Chinoplus

PACKAGE LEAFLET: INFORMATION FOR THE USER

CHINOPLUS

600 mg film-coated tablets
Prulifloxacin
Please read all of 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, ask 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 Chinoplus is and what it is used for
2. What you need to know before taking Chinoplus
3. How to take Chinoplus
4. Possible side effects
5. How to store Chinoplus
6. Contents of the pack and other information

1. What Chinoplus is and what it is used for

Chinoplus belongs to a group of antibiotics known as fluoroquinolones.
Chinoplus 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. Chinoplus 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 been ineffective.

2. What you need to know before taking Chinoplus

Do not take Chinoplus:

• 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 using other quinolones, such as tendon inflammation (tendinitis).
• if you are pregnant or breastfeeding.

Warnings and precautions
Before taking this medicine
Do not take quinolone/fluoroquinolone antibacterial medicines, including Chinoplus, if you have
previously had any serious adverse reaction during treatment with a quinolone or fluoroquinolone. In
such cases, inform your doctor as soon as possible.
Talk to your doctor or pharmacist before taking Chinoplus:

• Quinolone antibiotics may cause an increase above your normal blood sugar levels (hyperglycaemia) or a decrease below your normal blood sugar levels, which in severe cases could potentially lead to loss of consciousness (hypoglycaemic 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. Chinoplus has a very low potential for inducing 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 “Taking Chinoplus with other medicines”)
• if you have reduced activity of glucose-6-phosphate dehydrogenase (G6PD), as this medicine may not be suitable
• if you have liver or kidney problems
• if you are lactose intolerant, 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 been diagnosed with insufficiency of one of the heart valves (aortic or mitral regurgitation)
• if you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's disease, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease], or endocarditis [inflammation of the heart]).

While taking this medicine
During treatment with antibiotics, including Chinoplus, or even several weeks after stopping treatment,
diarrhoea may occur. If diarrhoea worsens or persists, or if you notice blood or mucus in your stools,
stop taking Chinoplus 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), have received an organ transplant, have kidney problems, or are
taking corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment
and up to several months after stopping Chinoplus. At the first sign of tendon pain or inflammation (e.g.
in the ankle, wrist, elbow, shoulder, or knee), stop taking Chinoplus, consult your doctor, and rest the
affected area. Avoid unnecessary movement, as this may increase the risk of tendon rupture.
Contact your doctor immediately and stop treatment with Chinoplus if, during treatment, you
experience muscle pain, muscle weakness, or dark urine.
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 taking
Chinoplus and contact your doctor immediately to prevent permanent nerve damage.
If you experience sudden, severe abdominal, chest, or back pain, which may be a sign of aortic
aneurysm or dissection, seek emergency medical attention immediately. The risk may be higher if you
are taking systemic corticosteroid medicines.
Contact your doctor immediately if you notice a sudden onset of shortness of breath, especially when
lying down, or swelling of the ankles, feet, or abdomen, or new episodes of palpitations (sensation of
rapid or irregular heartbeat).
Serious, prolonged, disabling, and potentially irreversible side effects
Fluoroquinolone/quinolone antibacterial medicines, including Chinoplus, 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, abnormal sensations such as pricking, tingling, itching, numbness, or burning (paraesthesia),
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 Chinoplus, contact your doctor immediately
before continuing treatment. Your doctor will decide, together 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 Chinoplus to prevent concentrated urine.
During treatment with this medicine, avoid excessive exposure to sunlight, ultraviolet lamps, or sunbeds,
as your skin may become more sensitive than normal.
Stop taking this medicine and contact your doctor immediately if you experience severe sun reactions
such as sunburn or peeling.
If your vision deteriorates or your eyes become 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 Chinoplus
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine.
Some medicines affect the action of Chinoplus. Chinoplus must 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

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

• Medicines for diabetes
• 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 to reduce uric acid in the blood
• Fenbufen to relieve arthritis pain
• Theophylline for asthma or breathing difficulties
• Medicines to prevent blood clotting such as warfarin
• Nicardipine used to treat angina (chest pain) or high blood pressure
• Steroids such as prednisolone, used to treat allergic or inflammatory conditions

Chinoplus with food and drink
Food and milk may affect the action of Chinoplus.
Chinoplus should be taken between meals on an empty stomach and should not be taken with milk or
dairy products.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Chinoplus may cause dizziness and confusion. If you experience any of these symptoms, do not drive or
operate any dangerous tools or machinery.
Chinoplus contains lactose
Chinoplus contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to
certain sugars, contact them before taking this medicine.
Chinoplus 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 Chinoplus

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Chinoplus tablets should be swallowed with water and taken between meals on an empty stomach. They must not be taken with milk or milk products.
Chinoplus 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.

You should drink plenty of water while taking Chinoplus.
The duration of treatment depends on the severity of the infection and the patient's response to therapy. You must always complete the entire course of tablets prescribed to you, even if you start to feel better and symptoms disappear.
The tablet may be divided into equal parts.
If you take more Chinoplus 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 take the packaging and the patient information leaflet with you, whether or not any Chinoplus remains in the pack.
If you forget to take Chinoplus
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 Chinoplus
If you stop taking this medicine too early, the infection may return.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Chinoplus can cause side effects, although not everyone gets them.
Immediately inform your doctor and stop treatment with Chinoplus if you experience any of the following symptoms after taking this medicine. Although very rare, these symptoms can 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 leading to blistering of the skin and sometimes inside the mouth and on the tongue. These could be symptoms of a condition known as Stevens-Johnson syndrome.
• Severe sunburn-like reactions such as sunburn or peeling skin.
• Symptoms of tendon inflammation such as swelling or pain in the affected limb. This most commonly affects the Achilles tendon and may even 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 bloody stools.
• Low blood sugar levels which may cause tremor and irritability.
• Numbness, loss of pain sensation.
• Redness and peeling of the skin (dermatitis).
• Formation of tiny crystals in the urine without 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
• Taste disturbances
• Sleep disorders, confusion or drowsiness
• Hearing loss
• 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), increased sensitivity to light, or development of red spots on the skin (urticaria)
• Increased liver enzymes detectable in blood tests
• Restlessness
• Mouth ulcers
• Widespread joint pain throughout the body
• Increased levels of albumin (protein) in the blood
• Increased blood calcium levels
• 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 prolonged (lasting for months or years) or permanent adverse drug reactions, 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), fatigue, impaired memory and concentration, mental health effects (which may include sleep disturbances, anxiety, panic attacks, depression and suicidal thoughts), 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.
Cases of aortic wall dilation and weakening or aortic wall tear (aneurysms and dissections), with possible rupture that may lead to death, as well as cases of blood regurgitation from heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may 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 Chinoplus

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 Chinoplus 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 no longer required. This will help protect the environment.

6. Package contents and other information

What Chinoplus contains

• The active substance is prulifloxacin. Each film-coated tablet contains 600 mg of prulifloxacin.
• The other components are: monohydrate lactose; microcrystalline cellulose; sodium croscarmellose; povidone; anhydrous colloidal silica; magnesium stearate; hypromellose; propylene glycol; titanium dioxide (E171); talc; iron oxide (E172).

Description of the appearance of Chinoplus and contents of the pack
Chinoplus tablets are yellow, oblong, film-coated tablets with a central score line.
They are available in cardboard packages containing a blister with 1, 2, 5 tablets or two blisters with 5 tablets each.
Not all pack sizes may be marketed.

Marketing Authorization Holder
SPA - Società Prodotti Antibiotici S.p.A.
Via Biella 8 - 20143 - Milan - 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 countries with the following names:
Italy: CHINOPLUS 600 mg film-coated tablets
Portugal: OLIFLOX, 600 mg, film-coated tablets
Greece: GLIMBAX 600 mg δισκία επικαλυμμένα με υμένιο