Package Insert: Information for the User

Azithromycin QUALIGEN 500 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication because 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 medication has been prescribed only for you, 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, even if they are not listed in this package insert. See section 4.

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).
• Paranasal sinus, throat, tonsil, or ear infections.
• Mild to moderate skin and soft tissue infections, for example, folliculitis, bacterial skin infection, and cellulitis, or erysipelas, a skin infection with swelling and bright red color.
• Infections caused by a bacteria called Chlamydia trachomatis, which can cause inflammation of the urethra or the cervix.

Do not take Azitromicina Qualigen

• if you are allergic to azithromycin, or to any of the other ingredients of this medicine (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 QUALIGEN 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 stop treatment.
• are taking medicines known as ergot alkaloids (such as ergotamine), used to treat migraine: azithromycin is not recommended (see “Taking Azitromicina Qualigen 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 heart function: azithromycin is not recommended.
• know that you have low levels of potassium or magnesium in your 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, a brain or nervous system disease.
• have mental, emotional or behavioral problems.
• if you have a condition 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).

Taking Azitromicina Qualigen with other medicines

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

• 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): 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 transplant): ciclosporin levels may increase. Your doctor will need to monitor your ciclosporin levels in the blood.
• Hydroxychloroquine (to treat rheumatic diseases or malaria): may cause heart problems.
• Cisapride (used to treat stomach problems): may occur heart problems.
• Astemizole, terfenadine (antihistamines used to treat allergic reactions), their effects may be increased.
• Alfentanil (sedative): 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), theophylline (for asthma) and trimethoprim/sulfamethoxazole (a combination antibiotic).

Taking Azitromicina Qualigen with food and drink

The tablets 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 are planning 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.

Breastfeeding is not recommended while taking this medicine, as it may cause side effects such as diarrhea and infection in the baby. You may continue breastfeeding two days after completing treatment with Azitromicina Qualigen.

Driving and operating machinery

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

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it 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.

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 normal 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 a single day.

Children and adolescents under 45 kg of weight:

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 the normal dose may need to be modified.

The groove is only for breaking the tablet if it is difficult to swallow it whole.

If you take more Azitromicina Qualigen than you should

If you (or someone) ingest many tablets at once or if you think a child has swallowed some 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 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 forget to take Azitromicina Qualigen

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

If you interrupt the treatment with Azitromicina Qualigen

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 Qualigen for the time your doctor has indicated, or the infection may recur.

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 Qualigen 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 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 side effects. You may need urgent medical attention or hospitalization

The following side effects have been reported:

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

• Diarrhea

Common (can affect up to 1 in 10 people)

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

Uncommon (can affect up to 1 in 100 people))

• Fungal infection, for example in the mouth (aphthae), vaginal infection, pneumonia, bacterial infection
• Throat pain, 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, throat pain, mouth or throat ulcers
• Allergic reactions
• Loss of appetite
• Nervousness, difficulty sleeping
• Dizziness, drowsiness, taste alterations, tingling or numbness
• Eye disorders
• Ear problems
• Dizziness (sensations of spinning)
• Abnormal heart rhythm or frequency and heart palpitations
• Hot flashes
• Difficulty breathing
• Nasal bleeding
• Stomach inflammation, constipation, gas, indigestion, difficulty swallowing
• Sensation of being bloated, dry mouth
• Belching, mouth ulcers, increased salivation, soft stools
• Liver problems, (such as liver inflammation, hepatitis)
• Itchy skin rash, hives (itchy rash)
• Skin inflammation, dry skin, increased sweating
• Bone and joint inflammation, muscle pain, back pain, neck pain
• Difficulty and pain urinating, kidney pain
• Vaginal inflammation, irregular menstrual bleeding, testicular disorders
• Chest pain, swelling, discomfort, weakness, fatigue
• Face inflammation, fever, pain.
• Changes in liver enzymes and blood values

Rare (can 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)
• Photosensitivity: Redness and blistering of the skin when exposed to sunlight
• Severe skin reactions: Skin rash characterized by rapid appearance of red skin areas with small white/yellow blisters.

Unknown (frequency cannot be estimated from available data)

• Intestinal infection (pseudomembranous colitis)
• Blood disorders characterized by rare or unexplained bleeding or bruising, decreased red blood cell count causing weakness or fatigue
• Anaphylactic reaction
• Sensation of bad mood, anxiety, confusion, seeing or hearing things that are not happening
• Loss of consciousness, seizures, decreased sensitivity, hyperactivity, alteration or loss of sense of smell, loss of sense of taste, myasthenia gravis (muscle weakness and fatigue, see "Warnings and precautions" above)
• Changes in hearing, including deafness and/or ringing in the ears.
• Changes in heart rhythm, changes in heart rhythm detected by electrocardiogram (prolongation of the QT interval and torsades 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 failure (rarely fatal)
• Itchy skin rash with blisters
• Joint pain (arthralgia)
• Kidney problems

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 (can affect more than 1 in 10 people):

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

Common (can 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 changes
• Deafness
• Skin rash
• Itching (pruritus)
• Joint pain (arthralgia)
• Fatigue

Uncommon (can affect up to 1 in 100 people))

• Reduced sensitivity (hypoaesthesia)
• Loss of hearing 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 can be caused by Stevens-Johnson syndrome.
• Allergic skin reactions such as sensitivity to sunlight, red, flaky, and inflamed skin
• Weakness (asthenia)
• Sensation of general 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 prospectus. 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.

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

Do not use Azitromicina Qualigen 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 unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Azitromicina Qualigen

• Each tablet contains 500 mg of the active ingredient azitromicina (as dihydrate).
• The other components are: core (calcium hydrogenphosphate, pregelatinized cornstarch, croscarmellose sodium, sodium laurylsulfate, magnesium stearate) and coating (hypromellose, polydextrose, titanium dioxide (E-171), macrogol 4000).

Appearance of the product and contents of the packaging

Coated tablets with a film coating, white, elongated, with biconvex faces, with a notch on one face and the inscription “500” on the other.

Each package contains 3 tablets in PVC/aluminum blisters.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible for manufacturing:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

(Barcelona)

Spain

Last review date of this leaflet:April 2023

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