Doporio 25 mg/100 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Doporio 25 mg/100 mg tablets EFG

Carbidopa/Levodopa

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Doporio is and what it is used for

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

• slow and unsteady movements.
• muscle stiffness.
• development of agitation or tremors.

If left untreated, Parkinson's disease can lead to difficulties in carrying out normal daily activities. Doporio contains two different active substances called: levodopa and carbidopa.

• Levodopa is converted in the brain into a substance called "dopamine." Dopamine helps improve the symptoms of Parkinson's disease.

• Carbidopa belongs to a group of medicines known as "aromatic amino acid decarboxylase inhibitors." It allows levodopa to work more effectively by slowing down the rate at which levodopa is broken down in the body.

2. What you need to know before taking Doporio

Do not take Doporio

• 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 (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 antidepressant medicines of the MAO inhibitor (monoamine oxidase) group
• if you have narrow-angle glaucoma
• if you suffer from hypertension attacks caused by a tumor of the adrenal medulla (pheochromocytoma)
• hormonal disorders (overproduction of cortisol or thyroid hormone)
• if you have severe heart disease.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine. It is important that before starting this medicine you inform your doctor of any medical problems you currently have or have had in the past, especially if you have or have had:

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

Inform your doctor if you or your family/carer notice that you are developing addiction-like symptoms, leading to a desire to take high doses of carbidopa/levodopa and other medicines used to treat Parkinson’s disease.

Inform your doctor if you, or your family/carer, notice that you are starting to behave in an unusual way, or if you feel the urge, impulse, or temptation to harm others or harm yourself. These behaviors are called impulse control disorders and may include gambling addiction, compulsive eating or spending, increased sexual desire, or increased sexual thoughts or urges. Your doctor may need to review your treatment.

This medicine may affect certain laboratory tests that your doctor may perform on blood or urine samples. Remember to inform your doctor if you are taking this medicine and are scheduled for any tests.

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

Children and adolescents

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

Other medicines and Doporio

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The effectiveness of treatment may change if carbidopa/levodopa is used together with other medicines. Inform your doctor if you are taking any of the following medicines:

• medicines for the treatment of high blood pressure. Dose adjustments of these medicines may be necessary.
• if you are taking medicines that may cause a drop in blood pressure when standing up from a chair or bed (orthostatic hypotension).
• iron or iron-containing products. Carbidopa/levodopa and iron preparations should be taken as far apart as possible.
• anticholinergics and sympathomimetics (medicines used to treat severe allergic reactions, asthma, chronic bronchitis, heart conditions, and low blood pressure).
• certain medicines for psychiatric disorders or antidepressants (such as phenothiazines, butyrophenones, and risperidone)
• medicines for the treatment of tuberculosis (isoniazid)
• medicines for muscle cramps, seizures, or other conditions causing involuntary movements (such as phenytoin)
• selegiline for the treatment of Parkinson’s disease (excessive drop in blood pressure may occur with concomitant use)
• other medicines for Parkinson’s disease such as tolcapone, entacapone, or amantadine.

Taking Doporio with food

Try to avoid taking carbidopa/levodopa with a meal high in protein (such as meat, eggs, milk, cheese), as the effectiveness of carbidopa/levodopa may be reduced.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Carbidopa/levodopa is not recommended during pregnancy or in women of childbearing age who are not using contraceptive methods unless the benefits to the mother outweigh the potential risks to the fetus.

Do not take carbidopa/levodopa if you are breastfeeding.

Driving and using machines

The effects of this medicine may vary from person to person. Adverse effects have been observed that in some patients may affect the ability to drive or operate machinery when taking carbidopa/levodopa (see "Possible side effects").

Carbidopa/levodopa may cause excessive drowsiness and sudden episodes of falling asleep within a short time. Therefore, you should avoid driving or performing activities (e.g., operating machinery) where reduced reaction ability could pose a risk of potentially fatal injury, until repeated episodes of sleep and/or drowsiness have resolved.

Doporio contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially "sodium-free".

3. How to take Doporio

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended daily dose may vary and is individually determined by your doctor through an individual dose adjustment based on the severity of your condition and your response to treatment. During the dose adjustment period, the patient must pay special attention to symptoms such as involuntary movements, and should inform their doctor immediately if these occur. Your doctor will adjust your dose as necessary.

Your doctor may prescribe you more than one strength of carbidopa/levodopa. If you have been prescribed different strengths of carbidopa/levodopa, make sure you are taking the correct tablet at the appropriate time.

For doses that are not achievable/practicable with this medicine, other medications are available.

How to take this medicine

• Take this medicine orally by swallowing the tablet whole.
• Although your medicine may start to work after one 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 timing of your tablet doses or of any other Parkinson's disease medication without first consulting your doctor.
• Try to avoid taking your tablets with a high-protein meal (see section 2 "Taking Doporio with food").

The tablet may be divided into equal doses.

If you take more Doporio than you should

If you have taken more carbidopa/levodopa than you should, or if a child has accidentally taken the medicine, consult your doctor or hospital for advice on the risk and instructions on what measures to take.

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

If you forget to take Doporio

Take Carbidopa/Levodopa exactly as prescribed. However, if you forget to take a dose, 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 your next scheduled dose. Do not take a double dose to make up for a missed dose.

If you stop taking Doporio

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

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

4. Possible adverse effects

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

Contact your doctor immediately if you experience any of the following symptoms:

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

Other adverse effects that may occur:

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

• involuntary movements, such as spasms and convulsions
• urinary tract infections

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

• loss of appetite
• depression, which may include suicidal tendencies, confusion, abnormal dreams
• slowness of movement (the "on-off" phenomenon), dizziness, burning and/or tingling or numbness of the skin, drowsiness, sudden episodes of falling asleep
• palpitations
• difficulty breathing
• nausea, vomiting, diarrhoea

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

• agitation
• fainting
• urticaria
• muscle spasms

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

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

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

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

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

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

• strong urge to gamble excessively despite serious personal or family consequences
• altered or increased sexual interest and behavior, or excessive preoccupation with oneself or others, for example, increased libido
• excessive and uncontrolled shopping or spending
• binge eating (consuming large amounts of food in a short time) or compulsive eating (eating more food than normal and more than necessary to satisfy hunger)

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

Other possible adverse effects:

• melanoma
• insomnia, anxiety, euphoria, disorientation, teeth grinding
• altered alertness, agitation, bitter taste in the mouth, weakness, headache, drooping eyelids and small pupils (Horner's syndrome activation), muscle tone disorders, increased hand tremor, numbness
• diplopia, blurred vision, dilated pupils, transient and involuntary upward gaze, eyelid spasms
• hot flushes, facial redness
• hoarseness, changes in breathing rhythm, hiccups
• dry mouth, increased salivation, difficulty swallowing, abdominal pain and discomfort, constipation, flatulence, heartburn or abdominal distension, burning sensation on 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 weight loss, falls

Carbidopa/Levodopa may affect certain blood test results, such as increasing liver function test values and blood sugar levels. Bacteria and blood may also be detected in the urine. Carbidopa/Levodopa may cause a false positive test result for ketones in urine.

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Doporio

Keep this medicine out of sight and reach of children.

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

Do not use this medicine after the expiry date stated on the label of the container and on the vial, after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Doporio

• The active substances 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, corn starch, mannitol (E421), povidone.

Nature of the product and pack size

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

Doporio is available in HDPE bottles containing 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

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: December 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/