AZITHROMYCIN ALTER 500 mg ORAL SUSPENSION GRANULES

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

Do not take Azithromycin Alter

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Azithromycin Alter if you:

• Have ever had an allergic reaction, characterized by symptoms such as itching, redness, skin rash, swelling, or difficulty breathing. If this happens, you should inform your doctor immediately.
• Suffer from liver problems; your doctor may need to monitor your liver function or interrupt treatment.
• During treatment with this medicine, your skin and/or the whites of your eyes turn yellow, inform your doctor immediately, as this could be a symptom of a serious liver disease (which can be fatal).
• Are taking medicines known as ergot alkaloids (such as ergotamine), used to treat migraines: azithromycin is not recommended (see "Use of Azithromycin Alter with other medicines").
• Suffer from severe kidney problems; your doctor may modify the dose.
• During treatment with this medicine or after completing it, you experience diarrhea, abdominal pain, or fever, inform your doctor.
• It is possible that, as with other antibiotics, during treatment with this medicine, a superinfection with resistant germs may occur, including fungi. If this is the case, inform your doctor.
• Know that you have or have been diagnosed with a prolonged QT interval (a heart disease), inform your doctor, as this medicine may contribute to worsening these alterations or triggering them.
• Know that you have a slow or irregular pulse or reduced heart function: 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.
• Suffer from a disease called myasthenia gravis, with muscle weakness and fatigue, as this medicine may contribute to worsening the symptoms of this disease or triggering it.

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

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

Children and adolescents

This presentation is only suitable for children and adolescents over 45 kg in weight. For those weighing less, other presentations are recommended (see section 3).

Use of Azithromycin Alter with other medicines

Inform your doctor if you are taking, have recently taken, or may need to take any other medicine, including those obtained without a prescription.

Azithromycin may interact with other medicines. Inform your doctor or pharmacist if you are taking any of the following medicines:

• Antacids (medicines used for digestive problems). If you are taking antacids (such as aluminum hydroxide) and Azithromycin Alter, it is recommended to avoid taking both medicines at the same time: take azithromycin at least 1 hour before or 2 hours after taking an antacid.
• Ergotamine derivatives, such as ergotamine, (used to treat migraines): should not be administered at the same time, as ergotism (a potentially serious side effect with numbness or tingling in the limbs, muscle cramps, headaches, seizures, or abdominal or chest pain) may develop.
• Coumarin derivatives, such as warfarin (used to prevent blood clotting): may increase the risk of bleeding.
• Digoxin (used to treat heart failure and arrhythmias): may increase digoxin levels in the blood.
• Colchicine (used for gout and familial Mediterranean fever)
• Zidovudine, nelfinavir (used in HIV treatment): azithromycin or zidovudine levels may increase. Rifabutin (used in HIV and bacterial infection treatment, including tuberculosis): a decrease in white blood cell count in the blood may occur.
• Cyclosporin (an immunosuppressant used after organ transplantation): cyclosporin levels may increase. Your doctor will need to monitor your cyclosporin levels in the blood.
• 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 sedative): the effect of alfentanil may be increased.
• Fluconazole (for fungal infections): azithromycin levels may be reduced.
• Amiodarone, propafenone (medicines for treating ventricular and supraventricular tachycardias).

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), theophylline (for asthma), and trimethoprim/sulfamethoxazole (a combination antibiotic).

If you are taking medicines that prolong the QT interval, you should not take this medicine.

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.

There is not enough information on the use of azithromycin in pregnant women. Therefore, azithromycin is not recommended during pregnancy and breastfeeding unless, in the doctor's opinion, the benefit outweighs the risk to the fetus.

It has been reported that azithromycin passes into breast milk, but there are no adequate and well-controlled studies in breastfeeding women that have shown how azithromycin passes into breast milk. Therefore, azithromycin is not recommended during pregnancy and breastfeeding unless, in the doctor's opinion, the benefit outweighs the risk to the child.

Driving and using machines

There is no evidence that Azithromycin Alter affects the ability to drive or use machines. However, as drowsiness and dizziness have been reported during treatment with azithromycin, the patient should be cautious when driving or using machines until it is established how azithromycin affects them individually.

Important information about some of the ingredients of Azithromycin Alter

This medicine contains sucrose and glucose (in maltodextrin from corn). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Azithromycin Alter effervescent granules contain sodium

This medicine contains 23.958 mg of sodium (the main component of cooking/table salt) in each sachet. This is equivalent to 1.2% of the maximum recommended daily intake of sodium for an adult.

3. How to take Azithromycin Alter

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

Azithromycin Alter is administered orally. The medicine must be reconstituted before administration. There are other presentations available for different dosing regimens. Do not stop treatment prematurely, as there is a risk of relapse of the disease.

Reconstitution instructions

Pour the contents of the sachet into a glass and add a little water, then mix well. The resulting suspension should be taken immediately.

The dose will be determined by your doctor based on your individual needs and the type of infection. To achieve optimal efficacy, follow your doctor's instructions regarding dose and treatment duration.

As a general rule, the dose of medicine and the frequency of administration are as follows:

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

The usual dose is 1500 mg divided into 3 or 5 days as follows:

• When taken for 3 days, 500 mg (1 sachet) once a day for 3 consecutive days, with a total dose of 1500 mg (3 sachets).
• When taken for 5 days, 500 mg on the first day and 250 mg from the 2nd to the 5th day.

Urethritis or cervicitis caused by Chlamydia

1000 mg taken as a single dose, in one day.

Children and adolescents under 45 kg in weight:

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.

Patients with liver or kidney problems

Inform your doctor if you have liver or kidney problems, as it may be necessary to modify the normal dose.

If you think the effect of Azithromycin Alter is too strong or too weak, tell your doctor or pharmacist.

If you take more Azithromycin Alter than you should

Inform your doctor or pharmacist immediately. Do not take a double dose to make up for forgotten doses.

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 taken. Bring this leaflet, any remaining sachets, and the packaging to the hospital or your doctor so they know what you have taken.

If you forget to take Azithromycin Alter

If you forget to take a dose, 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 Alter

Do not stop taking your medicine without consulting your doctor first, even if you feel better. It is very important that you continue taking Azithromycin Alter for the time indicated by your doctor, otherwise, the infection may recur. If you have any other 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 all people suffer from them.

If you experience any of the following, stop taking Azitromicina Alter and consult your doctor immediately or go to the emergency room of the nearest hospital:

• Allergic reaction (swelling of the lips, face, or neck, causing severe difficulty breathing; rash or hives on the skin)
• Blisters/bleeding of the lips, eyes, nose, mouth, and genitals, which can 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 adverse effects. You may need urgent medical attention or hospitalization.

Most of the adverse effects observed in clinical trials were mild to moderate, reversible after discontinuation of the drug, and mainly affected the digestive system, consisting mainly of nausea, vomiting, diarrhea, or abdominal pain. Potentially serious adverse reactions such as laryngeal edema (due to allergic reaction) or liver function alterations accompanied by yellowing of the skin occurred rarely.

The adverse effects reported during clinical trials and after marketing have been classified by frequency:

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

Uncommon (may affect up to 1 in 100 people)

• Fungal infection, for example, in the mouth (thrush), vaginal infection, pneumonia, bacterial infection
• Sore throat, inflammation of the stomach and intestine lining
• Shortness of breath, chest pain, wheezing, and cough (respiratory disorders), congested nose
• Blood disorders, alteration of platelet count (thrombocytopenia) and white blood cells (neutropenia), characterized by fever or chills, sore throat, ulcers in the mouth or throat
• Allergic reactions (angioedema)
• Lack of appetite
• Nervousness
• Difficulty sleeping
• Dizziness, drowsiness, alteration of taste, tingling or numbness
• Visual disturbances
• Hearing problems
• Vertigo (feeling of spinning)
• Abnormality in heart rhythm or frequency and detection of heartbeat (palpitations)
• Hot flashes
• Difficulty breathing
• Nosebleeds
• Inflammation of the stomach, constipation, gas, indigestion, difficulty swallowing, feeling of being bloated, dry mouth
• Belching, mouth ulcers, increased salivation, soft stools
• Hepatitis (inflammation of the liver)
• Skin rash, itching, hives (pruritic rash)
• Skin inflammation, dry skin, increased sweating
• Inflammation of the joints, muscle pain, back pain, neck pain
• Difficulty urinating, kidney pain
• Vaginal inflammation, irregular menstrual bleeding, testicular disorders
• Chest pain, swelling, discomfort, weakness, fatigue, facial inflammation, fever, pain
• Changes in liver enzymes and blood test values
• Complications after therapeutic procedures

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

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

Unknown frequency (cannot be estimated from the available data)

• Blood disorders characterized by uncommon bleeding or unexplained bruising, decrease in blood cell count causing weakness or uncommon 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" earlier)
• Alteration in hearing including deafness and/or ringing in the ears
• Change in heart rate, changes in heart rhythm detected on electrocardiogram (prolongation of QT interval and Torsade de Pointes)
• Decrease in blood pressure (which may be associated with weakness, dizziness, and fainting)
• Discoloration of the tongue, inflammation of the pancreas that produces nausea, vomiting, abdominal pain, back pain
• Liver failure (rarely fatal)
• Skin rash with spots and blisters
• Joint pain
• Kidney problems
• Severe inflammation of the intestine (pseudomembranous colitis)

Severe allergic reaction that can cause 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):

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

Common (may affect up to 1 in 10 people)

• Lack of appetite (anorexia)
• Feeling of dizziness (dizziness)
• Headache
• Feeling 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)

• Decreased sensitivity (hypoesthesia)
• Hearing loss or ringing in the ears
• Abnormality in heart rhythm or frequency and detection of heartbeat (palpitations)
• Liver problems such as hepatitis
• Blisters/bleeding of the lips, eyes, nose, mouth, and genitals, which can be caused by Stevens-Johnson syndrome
• Skin allergic reactions such as sensitivity to sunlight, red, scaly, and inflamed skin
• Weakness (asthenia)
• Feeling of general discomfort

Contact a doctor as soon as possible if you experience a severe skin reaction: a red, scaly rash with bumps under the skin and blisters (pustular exanthematous eruption). The frequency of this adverse effect is considered unknown (cannot be estimated from the available data).

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 is not listed in this leaflet. You can also report them through the Spanish Pharmacovigilance System for Human Use Medicines. https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Azitromicina Alter

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

Store below 30°C.

Do not use Azitromicina Alter after the expiration date stated on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Azitromicina Alter

The active ingredient is azithromycin. Each sachet contains 500 mg of azithromycin (as dihydrate).

The other ingredients (excipients) are: sucrose, sodium tribasic phosphate, sodium lauryl sulfate, xanthan gum (E 415), artificial cherry, vanilla, and banana flavors (containing glucose in maltodextrin from corn), sodium carboxymethylcellulose, and sodium saccharin.

Appearance of the Product and Package Contents

Azitromicina Alter 500 mg is an off-white granulate with a cherry odor, for oral suspension in sachets.

The sachets are available in a package of 3 sachets.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Date of the Last Revision of this Leaflet: January 2019

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