Portex

Patient Information Leaflet

PORTEX 500 mg film-coated tablets

Azithromycin dihydrate
“Generic medicine”
Please read all of this leaflet carefully before you take this medicine because it contains important information for you.

• Keep this leaflet. 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 give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What PORTEX is and what it is used for

PORTEX contains the active substance azithromycin. Azithromycin is an antibiotic that belongs to the group of antibiotics known as "macrolides", which block the growth of susceptible bacteria.
PORTEX is taken to treat the following infections:
Adults and adolescents weighing 45 kg or more

• infections of the tonsils (tonsillitis) and throat (pharyngitis) caused by streptococcal bacteria
• bacterial infections of the paranasal sinuses (sinusitis)
• bacterial infections of the middle ear (otitis media)
• lung infection (community-acquired pneumonia, not contracted in hospital)
• bacterial infections of the skin and underlying tissues
• bacterial infections of the gums (periodontitis) or gum abscess (periodontal abscess)
• infections of the urethra and cervix caused by the bacterium Chlamydia trachomatis
• bacterial genital infections with painful sores (chancroid).

Adults:

• bacterial infections in patients with long-standing inflammation of the bronchi (chronic bronchitis).

2. What you must know before taking PORTEX

Do not take PORTEX

• if you are allergic to azithromycin, erythromycin, other antibiotics known as "macrolides" or "ketolides", or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking PORTEX if you have or have had any of the following conditions:

• heart problems (e.g. heart rhythm disorders or heart failure) or low levels of potassium or magnesium in the blood: these conditions may contribute to serious cardiac side effects caused by azithromycin;
• liver problems: your doctor may need to monitor liver function or discontinue treatment;
• severe diarrhoea after taking other antibiotics;
• localized muscle weakness (myasthenia gravis), as symptoms of this disease may worsen during treatment;
• if you are taking ergot derivatives such as ergotamine (used to treat migraine), since these medicines must not be taken in combination with Portex;

Stop taking this medicine and contact your doctor immediately (see also "Serious side effects" in section 4):

• if you suspect you are having an allergic reaction (e.g. difficulty breathing, swelling of the face or throat, rash, blisters);
• if you notice any of the symptoms described in section 4 related to serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), reported in association with azithromycin treatment;
• if you experience an abnormal heartbeat or palpitations, dizziness or fainting while taking PORTEX;
• if you develop signs of liver problems (e.g. dark urine, loss of appetite, or yellowing of the skin or whites of the eyes);
• if you develop severe diarrhoea during or after treatment. Do not take any medicine for diarrhoea without first consulting your doctor. If diarrhoea persists or recurs within the first few weeks of treatment, inform your doctor.

Superinfection
Your doctor may monitor symptoms of additional bacterial or fungal infections that cannot be treated with PORTEX (superinfection).
Sexually transmitted infections
Your doctor may perform a test to rule out a possible syphilis infection, a sexually transmitted disease that could otherwise progress undetected and be diagnosed late. Furthermore, in cases of sexually transmitted bacterial infections, your doctor will carry out follow-up laboratory tests to monitor the effectiveness of treatment.
Children and adolescents
If your body weight is less than 45 kg, there are other azithromycin-containing medicines that may be more convenient for you to take.
Other medicines and PORTEX
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking PORTEX together with other medicines may cause side effects.
Therefore, it is particularly important that you inform your doctor if you are taking any of the following medicines:

• atorvastatin and other medicines in the statin group (to lower cholesterol in the blood and prevent heart disease, including heart attacks and strokes);
• cyclosporine (to prevent rejection of transplanted organs by the body);
• colchicine (for the treatment of gout and familial Mediterranean fever);
• dabigatran (to prevent and treat blood clot formation (anticoagulant));
• digoxin (for the treatment of heart conditions);
• warfarin or similar medicines used to thin the blood (anticoagulants);
• medicines that may cause the heart muscle to take longer than usual to contract and relax (QT interval prolongation), such as:
  • quinidine, procainamide, dofetilide, amiodarone and sotalol (for the treatment of irregular heartbeat, including cases of heartbeat that is too fast or too slow – cardiac arrhythmia);
  • pimozide (for the treatment of mental illnesses);
  • citalopram (for the treatment of depression);
  • moxifloxacin and levofloxacin (antibiotics);
  • cisapride (for the treatment of gastrointestinal tract disorders);
  • hydroxychloroquine or chloroquine (for the treatment of autoimmune diseases, including rheumatoid arthritis, or for treating or preventing malaria).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Your doctor will decide whether you can take this medicine during pregnancy, after ensuring that the benefits outweigh the potential risks.
Breastfeeding
PORTEX passes into breast milk. Therefore, your doctor will decide whether to discontinue breastfeeding or avoid treatment with PORTEX, taking into account both the benefit of breastfeeding for the child and the benefit of treatment for you.
Driving and using machines
PORTEX may have a moderate effect on the ability to drive and use machines.
Dizziness, drowsiness, seizures, and vision or hearing disturbances have been reported with PORTEX in some people. These possible side effects may affect the ability to drive and use machines.
PORTEX contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine. If you know you have such an intolerance, remember to consult your doctor before taking Portex.
PORTEX 500 mg tablets contain less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take PORTEX

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The amount of PORTEX you need to take each day depends on the bacterial infection being treated,
as well as the specific treatment regimen prescribed by your doctor or pharmacist.
Adults and adolescents with a body weight of 45 kg or more

Use in children and adolescents
If your body weight is less than 45 kg or you are unable to swallow this medicine, consult your
doctor or pharmacist, as other azithromycin-containing medicines are available which may be
more suitable for you.

Method of administration
For oral use.
PORTEX must be taken orally as a single daily dose. The tablets should be swallowed whole with water, with or without food. Taking this medicine shortly before a meal may help improve gastrointestinal tolerability.

If you take more PORTEX than you should
If you take more PORTEX than you should, you may feel unwell. Typical signs of overdose include vomiting, diarrhoea, abdominal pain and nausea. Inform your doctor immediately or contact the emergency department of the nearest hospital.

If you forget to take PORTEX
If you forget to take PORTEX, take it as soon as possible, provided that at least 12 hours remain before the next dose. If less than 12 hours remain before the next dose, do not take the missed dose; instead, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

If you stop taking PORTEX
If you stop treatment with PORTEX too early, the infection may recur. Take PORTEX for the full duration of treatment, even if you start to feel better.

If you have any doubts about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
Stop using PORTEX and contact your doctor immediately if you notice any of the following symptoms:

• sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching mainly affecting the whole body (anaphylactic reaction, frequency not known)
• fast or irregular heartbeat (cardiac arrhythmia or torsades de pointes, tachycardia, frequency not known)
• dark urine, loss of appetite, or yellowing of the skin or whites of the eyes, signs of liver problems (hepatic failure or hepatic necrosis, frequency not known)
• severe diarrhoea with abdominal cramps, blood in the stools and/or fever, which may indicate an infection of the large intestine (antibiotic-associated colitis, frequency not known). Do not take anti-diarrhoeal medicines that inhibit intestinal motility (antiperistaltics)
• red, non-elevated spots on the trunk, target-shaped or circular rashes, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome or toxic epidermal necrolysis, frequency not known)
• widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome, rare (may affect up to 1 in 1,000 people))
• widespread, red, scaly rash with subcutaneous bumps and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (acute generalized exanthematous pustulosis, rare (may affect up to 1 in 1,000 people)).

Other side 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, feeling unwell (nausea)
• changes in blood test results (decreased lymphocyte count, increased eosinophil count, increased basophil count, increased monocyte count, increased neutrophil count, decreased blood bicarbonate)

Uncommon (may affect up to 1 in 100 people):

• candidiasis (candidiasis), a fungal infection of the mouth and vagina, other fungal infections
• lung infection, bacterial throat infection, gastrointestinal tract inflammation, respiratory disorder, inflammation of the nasal mucosa, vaginal infection
• changes in white blood cell count (leucopenia, neutropenia, eosinophilia)
• increased platelet count
• reduced proportion of all blood cells in total blood volume (reduced haematocrit)
• allergic reactions, swelling of the hands, feet and face (angioedema)
• loss of appetite
• nervousness, difficulty sleeping (insomnia)
• dizziness, drowsiness (somnolence), altered taste sensation (dysgeusia), tingling sensation (paraesthesia)
• visual disturbances
• ear disorder
• dizziness (vertigo)
• awareness of heartbeat (palpitations)
• hot flush
• sudden wheezing, nosebleed
• constipation, intestinal gas, indigestion (dyspepsia), inflammation of the stomach lining (gastritis), difficulty swallowing (dysphagia), bloated stomach, dry mouth, burping, mouth ulceration, increased salivation
• rash, itching, hives, dermatitis, dry skin, abnormally increased sweating (hyperhidrosis)
• swelling and pain in joints (osteoarthritis), muscle pain, back pain, neck pain
• painful urination (dysuria), kidney pain
• irregular menstrual bleeding (metrorrhagia), testicular disorder
• swelling due to fluid retention, particularly of the face, ankles and feet (oedema, facial oedema, peripheral oedema)
• weakness, fatigue, general malaise, fever
• chest pain, pain
• abnormal laboratory test results (e.g. blood or liver tests)
• post-procedural complication

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

• sensation of irritation
• liver problems, yellowing of the skin or eyes
• increased sensitivity to sunlight

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

• reduction in red blood cells due to increased cell breakdown, which may cause fatigue and pale skin (haemolytic anaemia)
• reduction in platelet count, which may lead to bleeding and bruising (thrombocytopenia)
• feeling angry, aggressive, fearful or worried (anxiety), acute confusion (delirium)
• hallucination
• fainting (syncope)
• seizures (convulsive crisis)
• reduced sensitivity to touch, pain and temperature (hypoesthesia)
• feeling overactive
• change in sense of smell (anosmia, parosmia)
• complete loss of taste (ageusia)
• muscle weakness (myasthenia gravis)
• abnormal electrocardiogram (ECG) (prolongation of QT interval)
• deafness, reduced hearing or ringing in the ears (tinnitus)
• low blood pressure
• inflammation of the pancreas causing severe abdominal and back pain (pancreatitis)
• change in tongue colour
• joint pain (arthralgia)
• inflammation of the kidneys (interstitial nephritis), impaired kidney function

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PORTEX

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 that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What PORTEX contains

• The active substance is azithromycin, as azithromycin dihydrate. Each film-coated tablet contains 524.1 mg of azithromycin dihydrate, equivalent to 500 mg of azithromycin. The other components are: anhydrous calcium hydrogen phosphate, pregelatinized starch, sodium lauryl sulfate, sodium croscarmellose, sodium carmellose, magnesium stearate.

Coating:
Hypromellose (E464), titanium dioxide (E171), triacetin (E1518), monohydrate lactose.
Description of the appearance of PORTEX and contents of the package
Film-coated tablets.
Blister pack containing 3 film-coated tablets of 500 mg.
Marketing Authorization Holder
AGIPS FARMACEUTICI S.r.l., Via Amendola, 4 – 16035 Rapallo (GE)
Manufacturer
Special Product’s Line S.p.A., Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)