ORIDOPA 25 mg/100 mg Tabletki

Treść ulotki

1. Oridopa 25 mg/250 mg tablets, 25 mg/100 mg tablets
   1. What is Oridopa and what is it used for
   2. What you need to know before you take Oridopa
   3. How to take Oridopa
   4. Possible side effects
   5. How to store Oridopa
   6. Contents of the pack and other information

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

carbidopa/levodopa
Generic medicine

Read this leaflet carefully before you start to take 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Oridopa and what is it used for

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

• you become slow and unstable
• muscles become stiff
• you may experience spasms or tremors.

If left untreated, Parkinson's disease can make it difficult to perform normal daily activities.
Oridopa contains two different medicines: levodopa and carbidopa.

• Levodopa is converted in the brain into a substance called "dopamine". Dopamine helps to improve the symptoms of Parkinson's disease.
• Carbidopa belongs to a group of medicines called "aromatic amino acid decarboxylase inhibitors". It helps 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 you take 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 using so-called MAO inhibitors for the treatment of depression
• if you suffer from closed-angle glaucoma
• if you suffer from attacks of hypertension induced by a tumor of the adrenal medulla (pheochromocytoma)
• if you have hormonal problems (overproduction of cortisol or thyroid hormone)
• if you suffer from severe heart disease.

Warnings and precautions
Talk to your doctor or pharmacist before taking Oridopa. Before taking this medicine,
tell your doctor about any medical problems 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 problems
• ulcers
• if you have had seizures (convulsions) in the past
• suspicious skin lesions or if you have had skin cancer (melanoma) in the past.

Tell your doctor if you or a family member/caregiver notices the development of symptoms similar
to addiction that cause a desire to take high doses of Oridopa and other medicines
used for the treatment of Parkinson's disease.
Tell your doctor if you or a family member/caregiver notices the development of urges or
desires to behave in ways that are unusual for you and you cannot resist the impulse, urge, or
temptation to perform certain activities that could harm yourself or others. These
behaviors are called impulse control disorders and may include gambling addiction, excessive eating or spending, an abnormal, exaggerated
sexual desire or an increase in sexual thoughts or feelings. Your doctor may need to
re-evaluate your treatment.
This medicine may alter some laboratory tests that your doctor may perform on samples of
blood or urine. Remind your doctor that you are taking Oridopa if you are having laboratory tests.
Tell your doctor if you have used levodopa in the past.

Children and adolescents
The use of Oridopa is not recommended in patients under the age of 18.

Other medicines and Oridopa
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The effectiveness of the treatment may change if Oridopa is used in conjunction 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 a medicine that can cause a drop in blood pressure when you get up from a chair or bed (orthostatic hypotension) iron or iron-based products. Taking Oridopa and iron preparations should be separated by the longest possible interval.
• anticholinergics and sympathomimetics (medicines for treating severe allergic reactions, asthma, chronic bronchitis, heart conditions and low blood pressure)
• some medicines for the treatment of psychiatric conditions or antidepressants (such as phenothiazines, butyrophenones and risperidone)
• medicines for the treatment of tuberculosis (isoniazid)
• medicines for the treatment of muscle cramps, convulsions or other conditions that cause involuntary movements (such as phenytoin)
• selegiline for the treatment of Parkinson's disease (in case of concomitant use, an excessive drop in blood pressure may occur).
• 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 function of Oridopa may decrease.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Oridopa is not recommended during pregnancy or in women of childbearing potential who are not using
contraceptives, unless the benefits for the mother outweigh the possible risk to the fetus.
Do not take Oridopa if you are breastfeeding.

Driving and using machines
The effects of the medicine can vary individually. In relation to the use of carbidopa levodopa
adverse effects have been observed that in some patients may affect the ability to drive or
use machines (see "Possible side effects").
Oridopa can cause excessive drowsiness and sudden episodes of falling asleep.
For this reason, you must refrain from driving motor vehicles and situations (such as using machinery)
where reduced reactivity 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 following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The usual daily dose may vary and is established individually by the doctor based on
the severity of the disease and the response to treatment. During the dose adjustment period,
the patient should pay particular attention to symptoms such as involuntary movements and immediately inform
the doctor if this occurs. The doctor will modify the dosage as needed.
Your doctor may prescribe more than one dosage of Oridopa. If you have been prescribed different dosages of
Oridopa, make sure you take the correct tablet at the right time.
For doses not achievable/practicable with this medicine, other medicines are available.

How to take this medicine

• Take the medicine by mouth, swallowing the tablet.
• Even if the medicine may have an effect after one day, it may take up to seven days to take effect.
• Take the tablet at regular intervals according to your doctor's instructions.
• Do not change the time of taking the tablets and do not take other medicines for Parkinson's disease without first consulting your doctor.
• Avoid taking the tablets with a protein-rich meal (see section 2 "Oridopa with food").

Oridopa 25 mg/250 mg and Oridopa 25 mg/100 mg: the tablet can 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, always contact
your doctor or hospital for advice on the risk and instructions on what to do.

If you forget to take Oridopa
Try to take Oridopa according to the instructions. However, if you have forgotten to take a
tablet, take it as soon as you remember. If it is almost time to take the next tablet,
do not take the forgotten tablet, but continue according to the usual dosage 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 dosage without first discussing it with your doctor.
Stopping the medicine may cause some symptoms such as muscle stiffness, fever or changes
in mood.
If you have any doubts 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 which can cause breathing or swallowing problems
• chest pain
• irregular heartbeat
• dizziness when getting up quickly (orthostatic hypotension)
• depression or psychotic symptoms, including delusions or hallucinations
• muscle rigidity, high temperature, mental changes (may be signs of neuroleptic syndrome)
• gastrointestinal bleeding
• convulsions
• blood disorders, the signs of which can include paleness, fever, sore throat or easy 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 jerks and convulsions
• urinary tract infections.

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

• loss of appetite
• depression which can include 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 sleep
• palpitations
• shortness of breath
• nausea, vomiting, diarrhoea.

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

• agitation
• fainting
• hives
• muscle contractions.

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

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

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

• a desire for doses of carbidopa/levodopa in excess of those necessary to control motor symptoms, known as dopamine dysregulation syndrome. Some patients experience severe abnormal involuntary movements (dyskinesias), mood swings 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, urge or temptation to perform an action that could be
harmful to oneself or others, which may include:

• a strong urge to gamble excessively, despite serious personal or family consequences
• altered or increased sexual desire that causes significant distress to you or others
• uncontrolled 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 is needed to satisfy hunger).

Tell your doctor if you experience any of these behaviours, so they can decide how
to intervene to manage or reduce the 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 (activation of Horner’s syndrome), muscle tone disorders, increased hand tremor, numbness
• double vision, blurred vision, dilated pupils, gaze momentarily and inadvertently directed upwards, eyelid cramps
• hot flushes, flushing
• hoarseness, changes in breathing rhythm, hiccups
• dry mouth, increased salivation, difficulty swallowing, pain and abdominal discomfort, constipation, flatulence, heartburn or abdominal bloating, burning sensation in 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 can affect the results of some blood tests, such as increased values of liver function tests and blood glucose. Bacteria and blood have also been detected in urine. Oridopa can
cause a false positive for urinary ketones.
If you experience unusual symptoms, consult your doctor or go to an assistance center immediately.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through
the national reporting system at
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 the 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 particular storage temperature conditions. Store in the
original packaging to protect it from light.
Do not use this medicine after the expiry date which is stated on the package and bottle after
“Exp.” . The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Oridopa contains

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

Description of the appearance of Oridopa and contents of the pack
Oridopa 25 mg/250 mg are round white or off-white tablets, 16 mm in length and 8 mm
in thickness, marked and imprinted with “LC 250” on one side.
Oridopa 25 mg/100 mg are round white or off-white tablets, 10 mm in diameter,
marked and imprinted 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

Distributor:
Orion Pharma S.r.l. - Milan

Manufacturer
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
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

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