DOPORIO 25mg/100mg TABLETS

Introduction

Package Leaflet: Information for the User

Doporio 25 mg/100 mgTablets EFG

Carbidopa/Levodopa

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• 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 signs of illness 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 pack

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

1. What is Doporio and what is it used for

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

• slow and unstable movements.
• muscle stiffness.
• developing agitation or tremors.

If left untreated, Parkinson's disease can cause difficulties in leading a normal life. Doporio contains two different active substances called: levodopa and carbidopa.

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

• Carbidopa belongs to a group of medicines called "aromatic amino acid decarboxylase inhibitors". It allows levodopa to work more effectively by reducing the speed at which levodopa breaks down in your body.

2. What you need to know before you take Doporio

Do not takeDoporio

• 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 had skin cancer in the past
• if you are being treated with antidepressant medicines of the MAO inhibitor type (monoamine oxidase inhibitors)
• if you have narrow-angle glaucoma
• if you suffer from hypertension-induced attacks caused by a tumor of the adrenal gland (pheochromocytoma)
• hormonal problems (overproduction of cortisol or thyroid hormone)
• if you have severe heart disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine. It is important that before starting to take this medicine, you 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 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).

Tell your doctor if you or your family member/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 medicines used to treat Parkinson's disease.

Tell your doctor if you or your family member/caregiver notice that you are starting to behave abnormally, if you feel the impulse, initiative or temptation to harm others or yourself. These behaviors are called impulse control disorders and may include addiction to gambling, eating or spending excessively, increased sexual desire or an increase in sexual thoughts or desires. Your doctor may need to review your treatments.

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

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

Children and adolescents

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

Other medicines andDoporio

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

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

• medicines for the treatment of high blood pressure. It may be necessary to adjust the dose of these medicines.
• if you are taking medicines that can cause a drop in blood pressure when standing up from a chair or bed (orthostatic hypotension).
• iron or iron products. The intake of Carbidopa/Levodopa and iron preparations should be separated by the longest possible time interval
• anticholinergics and sympathomimetics (medicines for treating severe allergic reactions, asthma, chronic bronchitis, heart diseases and low blood pressure).
• certain medicines for the treatment of psychiatric diseases or antidepressants (such as phenothiazines, butyrophenones and risperidone)
• medicines for the treatment of tuberculosis (isoniazid)
• medicines for the treatment of muscle spasms, convulsions or other conditions that cause involuntary movements (such as phenytoin)
• selegiline for the treatment of Parkinson's disease (excessive blood pressure drop 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 that contains protein (such as meat, eggs, milk, cheese) as the function of Carbidopa/Levodopa may decrease.

Pregnancy andbreast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Do not take Carbidopa/Levodopa if you are breast-feeding.

Driving and using machines

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

Carbidopa/Levodopa may cause excessive drowsiness and sudden episodes of sleep. Therefore, you should avoid driving vehicles or performing activities (e.g. using machines) in which reduced reaction ability may pose a risk of potentially fatal injuries, until such repeated episodes of sleep and/or drowsiness have disappeared.

Doporio contains sodium

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

3. How to take Doporio

Follow exactly the administration instructions of this medicine 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 individually determined by the doctor through an individual dose adjustment according to the severity of your disease and your response to treatment. During the dose adjustment period, the patient should pay special attention to symptoms such as involuntary movements and inform their doctor immediately if this occurs. Your doctor will adjust your dose as necessary.

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

For doses that are not possible/practical with this medicine, other medicines are available.

How to take this medicine

• Take this medicine orally by swallowing the tablet.
• Although your medicine may take effect 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 schedule of your tablets or any other medicine for Parkinson's disease without first consulting your doctor.
• Try to avoid taking your tablets with a protein-rich meal (see section 2 "Taking Doporio with food").

The tablet can be divided into equal doses.

If you takemore Doporio than you should

If you have taken more carbidopa/levodopa than you should, or if a child has taken a medicine by accident, consult your doctor or hospital for an opinion on the risk and instructions on the measures to be taken.

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 medicine and the amount taken.

If you forget to takeDoporio

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 the 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 stop taking Doporio

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 that can cause breathing or swallowing problems
• chest pain
• irregular heartbeat
• dizziness when standing up quickly (orthostatic hypotension)
• depression or psychotic symptoms, including delirium 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 mild bruising 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 convulsions.
• urinary tract infections.

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, tingling and/or numbness of the skin, drowsiness, sudden episodes of sleep
• palpitations
• breathing difficulties
• nausea, vomiting, diarrhea.

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

• agitation
• fainting
• hives
• 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 carbidopa/levodopa treatment has been established
• high blood pressure, vein inflammation
• duodenal ulcer, dark urine, sweat and/or saliva
• itching, vascular inflammation that causes a reddish rash and possibly abdominal and joint pain (Henoch-Schönlein purpura), hair loss, rash.

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

• desire for large doses of carbidopa/levodopa above those necessary 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 large doses of carbidopa/levodopa.

Impulse control disorders may also occur:

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

• strong impulse to gamble excessively despite serious personal or family consequences
• altered or increased sexual interest and behavior towards yourself or others, for example, an increase in sexual desire
• uncontrolled or excessive shopping or spending
• binge eating (eating large amounts of food in a short time) or compulsive eating (eating more food than normal and more than necessary to satisfy your hunger).

Tell your doctor if you experience any of these behaviors as they will seek a way to control or reduce the symptoms.

Other possible side effects:

• melanoma
• insomnia, anxiety, euphoria, disorientation, abnormal dreams
• altered alertness, agitation, bitter taste in the mouth, weakness, headache, drooping eyelids and small pupils (activation of Horner's syndrome), muscle tone disorders, increased hand tremor, numbness
• double vision, blurred vision, dilated pupils, looking up momentarily and unintentionally, eyelid spasms
• hot flashes, flushing of the face
• hoarseness, 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)
• urination difficulties, 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 elevated liver function test values and blood sugar values. Bacteria and blood have also been detected in the urine. Carbidopa/Levodopa may cause a false positive reaction for ketone bodies in the urine.

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

Reporting of side effects

If you experience 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 through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Doporio

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

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

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. Packaging Contents and Additional Information

Doporio Composition

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

Product Appearance and Packaging Contents

Doporio 25 mg/100 mg are round white or almost white tablets, 10 mm in diameter, with a score line 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

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

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

Date of Last Revision of this Leaflet:December 2024

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