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

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.
• If you have any doubts, consult your 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 not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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, 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 stomach ulcers,
• 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 treatment with Viregyt-K, the patient should consult their doctor or pharmacist.

Warnings and precautions

Before starting treatment with Viregyt-K, the patient should consult their doctor or pharmacist.

Before starting treatment with Viregyt-K, the patient should consult their doctor:

• if they have liver or kidney disease,
• if they have a history of heart or blood vessel disease,
• if they currently have heart or blood vessel problems (heart problems that cause shortness of breath or swelling of the ankles),
• if they have a mental illness, such as schizophrenia or dementia,
• if they have increased intraocular pressure (glaucoma).

If any of the above points apply to the patient, and in case of any doubts, before starting treatment with Viregyt-K, the patient should consult their 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 impulses, 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 intensification of sexual thoughts or feelings. The doctor may modify the dose or stop the treatment with 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 cases, 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 their 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 thought, 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

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 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 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 machines 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 medicinal product.

3. How to take Viregyt-K

This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor.

The capsules should be swallowed whole with water.

The recommended dose is different depending on the disease being treated:

Parkinson's disease

Adults: 1 capsule, hard (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: 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.

In the treatment of 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.

Treatment of 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

If the patient or someone else has taken too many capsules, they should immediately inform their doctor or contact the nearest hospital emergency department. They should show the doctor the remaining medicine or the empty packaging.

Missing a dose of Viregyt-K

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

Stopping treatment with 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.

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 happens, 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 (livedo reticularis).

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, 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 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 impulse 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 not listed in this leaflet, they should tell their doctor, pharmacist, or nurse.

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, more information can be collected 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 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 pack and other information

What Viregyt-K contains

• The active substance is 100 mg of amantadine hydrochloride.
• The other ingredients are: lactose monohydrate, magnesium stearate. Capsule shell: quinoline yellow (E 104), indigotine (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, in a cardboard box with a patient leaflet.

The pack 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:

Delfarma Sp. z o.o.

ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.

ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Romanian export authorization number: 12264/2019/01

Parallel import authorization number: 12/23

Date of leaflet approval:24.01.2023

[Information about the trademark]