Package Insert: Information for the User

Azitromicina Alter 500 mgGranulated powder for oral suspension in a sachetEFG

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

- Keep this package insert, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.

- This medicine has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Azitromicina Alter and how is it used

2. What you need to know before starting to takeAzitromicina Alter

3. How to takeAzitromicina Alter

4. Possible adverse effects

5. Storage of Azitromicina Alter

6. Contents of the package and additional information

Azitromicina belongs to a group of antibiotics called macrolide antibiotics.

It is used for the treatment of the following bacterial infections caused by microorganisms sensitive to azitromicina:

• Acute bacterial sinusitis
• Acute bacterial otitis media
• Pharyngitis, tonsillitis
• Acute exacerbation of chronic bronchitis
• Mild to moderately severe community-acquired pneumonia.
• Mild to moderate skin and soft tissue infections, for example, folliculitis, cellulitis, erysipelas
• Uncomplicated urethritis and cervicitis caused byChlamydia trachomatis

Do not take Azitromicina Alter

If you are allergic (hypersensitive) to azithromycin, to another macrolide antibiotic or to any of the components of this medication (including those listed in section 6) or to another macrolide or ketolide antibiotic, for example, erythromycin or telithromycin.

Warnings and precautions

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

• Have ever had an allergic reaction, characterized by symptoms such as itching, redness, skin rash, swelling, or difficulty breathing. If this occurs, you should inform your doctor immediately.
• Have liver problems, your doctor may need to monitor your liver function or interrupt treatment.
• During treatment with this medication, your skin and/or the white part of your eyes turns yellow, inform your doctor immediately, as it could be a symptom of a serious liver disease (which can be fatal).
• Are taking medications known as ergot alkaloids (such as ergotamine), used to treat migraines: azithromycin is not recommended (see "Use of Azitromicina Alter with other medications").
• Have severe kidney problems, your doctor may modify the dose.
• During treatment with this medication or after it has been completed, experience diarrhea, abdominal pain, or fever, inform your doctor.
• It is possible that, like other antibiotics, during treatment with this medication, an overinfection by resistant germs, including fungi, may occur. If this is the case, inform your doctor.
• Know that you have or have been diagnosed with prolonged QT interval (a heart disease),inform your doctor, as this medication may contribute to worsening these alterations or triggering them.
• Know that you have a slow or irregular pulse or reduced cardiac function: azithromycin is not recommended.
• Are taking medications known as antiarrhythmics (used to treat abnormal heart rhythm), cisaprida (used to treat stomach problems) or terfenadine (an antihistamine used to treat allergies): azithromycin is not recommended.
• Have a disease called myasthenia gravis, with muscle weakness and fatigue, as this medication 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 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 under this weight, other presentations are recommended (see section 3).

Use of Azitromicina Alter with other medications

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

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

• Antacids(medications used for digestive problems).In the case of taking antacids (for example, aluminum hydroxide) and Azitromicina Alter, it is recommended to avoid simultaneous administration of both medications at the same time of day: take azithromycin at least 1 hour before or 2 hours after taking an antacid.
• Ergotamine derivatives, for example, ergotamine (used to treat migraines): 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 coagulation): may increase the risk of bleeding.
• Digoxin (used to treat heart failure and arrhythmias): 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.
• Cisaprida (used to treat stomach problems): may cause heart problems.
• Astemizol, terfenadine (antihistamines used to treat allergic reactions), their effects may be increased.
• Alfentanilo (sedative): the effect of alfentanilo may increase.
• Fluconazol(for fungal infections): azithromycin levels may be reduced.
• Amiodarona, propafenona (medications for treating ventricular and supraventricular tachycardias).

No interactions have been observed between azithromycin and cetirizine (an antihistamine); didanosina, efavirenz, indinavir (for HIV infection); atorvastatina (for cholesterol and heart problems); carbamazepina (for epilepsy), cimetidina (an antacid); metilprednisolona (to suppress the immune system); midazolam, triazolam (sedatives); sildenafilo (for impotence), teofilina (for asthma) and trimetoprima/sulfametoxazol (a combination antibiotic).

If you take medications that prolong the QT interval, do not take this medication.

Pregnancy, breastfeeding, and fertility

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

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

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

Driving and operating machinery

There is no evidence that Azitromicina Alterhas an effect on the ability to drive or operate machinery.However, due to the fact that during treatment with azithromycin, cases of drowsiness and dizziness have been reported, the patient should exercise caution when driving or operating machinery, until it is established how azithromycin may affect them individually.

Important information about some of the components of Azitromicina Alter

This medicationcontains saccharose and glucose (in maltodextrin from corn). If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Azitromicina Alter effervescent granules contain sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Azitromicina Alter is administered orally.The medication must be reconstituted before administration. There are other presentations available for different dosing regimens. Do not discontinue treatment as there is a risk of disease recurrence.

Reconstitution Instructions

Pour the contents of the package into a glass and add a little water and mix well.The obtained suspension must be ingested immediately.

The dose will be established by the doctor according to your individual needs and the type of infection. To achieve optimal efficacy, follow your doctor's instructions faithfully regarding the dose and duration of treatment.

As a general rule, the medication dose and administration frequency is as follows:

Adults (including elderly patients) and children with a weight of 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 package) once a day for 3 consecutive days, with a total dose of 1500 mg (3 packages).

• When taken for 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 a single day.

Children and adolescents under 45 kg of weight:

This presentation is only suitable for children and adolescents over 45 kg of weight, for whom the same dose as for adults is recommended. For those under 45 kg, 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 estimate that the action of Azitromicina Alter is too strong or too weak, inform your doctor or pharmacist.

If you take more Azitromicina Alter than you should

Inform your doctor or pharmacist immediately. Do not take a double dose to compensate for missed doses.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately 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 packages, and the packaging to the hospital or to your doctor so they know what you have taken.

If you forget to take Azitromicina 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 compensate for missed doses.

If you interrupt treatment with Azitromicina Alter

Do not stop taking your medication without consulting your doctor first, even if you feel better. It is very important that you continue taking Azitromicina Alter for the time your doctor has indicated, as if you do not, the infection could 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 Alter and seek medical attention immediately or visit the nearest hospital emergency room:

• 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 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.

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

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

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

• Diarhea

Common (may affect up to 1 in 10 people)

• Alteration of the number of certain 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 (aphthous ulcers), 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, alteration of the number of platelets (thrombocytopenia) and white blood cells (neutropenia), characterized by fever or chills, sore throat, mouth or throat ulcers
• Allergic reactions (angioedema)
• Loss of appetite
• Nervousness
• Difficulty sleeping
• Dizziness, drowsiness, taste alterations, tingling or numbness
• Eye disorders
• Hearing problems
• Dizziness (sensation of spinning)
• Abnormal heart rhythm or frequency and heart palpitations
• Hot flashes
• Difficulty breathing
• Nasal bleeding
• Inflammation of the stomach, constipation, gas, indigestion, difficulty swallowing, feeling bloated, dry mouth
• Belching, mouth ulcers, increased salivation, soft stools
• Jaundice (inflammation of the liver)
• Skin rash, itching, hives (skin rash with itching)
• Skin inflammation, dry skin, increased sweating
• Joint inflammation, muscle pain, back pain, neck pain
• Difficulty urinating, kidney pain
• 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
• Complications following therapeutic procedures

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 skin discoloration)
• Allergic reactions including angioneuritic 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 bruising, uncommon decrease in blood count causing weakness or fatigue
• Aggression, anxiety, confusion, seeing or hearing things that are not real
• Loss of consciousness, 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 tinnitus in the ears
• Change in heart rate, 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 loss of consciousness)
• Lingual discoloration, pancreatitis that causes nausea, vomiting, abdominal pain, back pain
• Acute liver failure (rarely fatal)
• Skin rash with blisters and ulcers
• Joint pain
• Kidney problems
• Severe inflammation of the intestine (pseudomembranous colitis)

Severe allergic reaction that may cause anaphylactic shock

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

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

• Diarhea
• 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 disturbances
• Deafness
• Skin rash
• Itching (pruritus)
• Joint pain (arthritis)
• Fatigue

Uncommon (may affect up to 1 in 100 people)

• Decreased sensitivity (hypoaesthesia)
• Loss of hearing or tinnitus in the ears
• Abnormal heart rhythm or frequency and heart palpitations
• Liver problems such as hepatitis
• Blisters/bleeding of the lips, eyes, nose, mouth, and genitals, which may be caused by Stevens-Johnson syndrome
• Allergic skin reactions such as sensitivity to sunlight, red, scaly, and inflamed skin
• Weakness (asthenia)
• General feeling of 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 exanthema). The frequency of this side effect is considered unknown (cannot be estimated from available data).

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 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.

Store below 30°C.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Azitromicina Alter

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

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

Appearance of the product and content of the packaging

Azitromicina Alter 500 mg is a marzipan-colored granule with a cherry odor, for oral suspension in sachets.

The sachets are available in a pack of 3 sachets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Last review date of this leaflet: January 2019

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