Oridopa

Package leaflet: Information for the patient

Oridopa 25 mg/250 mg tablets, 25 mg/100 mg tablets

carbidopa/levodopa
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Oridopa is and what it is used for

Oridopa improves the symptoms of Parkinson's disease in adults. Parkinson's disease is a long-term condition in which:

• movement becomes slow and unsteady
• muscles become stiff
• spasms or shaking (called "tremors") may occur.

If left untreated, Parkinson's disease can make it difficult to carry out normal daily activities.
Oridopa contains two different medicines: 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 called "aromatic amino acid decarboxylase inhibitors". It helps levodopa work more effectively by slowing down the rate at which levodopa is broken down in the body.

2. What you should know before taking Oridopa

Do not take Oridopa

• if you are allergic to levodopa and carbidopa or to any of the other ingredients of this medicine (listed in section 6)
• if you have suspicious skin lesions (moles) that have not been examined, or if you have had skin cancer
• if you are taking so-called MAO inhibitors for the treatment of depression
• if you have closed-angle glaucoma
• if you have hypertensive attacks caused by a tumor of the adrenal medulla (pheochromocytoma)
• if you have hormonal problems (overproduction of cortisol or thyroid hormone)
• if you have severe heart disease.

Warnings and precautions
Talk to your doctor or pharmacist before taking Oridopa. Before taking this medicine,
inform your doctor about any medical conditions you have or have had, especially if you have or have had:

• heart attacks or heart rhythm problems
• severe lung problems or asthmatic bronchitis
• kidney, liver or hormonal problems
• depression or mental health problems
• ulcers
• seizures (fits) in the past
• suspicious skin lesions or a history of skin cancer (melanoma).

Inform your doctor if you or a family member/caregiver notice the development of symptoms resembling
dependence, leading to a desire to take high doses of Oridopa and other medicines used to treat
Parkinson's disease.
Inform your doctor if you or a family member/caregiver notice the development of impulses or
urges to behave in ways that are unusual for you and that you cannot resist the impulse, drive, or
temptation to carry out certain activities that could harm yourself or others. These
behaviors are called impulse control disorders and may include gambling addiction, compulsive
eating or excessive spending, abnormally increased sexual desire, or increased sexual thoughts or feelings. Your doctor may consider it necessary
to reassess your treatment.
This medicine may interfere with certain laboratory tests that your doctor may perform on blood or
urine samples. Remember to inform your doctor that you are taking Oridopa if you are undergoing laboratory tests.
Inform your doctor if you have previously taken levodopa.
Children and adolescents
The use of Oridopa is not recommended in patients under 18 years of age.
Other medicines and Oridopa
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
The effectiveness of treatment may change if Oridopa is taken together with other medicines.
Inform your doctor if you are taking any of the following medicines:

• medicines for the treatment of high blood pressure. The dose of these medicines may need to be adjusted.
• medicines that may cause a drop in blood pressure when standing up from a chair or bed (orthostatic hypotension), iron or iron-containing products. Oridopa and iron-containing 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 the treatment of muscle cramps, seizures, or other conditions causing involuntary movements (such as phenytoin)
• selegiline for the treatment of Parkinson's disease (concomitant use may cause excessive drop in blood pressure)
• other medicines for Parkinson's disease, such as tolcapone, entacapone, or amantadine.

Oridopa with food
Avoid taking Oridopa with a meal containing protein (such as meat, eggs, milk, cheese),
as the effectiveness of Oridopa may be reduced.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Oridopa is not recommended during pregnancy or in women of childbearing age who do not use
contraception, unless the benefits to the mother outweigh the potential risks to the fetus.
Do not take Oridopa if you are breastfeeding.
Driving and using machines
The effects of the medicine may vary from person to person. Adverse effects have been observed with carbidopa/levodopa
that, in some patients, may impair the ability to drive or operate machinery (see "Possible side effects").
Oridopa may cause excessive drowsiness and episodes of sudden, brief sleep attacks.
Therefore, you must refrain from driving motor vehicles and from situations (such as operating machinery)
in which reduced reaction capacity could pose a risk of life-threatening injury,
until repeated episodes of sleep and drowsiness have resolved.
Oridopa contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is essentially "sodium-free".

3. How to take Oridopa

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The usual daily dose may vary and is individually determined by the doctor according to
the severity of the disease and the response to treatment. During the dose adjustment period,
the patient must pay particular attention to symptoms such as involuntary movements and must
inform the doctor immediately if this occurs. The doctor will adjust the dosage as necessary.
Your doctor may prescribe more than one strength of Oridopa. If you have been prescribed different strengths of
Oridopa, make sure to take the correct tablet at the right time.
For doses not achievable/practical with this medicine, other medicines are available.
How to take this medicine

• Take the medicine by mouth, swallowing the tablet whole.
• Although the medicine may have an effect after one day, it may take up to seven days to take full effect.
• Take the tablet at regular intervals as directed by your doctor.
• Do not change the timing of your doses and do not take any other medicines for Parkinson's disease without first consulting your doctor.
• Avoid taking the tablets with a meal high in protein (see section 2 "Oridopa with food").

Oridopa 25 mg/250 mg and Oridopa 25 mg/100 mg: the tablet may be divided into equal doses.
If you take more Oridopa than you should
If you take more medicine than you should, or if a child has taken the medicine by mistake, contact
your doctor or hospital immediately for advice on the risk and instructions on actions to be taken.
If you forget to take Oridopa
Try to take Oridopa as directed. However, if you forget to take a tablet, take it as soon as you remember.
If it is almost time for your next tablet, do not take the missed tablet but continue with your regular dosing schedule.
Do not take a double dose to make up for the forgotten tablet.
If you stop taking Oridopa
Do not stop taking Oridopa or reduce the dose without first discussing it with your doctor.
Stopping the medicine may cause certain symptoms such as muscle stiffness, fever, or mood changes.
If you have any questions about the use of this medicine, consult 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 urticaria, itching, skin rash, and swelling of the face, lips, tongue, and/or throat, which may cause breathing or swallowing difficulties
• chest pain
• irregular heart function
• dizziness when standing up suddenly (orthostatic hypotension)
• depression or psychotic symptoms, including delusions or hallucinations
• muscle rigidity, elevated body temperature, mental changes (may be signs of neuroleptic malignant syndrome)
• gastrointestinal bleeding
• seizures
• blood disorders, which may present with signs such as paleness, fever, sore throat, minor bruising, and prolonged bleeding after injury.

Other possible side effects include:
Very common ( may affect more than 1 in 10 people ):

• involuntary movements such as contractions and convulsions
• urinary tract infections.

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

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

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

• agitation
• fainting
• urticaria
• muscle contractions.

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

• anaemia
• dementia, seizures have been reported 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, sweating and/or saliva
• itching, vascular inflammation causing reddish skin rash and possibly abdominal and joint pain (Henoch-Schönlein purpura), hair loss, skin rash.

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

• desire to take higher doses of carbidopa/levodopa than needed to control motor symptoms, known as dopamine dysregulation syndrome. Some patients may experience severe abnormal involuntary movements (dyskinesia), mood swings, or other side effects after taking high doses of carbidopa/levodopa.

The following adverse effects related to impulse control disorders may also occur:
Inability to resist the impulse, urge, or temptation to carry out an action that could be harmful to oneself or others, which may include:

• strong urge to gamble excessively, despite serious personal or family consequences
• altered or increased sexual desire causing significant concern to the patient or others
• uncontrollable or excessive shopping or spending
• compulsive eating (eating large amounts of food in a short time) or bulimia (eating more food than normal and more than needed to satisfy hunger).

Inform your doctor if any of these behaviours occur, so that appropriate measures can be taken to manage or reduce symptoms.
Other possible side effects:

• melanoma
• insomnia, anxiety, euphoria, disorientation, teeth grinding
• reduced alertness, agitation, bitter taste in the mouth, weakness, headache, drooping eyelids and small pupils (Horner's syndrome), muscle tone disorders, increased hand tremor, numbness
• diplopia, blurred vision, dilated pupils, temporary and involuntary upward gaze, eyelid spasms
• hot flushes, flushing
• hoarseness, changes in breathing rhythm, hiccups
• dry mouth, increased salivation, difficulty swallowing, abdominal pain and discomfort, constipation, flatulence, heartburn or abdominal bloating, burning sensation of the tongue
• increased sweating
• muscle contractions, 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.

Oridopa may affect the results of certain blood tests, such as increased liver function test values and blood glucose levels. Bacteria and blood have also been detected in urine. Oridopa may cause a false positive result for urinary ketones.
If you experience any unusual symptoms, consult your doctor immediately or contact a healthcare facility.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Oridopa

Keep this medicine out of sight and reach of children.
Oridopa 25 mg/250 mg tablets.
This medicine does not require any special storage conditions.
Oridopa 25 mg/100 mg tablets.
This medicine does not require any special storage temperature conditions. Store in the
original packaging to protect it from light.
Do not use this medicine after the expiry date stated on the carton and bottle after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Oridopa contains

• The active substances are carbidopa and levodopa. Each tablet of Oridopa 25 mg/250 mg contains 25 mg of carbidopa and 250 mg of levodopa. Each tablet of Oridopa 25 mg/100 mg contains 25 mg of carbidopa and 100 mg of levodopa.
• The other components are croscarmellose sodium, magnesium stearate, maize starch, mannitol (E421), povidone.

Description of the appearance of Oridopa and contents of the pack
Oridopa 25 mg/250 mg are white or almost white, round tablets, 16 mm in length and 8 mm in thickness, marked with "LC 250" on one side.
Oridopa 25 mg/100 mg are white or almost white, round tablets, 10 mm in diameter, marked with "LC 100" on one side.
Oridopa is available in a bottle containing 100 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Concessionaire for sale:
Orion Pharma S.r.l. - Milan
Manufacturer
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland

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

This patient information leaflet was last updated on