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

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again later.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

• 1. What is Parkador and what is it used for
• 2. Before you take 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 is Parkador and what is it used for

Parkador is used to treat the symptoms of Parkinson's disease in adults. Parkinson's disease is a long-term disease in which:

• the patient's movements become slow and unsteady
• the muscles become stiff
• shaking or tremors may occur. Untreated Parkinson's disease can cause problems with everyday activities.

Parkador contains two different medicines called levodopa and carbidopa.

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

2. Before you take Parkador

When not to take Parkador

• if you are allergic to levodopa, carbidopa or any of the other ingredients of this medicine (listed in section 6)
• if you have suspicious skin lesions (moles) that have not been examined by a doctor or if you have had skin cancer in the past
• if you are taking certain medicines called monoamine oxidase inhibitors (MAOIs) used to treat depression
• if you have narrow-angle glaucoma
• if you have pheochromocytoma (a rare tumor of the adrenal gland)
• if you have hormonal disturbances (overproduction of cortisol or thyroid hormones)
• if you have severe heart disease.

Warnings and precautions

Before taking Parkador, discuss with your doctor or pharmacist. It is important to tell your doctor about all your health problems, especially if you:

• have had a heart attack or heart problems
• have severe lung disease or asthma
• have kidney, liver or hormonal problems
• have depression or mental problems
• have stomach ulcers
• have had seizures
• have had suspicious skin lesions or skin cancer in the past.

If you or your family/caregiver notice that you are developing addiction-like symptoms, such as a desire to take more Parkador or other Parkinson's disease medicines than prescribed, you should tell your doctor. If you or your family/caregiver notice that you are developing unusual urges or behaviors, or if you cannot resist impulses, urges or temptations to perform certain activities that could be harmful to you or others, you should discuss this with your doctor. These behaviors are called impulse control disorders and can include addiction to gambling, overeating or spending, an abnormally high sex drive, or compulsive behavior. Your doctor may need to review your medicines.

Parkador may affect the results of some laboratory tests, such as urine or blood tests ordered by your doctor. You should remind your doctor that you are taking Parkador before having any laboratory tests. If you have taken levodopa before, tell your 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 the medicines you are taking now or have recently taken, and about any medicines you plan to take. The effectiveness of your treatment may be affected if you take Parkador with certain other medicines. Tell your doctor if you are taking any of the following medicines:

• medicines used to treat high blood pressure. Your doctor may need to adjust the dose of these medicines
• medicines that can cause low blood pressure when standing up from a chair or bed (orthostatic hypotension)
• iron or iron preparations. The time between taking Parkador and iron preparations should be as long as possible
• anticholinergic medicines and sympathomimetics (used to treat severe allergic reactions, asthma, chronic bronchitis, heart disease, and low blood pressure)
• certain medicines used to treat mental disorders or antidepressants (such as phenothiazines, butyrophenones, and risperidone)
• medicines used to treat tuberculosis (isoniazid)
• medicines used to treat muscle spasms, seizures, or other disorders that cause involuntary movements (such as phenytoin)
• selegiline, used to treat Parkinson's disease (when taken together, an 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 that contains protein (such as meat, eggs, milk, cheese), as the effect of Parkador may be reduced.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Parkador should not be used during pregnancy or in women of childbearing age who are not using effective contraception, unless the benefits of treatment for the mother outweigh the potential risk to the unborn child. You should not take Parkador if you are breastfeeding.

Driving and using machines

Parkador can affect different people in different ways. While taking carbidopa with levodopa, side effects have been observed that may affect the ability to drive or use machines (see "Possible side effects"). Parkador can cause excessive sleepiness and sudden, short-term sleep attacks. Therefore, you should avoid driving or performing activities where impaired alertness may lead to serious, life-threatening injuries, until sleep attacks and sleepiness have resolved.

Parkador contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially "sodium-free".

3. How to take Parkador

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The usual daily dose may vary and will be determined by your doctor, depending on the severity of your disease and your response to treatment. During the dose adjustment period, you should pay special attention to symptoms such as involuntary movements, and if they occur, inform your doctor immediately. Your doctor may adjust the dose of Parkador if necessary. Your doctor may prescribe more than one strength of Parkador. If you have been given Parkador in different strengths, make sure you take the correct tablet at the correct time.

How to take this medicine

• Take the medicine by mouth, swallowing the tablet whole.
• Although the medicine may start working within one day, its full effect is achieved within seven days of treatment.
• Take the tablet at regular intervals, as directed by your doctor.
• Do not change the time of taking the tablets or take other medicines for Parkinson's disease without first discussing it with your doctor.
• Try to avoid taking the tablets with a meal that contains protein (see section 2 "Parkador with food").

Parkador 25 mg + 250 mg and Parkador 25 mg + 100 mg: The tablet can be divided into equal doses. Parkador 12.5 mg + 50 mg: The score line on the tablet is only to facilitate breaking the tablet if you have difficulty swallowing it whole, and not to divide it into equal doses.

If you take more Parkador than you should

If you have taken more tablets than your doctor prescribed, or if a child has taken some, contact your doctor or go to the hospital immediately for advice and instructions.

If you forget to take Parkador

Try to take Parkador as directed by your doctor. However, if you forget to take a tablet, take it as soon as you remember. If it is almost time for your next dose, skip the missed tablet and continue with your regular schedule. Do not take a double dose to make up for a missed dose.

If you stop taking Parkador

Do not stop taking Parkador or reduce the dose without first talking to your doctor. Stopping the medicine may cause symptoms such as muscle stiffness, fever, and mental changes. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following, tell your doctor immediately:

• allergic 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 when standing up quickly (orthostatic hypotension)
• depression or psychotic symptoms, including hallucinations or delusions
• muscle stiffness, high body temperature, changes in mental state (which can be symptoms of neuroleptic malignant syndrome)
• gastrointestinal bleeding
• seizures
• blood disorders, which may cause pale skin, fever, sore throat, or unexplained bruising or bleeding.

Other side effects that may occur:

Very common (may affect more than 1 in 10 people):

• involuntary movements, such as tremors and seizures.
• urinary tract infections.

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

• loss of appetite
• depression, which may include suicidal attempts, confusion, unusual dreams
• slowing of movement (on-off phenomenon), dizziness, tingling or numbness, drowsiness, sudden sleep attacks
• palpitations
• shortness of breath
• nausea, vomiting, diarrhea.

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

• agitation
• fainting
• hives
• muscle twitching.

Rare (may affect up to 1 in 1,000 people):

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

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

• desire to take more carbidopa and levodopa than necessary to control motor symptoms, known as dopamine dysregulation syndrome. In some patients, taking high doses of carbidopa and levodopa may cause severe disorders, such as involuntary movements (dyskinesia), mood swings, or other side effects.

The following side effects may also occur, related to impulse control disorders:

Inability to resist an impulse, drive, or temptation to perform an action that could be harmful to you or others, including:

• strong impulse to gamble excessively, despite serious personal or family consequences
• altered or increased sexual interest and behavior, of significant importance to you or others, e.g., increased sexual drive
• uncontrolled, compulsive shopping or spending
• episodic binge eating (eating large amounts of food in a short time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger).

If you experience any of these behaviors, you should talk to your doctor about how to manage them or reduce them.

Other possible side effects:

• malignant melanoma
• insomnia, anxiety, euphoria, disorientation, teeth grinding
• reduced alertness, agitation, bitter taste, weakness, headache, drooping eyelids, and narrowing of the pupils (Horner's syndrome), muscle tone disturbances, increased tremors, numbness
• double vision, blurred vision, dilated pupils, temporary, involuntary upward movement of the eyeballs
• hot flashes, flushing
• hoarseness, changes in breathing rhythm, hiccups
• dry mouth, excessive saliva production, difficulty swallowing, stomach pain and abdominal discomfort, constipation, bloating, heartburn, or abdominal bloating, burning sensation on the tongue
• excessive sweating
• muscle twitching, jaw stiffness (difficulty opening the mouth)
• urination problems, incontinence
• prolonged and painful erections
• weakness, general feeling of being unwell, swelling, fatigue, walking difficulties
• weight gain or loss, falls.

Parkador may affect the results of some blood tests, such as increased liver enzyme values and increased blood glucose levels. It has also been observed that white blood cells, bacteria, and blood may be present in the urine. Parkador may cause a false-positive result in urine ketone tests. If you experience any unusual symptoms, you should contact your doctor or seek medical attention immediately.

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the national reporting system via the contact details listed below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Parkador

Keep this medicine out of the sight and reach of children. Parkador 25 mg + 100 mg and Parkador 12.5 mg + 50 mg: There are no special storage instructions. Store in the original package to protect from light. Parkador 25 mg + 250 mg: There are no special storage instructions. Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. Medicines should 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 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 carboxymethylcellulose, magnesium stearate, cornstarch, mannitol, povidone K 30.

What Parkador looks like and contents of the pack

Parkador 25 mg + 250 mg is a white or almost white, oval tablet, 16 mm long and 8 mm wide, with a score line and marked "LC 250" on one side. Parkador 25 mg + 100 mg is a white or almost white, round tablet, 10 mm in diameter, with a score line and marked "LC 100" on one side. Parkador 12.5 mg + 50 mg is a white or almost white, round tablet, 7 mm in diameter, with a score line and marked "LC 50" on one side. Parkador is available in a bottle containing 100 tablets.

Marketing authorization holder

Orion Corporation, Orionintie 1, 02200 Espoo, Finland

Manufacturer

Orion Corporation, Orion Pharma, Joensuunkatu 7, 24100 Salo, Finland For further information on this medicine, contact the local representative of the marketing authorization holder: Orion Pharma Poland Sp. z o.o., kontakt@orionpharma.info.pl

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic: Pipoda Denmark, Finland, Ireland, Norway, Sweden: Carbidopa/Levodopa Orion Estonia, Latvia, Lithuania: Levodopa/Carbidopa Orion Hungary, France: Parlekarv Poland, Romania, Bulgaria: Parkador Slovakia: Carlevo Belgium, Croatia, Netherlands, Spain, Slovenia: Doporio Italy, Portugal: Oridopa

Date of last revision of the package leaflet: