Moxinea

Package Leaflet: Information for the User

Moxinea, 400 mg, Film-Coated Tablets

For Adults
Moxifloxacin

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Moxinea and What is it Used For
• 2. Important Information Before Taking Moxinea
• 3. How to Take Moxinea
• 4. Possible Side Effects
• 5. How to Store Moxinea
• 6. Contents of the Pack and Other Information

1. What is Moxinea and What is it Used For

Moxinea contains the active substance moxifloxacin, which belongs to a group of antibiotics called fluoroquinolones. Moxinea has a bactericidal effect on bacteria that cause infections.
Moxifloxacin is used in patients aged 18 and older to treat the following bacterial infections, if they are caused by bacteria susceptible to moxifloxacin. Moxinea can only be used to treat these infections if the use of commonly administered antibiotics is not possible or if they have been ineffective.

• Sinusitis, acute exacerbation of chronic bronchitis, or community-acquired pneumonia (except for severe cases).
• Mild or moderate upper genital tract infections (pelvic inflammatory disease), including salpingitis and endometritis. Moxinea tablets, when used as the only medication, are not sufficient to treat this type of infection, and therefore, the doctor should prescribe an additional antibacterial medication to treat upper genital tract infections (see sections: "2. Important Information Before Taking Moxinea", "Warnings and Precautions", "During Treatment with Moxinea").

Moxinea can also be used to complete treatment if initial intravenous moxifloxacin therapy has been 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 Taking Moxinea

In case of doubts regarding belonging to the groups mentioned below, the patient should consult a doctor.

When Not to Take Moxinea:

• If the patient is allergic to the active substance - moxifloxacin, other quinolone drugs, or 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 a history of tendon disease related to treatment with other quinolone drugs (see sections: "When to Exercise Caution" and section "4. Possible Side Effects").
• If the patient has:
• congenital or acquired ECG (electrocardiogram) abnormalities,
• electrolyte imbalance in the blood, especially decreased potassium or magnesium levels in the blood,
• very slow heart rate (bradycardia),
• heart failure,
• previously diagnosed heart rhythm disorders (arrhythmias), or
• if the patient is taking medications that can cause specific changes in the ECG (see "Taking Moxinea with Other Medications"). Moxinea may cause changes in the ECG, i.e., prolongation of the QT interval, which means delayed electrical signal conduction in the heart,
• if the patient has liver disease or liver enzyme activity (aminotransferases) exceeding 5 times the upper limit of normal.

Warnings and Precautions

Before taking this medication
Do not take antibacterial medications containing fluoroquinolones/quinolones, including Moxinea, if severe side effects have occurred in the past when taking quinolones or fluoroquinolones. In such a situation, inform your doctor as soon as possible.
Before taking Moxinea, consult a doctor:

• If the patient has diabetes, as moxifloxacin may affect blood sugar levels.
• If the patient has ever experienced severe skin rash or skin peeling after taking moxifloxacin.
• If the patient has been diagnosed with aortic aneurysm or large arterial occlusive disease.
• If the patient has a history of aortic dissection (tear in the aortic wall).
• If the patient has been diagnosed with heart valve regurgitation.
• If there is a history of aortic aneurysm or aortic dissection in the patient's family, or other risk factors or conditions predisposing to it (e.g., Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, or vascular diseases such as Takayasu arteritis, giant cell arteritis, or Behcet's disease, hypertension, or confirmed atherosclerosis), or rheumatoid arthritis or endocarditis.

Moxinea may affect the ECG, especially in women and the elderly. When taking medications that decrease potassium levels in the blood, consult a doctor before starting Moxinea (see sections: "When Not to Take Moxinea" and "Moxinea and Other Medications").
If the patient has epilepsy or conditions that may cause seizures, consult a doctor before starting Moxinea.
If the patient has or has had mental health problems before starting Moxinea, consult a doctor.
If the patient has myasthenia gravis (muscle weakness and in advanced cases, paralysis), taking Moxinea may worsen the symptoms of the disease. If this happens, consult a doctor immediately.
In case of glucose-6-phosphate dehydrogenase deficiency (a rare hereditary disease), inform the doctor, who will assess whether Moxinea is a suitable medication.
If the patient has a complicated upper genital tract infection (e.g., when there is an abscess of the fallopian tube, ovary, or pelvic area), the doctor may consider it necessary to administer the medication intravenously, as taking Moxinea tablets is not appropriate.
To treat mild or moderate upper genital tract infections, the doctor should prescribe an additional antibacterial medication to the patient, in addition to Moxinea. If symptoms do not improve within the first 3 days of treatment, the patient should consult a doctor.

During Treatment with Moxinea

If the patient experiences heart palpitations or irregular heart rhythm while taking Moxinea, they should contact their doctor immediately. The doctor may decide to perform an ECG.

• In case of sudden severe abdominal, back, or chest pain, which may be a sign of an aortic aneurysm or dissection, seek emergency medical attention immediately. The risk of these changes may be higher in patients treated with systemic corticosteroids.
• In case of sudden shortness of breath, especially after lying down, or swelling of the ankles, feet, or abdomen, or palpitations (feeling of rapid or irregular heartbeat), consult a doctor immediately.

The risk of heart rhythm disorders may increase with increasing doses. Therefore, the recommended dosage of Moxinea should be followed.
There is a small risk of severe, sudden allergic reactions (anaphylactic reaction or anaphylactic shock) even after the first dose of the medication, with symptoms such as chest tightness, dizziness, nausea, or fainting, and dizziness when standing up. If these symptoms occur, stop taking Moxinea and consult a doctor.
Moxinea may cause liver inflammation with a rapid and severe course, which can lead to life-threatening liver failure (including death, see section "4. Possible Side Effects").
Consult a doctor before continuing treatment if symptoms such as sudden deterioration of well-being and/or health, yellowing of the whites of the eyes, dark urine, itching, tendency to bleed, and liver-related disorders of brain function (symptoms of impaired liver function or rapidly progressing and severe liver inflammation) occur.
During moxifloxacin treatment, severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported.

• SJS/TEN may initially appear as red, target-like patches or circular patches, often with central blisters on the torso. They can also cause mouth, throat, nose, genital, and eye ulcers (red and swollen eyes). These serious skin rashes are often preceded by fever and flu-like symptoms. Rashes can lead to widespread skin peeling and life-threatening complications or death.
• AGEP appears at the beginning of treatment as a red, scaly, widespread rash with bumps under the skin and blisters, accompanied by fever. The most common location is mainly on skin folds, torso, and upper limbs.

If a severe rash or any of these skin symptoms occur, stop taking moxifloxacin and consult a doctor or seek immediate medical attention.
Quinolones, including Moxinea, can cause seizures. If seizures occur, stop taking Moxinea and consult a doctor.
Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness may occur, especially in the feet and legs or hands and arms. In such cases, stop taking Moxinea and inform the doctor immediately to prevent the development of a potentially irreversible condition.
Even with the first administration of quinolone antibiotics, including Moxinea, mental disorders can occur. In very rare cases, depression or other mental disorders leading to suicidal thoughts, self-harm, or suicide attempts may occur (see section "4. Possible Side Effects"). If such symptoms occur, consult a doctor immediately before continuing treatment.
During or after treatment with antibiotics, including Moxinea, diarrhea may occur.
In case of severe or prolonged diarrhea or blood and/or mucus in the stool, stop taking Moxinea and consult a doctor. In such situations, do not take medications that slow down or stop intestinal movement (peristalsis).
Pain and swelling of the joints and inflammation or rupture of tendons can occur rarely. The 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 ruptures can occur within the first 48 hours of treatment and even several months after stopping Moxinea. At the first signs of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, arm, or knee), stop taking Moxinea, consult a doctor, and rest the affected limb. Avoid unnecessary exercise, as it may increase the risk of tendon rupture.
Elderly patients with kidney function disorders should drink plenty of fluids, as dehydration can increase the risk of kidney failure.
If vision worsens or other vision disorders occur during Moxinea treatment, seek immediate ophthalmological attention (see section "Driving and Operating Machines" and section "4. Possible Side Effects").
Fluoroquinolone antibiotics can disrupt blood sugar levels, causing both hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar), potentially leading to loss of consciousness (hypoglycemic coma) in severe cases (see section 4. Possible Side Effects). If you have diabetes, closely monitor your blood sugar levels.
Disorders of blood sugar levels in patients treated with Moxinea occur mainly in the elderly who take oral antidiabetic medications that lower blood sugar levels (e.g., sulfonylureas) or insulin. Hypoglycemic coma due to significant lowering of blood sugar levels has been reported. In diabetic patients, monitor blood sugar levels (see section "4. Possible Side Effects").
Quinolone antibiotics can increase skin sensitivity to sunlight and UV radiation. During Moxinea treatment, avoid prolonged sun exposure, strong sunlight, and use of sunbeds or other UV radiation 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 side effects
Fluoroquinolone/quinolone antibacterial medications, including Moxinea, are associated with very rare but serious side effects, some of which are long-term (lasting months or years), causing disability or potentially being irreversible. These include tendon, muscle, and joint pain in the upper and lower limbs, walking difficulties, sensory disturbances such as pins and needles, tingling, burning, itching, numbness, or pain (paresthesia), sensory disturbances including impaired vision, taste, and smell, as well as hearing, depression, memory disorders, severe fatigue, and severe sleep disorders.
In case of any of these side effects after taking Moxinea, consult a doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, also considering an antibiotic from a different class.

Children and Adolescents

Moxinea should not be given to children or adolescents under 18 years of age, as its efficacy for this age group has not been established.

Moxinea and Other Medications

Inform your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
When taking Moxinea, be aware that:

• Concomitant use of Moxinea with other medications that affect heart function increases the risk of heart rhythm disorders. Therefore, do not take Moxinea with the following medications:
• antiarrhythmic medications (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide),
• antipsychotics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultopride),
• tricyclic antidepressants,
• certain antibacterial medications (e.g., sparfloxacin, intravenous erythromycin, pentamidine, antimalarial medications, especially halofantrine),
• certain antihistamines (e.g., terfenadine, astemizole, mizolastine),
• other medications (e.g., cisapride, intravenous vincamine, bepridil, and difemanil).

Inform your doctor if you are taking other medications that may decrease potassium levels in the blood (e.g., certain diuretics, laxatives, and enemas in large doses) or slow down the heart rate, as they may increase the risk of severe heart rhythm disorders when taking Moxinea.
All medications containing magnesium or aluminum, such as antacids used for digestive disorders, and all medications containing iron or zinc, or didanosine, or any medication containing sucralfate (for stomach disorders) may reduce the effectiveness of Moxinea tablets. Therefore, maintain a 6-hour interval between taking Moxinea tablets and other medications.
Concomitant administration of activated charcoal and Moxinea tablets reduces the effectiveness of Moxinea. Therefore, it is not recommended to take both medications together.
When taking medications that reduce blood clotting (oral anticoagulants such as warfarin), your doctor may order blood clotting tests.

Taking Moxinea with Food and Drink

Moxinea can be taken with or without food, including dairy products.

Pregnancy, Breastfeeding, and Fertility

Do not take Moxinea during pregnancy and breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before taking this medication.
Animal studies do not show a harmful effect of this medication on fertility.

Driving and Operating Machines

Moxinea may cause dizziness and a feeling of fainting, as well as sudden, transient loss of vision or short-term fainting. In case of such symptoms, do not drive vehicles or operate any machines.
Moxinea contains colorants: orange yellow (E110), lake, crimson lake (E124), lake, which may cause allergic reactions.
Moxinea contains sodium.
This medication contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e., it is essentially "sodium-free".

3. How to Take Moxinea

Always take Moxinea exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist again.
The usual dose for adults is one 400 mg film-coated tablet once daily.
Moxinea tablets are taken orally. Swallow the tablet whole (to avoid the bitter taste), with a large amount of fluid. Moxinea can be taken with or without food.
It is recommended to take Moxinea at the same time every day.
No dose adjustment is necessary for elderly patients, those with low body mass, or patients with impaired renal function.
The duration of treatment depends on the type of infection. Unless otherwise prescribed by your doctor, the recommended treatment duration with Moxinea is:

• acute exacerbation of chronic bronchitis: 5 to 10 days.
• community-acquired pneumonia, except for severe cases: 10 days.
• acute bacterial sinusitis: 7 days.
• mild or moderate upper genital tract infections (pelvic inflammatory disease), including salpingitis and endometritis: 14 days.

The following are the recommended total treatment durations for patients who are taking Moxinea tablets to complete treatment started with moxifloxacin infusion solution.

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

It is essential to complete the full treatment course, even if you feel better after a few days. If you stop taking the medication too early, the infection may not be completely cured, and the disease may recur or worsen, and bacteria may develop resistance to the antibiotic.
Do not exceed the recommended dose or prolong treatment (see section "2. Important Information Before Taking Moxinea", "During Treatment with Moxinea").

Taking a Higher Dose of Moxinea Than Recommended

If you have taken more than one prescribed tablet per day, seek medical attention immediately and, if possible, take all remaining tablets, packaging, and this leaflet to show your doctor or pharmacist.

Missing a Dose of Moxinea

If you forget to take a tablet at the usual time, take it as soon as you remember on the same day. If you miss a dose for one day, take your usual dose (one tablet) the next day.
Do not take a double dose to make up for a missed dose.
In case of doubts about taking the medication, consult a doctor or pharmacist.

Stopping Moxinea Treatment

If you stop taking the medication too early, the infection may not be completely cured. If you need to stop treatment early, consult your doctor.
In case of further doubts about taking this medication, consult a doctor or pharmacist.

4. Possible Side Effects

Like all medications, Moxinea can cause side effects, although not everybody gets them.
The most serious side effectsobserved during Moxinea treatment are listed below:
In case of the following side effects:

• abnormal heart rhythm (rare side effect),
• rapid deterioration of well-being, yellowing of the whites of the eyes, dark urine, itching, tendency to bleed, or feeling of weakness [these may be symptoms of life-threatening liver failure due to liver inflammation (very rare side effect)],

serious skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. They may appear as red, target-like patches or circular patches, often with central blisters on the torso, skin peeling, mouth, throat, nose, genital, and eye ulcers (red and swollen eyes), and may be preceded by fever and flu-like symptoms. Rashes can lead to widespread skin peeling and life-threatening complications or death (very rare side effects, potentially life-threatening),
red, scaly, widespread rash with bumps under the skin and blisters, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis) (frequency of this side effect is "unknown"),

• Syndrome associated with impaired water excretion and low sodium levels (SIADH) (very rare side effect),
• loss of consciousness due to significantly decreased blood sugar levels (hypoglycemic coma) (very rare side effect),
• vasculitis (usually manifested as red spots on the skin, most commonly on the lower legs, or joint pain) (very rare side effect),
• severe, rapidly spreading allergic reaction, including very rare life-threatening anaphylactic shock (e.g., difficulty breathing, low blood pressure, rapid heartbeat) (rare side effect),
• swelling, including swelling of the airways (rare side effect, potentially life-threatening),
• seizures (rare side effect),
• disorders of the nervous system, such as pain, burning, tingling, numbness, and/or weakness (rare side effect),
• depression (very rarely leading to self-harm, e.g., suicidal thoughts or attempts) (rare side effect),
• mental disorders (potentially leading to self-harm, e.g., suicidal thoughts or attempts) (very rare side effect),
• severe diarrhea with blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which can be life-threatening in very rare cases (rare side effect),
• pain and swelling of the tendons (tendinitis) (rare side effect) or tendon rupture (very rare side effect),
• muscle weakness, tenderness, or pain, especially if the patient feels unwell, has a fever, or has dark urine. These may be caused by abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (frequency of this side effect is "unknown").

Stop Moxinea treatment and consult a doctor immediately, as emergency medical attention may be necessary.
Additionally, if

• transient loss of vision (very rare side effect) occurs, consult an ophthalmologist immediately.

If Moxinea treatment causes abnormal heart rhythm, irregular heartbeat (torsade de pointes), or cardiac arrest (very rare side effect), consult a doctor immediately and stop Moxinea treatment.
In case of muscle weakness, consult a doctor immediately.
If you have diabetes and experience changes in blood sugar levels (rare or very rare side effect), consult a doctor immediately.
If an elderly patient with impaired renal function experiences decreased urine output, swelling of the feet, ankles, or hands, nausea, drowsiness, shortness of breath, or confusion (these may be symptoms of renal failure; rare side effect), consult a doctor immediately.
Other side effects observed during Moxinea treatment, with probable frequency, include:
Common(may occur in up to 1 in 10 people):

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

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

• rash,
• upset stomach (indigestion/heartburn),
• taste disorders (very rarely, loss of taste),
• sleep disorders (insomnia),
• increased liver enzyme activity in the blood (gamma-glutamyltransferase and/or alkaline phosphatase),
• decreased white blood cell count (leukocytes, neutrophils),
• constipation,
• itching,
• dizziness (spinning or falling),
• insomnia,
• gas,
• heart rhythm disorders (ECG),
• liver function disorders (including increased liver enzyme activity, such as lactate dehydrogenase (LDH)),
• decreased appetite and food intake,
• decreased white blood cell count,
• back, chest, pelvic, and limb pain,
• increased platelet count necessary for blood clotting,
• excessive sweating,
• increased white blood cell count (eosinophilia) in the blood,
• anxiety,
• malaise (especially weakness or fatigue),
• tremors,
• joint pain,
• palpitations,
• irregular and rapid heartbeat,
• breathing difficulties (including asthma attacks),
• increased activity of the digestive enzyme amylase in the blood,
• anxiety, agitation,
• tingling and/or numbness (pins and needles),
• hives on the skin,
• vasodilation,
• confusion, disorientation,
• decreased platelet count necessary for blood clotting,
• vision disorders, including double and blurred vision,
• decreased blood clotting,
• increased fat levels in the blood,
• decreased red blood cell count,
• muscle pain,
• allergic reactions,
• increased bilirubin levels in the blood,
• gastritis,
• dehydration,
• severe heart rhythm disorders,
• dry skin,
• angina pectoris.

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

• muscle tremors,
• muscle spasms,
• hallucinations,
• high blood pressure,
• swelling (of hands, feet, ankles, lips, mouth, throat),
• low blood pressure,
• kidney function disorders (including increased values of diagnostic tests for kidney function, such as urea and creatinine),
• liver inflammation,
• mouth infections,
• ringing in the ears,
• jaundice (yellowing of the eyes or skin),
• sensory disturbances on the skin,
• unusual dreams,
• impaired concentration,
• swallowing difficulties,
• smell disorders (including loss of smell),
• balance and coordination disorders (due to dizziness),
• partial or complete memory loss,
• hearing disorders, including hearing loss (usually temporary),
• increased uric acid levels in the blood,
• emotional instability,
• speech disorders,
• fainting,
• muscle weakness.

Very Rare(may occur in up to 1 in 10,000 people):

• arthritis,
• heart rhythm disorders,
• increased skin sensitivity,
• depersonalization (feeling of loss of one's identity),
• increased blood clotting,
• muscle stiffness,
• significant decrease in white blood cell count (agranulocytosis),
• decrease in red and white blood cell and platelet count (pancytopenia).

In addition, very rare side effects have been reported during Moxinea treatment, also described with other quinolone antibiotics: increased sodium levels in the blood, increased calcium levels in the blood, decreased red blood cell count (hemolytic anemia), muscle reactions with muscle cell damage, increased skin sensitivity to sunlight and UV radiation.
Very rare cases of long-term (months or years) or permanent side effects of Moxinea, such as tendon inflammation, tendon rupture, joint pain, limb pain, walking difficulties, sensory disturbances such as pins and needles, tingling, burning, itching, numbness, or pain (neuropathy), depression, fatigue, sleep disorders, memory disorders, 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.
Patients taking fluoroquinolones have reported cases of aortic dilatation and aortic aneurysm or aortic dissection, which can be fatal, as well as cases of heart valve regurgitation. See also section 2.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medication.

5. How to Store Moxinea

Keep the medication out of the reach and sight of children.
Do not take Moxinea after the expiration date stated on the carton and blister pack "Expiration Date (EXP)". The expiration date refers to the last day of the month.
Moxinea does not require special storage conditions.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Moxinea Contains

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

Each film-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, orange yellow (E 110), lake, crimson lake (E 124), lake, indigo carmine (E 132).

What Moxinea Looks Like and Contents of the Pack

Dark red, film-coated, elongated, and convex tablet with "MOXI" embossed on one side and "400" on the other.
Moxinea film-coated tablets are available in PVC/PVDC/Aluminum blisters, in cartons containing 5, 7, 10, or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization 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

Date of Approval of the Leaflet:

08-06-2017

Date of Last Revision of the Leaflet:

10-09-2021