Package Leaflet: Information for the User

Azitromicina pensa pharma 500 mg Film-Coated Tablets

Azitromycin (as dihydrate)

Read this 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Azitromicina pensa pharma is and what it is used for

2. What you need to know before you start taking Azitromicina pensa pharma

3. How to take Azitromicina pensa pharma

4. Possible side effects

5. Storage of Azitromicina pensa pharma

6. Contents of the pack and additional information

Azitromicina belongs to a group of medicines called macrolide antibiotics.

Azitromicina pensa pharmais usedto treat bacterial infections caused by microorganisms such as bacteria. These infections include:

• Bacterial infectionsof the thoracic region, such as acute exacerbation of chronic bronchitis (adequately diagnosed) and pneumonia,
• sinusitis, pharyngitis, tonsillitis, or otitis,
• Mild to moderate skin and soft tissue infections, such as folliculitis,bacterial skin infection, and its deep layers (cellulitis),skin infection with bright red inflammation (erysipela),

Infections caused by a bacteria calledChlamydia trachomatis, which can cause inflammation of the urethra or the cervix.

Do not take Azitromicina pensa pharma:

• if you are allergic to azithromycin dihydrate, erythromycin, or any of the other components 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 circumstances. If you are unsure, consult your doctor or pharmacist before using Azitromicina pensa pharma.

Warningsandprecautions

Consult your doctor or pharmacist before startingtotake this medication:

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

Stop taking Azitromicina pensa pharmaand visit your doctor immediately if you notice any of the following severe side effects while taking this medication:

• Inflammation of the face, lips, tongue, or throat; difficulty breathing or swallowing; skin rash that may progress from a pruritic rash to severe skin blisters or ulcers on the lips, eyes, nose, mouth, and genitals. These signs may indicate a severe allergic reaction, angioedema, or anaphylaxis.
• Prolonged or bloody diarrhea with mucus. These signs may indicate a severe intestinal problem called pseudomembranous colitis.

Other medications and Azitromicina pensa pharma

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

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

• Antacids (used for heartburn or indigestion). Azitromicina pensa pharmashould be taken at least 1 hour before or 2 hours after the antacid.
• Ergotamine (used for migraines) should not be taken simultaneously, as this may cause severe side effects (tingling or numbness in the extremities, muscle cramps, headache, seizures, and chest or abdominal pain).
• Warfarin or similar medications (used to thin the blood). Azitromicina pensa pharmamay thin the blood even further.
• Cisapride (used to treat stomach problems) should not be taken simultaneously, as this may cause severe heart problems (shown by an electrocardiogram or ECG device).
• Terfenadine (used to treat hay fever) should not be taken simultaneously, as this may cause severe heart problems (shown by an electrocardiogram or ECG device).
• Zidovudine or nelfinavir (used to treat HIV infections). Taking nelfinavir with Azitromicina pensa pharmamay increase the risk of side effects mentioned in this prospectus.
• Rifabutin (used to treat tuberculosis [TB])
• Quinidine (used to treat cardiac arrhythmias)
• Ciclosporina (used to prevent organ transplant rejection). Your doctor will regularly monitor the ciclosporin level in your blood and may adjust your dose.
• Notify your doctor or pharmacist if you are taking any of the following medications, as Azitromicina pensa pharmamay exacerbate their effects. Your doctor may adjust your dose:
• Triazolam, midazolam (sedatives)
• Alfentanil, an analgesic used, for example, during operations
• Theophylline (used to treat respiratory problems such as asthma and chronic obstructive pulmonary disease [COPD])
• Digoxin (used to treat heart failure)
• Colchicine (used to treat gout and familial Mediterranean fever)
• Astemizol (used to treat hay fever)
• Pimozide (used to treat mental health disorders)

Taking Azitromicina pensa pharmawith food and drinks

This medication can be taken with or without food.

Pregnancy and breastfeeding

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

Azitromicina should not be taken during pregnancy or if you plan to become pregnant. It should only be used during pregnancy when clearly necessary.

Do not breastfeed while taking azitromicina, as the risk to the infant cannot be ruled out.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

If the medication causes dizziness or you notice any other side effect that impairs your ability to concentrate, do not drive or operate machinery.

Azitromicina pensa pharmacontains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor again.

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

The groove should not be used to break the tablet.

The recommended dose is:

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

The recommended dose is 1,500 mg divided over 3 or 5 days in the following way:

• 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, on one day.

Children and adolescents under 45 kg of weight:

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

Patients with renal or hepatic impairments:

Inform your doctor immediately if you have kidney or liver problems as this may require modification of the usual dose.

If you take more Azitromicina pensa pharma than you should

If you (or another person) ingest many tablets together, or if you believe a child has ingested any of the tablets, contact your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount used. It is recommended to bring the packaging and leaflet to the healthcare professional. A overdose may cause reversible hearing loss, intense nausea (sensation of dizziness), vomiting, and diarrhea.

If you forgot to take Azitromicina pensa pharma

Do not take a double dose to compensate for the missed dose.

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

If you interrupt the treatment with Azitromicina pensa pharma

Do not stop taking the medication without consulting your doctor first, even if you feel better. It is essential to continue taking azitromicina for the indicated period of time by your doctor, if not, it is possible that the infection will recur.

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

Like all medicines, Azitromicina pensa pharmacan cause side effects, although not everyone will experience them.

Stop taking Azitromicina pensa pharmaand see your doctor immediately if you notice any of the following serious side effects, as they may require emergency medical treatment:

• inflammation of the face, lips, tongue, or throat; difficulty breathing or swallowing; skin rash that may range from a mild 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 skin patches, 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 patches dotted with small white/yellow pustules (small blisters filled with a white/yellow liquid).

Other side effects include:

Very common:

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

Common:

• loss of appetite
• feeling dizzy
• headache
• tingling or numbness (paresthesia)
• alterations in taste and smell
• eye problems
• hearing loss
• feeling unwell (vomiting), stomach pain or cramps, loss of appetite, difficulty digesting food
• skin rashes and itching
• joint pain (arthritis)
• fatigue
• change in white blood cell count and bicarbonate concentration in blood

Uncommon:

• mouth ulcers (candidiasis), a fungal infection in the mouth
• vaginal inflammation (vaginitis)
• reduction in white blood cell count
• angioedema
• hypersensitivity
• nervousness
• reduced sensitivity to touch (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 peeling of the skin
• urticaria
• chest pain
• swelling (edema)
• general feeling of being unwell
• weakness
• change in liver enzyme levels and concentration in blood

Rare:

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

Frequency not known:

• colon infection (pseudomembranous colitis)
• destruction of red blood cells leading to anemia (hemolytic anemia); reduction in platelet count
• anaphylactic reaction
• feeling furious and aggressive
• syncope (fainting)
• seizures (convulsions)
• feeling hyperactive
• alterations in sense of smell (anosmia, parosmia)
• alterations in sense of taste (ageusia)
• exacerbation or 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)
• change in tongue color
• allergic skin reactions
• kidney problems

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use. Website:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Do not use this medication after the expiration date that appears on the container, after CAD. 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 containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of A azitromicina pensa pharma 500 mg coated tablets

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

The other components (excipients) are:

• Tablet core: pregelatinized cornstarch, crospovidone, anhydrous calcium hydrogen phosphate, sodium lauryl sulfate, magnesium stearate
• Tablet coating: hypromellose, titanium dioxide (E-171), lactose monohydrate, glyceryl triacetate.

Appearance of the product and contents of the packaging

Azitromicina pensa pharma 500 mg is presented in the form of coated tablets of white color, oblong, biconvex, scored on one side.

The tablets are packaged in unit dose blisters of starch-coated paper and in PVC blisters united to an aluminum foil.

Clinical packaging of 150 tablets in PVC blisters united to an aluminum foil.

Packaging of 3 tablets in PVC blisters united to an aluminum foil.

Packaging containing 3 tablets in unit dose blisters of starch-coated paper.

Unit dose blister of starch-coated paper.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer:

Marketing authorization holder: :

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible 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

Last review date of this leaflet: May 2018

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/