AZITHROMYCIN QUALIGEN 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Azithromycin QUALIGEN 500 mg film-coated tablets 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 and other information

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

Azithromycin belongs to a group of antibiotics called macrolide antibiotics.

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Azithromycin QUALIGEN if you:

• Have ever had a severe allergic reaction with swelling of the face and throat and possible respiratory problems.
• Suffer from 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").
• Suffer from severe kidney problems; your doctor may need to modify the dose.
• Know that you have or have been diagnosed with a 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 potassium or magnesium levels in your blood: azithromycin is not recommended.
• Are taking medicines known as anti-arrhythmics (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 a neurological disease, a brain disease, or a nervous system disease.
• Have mental problems, emotional problems, or behavioral problems.
• If you suffer from 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 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 Azithromycin Qualigen with other medicines

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

• 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 the treatment of HIV): zidovudine or azithromycin levels may increase.
• Rifabutin (used in the treatment of HIV and bacterial infections, including tuberculosis): may occur with a decrease in the number of white blood cells in the blood.
• Cyclosporin (an immunosuppressant used after organ transplantation): cyclosporin levels may increase. Your doctor will need to monitor your cyclosporin levels in the blood.
• 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 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).

Using Azithromycin Qualigen with food and drinks

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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There is not enough information regarding the safety of azithromycin during pregnancy. Consequently, 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 this medicine, as it may cause side effects such as diarrhea and infection in the baby. You can continue breastfeeding two days after completing treatment with Azithromycin Qualigen.

Driving and using machines

Azithromycin is not expected to affect your ability to drive or use machines.

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

3. How to take Azithromycin Qualigen

Follow exactly the administration instructions of this medicine as 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 weighing over 45 kg:

The usual dose is 1500 mg divided over 3 or 5 days as follows:

• When taken for 3 days, 500 mg per day.
• When taken for 5 days, 500 mg on the first day and 250 mg from the 2nd to the 5th day.

Inflammation of the urethra or cervix caused by Chlamydia

1000 mg taken as a single dose, in one day.

Children and adolescents weighing less than 45 kg:

The tablets are not recommended for these patients. Other pharmaceutical forms containing azithromycin can be used (e.g., suspensions).

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 score line is only for breaking the tablet if you find it difficult to swallow it whole.

If you take more Azithromycin Qualigen than you should

If you (or someone else) swallow many tablets at the same time 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine 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 Azithromycin Qualigen

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 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, or the infection may recur.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following, stop taking Azithromycin Qualigen and contact your doctor immediately or go to the emergency department of your nearest hospital.

• Allergic reaction (swelling of the lips, face, or neck, causing severe difficulty 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 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 (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 infections, such as in the mouth (thrush), vaginal infection, pneumonia, bacterial infection
• Sore throat, inflammation of the stomach lining and intestine
• Shortness of breath, chest pain, wheezing, and cough (respiratory disorders), congested nose
• Blood disorders characterized by fever or chills, sore throat, mouth or throat ulcers
• Allergic reactions
• Lack of appetite
• Nervousness, difficulty sleeping
• Dizziness, drowsiness, taste disturbances, tingling or numbness
• Vision disorders
• Hearing problems
• Dizziness (vertigo)
• Abnormalities in heart rhythm or frequency and detection of heartbeat (palpitations)
• Hot flushes
• Difficulty breathing
• Nosebleeds
• Inflammation of the stomach, constipation, gas, indigestion, difficulty swallowing
• Feeling 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
• Inflammation of the bones and joints, muscle pain, back pain, neck pain
• Difficulty and pain when urinating, kidney pain
• Vaginal inflammation, irregular menstrual bleeding, testicular disorders
• 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)
• Photosensitivity: redness and blistering of the skin when exposed to sunlight
• Severe skin reactions: skin rash characterized by the rapid appearance of red skin areas with small blisters (small bumps filled with white/yellow liquid)

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

• Intestinal infection (pseudomembranous colitis)
• Blood disorders characterized by uncommon bleeding or unexplained bruising, decrease in red blood cell count causing weakness or fatigue
• Anaphylactic reaction
• Feeling unwell, anxiety, confusion, seeing or hearing things that are not happening
• Fainting, 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)
• Alteration in hearing including deafness and/or ringing in the ears
• Change in heart rate, changes in heart rhythm detected on an electrocardiogram (prolongation of the QT interval and torsades de pointes)
• Decrease in blood pressure (which may be associated with weakness, fainting, and fainting)
• Discoloration of the tongue, pancreatitis that causes nausea, vomiting, abdominal pain, back pain
• Liver failure (rarely fatal)
• 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 Mycobacterium AviumComplex (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 dizzy (dizziness)
• Headache
• Feeling of tingling or numbness (paresthesia)
• Taste changes (dysgeusia)
• Visual disturbances
• 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
• Abnormalities 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, scaly, and inflamed skin
• Weakness (asthenia)
• Feeling unwell

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them through the Spanish Pharmacovigilance System for Human Use Medicines. https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Azithromycin Qualigen

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

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

Do not use Azithromycin Qualigen after the expiration date stated on the packaging, after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Azitromicina Qualigen

• Each tablet contains 500 mg of the active ingredient azithromycin (as dihydrate).
• The other components are: core (calcium hydrogen phosphate, pregelatinized corn starch, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate) and coating (hypromellose, polydextrose, titanium dioxide (E-171), macrogol 4000).

Product Appearance and Packaging Contents

Film-coated tablets, 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.

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. Barcelona, 69

08970 Sant Joan Despí

(Barcelona)

Spain

Date of the Last Revision of this Leaflet:April 2023

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