Viregyt-k

Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is 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 for future reference.
• Consult your doctor or pharmacist if you have any questions.
• This medicine has been prescribed for a specific individual only. Do not share it with others. This medicine may harm others, even if their symptoms are identical.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse immediately. See section 4.

Table of contents:

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 can increase levels of certain chemical transmitters involved in nerve signaling, including in the brain. Viregyt-K also has antiviral properties.
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 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, and in case of any doubts,
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 heart or blood vessel disease,
• if the patient currently has heart function disorders or heart failure (heart problems causing shortness of breath or ankle swelling),
• if the patient has a mental illness, for example 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,
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 so-called impulse control disorders, which may include behaviors such as compulsive 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 stop using Viregyt-K.
Children and adolescents
Do not give this medicine to children under 5 years of age. Always consult a doctor before giving any medicine to a child.
Viregyt-K with other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
In particular, 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,
• antispasmodics - (used to treat stomach cramps) such as hyoscine,
• levodopa - a medicine used in the treatment of Parkinson's disease,
• antipsychotics - (used to improve thinking, emotions, and behaviors in certain mental illnesses) 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, 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 during 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 medicinal product.

3. How to use Viregyt-K

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor.
The capsules should be swallowed whole with water.
The recommended dose varies depending on the disease being treated:

Parkinson's disease
Adults: 1 hard 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 must 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) 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 there are kidney function disorders, your doctor may prescribe a lower dose.

Use in children and adolescents
Treatment of influenza virus infection (influenza A):
Children (10 to 15 years): 1 capsule (100 mg) daily.
Children (under 10 years): according to the doctor's instructions.

Taking more Viregyt-K than prescribed
If a patient or another person accidentally takes too many capsules, contact your doctor or the nearest hospital emergency department immediately. Show the doctor the remaining medicine or empty packaging.

Missed dose of Viregyt-K
Do not be alarmed. If you miss a dose, take the next dose as soon as you remember, unless it is almost time for the 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
Do not suddenly stop taking 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.

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

• fever,
• sweating,
• rapid heartbeat,
• muscle stiffness (difficulty moving),
• loss of bladder control (sudden need 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 questions about using 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 within 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 immediately:

• 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 affect more than 1 in 10 people):

• ankle swelling,
• red spots on the skin (mottled rash).

Common adverse reactions (may affect up to 1 in 10 people):
anxiety, excessive improvement in mood, 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 feeling faint. Difficulty controlling movements, dry mouth, speech disorders, loss of appetite, visual disturbances, feeling unwell, difficulty concentrating, constipation, feeling restless, sweating, depression.
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, tremor, difficulty moving, neuroleptic malignant syndrome. A sensation of heat and muscle stiffness may occur. Diarrhoea, rash, burning and redness of the eyes, corneal damage, corneal oedema, 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):
Cardiac dysfunction causing breathlessness or ankle swelling, decreased 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), which may occur especially in children.
Irresistible urge to behave in an unusual manner – strong impulse towards excessive gambling, disturbed or increased sexual drive, uncontrolled excessive shopping or spending, 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, pharmacist or nurse. Adverse reactions can be reported directly to the Department for 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

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 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 package and other information

What Viregyt-K contains

• The active substance is 100 mg of amantadine hydrochloride.
• The other ingredients are: monohydrate lactose, magnesium stearate. Coating: 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 and tamper-evident seal with a shock absorber, contained in a cardboard box together with the patient leaflet.
The pack contains 50 hard capsules.
For further information, please contact the responsible party or parallel importer:
Responsible party 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Permit number in Romania, country of export: 12264/2019/01
Parallel import permit number: 12/23