).

Use of Azitromicina Auxil with other medicines

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

• Antacids, for example, aluminum hydroxide: take azithromycin at least 1 hour before or 2 hours after taking an antacid.
• Ergot derivatives, for example, ergotamine (used to treat migraine): Do not administer at the same time as it may develop ergotism (a potentially serious adverse effect with numbness or tingling in the extremities, muscle cramps, headaches, convulsions, or abdominal or chest pain).
• Coumarin derivatives, for example, 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 to treat gout and familial Mediterranean fever).
• Zidovudine, nelfinavir (used in HIV treatment): zidovudine or azithromycin levels may increase.
• Rifabutin (used in HIV and bacterial infections, including tuberculosis): may occur a decrease in the number of white blood cells in the blood.
• Ciclosporin (an immunosuppressant used after organ transplantation): ciclosporin levels may increase. Your doctor will need to monitor your ciclosporin levels in the blood.
• Cisapride (used to treat stomach problems): may occur heart problems.
• Astemizol, terfenadine (antihistamines used to treat allergic reactions), their effects may be increased.
• Alfentanil (sedative): the effect of alfentanil may increase.
• Fluconazole (for fungal infections): azithromycin levels may be reduced.

No interactions have been observed between azithromycin and cetirizine (an antihistamine); didanosine, efavirenz, indinavir (for HIV infection); atorvastatin (for cholesterol and heart problems); carbamazepine (for epilepsy), cimetidine (an antacid); methylprednisolone (to suppress the immune system); midazolam, triazolam (sedatives); sildenafil (for impotence) and trimethoprim/sulfamethoxazole (a combination antibiotic).

Use of Azitromicina Auxil with food and drinks

The oral suspension can be taken with or without food and drink.

Pregnancy, breastfeeding, and fertility

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

There is not enough information about the safety of azithromycin during pregnancy. Therefore, azithromycin is not recommended if you are pregnant or wish to become pregnant. However, your doctor may prescribe it in serious circumstances.

It is not recommended to breastfeed while taking this medicine as it may cause side effects such as diarrhea and infection in the baby. You can continue breastfeeding two days after completing treatment with Azitromicina Auxil.

Driving and operating machinery

Azithromycin is not expected to affect your ability to drive or operate machinery.

Azitromicina Auxil contains lactose:

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

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

Take the tablets preferably with a glass of water, they can be taken with or without food. There are other presentations available for different dosing regimens.

The usual dose is:

Adults (including elderly patients) and children with a weight of 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 the 2nd to the 5th day.

Urethral or cervical inflammation caused by Chlamydia

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

Children and adolescents under 45 kg of weight:

The tablets are not recommended for these patients. Other pharmaceutical forms containing azitromicina (e.g. suspensions) may be used.

Patients with liver or kidney problems

Inform your doctor if you have liver or kidney problems, as the usual dose may need to be modified.

If you take more Azitromicina Auxil than you should

If you (or someone) have ingested many tablets at once or if you think a child has swallowed a tablet, contact your doctor or pharmacist immediately. Overdose may cause reversible hearing loss, severe nausea, vomiting, and diarrhea.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological 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 they know which tablets you have taken.

If you forget to take Azitromicina Auxil

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

If you interrupt treatment with Azitromicina Auxil

Do not stop taking your medication without consulting your doctor, even if you feel better. It is very important that you continue to take Azitromicina Auxil for the time your doctor has indicated, as the infection may recur if you stop treatment prematurely.

If you have any other questions 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 Auxil and seek medical attention immediately or visit the nearest hospital emergency room:

• Allergic reaction (swelling of the lips, face, or neck, which causes severe difficulty breathing; skin rash or hives).
• Blisters/blood from lips, eyes, nose, mouth, and genitals, which may be caused by Stevens-Johnson syndrome or toxic epidermal necrolysis, which are serious diseases.
• Irregular heartbeat
• Prolonged diarrhea with blood and mucus.

These are very serious but rare side effects. You may need urgent medical attention or hospitalization.

The following are other reported side effects described below:

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

• Diarrhea

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Fungal infection, for example in the mouth (aphthae), vaginal infection, pneumonia, bacterial infection
• Sore throat, inflammation of the stomach lining and intestine
• Shortness of breath, chest pain, wheezing, and cough (respiratory disorders), nasal congestion
• Blood disorders characterized by fever or chills, sore throat, mouth or throat ulcers
• Allergic reactions
• Loss of appetite
• Nervousness
• Difficulty sleeping
• Dizziness, drowsiness, taste alterations, tingling or numbness
• Visual disturbances
• Auditory problems
• Dizziness (sensation of spinning)
• Abnormal heart rhythm or frequency and heart palpitations
• Hot flashes
• Difficulty breathing
• Nasal bleeding
• Inflammation of the stomach, constipation, difficulty swallowing, feeling bloated, dry mouth
• Belching, mouth ulcers, increased salivation, soft stools
• Hepatitis (liver inflammation)
• Skin rash, itching, hives (rash with itching)
• Skin inflammation, dry skin, increased sweating
• Joint inflammation, muscle pain, back pain, neck pain
• Difficulty urinating - Vaginal inflammation, irregular menstrual bleeding, testicular disorders - Chest pain, swelling, discomfort, weakness, fatigue, inflammation of the face, fever, pain.
• Changes in liver enzymes and blood values

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

• Agitation
• Sensation that things are unreal.
• Confusion, especially in elderly patients.
• Teeth discoloration
• Abnormal liver function, jaundice (yellow pigmentation of the skin)
• Allergic reactions including angioneurotic edema
• Redness and blistering of the skin upon exposure to sunlight

Unknown (frequency cannot be estimated from available data)

• Blood disorders characterized by rare bleeding or unexplained bruises, decreased blood count causing weakness or fatigue
• Aggression, anxiety, confusion, seeing or hearing things that are not real
• Fainting, seizures, decreased sensitivity, hyperactivity, alteration or loss of sense of smell, alteration or loss of sense of taste, myasthenia gravis (muscle weakness and fatigue, see "Warnings and precautions" above)
• Alteration in hearing including deafness and/or ringing in the ears
• Changes in heart rhythm, changes in heart rhythm detected on electrocardiogram (prolongation of the QT interval and Torsade de Pointes)
• Decreased blood pressure (which may be associated with weakness, dizziness, and fainting)
• Discoloration of the tongue, pancreatitis that causes nausea, vomiting, abdominal pain, back pain - Liver insufficiency (rarely fatal)
• Skin rash with blisters and ulcers
• Renal problems
• Severe inflammation of the intestine (pseudomembranous colitis)
• Severe allergic reaction that can cause anaphylactic shock

The following side effects have been reported in patients treated with azithromycin for the prevention of infections by Mycobacterium Avium Complex (MAC):

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

• Diarrhea
• Abdominal pain
• Nausea
• Gas (flatulence)
• Abdominal discomfort
• Soft stools

Common (may affect up to 1 in 10 people)

• Loss of appetite (anorexia)
• Dizziness (dizziness)
• Headache
• Sensation of tingling or numbness (paresthesia)
• Changes in taste (dysgeusia)
• Visual impairment
• Deafness
• Skin rash
• Itching (pruritus)
• Joint pain (arthralgia)
• Fatigue

Uncommon (may affect up to 1 in 100 people)

• Reduced sensitivity (hypoaesthesia) - Hearing loss or ringing in the ears
• Abnormal heart rhythm or frequency and heart palpitations
• Liver problems such as hepatitis
• Blisters/blood from lips, eyes, nose, mouth, and genitals, which may be caused by Stevens-Johnson syndrome.
• Skin reactions such as sun sensitivity, red, flaky, and inflamed skin
• Weakness (asthenia)
• General feeling of discomfort

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 through the Spanish System for the 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 medicine.

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

No special storage conditions are required. Store in the original packaging.

Do not use this medication after the expiration date shown on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Azitromicina Auxil

• The active ingredient is: azitromicina. Each tablet contains 500 mg of the active ingredient azitromicina (as dihydrate).
• The other components (excipients) are: pregelatinized starch, crospovidone, anhydrous calcium hydrogen phosphate, sodium lauryl sulfate, magnesium stearate, hydroxypropylmethylcellulose, titanium dioxide (E171), lactose, and triacetin.

Appearance of the product and contents of the packaging

Thetabletsare packaged in PVC-Aluminum blisters. Azitromicina Auxil 500 mg film-coated tablets are presented in packs of 3 and 150 tablets (clinical pack).

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorizationAuxilto Healthcare GmbH

Opernplatz 14

60313 Frankfurt am Main (Germany)

Responsible for manufacturing

Kern Pharma S.L.

Poligono Ind. Colón II Venus, 72

08228 Terrassa (Barcelona)

O

Holder of the marketing authorization and responsible for manufacturing

Auxilto Healthcare GmbH

Opernplatz 14

60313 Frankfurt am Main (Germany)

Local representative:

Vegal Farmacéutica S.L.

Vía de las Dos Castillas, 9, portal 2 2ºC

28224 Pozuelo de Alarcón, Madrid (Spain)

Last review date of this leaflet: December 2023

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