Keraflx

PACKAGE LEAFLET: INFORMATION FOR THE USER

KERAFLOX 600 mg film-coated tablets

Prulifloxacin
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as 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 Keraflox is and what it is used for
2. What you need to know before taking Keraflox
3. How to take Keraflox
4. Possible side effects
5. How to store Keraflox
6. Contents of the pack and other information

1. What Keraflox is and what it is used for

Keraflox belongs to a group of antibiotics known as fluoroquinolones.
Keraflox is indicated for the treatment of infections caused by bacteria sensitive to prulifloxacin in the following conditions:

• Lower urinary tract infections (uncomplicated cystitis).
• Lower urinary tract infections associated with other medical urinary complications (complicated cystitis).
• Acute exacerbation of chronic bronchitis.
• Acute bacterial rhinosinusitis. The physician will diagnose and treat infectious rhinosinusitis in accordance with national and local guidelines on the management of infections. Keraflox may be used to treat infectious rhinosinusitis with symptoms lasting less than 4 weeks, and in cases where standard antibiotics cannot be used or have not been effective.

2. What you need to know before taking Keraflox

Do not take Keraflox:

• if you are allergic to prulifloxacin, to other fluoroquinolones, or to any of the other ingredients of this medicine (listed in section 6).
• if you have previously experienced tendon problems after taking other quinolones, such as tendon inflammation (tendinitis).
• if you are pregnant or breastfeeding.

Warnings and precautions
Before taking this medicine
You must not take quinolone/fluoroquinolone antibacterial medicines, including Keraflox, if in the past you have had any serious adverse reaction during treatment with a quinolone or fluoroquinolone. In such a case, inform your doctor as soon as possible.
Consult your doctor or pharmacist before taking Keraflox:

• Quinolone antibiotics may cause an increase above your normal blood sugar levels (hyperglycemia) or a decrease below your normal blood sugar levels, which in severe cases could potentially lead to loss of consciousness (hypoglycemic coma) (see section 4). This is particularly important for people with diabetes. If you have diabetes, your blood sugar levels must be closely monitored.
• If you have epilepsy or a condition that makes seizures (convulsions) more likely.
• Since changes in heart rhythm (observed on ECG, a recording of the heart's electrical activity) have been reported with other antibiotics belonging to the fluoroquinolone class, inform your doctor if you have a history of heart rhythm disorders. Keraflox has a very low potential to induce QT interval prolongation.
• If you are taking medicines to control your heart rhythm or medicines that may have cardiac effects, such as antidepressants or other antibiotics (see "Other medicines and Keraflox").
• If you have glucose-6-phosphate dehydrogenase (G6PD) enzyme deficiency, as this medicine may not be suitable.
• If you have liver or kidney problems.
• If you suffer from lactose intolerance, as this medicine contains lactose.
• If you have myasthenia gravis (muscle weakness).
• If you have been diagnosed with 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 have vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet’s syndrome, high blood pressure, or known atherosclerosis).

If you experience sudden pain in the abdomen, chest, or back, go immediately to the emergency room.
While taking this medicine
While taking antibiotics, including Keraflox, or even several weeks after stopping treatment, diarrhea may occur. If diarrhea worsens or persists, or if you notice blood or mucus in your stool, stop taking Keraflox immediately and consult your doctor.
Do not take medicines that block or slow intestinal movements.
Rarely, joint pain and swelling, or tendon inflammation or rupture, may occur. The risk is higher if you are elderly (over 60 years of age), if you have received an organ transplant, if you have kidney problems, or if you are being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and up to several months after stopping Keraflox.
At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop treatment with Keraflox, consult your doctor, and rest the affected area.
Avoid any unnecessary movement, as this could increase the risk of tendon rupture.
Immediately inform your doctor and stop treatment with Keraflox if, during treatment, you experience muscle pain, muscle weakness, or dark urine. The affected limb(s) must be kept at rest until examined by your doctor.
Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, particularly in the feet and legs or hands and arms, may occur. In such cases, stop treatment with Keraflox and inform your doctor immediately to prevent permanent nerve damage.
Serious, prolonged, disabling, and potentially irreversible side effects
Fluoroquinolone/quinolone antibacterial medicines, including Keraflox, have been associated with very rare but serious side effects, some of which may be prolonged (lasting months or years), disabling, or may not improve. These include tendon, muscle, and joint pain in the arms and legs, difficulty walking, unusual sensations such as pricking, tingling, itching, numbness, or burning (paresthesia), sensory organ disturbances such as changes in vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and severe sleep disturbances.
If you experience any of these side effects after taking Keraflox, consult your doctor immediately before continuing treatment. Your doctor will decide with you whether to continue treatment and may consider using an antibiotic from another class.
Since this medicine may cause the formation of tiny crystals in the urine, it is necessary to maintain a high fluid intake during treatment with Keraflox to prevent urine concentration.
During treatment with this medicine, avoid excessive exposure to sunlight, ultraviolet lamps, or sunbeds, as your skin may become more sensitive than normal. Stop treatment with this medicine and inform your doctor immediately if you experience severe sun reactions such as sunburn or peeling.
If your vision deteriorates or if your eyes are otherwise affected, consult an ophthalmologist immediately.
Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age due to safety concerns.
Other medicines and Keraflox
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Some medicines affect the action of Keraflox. Keraflox should be taken 2 hours before or at least 4 hours after taking these medicines.

• Medicines for indigestion, heartburn, or ulcers, such as cimetidine or antacids containing aluminium or magnesium.
• Medicines containing iron or calcium.

Keraflox, in turn, may affect the action of other medicines and increase the risk of side effects.
Inform your doctor if you are taking:

• Diabetes medicines.
• Medicines to control heart rhythm such as amiodarone, quinidine, or procainamide.
• Other antibiotics such as erythromycin, clarithromycin, or azithromycin.
• Medicines for depression such as amitriptyline, clomipramine, or imipramine.
• Probenecid, used to reduce uric acid in the blood.
• Fenbufen, used to relieve arthritis pain.
• Theophylline, used for asthma or breathing difficulties.
• Medicines to prevent blood clotting such as warfarin.
• Nicardipine, used in the treatment of angina (chest pain) or high blood pressure.
• Steroids such as prednisolone, used to treat allergic or inflammatory conditions.

Keraflox with food and drink
Food and milk can affect the action of Keraflox.
Keraflox should be taken between meals on an empty stomach and should not be taken with milk or milk products.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Keraflox may cause dizziness and confusion. If you experience any of these symptoms, do not drive or operate any dangerous tools or machinery.
Keraflox contains lactose
Keraflox contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Keraflox contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e., essentially ‘sodium-free’.

3. How to take Keraflox

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Keraflox tablets must be swallowed with water and taken between meals on an empty stomach. They must not be taken with milk or dairy products.
Keraflox is for adults only. The recommended dose is:

• For uncomplicated cystitis: one 600 mg tablet as a single dose.
• For complicated cystitis: one 600 mg tablet once daily for up to a maximum of 10 days of treatment.
• For acute exacerbation of chronic bronchitis: one 600 mg tablet once daily for up to a maximum of 10 days of treatment.
• For acute bacterial rhinosinusitis: one 600 mg tablet once daily for up to a maximum of 10 days of treatment. It is necessary to drink plenty of water during Keraflox treatment.

The duration of treatment depends on the severity of the infection and the patient's response to therapy. You must always complete the entire prescribed course of tablets, even if you start to feel better and symptoms disappear.
The tablet may be divided into equal parts.
If you take more Keraflox than you should
In case of overdose, contact your doctor immediately or go to the nearest hospital emergency department. The hospital doctor may need to perform a stomach emptying procedure. Always bring the packaging and the package leaflet with you, even if some of the

Keraflox or fewer tablets in the pack.

If you forget to take Keraflox
If you forget to take a dose, take it as soon as you remember, unless it is already time for the next dose.
Do not take a double dose to make up for the missed dose.
If you stop taking Keraflox
If you stop taking this medicine too early, the infection may come back.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Keraflox may cause side effects, although not everyone experiences them.
Immediately inform your doctor and stop taking Keraflox if you experience any
of the following symptoms after taking this medicine.
Although very rare, these symptoms may be serious.

• Sudden shortness of breath, difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching (especially affecting the entire body).
• Severe skin rash causing blisters on the skin and sometimes in the mouth and on the tongue. These could be symptoms of a condition known as Stevens-Johnson syndrome.
• Severe sun reactions such as sunburn or skin peeling.
• Symptoms of tendon inflammation such as swelling or pain in the affected limb. This most frequently affects the Achilles tendon and may lead to tendon rupture. The affected area should be kept at rest until examined by a doctor.
• Muscle pain, muscle weakness or dark urine.
• Severe episodes of watery diarrhoea, black-tarry or containing blood.
• Low blood sugar levels which may cause tremor and irritability.
• Numbness, loss of pain sensation.
• Skin redness and peeling (dermatitis).
• Formation of tiny crystals in the urine in the absence of symptoms.

Other possible side effects are:
Common side effects (affecting less than 1 in 10 people):

• abdominal pain.

Uncommon side effects (affecting less than 1 in 100 people):

• feeling unwell;
• diarrhoea, vomiting, stomach inflammation;
• headache, dizziness;
• itching or skin rash;
• loss of appetite.

Rare side effects (affecting less than 1 in 1,000 people):

• fever, hot flushes;
• altered taste;
• sleep disturbances, confusion or drowsiness;
• reduced hearing;
• redness and irritation of the eyes;
• stomach pain, flatulence, bloating, indigestion or heartburn, abnormal stools;
• irritation of the lips, tongue or mouth, or fungal infection (oral candidiasis);
• muscle spasms, muscle damage;
• dry and itchy skin (eczema), light sensitivity or development of red spots on the skin (urticaria);
• increased liver enzymes detectable in blood tests;
• feeling restless;
• mouth ulcer;
• widespread joint pain throughout the body;
• increased levels of albumin (protein) in the blood;
• increased levels of calcium in the blood;
• increased number of white blood cells.

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

• anaphylactic/anaphylactoid reactions including angioedema (symptoms of which may include lip swelling and facial swelling);
• dyspnoea;
• Stevens-Johnson syndrome;
• hypoglycaemia;
• hypoesthesia;
• paresthesia;
• tremor;
• drug-induced dermatitis;
• rhabdomyolysis;
• phototoxicity;
• tachycardia;
• pseudomembranous colitis;
• muscle weakness. This is important for patients suffering from myasthenia gravis (a rare disorder of the nervous system);
• loss of consciousness due to a severe drop in blood sugar levels (hypoglycaemic coma). See section 2.

Very rare cases of adverse drug reactions, prolonged (lasting for months or years) or permanent, such as
tendon inflammation, tendon rupture, joint pain, pain in arms or legs, difficulty walking, abnormal sensations such as pricking, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disturbances, memory impairment, and changes in hearing, vision, taste and smell, have been associated with the use of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.
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 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 Keraflox

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Store in the original container.
Do not use Keraflox after the expiry date stated on the packaging. The expiry date refers to the last day of the 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 Keraflox contains
The active substance is prulifloxacin.
Each film-coated tablet contains 600 mg of prulifloxacin.
The other components are: lactose monohydrate; microcrystalline cellulose; sodium croscarmellose; povidone;
anhydrous colloidal silica; magnesium stearate; hypromellose; propylene glycol; titanium dioxide (E171); talc;
iron oxide (E 172).

Description of the appearance of Keraflox and contents of the pack
Keraflox tablets are yellow, oblong, film-coated, with a central score line, and are available in cardboard packs containing a blister with 1, 2, or 5 tablets, or two blisters with 5 tablets each.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
EG S.p.A. Via Pavia, 6 - 20136 Milan – Italy

Marketing Authorization Holder's Representative
S.F. Group S.r.l. Via Tiburtina, 1143 – 00156 Rome, Italy

Manufacturer
A.C.R.A.F. S.p.A. - Via Vecchia del Pinocchio, 22-60131 Ancona - Italy.

This medicinal product is authorized in the European Economic Area Member States under the following
names:
Italy: KERAFLOX 600 mg film-coated tablets
Portugal: OLIFLOX 600 mg, film-coated tablets