Trissil

Patient Information Leaflet

TRISSIL 250 mg film-coated tablets, 500 mg film-coated tablets

Levofloxacin
Generic medicine
Read this entire leaflet carefully before taking this medicine, as 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 others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What TRISSIL is and what it is used for

TRISSIL contains the active substance levofloxacin, which belongs to a group of medicines called quinolone antibiotics. These medicines work by killing bacteria responsible for infections in the body.
This medicine is indicated in adults for the treatment of the following infections:

• of the facial sinuses (acute bacterial sinusitis), when treatment with other medicines has been ineffective;
• of the bronchi, in patients who already have this infection and are experiencing a worsening of their condition (acute bacterial exacerbation of chronic bronchitis), and when other treatments have not been effective;
• of the lungs, when the infection was acquired in hospital and has not responded to other treatments;
• of the urinary tract, including infections of the kidneys and bladder (pyelonephritis);
• of the prostate (chronic bacterial prostatitis);
• of the skin and soft tissues.

2. What you need to know before taking TRISSIL

Do not take TRISSIL

• if you are allergic (hypersensitive) to levofloxacin, to any other quinolone antibiotic such as moxifloxacin, ciprofloxacin, ofloxacin, or to any of the other ingredients of this medicine (listed in section 6).
• Signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue;
• if you have or have had epilepsy;
• if you have had tendon problems, such as tendinitis, related to treatment with a "quinolone antibiotic". Tendons are fibrous structures that connect muscles to the skeleton;
• if you are a child or adolescent during the growth period (see section “Children and adolescents”);
• if you are pregnant, could become pregnant, or think you may be pregnant;
• if you are breastfeeding.

Do not take this medicine if any of the above applies to you. If you have any
doubts, consult your doctor, nurse, or pharmacist before taking TRISSIL.
Warnings and precautions
Consult your doctor or pharmacist before taking this medicine if:

• you are 60 years old or older;
• you are taking corticosteroids, sometimes called steroids (see “Other medicines and TRISSIL”);
• you have had seizures;
• you have suffered brain damage due to stroke or other brain injuries;
• you have kidney problems;
• you suffer from a condition known as “glucose-6-phosphate dehydrogenase deficiency”. Administration of this medicine increases the likelihood of developing serious blood-related problems;
• you have suffered from mental health problems;
• you have had heart problems: you should exercise caution when using this type of medicine if you were born with or have a family history of QT interval prolongation (seen on electrocardiogram, the electrical tracing of the heart), have an electrolyte imbalance in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (called “bradycardia”), have a weak heart (heart failure), have had a heart attack (myocardial infarction), are female or elderly, or are taking other medicines that may alter the electrocardiogram (see section “Other medicines and TRISSIL”);
• if you have been diagnosed with an enlargement or “bulging” of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel).
• if you have previously experienced episodes of aortic dissection (a tear in the wall of the aorta).
• if you have a family history of aortic aneurysm, aortic dissection, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, vascular Ehlers-Danlos syndrome, or if you suffer from vascular conditions such as Takayasu arteritis, giant cell arteritis, Behcet's syndrome, high blood pressure, or known atherosclerosis).
• you have diabetes;
• you have had liver problems;
• you have myasthenia gravis.

If you have any doubts whether any of the above may apply to you, consult your doctor or
pharmacist before taking TRISSIL.
If you experience sudden pain in the abdomen, chest, or back, go immediately to
the emergency room.
Other medicines and TRISSIL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines. This is because TRISSIL may affect the way other
medicines work. Likewise, some medicines may affect the way TRISSIL works.
In particular, inform your doctor if you are taking any of the following medicines. This
is because taking TRISSIL together with other medicines may increase the
likelihood of you experiencing side effects:

• corticosteroids, sometimes called steroids – used to treat inflammation. The risk of developing inflammation and/or rupture of tendons is higher.
• Warfarin – used to thin the blood. The risk of bleeding is higher. Your doctor may ask you to have regular blood tests to monitor blood clotting.
• Theophylline – used for respiratory problems. The risk of having a seizure (epileptic fit) is higher if you take theophylline together with TRISSIL.
• Non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as aspirin, ibuprofen, fenbufen, ketoprofen, and indometacin. The risk of having a seizure (epileptic fit) is higher if taken together with TRISSIL.
• Cyclosporine – used for organ transplants. The risk of experiencing typical side effects of cyclosporine is higher.
• Medicines known for their effects on heart rhythm. These include medicines used to treat abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (macrolide antibiotics such as erythromycin, azithromycin, and clarithromycin).
• Probenecid – used to treat gout. Your doctor may prescribe a lower dose if you have kidney problems.
• Cimetidine – used for ulcers and heartburn. Your doctor may prescribe a lower dose if you have kidney problems. Consult your doctor if any of the above applies to you.

Do not take TRISSIL tablets together with the following medicines. This is because the
effectiveness of TRISSIL tablets may be affected:

• iron salts in tablets (for anaemia), zinc supplements, antacids containing magnesium or aluminium (for acidity or heartburn), didanosine, or sucralfate (for gastric ulcers). See section 3 “If you are taking iron salts in tablets, zinc supplements, antacids, didanosine, or sucralfate”.

Urine test for opiates
In patients taking TRISSIL, urine tests may give "false-positive" results for
strong painkillers called "opiates". If your doctor considers it necessary to perform
urine tests, inform them that you are taking TRISSIL.
Tuberculosis testing
This medicine may cause "false-negative" results in certain laboratory tests that detect
the bacteria causing tuberculosis.
Pregnancy and breastfeeding
Do not take this medicine if:

• you are pregnant, could become pregnant, or think you may be pregnant;
• you are breastfeeding or think you may breastfeed.

Driving and using machines
Some side effects may occur after taking this medicine, including dizziness, drowsiness, subjective sensation of movement (vertigo), or visual disturbances.
Some of these side effects may affect your ability to concentrate and your reaction speed. If this occurs, do not drive vehicles and do not perform activities that require a high level of attention.

3. How to take TRISSIL

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

How to take this medicine

• Take this medicine by mouth.
• Swallow the tablets whole with water.
• The tablets may be taken with or without food.

If you are already taking iron tablets, zinc supplements, antacids, didanosine, or sucralfate

• Do not take these medicines at the same time as TRISSIL. Take the prescribed dose of these medicines at least 2 hours before or after taking TRISSIL tablets.

How much medicine to take

• Your doctor will decide how much TRISSIL tablets you should take.
• The dose will depend on the type of infection you have and where in the body the infection is located.
• The duration of treatment will depend on the severity of the infection.
• If you think the effect of the medicine is too weak or too strong, do not change the dose on your own; consult your doctor.

Adults and elderly

• Sinus infection (acute sinusitis): The recommended dose is 500 mg once daily for 10–14 days.
• Worsening of a bronchial infection (acute exacerbation of chronic bronchitis): The recommended dose is 250 to 500 mg once daily for 7–10 days.
• Lung infection (hospital-acquired): The recommended dose is 500 mg 1–2 times daily for 7–14 days.
• Uncomplicated urinary tract infections: The recommended dose is 250 mg once daily for 3 days.
• Complicated urinary tract infections (pyelonephritis): The recommended dose is 250 mg once daily for 7–10 days.
• Prostate infections (chronic bacterial prostatitis): The recommended dose is 500 mg once daily for 28 days.
• Skin and soft tissue infections: The recommended dose is 250 mg once daily or 500 mg 1–2 times daily for 7–14 days.

Adults and elderly with kidney problems
Your doctor may consider it necessary to reduce the dose.

Children and adolescents
This medicine must not be given to children or adolescents.

Protect your skin from sunlight
Do not expose yourself to direct sunlight during treatment with this medicine and for 2 days after stopping treatment. This is because your skin will become much more sensitive to sunlight and may burn, itch, or develop severe blistering if you do not follow these precautions:

• Be sure to use a high-protection sunscreen.
• Always wear a hat and clothing covering arms and legs.
• Avoid sunbeds.

If you take more TRISSIL than you should
If you take or ingest too much of this medicine, contact your doctor immediately or go to the nearest hospital.
Take the medicine pack with you. This will allow the doctor to see what you have taken. The following side effects may occur: seizures (epileptic fit), confusion, dizziness, feeling faint, tremor, and heart problems – which may lead to irregular heartbeat and feelings of discomfort (nausea) or stomach burning.

If you forget to take TRISSIL
If you forget to take a dose, 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 a forgotten dose.

If you stop taking TRISSIL
Do not stop taking TRISSIL just because you feel better. It is important that you complete the full course of tablets prescribed by your doctor. If you stop taking the tablets too early, the infection may return, your condition may worsen, or the bacteria may become resistant to the medicine.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Usually, these effects are mild or moderate and often disappear after a short time.
Stop taking TRISSIL and go immediately to a doctor or hospital if you notice the following side effect:
Very rare (may affect up to 1 in 10,000 people)

• you have an allergic reaction. Signs may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue

Stop taking TRISSIL and contact your doctor immediately if you notice any of the following side effects – you may need urgent medical treatment:
Rare (may affect up to 1 in 1,000 people)

• watery diarrhoea, possibly with blood, sometimes accompanied by stomach cramps and high fever. This may be a sign of a serious bowel problem
• pain and inflammation of tendons or ligaments, which in some cases may rupture. The Achilles tendon is most commonly affected
• seizures

Very rare (may affect up to 1 in 10,000 people)

• burning, tingling, pain or numbness. These signs may indicate a condition called "neuropathy"

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

• severe skin rash that may include lesions or peeling of the skin around the lips, eyes, mouth, nose and genitals
• loss of appetite, yellowing of the skin and eyes, dark-coloured urine, itching or abdominal pain. These may be signs of liver problems, which may include fatal liver failure (liver failure that can lead to death)

If your vision becomes blurred or if you experience any eye discomfort while taking TRISSIL, consult an ophthalmologist immediately.
Inform your doctor if any of the following side effects worsen or last longer than a few days:
Common (may affect up to 1 in 10 people)

• difficulty sleeping
• headache, dizziness
• feeling unwell (nausea, vomiting) and diarrhoea
• increased levels of liver enzymes in the blood

Uncommon (may affect up to 1 in 100 people)

• changes in the number of other bacteria or fungi, fungal infection called Candida, which may require treatment
• changes in white blood cell count shown in blood test results (leucopenia, eosinophilia)
• feeling stressed (anxiety), confusion, nervousness, drowsiness, tremor, dizziness
• shortness of breath (dyspnoea)
• change in taste, loss of appetite, stomach discomfort or indigestion (dyspepsia), stomach pain, bloating (flatulence), constipation
• itching and skin rash, severe itching or hives, excessive sweating (hyperhidrosis)
• joint pain or muscle pain
• blood tests may show abnormal results due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
• generalised weakness

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

• bruising and increased bleeding tendency due to reduced platelet count in the blood (thrombocytopenia)
• low white blood cell count (neutropenia)
• exaggerated immune response (hypersensitivity)
• decreased blood sugar levels (hypoglycaemia). This is important for people with diabetes
• seeing or hearing things that are not there (hallucinations, paranoia), changes in thinking and second thoughts (psychotic reactions), possibly leading to suicidal ideation or suicide attempts
• feeling depressed, mental problems, feeling restless (agitation), abnormal dreams or nightmares
• tingling sensation in hands and feet (paraesthesia)
• hearing problems (tinnitus) or vision problems (blurred vision)
• unusually fast heartbeat (tachycardia) or low blood pressure (hypotension)
• muscle weakness. This is important for patients with myasthenia gravis (a rare nervous system disorder)
• changes in kidney function and occasional kidney failure, which may be caused by an allergic reaction affecting the kidneys called interstitial nephritis
• fever

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

• decrease in red blood cells (anaemia). This may lead to paleness or yellowish skin due to damage to red blood cells and a decrease in all types of blood cells (pancytopenia)
• fever, sore throat and a general feeling of illness that does not go away. This may be due to a decrease in white blood cells in the blood (agranulocytosis)
• lack of blood flow (anaphylactic shock)
• increased blood sugar levels (hyperglycaemia) or decreased blood sugar levels leading to coma (hypoglycaemic coma). This is important for people with diabetes
• change in smell, loss of smell or taste (parosmia, anosmia, ageusia)
• difficulty moving or walking (dyskinesia, extrapyramidal disorders)
• temporary loss of consciousness or posture (syncope)
• temporary loss of vision, eye inflammation
• worsening or loss of hearing
• unusually fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, changes in heartbeat (called "prolongation of the QT interval" seen on electrocardiogram, electrical activity of the heart)
• difficulty breathing or wheezing (bronchospasm)
• allergic reactions affecting the lungs
• pancreatitis
• inflammation of the liver (hepatitis)
• increased sensitivity of the skin to sunlight or ultraviolet rays (photosensitivity)
• inflammation of blood vessels throughout the body due to an allergic reaction (vasculitis)
• inflammation of the internal tissues of the mouth (stomatitis)
• muscle rupture and muscle breakdown (rhabdomyolysis)
• redness and swelling of joints (arthritis)
• pain, including back pain, chest pain and pain in the extremities
• attacks of porphyria in patients who already have porphyria (a very rare metabolic disorder)
• persistent headache with or without blurred vision (benign intracranial hypertension)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TRISSIL

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.
Do not dispose of any medicine 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 TRISSIL 250 mg film-coated tablets contains

• The active substance is levofloxacin. Each tablet contains 250 mg of levofloxacin.
• The excipients are: tablet core: microcrystalline cellulose, crospovidone, hypromellose, talc, magnesium stearate. Coating: hypromellose, titanium dioxide, macrogol 400, talc, yellow iron oxide, red iron oxide.

What TRISSIL 500 mg film-coated tablets contains

• The active substance is levofloxacin. Each tablet contains 500 mg of levofloxacin.
• The excipients are: tablet core: microcrystalline cellulose, crospovidone, hypromellose, talc, magnesium stearate. Coating: hypromellose, titanium dioxide, macrogol 400, talc, yellow iron oxide, red iron oxide.

Description of the appearance of TRISSIL and contents of the pack
TRISSIL 250 mg tablets
Pack size: 5 tablets.
TRISSIL 500 mg tablets
Pack size: 5 tablets.
Marketing Authorization Holder
PIAM Farmaceutici S.p.A. – Via Fieschi, 8 – 16121 Genoa, Italy
Manufacturer
PSI Supply nv Axxes Business Park, Guldensporenpark 22, Block C 9820 Merelbeke, Belgium
PharmaS d.o.o. - PharmaS Centre - Industrijska cesta 5 - Potok, Popovača – Croatia
Special Product's Line S.p.A. Fratta Rotonda Vado Largo, 1 – 03012 - Anagni (FR), Italy