Parkador

Package leaflet: Information for the user

Parkador, 25 mg + 250 mg, tablets
Parkador, 25 mg + 100 mg, tablets
Parkador, 12.5 mg + 50 mg, tablets
Carbidopa + Levodopa
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet so that you can read it again if needed.
• 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. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Parkador is and what it is used for
2. What you need to know before taking Parkador
3. How to take Parkador
4. Possible side effects
5. How to store Parkador
6. Contents of the pack and other information

1. What Parkador is and what it is used for

Parkador helps relieve the symptoms of Parkinson's disease in adults. Parkinson's disease is a chronic condition in which:

• the patient's movements become slow and unsteady
• muscles become stiff
• muscle tremors or shaking may occur

Untreated Parkinson's disease can cause difficulty in performing ordinary, daily activities.

Parkador contains two different medicines called levodopa and carbidopa.

• Levodopa is converted in the brain into a substance called "dopamine". Dopamine helps relieve the symptoms of Parkinson's disease.
• Carbidopa belongs to a group of medicines known as "aromatic amino acid decarboxylase inhibitors". It increases the effectiveness of levodopa by slowing down its breakdown in the body.

2. Information before taking Parkador

When not to take Parkador

• if the patient is allergic to levodopa, carbidopa, or any of the other ingredients of this medicine (listed in section 6)
• if the patient has suspicious skin lesions (moles) that have not been examined by a doctor, or if the patient has ever previously had skin cancer
• if the patient is taking so-called monoamine oxidase inhibitors (MAOIs), used in the treatment of depression
• if the patient has narrow-angle glaucoma
• if the patient has episodes of hypertension caused by a tumor of the adrenal gland (pheochromocytoma)
• if the patient has hormonal disorders (excessive production of cortisol or thyroid hormones)
• if the patient has severe heart disease.

Warnings and precautions
Before starting to take Parkador, it is important to discuss this with your doctor or pharmacist.
It is important to tell your doctor about any medical conditions you currently have or have had in the past, especially if you have or have had:

• heart attack or heart problems
• severe lung disease or bronchial asthma
• kidney, liver or hormonal disorders
• depression or psychiatric disorders
• peptic ulcer
• seizures in the past
• suspicious skin lesions or a history of skin cancer (melanoma).

If the patient or their family and (or) caregiver notice symptoms resembling addiction, leading to a desire to take high doses of Parkador or other medicines used in the treatment of Parkinson's disease, this should be reported to the doctor.
The doctor should be informed if the patient, their family and (or) caregiver notice the occurrence of unusual impulses or compulsive behaviors, or if the patient cannot resist impulses, urges, or compulsions to perform certain actions that may be harmful to themselves or others. These behaviors are known as impulse control disorders and may include gambling addiction, excessive eating or spending, abnormally high sex drive, and increased sexual thoughts and feelings. The doctor may need to review the medications the patient is taking.
This medicine may interfere with laboratory blood or urine test results ordered by a doctor. Always remind your doctor that you are taking Parkador before any laboratory tests are performed.
If the patient has previously taken levodopa, this should be reported to the doctor.

Children and adolescents
Parkador is not recommended for use in patients under 18 years of age.

Parkador with 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.
The effectiveness of treatment may change if Parkador is taken simultaneously with certain other medicines. Tell your doctor if the patient is taking any of the following medicines:

• medicines used to treat high blood pressure. Dose adjustment of these medicines may be necessary
• medicines that may cause a drop in blood pressure when standing up from sitting or lying down (orthostatic hypotension)
• iron or iron-containing preparations. The interval between taking Parkador and iron preparations should be as long as possible.
• anticholinergic and sympathomimetic medicines (used to treat severe allergic reactions, asthma, chronic bronchitis, heart disease, and low blood pressure)
• certain medicines used to treat psychiatric disorders or antidepressants (such as phenothiazine derivatives, butyrophenone derivatives, and risperidone)
• medicines used to treat tuberculosis (isoniazid)
• medicines used to treat muscle spasms, seizures, or other disorders causing involuntary movements (such as phenytoin)
• selegiline, used in the treatment of Parkinson's disease (when used concomitantly, excessive drop in blood pressure may occur)
• other medicines used to treat Parkinson's disease, such as tolcapone, entacapone, or amantadine.

Parkador with food
Avoid taking Parkador with a meal containing protein (such as meat, eggs, milk, cheese), as the effect of Parkador may be reduced.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before taking this medicine.
The use of Parkador is not recommended during pregnancy or in women of childbearing potential who are not using effective contraception, unless the benefits of treatment for the mother outweigh the possible risks to the unborn child.
Parkador must not be taken during breastfeeding.

Driving and operating machinery
Parkador may affect individuals differently. When carbidopa is used with levodopa, adverse effects have been observed that may impair the ability to drive and operate machinery in some patients (see "Possible side effects").
Parkador may cause excessive drowsiness and episodes of sudden, brief sleep. For this reason, driving or performing activities in which impaired reaction ability could lead to serious, life-threatening injury should be avoided until episodes of sudden sleep and drowsiness have resolved.

Parkador contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".

3. How to take Parkador

This medicine should always be taken as directed by a physician or pharmacist. In case of
doubt, consult a physician or pharmacist.
The usual daily dose may vary and will be determined individually by the physician for each patient, depending on the severity of the disease and the response to
treatment. During the dose adjustment period, the patient should pay particular attention to symptoms such as involuntary movements and, if they occur, inform the physician immediately.
The physician may adjust the dose as necessary.
The physician may prescribe more than one strength of Parkador. If the patient has been given Parkador tablets of different strengths, they should ensure that they are taking the correct tablet at the correct time.
In cases where doses are impractical or impossible to achieve with this medicine, alternative medicines are available.
How to take this medicine

• The medicine should be taken orally by swallowing the tablet.
• Although the medicine may begin to work within one day, full effectiveness is achieved within seven days of treatment.
• The tablet should be taken at regular intervals as directed by the physician.
• Do not change the time of taking the tablets or take other medicines for Parkinson's disease without first consulting the physician.
• Try to avoid taking the tablets with meals high in protein (see section 2 "Parkador and food").

Parkador 25 mg + 250 mg and Parkador 25 mg + 100 mg: The tablet may be divided into equal doses.
Parkador 12.5 mg + 50 mg: The score line on the tablet is intended only to facilitate breaking the tablet if the patient has difficulty swallowing it whole, and not for dividing into equal doses.
Accidental overdose of Parkador
If more tablets than recommended have been taken or if the medicine has been accidentally ingested by a child, seek medical advice immediately from a physician or go to a hospital to obtain information on potential risks and instructions on actions to be taken.
Missed dose of Parkador
Try to take Parkador as directed by the physician. However, if a dose is missed, take it as soon as remembered. If it is almost time for the next dose, do not take the missed dose but continue treatment as prescribed. Do not take a double dose to make up for a missed dose.
Stopping Parkador treatment
Do not stop taking Parkador or reduce the dose without first discussing it with the physician. Stopping treatment may lead to symptoms such as muscle stiffness, fever, and psychiatric disturbances.
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following symptoms occur, contact a doctor immediately:

• hypersensitivity reactions such as hives, itching, rash, and swelling of the face, lips, tongue, and (or) throat, which may cause difficulty breathing or swallowing
• chest pain
• irregular heartbeat
• dizziness upon standing quickly (orthostatic hypotension)
• depression or psychotic symptoms, including delusions or hallucinations
• muscle rigidity, high body temperature, changes in mental status (may be symptoms of neuroleptic malignant syndrome)
• gastrointestinal bleeding
• seizures
• blood disorders, which may present as pale skin, fever, sore throat, minor bruising, and prolonged bleeding after injury.

Other possible adverse reactions:
Very common ( may affect more than 1 in 10 people ):

• involuntary movements, such as tremors and twitching
• urinary tract infections

Common ( may affect up to 1 in 10 people ):

• loss of appetite
• depression, which may include suicidal attempts, confusion, unusual dreams
• motor slowing (‘on-off’ phenomenon), dizziness, tingling and (or) numbness or prickling of the skin, somnolence, episodes of sudden sleep
• palpitations
• shortness of breath
• nausea, vomiting, diarrhoea

Uncommon ( may affect up to 1 in 100 people ):

• restlessness
• fainting
• urticaria
• muscle twitching

Rare ( may affect up to 1 in 1000 people ):

• anaemia
• dementia; in rare cases, seizures have occurred, but a causal relationship with carbidopa/levodopa treatment has not been established
• high blood pressure, phlebitis
• duodenal ulcer, dark discoloration of urine, sweat, and (or) saliva
• itching, vasculitis causing reddish rash and possibly abdominal pain and joint pain (Henoch-Schönlein purpura), hair loss, rash

Unknown frequency ( frequency cannot be estimated from available data ):

• an urge to take higher doses of carbidopa/levodopa than necessary to control motor symptoms, known as dopamine dysregulation syndrome. In some patients, high doses of carbidopa/levodopa may lead to severe disorders such as involuntary movements (dyskinesias), mood fluctuations, or other adverse reactions.

The following adverse reactions related to impulse control disorders may also occur:
Inability to resist the impulse, urge, or compulsion to perform actions that may be
harmful to the patient or others, including:

• strong impulse towards uncontrollable gambling, despite serious personal or family consequences
• altered or increased interest in and engagement in sexual activities, significant to the patient or others, e.g. activities related to increased sexual drive
• uncontrolled, compulsive buying or spending of money
• binge eating (consuming large amounts of food in a short time) or compulsive eating (eating more food than normal and in quantities greater than needed to satisfy hunger). If any of these behaviours occur, consult a doctor to discuss ways of managing or alleviating the symptoms.

Other possible adverse reactions:

• melanoma
• insomnia, anxiety, euphoria, disorientation, teeth grinding
• reduced alertness, restlessness, bitter taste in mouth, weakness, headache, drooping eyelids and constricted pupils (Horner’s syndrome activation), muscle tone disorders, increased hand tremors, numbness
• double vision, blurred vision, dilated pupils, brief, involuntary upward eye movement, eyelid spasms
• hot flushes, facial flushing
• hoarseness, changes in breathing rhythm, hiccups
• dry mouth, excessive saliva production, difficulty swallowing, abdominal pain and discomfort, constipation, bloating, heartburn or abdominal distension, burning tongue pain
• excessive sweating
• muscle twitching, trismus (difficulty opening the mouth)
• difficulty urinating, urinary incontinence
• prolonged and painful penile erection
• weakness, malaise, swelling, fatigue, difficulty walking
• increased or decreased body weight, falls

Parkador may cause changes in the results of certain blood tests, such as increased liver function test values and increased blood glucose levels.
The presence of white blood cells, bacteria, and blood in urine has also been observed. Parkador may cause a false positive result in urine ketone tests.
If unusual symptoms occur, contact a doctor or seek medical help immediately.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02-222 Warsaw
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Parkador

Keep this medicine out of sight and reach of children.
Parkador, 25 mg + 100 mg and Parkador, 12.5 mg + 50 mg
No special storage temperature requirements. Store in the original packaging to protect from light.
Parkador, 25 mg + 250 mg
No special storage requirements.
Do not use this medicine after the expiry date stated on the carton and bottle label after: EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Parkador contains

• The active substances in this medicine are carbidopa and levodopa. Each Parkador 25 mg + 250 mg tablet contains 25 mg of carbidopa and 250 mg of levodopa. Each Parkador 25 mg + 100 mg tablet contains 25 mg of carbidopa and 100 mg of levodopa. Each Parkador 12.5 mg + 50 mg tablet contains 12.5 mg of carbidopa and 50 mg of levodopa.
• The other ingredients are: sodium carboxymethyl starch, magnesium stearate, maize starch, mannitol, povidone K 30.

What Parkador looks like and contents of the pack
Parkador 25 mg + 250 mg is available as white or almost white, oval tablets, 16 mm long and 8 mm wide, with a score line and marked "LC 250" on one side.
Parkador 25 mg + 100 mg is available as white or almost white, round tablets, 10 mm in diameter, with a score line and marked "LC 100" on one side.
Parkador 12.5 mg + 50 mg is available as white or almost white, round tablets, 7 mm in diameter, with a score line and marked "LC 50" on one side.
Parkador is available in bottles containing 100 tablets.

Marketing Authorisation Holder
Orion Corporation
Orionintie 1
02200 Espoo
Finland

Manufacturer
Orion Corporation Orion Pharma
Joensuunkatu 7
24100 Salo
Finland

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]

This medicinal product is authorised in the European Economic Area under the following names:
Czech Republic: Pipoda
Denmark, Finland, Ireland, Norway, Sweden: Carbidopa/Levodopa Orion
Lithuania, Estonia, Latvia: Levodopa/Carbidopa Orion
Hungary, France: Parlekarv
Poland, Romania, Bulgaria: Parkador
Slovakia: Carlevo
Belgium, Croatia, Netherlands, Spain, Slovenia: Doporio
Italy, Portugal: Oridopa