Viregit-k

Leaflet attached to the packaging: 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

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.
• In case of any doubts, you should 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 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 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 of the other ingredients 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 baby (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 heart or blood vessel problems (heart problems that cause 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, the patient should consult a doctor or pharmacist.
The patient should inform their doctor if they or their family members and/or caregivers notice that they have a desire or irresistible urge to behave in a way that is unusual for them and they cannot resist these urges, a desire or temptation to behave in a way that could be harmful to themselves or others. These are so-called impulse control disorders, which can include behaviors such as compulsive gambling, overeating, or spending money, inappropriate increased sexual desire or increased sexual thoughts or feelings. The doctor may adjust the dose or stop taking Viregyt-K.
If the patient experiences blurred vision or other vision 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, the patient should immediately inform their doctor and stop taking Viregyt-K.

Children and adolescents

This medicine should not be given to children under 5 years of age. 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
• 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 some 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, drink, and alcohol

During treatment with 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 baby, 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 harm the baby.

Driving and using machines

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

Viregyt-K contains 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 as directed by the doctor. In case of doubts, the patient should consult their doctor.
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 (200 mg) per day.
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: 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.
When treating flu, Viregyt-K should be taken for about 4 to 5 days.
In case of kidney problems, the doctor may prescribe a lower dose.

Taking Viregyt-K in children and adolescents.

Treating influenza A virus infections:
Children (10 to 15 years): 1 capsule (100 mg) per day.
Children (under 10 years): as directed by the doctor.

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 their 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 next dose should be taken as soon as possible, unless it is almost time for the next dose. Then, the patient should return to their regular dosing schedule. The patient should not take a double dose to make up for the missed dose.

Stopping Viregyt-K

The patient should not suddenly stop taking Viregyt-K, as the symptoms of the disease 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 develop 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.
If the patient has any further doubts about taking this medicine, they 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 several 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
• fainting
• seizures

The patient should inform their doctor or pharmacist if they experience any of the following symptoms or other symptoms related to treatment with 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, 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 a feeling of 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 1000 people):
Confusion, disorientation (loss of sense of time and place), mental disorders and behaviors such as feelings of paranoia, tremors, difficulty moving, malignant neuroleptic syndrome. The patient may feel hot and have muscle stiffness. Diarrhea, rash, burning, and redness of the eyes, corneal damage, corneal edema, decreased vision, 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 problems that cause shortness of breath or swelling of the ankles, decreased white blood cell count, which increases the risk of infections, changes in blood test results for 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 urge to gamble excessively, disturbed or increased sexual desire, 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 the patient experiences any side effects, including any side effects not listed in the leaflet, they 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, it is possible to gather more information on the safety of the medicine.

5. How to store Viregyt-K

Store in a temperature below 25°C, in the original packaging.
The medicine should be stored 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 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.
• 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 what the packaging contains

Green hard capsules in a brown glass bottle with a PE cap and a guarantee seal, in a cardboard box with a patient leaflet.
The packaging contains 50 hard capsules.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

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

Manufacturer:

Egis Pharmaceuticals PLC
Mátyás király u. 65
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 Romania, the country of export:12264/2019/01

Parallel import authorization number: 156/22 Date of approval of the leaflet: 08.04.2022

[Information about the trademark]