PROSPECTO: INFORMATION FOR THE USER

Azitromicina Qualigen 200 mg/5 ml powder for oral suspension EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you

• Keep this prospect, as you may have to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor, even if they are not listed in this prospect. See section 4

Azitromicina belongs to a group of antibiotics called macrolides.

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).
• Upper respiratory tract infections, throat, tonsils, 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 redness and swelling.
• Infections caused by a bacteria called Chlamydia trachomatis, which can cause inflammation of the urethra or cervix.

Do not take Azitromicina Qualigen:

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

Warnings and precautions

Consult your doctor 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 medications known as ergot alkaloids (such as ergotamine), used to treat migraines: azithromycin is not recommended (see “Use of Azitromicina Qualigen with other medications”).
• 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 cardiac function: azithromycin is not recommended.
• Know that you have low levels of potassium or magnesium in your blood: azithromycin is not recommended.
• 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.
• Have been diagnosed with any neurological disease, brain disease, or nervous system disease.
• Have mental, emotional, or behavioral problems.
• If you have myasthenia gravis, a disease characterized by muscle weakness and fatigue, as azithromycin may worsen symptoms or trigger the disease.

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 medication is not indicated for children under 1 year of age.

For the treatment of sinusitis, available data in children under 16 years are limited (see section 3).

Use of Azitromicina Qualigen with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

• Antacids, such as aluminum hydroxide: take azithromycin at least 1 hour before or 2 hours after taking an antacid.
• Ergot derivatives, such as 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, seizures, or abdominal or chest pain).
• Coumarin derivatives, such as 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 white blood cell count.
• Ciclosporin (an immunosuppressant used after organ transplant): ciclosporin levels may increase. Your doctor will need to monitor your ciclosporin levels in the blood.
• Hydroxychloroquine (used to treat rheumatic diseases or malaria): may cause heart problems.
• Cisapride (used to treat stomach problems): may cause heart problems.
• Astemizol, terfenadine (antihistamines used to treat allergic reactions), their effects may be increased.
• Alfentanil (sedative): alfentanil effect may increase.
• 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).

Use of Azitromicina Qualigen 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 before using this medication.

There is not enough information about the use of azithromycin during pregnancy. Therefore, azithromycin is not recommended if you are pregnant or plan to become pregnant. However, your doctor may prescribe it in serious cases.

Azithromycin is not recommended during breastfeeding as it may cause side effects such as diarrhea and infection in the baby. You can continue breastfeeding two days after completing treatment with Azitromicina Qualigen.

Driving and operating machinery

There is no evidence that Azitromicina Qualigen affects the ability to drive or operate machinery.

Azitromicina Qualigen contains saccharose and glucose

This medication contains saccharose and glucose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Patients with diabetes mellitus should note that this medication contains 3.869 g of saccharose per 5 ml of reconstituted suspension.

This medication contains less than 23 mg of sodium (1 mmol) per 12.5 ml of reconstituted suspension; it is essentially “sodium-free”.

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

This medication is administered orally. To facilitate administration, each bottle is accompanied by a dosing syringe.

This medication is not indicated for children under 1 year of age, see the sectionChildren and Adolescents.

Dose

The azithromycin suspension should be administered in a single dose once a day, with or without food.

Shake the bottle vigorously before using the suspension.

There are other presentations available for different dosing regimens. The usual dose is as follows:

Use in children and adolescents over 45 kg of weight, adults, and elderly people

The total dose of azithromycin is 37.5ml (1,500 mg) administered over 3 days (12.5 ml (500 mg) once a day). Alternatively, the dose can be administered over 5 days (12.5 ml (500 mg) as a single dose on the first day and continue with 6.25 ml (250 mg) once a day).

For urethritis or cervicitis caused byChlamydia, the dose is 25 ml (1,000 mg) as a single dose.

The treatment of sinusitis is only indicated for adults and adolescents over 16 years of age.

There are other presentations available that are more suitable for patients with a weight over 45 kg.

Use in children and adolescents under 45 kg of weight

The treatment with azithromycin suspension should be measured carefully, with the help of the dosing syringe that comes with it, according to the child's weight, according to the following table:

For the treatment of pharyngitis/tonsillitis in children 2 years of age or older: the recommended dose of azithromycin is a single dose of 10 mg/kg or 20 mg/kg over 3 days, in which a maximum daily dose of 500 mg should not be exceeded.

Sinusitis

For the treatment of sinusitis, the available data in children under 16 years of age are limited.

Patients with liver or kidney problems:

Inform your doctor if you have liver or kidney problems as you may need to modify the usual dose.

Preparation of the suspension

1. Preparation of the suspension

Each 5 ml of reconstituted suspension will contain 200 mg of Azithromycin.

The oral suspension, reconstituted can be kept at room temperature for a period of 10 days; after this time, the remaining solution should be discarded.

The powder for suspension can exceed the level marked on the bottle, due to the specific density of the preparation.

2. Administration of the dose

The dosing syringe is also graduated to be able to administer the dose according to the child's weight.

Once the syringe is prepared, administer immediately.

WARNING: ADMINISTER THE MEDICINE SLOWLY TO THE CHILD AND ENSURE IT IS INCORPORATED. IN THIS WAY, YOU WILL AVOID THE RISK OF ASPHYXIATION.

If you take more Azithromycin Qualigen than you should

If you (or someone) take more azithromycin than you should, inform your doctor or pharmacist immediately. A overdose is likely to cause temporary hearing loss, intense 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.

If you forget to take Azithromycin Qualigen

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Azithromycin Qualigen

Do not stop taking your medication without consulting your doctor, even if you feel better. It is very important that you continue to take Azithromycin Qualigen for the time your doctor has indicated, if not, the infection could reappear.

If you have any other questions about the use of this product, 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 the tablets and seek immediate medical attention or go to the nearest hospital emergency department.

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

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

The following side effects have been reported:

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 some 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
• Throat pain, inflammation of the stomach and intestine lining
• 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,
• Dizziness, drowsiness, taste alterations, tingling or numbness
• Visual disorders
• Auditory problems
• Dizziness (sensation of spinning)
• Abnormal heart rhythm or frequency and heart palpitations
• Hot flashes
• Difficulty breathing
• Nasal bleeding
• Stomach inflammation, constipation, difficulty swallowing, feeling bloated, dry mouth
• Belching, mouth ulcers, increased salivation, soft stools
• Jaundice (liver inflammation)
• Skin rash, itching, urticaria (itchy rash)
• Skin inflammation, dry skin, increased sweating.
• Joint inflammation, muscle pain, back pain, neck pain
• Difficulty urinating
• Vaginal inflammation, irregular menstrual bleeding, testicular disorder
• Chest pain, swelling, discomfort, weakness, fatigue, inflammation of the face, fever, pain.
• Changes in liver enzymes and blood values

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

• Agitation
• Feeling that things are unreal.
• Confusion, especially in elderly patients.
• Teeth discoloration
• Abnormal liver function, jaundice (yellowing of the skin)
• Allergic reactions including angioneurotic edema
• Redness and blistering of the skin upon exposure to sunlight
• Severe skin reactions: skin rash characterized by rapid appearance of red skin areas dotted with small white/yellow-filled blisters.

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

• Blood disorders characterized by rare bleeding or bruising, decreased blood count causing weakness or 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" above)
• Alteration 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 causing nausea, vomiting, abdominal pain, back pain
• Acute liver failure (rarely fatal)
• Skin rash with spots and blisters
• Renal problems
• Severe inflammation of the intestine (pseudomembranous colitis)
• Severe allergic reaction that can cause anaphylactic shock

The following side 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)

• Loss of appetite (anorexia)
• Dizziness
• Headache
• 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)

• 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 the 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

Reporting of side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines for Human Use Pharmacovigilance System Website: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Reconstituted solution: 10 days.Record the date of reconstitution in the designated box on both the box and the vial label. Do not take the medication after 10 days of reconstitution; discard any remaining solution.

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

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

Composition of Azitromicina Qualigen 200 mg / 5 ml powder for oral suspension

• The active ingredient is azithromycin (as dihydrate). Each 5 ml of reconstituted suspension contains 200 mg of azithromycin (as dihydrate). Each ml of reconstituted suspension contains 40 mg of azithromycin (as dihydrate).
• The other components (excipients) are: Sucrose, anhydrous trisodium phosphate, hydroxypropylcellulose, xanthan gum, banana flavor (contains glucose and cornstarch), strawberry flavor (contains glucose and cornstarch).

Appearance of the product and contents of the packaging

This medicine is an almost white powder for oral suspension with a banana-strawberry odor. It is packaged in amber type III glass bottles, closed with a polyethylene cap with a polyethylene stopper.

Each carton box contains a 15 ml or 30 ml bottle.

A polypropylene/polietilene dosing syringe with a polyethylene stopper is included.

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. de Barcelona, 69.

08970 Sant Joan Despí – Barcelona

Spain

This leaflet was approved in April 2023

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.gob.aemps