Amantix

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Amantix(PK-Merz)

100 mg, coated tablets

Amantadine sulfate
Amantix and PK-Merz are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Amantix and what is it 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 packaging and other information

1. What is Amantix and what is it used for

Amantix is a dopaminergic medicine, which means it can increase the level of certain chemical compounds that transmit impulses in the nervous system, including the brain.
Amantix reduces the severity of Parkinson's disease symptoms (anti-Parkinsonian medicine).
Amantix tablets are used:

• to treat Parkinson's disease symptoms such as stiffness, tremors, hypokinesia (reduced movement) or akinesia (immobility);
• to treat movement disorders similar to Parkinson's disease caused by certain medications (neuroleptics and drugs with a similar mechanism of action) (extrapyramidal symptoms, such as early dyskinesia, irresistible urge to move (akathisia) and parkinsonism).

2. Important information before taking Amantix

When not to take Amantix:

torsades de pointes);

Warnings and precautions

Before starting Amantix, you should discuss it with your doctor or pharmacist.
You should be particularly careful when taking Amantix if you have:

• prostate enlargement;
• increased intraocular pressure (narrow-angle glaucoma);
• renal impairment of varying severity (risk of drug accumulation due to impaired renal filtration) (see section 3);
• states of agitation or confusion (disorientation) currently or in the past;
• psychiatric disorders (delirium syndromes or exogenous psychoses in the past);
• diarrhea, vomiting, taking diuretics or insulin in emergency situations, with kidney disease or anorexia (risk of water and electrolyte imbalance);
• being treated with memantine at the same time (see section 2 - Amantix and other medications).

Other important information about taking Amantix

Before starting treatment and after 1 and 3 weeks from the start of therapy, you should have an ECG and determine the corrected QT value using the Bazett method (QTc). The ECG should also be performed before increasing the dose and 2 weeks after each dose increase. Further control ECGs should be performed at least once a year.
In the case of patients with pacemakers, it is not possible to accurately determine the QT interval, so the decision to use Amantix should be made individually for each patient, after consulting a cardiologist.
In patients with impaired renal function, drug accumulation may occur due to impaired excretion by the kidneys. This can lead to the occurrence of symptoms related to drug overdose. The doctor should carefully adjust the dose, measure and monitor the glomerular filtration rate (see section 3).
In patients with organic brain syndrome or previously occurring seizures, particular caution should be exercised when taking Amantix due to the possible exacerbation of individual symptoms and the possibility of seizures (see sections 3 and 4).
During Amantix treatment, the doctor must regularly monitor patients prone to seizures, including those who have had seizures before, as well as patients with cardiovascular diseases.
If a patient experiences palpitations, dizziness, or short-term loss of consciousness (syncope) while taking Amantix, they should immediately stop taking the medicine and consult a doctor to check heart function (heart rhythm) through 24-hour monitoring. If the doctor does not find any heart function disorders, Amantix treatment can be continued, taking into account contraindications and interactions (see section 4).
Patients treated with neuroleptic medications (medications used to treat mental disorders) and Amantix are at risk of developing a life-threatening condition - malignant neuroleptic syndrome - if Amantix treatment is suddenly stopped.
This syndrome is characterized by: sudden increase in temperature, muscle stiffness, and autonomic nervous system disorders.
In patients with Parkinson's disease, clinical symptoms such as decreased blood pressure, salivation, sweating, increased body temperature, fluid retention, and depression are often observed. When taking Amantix in this patient group, particular attention should be paid to its side effects and interactions.
Patients who experience difficulty urinating should contact their doctor.
If a patient experiences blurred vision or other vision disturbances, they should immediately contact an ophthalmologist.
You should inform your doctor if you or your family members and/or caregivers notice that you have a desire or irresistible urge to behave in a way that is unusual for you and you are unable to resist these impulses, or a desire or temptation to behave in a way that could be harmful to you or others. These are so-called impulse control disorders, which can include behaviors such as compulsive gambling, overeating or spending money, inappropriate increased sexual drive or increased sexual thoughts or feelings. The doctor may adjust the dose or stop Amantix treatment.
You should avoid taking amantadine for the prevention and treatment of influenza A virus infections due to the risk of overdose.

Children and adolescents

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

Elderly

In older people, the dose should be chosen carefully, especially if there are symptoms of agitation and confusion or delirium syndrome (see section 3).

Amantix and other medications

You should tell your doctor about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Amantix should not be taken with other medications that prolong the QT interval, such as:

• certain medications used to treat irregular heart rhythm (antiarrhythmic medications of class IA, e.g. quinidine, disopyramide, procainamide, and class III, e.g. amiodarone, sotalol);
• certain medications used to treat mental disorders (antipsychotic medications, e.g. thioridazine, chlorpromazine, haloperidol, pimozide);
• certain medications used to treat depression (tricyclic and tetracyclic antidepressants, e.g. amitriptyline);
• certain medications used to treat allergies, e.g. hay fever (antihistamines, e.g. astemizole, terfenadine);
• certain medications used to treat bacterial infections (macrolide antibiotics, e.g. erythromycin, clarithromycin, and gyrase inhibitors, e.g. sparfloxacin);
• certain medications used to treat fungal infections (azoles);
• other medications, such as budipine, halofantrine, cotrimoxazole, pentamidine, cisapride, or bepridil. The above list may not be exhaustive. Before taking Amantix with another medication, the doctor should check for possible interactions caused by QT interval prolongation. It is possible to treat Amantix in combination with other medications used in Parkinson's disease. To eliminate side effects (e.g. psychotic reactions), it may be necessary to reduce the dose of the prescribed medication or both medications. Concomitant use of Amantix and each of the types of medications or active substances listed below may lead to the following interactions:

Anticholinergic medications
Increased side effects of anticholinergic medications (confusion and hallucinations) (e.g. trihexyphenidyl, benzatropine, scopolamine, biperiden, orphenadrine).
Sympathomimetics indirectly active on the central nervous system
Increased central action of amantadine.
Levodopa (medication used in Parkinson's disease)
Mutual enhancement of therapeutic effect (so levodopa can be taken with Amantix).
Memantine (medication used in dementia)
Memantine may enhance the effect and side effects of Amantix (see section 2 - Warnings and precautions).
Other medications
Concomitant use of diuretics containing triamterene in combination with hydrochlorothiazide may lead to decreased plasma clearance of amantadine, resulting in toxic concentrations in the serum. Therefore, concomitant use of amantadine and such medications should be avoided.
It should be emphasized that the interactions listed above may also apply to medications used in the past.

Taking Amantix with food, drink, and alcohol

You should avoid consuming alcoholic beverages while taking Amantix, as the medication reduces alcohol tolerance.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor or pharmacist before taking this medication.
Amantix tablets are contraindicated in pregnancy and breastfeeding.

Driving and using machines

It cannot be ruled out that Amantix affects concentration and alertness, as well as eye accommodation (adaptation to seeing at different distances), especially in combination with the action of other medications used in Parkinson's disease.
In the early stages of treatment, there may be a further worsening of the ability to drive and operate machines, greater than the impairment caused by the disease itself.
Patients may not be able to react quickly and decisively in unexpected and sudden situations.
You should not drive or operate machines and electrical appliances without consulting a doctor.
Remember that alcohol can increase the impairment of driving ability.

Amantix contains lactose monohydrate and orange yellow (E 110)

Amantix contains lactose monohydrate. Patients with intolerance to some sugars should contact their doctor before taking this medication.
Amantix contains a coloring agent - orange yellow (E 110), which can cause allergic reactions.

3. How to take Amantix

This medication should always be taken according to the doctor's instructions. If you have any doubts, you should consult a doctor or pharmacist.
The following information concerns the dosage of Amantix, unless the doctor recommends otherwise. You should follow the instructions for use, otherwise Amantix may not work properly.

Duration of treatment

Tablets should be taken orally with a small amount of liquid, preferably in the morning and afternoon.
The last daily dose should not be taken later than 4 pm.
You should not stop taking the tablets without consulting a doctor. The doctor determines the duration of treatment based on the patient's condition and individual response to treatment.

Dosage

Treatment of patients with parkinsonian syndromes and drug-induced movement disorders is usually gradual. The required dose and duration of treatment depend on the type and severity of symptoms and are determined by the doctor.
Treatment starts with 1 Amantix tablet once a day for the first 4 to 7 days (corresponding to 100 mg of amantadine sulfate per day). Then the daily dose is increased by 100 mg at weekly intervals until the maintenance dose is reached. The recommended maintenance dose is usually 1 to 3 tablets twice a day (corresponding to 200-600 mg of amantadine sulfate per day). The daily dose can be taken in three divided doses, after consulting a doctor.
In older patients, especially those with agitation, confusion, or delirium syndrome, treatment should be started with a lower dose.
If the patient is taking other anti-Parkinsonian medications, the doctor will determine the Amantix dose 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 will use amantadine in the form of an infusion solution in the event of an acute worsening of Parkinson's disease symptoms (akinesia crisis).

Patients with renal impairment:

The dosage of Amantix tablets must be adjusted according to the glomerular filtration rate (a parameter that determines the degree of kidney function). The appropriate dose of the medication is determined by the doctor.

Use in children and adolescents

There is no data on the use of this medication in children and adolescents.

Taking a higher dose of Amantix than recommended

In case of taking a higher dose of the medication, you should inform your doctor or ask a family member to inform your doctor and agree to be referred to a hospital if severe poisoning occurs, characterized by: nausea, vomiting, tremors or seizures, unsteady gait, blurred vision, lethargy, depression, speech disorders, heart function disorders. After taking Amantix with other medications used in parkinsonism, confusion with hallucinations, and even coma, as well as muscle tremors, have been observed. There is no specific pharmacological treatment or antidote in case of Amantix overdose. The doctor will induce vomiting or perform gastric lavage.
Blood purification by dialysis (hemodialysis) is not recommended due to the low elimination of amantadine during dialysis (about 5%).
In case of life-threatening poisoning, intensive therapy is necessary. The therapeutic procedure should include: administration of fluids and acidification of the urine to accelerate the elimination of the toxic substance, if possible sedation, administration of anticonvulsant and antiarrhythmic medications (lidocaine intravenously). There is no specific medication or antidote.
In the treatment of neurotoxicity symptoms (such as those described above), an attempt can be made to administer physostigmine intravenously in 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 control the conditions that contribute to the development of heart arrhythmia, if necessary, e.g. lack of electrolyte balance (potassium or magnesium deficiency in the blood) or slow heart rate.

Missing a dose of Amantix

You should not take a double dose to make up for a missed dose.
You should continue taking the single dose prescribed by your doctor.

Stopping Amantix treatment

Under no circumstances should you stop treatment without consulting a doctor.
If you want to stop treatment, e.g. due to intolerance to the medication or worsening of symptoms, you should inform your doctor. You should not suddenly stop treatment, as this can cause worsening of symptoms and withdrawal symptoms. In patients with Parkinson's disease, sudden discontinuation of Amantix can lead to severe movement disorders, sometimes including inability to move.

4. Possible side effects

Like all medications, Amantix can cause side effects, although not everyone will experience them.

Possible side effects of Amantix:

Frequent (occurring in more than 1 in 100 people, but less than 1 in 10 people):

• sleep disorders
• anxiety and agitation
• urinary retention in patients with prostate enlargement
• delusional (paranoid) (perception and behavior disorders) with accompanying visual hallucinations, mainly in older patients, these side effects occur more frequently in patients treated with Amantix and other anti-Parkinsonian medications (e.g. levodopa, bromocriptine) or memantine
• marbled blue discoloration (red-blue spots on the skin arranged in a grid), sometimes with accompanying swelling of the legs and ankles
• nausea
• dizziness
• dry mouth
• sudden drop in blood pressure when standing up from a lying or sitting position, which can cause dizziness or fainting (orthostatic hypotension).

Uncommon (affects less than 1 in 100 people):

• blurred vision.

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

• corneal damage, corneal edema, decreased visual acuity.

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

• leukopenia (decreased white blood cell count) and thrombocytopenia (decreased platelet count)
• heart function disorders, such as ventricular tachycardia, atrial fibrillation, torsades de pointes, and QT interval prolongation; these disorders occur most often after exceeding the recommended doses or when taking amantadine with other medications with proarrhythmic action or in the presence of other risk factors for heart function disorders (see section 2 "When not to take Amantix" and "Amantix and other medications")
• transient loss of vision
• increased sensitivity to light
• seizures (usually after exceeding the recommended dose)
• muscle cramps
• disorders of sensation in the limbs.

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

• irresistible urge to behave in an unusual way - strong desire for excessive gambling, disturbed or increased sexual drive, uncontrolled excessive spending or eating, or compulsive overeating.

In case of vision disturbances, such as loss of visual acuity or blurred vision, you should contact a doctor to rule out corneal edema (see section 2).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, ul. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help gather more information on the safety of the medication.

5. How to store Amantix

The medication should be stored out of sight and reach of children.
You should not use this medication after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Store at a temperature below 25°C.
Translation of some information on the immediate packaging:
Batch No.:, Mfg. Dt. andExp. Dt.: see stamp/No. de lote:, Fabr.: yVto.: véase estampado - batch number, production date, and expiration date: see stamp
Партида. N ., Годен до: вж. щампата - batch number and expiration date: see stamp
Medications should not be disposed of in wastewater or household waste. You should ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Amantix contains

The active substance of Amantix is amantadine sulfate.
Each coated tablet contains 100 mg of amantadine sulfate.
The excipients are: lactose monohydrate, microcrystalline cellulose, potato starch, gelatin, povidone K 25, talc, colloidal silica, magnesium stearate, sodium carmellose coating: talc, methacrylic acid butyl copolymer (Eudragit E), titanium dioxide (E 171), magnesium stearate, orange yellow (E 110).

What Amantix looks like and what the packaging contains

Amantix has the form of orange-colored, scored, round tablets. The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow, and not to divide it into equal doses.
The packaging contains 30 or 100 coated tablets in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Merz Pharmaceuticals GmbH
Eckenheimer Landstrasse 100
60318 Frankfurt am Main
Germany

Manufacturer:

Merz Pharmaceuticals GmbH
Eckenheimer Landstrasse 100
60318 Frankfurt am Main
Germany

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Bulgaria, the country of export: 9800025

Parallel import authorization number: 185/25

Date of leaflet approval: 23.05.2025

[Information about the trademark]