Precifit

Leaflet accompanying the packaging: information for the user

Precifit, 5 mg + 1.25 mg, tablets for suspension, for dispenser
Levodopa / Carbidopa

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Precifit and what is it used for

Precifit alleviates the symptoms of Parkinson's disease. Parkinson's disease is a chronic condition, during which:

• the patient's movements become slow and unsteady,
• the muscles become stiff,
• tremors may occur.

Untreated Parkinson's disease can make it difficult to perform everyday activities.
Precifit contains two separate active substances — levodopa and carbidopa.

• Levodopa is converted in the brain into a substance called dopamine. Dopamine helps to alleviate the symptoms of Parkinson's disease.
• Carbidopa belongs to a group of medicines called aromatic amino acid decarboxylase inhibitors. It enhances the effect of levodopa by slowing down its breakdown in the body.

Precifit is in the form of small tablets (microtablets) that are taken using a dispenser.
The dispenser, programmed by a doctor or nurse, dispenses a specified number of tablets for each planned dose.

2. Important information before taking Precifit

When not to take Precifit:

• if the patient is allergic to carbidopa or levodopa, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has had a skin cancer or if they currently have unusual moles that have not been examined by a doctor;
• if the patient is taking certain antidepressants, called monoamine oxidase inhibitors (MAOIs). It is necessary to stop taking these medicines at least two weeks before starting to take Precifit (see also the section "Precifit and other medicines" below);
• if the patient has a condition called narrow-angle glaucoma, which can cause a sudden increase in pressure in the eye;
• if the patient has attacks of high blood pressure caused by a tumor of the adrenal gland (pheochromocytoma);
• if the patient has hormonal disorders (excessive production of cortisol or thyroid hormones);
• if the patient has severe heart disease.

If the patient has any of the above conditions, they should not take Precifit. In case of doubts, they should consult a doctor or pharmacist before taking Precifit.

Warnings and precautions

Before starting to take Precifit, the patient should discuss it with their doctor or pharmacist if:

• they have had seizures in the past;
• they have respiratory problems (such as asthma);
• they have had stomach or duodenal ulcers or have vomited blood;
• they have had a heart attack, heart problems, or circulation problems;
• they are taking medicines that can cause low blood pressure when standing up from a chair or bed (orthostatic hypotension),
• they have kidney or liver problems;
• they have hormonal disorders;
• they have had depression or other mental disorders;
• they have a condition called chronic open-angle glaucoma, which can lead to increased pressure in the eye. The patient will have their eye pressure measured regularly;
• they experience sudden attacks of sleep or excessive sleepiness;
• they will be undergoing surgery soon.

The patient should inform their doctor if they, their family, or caregiver notice the patient experiencing unusual urges or compulsive behaviors, or if the patient cannot resist impulses, urges, or compulsions to perform certain actions that may be harmful to themselves or others. Such behaviors are called impulse control disorders and may include gambling addiction, overeating, or excessive spending, as well as an unusually high sex drive and increased sexual thoughts and feelings. The doctor may need to assess the medicines the patient is taking.
If the patient or their family (caregiver) notice symptoms similar to addiction, leading to a desire to take high doses of Precifit and other medicines used to treat Parkinson's disease, they should tell their doctor.
The medicine may interfere with the results of laboratory tests of urine or blood ordered by the doctor.
In case of doubts about any of the above information, the patient should consult their doctor or pharmacist.

Precifit and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes herbal preparations. The effectiveness of the treatment may change if Precifit is taken with certain other medicines.
In particular, the patient should tell their doctor or pharmacist if they are taking any of the following medicines:

• medicines used to treat Parkinson's disease (such as tolcapone, entacapone, amantadine),
• medicines used to treat severe allergic reactions, asthma, chronic bronchitis, heart disease, and low blood pressure (such as anticholinergic and sympathomimetic medicines),
• medicines used to treat seizures or epilepsy (such as phenytoin),
• medicines used to treat high blood pressure (hypotensive medicines),
• medicines used to treat mental disorders (antipsychotic medicines such as phenothiazine derivatives, butyrophenone derivatives, and risperidone),
• medicines used to treat depression (such as tricyclic antidepressants or non-selective monoamine oxidase inhibitors),
• medicines used to treat tuberculosis (such as isoniazid),
• anxiolytic medicines (such as benzodiazepines),
• medicines used to treat anemia (such as iron preparations),
• antiemetic medicines (such as metoclopramide),
• medicines used to treat vascular spasms (such as papaverine).

If the patient is not sure if any of the above information applies to them, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy, breastfeeding, and fertility

Precifit should not be taken during pregnancy, as there is not enough experience with its use in pregnant women.
Precifit should not be taken during breastfeeding, as levodopa passes into human milk.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

• Precifit has a different effect on different people. Precifit may lower blood pressure, which can lead to dizziness and dizziness. Therefore, caution should be exercised when driving vehicles and operating machines (see section "Possible side effects").
• Precifit may cause sleepiness and sudden sleep attacks. In such cases, the patient should not drive vehicles or operate machines. The doctor will decide whether the patient can drive again if the attacks stop.

3. How to take Precifit

This medicine should always be taken according to the doctor's or pharmacist's instructions. In case of doubts, the patient should consult their doctor or pharmacist.
The dose of the medicine will be determined by the doctor, who will adjust it individually according to the patient's needs.
The doctor will monitor the patient during treatment and, if necessary, change the dose of the medicine.

Taking this medicine

• The tablets should be dissolved in half a glass of water. After dissolving in water, a white solution will form, which should be taken immediately.
• Precifit should only be used with the MyFID dispenser. The doctor will adjust the dose according to the patient's needs using the dispenser's functions.
• The tablets should be taken at regular intervals. The dispenser has a reminder function and makes it easier to remember to take the tablets.
• The dispenser records the taken doses and has a system for assessing the severity of symptoms, the data from which can be sent to the doctor.
• The dispenser contains a cartridge containing 750 tablets for suspension. With normal dosing, the contents of one cartridge are sufficient for 1-2 weeks. Before inserting the cartridge into the dispenser, the foil packaging should be removed.

The tablets should be taken as follows:

• The MyFID dispenser will generate a notification, and a message "TAKE DOSE" and the specified time will appear on the screen, alternating. The patient should press this message. The dose can be taken 15 minutes before or 15 minutes after the specified time. Before taking the dose, the dispenser should be turned upside down to release any blocked tablets. After pressing the "TAKE DOSE" message, a window will open. If necessary and according to the doctor's instructions, the dose can be adjusted (increased or decreased). The patient should remember that the doctor sets the value by which the patient can change the dose. Then, the patient should press the "TAKE DOSE" message again. The tablets are counted and collected in a container inside the dispenser. During the tablet counting process, the MyFID dispenser should be held vertically. The microtablets are then dispensed into the container inside the dispenser. After the tablet counting is complete, a new window will appear. Holding the dispenser vertically over a glass, the patient should press the "EJECT" button, which will release the microtablets into the glass/cup. Until the tablet dispensing is complete, the dispenser should be held vertically.
• After releasing the tablets, the patient should add ½ to 1 deciliter of water. The tablets will dissolve within 15 seconds, and a clear solution with a white sediment will form. The patient should stir the contents of the glass to distribute the sediment in the solution and drink everything, including the sediment. The glass should be rinsed with an additional amount of water (½ deciliter) to ensure that the entire dose is taken. The solution should be taken immediately after preparation.
• In the case of doses exceeding 100 mg, i.e., more than 20 tablets, the tablets will be counted and dispensed in two stages. The dispenser will display an instruction to dispense the tablets twice. The patient should follow the instructions on the screen. The tablets from the second stage will be dispensed only after pressing the "EJECT" button.
• Further information can be found in the dispenser's user manual.
• Precifit with food and drink:In some patients, the effect of Precifit may be slightly reduced when taken with a protein-rich meal. Protein is found in products such as meat, fish, eggs, legumes, milk, and cheese. If possible, Precifit should be taken 30 minutes before a meal or 1 hour after a meal.

If the patient has not taken levodopa before

100 mg (20 tablets for suspension) three times a day. The doctor will gradually increase the dose using the dose increase scheme in the dispenser.
In the case of patients with unsatisfactory effect of the medicine at the end of the dose interval (wearing offphenomenon), the dosing of the medicine can be divided into smaller and more frequent doses, without changing the daily dose. The doctor will recommend the appropriate dose adjustment and frequency of taking the medicine.

If the patient has taken levodopa

The doctor will recommend stopping the previously taken medicines for Parkinson's disease before starting to take Precifit.

Use in children and adolescents

The safety of using Precifit in patients under 18 years of age has not been established. There is no appropriate use of Precifit in children and adolescents for the treatment of Parkinson's disease.

Taking a higher dose of Precifit than recommended

In case of taking a higher number of tablets than recommended, the patient should immediately consult a doctor.

Missing a dose of Precifit

The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Precifit

The patient should not stop taking Precifit without first consulting their doctor.
If the patient stops taking Precifit, they may experience muscle stiffness, elevated temperature (fever), and mental disorders.
If it is necessary to temporarily stop treatment with Precifit, e.g., before surgery, the patient should resume taking their usual doses as soon as possible.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The patient should stop taking Precifit and immediately consult their doctor if they notice any of the following symptoms:

• allergic reactions, symptoms may include hives, itching, rash, swelling of the face, lips, tongue, or throat, which may lead to difficulty breathing or swallowing,
• chest pain,
• irregular heartbeat or palpitations,
• gastrointestinal bleeding, which can be observed as blood in the stool or darker stool (gastrointestinal bleeding),
• blood disorders, symptoms may include paleness, fatigue, fever, sore throat, or moderate bruising and prolonged bleeding after injury,
• muscle stiffness, increased inability to sit still, high fever, sweating, increased salivation, and impaired consciousness (neuroleptic malignant syndrome),
• mental changes including delusions, hallucinations, and depression (very rare), suicidal tendencies,
• seizures.

Other side effects that may occur when taking this medicine:

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

• Urinary tract infections

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

• loss of appetite (anorexia),
• confusion, dizziness, nightmares, sleepiness, fatigue, insomnia, elevated mood (euphoria), dementia, feeling of excitement, sleep disorders,
• movement disorders (dyskinesia), disorders characterized by involuntary movements (chorea), muscle tone disorders (dystonia), movement disorders caused by non-neurological causes, sudden changes in Parkinson's disease symptoms (on-offphenomenon), slow movement during on-offperiods (bradykinesia),
• decrease in blood pressure caused by, for example, standing up too quickly from a sitting or lying position, in some cases accompanied by dizziness (orthostatic hypotension), tendency to faint,
• sudden loss of consciousness,
• nausea, vomiting, dry mouth, bitter taste.

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

• weight loss or gain,
• coordination disorders (ataxia), increased hand tremors,
• increased blood pressure,
• hoarseness, chest pain,
• constipation, diarrhea, bloating,
• increased salivation, difficulty swallowing,
• fluid accumulation in the body (edema),
• muscle cramps,
• dark urine,
• weakness (asthenia), feeling of weakness,
• feeling unwell (general malaise),
• hot flashes.

Rare (may affect up to 1 in 1000 people):

• blood disorders (leukopenia) with increased susceptibility to infections, anemia, blood disorder (thrombocytopenia) with bruising and tendency to bleed (thrombocytopenia),
• feeling of excitement (agitation), anxiety, thinking disorders, disorientation, headache, increased sex drive, numbness, seizures,
• episodes of severe mental illness, during which the patient's ability to control their behavior is impaired,
• severe disorders, such as those caused by taking neuroleptic medicines, which can occur in the form of muscle stiffness, severe inability to sit still, high fever, sweating, increased salivation, and impaired consciousness (neuroleptic malignant syndrome),
• feeling of tingling, numbness, and itching without an apparent cause,
• increased frequency of falls, gait disorders, jaw stiffness,
• blurred vision, spasms of the eye muscle (may be a sign of overdose), reactivation of previously existing Horner's syndrome (eye disorder), double vision, dilated pupils, impaired eye movement,
• inflammation of the veins,
• shortness of breath, abnormal breathing patterns,
• digestive disorders occurring with symptoms such as a feeling of heaviness in the abdomen, upper abdominal pain, belching, nausea, vomiting, and heartburn (dyspepsia), abdominal and intestinal pain,

and darkening of saliva, teeth grinding, hiccups, gastrointestinal bleeding, burning sensation on the tongue, duodenal ulcers,

• sudden accumulation of fluid in the skin and mucous membranes (e.g., throat and tongue), difficulty breathing, and (or) itching and rash, often occurring as an allergic reaction (angioedema),
• skin rash with severe itching and blistering (urticaria), itching, flushing, hair loss, skin rash, excessive sweating, darkening of sweat,
• in children, bleeding in the skin and gastrointestinal tract associated with allergy (Henoch-Schönlein purpura),
• urinary retention, involuntary urination, prolonged erection (priapism).

Very rare (may affect up to 1 in 10,000 people):

• very severe blood disorders (agranulocytosis) occurring with sudden high fever, severe sore throat, and mouth ulcers,
• sleepiness and constant fatigue during the day, sudden sleep attacks.

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

• muscle tremors,
• inability to resist the impulse to perform actions that may be harmful; this may include:
• a strong impulse to gamble uncontrollably, despite significant personal or family consequences,
• changed or increased sexual interests and behaviors that are significant to the patient or others, e.g., activities related to increased sex drive,
• compulsive, uncontrolled spending or buying,
• episodes of binge eating (consuming large amounts of food in a short time) or compulsive eating (consuming more food than normal and more than needed to satisfy hunger).
• The desire to take high doses of Precifit, higher than necessary to control motor symptoms, is called dopamine dysregulation syndrome. In some patients, after taking high doses of Precifit, severe disorders may occur, such as involuntary movements (dyskinesia), mood swings, or other side effects.

If the patient experiences any of the above behaviors, they should consult their doctor.
The doctor will discuss how to treat or alleviate these symptoms.
If any of the above symptoms do not improve or if the patient experiences side effects not listed in this leaflet, they should tell their doctor or pharmacist.
It may be helpful to note the symptoms, the date they occurred, and the duration.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the national reporting system of the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist.

5. How to store Precifit

• The medicine should be stored out of sight and reach of children.
• Store in the original packaging to protect from light and moisture.
• After removing the foil packaging, the cartridge should be used within 2 months and stored at a temperature below 30°C. The cartridge should not be exposed to moisture.
• Do not use this medicine after the expiry date stated on the cartridge after: EXP. The expiry date refers to the last day of the specified month.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Precifit contains

• The active substances of the medicine are levodopa and carbidopa. The other ingredients are: microcrystalline cellulose silanized (microcrystalline cellulose, colloidal silica anhydrous), cornstarch, sodium carboxymethylcellulose (type A), magnesium stearate.

What Precifit looks like and what the pack contains

A dispenser cartridge in a PP bag with an aluminum/PE/polyester pouch in a cardboard box.
Contains 750 white, spherical tablets for suspension, approximately 3 mm in diameter.
Pack size: 10 x 750 tablets for suspension.
Precifit should only be used with the MyFID dispenser. Only the MyFID dispenser should be used.

Marketing authorization holder

Orion Corporation
Orionintie 1
FI 02200 Espoo
Finland

Manufacturer

Desitin Arzneimittel GmbH
Weg beim Jaeger 214
22335 Hamburg
Germany

Date of last revision of the leaflet: 05/2025