Azithromycin Auxil 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Azithromycin Auxil 500 mg film-coated tablets EFG

Read the entire 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, and you must not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Azithromycin Auxil tablets are and what they are used for
2. What you need to know before taking Azithromycin Auxil tablets
3. How to take Azithromycin Auxil tablets
4. Possible adverse effects
5. How to store Azithromycin Auxil tablets
6. Contents of the pack and other information

1. What Azithromycin Auxil is and what it is used for

Azithromycin 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:

• Exacerbations of chronic bronchitis and pneumonia (mild to moderate severity).
• Infections of the paranasal sinuses, throat, tonsils, or ears.
• Mild to moderate infections of the skin and soft tissues, for example infection of the hair follicles (folliculitis), bacterial infection of the skin and its deeper layers (cellulitis), and skin infection with swelling and bright red coloration (erysipelas).
• Infections caused by a bacterium called Chlamydia trachomatis, which can cause inflammation of the tube that carries urine from the bladder (urethra) or of the area where the uterus joins the vagina (cervix).

2. What you need to know before taking Azithromycin Auxil

Do NOT take Azithromycin Auxil:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Azithromycin Auxil if:

• you have ever had a severe allergic reaction with swelling of the face and throat, possibly causing breathing difficulties.
• you have liver problems; your doctor may need to monitor your liver function or discontinue treatment.
• you are taking medicines known as ergot alkaloids (such as ergotamine), used to treat migraine: azithromycin is not recommended (see "Use of Azithromycin Auxil with other medicines").
• you have severe kidney problems; your doctor may need to adjust your dose.
• you know you have or have been diagnosed with prolonged QT interval (a heart condition): azithromycin is not recommended.
• you know you have a slow or irregular heartbeat or reduced heart function: azithromycin is not recommended.
• you know you have low levels of potassium or magnesium in your blood: azithromycin is not recommended.
• you 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.
• you have been diagnosed with a neurological disease, or a brain or nervous system disorder.
• you have mental, emotional, or behavioral problems.
• you have a condition called myasthenia gravis, which causes muscle weakness and fatigue, as azithromycin may worsen symptoms or trigger the condition.

If you develop severe and persistent diarrhoea, especially with blood or mucus, during or after treatment, contact 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 Azithromycin Auxil with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines:

• Antacids, for example, aluminium hydroxide: take azithromycin at least 1 hour before or 2 hours after taking an antacid.
• Ergot derivatives, for example ergotamine (used to treat migraine): should not be given at the same time, as ergotism (a potentially serious adverse effect with numbness or tingling in the limbs, muscle cramps, headaches, seizures, or abdominal or chest pain) may occur.
• 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 for gout and familial Mediterranean fever).
• Zidovudine, nelfinavir (used in the treatment of HIV): levels of zidovudine or azithromycin may increase.
• Rifabutin (used in the treatment of HIV and bacterial infections including tuberculosis): may cause a decrease in white blood cell count.
• Cyclosporine (an immunosuppressant used after organ transplantation): cyclosporine levels may increase. Your doctor will need to monitor your blood levels of cyclosporine.
• Cisapride (used to treat stomach problems): heart problems may occur.
• Astemizole, terfenadine (antihistamines used to treat allergic reactions): their effects may be increased.
• Alfentanil (a painkiller): the effect of alfentanil may be increased.
• 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 (an antibiotic combination).

Use of Azithromycin 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 insufficient information on the safety of azithromycin during pregnancy. Therefore, the use of azithromycin is not recommended if you are pregnant or planning to become pregnant. However, your doctor may prescribe it under serious circumstances.

Breastfeeding is not recommended while taking this medicine, as it may cause side effects such as diarrhoea or infection in the infant. You may resume breastfeeding two days after completing treatment with Azithromycin Auxil.

Driving and using machines

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

Azithromycin Auxil contains lactose:

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Azithromycin Auxil

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Take the tablets preferably with a glass of water. They may be taken with or without food. Other dosage forms are available for different dosing regimens.

The usual dose is:

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.

Urethritis or cervicitis caused by Chlamydia

1000 mg taken as a single dose on one day.

Children and adolescents weighing less than 45 kg:

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

Patients with liver or kidney problems

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

If you take more Azithromycin Auxil than you should

If you (or someone) take many tablets at once, or if you suspect a child has swallowed any tablets, 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 Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. Take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so they know which tablets have been taken.

If you forget to take Azithromycin Auxil

If you forget to take a tablet, take it as soon as you remember, 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 Auxil

Do not stop taking this medicine without first consulting your doctor, even if you feel better. It is very important that you continue taking Azithromycin Auxil for the length of time prescribed by your doctor; otherwise, the infection may return.

If you have any further questions about 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 everyone experiences them.

If you experience any of the following, stop taking Azithromycin Auxil and contact your doctor immediately or go to the nearest hospital emergency department:

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

These are very serious but rare adverse effects. You may require urgent medical attention or hospitalization.

Other adverse effects reported are listed below:

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

• Diarrhoea

Common (may affect up to 1 in 10 people):

• Changes in the number of certain types of white blood cells and bicarbonate levels in blood
• Headache
• Vomiting, stomach pain, nausea

Uncommon (may affect up to 1 in 100 people):

• Fungal infections, for example in the mouth (thrush), vaginal infection, pneumonia, bacterial infection
• Sore throat, inflammation of the stomach and intestinal lining
• 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 disturbances, tingling or numbness
• Vision disorders
• Hearing problems
• Vertigo (spinning sensation)
• Abnormal heart rhythm or rate and awareness of heartbeat (palpitations)
• Hot flushes
• Difficulty breathing
• Nosebleeds
• Stomach inflammation, constipation, difficulty swallowing, bloating, dry mouth
• Burping, mouth ulcers, increased salivation, soft stools
• Hepatitis (liver inflammation)
• Skin rash, itching, hives (itchy rash)
• Skin inflammation, dry skin, increased sweating
• Joint swelling, muscle pain, back pain, neck pain
• Difficulty urinating – Vaginal inflammation, irregular menstrual bleeding, testicular disorders – Chest pain, swelling, malaise, weakness, fatigue, facial swelling, fever, pain
• Changes in liver enzymes and blood test values

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

• Restlessness
• Feeling that things are unreal
• Confusion, especially in elderly patients
• Discoloration of teeth
• Abnormal liver function, jaundice (yellowing of the skin)
• Allergic reactions including angioedema
• Redness and blistering of the skin upon exposure to sunlight

Not known (frequency cannot be estimated from available data):

• Blood disorders characterized by unusual bleeding or unexplained bruising, decreased blood cell counts causing unusual weakness or fatigue
• Aggression, anxiety, confusion, seeing or hearing things that are not real
• Fainting, seizures, decreased sensation, hyperactivity, altered or loss of sense of smell, altered or loss of sense of taste, myasthenia gravis (muscle weakness and fatigue, see “Warnings and precautions” above)
• Hearing disturbances including deafness and/or ringing in the ears (tinnitus)
• Changes in heart rate, changes in heart rhythm detected on electrocardiogram (prolongation of QT interval and Torsade de Pointes)
• Decreased blood pressure (which may be associated with weakness, dizziness and fainting)
• Tongue discoloration, pancreatitis causing nausea, vomiting, abdominal pain, back pain – Liver failure (rarely fatal)
• Skin rash with spots and blisters
• Kidney problems
• Severe inflammation of the intestine (pseudomembranous colitis)
• Severe allergic reaction which may lead to shock (anaphylactic reaction)

The following adverse effects have been reported in patients treated with azithromycin for the prevention of Mycobacterium avium complex (MAC) infections:

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

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

Common (may affect up to 1 in 10 people):

• Loss of appetite (anorexia)
• Dizziness
• Headache
• Tingling or numbness sensation (paraesthesia)
• Taste changes (dysgeusia)
• Visual disturbances
• Deafness
• Skin rash
• Itching (pruritus)
• Joint pain (arthralgia)
• Fatigue

Uncommon (may affect up to 1 in 100 people):

• Reduced sensation (hypoesthesia)
• Hearing loss or ringing in the ears
• Abnormal heart rhythm or rate and awareness of heartbeat (palpitations)
• Liver problems such as hepatitis
• Blisters/bleeding of the lips, eyes, nose, mouth and genitals, which may be caused by Stevens-Johnson syndrome
• Skin allergic reactions such as photosensitivity, red, peeling and inflamed skin
• Weakness (asthenia)
• Feeling of general malaise

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Azithromycin Auxil

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

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

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 must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the container and additional information

Composition of Azithromycin Auxil

• The active substance is: azithromycin. Each tablet contains 500 mg of the active substance azithromycin (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 glyceryl triacetate.

Appearance of the product and contents of the container

The tablets are packaged in PVC-aluminum blisters. Azithromycin Auxil 500 mg film-coated tablets are available in packs of 3 and 150 tablets (hospital pack).

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder Auxilto Healthcare GmbH Opernplatz 14

60313 Frankfurt am Main (Germany)

Manufacturer

Kern Pharma S.L.

Poligono Ind. Colón II Venus, 72

08228 Terrassa (Barcelona)

OR

Marketing Authorization Holder and Manufacturer

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)

Date of the most recent review of this package leaflet: December 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es