Amantix

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging 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 entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What AMANTIX is and what it is used for
2. Important information 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 medicine, meaning it can increase the levels of certain chemical compounds that transmit impulses in the nervous system, including in the brain.
AMANTIX reduces the severity of symptoms of Parkinson's disease (an antiparkinsonian medicine).
AMANTIX tablets are used:

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

2. Important information before using the medicine 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 or visible U waves, or if there is a family history of congenital long QT syndrome;
• if the patient has severe cardiac arrhythmias (ventricular arrhythmias, including a history of torsades de pointes);
• if the patient has low levels of potassium or magnesium in the blood;
• 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 it 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 renal filtration) (see section 3);
• current or past episodes of agitation or confusion (disorientation);
• psychiatric disorders (history of delirium or exogenous psychoses);
• diarrhea, vomiting, use of diuretics or emergency insulin administration, kidney disease, or anorexia (risk of water and electrolyte imbalance);
• concomitant treatment with memantine (see section 2 – AMANTIX and other medicines).

Other important information regarding the use of AMANTIX
Before starting treatment and again 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 escalation. Subsequent follow-up ECGs should be performed at least once a year.
In patients with cardiac pacemakers, accurate assessment of the QT interval duration may not be possible; therefore, the decision to use AMANTIX should be made individually for each patient after consultation with a cardiologist.
In patients with impaired renal function, drug accumulation may occur due to reduced renal excretion. This may lead to symptoms associated with overdose. The physician should carefully adjust the dose 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 risk of symptom exacerbation and possible occurrence of seizures (see sections 3 and 4).
During treatment with AMANTIX, the physician 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 (fainting) occur during treatment with AMANTIX, treatment should be discontinued immediately and the patient should consult a doctor for cardiac function assessment (heart rhythm) via 24-hour monitoring. If the physician does not detect any cardiac disturbances, treatment with AMANTIX may be continued, taking into account contraindications and interactions (see section 4).
Patients receiving concomitant neuroleptic therapy (medicines used to treat psychiatric disorders) and AMANTIX are – in case of 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 dysfunction.

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 potential interactions.
Patients experiencing difficulty urinating should contact their doctor.
If blurred vision or other visual disturbances occur, the patient should immediately consult an ophthalmologist.
Inform the doctor if the patient or family members and/or caregivers notice an urge or irresistible desire to behave in an unusual way, or inability to resist impulses, or urges or cravings to act in ways that could be harmful to the patient or others. These are known as impulse control disorders, which may include behaviors such as compulsive gambling, binge 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 influenza A virus infection 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 carefully selected, especially in cases of agitation, confusion, or delirium (see section 3).

AMANTIX and other medicines
Inform your doctor about all medicines currently used, recently used, or planned for use.
AMANTIX must not be used concomitantly with other medicines that prolong the QT interval, such as:

• certain medicines used to treat irregular heart rhythms (Class IA antiarrhythmics, e.g., quinidine, disopyramide, procainamide, and Class III antiarrhythmics, 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, co-trimoxazole, pentamidine, cisapride, or bepridil.

The above list may not be complete. Before using AMANTIX together with another medicine, the doctor should check for possible interactions leading to 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.
Concomitant use of AMANTIX with any of the medicines or active substances listed below may lead to the following interactions:

Anticholinergic medicines
Increased anticholinergic adverse effects (confusion, hallucinations) when used with anticholinergics (e.g., trihexyphenidyl, benzatropine, scopolamine, biperiden, orphenadrine).

Indirectly acting centrally-acting sympathomimetics
Enhanced central nervous system effects of amantadine.

Levodopa (medicine used in Parkinson's disease)
Mutual enhancement of therapeutic effect (levodopa may therefore be administered concomitantly with AMANTIX).

Memantine (medicine used in dementia)
Memantine may enhance the effects and adverse reactions 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 products should be avoided.
It should be emphasized that the interactions listed above may also apply to medicines previously used.

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 a 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 ocular accommodation (the eye's ability to adjust focus for different distances) cannot be ruled out, especially in combination with other medicines used in 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 devices should not be undertaken without prior consultation with a doctor.
Bear in mind that alcohol may worsen the impairment of driving ability.

AMANTIX contains lactose monohydrate and sunset yellow (E 110)
AMANTIX contains lactose monohydrate. Patients with intolerance to certain sugars should consult their doctor before starting treatment with this medicine.
AMANTIX contains a colouring agent – sunset yellow (E 110), which may cause allergic reactions.

3. How to use AMANTIX

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
The following information refers to the dosing of AMANTIX unless otherwise advised by your doctor. Follow the instructions carefully; otherwise, AMANTIX may not work properly.

Duration of treatment
The tablets should be taken orally with a small amount of fluid, 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 doctor 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 daily dose may be divided into three divided doses, as determined by the doctor.
In elderly patients, especially those presenting with agitation, confusion, or symptoms of delirium, treatment should be initiated with a lower dose.
If the patient is concurrently taking other anti-Parkinson medications, the doctor 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 doctor may use a higher initial dose.
The doctor may use amantadine infusion solution in cases of acute worsening of Parkinson's disease symptoms (akinetic crisis).

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

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

Taking more AMANTIX than recommended
If a higher than recommended dose is taken, inform your doctor or ask a family member to inform the doctor and agree to be referred to hospital by the doctor if severe poisoning occurs, manifesting as: nausea, vomiting, tremors or convulsions, unsteady gait, blurred vision, lethargy, depression, speech disturbances, or cardiac dysfunction.
When AMANTIX is taken concomitantly with other drugs used in Parkinsonism, states of confusion with hallucinations, even coma, as well as muscle tremors, have been observed.
There is no known specific pharmacological treatment or antidote for AMANTIX overdose. The doctor may induce vomiting or perform gastric lavage.
Blood purification via 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 possible, administration of anticonvulsant and antiarrhythmic drugs (intravenous lidocaine). No specific antidote or drug is known.
In treating 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 x 0.5 mg with a 5–10 minute interval, up to a maximum dose of 2 mg in children.
The doctor will perform an ECG and carefully monitor conditions favoring the development of cardiac arrhythmias, if necessary, e.g., electrolyte imbalance (hypokalemia or hypomagnesemia) 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.

Stopping treatment with 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 stop treatment abruptly, as this may worsen disease symptoms and cause withdrawal symptoms.
In patients with Parkinson's disease, AMANTIX must not be discontinued abruptly, 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 experiences them.
Possible adverse reactions of AMANTIX:

Frequently (occurring more often than in 1 in 100 people, but less frequently than in 1 in 10 people):

• sleep disturbances
• anxiety and agitation
• urinary retention in patients with benign prostatic hyperplasia (enlarged prostate)
• delusional (paranoid) disorders (disturbances in perception and behavior) accompanied by visual hallucinations, mainly occurring in elderly patients; these adverse reactions occur more frequently in patients treated simultaneously with AMANTIX and other antiparkinsonian medicines (e.g. levodopa, bromocriptine) or memantine
• livedo reticularis (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 when standing up quickly from a lying or sitting position. This may cause dizziness or a feeling of fainting (orthostatic hypotension)

Uncommonly (affecting fewer than 1 in 100 people):

• blurred vision

Rarely (occurring more frequently than in 1 in 10,000 people, but less frequently than in 1 in 1,000 people):

• corneal damage, corneal edema, decreased visual acuity

Very rarely (occurring less frequently than in 1 in 10,000 people):

• leukopenia (reduced number of white blood cells) and thrombocytopenia (reduced number of platelets)
• cardiac arrhythmias 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 drugs having proarrhythmic effects, or in the presence of other risk factors for cardiac arrhythmias (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):

• uncontrollable urge to behave in an unusual manner – strong drive towards excessive gambling, disordered or increased sexual drive, uncontrolled excessive shopping or spending, binge eating (eating large amounts of food in a short time) or compulsive overeating (eating 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 edema (see section 2).
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 to provide more information on the safety of the medicine.

5. How to store AMANTIX medicine

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the stated month.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
Translation of some abbreviations appearing on the immediate packaging:
Č. šarže:; EXP.: pozri vyrazené - batch number and expiry date: see imprint
Číslo šarže.; Použitelné do: víz vyraženo - batch number and expiry date: see imprint

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.
Excipients: monohydrate lactose, microcrystalline cellulose, potato starch, gelatin, povidone K 25, sodium carmellose, talc, colloidal anhydrous silica, magnesium stearate.
Coating: talc, basic butyl methacrylate copolymer, titanium dioxide, magnesium stearate, orange yellow.

What AMANTIX looks like and contents of the pack
AMANTIX is a round, orange, film-coated tablet with a central dividing groove on one side. The break line on the tablet is intended only to facilitate breaking the tablet for easier swallowing and does not ensure equal dose division.
The pack contains 30 or 100 film-coated tablets in a cardboard box.

For further detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in the Czech Republic, 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing authorisation number in the Czech Republic, country of export: 27/219/93-C
Parallel import authorisation number: 213/22