Viregit-k

Package Leaflet: Information for the User

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Viregyt-K, 100 mg,hard capsules
Amantadine hydrochloride

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

• Keep this leaflet, so you can read it again if needed.
• 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 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 pack and other information

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

Viregyt-K is a dopaminergic medicine, meaning 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 drooling
• 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 other ingredient of this medicine (listed in section 6),
• if the patient has seizures, such as epilepsy,
• if the patient has had stomach ulcers,
• if the patient has severe kidney disease,
• if the patient is pregnant or planning 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, consult a doctor or pharmacist.

Warnings and precautions

Before starting to take Viregyt-K, consult a doctor or pharmacist.
Before starting to take Viregyt-K, 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 heart or blood vessel problems (heart problems causing shortness of breath or swelling of the ankles),
• 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, consult a doctor or pharmacist.
Tell your doctor if you or your family members or caregivers notice that you have a desire or irresistible urge to behave in a way that is unusual for you and you cannot resist these urges, a desire or temptation to behave in a way that could be harmful to you 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. Your doctor may adjust the dose or stop taking Viregyt-K.
If the patient experiences blurred vision or other eye problems, they should immediately contact an ophthalmologist.
Abnormally low body temperature (below 35°C) may occur, especially in children being treated for flu. In such a case, immediately inform a doctor and stop taking Viregyt-K.

Children and adolescents

Do not give this medicine to children under 5 years of age. Before giving any medicine to a child, always consult a doctor.

Viregyt-K and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, and about any medicines you 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
• antispasmodic medicines - (used to treat stomach cramps) such as hyoscine
• levodopa - a medicine used to treat Parkinson's disease
• antipsychotic medicines - (used to improve thinking, emotional, and behavioral disorders in certain mental illnesses) such as chlorpromazine, haloperidol
• diuretic medicines - (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

Do not drink alcoholic beverages while being treated with Viregyt-K.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before taking this medicine.
Do not take Viregyt-K during pregnancy or when planning to become pregnant.
Do not take Viregyt-K during breastfeeding, as the medicine passes into breast milk and may harm the baby.

Driving and using machines

Taking Viregyt-K may cause vision problems or dizziness. If you experience such symptoms, do not drive or operate machinery until the symptoms have resolved.

Viregyt-K contains lactose monohydrate

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Viregyt-K

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor.
Swallow the capsules whole with a glass of water.
The recommended dose is different depending on the disease being treated:
Parkinson's disease
Adults: 1 capsule (100 mg) per day for the first week.
Your doctor will increase the dose to 2 capsules (200 mg) per day.
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: 1 capsule (100 mg) once a day.
Influenza A virus infections
Adults: 1 capsule (100 mg) per day.
Adults over 65 years: 1 capsule (100 mg) once a day.
For flu treatment: Viregyt-K should be taken for about 4 to 5 days.
In case of kidney problems, your doctor may prescribe a lower dose.

Taking Viregyt-K in children and adolescents.

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

Taking a higher dose of Viregyt-K than recommended

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

Missing a dose of Viregyt-K

Do not worry. If you miss a dose, take the next dose as soon as you remember, unless it is almost time for the next dose. Then continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.

Stopping Viregyt-K treatment

Do not suddenly stop taking Viregyt-K, as the disease symptoms may worsen.
If you want to stop taking Viregyt-K, ask your doctor, who will tell you how to gradually reduce the dose.
If you are taking antipsychotic medicines (used to treat mental disorders) and suddenly stop taking Viregyt-K, you may experience a set of symptoms including:

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

If you experience these symptoms, immediately contact your doctor.
Some patients may notice that this medicine loses its effect in Parkinson's disease after regular use for several months. If you notice this, inform your doctor.
If you have any further doubts about taking this medicine, consult your 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 side effects are severe and persist for several days, inform your doctor or pharmacist.
If you experience any of the following symptoms, contact your doctor or the nearest hospital:

• dizziness
• fainting
• seizures

Inform your doctor or pharmacist if you experience any of the following or other symptoms related to Viregyt-K treatment.
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, excessive mood improvement, difficulty sleeping, muscle pain, headache, rapid or irregular heartbeat, feeling tired, hallucinations, nightmares, loss of bladder control. This may cause dizziness or fainting. Difficulty controlling movements, dry mouth, speech disorders, loss of appetite, vision problems, feeling sick, difficulty concentrating, constipation, feeling nervous, sweating, depression.
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, tremors, difficulty moving, malignant neuroleptic syndrome. You may feel hot and have muscle stiffness. Diarrhea, rash, burning, and redness of the eyes, corneal damage, corneal edema, decreased visual acuity, loss of bladder control. You may experience difficulty urinating or a sudden need to urinate.
Very rare side effects (may affect up to 1 in 10,000 people):
Heart problems 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 (cannot be estimated from the available data):
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, disturbed or increased sexual drive, uncontrolled excessive eating or spending money, binge eating (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)

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. 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 provide more information on the safety of this medicine.

5. How to store Viregyt-K

Store in a temperature below 30°C, in the original packaging to protect from light.
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 month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Viregyt-K contains

• The active substance is 100 mg of amantadine hydrochloride.
• The other ingredients are: magnesium stearate, lactose monohydrate. 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 a PE cap and a guarantee seal, with a cardboard box and patient leaflet.
The pack contains 50 hard capsules.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

Egis Pharmaceuticals PLC
Keresztúri út 30-38.
H-1106 Budapest
Hungary

Manufacturer:

Egis Pharmaceuticals PLC.
Mátyás király u. 65.
H-9900 Körmend
Hungary

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 the Czech Republic, the country of export:27/014/74-S/C

Parallel import authorization number: 67/22 Date of approval of the leaflet: 02.02.2022

[Information about the trademark]