Patient Information Leaflet

Moxinea, 400 mg, film-coated tablets
For adults
Moxifloxacinum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

What Moxinea is and what it is used for
Important information before taking Moxinea
How to take Moxinea
Possible side effects
How to store Moxinea
Contents of the pack and other information

1. What Moxinea is and what it is used for

Moxinea contains the active substance moxifloxacin, which belongs to a group of antibiotics known as fluoroquinolones. Moxifloxacin acts bactericidally against bacteria causing infections.
Moxifloxacin is used in patients aged 18 years and older for the treatment of the bacterial infections listed below, when caused by bacteria sensitive to moxifloxacin. Moxinea may be used to treat these infections only when commonly prescribed antibiotics are not suitable or have proven ineffective.

Sinusitis, acute exacerbation of chronic bronchitis, or community-acquired pneumonia (excluding severe cases).
Mild to moderate infections of the upper genital tract (pelvic inflammatory disease), including infections of the fallopian tubes and endometritis. Moxinea tablets alone are not sufficient to treat these types of infections; therefore, your doctor should prescribe an additional antibacterial agent for the treatment of upper female genital tract infections (see section: "2. Important information before taking Moxinea", "Warnings and precautions", "While taking Moxinea").

Moxinea may also be used to complete treatment if initial intravenous moxifloxacin has proven effective, in the following cases:

Community-acquired pneumonia,
Skin and soft tissue infections.
Moxinea should not be used as initial therapy for any skin and soft tissue infection or for severe pneumonia.

2. Important information before using Moxinea

In case of any doubts regarding whether the patient belongs to any of the groups listed below,
you should contact a doctor.
When not to use Moxinea:

If the patient is allergic to the active substance – moxifloxacin, to other drugs from the quinolone group, or to any of the excipients of Moxinea (see section “6. Contents of the pack and other information”),
During pregnancy and breastfeeding,
In patients under 18 years of age,
If the patient has previously experienced tendon disorders associated with treatment with other quinolone drugs (see sections: “When to exercise particular caution” and “4. Possible side effects”).
If the patient has:
congenital or acquired abnormalities in the ECG (electrocardiogram – recording of the heart's electrical activity),
electrolyte imbalance in the blood, especially low potassium or magnesium levels,
very slow heart rate (bradycardia),
impaired heart function (heart failure),
previously diagnosed heart rhythm disorders (arrhythmias), or
if the patient is taking medications that may cause specific changes in the ECG (see “Use of Moxinea with other medicines”). Moxinea may cause changes in the ECG, namely QT interval prolongation, which means delayed conduction of electrical signals in the heart,
if the patient has liver disease or liver enzyme activity (aminotransferases) exceeds five times the upper limit of normal.

Warnings and precautions
Before taking this medicine
Do not take antibacterial drugs containing fluoroquinolones/quinolones, including
Moxinea, if serious adverse reactions occurred during previous use of quinolones or fluoroquinolones. In such a case, inform your doctor as soon as possible.
Before taking Moxinea, consult your doctor:

If the patient has diabetes, as moxifloxacin may affect blood glucose levels.
If severe skin rash, skin peeling, blisters, and/or oral mucosal ulceration occurred after taking moxifloxacin.
If the patient has been diagnosed with enlargement of a large blood vessel (aortic aneurysm or large peripheral artery).
If the patient has previously experienced aortic dissection (tearing of the aortic wall).
If the patient has been diagnosed with heart valve insufficiency.
If there is a family history of aortic aneurysm or aortic dissection, or congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome or vascular Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease], or vascular diseases such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, or confirmed arterial atherosclerosis, rheumatoid arthritis [joint disease], or endocarditis [heart infection]). Moxinea may alter the ECG, especially in women and elderly patients. If the patient is taking medications that reduce potassium levels in the blood, consult a doctor before starting Moxinea (see sections: “When not to use Moxinea” and “Moxinea and other medicines”).
If the patient has epilepsy or conditions that may cause seizures, consult a doctor before starting Moxinea.
If the patient has or has previously had psychiatric disorders before starting Moxinea, consult a doctor.
If the patient has myasthenia gravis (muscle weakness and, in advanced cases, paralysis), taking Moxinea may worsen symptoms. If this occurs, contact a doctor immediately.
If the patient or someone in their family has glucose-6-phosphate dehydrogenase deficiency (a rare inherited disorder), inform the doctor, who will assess whether Moxinea is appropriate.
If a female patient has a complicated upper genital tract infection (e.g. tubo-ovarian abscess or pelvic abscess), the doctor may consider intravenous administration necessary, as oral Moxinea tablets are not suitable.
For treatment of mild to moderate upper genital tract infections, the doctor should prescribe an additional antibacterial agent alongside Moxinea. If symptoms do not begin to improve within the first 3 days of treatment, the patient should consult a doctor.

While taking Moxinea
If palpitations or irregular heartbeat occur during treatment with Moxinea, contact a doctor immediately. The doctor may decide to perform an ECG.

If sudden, severe abdominal, back, or chest pain occurs, which may indicate aortic aneurysm or dissection, seek emergency medical attention immediately. The risk of these events may be higher in patients receiving systemic corticosteroids.
If sudden shortness of breath occurs, especially when lying down, or if swelling of the ankles, feet, or abdomen is observed, or palpitations (sensation of rapid or irregular heartbeat) develop, seek medical advice without delay.

The risk of cardiac dysfunction may increase with higher doses. Therefore, the recommended dosage must be strictly followed.
There is a small risk of severe, sudden allergic reaction (anaphylactic reaction or anaphylactic shock), even after the first dose, with symptoms such as chest tightness, dizziness, nausea or fainting, and dizziness upon standing. If these occur, stop taking Moxinea immediately and seek medical advice.
Moxinea may cause severe, rapidly progressing hepatitis, which may lead to life-threatening liver failure (including death; see section “4. Possible side effects”).
Contact a doctor before continuing treatment if symptoms such as sudden worsening of general health and/or condition associated with yellowing of the whites of the eyes, dark urine, skin itching, tendency to bleed, or brain dysfunction due to liver disease (symptoms of impaired liver function or rapidly progressive, severe hepatitis) occur.
Severe skin reactions have been reported during moxifloxacin treatment, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP).

SJS/TEN may initially present as red, target-like or circular spots, often with central blisters, on the trunk. Oral, throat, nasal, genital, or ocular ulcers (red, swollen eyes) may also occur. These serious rashes are often preceded by fever and/or flu-like symptoms. The rashes may lead to extensive skin shedding and life-threatening complications or death.
AGEP appears early in treatment as a widespread, red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Most common locations: skin folds, trunk, and upper limbs.

If a severe rash or any of these skin symptoms occur, stop taking moxifloxacin and contact a doctor or seek immediate medical help.
Quinolones, including Moxinea, may cause seizures. If seizures occur, stop taking Moxinea and contact a doctor.
Rarely, nerve damage symptoms (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 Moxinea and inform the doctor immediately to prevent potentially irreversible damage.
Psychiatric disturbances may occur even with the first dose of quinolone antibiotics, including Moxinea. In very rare cases, depression or other psychiatric disorders leading to suicidal thoughts, self-harm behaviors, or suicide attempts may occur (see section “4. Possible side effects”). If such symptoms occur, contact a doctor immediately before continuing treatment.
Diarrhea may occur during or after treatment with antibiotics, including Moxinea. If severe or persistent diarrhea occurs, or blood or mucus is observed in the stool, stop taking Moxinea immediately and consult a doctor. In such cases, do not use medications that inhibit or slow intestinal motility (peristalsis).
Joint pain, inflammation, or tendon rupture may rarely occur. Risk is increased if the patient is elderly (over 60 years), has undergone organ transplantation, has kidney problems, or is being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment or even several months after stopping Moxinea. At the first sign of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder, or knee), stop taking Moxinea, contact a doctor, and rest the affected limb. Avoid unnecessary exercise, as it may increase the risk of tendon rupture.
Elderly patients with kidney dysfunction should drink plenty of fluids, as dehydration may increase the risk of kidney failure.
If vision deteriorates or other visual disturbances occur during treatment with Moxinea, seek immediate advice from an ophthalmologist (see section “Driving and operating machinery” and section “4. Possible side effects”).
Fluoroquinolone antibiotics may affect blood glucose levels, causing both decreased levels below normal (hypoglycemia) and increased levels above normal (hyperglycemia), potentially leading to loss of consciousness (hypoglycemic coma) in severe cases (see section “4. Possible side effects”). If you have diabetes, monitor your blood glucose levels closely.
Blood glucose disturbances in patients treated with Moxinea occur primarily in elderly patients taking oral antidiabetic drugs that lower blood glucose (e.g. sulfonylureas) or insulin. Loss of consciousness due to significant decrease in blood glucose (hypoglycemic coma) has been reported. Blood glucose levels should be monitored in diabetic patients (see section “4. Possible side effects”).
Quinolone antibiotics may increase skin sensitivity to sunlight and UV radiation. During treatment with Moxinea, avoid prolonged sun exposure, intense sunlight, and using tanning beds or other UV sources.
The efficacy of Moxinea (infusion solution) in treating severe burns, deep tissue infections, “diabetic foot” infections, or osteomyelitis has not been established.
Long-term, disabling, and potentially irreversible serious adverse effects
Fluoroquinolone/quinolone antibacterial drugs, including Moxinea, are associated with very rare but serious adverse effects, some of which are long-lasting (lasting months or years), causing disability or potentially irreversible damage. These include tendon disorders, muscle and joint pain in the upper and lower limbs, difficulty walking, sensory disturbances such as pins and needles, tingling, tickling, numbness, or burning (paresthesia), sensory disturbances including impaired vision, taste, and smell, hearing problems, depression, memory disturbances, severe fatigue, and severe sleep disturbances.
If any of these adverse effects occur after taking Moxinea, contact a doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, possibly considering an antibiotic from another class.
Children and adolescents
Moxinea should not be given to children or adolescents under 18 years of age, as the efficacy of Moxinea has not been established in this age group.
Moxinea and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use.
When taking Moxinea, be aware that:
The risk of cardiac rhythm disturbances increases when Moxinea is used with other drugs affecting heart function. Therefore, do not take Moxinea simultaneously with the following medicines:

drugs belonging to the antiarrhythmic group (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide),
neuroleptics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sulpiride),
tricyclic antidepressants,
certain antibacterial drugs (e.g. sparfloxacin, intravenous erythromycin, pentamidine, antimalarials, particularly halofantrine),
certain antihistamines (e.g. terfenadine, astemizole, mizolastine),
other drugs (e.g. cisapride, intravenous vinpocetine, bepridil, difemanil).

Inform your doctor if the patient is taking other medicines that may reduce potassium levels in the blood (e.g. certain diuretics, laxatives and enemas (high doses), or corticosteroids (anti-inflammatory drugs), amphotericin B) or slow heart rate, as they may increase the risk of severe arrhythmias when used with Moxinea.
All medicines containing magnesium or aluminium, such as antacids used for digestive disorders, and all medicines containing iron or zinc, or didanosine, or any medicine containing sucralfate (used for gastric disorders) may reduce the effectiveness of Moxinea tablets. Therefore, a 6-hour interval should be maintained between taking Moxinea tablets and other medicines.
Concomitant administration of activated charcoal and Moxinea tablets reduces the effect of Moxinea. Therefore, simultaneous use of both medicines is not recommended.
If taking drugs that reduce blood coagulation (oral anticoagulants such as warfarin), the doctor may order blood clotting time tests.
Taking Moxinea with food and drink
Moxinea may be taken with or without food, including dairy products.
Pregnancy, breastfeeding, and fertility
Do not use Moxinea during pregnancy or breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Animal studies have not shown harmful effects of this medicine on fertility.
Driving and operating machinery
Moxinea may cause dizziness and lightheadedness, as well as sudden, transient loss of vision or brief fainting. If such symptoms occur, do not drive or operate machinery.
Moxinea contains colourants: sunset yellow (E110), lake, carmine red (E124), lake, which may cause allergic reactions.
Moxinea contains sodium.
This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, i.e. essentially “sodium-free”.

3. How to take Moxinea

Moxinea should always be taken as prescribed by your doctor. If you have any doubts,
you should contact your doctor or pharmacist again.
The usual dose for adults is one 400 mg coated tablet once daily.
Moxinea tablets are taken orally. The tablet should be swallowed whole (to avoid the bitter
taste) with plenty of fluid. Moxinea may be taken regardless of meals.
It is recommended to take Moxinea at the same time each day.
Dose adjustment is not necessary in elderly patients, patients with low body weight,
or patients with renal function impairment.
The duration of treatment depends on the type of infection. Unless otherwise directed by your doctor,
the recommended duration of treatment with Moxinea is:

Acute exacerbation of chronic bronchitis: 5 to 10 days.
Community-acquired pneumonia, excluding severe cases: 10 days.
Acute bacterial sinusitis: 7 days.
Mild to moderate upper genital tract infections (pelvic inflammatory disease), including salpingitis and endometritis: 14 days.

Below is the recommended total treatment duration for patients in whom Moxinea in the form of
coated tablets is used to complete treatment initiated with moxifloxacin as an infusion solution.

Community-acquired pneumonia: 7–14 days. Most patients with community-acquired pneumonia switch to oral moxifloxacin treatment within 4 days.
Skin and soft tissue infections: 7–21 days. Most patients with skin and soft tissue infections switch to oral moxifloxacin treatment within 6 days.

It is important to complete the full course of treatment, even if you start feeling better after a few days.
Premature discontinuation of the medication may result in incomplete eradication of the infection,
relapse of the disease, worsening of symptoms, or development of bacterial resistance to antibiotics.
Do not exceed the recommended dose or prolong the duration of treatment (see section "2. Important information before using Moxinea", "While taking Moxinea").
Taking more Moxinea than prescribed
If more than the prescribed number of tablets is taken in one day, seek immediate medical help.
If possible, bring any remaining tablets, the packaging, and this patient information leaflet
to show the doctor or pharmacist.
Missing a dose of Moxinea
If a patient forgets to take the tablet at the usual time, they should take it as soon as they remember,
on the same day. If a dose is missed for one day, the patient should take the usual dose (one tablet)
the next day.
Do not take a double dose to make up for a missed dose.
If you have any doubts about how to take this medicine, consult your doctor or pharmacist.
Stopping Moxinea treatment prematurely
If treatment is stopped too early, the infection may not be completely cured.
If early discontinuation of treatment is necessary, consult your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, Moxinea may cause adverse effects, although not everyone experiences them.
The most serious adverse effects observed during treatment with Moxinea are listed below:
If any of the following adverse effects occur:

irregularly rapid heartbeat (rare adverse effect),
rapid deterioration in general condition, yellowing of the whites of the eyes, dark urine, skin itching, tendency to bleeding, or feeling of weakness [these may be symptoms of fulminant hepatitis threatening life due to liver failure (very rare adverse effect observed in a few cases)],
severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear as red, target-like spots or round lesions, often with central blisters on the trunk, skin peeling, ulcers in the mouth, throat, nose, genital organs and eyes, and may be preceded by fever and flu-like symptoms (very rare adverse effects, potentially life-threatening), a red, peeling widespread rash with subcutaneous nodules and blisters accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis) (frequency of this adverse effect is "unknown"),
syndrome associated with impaired water excretion and low sodium levels (SIADH) (very rare adverse effect),
loss of consciousness due to significantly reduced blood glucose levels (hypoglycaemic coma) (very rare adverse effect),
inflammation of blood vessels (usually presenting as red spots on the skin, most commonly on the lower legs, or joint pain) (very rare adverse effect),
severe, rapidly spreading allergic reaction, including very rarely life-threatening anaphylactic shock (e.g. breathing difficulties, drop in blood pressure, rapid pulse) (rare adverse effect),
swelling, including swelling of the airways (rare adverse effect, potentially life-threatening),
seizures (rare adverse effect),
nervous system disorders such as pain, burning sensation, tingling, numbness, and (or) weakness in the limbs (rare adverse effect),
depression (very rarely leading to self-harm, e.g. hallucinations, suicidal thoughts or suicide attempts) (rare adverse effect),
psychiatric disorders (potentially leading to self-harm, e.g. hallucinations, suicidal thoughts or suicide attempts) (very rare adverse effect),
severe diarrhoea with blood and (or) mucus (antibiotic-associated colitis, including pseudomembranous colitis), which may in very rare cases be life-threatening (rare adverse effect),
tendon pain and swelling (tendinitis) (rare adverse effect) or tendon rupture (very rare adverse effect),
muscle weakness, tenderness or pain, especially if the patient also feels unwell, has fever or dark urine. These may be caused by abnormal muscle breakdown, which may be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (frequency of this adverse effect is "unknown").

Treatment with Moxinea should be stopped immediately and medical advice sought, as immediate medical intervention may be necessary.
Additionally, if

transient loss of vision (very rare adverse effect) occurs, contact an ophthalmologist immediately.

If, during treatment with Moxinea, irregular heart rhythm, irregular heartbeat (torsade de pointes), or cardiac arrest (very rare adverse effect) occurs, contact a doctor immediately and discontinue treatment with Moxinea.
Muscle fatigue has very rarely been reported; if this occurs, contact a doctor immediately.
In patients with diabetes, if changes in blood glucose levels are observed (rare or very rare adverse effect), contact a doctor immediately.
If an elderly patient with impaired kidney function develops reduced urine volume, swelling of the feet, ankles or legs, nausea, drowsiness, shortness of breath or confusion (these may be objective and subjective symptoms of kidney failure; rare adverse effect), seek immediate medical advice.

Other adverse effects observed during treatment with Moxinea, listed below with their probable frequency, include:
Common (may affect up to 1 in 10 people):

nausea,
diarrhoea,
dizziness,
stomach and abdominal pain,
vomiting,
headache,
increased liver enzyme activity (aminotransferases) in blood,
infections with resistant bacteria or fungi, e.g. Candida fungal infection,
changes in heart rhythm (ECG) in patients with low blood potassium levels.

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

rash,
stomach upset (dyspepsia/heartburn),
taste disturbances (very rarely loss of taste),
sleep disorders (insomnia),
increased liver enzyme activity in blood (gamma-glutamyl transferase and (or) alkaline phosphatase),
decreased number of white blood cells (leukocytes, neutrophils),
constipation,
itching,
vertigo (spinning or falling sensation),
insomnia,
flatulence,
heart rhythm disturbances (ECG),
liver function disorders (including increased activity of the liver enzyme lactate dehydrogenase (LDH)),
decreased appetite and food intake,
decreased number of white blood cells,
back, chest, pelvic and limb pain,
increased number of blood platelets necessary for blood clotting,
excessive sweating,
increased number of white blood cells (eosinophils) in blood,
restlessness,
malaise (especially weakness or fatigue),
tremor,
joint pain,
palpitations,
irregular and rapid heartbeat,
breathing difficulties (including asthma attacks),
increased blood activity of a digestive enzyme called amylase,
restlessness, agitation,
tingling (pins and needles) and (or) numbness,
skin urticaria,
vasodilation,
confusion, disorientation,
decreased number of blood platelets necessary for clotting,
vision disturbances, including double and blurred vision,
reduced blood coagulability,
increased blood lipid levels,
decreased number of red blood cells,
muscle pain,
allergic reactions,
increased blood bilirubin levels,
gastritis,
dehydration,
severe heart rhythm disturbances,
dry skin,
angina pectoris.

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

muscle tremor,
muscle cramps,
hallucinations,
high blood pressure,
oedema (hands, feet, ankles, lips, mouth, larynx),
low blood pressure,
kidney function impairment (including increased values in diagnostic tests for kidney function, such as urea and creatinine levels),
hepatitis,
oral infections,
tinnitus,
jaundice (yellowing of eyes or skin),
skin sensory disturbances,
unusual dreams,
impaired concentration,
difficulty swallowing,
smell disturbances (including loss of smell),
balance disturbances and poor motor coordination (due to dizziness),
partial or complete memory loss,
hearing disturbances, including deafness (usually transient),
increased blood uric acid levels,
emotional lability,
speech disorders,
fainting,
muscle weakness.

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

arthritis,
heart rhythm disturbances,
increased skin sensory sensitivity,
depersonalization (feeling of loss of self-identity),
increased blood coagulation,
muscle stiffness,
significant decrease in white blood cells (agranulocytosis),
decreased number of red and white blood cells and platelets (pancytopenia).

Additionally, during treatment with Moxinea, the following adverse effects, described after treatment with other quinolone antibiotics, have very rarely occurred: increased blood sodium levels, increased blood calcium levels, decreased number of certain types of red blood cells (haemolytic anaemia), muscle reactions with damage to muscle cells, increased skin sensitivity to sunlight and UV radiation.
Very rare cases of long-term (up to months or years) or permanent adverse effects of the drug, such as tendon inflammation, tendon rupture, joint pain, limb pain, walking difficulties, sensory disturbances such as pins and needles, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disturbances, memory disturbances, as well as impaired hearing, vision, taste and smell, have been associated with quinolone and fluoroquinolone antibiotics; in some cases, regardless of pre-existing risk factors.
In patients receiving fluoroquinolones, cases of aortic aneurysm and dissection (dilatation and weakening or rupture of the arterial wall) have been reported, which may result in rupture and lead to death, as well as cases of heart valve regurgitation. See also section 2.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw,
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to gather more information on the safety of the medicine.

5. How to store Moxinea

Keep this medicine out of the sight and reach of children.
Do not use Moxinea after the expiry date stated on the carton and blister pack "Expiry date (EXP)". The expiry date refers to the last day of that month.
Moxinea does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Moxinea contains

The active substance is moxifloxacin in the form of moxifloxacin hydrochloride.

Each coated tablet contains 436.8 mg of moxifloxacin hydrochloride, equivalent to 400 mg of moxifloxacin.
The other ingredients are:

Tablet core: Mannitol, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
Coating: Polyvinyl alcohol, macrogol 4000, titanium dioxide (E 171), talc, sunset yellow (E 110), lake, carmine red (E 124), lake, indigo carmine (E 132).

What Moxinea looks like and contents of the pack
Dark red, coated, elongated, convex-shaped tablets with the imprint "MOXI" on one side and "400" on the other.
The coated tablets are available in PVC/PVDC/Aluminium blisters, packed in cardboard boxes containing 5, 7, 10 or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
SOLINEA Sp. z o.o. Sp. K.
Elizówka 65
Hala I
21-003 Ciecierzyn
Poland
Manufacturer
Bluepharma - Indústria Farmacêutica, S.A.
S. Martinho do Bispo
3045-016 Coimbra
Portugal
08-06-2017
Date of the latest revision of the leaflet:
10-09-2021