Azithromycin Ratio 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Azithromycin ratio 500 mg film-coated tablets EFG

Azithromycin (dihydrate)

Package leaflet contents:

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

1. What Azitromicina ratio is and what it is used for

Azitromicina belongs to a group of antibiotics known as macrolide antibiotics. It is used to treat bacterial infections caused by certain microorganisms, namely bacteria. These infections include:

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

2. What you need to know before taking Azithromycin Ratio

DO NOT take Azithromycin Ratio

• if you are allergic to azithromycin or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to any other macrolide or ketolide antibiotic, for example erythromycin or telithromycin.

Warnings and precautions

Talk to your doctor before taking Azithromycin Ratio if you:

• have ever had a severe allergic reaction with swelling of the face and throat, possibly causing breathing difficulties.
• have severe kidney problems. Your doctor may need to adjust your dose.
• have liver problems. Your doctor may need to monitor your liver function or discontinue treatment.
• know you have or have been diagnosed with prolonged QT interval (a heart condition). Azithromycin Ratio is not recommended.
• know you have a slow or irregular heartbeat or reduced heart function. Azithromycin Ratio is not recommended.
• know you have low levels of potassium or magnesium in your blood. Azithromycin Ratio is not recommended.
• are taking medicines 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, levofloxacin). Azithromycin should be used with caution.
• are taking medicines known as ergot alkaloids (such as ergotamine), used to treat migraine: azithromycin is not recommended (see "Use of Azithromycin Ratio with other medicines").
• have been diagnosed with a neurological disease, or a disease affecting the brain or nervous system.
• have mental, emotional, or behavioral problems.
• have a condition called myasthenia gravis, which causes muscle weakness and fatigue, as azithromycin may worsen symptoms of this disease or trigger its onset.

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 contact your doctor immediately.

If you have an allergic reaction (for example, difficulty breathing, dizziness, swelling of the face or throat, skin rash, hives, blisters), stop taking Azithromycin Ratio and contact a doctor immediately.

If you develop 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 medicines and Azithromycin Ratio

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.

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

• 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): should not be administered at the same time, as ergotism (a potentially serious adverse effect with numbness or tingling in the limbs, muscle cramps, headaches, seizures, or abdominal or chest pain) may occur.
• oral anticoagulants of the coumarin type, for example, warfarin (used to prevent blood clotting): may increase the risk of bleeding.
• digoxin (used to treat heart failure) or colchicine (used for gout and familial Mediterranean fever): levels of digoxin/colchicine in the blood may increase.
• zidovudine, nelfinavir (used in the treatment of HIV): levels of zidovudine or azithromycin may increase.
• rifabutin (used in the treatment of HIV and bacterial infections including tuberculosis): a decrease in white blood cell count may occur.
• cyclosporine (an immunosuppressant used after organ transplantation): levels of cyclosporine may increase. Your doctor will need to monitor your blood levels of cyclosporine.
• 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 painkiller): the effect of alfentanil may increase.
• fluconazole (for fungal infections): levels of azithromycin may be reduced.
• atorvastatin (a medicine to lower cholesterol). Concomitant use of azithromycin and atorvastatin has been associated with an increased risk of muscle tissue breakdown (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 (an antibiotic combination).

Pregnancy and breastfeeding

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

Pregnancy

Your doctor will decide whether you should take this medicine during pregnancy, only after ensuring that the benefits outweigh the potential risks.

Breastfeeding

It has been reported that azithromycin is excreted in breast milk. No serious adverse reactions of azithromycin have been observed in infants. However, Azithromycin Ratio may cause side effects such as diarrhea and infection in the infant.

Driving and using machines

This medicine may cause drowsiness and dizziness. If affected, do not drive or operate machinery.

Azithromycin Ratio contains sodium

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

3. How to take Azitromycin ratio

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Take the tablets preferably with a glass of water. They may be taken with or without food.

The tablet may 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 over 3 days: 500 mg once daily.
• When taken over 5 days: 500 mg on the first day and 250 mg from day 2 to day 5, once daily.

Inflammation of the urethra or cervix caused by Chlamydia

1000 mg taken as a single dose on one day.

Children and adolescents weighing less than 45 kg:

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 your normal dose may need to be adjusted.

If you take more Azitromycin ratio than you should

If you (or someone) take many tablets at once or if you think a child has swallowed any 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 at telephone number 91 562 04 20, indicating the medicine and the amount ingested. Take this leaflet, any remaining tablets, and the container with you to the hospital or to your doctor so they know which tablets have been taken.

If you forget to take Azitromycin 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 Azitromycin ratio

Do not stop taking this medicine without first consulting your doctor, even if you feel better. It is very important that you continue taking Azitromycin ratio for the length of time prescribed by your doctor; otherwise, the infection could return.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

Uncommon: may affect up to 1 in 100 people

• Angioedema: swelling of the lips, face or neck, causing severe breathing difficulty; skin rash or eruption.

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

• Skin rash characterized by rapidly appearing red skin areas dotted with small pustules (small blisters filled with white/yellow fluid).

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

• Hypersensitivity reaction with skin rash, fever, swollen lymph nodes, and possible organ involvement (DRESS).

Not known: frequency cannot be estimated from available data

• Anaphylactic reaction: severe allergic reaction causing difficulty breathing or dizziness.
• Severe liver disorders or liver failure (rarely life-threatening): signs may include fatigue associated with yellowing of the skin or whites of the eyes (jaundice), dark urine, and tendency to bleed.
• Blisters/bleeding of lips, eyes, nose, mouth, and genitals, which may be due to Stevens-Johnson syndrome, erythema multiforme, or toxic epidermal necrolysis, all of which are serious conditions.
• Changes in heart rate, changes in heart rhythm on electrocardiogram (prolongation of QT interval, ventricular tachycardia, and torsades de pointes).
• Prolonged diarrhoea with blood and mucus (pseudomembranous colitis).

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

Other adverse effects

Very common: may affect more than 1 in 10 people

• Diarrhoea

Common: may affect up to 1 in 10 people

• Headache
• Vomiting, stomach pain, nausea
• Changes in the number of certain 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 intestinal lining
• Shortness of breath, chest pain, wheezing and cough (respiratory disorders), nasal congestion
• Blood disorders characterized by fever or chills, sore throat, mouth or throat ulcers
• Allergic reactions
• Loss of appetite
• Nervousness, difficulty sleeping
• Dizziness, drowsiness, taste disturbances, tingling or numbness
• Vision disorders
• Hearing problems
• Vertigo (spinning sensation)
• Abnormal heart rhythm or heart rate and awareness of heartbeat (palpitations)
• Hot flushes
• Difficulty breathing
• Nosebleed
• Stomach inflammation, constipation, gas, indigestion, difficulty swallowing
• Feeling of bloating, dry mouth
• Belching, mouth ulcers, increased salivation, soft stools
• Liver problems (such as liver inflammation, hepatitis)
• Itchy 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, loin pain (kidney pain)
• Vaginal inflammation, irregular menstrual bleeding, testicular disorders
• Chest pain, swelling, malaise, weakness, fatigue
• Facial, hand, leg and/or foot swelling, fever, pain
• Changes in liver enzymes and blood test values

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

• Restlessness
• Feeling that things are unreal
• Confusion, especially in elderly patients
• Discoloration of teeth
• Abnormal liver function, jaundice (yellowish skin pigmentation)
• Photosensitivity: redness and blistering of the skin upon exposure to sunlight

Not known: frequency cannot be estimated from available data

• Blood disorders characterized by unusual bleeding or unexplained bruising, decreased red blood cell count causing unusual weakness or fatigue
• Irritability, anxiety, confusion, seeing or hearing things that are not happening
• Fainting, seizures, decreased sensitivity, hyperactivity, alteration or loss of sense of smell, loss of taste, myasthenia gravis (muscle weakness and fatigue, see section 2 “Warnings and precautions”)
• Hearing disturbances including deafness and/or tinnitus
• Decreased blood pressure (which may be associated with weakness, fainting, and collapse)
• Tongue discoloration, pancreatitis causing nausea, vomiting, abdominal pain, back pain
• Skin rash with spots and blisters
• Joint pain (arthralgia)
• Kidney problems

The following adverse effects have been reported in patients treated with azithromycin for prevention of infections by Mycobacterium Avium Complex (MAC):

Very common: may affect more than 1 in 10 people

• Diarrhoea
• 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 sensation (paraesthesia)
• Taste changes (dysgeusia)
• Visual disturbances
• Deafness
• Skin rash
• Itching (pruritus)
• Joint pain (arthralgia)
• Fatigue

Uncommon: may affect up to 1 in 100 people

• Reduced sensitivity (hypoesthesia)
• Hearing loss or ringing in the ears
• Abnormal heart rhythm or heart rate and awareness of heartbeat (palpitations)
• Liver problems such as hepatitis
• Blisters/bleeding of lips, eyes, nose, mouth, and genitals, which may be due to Stevens-Johnson syndrome
• Skin allergic reactions such as sensitivity to sunlight, red, scaly, and inflamed skin
• Weakness (asthenia)
• General malaise

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products website: www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging, after EXP.

The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Azithromycin ratio

• The active substance is azithromycin.

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

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

Appearance of the product and contents of the pack

• Azithromycin ratio 500 mg tablets are pale blue, oblong, biconvex, film-coated tablets, marked with AI 500 and a groove 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, 1st floor

28108 Alcobendas, Madrid (Spain)

Manufacturer:

Teva Operations Poland Sp. z.o.o.

ul. Mogilska 80

31-546 Kraków

Poland

Merckle GmbH

Ludwig Merckle Straße 3

89143 Blaubeuren

Germany

Pharmachemie B.V.

Swensweg, 5

Haarlem

The Netherlands

or

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

Prilaz Baruna Filipovica 25

10000 Zagreb

Croatia

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

Date of the last revision of this leaflet: November 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es