Viregyt-k

Package leaflet: Information for the user

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Viregyt-K (Viregyt), 100 mg, hard capsules
Amantadini hydrochloridum
Viregyt-K and Viregyt are different trade names of the same medicinal product.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

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

Viregyt-K is a dopaminergic medicine, which means it can increase the levels of certain chemical substances that transmit impulses in the nervous system, including the brain. Viregyt-K also has antiviral activity.
Viregyt-K is used:

• in the treatment of Parkinson's disease by improving muscle control and reducing stiffness, tremor, and slowness
• in the treatment of certain types of influenza (influenza A).

2. Important information before using Viregyt-K

When not to use 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, for example epilepsy,
• if the patient has a history of peptic ulcer disease,
• if the patient has severe kidney disease,
• if the patient is pregnant or planning to become pregnant (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, or if there is any uncertainty,
consult a doctor or pharmacist before starting treatment with Viregyt-K.
Warnings and precautions
Consult a doctor or pharmacist before starting treatment with Viregyt-K.
Consult a doctor before starting treatment with Viregyt-K:

• if the patient has liver or kidney disease,
• if the patient has a history of cardiovascular disease,
• if the patient currently has heart function disorders or heart failure (heart problems causing shortness of breath or ankle swelling) or a condition that may predispose to certain changes in the electrocardiogram (ECG),
• if the patient has a psychiatric disorder, for example schizophrenia or dementia,
• if the patient has increased intraocular pressure (glaucoma).

If any of the above points apply to the patient, or if there is any uncertainty,
consult a doctor or pharmacist before starting treatment with Viregyt-K.
Inform the doctor if the patient or family members and/or caregivers notice
an urge or irresistible desire to behave in an unusual way, and the patient is unable to resist these impulses, urges, or cravings to act in a way that could be harmful to the patient or others. These are known as impulse control disorders, which may include behaviors such as pathological gambling, excessive eating or spending, abnormally increased sexual drive, or intensified sexual thoughts or feelings. The doctor may adjust the dose or discontinue treatment with Viregyt-K.
If the patient experiences blurred vision or other vision problems, contact an ophthalmologist immediately.
Abnormally low body temperature (below 35°C) may occur, especially in children treated for influenza. In such a case, inform the doctor immediately and discontinue use of Viregyt-K.
Children and adolescents
The dosage has not been established in children under 10 years of age for influenza A virus infections. Always consult a doctor before giving any medicine to a child.
Viregyt-K and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, mention the following medicines, as they may interfere with the action of Viregyt-K:

• anticholinergic drugs – used in the treatment of Parkinson's disease, such as procyclidine;
• levodopa – used in the treatment of Parkinson's disease;
• medicines that may enhance cholinergic-type effects – for example, antidepressants, antidyskinetic drugs (relieving involuntary, rapid, sudden, irregular, and stereotyped movements), antihistamines (suppressing allergic reactions), phenothiazine derivatives (used in the treatment of severe psychiatric disorders);
• antispasmodic drugs – used to treat stomach cramps, such as hyoscine;
• medicines that may cause certain changes in the ECG (electrocardiogram), e.g. ziprasidone;
• antipsychotic drugs – used to improve disturbances in thinking, emotions, and behavior occurring in certain psychiatric disorders, such as chlorpromazine, haloperidol;
• diuretics – used to reduce fluid retention in the body and lower high blood pressure, such as hydrochlorothiazide, amiloride, or triamterene.

Taking Viregyt-K with food, drink, and alcohol
Do not drink alcoholic beverages during treatment with Viregyt-K.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Do not take Viregyt-K during pregnancy or when planning to become pregnant.
Do not take Viregyt-K while breastfeeding, as the medicine passes into breast milk and may have harmful effects on the infant.
Driving and operating machinery
Treatment with Viregyt-K may cause visual disturbances or dizziness. If such symptoms occur, the patient should not drive or operate machinery until symptoms resolve.
Viregyt-K contains monohydrate lactose
Each capsule contains 98 mg of monohydrate lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Viregyt-K

This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor.
The capsules should be taken orally. Swallow the capsules 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.
Your 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. Do not exceed the dose of 400 mg/day.
Adults over 65 years of age: 1 capsule (100 mg) once daily. Your doctor may prescribe a lower dose.
Influenza virus infection (influenza A)
Adults: 1 capsule (100 mg) per day.
Adults over 65 years of age: 1 capsule (100 mg) once daily.
In the treatment of influenza: Viregyt-K should be used for approximately 4 to 5 days.
If renal function is impaired, your doctor may prescribe a lower dose.
Use in children and adolescents.
Treatment of influenza virus infection (influenza A):
Children and adolescents (10 to 15 years): 1 capsule (100 mg) per day.
Children (under 10 years): as directed by the physician.
Use of a higher than recommended dose of Viregyt-K
If an excessive number of capsules has been accidentally ingested by the patient or another person, contact a doctor immediately or go to the nearest hospital emergency department. Show the doctor the remaining medicine or empty packaging.
Missed dose of Viregyt-K
Do not be alarmed. If a dose is missed, take the next dose as soon as you remember, unless it is almost time for the next scheduled dose. Then continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.
Stopping Viregyt-K
In Parkinson's disease, do not suddenly stop using Viregyt-K, as symptoms may worsen.
If you wish to discontinue Viregyt-K, consult your doctor, who will advise you on how to gradually reduce the dose.
In patients taking antipsychotic medicines (used to treat psychiatric disorders), abrupt discontinuation of Viregyt-K may lead to the development of a group of symptoms including:

• fever,
• sweating,
• rapid heartbeat,
• muscle rigidity (difficulty moving),
• loss of bladder control (sudden urge to urinate).

If these symptoms occur, contact your doctor immediately.
Some patients may notice that this medicine loses its effect in Parkinson's disease after regular use for several months. If this occurs, inform your doctor.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
These reactions are often mild and may resolve after a few days of treatment. If adverse reactions are severe and persist for several days, inform your doctor or pharmacist.
If any of the following symptoms occur, contact your doctor or nearest hospital:

• dizziness or feeling faint,
• fainting,
• seizures.

Inform your doctor or pharmacist if any of the following or other symptoms occur during treatment with Viregyt-K.
Very common adverse reactions (may affect more than 1 in 10 people):
swelling of the ankles, red spots on the skin (livedo reticularis).
Common adverse reactions (may affect up to 1 in 10 people):
anxiety, improved mood, lethargy, nervousness, depression, insomnia, feeling faint, headache,
difficulty controlling movements (ataxia), slurred speech, loss of attention concentration, rapid or
irregular heartbeat (palpitations), low blood pressure upon standing from a lying position, which
may cause dizziness or feeling faint (orthostatic hypotension), dry mouth, loss of appetite, nausea,
vomiting, constipation, excessive sweating, muscle pain.
Hallucinations, confusion, and nightmares (if amantadine is administered concomitantly with anticholinergic drugs or in patients with psychiatric illness).
Uncommon adverse reactions (may affect up to 1 in 100 people):
blurred vision.
Rare adverse reactions (may affect up to 1 in 1,000 people):
confusion, disorientation (lack of awareness of time and place), mental and behavioural disturbances such as paranoid feelings (psychosis), tremor, difficulty moving, seizures, symptoms resembling neuroleptic malignant syndrome (may include feeling hot, muscle rigidity, altered consciousness), diarrhoea, rash, eye problems (such as burning and redness of eyes, corneal damage, corneal swelling, decreased visual acuity), loss of bladder control. Difficulty passing urine or sudden urge to urinate may occur.
Very rare adverse reactions (may affect up to 1 in 10,000 people):
heart function disturbances causing breathlessness or ankle swelling, decreased white blood cell count, which increases the likelihood of infections, changes in blood test results indicating liver function abnormalities, light sensitivity.
Frequency not known (frequency cannot be estimated from available data):
delirium (disturbance in attention, perception, thinking and memory), hypomanic state and mania (feeling unusually good mood).
Abnormally low body temperature (below 35°C) may occur, especially in children.
Irresistible urge to behave in an unusual way – strong impulse to gamble excessively, increased or abnormal sexual drive, uncontrolled excessive shopping or spending, binge eating (eating large amounts of food in a short time), or compulsive overeating (eating more food than usual and more than needed to satisfy hunger).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 (22) 49 21 301
Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Viregyt-K

Do not store above 25°C.
Keep the medicine out of the 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 specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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 hard capsule.
• The other ingredients are: monohydrate lactose, magnesium stearate. Capsule shell: quinoline yellow (E 104), indigo carmine (E 132), titanium dioxide (E 171), gelatin.

What Viregyt-K looks like and contents of the pack
Green hard capsules in a brown glass bottle with white FG-7 type PE cap, with a tamper-evident ring and PE shock absorber, packed in a cardboard box together with the patient leaflet.
The pack contains 30 hard capsules.
For more detailed information, please contact the marketing authorisation holder or the parallel importer:
Marketing authorisation holder in Hungary, country of export:
Egis Gyógyszergyár Zrt., 1106 Budapest, Keresztúri út 30-38., Hungary
Manufacturer:
Egis Gyógyszergyár Zrt., 9900 Körmend, Mátyás király u. 65., Hungary
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Hungarian marketing authorisation number in the country of export: OGYI-T-3447/01
Parallel import authorisation number: 241/23