Amantix

Leaflet attached to the packaging: patient information

AMANTIX, 100 mg, coated tablets

Amantadine sulfate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet, so you can read it again if you need to.
In case of any doubts, consult a doctor or pharmacist.
This medicine has been prescribed to a specific person. 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 the medicine and what is it used for
• 2. Important information before taking the medicine
• 3. How to take the medicine
• 4. Possible side effects
• 5. How to store the medicine
• 6. Contents of the packaging and other information

1. What is AMANTIX medicine and what is it used for

The medicine 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.
The medicine reduces the severity of Parkinson's disease symptoms (anti-Parkinsonian medicine).
The tablet is used:
to treat symptoms of Parkinson's disease and parkinsonian syndromes, such as stiffness, tremors, hypokinesia (reduced motor activity) or akinesia (immobility);
to treat 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, irresistible urge to move (akathisia) and parkinsonism).

2. Important information before taking AMANTIX medicine

When not to take AMANTIX medicine:

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 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 low potassium or magnesium levels in the blood;
if the patient is pregnant or breastfeeding;
if the patient is taking medicines that prolong the QT interval (see section 2 – Medicine and other medicines).

Warnings and precautions

Before starting treatment, discuss it with your doctor or pharmacist.
Be particularly careful when taking the medicine to patients with:
prostate enlargement (prostate);
increased pressure in the eye (narrow-angle glaucoma);
kidney failure of varying severity (risk of medicine accumulation due to impaired renal filtration) (see section 3);
states of agitation or confusion (disorientation) currently or in the past;
psychiatric disorders (delirious 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-electrolyte imbalance);
treated with memantine (see section 2 – Medicine and other medicines).

Other important information about taking AMANTIX medicine

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 the medicine should be made individually for each patient, after consulting a cardiologist.
In patients with impaired kidney function, medicine accumulation may occur due to impaired excretion by the kidneys. This can lead to the occurrence of symptoms related to medicine 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 the medicine due to the possible exacerbation of individual symptoms and the possibility of seizures (see sections 3 and 4).
During treatment with amantadine, cases of suicidal thoughts and behaviors have occurred. If the patient has thoughts of self-harm or suicide or attempts to do so, they should contact their doctor immediately.
The patient should inform their doctor if they or their family members and/or caregivers notice that the patient has a desire or irresistible urge to behave in a way that is unusual 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 increased sexual drive or increased sexual thoughts or feelings. The doctor may modify the dose or discontinue the medicine.
Amantadine should be avoided in the prophylaxis 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 people

In elderly people, the dose should be chosen carefully, especially in the case of agitation and confusion or delirious syndrome (see section 3).

AMANTIX medicine and other medicines

Tell your doctor about all medicines you are taking now or recently, and about medicines you plan to take.
The medicine cannot be taken with other medicines that cause QT interval prolongation, such as:
certain medicines used to treat irregular heart rhythm (antiarrhythmic medicines of class IA, e.g. quinidine, disopyramide, procainamide, and class III, e.g. amiodarone, sotalol);
certain medicines used to treat mental illnesses (antipsychotic medicines, 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, cotrimoxazole, pentamidine, cisapride, or bepridil.
The above list may be incomplete. Before taking the medicine with another medicine, the doctor should check for the possibility of an interaction caused by QT interval prolongation.
It is possible to treat with the medicine and other medicines used in Parkinson's disease. To eliminate side effects (e.g. psychotic reactions), it may be necessary to reduce the dose of the administered medicine or both medicines.
Concomitant use of the medicine and each of the types of medicines or active substances listed below may lead to the following interactions:
Anticholinergic medicines
Increased side effects of anticholinergic medicines (e.g. trihexyphenidyl, benzatropine, scopolamine, biperiden, orphenadrine).
Sympathomimetics indirectly active on the central nervous system
Increased central action of amantadine.
Levodopa (medicine used in Parkinson's disease)
Mutual enhancement of therapeutic action (so levodopa can be taken with the medicine).
Memantine (medicine used in dementia)
Memantine may enhance the action and side effects of the medicine (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 concentrations in the serum. Therefore, concomitant use of amantadine and such products should be avoided.

Taking AMANTIX medicine with food, drink, and alcohol

Alcoholic beverages should be avoided while taking the medicine, as it 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 taking this medicine.
The tablet is contraindicated in pregnancy and breastfeeding.

Driving and using machines

The medicine may affect concentration and alertness, as well as eye accommodation (adaptation to seeing at different distances), especially in combination with other medicines used in Parkinson's disease.
At the beginning of treatment, there may be a further deterioration of driving ability and machine operation, 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.
Do not drive or operate machines and electrical devices without consulting a doctor.
Remember that alcohol can increase the deterioration of driving ability.

AMANTIX medicine contains lactose and orange yellow

The medicine contains lactose (in the form of monohydrate). If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains a coloring agent - orange yellow (E 110), which can cause allergic reactions.

3. How to take AMANTIX medicine

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The following information is about the dosage of the medicine, unless your doctor has prescribed otherwise. Follow the instructions for use, otherwise the medicine 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.
Do not stop taking the tablets without consulting your doctor. The doctor determines the duration of treatment depending on the patient's condition and individual reaction 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 tablet of the medicine 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 usual recommended maintenance dose is 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 delirious syndrome, treatment should be started with a lower dose.
If the patient is also taking other anti-Parkinsonian medicines, the doctor will determine the dose of the medicine 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 treatment in the form of an infusion solution in the case of acute worsening of Parkinson's disease symptoms (akinesia crisis).

Patients with kidney function disorders:

The dosage of the tablet 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 the medicine in children and adolescents.

Taking a higher dose of AMANTIX medicine than recommended

In case of taking a higher dose of the medicine, inform your doctor or ask a family member to inform your doctor and agree to be referred by the doctor to the hospital if severe poisoning occurs, characterized by: nausea, vomiting, tremors or seizures, unsteady gait, blurred vision, lethargy, depression, speech disorders, heart rhythm disorders.
After taking the medicine with other medicines 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 overdose of the medicine. 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 case of life-threatening poisoning, intensive therapy is necessary. The therapeutic procedure should include: administration of fluids and acidification of urine to accelerate the elimination of the toxic substance, if possible sedation, administration of anticonvulsant and antiarrhythmic medicines (lidocaine intravenously). There is no specific medicine 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 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 medicine

Do not take a double dose to make up for a missed dose.
Continue taking the single dose prescribed by your doctor.

Stopping AMANTIX medicine

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects:

If the patient experiences any of the following side effects, they should inform their doctor, who will decide on further action.
Frequent (affects less 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 in elderly patients, these side effects occur more frequently in patients treated with the medicine and other anti-Parkinsonian medicines (e.g. levodopa, bromocriptine) or memantine
livedo reticularis (mottled discoloration of the skin), 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
Very rare (affects less than 1 in 100 people):
blurred vision
Rare (affects less than 1 in 1000 people):
corneal damage, corneal edema, decreased visual acuity
Very rare (affects less than 1 in 10,000 people):
leukopenia (decreased white blood cell count) and thrombocytopenia (decreased platelet count)
heart rhythm disorders, such as ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT interval prolongation; these disorders occur most frequently after exceeding the recommended doses or when taking amantadine with other medicines with proarrhythmic action or in the presence of other risk factors for heart rhythm disorders (see section 2 "When not to take the medicine" and "Medicine and other medicines")
transient vision loss
increased sensitivity to light
seizures (usually after exceeding the recommended dose)
muscle cramps
numbness or tingling in the limbs
Frequency not known (cannot be estimated from the available data):

• irresistible urge to behave in an unusual way - strong desire for excessive gambling, disturbed or increased sexual drive, uncontrolled excessive buying or spending money, overeating (eating a large amount of food in a short time) or compulsive overeating (eating more food than usual and more than needed to satisfy hunger)

In case of visual disturbances, such as blurred vision or loss of visual acuity, consult 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 or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store AMANTIX medicine

Keep the medicine out of the 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.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What does AMANTIX medicine contain

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

What AMANTIX medicine looks like and what the pack contains

The medicine is in the form of orange, round, 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 pack contains 30 or 100 coated tablets in a cardboard box
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Merz Pharmaceuticals GmbH
Eckenheimer Landstrasse 100
60318 Frankfurt/Main
Germany
Tel: +49 69 1503 0
e-mail: [email protected]

Manufacturer

Merz Pharma GmbH & Co. KGaA
Eckenheimer Landstrasse 100
60318 Frankfurt/Main
Germany

Date of last revision of the leaflet: