Amantix

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. 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, pharmacist, or nurse. 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-Parkinson's medicine).
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 medications 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:

• 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 (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 slow heart rate (less than 55 beats per minute);
• if the patient has changes in the electrocardiogram (ECG) such as a 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 those who have had torsades de pointes);
• if the patient has low 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 treatment with AMANTIX, you should discuss it with your doctor or pharmacist.
You should be particularly careful when taking AMANTIX if you have:

• prostate enlargement;
• increased pressure in the eye (narrow-angle glaucoma);
• kidney failure of varying severity (risk of accumulation of the medicine due to impaired renal clearance) (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 balance disorders);
• 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 QT interval corrected by 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 kidney function, accumulation of the medicine may occur due to impaired excretion by the kidneys. This can lead to the occurrence of symptoms related to overdose of the medicine. 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, you should be particularly careful when taking AMANTIX due to the possible exacerbation of individual symptoms and the possibility of seizures (see sections 3 and 4).
During treatment with 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 the patient experiences palpitations, dizziness, or short-term loss of consciousness (fainting) 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, treatment with 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 at the same time 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.

• Patients with Parkinson's disease often experience clinical symptoms such as: decreased blood pressure, salivation, sweating, increased body temperature, fluid retention, and depression. When taking AMANTIX in this group of patients, you should particularly consider its side effects and interactions.
  Patients who experience difficulties in urinating should contact their doctor.
  If the patient experiences blurred vision or other vision disorders, they should immediately contact an ophthalmologist.
  You should inform your doctor if you or your 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 can include behaviors such as compulsive gambling, overeating or spending money, inappropriate or increased sexual urge, or intensification of sexual thoughts or feelings. The doctor may adjust the dose or discontinue AMANTIX.
  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 elderly patients, the dose should be chosen carefully, especially in the presence of agitation, 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 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 antifungals);
• 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 prolongation of the QT interval.
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 administered medication or both medications.
Taking 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 (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: taking diuretics containing triamterene in combination with hydrochlorothiazide may reduce the plasma clearance of amantadine, leading to toxic concentrations in the serum. Therefore, you should avoid taking amantadine and these types of products at the same time.

Note 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 medicine 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 your doctor or pharmacist before taking this medicine.
AMANTIX tablets are contraindicated in pregnancy and breastfeeding.

Driving and using machines

It cannot be excluded 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.
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.
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 deterioration of the ability to drive.

AMANTIX contains lactose monohydrate and orange yellow

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

3. How to take AMANTIX

This medicine 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 prescribes 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 taking 1 AMANTIX tablet 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 taking 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 a doctor.
In elderly 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 been previously treated with amantadine in the form of an infusion solution, the doctor may use a higher initial dose.
The doctor will use amantadine treatment in the form of an infusion solution in the event of acute worsening of Parkinson's disease symptoms (akinesia crisis).

Patients with kidney function disorders:

The dosage of AMANTIX tablets must be adjusted according to the value of renal clearance (a parameter that determines the degree of kidney function). The appropriate dose of the medicine is determined by the doctor.

Use in children and adolescents

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

Taking a higher dose of AMANTIX than recommended

In the event of taking a higher dose of the medicine, 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, 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 an interval of 5-10 minutes, up to a maximum dose of 2 mg in children.
The doctor will perform an ECG and carefully control the conditions conducive 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 treatment with AMANTIX

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

4. Possible side effects

Like all medicines, AMANTIX can cause side effects, although not everybody gets 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) disorders with accompanying visual hallucinations, mainly in elderly patients, these side effects occur more frequently in patients treated with AMANTIX and other anti-Parkinson's medications (e.g., levodopa, bromocriptine) or memantine
• mottled discoloration of the skin (livedo reticularis), 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 (affecting 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 (decrease in white blood cell count) and thrombocytopenia (decrease in 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 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 estimated from the available data):

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

In the event of vision disorders, 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 this leaflet, you should tell your doctor, pharmacist, or nurse.
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, you can help gather more information on the safety of the medicine.

5. How to store AMANTIX

The medicine should be stored in a place that is 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 month.
Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

Translation of some abbreviations on the immediate packaging:

Č. šarže:; EXP.: see the embossing - batch number and expiry date: see the embossing
Číslo šarže.; Použitelné do: see the embossing - batch number and expiry date: see the embossing

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, sodium carmellose, talc, anhydrous colloidal silica, magnesium stearate.
Coating: talc, methacrylic acid butyl ester copolymer, titanium dioxide, magnesium stearate, orange yellow.

What AMANTIX looks like and what the pack contains

AMANTIX has the form of orange, round, coated tablets with a dividing line on one side. The dividing line on the tablet only facilitates breaking the tablet, for easier swallowing, and does not allow for dividing into equal doses.
The packaging contains 30 or 100 coated tablets in a cardboard box
To obtain more detailed information, you should contact the marketing authorization holder or 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:

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

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
License number in the Czech Republic, the country of export: 27/219/93-C

Parallel import license number: 213/22 Date of leaflet approval: 18.05.2022

[Information about the trademark]