AZITHROMYCIN QUALIGEN 200 mg/ 5 ml ORAL SUSPENSION POWDER

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Azithromycin Qualigen is and what it is used for
2. What you need to know before you take Azithromycin Qualigen
3. How to take Azithromycin Qualigen
4. Possible side effects
5. Storage of Azithromycin Qualigen
6. Contents of the pack and other information

1. What Azithromycin Qualigen is and what it is used for

Azithromycin belongs to a group of antibiotics called macrolide antibiotics.

It is used to treat bacterial infections caused by certain microorganisms, such as bacteria. These infections include:

• Worsening of chronic bronchitis and pneumonia (mild to moderate severity).
• Infections of the paranasal sinuses, throat, tonsils, or ears.
• Mild to moderate skin and soft tissue infections, such as hair follicle infection (folliculitis), bacterial skin infection and its deeper layers (cellulitis), or skin infection with swelling and bright red color (erysipelas).
• Infections caused by a bacterium called Chlamydia trachomatis, which can cause inflammation of the tube that carries urine from the bladder (urethra) or the area where the uterus connects with the vagina (cervix).

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

Do not take Azithromycin Qualigen:

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

Warnings and precautions

Consult your doctor before starting to take Azithromycin Qualigen if you:

• Have ever had a severe allergic reaction with facial and throat swelling and potential respiratory problems.
• Have liver problems; your doctor may need to monitor your liver function or interrupt treatment.
• Are taking medicines known as ergot alkaloids (such as ergotamine), used to treat migraines: azithromycin is not recommended (see "Using Azithromycin Qualigen with other medicines").
• Have severe kidney problems; your doctor may need to modify the dose.
• Know you have or have been diagnosed with a prolonged QT interval (a heart disease): azithromycin is not recommended.
• Know you have a slow or irregular pulse or reduced heart function: azithromycin is not recommended.
• Know you have low potassium or magnesium levels in your blood: azithromycin is not recommended.
• Are taking medicines known as antiarrhythmics (used to treat abnormal heart rhythm), cisapride (used for stomach problems), or terfenadine (an antihistamine used to treat allergies): azithromycin is not recommended.
• Have been diagnosed with a neurological disease, a brain disease, or a nervous system disease.
• Have mental, emotional, or behavioral problems.
• If you have a disease called myasthenia gravis, with muscle weakness and fatigue, as azithromycin 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 finishing treatment with azithromycin or if you notice any new and persistent symptoms, inform your doctor.

Children and adolescents

This medicine is not indicated in children under 1 year of age.

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

Taking Azithromycin Qualigen with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• Antacids, such as aluminum hydroxide: 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): may increase digoxin levels in the blood.
• Colchicine (used for gout and familial Mediterranean fever)
• Zidovudine, nelfinavir (used in HIV treatment): zidovudine or azithromycin levels may increase.
• Rifabutin (used in HIV and bacterial infection treatment, including tuberculosis): a decrease in the number of white blood cells in the blood may occur.
• Cyclosporin (an immunosuppressant used after organ transplantation): cyclosporin levels may increase. Your doctor will need to monitor your cyclosporin blood levels.
• Hydroxychloroquine (to treat rheumatic diseases or malaria): may cause heart problems.
• Cisapride (used to treat stomach problems): heart problems may appear.
• Astemizole, terfenadine (antihistamines used to treat allergic reactions), their effects may be increased.
• Alfentanil (a pain reliever): the effect of alfentanil 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).

Using Azithromycin 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 are planning to have a baby, ask your doctor for advice before taking this medicine.

There is not enough information on the use of azithromycin during pregnancy. Therefore, the use of 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 being treated with Azithromycin Qualigen, as it may cause side effects such as diarrhea and infection in the baby. You can resume breastfeeding two days after finishing treatment with Azithromycin Qualigen.

Driving and using machines

There is no evidence that Azithromycin Qualigen affects the ability to drive or use machines.

Azithromycin Qualigen contains sucrose and glucose

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

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

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

3. How to take Azithromycin Qualigen

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

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

This medicine is not indicated in children under 1 year of age; see the "Children and adolescents" section.

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 in weight, adults, and the elderly

The total dose of azithromycin is 37.5 ml (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 continuing with 6.25 ml (250 mg) once a day).

For the treatment of urethra or cervix inflammation caused by Chlamydia, the dose is 25 ml (1,000 mg) in a single dose.

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 weighing over 45 kg.

Use in children and adolescents under 45 kg in weight

Treatment with azithromycin suspension must be carefully measured, with the help of the dosing syringe that comes with it, based on the child's weight, according to the following table:

For the treatment of tonsillitis/pharyngitis 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 for 3 days, not exceeding a maximum daily dose of 500 mg.

Sinusitis

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

Patients with liver or kidney problems:

You should inform your doctor if you have liver or kidney problems, as you may need to modify the normal dose.

Preparation of the suspension

1. Preparation of the suspension

Each 5 ml of reconstituted suspension contains 200 mg of Azithromycin.

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

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

1. Administration of the dose

The dosing syringe is also graduated 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 SWALLOWED. THIS WILL AVOID THE RISK OF ASPHYXIA.

If you take more Azithromycin Qualigen than you should

If you (or someone else) take more azithromycin than you should, inform your doctor or pharmacist immediately. A overdose is likely to cause temporary hearing loss, severe nausea, vomiting, and diarrhea.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20.

If you forget to take Azithromycin Qualigen

Do not take a double dose to make up for forgotten doses.

If you stop taking Azithromycin Qualigen

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 Qualigen for the time indicated by your doctor, otherwise, the infection may recur.

If you have any further questions on the use of this product, 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 the tablets and go to your doctor immediately or to the emergency department of the nearest hospital.

• Allergic reaction (swelling of the lips, face or neck, which causes severe difficulty in 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, erythema multiforme or toxic epidermal necrosis, which are serious diseases.
• Irregular heartbeat
• Prolonged diarrhea with blood and mucus.

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

Other adverse effects have been reported, which are described below:

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 (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 characterized by fever or chills, sore throat, ulcers in the mouth or throat
• Allergic reactions
• Loss of appetite
• Nervousness
• Dizziness, drowsiness, taste disturbances, 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
• Stomach inflammation, constipation, difficulty swallowing, feeling of being bloated, dry mouth
• Belching, mouth ulcers, increased salivation, soft stools
• Hepatitis (inflammation of the liver)
• Skin rash, itching, hives (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, facial inflammation, fever, pain
• Changes in liver enzymes and blood test values

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
• Severe skin reactions: skin rash characterized by the rapid appearance of red skin areas sprinkled with small pus-filled bumps (small blisters filled with white/yellow liquid)

Unknown (frequency cannot be estimated from available data)

• Blood disorders characterized by uncommon bleeding or bruising, decrease in blood cell 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)
• Changes 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 torsades de pointes)
• Decrease in 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)
• Skin rash with spots and blisters
• Kidney problems
• Severe intestinal inflammation (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)
• Taste changes (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, flaky and inflamed skin
• Weakness (asthenia)
• Feeling of general discomfort

Reporting of Adverse Effects

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

5. Storage of Azitromicina Qualigen

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

Reconstituted solution: 10 days. Note in the box provided for this purpose, both on the box and on the bottle label, the day and month of reconstitution of the suspension. Do not take the medicine after 10 days of reconstitution; discard the remaining solution.

Keep this medicine 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 thrown away through the sewers or in the trash. Deposit the packaging and medicines that are no longer needed in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This way, you will help protect the environment.

6. Package Contents and Additional Information

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 Package Contents

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

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

A polypropylene/polyethylene dosing syringe with a polyethylene plug is included.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. de Barcelona, 69

08970 Sant Joan Despí – Barcelona

Spain

This leaflet was approved in April 2023

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