Viregit-k

Leaflet accompanying the packaging: information for the user

Viregyt-K, 100 mg, capsules

Amantadine hydrochloride

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

• Please 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 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 inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Viregyt-K and what is it used for
• 2. Important information before taking Viregyt-K
• 3. How to take Viregyt-K
• 4. Possible side effects
• 5. How to store Viregyt-K
• 6. Contents of the packaging and other information

1. What is Viregyt-K and what is it used for

Viregyt-K 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. Viregyt-K also has antiviral properties.
Viregyt-K is used

• to treat Parkinson's disease by improving muscle control and reducing stiffness, tremors, and bradykinesia,
• to treat a certain type of flu (influenza A).

2. Important information before taking Viregyt-K

When not to take Viregyt-K:

• if the patient is allergic to amantadine or any of the other ingredients of this medicine (listed in section 6),
• if the patient has seizures, such as epilepsy,
• if the patient has had a stomach ulcer,
• if the patient has severe kidney disease,
• if the patient is pregnant or plans to have a child (see section 2 Pregnancy and breastfeeding),
• if the patient is breastfeeding (see section 2 Pregnancy and breastfeeding).

If any of the above points apply to the patient, and in case of any doubts, before starting to take Viregyt-K, the patient should consult a doctor or pharmacist.

Warnings and precautions

Before starting to take Viregyt-K, the patient should consult a doctor or pharmacist.
Before starting to take Viregyt-K, the patient should consult a doctor:

• if the patient has liver or kidney disease,
• if the patient has a history of heart or blood vessel disease,
• if the patient currently has disorders of heart function or heart failure (heart function disorders causing shortness of breath or swelling of the ankles) or a condition that predisposes the patient to certain changes in the electrocardiogram (ECG),
• if the patient has a mental illness, such as schizophrenia or dementia,
• if the patient has increased intraocular pressure (glaucoma).

If any of the above points apply to the patient, and in case of any doubts, before starting to take Viregyt-K, the patient should consult a doctor or pharmacist.
The patient should inform the 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 untypical for them and the patient is unable to resist these impulses, 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 urge or increased sexual thoughts or feelings. The doctor may modify the dose or stop the use of Viregyt-K.
During treatment with amantadine, there have been cases of suicidal thoughts and behaviors. If the patient has thoughts of self-harm or suicide or attempts to do so, they should contact their doctor immediately.
If the patient experiences blurred vision or other vision problems, they should contact an ophthalmologist immediately.
Abnormally low body temperature (below 35°C) may occur, especially in children being treated for flu. In such a case, the patient should immediately inform their doctor and stop taking Viregyt-K.

Children and adolescents

The dosage for children under 10 years of age in influenza A virus infections has not been established. Before giving any medicine to a child, the patient should always consult a doctor.

Viregyt-K and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Especially about the following medicines, as they may interfere with the action of Viregyt-K:

• anticholinergic medicines - used to treat Parkinson's disease, such as procyclidine;
• levodopa - used to treat Parkinson's disease;
• medicines that may enhance the effects of anticholinergic type - such as medicines used to treat depression, antipsychotic medicines (used to treat severe mental disorders), antihistamine medicines (used to suppress allergic reactions), phenothiazine derivatives (used to treat severe mental disorders);
• antispasmodic medicines - used to treat stomach cramps, such as hyoscine;
• medicines that may cause certain changes in the ECG (electrocardiogram, e.g., ziprasidone);
• antipsychotic medicines - used to improve thinking, emotional, and behavioral disorders in certain mental illnesses, such as chlorpromazine, haloperidol;
• diuretic medicines (diuretics) - used to reduce water retention in the body and lower high blood pressure, such as hydrochlorothiazide, amiloride, or triamterene.

Taking Viregyt-K with food, drinks, and alcohol

While taking Viregyt-K, the patient should not drink alcoholic beverages.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The patient should not take Viregyt-K during pregnancy or when planning to become pregnant.
The patient should not take Viregyt-K during breastfeeding, as the medicine passes into breast milk and may have a harmful effect on the child.

Driving and using machines

Taking Viregyt-K may cause vision disturbances or dizziness. If such symptoms occur, the patient should not drive or operate machines until the symptoms have resolved.

Viregyt-K contains lactose monohydrate

Each capsule contains 98 mg of lactose monohydrate. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to take Viregyt-K

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor.
The capsules should be taken orally. The capsules should be swallowed whole with water.
The recommended dose varies depending on the disease being treated:
Parkinson's disease
Adults:1 capsule (100 mg) per day for the first week.
The doctor will increase this dose to 2 capsules per day (200 mg).
In some cases, higher doses may be used, up to 4 capsules (400 mg) per day. The dose should not exceed 400 mg/day.
Adults over 65 years of age:1 capsule (100 mg) once a day. The doctor may prescribe a lower dose.
Influenza A virus infections
Adults:1 capsule (100 mg) per day.
Adults over 65 years of age:1 capsule (100 mg) once a day.
In the treatment of flu: Viregyt-K should be taken for about 4 to 5 days.
In case of kidney function disorders, the doctor may prescribe a lower dose.

Use in children and adolescents

Treatment of influenza A virus infections
Children and adolescents (10 to 15 years):1 capsule (100 mg) per day.
Children (under 10 years):according to the doctor's recommendations.

Taking a higher dose of Viregyt-K than recommended

In case of accidental ingestion of too many capsules by the patient or another person, the patient should immediately inform their doctor or contact the nearest hospital emergency department. The patient should show the doctor the remaining medicine or the empty packaging.

Missing a dose of Viregyt-K

The patient should not worry. If a dose is missed, the patient should take the next dose as soon as they remember, unless it is almost time for the next dose. Then, the patient should continue with the prescribed dosing schedule. The patient should not take a double dose to make up for the missed dose.

Stopping the use of Viregyt-K

In Parkinson's disease, the patient should not suddenly stop taking Viregyt-K, as the disease symptoms may worsen.
If the patient wants to stop taking Viregyt-K, they should ask their doctor, who will inform them how to gradually reduce the dose of the medicine.
If the patient is taking antipsychotic medicines (used to treat mental disorders) and suddenly stops taking Viregyt-K, they may experience a set of symptoms including:

• fever
• sweating
• rapid heartbeat
• muscle stiffness (difficulty moving)
• loss of bladder control (sudden need to urinate).

If these symptoms occur, the patient should immediately contact their doctor.
Some patients may notice that this medicine loses its effect in Parkinson's disease after regular use for several months. If this is the case, the patient should inform their doctor.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Viregyt-K can cause side effects, although not everybody gets them.
These effects are usually mild and may disappear after a few days of treatment. If the side effects are severe and persist for a few days, the patient should inform their doctor or pharmacist.
If the patient experiences any of the following symptoms, they should contact their doctor or the nearest hospital:

• dizziness or feeling of emptiness in the head
• fainting
• seizures

The patient should inform their doctor or pharmacist if they experience any of the following symptoms or other symptoms related to the use of Viregyt-K.
Very common side effects (may affect more than 1 in 10 people):
swelling of the ankles, red spots on the skin (mottled discoloration).
Common side effects (may affect up to 1 in 10 people):
anxiety, improved mood, lethargy, nervousness, depression, insomnia, feeling of emptiness in the head, headache, difficulty controlling movements (ataxia), slurred speech, loss of concentration, rapid or irregular heartbeat (palpitations), low blood pressure when standing up from a lying position, which may cause dizziness or fainting (orthostatic hypotension), dry mouth, loss of appetite, nausea, vomiting, constipation, excessive sweating, muscle pain.
Hallucinations, confusion, and nightmares (if amantadine is given with anticholinergic medicines or the patient has a mental illness).
Uncommon side effects (may affect up to 1 in 100 people):
blurred vision.
Rare side effects (may affect up to 1 in 1,000 people):
confusion, disorientation (loss of sense of time and place), mental disorders and behaviors such as paranoid feelings (psychosis), tremors, difficulty moving, seizures, symptoms such as those of malignant neuroleptic syndrome (may include feelings of heat, muscle stiffness, altered consciousness), diarrhea, rash, eye problems (such as burning and redness of the eyes, corneal damage, corneal edema, decreased visual acuity), loss of bladder control. The patient may experience difficulty urinating or a sudden need to urinate.
Very rare side effects (may affect up to 1 in 10,000 people):
heart function disorders causing shortness of breath or swelling of the ankles, decreased white blood cell count, which increases the risk of infections, changes in blood test results related to liver function, hypersensitivity to light.
Frequency not known (frequency cannot be estimated from the available data):
delirium (disorder of attention, perception, thinking, and memory), hypomanic and manic states (feeling unusually good mood).
Abnormally low body temperature (below 35°C) may occur, especially in children.
Irresistible urge to behave in an untypical way - strong impulse to gamble excessively, disturbed or increased sexual urge, uncontrolled excessive spending or buying, pathological overeating (consuming a large amount of food in a short time) or compulsive overeating (consuming more food than usual and more than needed to satisfy hunger).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their 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, more information can be collected on the safety of the medicine.

5. How to store Viregyt-K

Store in a temperature below 25°C.
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 packaging. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Viregyt-K contains

• The active substance is 100 mg of amantadine hydrochloride in each capsule.
• The other ingredients are: magnesium stearate, lactose monohydrate. Capsules: quinoline yellow (E 104), indigo carmine (E132), titanium dioxide (E 171), gelatin.

What Viregyt-K looks like and what the packaging contains

Green capsules in an orange glass bottle with an LDPE cap with a guarantee seal and a shock absorber in a cardboard box with a patient leaflet.
The packaging contains 50 capsules.
Green capsules in a brown glass bottle with a volume of 30 mL with a cap with a guarantee ring and a shock absorber made of polyethylene (LDPE) type FG-7 in a cardboard box with a patient leaflet.
The packaging contains 30 capsules.

Marketing authorization holder

EGIS Pharmaceuticals PLC 1106 Budapest, Keresztúri út 30-38 Hungary

Manufacturer

EGIS Pharmaceuticals PLC. 9900 Körmend, Mátyás király u. 65 Hungary For more detailed information on this medicine, the patient should contact the local representative of the marketing authorization holder: EGIS Polska Sp. z o.o. ul. Komitetu Obrony Robotników 45D 02-146 Warsaw Tel.: +48 22 417 92 00

Date of last revision of the leaflet: 4.12.2024