Package Insert: Information for the User

Doporio 25 mg/100mg EFG Tablets

Carbidopa/Levodopa

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Doporio and how is it used

2. What you need to know before starting to take Doporio

3. How to take Doporio

4. Possible adverse effects

5. Storage of Doporio

6. Contents of the package and additional information

Doporio improves the symptoms of Parkinson's disease in adults. Parkinson's disease is a chronic disease characterized by:

• slow and unsteady movements
• muscle rigidity
• developing agitation or tremors.

If left untreated, Parkinson's disease can lead to difficulties in living a normal life. Doporio contains two different medications called: levodopa and carbidopa.

• levodopa is converted into a substance called “dopamine” in the brain. Dopamine helps to improve the symptoms of Parkinson's disease.

• carbidopa belongs to a group of medications known as “aromatic amino acid decarboxylase inhibitors”. It allows levodopa to work more effectively by reducing the rate at which levodopa breaks down in the body.

Do not takeDoporio

• if you are allergic to levodopa, carbidopa, or any of the other components of this medication (listed in section 6)
• if you have suspicious skin lesions (such as moles) that have not been examined by your doctor or if you have ever had skin cancer
• if you are being treated with MAO inhibitors (monoamine oxidase) antidepressants
• if you have closed-angle glaucoma
• if you have hypertension attacks induced by a tumor of the adrenal gland (pheochromocytoma)
• hormonal problems (overproduction of cortisol or thyroid hormone)
• if you have a severe heart disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication. It is essential to inform your doctor of any medical problem you have or have had, especially if you have or have had

• heart attack or heart rhythm problems
• severe lung problems or bronchial asthma
• kidney, liver, or hormonal problems
• depression or mental problems
• ulcer
• a history of seizures (convulsions)
• suspicious skin lesions or if you have had skin cancer (melanoma).

Inform your doctor if you or your family/caregiver notice that you are developing symptoms similar to those of addiction, which lead to a desire to take large doses of Carbidopa/Levodopa and other medications used to treat Parkinson's disease.

Inform your doctor if you, or your family/caregiver, notice that you are starting to behave in an unusual manner, if you feel the impulse, initiative, or temptation to harm others or to self-aggression. These behaviors are called impulse control disorders and may include excessive gaming, eating, or spending, increased normal sexual desire, or an increase in thoughts or desires for sex. Your doctor may need to review your treatments.

This medication may affect some laboratory tests that your doctor may perform on blood or urine samples. Remember to inform your doctor if you are taking this medication and are going to undergo any testing.

Inform your doctor if you have been previously treated with levodopa.

Children and adolescents

Carbidopa/Levodopa is not recommended for patients under 18 years old.

Other medications and Doporio

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

The effectiveness of treatment may change if Carbidopa/Levodopa is used concomitantly with other medications. Inform your doctor if you are taking any of the following medications:

• blood pressure medications. It may be necessary to adjust the dose of these products.
• iron or iron preparations. The intake of Carbidopa/Levodopa and iron preparations should be separated by the longest possible interval
• anticholinergics and sympathomimetics
• certain medications for psychiatric disorders or antidepressants (such as phenothiazines, butyrophenones, and risperidone)
• medications for tuberculosis (isoniazid)
• medications for muscle cramps, seizures, or other conditions that cause involuntary movements (such as phenytoin)
• selegiline for Parkinson's disease treatment (may cause excessive blood pressure drop with concomitant use)
• other Parkinson's disease medications such as tolcapone, entacapone, or amantadine.

Taking Doporio with food

Try to avoid taking Carbidopa/Levodopa with a meal that contains proteins (such as meat, eggs, milk, cheese) as the function of Carbidopa/Levodopa may decrease.

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Carbidopa/Levodopa is not recommended during pregnancy or in women of childbearing age who do not use contraceptive methods unless the benefits for the mother outweigh the possible risk to the fetus.

Do not take Carbidopa/Levodopa if you are breastfeeding.

Driving and operating machinery

The effects of the medication may vary individually. Adverse effects have been observed that in some patients may affect the ability to drive or use machinery related to the use of carbidopa/levodopa (see “Possible adverse effects”).

Carbidopa/Levodopa may cause excessive drowsiness and sudden episodes of short-term sleep. Therefore, do not drive vehicles or perform activities in which a lack of attention may pose a risk in which reduced reaction capacity may cause potentially fatal injuries (e.g., operating machinery), until such episodes and/or drowsiness have disappeared.

Doporio contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended daily dose may be variable and is determined individually by your doctor through an individualized dose adjustment based on the severity of your disease and your response to treatment. During the dose adjustment period, the patient must pay special attention to symptoms such as involuntary movements, and inform your doctor immediately if this occurs. Your doctor will adjust your dose as needed.

Your doctor may prescribe you more than one dose of Carbidopa/Levodopa. If you have been administered different concentrations of Carbidopa/Levodopa, make sure you are taking the correct tablet at the right time.

How to take this medication

• Take this medication orally by swallowing the tablet.
• Although your medication may take effect after a day, it may take up to seven days to take effect.
• Take the tablet at regular time intervals as instructed by your doctor.
• Do not change the schedule of taking your tablets or any other medication for Parkinson's disease without first consulting your doctor.
• Try to avoid taking your tablets with a high-protein meal (see section 2 “Taking Doprio with food”)

The tablet can be divided into equal doses.

If you takemore Doprio than you should

If you have taken more medication than you should, or if a child has taken a medication by accident, always contact your doctor or hospital for an opinion on the risk and instructions on what to do.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

If you forget to takeDoprio

Take Carbidopa/Levodopa as prescribed. However, if you forget to take a tablet, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose and wait until the next dose. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Doprio

Do not stop taking Carbidopa/Levodopa or reduce the dose without first consulting your doctor. Stopping the medication may cause some symptoms such as muscle stiffness, fever, or mood changes.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Get in touch with your doctor immediately if you experience any of the following symptoms:

• allergic reactions, such as hives, itching, skin rash, and swelling of the face, lips, tongue, and/or throat that may cause breathing or swallowing problems
• chest pain
• irregular heart function
• dizziness when standing up quickly
• depression or psychotic symptoms, including delusions or hallucinations
• muscle stiffness, high body temperature, mental changes (these may be signs of neuroleptic syndrome)
• gastrointestinal bleeding
• seizures
• blood disorders, whose signs may include pale skin, fever, sore throat, or light bruises and prolonged bleeding after an injury.

Other side effects that may occur:

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

• involuntary movements, such as spasms and seizures.
• urinary tract infection.

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

• loss of appetite
• depression that may involve suicidal tendencies, confusion, abnormal dreams
• slowness of movement (the "on-off" phenomenon), dizziness, itching, or numbness or tingling of the skin, drowsiness, sudden episodes of sleep
• palpitations
• difficulty breathing
• nausea, vomiting, diarrhea.

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

• agitation
• syncope
• urticaria
• muscle spasms.

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

• anemia
• dementia, seizures have occurred in rare cases, but no causal relationship with treatment with carbidopa/levodopa has been established
• high blood pressure, inflammation of the veins
• duodenal ulcer, dark urine, sweat, or saliva, pruritus, vascular inflammation causing red rash and possibly abdominal and joint pain (Henoch-Schönlein purpura), hair loss, rash.

Frequency not known(cannot be estimated from available data)):

• desire for large doses of carbidopa/levodopa above those needed to control motor symptoms, known as dopamine dysregulation syndrome. Some patients experience abnormal involuntary movements (dyskinesias), mood changes, or other side effects after taking large doses of carbidopa/levodopa.

The following side effects associated with impulse control disorders may also occur:

Inability to resist the impulse to carry out an action that could be harmful, including:

• strong impulse to gamble excessively despite severe personal or family consequences
• altered or increased sexual interest and compulsive behavior towards oneself or others, for example, increased libido
• excessive or uncontrolled spending
• 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).

Inform your doctor if you experience any of these behaviors, as they will seek to control or reduce symptoms.

Other possible side effects:

• melanoma
• insomnia, anxiety, euphoria, disorientation, grinding of teeth
• altered state of alertness, agitation, bitter taste in the mouth, weakness, headache, drooping eyelids, and small pupils (Horner's syndrome activation), muscle tone disorders, increased tremor, numbness
• diplopia, blurred vision, dilated pupils, looking up momentarily and unaware, eyelid spasms
• angina, flushing of the face
• snoring, changes in breathing rhythm, hiccups
• dry mouth, increased salivation, difficulty swallowing, abdominal pain and discomfort, constipation, flatulence, heartburn or abdominal distension, burning sensation in the tongue
• increased sweating
• muscle spasms, trismus (difficulty opening the mouth)
• difficulty urinating, urinary incontinence
• prolonged and painful erection
• weakness, general malaise, swelling, fatigue, difficulty walking
• weight gain or loss, falls.

Carbidopa/Levodopa may affect some blood test results, such as elevating liver function test values and blood sugar levels. It has also been detected in urine and blood. Carbidopa/Levodopa may cause a false-positive reaction for ketones in urine.

If you experience unusual symptoms, consult your doctor or seek immediate treatment.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

This medication does not require any special storage temperature. Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the label of the container and the bottle after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Doporio

• The active principles are carbidopa and levodopa. Each tablet contains carbidopa monohydrate equivalent to 25 mg of carbidopa and 100 mg of levodopa.
• The other components are croscarmellose sodium, magnesium stearate, cornstarch, mannitol (E421), povidone.

Appearance of the product and contents of the package

Doporio 25 mg/100 mg are round white or off-white tablets, 10 mm in diameter, with a notch and marked with “LC 100” on one side.

Doporio is available in HDPE bottles of 100 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer:

Orion Corporation Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

This medicine is authorized in the member states of the European Economic Area with the following names:

Czech Republic: Pipoda

Denmark, Finland, Ireland, Norway, Sweden: Carbidopa/Levodopa Orion

Hungary: Parlekarv

Poland: Parkador

Slovakia: Carlevo

Spain: Doporio

Italy, Portugal: Oridopa

Netherlands: Doporio

Slovenia: Doporio 100 mg/25 mg tablets

Belgium: Doporio 25 mg/100 mg Tabletten / Tabletten / Comprimés

Doporio 12.5 mg/50 mg Tabletten / Tabletten / Comprimés

Last review date of this leaflet:September 2023

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/