AZITHROMYCIN VEGAL 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Azithromycin VEGAL 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:

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

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

Azithromycin belongs to a group of antibiotics called macrolide antibiotics.

Antibiotics are used to treat bacterial infections and will not work for viral infections such as the common cold or flu.

It is important that you follow the instructions regarding dose, administration interval, and treatment duration as indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

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 with the vagina (cervix).

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

Do not take Azithromycin VEGAL

• 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 VEGAL if you:

• Have ever had a severe allergic reaction with facial and throat swelling and potential 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 VEGAL 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 cardiac 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 antiarrhythmics (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 disorder, a brain or nervous system disease.
• Have mental, emotional, 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

Tablets are not recommended for children and adolescents weighing less than 45 kg (see section 3).

Using Azithromycin VEGAL with other medicines

Tell your doctor 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 azithromycin, 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.
• Zidovudine, nelfinavir (used to treat HIV): zidovudine or azithromycin levels may increase.
• Rifabutin (used to treat HIV and bacterial infections, including tuberculosis): a decrease in the number of white blood cells in the blood may occur.
• Ciclosporin (an immunosuppressant used after organ transplantation): ciclosporin levels may increase. Your doctor will need to monitor your ciclosporin blood levels.
• Cisapride (used to treat stomach problems): 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.

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 VEGAL with food and drink

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. 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 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 VEGAL.

Driving and using machines

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

Azithromycin VEGAL contains lactose

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

3. How to take Azithromycin VEGAL

Follow exactly the administration instructions of this medicine as indicated by your doctor or pharmacist. 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. Other presentations are 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:

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

Patient with liver or kidney problems:

Tell your doctor if you have liver or kidney problems, as the normal dose may need to be modified.

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

If you take more Azithromycin VEGAL than you should

If you (or someone else) swallow many tablets at the same time or if you think a child has swallowed some, 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 Toxicological Information Service, telephone 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 VEGAL

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 VEGAL

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 VEGAL for the time indicated by your doctor, or the infection may recur.

If you have any further questions on 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 VEGAL 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 breathing difficulties; 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, both of 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 other 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 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 thrush (in the mouth), vaginal infection, pneumonia, bacterial infection
• Sore throat, inflammation of the stomach lining and intestines
• 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)
• Abnormal heart rhythm or frequency and detection of heartbeat (palpitations)
• Hot flushes
• Breathing difficulties
• 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 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, kidney pain
• Vaginal inflammation, irregular menstrual bleeding, testicular disorders
• Chest pain, swelling, discomfort, weakness, tiredness
• 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 not real.
• 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

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

• Intestinal infection (pseudomembranous colitis)
• Blood disorders characterized by uncommon bleeding or unexplained bruising, decreased red blood cell count causing weakness or tiredness
• Anaphylactic reaction
• Feeling unwell, anxiety, confusion, seeing or hearing things that are not happening
• Fainting, seizures, decreased sensitivity, hyperactivity, altered or lost sense of smell, lost sense of taste, myasthenia gravis (muscle weakness and fatigue, see "Warnings and precautions" above)
• Abnormalities in hearing, including deafness and/or ringing in the ears
• Changes in heart rhythm or frequency and detection of heartbeat (palpitations)
• Decrease in blood pressure (which may be associated with weakness, fainting, and fainting spells)
• Discoloration of the tongue, pancreatitis that causes nausea, vomiting, abdominal pain, back pain
• Liver failure (rarely fatal)
• Rash with spots and 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
• Rash
• Itching (pruritus)
• Joint pain (arthralgia)
• Tiredness

Uncommon (may affect up to 1 in 100 people)

• Decreased sensitivity (hypoesthesia)
• Hearing loss or ringing in the ears
• Abnormal 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 VEGAL

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

No special storage conditions are required.

Do not use Azithromycin VEGAL 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. Return the packaging and any unused medicine to the pharmacy's SIGRE Point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Azitromicina VEGAL Composition

• Each tablet contains 500 mg of the active ingredient azithromycin (as dihydrate).
• The other components are: pregelatinized corn starch, crospovidone, anhydrous calcium hydrogen phosphate, sodium lauryl sulfate, magnesium stearate, hypromellose, titanium dioxide (E171), lactose, and triacetin

Product Appearance and Package Contents

Film-coated tablets, white, capsule-shaped, and scored with a transverse line on one side. Each package contains 3 tablets. Clinical packages of 150 tablets are also available

They are presented in white polyvinyl chloride (PVC) blisters sealed with a heat-sealable aluminum foil.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Vegal Farmaceutica, S.L.

Vía de las Dos Castillas 9C, portal 2, 2ºC.

28224 Pozuelo de Alarcón, Madrid.

Spain

Manufacturer:

Kern Pharma, S.L.

Polígono Ind. Colón II

C/Venus, 72

08228 Terrassa (Barcelona)

Date of the Last Revision of this Leaflet: June 2016

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