Leaflet: information for the user

Azitromicina Alter 500 mgfilm-coated tabletsEFG

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, consult 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, 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 Alterand what is it used for

2. What you need to know before you start takingAzitromicina Alter

3. How to takeAzitromicina Alter

4. Possible side effects

5. Storage ofAzitromicina Alter

6. Contents of the pack 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 (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 must inform your doctor immediately.
• Have liver problems, your doctor may need to monitor your liver function or discontinue treatment.
• During treatment with this medication, your skin and/or the white of your eyes turns yellow, inform your doctor immediately, as it may be a symptom of a serious liver disease (which can be fatal).
• You 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").
• You have severe kidney problems, your doctor may modify the dose.
• During treatment with this medication or after it has been completed, you experience diarrhea, abdominal pain, or fever, inform your doctor.
• It is possible that, like with other antibiotics, during treatment with this medication, an overinfection by resistant germs, including fungi, may occur. If this is the case, inform your doctor.
• You know that you have or have been diagnosed with a prolonged QT interval (a heart disease),inform your doctor, as this medication may contribute to worsening these alterations or triggering them.
• You know that you have a slow or irregular pulse or reduced cardiac function: 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): azithromycin is not recommended.
• You 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

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

Other medications and Azitromicina Alter

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. If you are taking antacids (such as 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.

• Ergot 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).

• Cumarin 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.

• Cyclosporine (an immunosuppressant used after organ transplantation): cyclosporine levels may increase. Your doctor will need to monitor your cyclosporine levels in the blood.

• Cisapride (used to treat stomach problems): may cause heart problems.

• Astemizole, 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. • Amiodarone, propafenone (medications 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 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 plan 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.

Azitromicina Alter contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially

“sodium-free”.

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.Take the tablets preferably with a glass of water, they can be taken with or without food. Other presentations are available for different dosing regimens. Do not discontinue treatment as there is a risk of disease relapse.

The dose will be established by your doctor infunction of 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 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 a single 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) can be used.

Patients with liver or kidney problems

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

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 shouldInform your doctor or pharmacist immediately. If you (or someone) ingest 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 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 tablets, and the packaging to the hospital or to your doctor so they know what tablets you have taken.

If you forgot to take Azitromicina Alter

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 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, if not, the infection may reappear. 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 Alter and seek medical attention immediately or visit the nearest hospital emergency room:

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

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

The majority of 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.

The 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 (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, 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, somnolence, taste alterations, tingling or numbness
• Visual disturbances
• Auditory problems
• Dizziness (sensations of spinning)
• Abnormal heart rhythm or frequency and heart palpitations
• Hot flashes
• Difficulty breathing
• Nasal bleeding
• Stomach inflammation, constipation, indigestion, difficulty swallowing, feeling bloated, dry mouth
• Belching, mouth ulcers, increased salivation, soft stools
• Hepatitis (liver inflammation)
• 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 hematomas, rare decrease in blood count causing weakness or fatigue
• Aggression, anxiety, confusion, seeing or hearing things that are not real
• Loss of consciousness, convulsions, 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
• Change in heart rate, changes in heart rhythm detected by 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 sores
• Joint pain
• Renal problems
• Severe intestinal inflammation (pseudomembranous colitis)
• Severe allergic reaction that can cause shock (anaphylactic reaction)

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
• Abnormal heart rhythm or frequency and heart palpitations
• Liver problems such as hepatitis
• Blisters/blood from lips, eyes, nose, mouth, and genitals, which can 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

Seek medical attention 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 the Vigilance 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 packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Azitromicina Alter

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

The other components (excipients) are: pregelatinized starch, cornstarch, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate, anhydrous calcium hydrogen phosphate, hypromellose (hydroxypropylmethylcellulose), titanium dioxide (E 171), and purified water, triacetin (glycerol triacetate).

Appearance of the product and content of the packaging

Azitromicina Alter 500 mg are film-coated, white, scored, and capsule-shaped tablets.

The tablets are available in packs of 3 and 500 tablets (clinical pack).

Only some pack sizes may be marketed.

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