Viregyt-k

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Viregyt-K
100 mg, hard capsules
Amantadini hydrochloridum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. 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 adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

Viregyt-K is a dopaminergic agent, meaning it may increase levels of certain chemical transmitters involved in nerve impulse transmission, including in 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 of movement
• in the treatment of a certain type 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, and in case of any doubts,
consult a doctor or pharmacist before starting to use Viregyt-K.
Warnings and precautions
Consult a doctor or pharmacist before starting to use Viregyt-K.
Consult a doctor before starting to use 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 breathlessness or ankle swelling),
• if the patient has a psychiatric disorder, for example schizophrenia or dementia,
• if the patient has increased intracranial pressure (glaucoma).

If any of the above points apply to the patient, and in case of any doubts,
consult a doctor or pharmacist before starting to use Viregyt-K.
Inform the doctor if the patient or members of their family 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 manner that could be harmful to the patient or others. These are so-called impulse control disorders, which may include behaviors such as compulsive gambling, binge eating or excessive spending, abnormally increased sexual drive or intensified sexual thoughts or feelings. The doctor may modify 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
Do not administer this medicine to children under 5 years of age. 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.
Especially about 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,
• antispasmodic drugs - (used to treat stomach cramps) such as hyoscine,
• levodopa - a medicine used in the treatment of Parkinson's disease,
• antipsychotic drugs - (used to improve thinking, emotions, and behaviors in certain mental 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. Use of 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 have a child, 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, do not drive or operate machinery until symptoms subside.
Viregyt-K contains 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 taken exactly as your doctor has told you. If in doubt, consult your doctor.
The capsules should be swallowed whole with water.
The recommended dose varies depending on the condition being treated:

Parkinson's disease
Adults: 1 capsule (100 mg) once daily for the first week.
Your doctor will increase this dose to 2 capsules daily (200 mg).
In some cases, higher doses may be used, up to 4 capsules (400 mg) daily. The dose of 400 mg/day should not be exceeded.
Adults over 65 years of age: 1 capsule (100 mg) once daily.

Influenza virus infection (influenza A)
Adults: 1 capsule (100 mg) once daily.
Adults over 65 years of age: 1 capsule (100 mg) once daily.
For treatment of influenza: Viregyt-K should be used for approximately 4 to 5 days.
If you have kidney function impairment, your doctor may prescribe a lower dose.

Use in children and adolescents
Treatment of influenza virus infection (influenza A):
Children (10 to 15 years of age): 1 capsule (100 mg) once daily.
Children under 10 years of age: as directed by the doctor.

Taking more Viregyt-K than recommended
If you or someone else accidentally takes too many capsules, contact your doctor or the nearest hospital emergency department immediately. Show the doctor the remaining medicine or empty packaging.

If you miss a dose of Viregyt-K
Do not be alarmed. If you forget to take a dose, take the next dose as soon as you remember, unless it is almost time for your next scheduled dose. Then return to your regular dosing schedule. Do not take a double dose to make up for a missed dose.

Stopping Viregyt-K treatment
Do not stop taking Viregyt-K suddenly, as symptoms may worsen.
If you wish to discontinue treatment with Viregyt-K, consult your doctor, who will advise you on how to gradually reduce the dose.

If you are taking antipsychotic medicines (used to treat psychiatric disorders) and stop taking Viregyt-K suddenly, a group of symptoms may develop, including:

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

If any of these symptoms occur, contact your doctor immediately.

Some patients may notice that this medicine becomes less effective in Parkinson's disease after regular use for several months. If this occurs, inform your doctor.

If you have any further questions about 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 everyone experiences them.
These reactions are often mild and may resolve within a few days of treatment. If adverse reactions
are severe and persist for several days, inform your doctor or pharmacist.
Contact your doctor or nearest hospital immediately if any of the following symptoms occur:

• dizziness
• fainting
• seizures

Inform your doctor or pharmacist if you experience any of the following or other symptoms
during treatment with Viregyt-K.

Very common adverse reactions (may occur in more than 1 in 10 people):

• ankle swelling
• red skin spots (mottled rash, livedo reticularis)

Common adverse reactions (may occur in up to 1 in 10 people):
anxiety, excessive mood elevation, difficulty sleeping, muscle pain, headache, rapid or
irregular heartbeat, feeling tired, hallucinations, nightmares, low blood pressure upon
standing from a lying position. This may cause dizziness or a feeling of fainting.
Difficulty controlling movements, dry mouth, speech disorders, loss of appetite, vision disturbances,
feeling unwell, difficulty concentrating, constipation, feeling nervous, sweating, depression.

Uncommon adverse reactions (may occur in up to 1 in 100 people):
blurred vision

Rare adverse reactions (may occur in up to 1 in 1000 people):
confusion, disorientation (lack of awareness of time and place), mental and behavioural disorders such as paranoid feelings, tremor, difficulty moving, neuroleptic malignant syndrome. This may include feelings of heat and muscle stiffness. Diarrhoea, rash, burning and redness of the eyes, corneal damage, corneal swelling, decreased visual acuity, loss of bladder control. There may be difficulty passing urine or a sudden need to urinate.

Very rare adverse reactions (may occur in up to 1 in 10,000 people):
heart function disorders causing breathlessness or ankle swelling, reduced white blood cell count, increasing the likelihood of infections, changes in blood test results indicating liver function abnormalities, photosensitivity.

Frequency not known (cannot be estimated from available data):
Abnormally low body temperature (below 35°C), particularly in children.
Irresistible urge to behave in an unusual manner – strong impulse towards excessive gambling, disturbed or increased sexual drive, uncontrolled excessive spending or shopping, binge eating (consuming large amounts of food in a short time), or compulsive overeating (consuming larger amounts of food than usual and more than needed to satisfy hunger).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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, tel.: +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

Store below 25°C in the original packaging.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated 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 packaging and other information

What Viregyt-K contains

• The active substance is 100 mg of amantadine hydrochloride.
• The other ingredients are: magnesium stearate, monohydrate lactose. 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 screw cap with tamper-evident seal and cushioning insert, packed in a cardboard box together with the patient leaflet. The pack contains 50 hard capsules. For more detailed information, please contact the marketing authorization holder or parallel importer.

Marketing Authorization Holder in Romania, 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, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorization Number in Romania, country of export: 12264/2019/01
Parallel Import Authorization Number: 156/22