Amantix

Leaflet attached to 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 drug.

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

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform 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 using Amantix
• 3. How to use 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 drug, 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-Parkinson's drug).
Amantix, tablets are used:

• to treat symptoms of Parkinson's disease, 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 using Amantix

When not to use Amantix:

• if the patient is allergic to amantadine or any of the other ingredients of this drug (listed in section 6);
• if the patient has severe uncontrolled heart failure (grade IV according to NYHA);
• if the patient has heart diseases such as cardiomyopathy, myocarditis;
• if the patient has conduction disorders in the heart (second or third degree atrioventricular block);
• if the patient has a heart rate of 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 heart rhythm disorders (ventricular arrhythmias, including torsades de pointes );
• if the patient has decreased potassium or magnesium levels in the blood;
• if the patient is pregnant or breastfeeding;
• if the patient is taking medications that prolong the QT interval (see section 2 - Amantix and other medications).

Warnings and precautions

Before starting to use Amantix, you should discuss it with your doctor or pharmacist.
You should be particularly careful when using Amantix in patients with:

• prostate enlargement (prostate);
• 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 diuretic medications 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 using Amantix

Before starting treatment and after 1 and 3 weeks from the start of therapy, an ECG should be performed and the corrected QT value (QTc) should be determined using the Bazett method. 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 may 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 using Amantix due to the possible exacerbation of individual symptoms and the possibility of seizures (see sections 3 and 4).
During the use of Amantix, the doctor must regularly monitor patients prone to seizures, including those who have had seizures in the past, as well as patients with cardiovascular diseases.
If, during the use of Amantix, the patient experiences palpitations, dizziness or short-term loss of consciousness (syncope), the use of Amantix should be discontinued immediately and a doctor should be consulted to check the heart function (heart rhythm) through 24-hour monitoring. If the doctor does not find any heart function disorders, the use of Amantix 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, in the event of sudden discontinuation of Amantix, at risk of developing a life-threatening condition - so-called malignant neuroleptic syndrome.
This syndrome is accompanied 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 using Amantix in this group of patients, particular attention should be paid to its adverse reactions and interactions.
Patients who experience difficulty urinating should contact their doctor.
If the patient experiences blurred vision or other vision disturbances, they should immediately contact an ophthalmologist.
The doctor should be informed if the patient or their family members and/or caregivers notice that the patient has a desire or irresistible urge to behave in a way that is atypical for them and the patient is unable to resist these urges, or a desire or temptation to behave in a way that could be harmful to the patient or others. These are so-called impulse control disorders, which may include behaviors such as compulsive gambling, overeating or spending money, inappropriate or increased sexual urge or increased thoughts or feelings of a sexual nature. The doctor may modify the dose or discontinue the use of 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 on the use of this drug in children and adolescents.

Elderly

In older people, the dose should be chosen carefully, especially in the presence of agitation, confusion or delirium syndrome (see section 3).

Amantix and other medications

The patient should tell their doctor about all medications they are currently taking or have recently taken, as well as medications they plan to take.
Amantix should not be used at the same time as 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 illnesses (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 (azole antifungal medications);
• other medications, such as budipine, halofantrine, cotrimoxazole, pentamidine, cisapride or bepridil.

The above list may be incomplete. Before using Amantix at the same time as another medication, the doctor should check for the possibility of an interaction caused by prolongation of the QT interval.
It is possible to use Amantix in combination with other medications used to treat Parkinson's disease. In order to eliminate adverse reactions (e.g. psychotic reactions), it may be necessary to reduce the dose of the administered medication or both medications.
The simultaneous use of Amantix and each of the types of medications or active substances listed below may lead to the following interactions:
Anticholinergic medications
Increased adverse reactions (confusion and hallucinations) of anticholinergic medications (e.g. trihexyphenidyl, benzatropine, scopolamine, biperiden, orphenadrine).
Sympathomimetics with indirect action on the central nervous system
Increased central action of amantadine.
Levodopa (medication used to treat Parkinson's disease)
Mutual enhancement of therapeutic action (so levodopa can be administered simultaneously with Amantix).
Memantine (medication used to treat dementia)
Memantine may enhance the action and adverse reactions of Amantix (see section 2 - Warnings and precautions).
Other medications
The simultaneous use of diuretic medications containing triamterene in combination with hydrochlorothiazide may lead to a decrease in the plasma clearance of amantadine, resulting in toxic concentrations in the serum. Therefore, the simultaneous use of amantadine and such medications should be avoided.

Using Amantix with food, drink and alcohol

The patient should avoid consuming alcoholic beverages while using Amantix, as the drug reduces alcohol tolerance.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before using this medication.
Amantix, tablets are contraindicated in pregnancy and breastfeeding.

Driving and using machines

It cannot be excluded that Amantix may affect concentration and alertness, as well as eye accommodation (adaptation to seeing at different distances), especially in combination with the action of other medications used to treat Parkinson's disease.
At the beginning of treatment, there may be a further deterioration in the ability to drive and operate machines, greater than the impairment caused by the disease itself.
The patient may not be able to react quickly and decisively in unexpected and sudden situations.
Driving and operating machines and electrical equipment should not be performed without consulting a doctor.
It should be remembered that alcohol can exacerbate the deterioration of the ability to drive.

Amantix contains lactose monohydrate and orange yellow (E 110)

Amantix contains lactose monohydrate. Patients with intolerance to some sugars should consult their doctor before starting to use this medication.
Amantix contains a colorant - orange yellow (E 110), which may cause allergic reactions.

3. How to use Amantix

This medication should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
The following information concerns the dosing of Amantix, unless the doctor recommends otherwise. The patient should follow the instructions for use, 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 afternoon.
The last daily dose should not be taken later than 4 pm.
The patient should not stop taking the tablets without consulting their doctor. The doctor determines the duration of treatment depending on the patient's condition and their individual reaction to the treatment.

Dosing

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 tablet of Amantix once a day for the first 4 to 7 days (which corresponds 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 (which corresponds to 200-600 mg of amantadine sulfate per day). The daily dose can be taken in three divided doses, after consulting the 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-Parkinson's medications, the doctor will determine the 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 will use amantadine in the form of an infusion solution in the event of an acute worsening of Parkinson's disease symptoms (akinetic crisis).

Patients with renal impairment:

The dosing 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.

Using a higher than recommended dose of Amantix

In the event of taking a higher dose of the medication, the patient should inform their doctor or ask a family member to inform their doctor and agree to be referred to a hospital if severe poisoning occurs, manifested by: nausea, vomiting, tremors or seizures, unsteady gait, blurred vision, lethargy, depression, speech disorders, heart function disorders. After taking Amantix simultaneously with other medications used in parkinsonism, states of confusion with hallucinations, and even coma, as well as muscle tremors, have been observed. There is no specific pharmacological treatment or antidote in the event of an overdose of Amantix. 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 the event 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 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 cardiac arrhythmia, if necessary, e.g. electrolyte imbalance (potassium or magnesium deficiency in the blood) or slow heart rate.

Missing a dose of Amantix

The patient should not take a double dose to make up for a missed dose.
The patient should continue taking the single dose prescribed by their doctor.

Discontinuing Amantix

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

4. Possible side effects

Like any medication, Amantix can cause side effects, although not everyone will experience them.

Possible side effects of Amantix:

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

• sleep disorders
• anxiety and agitation
• urinary retention in patients with prostate enlargement (prostate)
• delusional (paranoid) (perception and behavior disorders) with accompanying visual hallucinations, usually occurring in older patients, these side effects occur more frequently in patients treated simultaneously with Amantix and other anti-Parkinson's medications (e.g. levodopa, bromocriptine) or memantine
• marbled discoloration of the skin (red-blue spots on the skin, arranged in a grid-like pattern), 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 a feeling of fainting (orthostatic hypotension)

Uncommon (affecting less than 1 in 100 people):

• blurred vision

Rare (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 rare (occurring less frequently than in 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 frequently after exceeding the recommended doses or when using amantadine in combination with other medications with proarrhythmic action or in the presence of other risk factors for heart function disorders (see section 2 "When not to use Amantix" and "Amantix and other medications")
• transient loss of vision
• increased sensitivity to light
• seizures (usually after exceeding the recommended dose)
• muscle spasms
• disorders of sensation in the limbs

Frequency not known (cannot be determined based on available data):

• irresistible urge to behave in an atypical way - strong desire for excessive gambling, disturbed or increased sexual urge or increased thoughts or feelings of a sexual nature, uncontrolled or excessive spending of money, overeating or compulsive eating (eating a large amount of food in a short time) or binge eating

In the event of vision disturbances, such as loss of visual acuity or blurred vision, the patient should contact their doctor to rule out corneal edema (see section 2).

Reporting side effects

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

5. How to store Amantix

The medication should be stored in a place that is not visible and inaccessible to children.
The medication should not be used after the expiration date stated on the packaging. The expiration date indicates the last day of the specified month.
Store at a temperature below 25°C.

Translation of some information on the immediate packaging:

Batch number:; EXP.: see embossing - batch number and expiration date: see embossing
Batch number.; Valid until: see embossing - batch number and expiration date: see embossing
Medications should not be thrown into the sewage system or household waste containers. The patient should ask their 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, anhydrous colloidal silica, magnesium stearate, sodium carmellose, butyl methacrylate copolymer, orange yellow (E 110), titanium dioxide (E 171).

What Amantix looks like and what the packaging contains

Amantix has the form of orange-colored, coated tablets with a dividing line on one side. The dividing line on the tablet is only to facilitate breaking the tablet, not to divide it into equal doses.
The packaging contains 30 or 100 coated tablets in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, 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:

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

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in the Czech Republic, the country of export: 27/219/93-C

Parallel import authorization number: 161/23

Date of leaflet approval: 16.08.2023

[Information about the trademark]