AZITHROMYCIN RATIO 500 mg FILM-COATED TABLETS

2. What you need to know before taking Azithromycin ratio

DO NOT take Azithromycin ratio

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

Warnings and precautions

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

• have ever had a severe allergic reaction with facial and throat swelling and possible breathing problems.
• have severe kidney problems. Your doctor may need to adjust the dose.
• have liver problems. Your doctor may need to monitor your liver function or stop treatment.
• know you have or have been diagnosed with a prolonged QT interval (a heart condition). Azithromycin ratio is not recommended.
• know you have a slow or irregular heartbeat or reduced cardiac function. Azithromycin ratio is not recommended.
• know you have low potassium or magnesium levels in your blood. Azithromycin ratio is not recommended.
• are taking medications known as antiarrhythmics (used to treat abnormal heart rhythm), hydroxychloroquine (used to treat rheumatic diseases or malaria), cisapride (used to treat stomach problems), or terfenadine (an antihistamine used to treat allergies), antipsychotics (e.g., pimozide), antidepressants (e.g., citalopram), or certain antibiotics (e.g., moxifloxacin, levofloxacino). Azithromycin should be used with caution.
• are taking medications known as ergot alkaloids (such as ergotamine), used to treat migraines: azithromycin is not recommended (see "Using Azithromycin ratio with other medications").
• have been diagnosed with a neurological disorder, a brain disorder, or a nervous system disorder.
• 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 any symptoms of liver dysfunction, such as loss of appetite, yellowing of the skin or whites of the eyes, dark urine, itching, or abdominal pain, stop taking Azithromycin ratio and inform your doctor immediately.

If you have an allergic reaction (e.g., difficulty breathing, dizziness, facial or throat swelling, skin rash, hives, blisters), stop taking Azithromycin ratio and contact a doctor immediately.

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 ratio or if you notice any new and persistent symptoms, inform your doctor.

Other medications and Azithromycin ratio

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

Inform your doctor if you are taking any of the following medications:

• 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.
• cumarin derivatives, such as warfarin (used to prevent blood clotting): may increase the risk of bleeding.
• digoxin (used to treat heart failure) or colchicine (used to treat gout and familial Mediterranean fever): may increase digoxin/colchicine levels in the blood.
• zidovudine, nelfinavir (used to treat HIV): azithromycin or zidovudine levels may increase.
• rifabutin (used to treat HIV and bacterial infections, including tuberculosis): may result in 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.
• cisapride (used to treat stomach problems): heart problems may occur.
• hydroxychloroquine (used to treat rheumatic diseases or malaria): heart problems may occur.
• astemizole, terfenadine (antihistamines used to treat allergic reactions): their effects may be increased.
• alfentanil (a pain reliever): the effect of alfentanil may be increased.
• fluconazole (for fungal infections): azithromycin levels may be reduced.
• atorvastatin (a cholesterol-lowering medication). Concomitant use of azithromycin and atorvastatin has been associated with an increased risk of muscle tissue damage (rhabdomyolysis) leading to muscle pain and dark urine.

No interactions have been observed between azithromycin and cetirizine (an antihistamine); didanosine, efavirenz, indinavir (for HIV infection); 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).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant or are breastfeeding, inform your doctor or pharmacist before using this medication.

There is not enough information regarding 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 severe circumstances.

Talk to your doctor before taking Azithromycin ratio if you are breastfeeding. Your doctor will decide whether Azithromycin Teva can be used during breastfeeding.

Azithromycin has been reported to be excreted in breast milk. No serious adverse reactions to azithromycin have been observed in babies.

Azithromycin ratio, as it may cause side effects such as diarrhea and infection in the baby.

Driving and using machines

This medication may cause drowsiness and dizziness. If it affects you, do not drive or use machines.

Azithromycin ratio contains sodium

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

3. How to take Azithromycin ratio

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

Take the tablets preferably with a glass of water; they can be taken with or without food.

The tablet can be divided into equal doses.

The recommended dose is:

Adults (including elderly patients) and children weighing over 45 kg:

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

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

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:

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 adjusted.

If you take more Azithromycin ratio than you should

If you (or someone else) swallow 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Bring this leaflet, any remaining tablets, and the packaging to the hospital or your doctor so they know what tablets you have taken.

If you forget to take Azithromycin ratio

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 ratio

Do not stop taking your medication without consulting your doctor first, even if you feel better. It is very important that you continue taking Azithromycin ratio for the time indicated by your doctor, or the infection may recur.

If you have any further questions about the use of this medication, 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 Azithromycin ratio and go to your doctor immediately or to the emergency room of the nearest hospital.

Uncommon: may affect up to 1 in 100 people

• Angioedema: swelling of the lips, face, or neck, which causes severe difficulty breathing; rash or hives on the skin.

Rare: may affect up to 1 in 10,000 people

• Skin rash characterized by the rapid appearance of red skin areas sprinkled with small blisters (small blisters filled with white/yellow liquid)

Very rare: may affect up to 1 in 10,000 people

• Hypersensitivity reaction with skin rash, fever, lymph node inflammation, and possible organ damage (DRESS)

Unknown: frequency cannot be estimated from available data

• Anaphylactic reaction: severe allergic reaction that causes difficulty breathing or dizziness

• Severe liver disorders or liver failure (rarely life-threatening): signs may include fatigue associated with yellowing of the skin or the whites of the eyes (jaundice), dark urine, tendency to bleed
• Blisters/bleeding of lips, eyes, nose, mouth, and genitals, which can be caused by Stevens-Johnson syndrome, erythema multiforme, or toxic epidermal necrosis, which are serious diseases.
• Changes in heart rate, changes in heart rhythm on the electrocardiogram (prolongation of the QT interval, ventricular tachycardia, and torsades de pointes)
• Prolonged diarrhea with blood and mucus (pseudomembranous colitis).

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

Other Adverse Effects

Very common: may affect more than 1 in 10 people

• Diarrhea

Common: may affect up to 1 in 10 people

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

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
• Lack of appetite
• Nervousness, difficulty sleeping
• Dizziness, drowsiness, alteration of taste, 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
• Inflammation of the stomach, constipation, gas, indigestion, difficulty swallowing
• Feeling 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
• Inflammation of bones and joints, muscle pain, back pain, neck pain
• Difficulty and pain when urinating, pain in the kidneys (kidney pain)
• Inflammation of the vagina, irregular menstrual bleeding, testicular disorders
• Chest pain, swelling, discomfort, weakness, fatigue
• Inflammation of the face, hands, legs, and/or feet, 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 teeth
• Abnormal liver function, jaundice (yellow pigmentation of the skin)
• Photosensitivity: redness and blistering of the skin when exposed to sunlight

Unknown: frequency cannot be estimated from available data

• Blood disorders characterized by uncommon bleeding or unexplained bruising, decrease in red blood cell count causing weakness or uncommon fatigue
• Feeling of ill humor, 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 2 "Warnings and Precautions")
• Alteration in hearing including deafness and/or ringing in the ears.
• Decrease in blood pressure (which may be associated with weakness, fainting, and fainting)
• Discoloration of the tongue, inflammation of the pancreas that produces nausea, vomiting, abdominal pain, back pain
• Skin rash with spots and blisters
• Pain in the joints (arthralgia)
• Kidney problems

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
• Headache
• Feeling of tingling or numbness (paresthesia)
• Changes in taste (dysgeusia)
• Visual impairment
• Deafness
• Skin rash
• Itching (pruritus)
• Pain in the joints (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 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)
• 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 Medicines Agency's website: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Azithromycin Ratio

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

Do not use this medicine after the expiration date that appears on the packaging, after CAD.

The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Azithromycin Ratio

• The active ingredient is azithromycin.

Each film-coated tablet contains 500 mg of azithromycin (as dihydrate).

• The other ingredients are calcium hydrogen phosphate, anhydrous, hypromellose, corn starch, pregelatinized corn starch, microcrystalline cellulose, magnesium stearate, sodium lauryl sulfate, indigo carmine (E132), titanium dioxide (E171), polysorbate 80, and talc.

Appearance of the Product and Package Contents

• Azithromycin ratio 500 mg film-coated tablets are pale blue, oblong, biconvex, and marked with AI 500 and a score line on one side.
• The 500 mg tablets are available in pack sizes of: 1, 2, 3, 6, or 30 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1ª planta

28108 Alcobendas, Madrid (Spain)

Manufacturer:

Teva Operations Poland Sp. z.o.o.

ul. Mogilska 80

31-546 Cracovia

Poland

Merckle GmbH

Ludwig Merckle Straβe 3

89143 Blaubeuren

Germany

Pharmachemie B.V.

Swensweg, 5

Haarlem

Netherlands

or

Pliva Croatia Limited (PLIVA KRVATSKA D.O.O.)

Prilaz Baruna Filipovica 25

10000 Zagreb

Croatia

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet: July 2022

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