AZITHROMYCIN PENSA PHARMA 500 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Azithromycin Pensa Pharma 500 mg film-coated tablets EFG

Azithromycin (as dihydrate)

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the package leaflet:

1. What is Azithromycin Pensa Pharma and what is it used for
2. What you need to know before taking Azithromycin Pensa Pharma
3. How to take Azithromycin Pensa Pharma
4. Possible side effects
5. Storage of Azithromycin Pensa Pharma
6. Package contents and additional information

1. What is Azithromycin Pensa Pharma and what is it used for

Azithromycin belongs to a group of medications called macrolide antibiotics.

Azithromycin Pensa Pharma is used to treat bacterial infections caused by microorganisms such as bacteria. These infections include:

• thoracic infections such as acute exacerbation of chronic bronchitis (properly diagnosed) and pneumonia,
• sinusitis, pharyngitis, tonsillitis, or otitis,
• mild to moderate skin and soft tissue infections, such as folliculitis (infection of the hair follicles), bacterial skin infection and its deep layers (cellulitis), skin infection with bright red inflammation (erysipelas),

Infections caused by a bacterium called Chlamydia trachomatis, which can cause inflammation of the urethra or cervix.

2. What you need to know before taking Azithromycin Pensa Pharma

Do not take Azithromycin Pensa Pharma:

• if you are allergic to azithromycin dihydrate, erythromycin, or any other component of this medication (listed in section 6),
• if you are allergic (hypersensitive) to any macrolide or ketolide antibiotic.

Do not take this medication if you have any of the above conditions. If you are unsure, consult your doctor or pharmacist before using Azithromycin Pensa Pharma.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• if you have severe liver or kidney disease,
• if you have serious heart problems or cardiac rhythm abnormalities, such as long QT syndrome (shown by an electrocardiogram or ECG equipment),
• if you have low potassium or magnesium levels in your blood,
• if you develop signs of another infection,
• if you have neurological (neurological) or mental health (psychiatric) problems.

Stop taking Azithromycin Pensa Pharma and visit your doctor immediately if you notice any of the following serious side effects while taking this medication:

• Facial, lip, tongue, or throat inflammation; difficulty breathing or swallowing; skin rash that can range from an itchy rash to severe blisters on the skin or ulcers on the lips, eyes, nose, mouth, and genitals. These signs may indicate a severe allergic reaction, angioedema, or anaphylaxis.
• Severe, prolonged diarrhea or diarrhea with blood and mucus. These signs may indicate a serious intestinal problem called pseudomembranous colitis.

Other medications and Azithromycin Pensa Pharma

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

Tell your doctor or pharmacist if you are taking any of the following medications:

• Antacids (used for heartburn or indigestion). Azithromycin Pensa Pharma should be taken at least 1 hour before or 2 hours after the antacid.
• Ergotamine (used for migraines) should not be taken simultaneously, as serious side effects can occur (with numbness or tingling in the extremities, muscle cramps, headache, seizures, and chest or abdominal pain).
• Warfarin or similar medications (used to thin the blood). Azithromycin Pensa Pharma may make the blood thinner.
• Cisapride (used to treat stomach problems) should not be taken simultaneously, as it can cause serious heart problems (shown by an electrocardiogram or ECG equipment).
• Terfenadine (used to treat hay fever) should not be taken simultaneously, as it can cause serious heart problems (shown by an electrocardiogram or ECG equipment).
• Zidovudine or nelfinavir (used to treat HIV infections). Taking nelfinavir with Azithromycin Pensa Pharma may increase the occurrence of side effects mentioned in this package leaflet.
• Rifabutin (used to treat tuberculosis [TB])
• Quinidine (used to treat heart rhythm disorders)
• Cyclosporin (used to prevent organ transplant rejection). Your doctor will regularly monitor the cyclosporin level in your blood and may adjust the dose.
• Tell your doctor or pharmacist if you are taking any of the following medications, as Azithromycin Pensa Pharma may exacerbate their effects. Your doctor may adjust the dose:
• Triazolam, midazolam (sedatives)
• Alfentanil, an analgesic used, for example, during operations
• Theophylline (used for respiratory problems such as asthma and chronic obstructive pulmonary disease [COPD])
• Digoxin (used to treat heart failure)
• Colchicine (used for gout and familial Mediterranean fever)
• Astemizole (used to treat hay fever)
• Pimozide (used to treat mental health disorders)

Taking Azithromycin Pensa Pharma with food and drinks

This medication can be taken with or without food.

Pregnancy and breastfeeding

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

Azithromycin is not recommended during pregnancy or if you plan to become pregnant. Azithromycin should only be used during pregnancy when clearly necessary.

Do not breastfeed if you are taking azithromycin, as a risk to the infant cannot be excluded.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

If the medication makes you dizzy or you notice any other side effect that reduces your ability to concentrate, do not drive or operate machinery.

Azithromycin Pensa Pharmacontains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Azithromycin Pensa Pharma

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor again.

The tablets should be swallowed preferably with water and can be taken with or without food.

The score line should not be used to divide the tablet.

The recommended dose is:

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

The recommended dose is 1,500 mg divided over 3 or 5 days as follows:

• For 3 days, 500 mg per day.
• For 5 days, 500 mg on the first day and then 250 mg on days 2 to 5.

Urethral or cervical inflammation caused by Chlamydia:

1,000 mg taken as a single dose, in one day.

Children and adolescents under 45 kg in weight:

The tablets are not indicated for these patients. Other pharmaceutical forms of azithromycin-containing medications (e.g., suspensions) may be used.

Patients with renal or hepatic impairment:

You should inform your doctor immediately if you have kidney or liver problems, as they may need to adjust the usual dose.

If you take more Azithromycin Pensa Pharma than you should

If you (or someone else) swallow many tablets at once, or if you think a child has swallowed some of the tablets, contact your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used. It is recommended to take the package and package leaflet to the healthcare professional. An overdose can cause reversible hearing loss, severe nausea (feeling of dizziness), vomiting, and diarrhea.

If you forget to take Azithromycin Pensa Pharma

Do not take a double dose to make up for the forgotten dose.

If you forget to take a tablet, take it as soon as possible, unless it is almost time for the next dose.

If you stop taking Azithromycin Pensa Pharma

Do not stop taking the medication without consulting your doctor first, even if you feel better. It is essential to continue taking azithromycin for the period indicated by your doctor; otherwise, the infection may recur.

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

4. Possible side effects

Like all medications, Azithromycin Pensa Pharma can cause side effects, although not everyone gets them.

Stop taking Azithromycin Pensa Pharma and visit your doctor immediately if you notice any of the following serious side effects, as they may require urgent medical treatment:

• Facial, lip, tongue, or throat inflammation; difficulty breathing or swallowing; skin rash that can range from an itchy rash to severe blisters on the skin or ulcers on the lips, eyes, nose, mouth, and genitals. These signs may indicate a severe allergic reaction, angioedema, or anaphylaxis.
• Severe, prolonged diarrhea or diarrhea with blood or mucus. These signs may indicate a serious intestinal problem called pseudomembranous colitis.
• Fever, red spots on the skin, blisters, or skin peeling, joint pain, and swollen eyes. These signs may indicate a severe reaction such as Stevens-Johnson syndrome or toxic epidermal necrolysis. Skin rash characterized by the rapid appearance of red skin areas with small pus-filled blisters (pustules).

Other side effects include:

Very common:

• diarrhea
• abdominal pain
• feeling unwell (nausea)
• flatulence

Common:

• anorexia
• feeling dizzy
• headache
• tingling or numbness (paresthesia)
• taste and smell disorders
• vision problems
• deafness
• feeling unwell (vomiting), stomach pain or cramps, loss of appetite, digestion problems
• skin rashes and itching
• joint pain (arthralgia)
• fatigue
• changes in white blood cell count and blood bicarbonate concentration

Uncommon:

• thrush (candidiasis), a fungal infection in the mouth
• vaginal inflammation (vaginitis)
• reduced white blood cell count
• angioedema
• hypersensitivity
• nervousness
• reduced tactile sensitivity (hypoesthesia)
• drowsiness
• difficulty sleeping (insomnia)
• hearing loss or ringing in the ears
• palpitations
• gastritis
• constipation
• liver problems such as hepatitis or jaundice
• allergic skin reactions such as sensitivity to sunlight or redness, inflammation, and skin peeling
• urticaria
• chest pain
• inflammation (edema)
• general malaise
• weakness
• changes in liver enzyme levels and blood concentration

Rare:

• feeling nervous
• vertigo
• abnormal liver function
• allergic skin reactions

Frequency not known:

• colon infection (pseudomembranous colitis)
• reduced red blood cell count due to destruction (hemolytic anemia); reduced platelet count
• anaphylactic reaction
• feeling furious and aggressive
• fainting (syncope)
• seizures (convulsions)
• feeling hyperactive
• olfactory disorders (anosmia, parosmia)
• taste disorders (ageusia)
• worsening of myasthenia gravis
• rapid or irregular heartbeats, sometimes potentially fatal; changes in heart rhythm determined by an electrocardiogram
• hypotension
• pancreatitis (inflammation of the pancreas)
• changes in tongue color
• allergic skin reactions
• kidney problems

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use. Website: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Azithromycin Pensa Pharma

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions. Do not transfer the tablets to another container.

Do not use this medication after the expiration date stated on the package, after EXP. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Azithromycin Pensa Pharma 500 mg film-coated tablets

The active ingredient is azithromycin. Each tablet contains 500 mg of azithromycin (as azithromycin dihydrate).

The other ingredients (excipients) are:

• Core of the tablet: pregelatinized cornstarch, crospovidone, anhydrous calcium hydrogen phosphate, sodium lauryl sulfate, magnesium stearate
• Coating of the tablet: hypromellose, titanium dioxide (E-171), lactose monohydrate, triacetin

Appearance of the product and package contents

Azithromycin Pensa Pharma 500 mg is presented in the form of white, oblong, biconvex film-coated tablets with a score line on one side.

The tablets are packaged in single-dose paper-based sachets and in PVC blisters attached to an aluminum foil sheet.

Clinical packages of 150 tablets in PVC blisters attached to an aluminum foil sheet.

Packages of 3 tablets in PVC blisters attached to an aluminum foil sheet.

Packages containing 3 tablets in single-dose paper-based sachets.

Single-dose paper-based sachet.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

Bluepharma Industria Farmacêutica S.A.

S.Martinho do Bispo 3045-016

Coimbra

Portugal

or

Sincrofarm, S.L.

C/ Mercurio Nº 10,

Pol. Ind. Almeda, 08940

Cornellá de Llobregat, Barcelona

Spain

Date of the last revision of this package leaflet:May 2018

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/