Azithromycin Aurovitas 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Azithromycin Aurovitas 500 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Leaflet contents

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

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

Azithromycin belongs to a group of antibiotics known as macrolide antibiotics. Antibiotics are used to treat infections caused by microorganisms such as bacteria.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

It is used to treat certain bacterial infections caused by bacteria sensitive to it, such as:

• Chest, throat or nasal infections (such as bronchitis, pneumonia, tonsillitis, sore throat (pharyngitis), and sinusitis).
• Ear infections.
• Skin and soft tissue infections.

Infections of the tube carrying urine from the bladder (urethra) or of the neck of the uterus (cervix) caused by a bacterium called Chlamydia trachomatis.

2. What you need to know before taking Azithromycin Aurovitas

Do not take Azithromycin Aurovitas:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking azithromycin if:

• You have ever had a severe allergic reaction with swelling of the face and throat, possibly with breathing difficulties, rash, fever, swollen glands, or increased eosinophils (a type of white blood cell).
• You develop persistent and severe diarrhoea during or after treatment.
• You have severe liver or kidney disease.
• You have serious heart problems or issues with your heart rhythm, such as prolonged QT interval (shown on an electrocardiogram or ECG machine).
• Your potassium or magnesium levels are too low.
• You develop signs of another infection.
• You are taking ergot derivatives such as ergotamine (used to treat migraine), as these medicines should not be taken together with azithromycin (see section “Taking Azithromycin Aurovitas with other medicines”).
• You suffer from a certain type of muscle weakness called myasthenia gravis.
• You have neurological or psychiatric problems.
• Your newborn baby experiences vomiting and irritability during feeding.

Other medicines and Azithromycin Aurovitas

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

• Antacids – used for heartburn and indigestion. Azithromycin should be taken at least 1 hour before or 2 hours after antacids.
• Ergotamine – dihydroergotamine (for treating migraine) must not be administered at the same time, as serious adverse effects may occur (ergotism – e.g., itching in the limbs, muscle spasms, and gangrene of hands and feet due to poor blood circulation).
• Cholesterol-lowering medicines (statins).
• Warfarin or similar medicines – used to prevent blood clots: concomitant use may increase the risk of bleeding.
• Hydroxychloroquine (used to treat rheumatic diseases or malaria): may cause heart problems.
• Cisapride – (for treating stomach problems) or terfenadine (for treating allergic rhinitis): must not be administered at the same time, as this may cause serious heart problems (as shown on electrocardiogram or ECG machine).
• Zidovudine or nelfinavir – used for treating HIV infections. Taking nelfinavir with azithromycin may increase the risk of adverse effects mentioned in this leaflet.
• Rifabutin – used for treating tuberculosis (TB).
• Quinidine – used to treat heart rhythm problems (antiarrhythmics).
• Cyclosporine – used to suppress the immune system to prevent and treat rejection of organ or bone marrow transplants. Your doctor will monitor your blood levels of cyclosporine regularly and may adjust your dose.

Inform your doctor or pharmacist if you are taking any of the following medicines.

Azithromycin Aurovitas may enhance the effects of other medicines. Your doctor may adjust your dose:

• Alfentanil – a painkiller used, for example, during surgery.

• Theophylline – used to treat breathing problems such as asthma or chronic obstructive pulmonary disease (COPD).

• Digoxin – used to treat heart failure.

• Colchicine – used to treat gout and familial Mediterranean fever.

• Astemizole – used for allergic rhinitis.

• Pimozide – used to treat mental disorders.

Taking Azithromycin Aurovitas with food and drink

This medicine can be taken with or without food.

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 insufficient information available on the use of azithromycin during pregnancy. Therefore, azithromycin is not recommended during pregnancy unless explicitly prescribed by your doctor.

Azithromycin is partially excreted in breast milk. It is unknown whether azithromycin may have adverse effects on the infant. Therefore, breastfeeding should be discontinued during treatment with azithromycin. It is recommended to discard breast milk during treatment and for 2 days after stopping treatment. Breastfeeding may be resumed thereafter.

Driving and using machines

There is no evidence that azithromycin affects the ability to drive or operate machinery. However, azithromycin may cause dizziness and seizures; therefore, ensure you are not impaired before driving or operating machinery.

Azithromycin Aurovitas contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially “sodium-free”.

3. How to take Azithromycin Aurovitas

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

The recommended dose is:

For adults and children weighing 45 kg or more:

Azithromycin is taken over a period of 3 or 5 days:

• 3 days: take 500 mg (two 250 mg tablets or one 500 mg tablet) once daily.

• 5 days:

• Take 500 mg on the first day (two 250 mg tablets).

• Take 250 mg (one 250 mg tablet) on days 2, 3, 4 and 5.

For infections of the cervix and urethra caused by Chlamydia trachomatis

A single dose of 1,000 mg (four 250 mg tablets or two 500 mg tablets), taken as a single dose.

Children and adolescents weighing less than 45 kg:

The tablets are not recommended. Other pharmaceutical forms of this medicine should be used for children with a body weight below 45 kg.

Patients with liver or kidney problems

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

Elderly patients

For elderly patients, the same dose applies as for adult patients.

The tablet may be divided into equal doses.

Method of administration

The tablets should be taken with half a glass of water.

The tablets may be taken with or without food.

If you take more Azithromycin Aurovitas than you should

If you take more azithromycin than you should, consult your doctor, pharmacist or go to the emergency department immediately.

Symptoms of overdose include hearing loss, feeling unwell or sick, and diarrhoea. In case of overdose, hospitalization may be necessary.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Azithromycin Aurovitas

If you forget to take azithromycin, take your dose as soon as possible. If it is almost time for your next dose, skip the missed dose and take the next one at the scheduled time. In case of doubt, please contact your doctor or pharmacist. If you need to skip a dose, still take all your tablets. This means you will finish your treatment one day later. Do not take a double dose to make up for a missed dose.

If you stop taking Azithromycin Aurovitas

Never stop taking azithromycin treatment on your own; first consult your doctor. If the prescribed treatment is not completed fully, the infection may 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 symptoms of a serious allergic reaction, stop taking this medicine immediately and contact your doctor right away or go to the nearest hospital emergency department.

The frequency of these reactions is not known (cannot be estimated from available data):

• Sudden difficulty breathing, speaking, or swallowing.

• Swelling of the lips, tongue, face, and neck.

• Dizziness or severe collapse.

• Severe or itchy skin rash, especially if it develops blisters and if there is discomfort in the eyes, mouth, or genital organs.

• Serious skin reactions:

• Appearance of blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson Syndrome (SJS)).

• Appearance of blisters on the skin, severe skin reaction (Toxic Epidermal Necrolysis (TEN)).

• Skin rash accompanied by other symptoms such as fever, swollen glands, and increased eosinophils (a type of white blood cell). The rash appears as small, red, itchy bumps (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).

If you experience any of the following adverse effects, contact your doctor as soon as possible.

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

• Increased or decreased urine production, or blood in the urine.
• Skin rash characterized by the rapid appearance of red skin areas dotted with small pustules (small blisters filled with white/yellow fluid).

Frequency not known (cannot be estimated from available data):

• Severe, persistent diarrhea, or diarrhea containing blood, accompanied by stomach pain or fever. This may be a sign of severe intestinal inflammation. This is something that may rarely occur after taking antibiotics.
• Yellowing of the skin or whites of the eyes (jaundice) caused by liver problems.
• Inflammation of the pancreas (pancreatitis), causing severe pain in the abdomen and back.
• Increased or decreased urine production or blood in the urine.
• Skin rash caused by sensitivity to sunlight.
• Unusual bleeding or bruising.
• Irregular heartbeat.

These are all serious adverse effects. You may require urgent medical attention.

Other adverse effects include:

Very common (may affect more than 1 in 10 people)

• Diarrhea.
• Abdominal pain.
• Feeling unwell (nausea).
• Gas (flatulence).

Common (may affect up to 1 in 10 people)

• Loss of appetite (anorexia).
• Headache.
• Dizziness.
• Tingling or numbness sensation (paresthesia).
• Changes in taste sensation.
• Visual disturbances.
• Deafness.
• Feeling sick (vomiting), stomach pain or cramps, loss of appetite, difficulty digesting food.
• Skin rash and itching.
• Joint pain (arthralgia).
• Tiredness.
• Changes in the number of white blood cells and blood bicarbonate concentration.

Uncommon (may affect up to 1 in 100 people)

• Oral candidiasis – a fungal infection.
• Bacterial infection.
• Inflammation of the throat (pharyngitis).
• Shortness of breath, chest pain, wheezing, and cough (respiratory disorder).
• Inflammation of the inner mucous membrane of the nose (rhinitis).
• Stomach flu (gastroenteritis).
• Inflammation of the vagina (vaginitis).
• Pneumonia.
• Decrease in the number of white blood cells.
• Angioedema.
• Hypersensitivity.
• Nervousness.
• Decreased sense of touch (hypoesthesia).
• Drowsiness (somnolence).
• Difficulty sleeping (insomnia).
• Hearing disorder.
• Dizziness.
• Abnormal sensation of movement (vertigo).
• Palpitations.
• Hot flushes.
• Shortness of breath.
• Epistaxis (nosebleed).
• Inflammation of the stomach lining (gastritis).
• Constipation.
• Difficulty swallowing.
• Abdominal swelling.
• Dry mouth.
• Belching.
• Mouth ulcer.
• Increased saliva flow.
• Liver problems such as hepatitis.
• Skin allergic reactions such as sensitivity to sunlight, redness, peeling, and inflamed skin.
• Skin rash.
• Itching.
• Skin inflammation (dermatitis).
• Dry skin.
• Increased sweating.
• Pain, swelling, and reduced joint mobility (osteoarthritis).
• Muscle pain.
• Back pain.
• Neck pain.
• Increased blood urea levels.
• Painful or difficult urination.
• Pain in the upper back (renal pain).
• Irregular bleeding.
• Testicular disorder.
• Urticaria.
• Chest pain.
• Swelling of the face.
• Fever.
• Pain.
• Swelling of the limbs (peripheral edema).
• Inflammation (edema).
• General feeling of discomfort (malaise).

Weakness (asthenia).

• Changes in liver enzyme levels and blood levels.

• Post-procedure complications.

• Skin more sensitive than usual to sunlight.

• Laboratory tests showing abnormal results (e.g.: blood tests or liver function tests).

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

• Feeling restless, feeling of unreality.

• Abnormal liver function.

• Skin allergic reactions.

• Skin rash characterized by the rapid appearance of red skin areas dotted with small pustules (small blisters filled with white/yellow fluid).

• Swelling of hands, feet, lips, genitals, or throat (angioneurotic edema).

• Kidney problems.

Frequency not known (cannot be estimated from available data)

• Abdominal infection (colon) (pseudomembranous colitis).
• Reduction in red blood cells due to destruction (hemolytic anemia); reduction in platelet count (thrombocytopenia).
• Anaphylactic reaction.
• Feeling angry, aggressive.
• Anxiety.
• Confusion.
• Hallucinations.
• Fainting (syncope).
• Seizures (convulsions).
• Decreased sense of touch (hypoesthesia).
• Feeling hyperactive.
• Change in sense of smell (anosmia, parosmia).
• Change in taste sensation (ageusia).
• Exacerbation or worsening of muscle weakness (myasthenia gravis).
• Blurred vision.
• Hearing problems, including hearing loss, ringing in the ears.
• Rapid (ventricular tachycardia) or irregular heartbeats, sometimes life-threatening, changes in heart rhythm detected on an electrocardiogram (QT interval prolongation and torsades de pointes).
• Low blood pressure.
• Inflammation of the pancreas (pancreatitis).
• Change in tongue color.
• Liver failure.
• Severe skin allergic reactions.
• Inflammation of the kidneys.

The following adverse effects have been reported during prophylactic treatment against Mycobacterium Avium complex (MAC):

Very common (may affect more than 1 in 10 people)

• Diarrhea.
• Abdominal pain.
• Feeling unwell (nausea).
• Gas (flatulence).
• Abdominal discomfort.
• Loose stools.

Common (may affect up to 1 in 10 people)

• Loss of appetite (anorexia).
• Dizziness.
• Headache.
• Tingling or numbness sensation (paresthesia).
• Change in taste sensation.
• Visual impairment.
• Deafness.
• Feeling sick (vomiting), stomach pain or cramps, loss of appetite, difficulty digesting food.
• Skin rash and itching.
• Joint pain (arthralgia).
• Fatigue.

Uncommon (may affect up to 1 in 100 people)

• Decreased sense of touch (hypoesthesia).
• Hearing loss or ringing in the ears.
• Palpitations.
• Liver problems such as hepatitis.
• Severe skin redness.
• Skin allergic reactions such as sensitivity to sunlight, redness, peeling, and swollen skin.
• General feeling of discomfort (malaise).
• Weakness (asthenia).

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Azithromycin Aurovitas Storage

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Azithromycin Aurovitas

• The active substance is azithromycin dihydrate.

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

• Other components are:

Tablet core: calcium hydrogen phosphate, pregelatinized corn starch, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate.

Tablet coating: lactose monohydrate, hypromellose, titanium dioxide (E 171), triacetin.

Appearance of the product and contents of the pack

Film-coated tablet.

Azithromycin Aurovitas 500 mg film-coated tablets EFG:

Oval-shaped, white to off-white, film-coated tablet, marked with “6” and “7” on either side of the score line on one side, and with “D” on the other side. Size: 17.1 mm x 8.5 mm.

Azithromycin Aurovitas 500 mg film-coated tablets are available in transparent PVC/aluminum blisters.

Pack sizes: 2, 3, 4, 6, 12 and 24 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Half Far Industrial Estate, Hal Far,

Birzebbuggia, BBG 3000

Malta

This medicinal product is authorized in the European Economic Area member states under the following names:

Belgium: Azithromycin AB 500 mg filmomhulde tabletten

Spain: Azitromicina Aurovitas 500 mg comprimidos recubiertos con película EFG

Netherlands: Azitromycine Aurobindo 500 mg, filmomhulde tabletten

Hungary: Azitromicin Aurovitas 500 mg filmtabletta

Poland: Azithromycin Aurovitas

Portugal: Azitromicina Aurovitas

Czech Republic: Azithromycin Aurovitas 500 mg potahované tablety

Date of the most recent review of this leaflet: December 2022

Detailed 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/)