PACKAGE LEAFLET: INFORMATION FOR THE USER

MONOS “200 mg film-coated tablets”

Rufloxacin
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, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What MONOS is and what it is used for
What you need to know before taking MONOS
How to take MONOS
Possible side effects
How to store MONOS
Contents of the pack and other information

1. What MONOS is and what it is used for

MONOS contains the active substance Rufloxacin.
Rufloxacin is an antibiotic belonging to the class of fluoroquinolones, antibiotics that act against certain types of germs.
MONOS is indicated for the treatment of acute infection in the case of a respiratory tract disease called chronic obstructive bronchopneumopathy, which includes chronic bronchitis, and for the treatment of acute bladder infection (uncomplicated acute cystitis).

2. What you should know before taking MONOS

Do not use MONOS

If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
If you are allergic (hypersensitive) to any other medicine in the quinolone class
If you suffer from seizures or have previously experienced episodes of convulsions: in this case, taking any medicine of the fluoroquinolone class is contraindicated
If you have previously experienced tendon damage after taking a medicine of the quinolone class
If you are pregnant or breastfeeding
If the patient to be treated is a child or a young person with incomplete skeletal development.

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

If you have previously had tendon disorders (tendinopathies) due to taking fluoroquinolone medicines.
If you have severe kidney problems (renal insufficiency), as MONOS, like other fluoroquinolones, is mainly eliminated via the kidneys.
If you have severe liver problems (hepatic damage).
If you have nervous system disorders (alterations of the central nervous system).
If you have heart conditions (cardiac disorders) or have previously had cardiac rhythm disturbances.
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 been diagnosed with insufficiency of one of the heart valves (aortic and 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, Behçet's disease, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease], or endocarditis [inflammation of the heart]).
If you experience sudden pain in the abdomen, chest, or back, go immediately to the emergency room.

Rarely, joint pain and swelling, and inflammation or rupture of tendons 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 being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and up to several months after stopping treatment with MONOS. At the first signs of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop treatment with MONOS, consult your doctor, and keep the affected area at rest. Avoid any unnecessary movement, as the risk of tendon rupture may increase.

Rarely, symptoms of nerve damage (neuropathy) may occur, such as pain, burning, tingling, numbness, and/or weakness, particularly in the feet and legs or hands and arms. In such cases, stop treatment with MONOS and inform your doctor immediately to prevent permanent nerve damage.

Stop treatment with MONOS and inform your doctor immediately:

if you develop severe and persistent diarrhea during or after treatment, as this may indicate a serious intestinal inflammation (pseudomembranous colitis).

Serious, prolonged, disabling, and potentially irreversible side effects.
Fluoroquinolone/quinolone antibacterial medicines, including MONOS, have been associated with very rare but serious side effects, some of which may be prolonged (lasting months or years), disabling, or may not resolve. These include tendon, muscle, and joint pain in arms and legs, difficulty walking, abnormal sensations such as pricking, tingling, tickling, numbness, or burning (paresthesia), sensory organ disorders 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 MONOS, consult 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.

During treatment with MONOS:

if you experience sudden, severe pain in the abdomen, chest, or back, which may be a sign of aortic aneurysm or dissection, go immediately to the emergency room. The risk may be higher if you are taking systemic corticosteroid medicines.
Inform your doctor immediately if you notice a rapid 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).

Exercise particular caution in the following cases
During treatment with MONOS, avoid direct sunlight or UVA radiation (tanning beds), as skin damage (photosensitivity reaction) may occur.
Prolonged use of this product, as with other antibiotics, may promote the growth of microorganisms not sensitive to MONOS, including fungi: in such cases, consult your doctor for advice on appropriate therapy.
If your vision deteriorates or you develop sudden eye problems, consult an ophthalmologist immediately.

Children and adolescents
There are no safety data on the use of MONOS in children and adolescents under 18 years of age. Since damage to joints (articular cartilage) cannot be ruled out, MONOS must not be administered to pediatric patients or to young individuals with incomplete bone formation (skeletal development).

Elderly
MONOS should be used with caution in elderly patients.

Other medicines and MONOS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines:

Medicines for gastric acidity (antacids) containing aluminium or magnesium hydroxide: these medicines reduce the absorption of the drug. To minimize this effect, it is recommended that they be taken at least 4 hours before or after MONOS
Non-steroidal anti-inflammatory drugs (NSAIDs).

MONOS with food and drinks
MONOS does not affect the elimination of caffeine; however, in sensitive individuals, it is advisable to reduce consumption of substances containing theophylline and its derivatives (such as tea and coffee) and to consult your doctor for possible blood tests to monitor the concentration of these substances.

Pregnancy and breastfeeding
Since safety has not been established, and particularly because damage to joints (articular cartilage) in developing organisms cannot be excluded, MONOS must not be administered to pregnant women or during breastfeeding.

Driving and using machines
MONOS may affect reaction capacity, even when used at normal dosage, thereby affecting the ability to drive cars or operate machinery.

MONOS contains LACTOSE
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take MONOS

Take this medicine exactly as directed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Dosage, method and duration of administration
Due to its characteristics, MONOS must be taken as a single daily dose.
The recommended dose is 2 tablets taken together on the first day, followed by one tablet per day
on subsequent days.
The duration of treatment should be adjusted according to the severity and course of the disease:
generally, 5 to 10 days of therapy are sufficient.
For the treatment of uncomplicated cystitis, a single dose of 400 mg of MONOS (2 tablets taken together at once) is sufficient.
If you have kidney or liver function problems, your doctor will determine whether the dose needs to be adjusted.
If you take more MONOS than you should
If you have taken more MONOS than prescribed, contact your doctor immediately.
If you forget to take MONOS
Do not take a double dose to make up for a forgotten tablet.
If you stop taking MONOS
Consult your doctor before stopping the treatment.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them. The most frequently observed side effects in clinical studies were:

stomach pain (epigastralgia), nausea, heartburn (pyrosis), difficulty digesting (dyspepsia), diarrhoea, vomiting
headache (cephalalgia), agitation, anxiety, dizziness, insomnia, tremors, fatigue
skin reactions (rash, urticaria, erythema, eruptions) and itching
severe allergic reactions (anaphylactoid reactions), characterized by swelling (edema) of the tongue, swelling (edema) of the glottis, difficulty breathing (dyspnea), severe drop in blood pressure (arterial hypotension up to shock).

Less frequently observed side effects include:
dry mouth, intestinal gas formation (flatulence), loss of sensation in part of the body with tingling (paresthesia), confusion, hallucinations, ringing in the ears (tinnitus), sweating, muscle pain, and skin sensitivity to sunlight (photosensitization).
Very rare cases of prolonged (lasting months or years) or permanent adverse reactions to the drug, such as tendon inflammation, tendon rupture, joint pain, pain in arms or legs, difficulty walking, abnormal sensations such as prickling, tingling, tickling, burning, numbness or pain (neuropathy), fatigue, memory and concentration impairment, effects on mental health (which may include sleep disturbances, anxiety, panic attacks, depression and suicidal thoughts), and disturbances 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, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website:
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 MONOS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the product stored in its original intact packaging and properly stored.
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 MONOS contains
The active substance is Rufloxacin hydrochloride 200 mg.
The other excipients are: microcrystalline cellulose, maize starch, lactose monohydrate,
sodium croscarmellose, pregelatinized maize starch, magnesium stearate, hypromellose, titanium
dioxide, macrogol 400.
Description of the appearance of MONOS and pack contents
Carton pack containing 6 film-coated tablets of 200 mg.
MARKETING AUTHORISATION HOLDER
LANOVA FARMACEUTICI S.r.l. – Via Conca D’Oro, 212 – 00141 Rome
MANUFACTURER
SPECIAL PRODUCT'S LINE S.P.A
Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)