Amantix

Leaflet attached to the packaging: patient information

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 using 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 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 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 symptoms of Parkinson's disease, such as stiffness, tremors, hypokinesia (reduced motor activity) 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 using Amantix

When not to use Amantix:

torsades de pointes);

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)
• with 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 using Amantix

Before starting treatment and after 1 and 3 weeks from the start of therapy, an ECG and the corrected QT value using the Bazett method (QTc) should be performed. The ECG should also be performed before increasing the dose and 2 weeks after each dose increase. Further control ECG examinations 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 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 before, as well as patients with cardiovascular diseases.
If the patient experiences palpitations, dizziness, or short-term loss of consciousness (syncope) while using Amantix, they should immediately stop using Amantix and consult a doctor to check 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.

• Patients with Parkinson's disease often exhibit clinical symptoms such as: decreased blood pressure, salivation, sweating, increased body temperature, fluid retention, and depression. When using Amantix in this group of patients, particular attention should be paid to its side effects and interactions.

Patients who experience difficulties in 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 impulses, 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 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 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

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

The above list may be incomplete. Before using Amantix with another medication, the doctor should check for possible interactions caused by QT interval prolongation.
Concomitant treatment with Amantix and other medications used in Parkinson's disease is possible. To eliminate side effects (e.g., psychotic reactions), it may be necessary to reduce the dose of the administered 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 action (so levodopa can be administered concomitantly with Amantix).
Memantine (medication used in dementia)
Memantine may enhance the action 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

Using Amantix with food, drink, and alcohol

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects 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

The patient should not exclude the influence of Amantix on concentration and alertness, as well as on 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 vehicles 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.
The patient should not drive vehicles and operate machines and electrical devices without consulting their doctor.
The patient should remember that alcohol can exacerbate the deterioration of the ability to drive vehicles.

Amantix contains lactose, orange yellow S (E 110), and sodium

Amantix contains lactose. Patients with intolerance to some sugars should contact their doctor before starting to use this medication.
Amantix contains a colorant - orange yellow S (E 110), which may cause allergic reactions.
This medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to use Amantix

This medication should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor or pharmacist.
The following information concerns the dosing of Amantix, unless the doctor prescribes 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 based on the patient's condition and individual response to 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 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 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 elderly patients, especially those with agitation, confusion, or delirium syndrome, treatment should be started with a lower dose.
If the patient is also taking other anti-Parkinsonian 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 acute worsening of Parkinson's disease symptoms (akinesia crisis).

Patients with renal impairment

The dosing of Amantix tablets must be adjusted according to the creatinine clearance value (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 the 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 rhythm disorders.
After concomitant administration of Amantix with other medications used in parkinsonism, states of confusion with hallucinations, and even coma, have been observed, as well as muscle tremors.
There is no known specific pharmacological treatment or antidote in the event of an overdose of Amantix. The doctor will induce vomiting or perform gastric lavage.
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 approach 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 known 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 examination and carefully control the conditions that contribute to the development of heart 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.

Stopping the use of Amantix

Under no circumstances should the patient stop treatment without consulting their doctor.
If the patient wants to stop treatment, e.g., due to intolerance to the medication or worsening of symptoms, they should inform their doctor. The patient should not suddenly stop treatment, as this may cause worsening of symptoms and withdrawal symptoms.
In patients with Parkinson's disease, the patient should not suddenly stop taking Amantix, as this may lead to severe movement disorders, sometimes including the 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 more frequently than 1 in 100 people, but less frequently than 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, mainly occurring in older patients, these side effects occur more frequently in patients treated concomitantly with Amantix and other anti-Parkinsonian medications (e.g., levodopa, bromocriptine) or memantine
• mottled discoloration of the skin (livedo reticularis), sometimes with accompanying edema of the lower limbs 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 1 in 10,000 people, but less frequently than 1 in 1,000 people):

• corneal damage, corneal edema, decreased visual acuity

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

• leukopenia (decreased white blood cell count) and thrombocytopenia (decreased platelet count)
• heart rhythm 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 rhythm 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 from available data):

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

In the event of visual 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 side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration 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 patient should not use this medication after the expiration date stated on the packaging. The expiration date indicates the last day of the specified month.
The patient should not store the medication at a temperature above 25°C.

Translation of some information on the immediate packaging:

Ch.-B.:/Verwedbar bis: see imprint - batch number; expiration date: see imprint
Medications should not be disposed of in wastewater or household waste. 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 25, sodium croscarmellose, talc, anhydrous colloidal silica, magnesium stearate, methacrylic acid butyl ester copolymer, orange yellow S (E 110), titanium dioxide.

What Amantix looks like and what the packaging contains

Amantix has the form of orange-colored, scored, round coated 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 100 coated tablets in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization 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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Germany, the country of export:6423692.00.00

Parallel import authorization number: 40/23 Date of leaflet approval: 09.03.2023

[Information about the trademark]