AMANTIX

Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Amantix (PK-Merz), 100 mg, coated tablets
Amantadini sulfas
Amantix and PK-Merz are different trade names for the same medicinal product.
Please read the following information carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are identical.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of contents of the leaflet :

1. What Amantix is and what it is used for
2. What you need to know before taking Amantix
3. How to take Amantix
4. Possible side effects
5. How to store Amantix
6. Contents of the pack and other information

1. What Amantix is and what it is used for

Amantix is a dopaminergic agent, meaning that it may increase levels of certain chemical substances involved in transmitting nerve impulses in the nervous system, including the brain.
Amantix reduces the severity of symptoms of Parkinson's disease (it is an antiparkinsonian medicine).
Amantix tablets are used:

• in the treatment of symptoms of Parkinson's disease and parkinsonism, such as rigidity, tremor, hypokinesia (reduced motor function), or akinesia (lack of movement);
• in the treatment of movement disorders resembling Parkinson's disease induced by certain medications (neuroleptics and drugs with similar mechanism of action) (extrapyramidal symptoms, such as early dyskinesia, an uncontrollable urge to move (akathisia), and parkinsonism).

2. Important information before using Amantix

When not to use Amantix:

• if the patient is allergic to amantadine or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe, uncontrolled heart failure (NYHA class IV);
• if the patient has heart diseases such as cardiomyopathy or myocarditis;
• if the patient has disturbances in the conduction of electrical impulses in the heart (second- or third-degree atrioventricular block);
• if the patient has a slow heart rate (less than 55 beats per minute);
• if the patient has changes in the electrocardiogram (ECG) such as prolonged QT interval, visible U waves, or has a family history of congenital long QT syndrome;
• if the patient has severe heart rhythm disorders (ventricular arrhythmias, including a history of torsades de pointes);
• if the patient has low blood levels of potassium or magnesium;
• if the patient is pregnant or breastfeeding;
• if the patient is taking medicines that prolong the QT interval (see section 2 - Amantix and other medicines).

Warnings and precautions
Before starting treatment with Amantix, discuss this with your doctor or pharmacist.
Special caution is required when using Amantix in patients with:

• benign prostatic hyperplasia (enlarged prostate);
• increased intraocular pressure (narrow-angle glaucoma);
• renal impairment of varying severity (risk of drug accumulation due to reduced kidney filtration) (see section 3);
• current or past states of agitation or confusion (disorientation);
• psychiatric disorders (history of delirium or exogenous psychoses);
• diarrhea, vomiting, use of diuretics or insulin administered acutely in emergency conditions, kidney disease, or anorexia (risk of water-electrolyte imbalance);
• patients concurrently treated with memantine (see section 2 - Amantix and other medicines).

Other important information about using Amantix
Before starting treatment, and after 1 and 3 weeks of therapy, an ECG should be performed and the QT interval corrected using Bazett's formula (QTc) should be determined. An ECG should also be performed before any dose increase and 2 weeks after each dose increase. Subsequent ECG monitoring should be performed at least once a year.
In patients with cardiac pacemakers, accurate assessment of the QT interval duration is not possible; therefore, the decision to use Amantix should be made individually for each patient after consultation with a cardiologist.
In patients with impaired kidney function, drug accumulation may occur due to reduced renal excretion. This may lead to symptoms associated with overdose. The doctor should carefully adjust the dose, measure, and monitor glomerular filtration rate (see section 3).
Particular caution is required when using Amantix in patients with organic brain syndrome or a history of seizures, due to the possible worsening of symptoms and risk of seizures (see sections 3 and 4).
During treatment with Amantix, the doctor must regularly monitor patients at risk of seizures, including those with a prior history of seizures and patients with cardiovascular diseases.
If palpitations, dizziness, or brief loss of consciousness (syncope) occur during treatment with Amantix, the use of Amantix should be discontinued immediately and the patient should consult a doctor to evaluate heart function (heart rhythm) via 24-hour monitoring. If the doctor does not detect any cardiac disturbances, treatment with Amantix may be continued, taking into account contraindications and interactions (see section 4).
Patients treated concomitantly with neuroleptic medicines (medicines used to treat psychiatric disorders) and Amantix are—upon abrupt discontinuation of Amantix—at risk of developing a life-threatening condition known as neuroleptic malignant syndrome. This syndrome is characterized by sudden high fever, muscle rigidity, and autonomic nervous system disturbances.
In patients with Parkinson's disease, clinical symptoms such as low blood pressure, drooling, sweating, elevated body temperature, fluid retention, and depression are commonly observed. When using Amantix in these patients, special consideration should be given to its adverse effects and interactions.
Patients who experience difficulty urinating should contact their doctor.
If a patient develops blurred vision or other visual disturbances, they should contact an ophthalmologist immediately.
Cases of suicidal thoughts and behaviors have been reported during treatment with amantadine. If a patient experiences thoughts about self-harm or suicide, or attempts such behavior, they should contact their doctor immediately.
Inform the doctor if the patient or family members and/or caregivers notice an urge or irresistible desire to behave in ways that are unusual for the patient and which the patient cannot resist, or a desire or compulsion to act in a manner that could be harmful to the patient or others. These are known as impulse control disorders, which may include behaviors such as pathological gambling, compulsive eating or spending, abnormally increased sexual drive, or intensified sexual thoughts or feelings. The doctor may modify the dose or discontinue Amantix.
Amantadine should be avoided for prophylaxis and treatment of type A influenza virus infections due to the risk of overdose.

Children and adolescents
There is no data available on the use of this medicine in children and adolescents.

Elderly patients
In elderly patients, the dose should be selected carefully, especially in cases of agitation, confusion, or delirium (see section 3).

Amantix and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Amantix must not be used concomitantly with other medicines that prolong the QT interval, such as:

• certain medicines used to treat irregular heart rhythms (antiarrhythmics of class IA, e.g. quinidine, disopyramide, procainamide, and class III, e.g. amiodarone, sotalol);
• certain medicines used to treat psychiatric disorders (antipsychotics, e.g. thioridazine, chlorpromazine, haloperidol, pimozide);
• certain medicines used to treat depression (tricyclic and tetracyclic antidepressants, e.g. amitriptyline);
• certain medicines used to treat allergies, e.g. hay fever (antihistamines, e.g. astemizole, terfenadine);
• certain medicines used to treat bacterial infections (macrolide antibiotics, e.g. erythromycin, clarithromycin, and gyrase inhibitors, e.g. sparfloxacin);
• certain medicines used to treat fungal infections (azole antifungals);
• other medicines such as budipine, halofantrine, cotrimoxazole, pentamidine, cisapride, or bepridil.

The above list may not be complete. Before using Amantix with another medicine, the doctor should check for possible interactions causing QT prolongation.
Concomitant treatment with Amantix and other medicines used in Parkinson's disease may be possible. To avoid adverse effects (e.g. psychotic reactions), it may be necessary to reduce the dose of one or both medicines.
Concurrent use of Amantix with any of the medicines or active substances listed below may lead to the following interactions:
Anticholinergics
Increased adverse effects (confusion and hallucinations) of anticholinergic medicines (e.g. trihexyphenidyl, benzatropine, scopolamine, biperiden, orphenadrine).
Indirectly acting sympathomimetics affecting the central nervous system
Enhanced central effects of amantadine.
Levodopa (medicine used in Parkinson's disease)
Mutual enhancement of therapeutic effect (therefore, levodopa may be administered concomitantly with Amantix).
Memantine (medicine used in dementia)
Memantine may enhance the effects and adverse effects of Amantix (see section 2. Warnings and precautions).
Other medicines
Concomitant use of diuretics containing triamterene in combination with hydrochlorothiazide may reduce the plasma clearance of amantadine, leading to toxic serum concentrations. Therefore, concomitant use of amantadine and such medicines should be avoided.
It should be emphasized that the interactions listed above may also apply to medicines previously used.

Taking Amantix with food, drink, and alcohol
Alcoholic beverages should be avoided during treatment with Amantix, as this medicine reduces alcohol tolerance.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Amantix tablets are contraindicated during pregnancy and in women who are breastfeeding.

Driving and operating machinery
The effect of Amantix on concentration, alertness, and eye accommodation (the eye's ability to focus at varying distances) cannot be ruled out, especially when combined with other medicines used to treat Parkinson's disease.
At the beginning of treatment, the ability to drive and operate machinery may be further impaired beyond the impairment caused by the disease itself.
The patient may be unable to react quickly and decisively in unexpected or sudden situations.
Driving and operating machinery or electrical equipment should not be undertaken without consulting a doctor.
Bear in mind that alcohol may worsen the impairment of driving ability.

Amantix contains lactose, sunset yellow FCF (E 110), and sodium
Amantix contains lactose (in the form of monohydrate). If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
Amantix contains the coloring agent sunset yellow FCF (E 110), which may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free."

3. How to use Amantix

This medicine should always be taken as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
The following information refers to the dosage of Amantix, unless otherwise instructed by your
physician. Follow the instructions for use carefully; otherwise, Amantix may not work properly.

Duration of treatment
The tablets should be taken orally with a small amount of liquid, preferably in the morning and in the afternoon.
The last daily dose should not be taken after 4 p.m.
Do not stop taking the tablets without consulting your doctor. The duration of treatment is determined by the
physician according to the patient's condition and individual response to therapy.

Dosage
Treatment of patients with parkinsonian syndromes and drug-induced movement disorders is usually initiated gradually.
The required dose and duration of treatment depend on the type and severity of symptoms and are determined by the physician.
Treatment is initiated with 1 tablet of Amantix once daily for the first 4 to 7 days (corresponding to 100 mg of amantadine sulfate per day).
The daily dose is then increased by 100 mg at weekly intervals until the maintenance dose is reached.
The usual maintenance dose is 1 to 3 tablets twice daily (corresponding to 200–600 mg of amantadine sulfate per day).
The total daily dose may be divided into three doses, as determined by the physician.

In elderly patients, particularly those with symptoms of agitation, confusion, or delirium, treatment should be initiated with a lower dose.
If the patient is concurrently taking other anti-parkinsonian medications, the physician will determine the appropriate dose of Amantix individually.
If the patient has previously been treated with amantadine in the form of an infusion solution, the physician may use a higher initial dose.
The physician may use amantadine infusion solution in cases of acute worsening of Parkinson's disease symptoms (akinetic crisis).

Patients with renal impairment
The dosage of Amantix tablets must be adjusted according to renal clearance (a parameter indicating kidney function).
The appropriate dose is determined by the physician.

Use in children and adolescents
There is no data available on the use of this medicine in children and adolescents.

Overdose of Amantix
If a higher than recommended dose is taken, inform your doctor or ask a family member to inform the doctor.
Agree to be referred to hospital by the doctor if severe poisoning occurs, manifested by: nausea, vomiting, tremors or seizures, unsteady gait, blurred vision, lethargy, depression, speech disturbances, or cardiac dysfunction.

When Amantix is taken together with other medications used for Parkinson's disease, states of confusion with hallucinations, even coma, and muscle tremors have been observed.
There is no known specific pharmacological treatment or antidote for Amantix overdose.
The physician may induce vomiting or perform gastric lavage.
Blood purification by dialysis (hemodialysis) is not recommended due to the low elimination of amantadine during dialysis (approximately 5%).

In life-threatening poisoning, intensive therapy is required. Therapeutic measures should include: fluid administration and acidification of urine to accelerate elimination of the toxic substance, sedation if necessary, administration of anticonvulsant and antiarrhythmic drugs (intravenous lidocaine).
No specific drug or antidote is known.

For the treatment of neurotoxic symptoms (as described above), an attempt may be made to administer physostigmine intravenously at a dose of 1–2 mg every 2 hours in adults, and 2 × 0.5 mg with a 5–10 minute interval, up to a maximum dose of 2 mg in children.

The physician will perform an ECG and carefully monitor conditions favoring the development of cardiac arrhythmias, if deemed necessary, e.g., electrolyte imbalance (potassium or magnesium deficiency in blood) or bradycardia.

Missed dose of Amantix
Do not take a double dose to make up for a missed dose.
Continue taking the single dose prescribed by your doctor.

Discontinuation of Amantix
Under no circumstances should treatment be stopped without consulting your doctor.
If the patient wishes to discontinue treatment, e.g., due to intolerance or worsening of disease symptoms, they should inform the doctor.
Do not abruptly stop treatment, as this may worsen disease symptoms and cause withdrawal symptoms.
In patients with Parkinson's disease, Amantix should not be abruptly discontinued, as this may lead to severe movement disorders, sometimes including inability to move.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Possible adverse reactions:
If any of the adverse reactions listed below occur in a patient, a doctor should be informed immediately. The doctor will decide on further management.

Common (affects less than 1 in 10 people):

• Sleep disturbances
• Anxiety and agitation
• Urinary retention in patients with benign prostatic hyperplasia (enlarged prostate)
• Delusional (paranoid) symptoms (disturbances in perception and behavior), accompanied by visual hallucinations, mainly occurring in elderly patients. These adverse reactions occur more frequently in patients treated concomitantly with Amantix and other antiparkinsonian medicines (e.g. levodopa, bromocriptine) or memantine
• Livedo reticularis (a mottled red-blue skin discoloration in a net-like pattern), sometimes accompanied by swelling of the lower legs and ankles
• Nausea
• Dizziness
• Dry mouth
• Sudden drop in blood pressure upon standing up quickly from a lying or sitting position. This may cause dizziness or a feeling of fainting (orthostatic hypotension)

Uncommon (affects less than 1 in 100 people):

• Blurred vision

Rare (affects less than 1 in 1,000 people):
Corneal damage, corneal oedema, reduced visual acuity

Very rare (affects less than 1 in 10,000 people):

• Leukopenia (reduced white blood cell count) and thrombocytopenia (reduced platelet count)
• Cardiac disorders such as ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT interval prolongation; these disorders most commonly occur after exceeding the recommended doses or when amantadine is used concomitantly with other medicines with proarrhythmic effects, or in the presence of other risk factors for cardiac disorders (see section 2 "When not to use Amantix" and "Amantix and other medicines")
• Transient loss of vision
• Increased sensitivity to light
• Seizures (usually after exceeding the recommended dose)
• Muscle cramps
• Sensory disturbances in the limbs

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

• Irresistible urge to behave in an unusual manner – strong compulsion towards excessive gambling, disturbed or increased sexual drive, uncontrollable excessive shopping or spending, binge eating (consuming large amounts of food in a short time) or compulsive overeating (consuming more food than usual and more than needed to satisfy hunger)

If visual disturbances occur, such as loss of visual acuity or blurred vision, consult a doctor to rule out corneal oedema (see section 2).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Amantix

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Translation of some information on the immediate packaging:
Ch.-B.:/Verwedbar bis: siehe Prägung/Aundruck – batch number; expiry date: see embossing/print
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Amantix contains
The active substance in Amantix is amantadine sulfate.
Each coated tablet contains 100 mg of amantadine sulfate.
The excipients are: monohydrate lactose, microcrystalline cellulose, potato starch, gelatin, povidone 25, sodium croscarmellose, talc, colloidal anhydrous silica, magnesium stearate, basic butyl methacrylate copolymer, Orange Yellow S (E 110), titanium dioxide.

What Amantix looks like and contents of the pack
Amantix is a round, orange-coated tablet with a score line on one side. The break line is intended only to facilitate breaking the tablet for easier swallowing and does not ensure equal dosing.
The pack contains 100 coated tablets in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Germany, the country of export:
Merz Pharmaceuticals GmbH
Eckenheimer Landstrasse 100
60318 Frankfurt am Main
Germany

Manufacturer:
Merz Pharma GmbH & Co. KGaA
Eckenheimer Landstrasse 100
60318 Frankfurt am Main
Germany

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

German Marketing Authorisation Number (country of export): 6423692.00.00
Parallel Import Authorisation Number: 40/23