Nakom Mite

Package Leaflet: Information for the Patient

Nakom mite, 100 mg + 25 mg, tablets

Levodopa + Carbidopa

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1 What is Nakom mite and what is it used for
Nakom mite is used to treat the symptoms of Parkinson's disease and parkinsonian syndrome. Parkinson's disease is a chronic condition characterized by slow and uncoordinated movements, muscle stiffness, and tremors. Untreated Parkinson's disease can cause difficulties in performing daily activities.
The symptoms of Parkinson's disease are caused by a lack of dopamine (a chemical substance naturally found in the body), which is produced by certain brain cells. Dopamine is a neurotransmitter in the areas of the brain responsible for controlling muscle movements.
Difficulty in moving is a result of insufficient dopamine production.
Nakom mite tablets contain a combination of two active substances: levodopa (a precursor of dopamine) and carbidopa (an inhibitor of aromatic amino acid decarboxylase).
Levodopa compensates for the lack of dopamine, and carbidopa ensures that the right amount of levodopa reaches the brain. In many patients, this reduces the severity of Parkinson's disease symptoms.

2. Important information before taking Nakom mite

When not to take Nakom mite

Do not take Nakom mite if:

• you are allergic (hypersensitive) to levodopa, carbidopa, or any of the other ingredients of this medicine (listed in section 6);
• you have increased intraocular pressure (narrow-angle glaucoma);
• you have severe heart failure;
• you have severe cardiac arrhythmias;
• you are in the acute phase of a stroke;
• you have been diagnosed with malignant melanoma;
• you have skin changes that have not been diagnosed by a doctor;
• you have severe psychosis;
• you are not allowed to take drugs that act on the central nervous system (sympathomimetic drugs)
• you are taking antidepressant drugs (from the group of so-called monoamine oxidase inhibitors - MAO), see below.

Concomitant use of Nakom mite and non-selective monoamine oxidase inhibitors (MAO) and selective type A inhibitors is contraindicated. These drugs should be discontinued at least 2 weeks before starting Nakom mite.
Nakom mite can be used concomitantly with selective MAO type B inhibitors (e.g., selegiline hydrochloride) at the recommended dose, see "Nakom mite and other drugs".

Warnings and precautions

Before starting to take Nakom mite, discuss it with your doctor or pharmacist if:

• you are or have been treated with levodopa alone. You should wait at least 12 hours before starting Nakom mite;
• you have movement disorders, such as facial muscle tremors, muscle stiffness, difficulty starting movement, finger or hand tremors. It may be necessary to reduce the dose of the medicine;
• you have had involuntary movements or psychiatric disorders; you have had depression and suicidal tendencies, you should contact your doctor immediately;
• you have had a psychotic episode or psychosis (a serious mental illness in which control over one's own behavior and actions is impaired) in the past;
• you have taken psychotropic drugs;
• you have severe cardiovascular diseases;
• you have severe lung disease or sudden shortness of breath with muscle spasm and swelling of the mucous membrane in the airways, often accompanied by coughing and expectoration of sputum (asthma);
• you have kidney or liver function disorders;
• you have endocrine system disorders (glands that secrete hormones into the blood);
• you have had stomach or intestinal ulcers (due to the increased risk of gastrointestinal bleeding);
• you vomit blood;
• you have recently had a heart attack and still have arrhythmias;
• you have chronic glaucoma with a wide angle of filtration (increased pressure in the eyeball). Patients with this condition may take Nakom mite provided that the intraocular pressure is well controlled.
• you experience excessive drowsiness and/or a tendency to fall asleep suddenly - in such a case, the doctor will consider reducing the dose of the medicine or discontinuing its use;
• you need to undergo general anesthesia;
• you have had seizures in the past;
• you have a hereditary disease characterized by sudden, but coordinated, involuntary movements (Huntington's chorea). The use of Nakom mite is not recommended.

Sudden reduction or discontinuation of Nakom mite (especially if the patient is also taking antipsychotic drugs) may cause consciousness disorders.
Sudden reduction or discontinuation of Nakom mite may cause the occurrence of symptoms similar to malignant neuroleptic syndrome. This syndrome is characterized by muscle stiffness, increased body temperature, mental changes, and increased creatine kinase enzyme activity in serum.
Due to the risk of developing melanoma (malignant skin or mucous membrane tumor), the patient's skin should be regularly checked for changes that may indicate the development of melanoma. The best solution is to have the skin checked periodically by a qualified person (e.g., a dermatologist).
If the patient or their relatives/caregivers notice unusual behaviors resulting from irresistible impulse, compulsion, or repetitive behavior, which may be harmful to the patient or others, they should inform the doctor, as it may be necessary to re-evaluate the treatment.
If the patient or their family (caregiver) notices the occurrence of symptoms similar to addiction, leading to the desire to take large doses of Nakom mite and other drugs used to treat Parkinson's disease, they should tell the doctor.
During long-term therapy, the doctor will recommend control tests of liver, kidney, hematopoietic, and circulatory functions.
Taking Nakom mite may cause false-positive results in some laboratory tests. Before performing any laboratory tests, the medical staff should be informed about the use of Nakom mite.
Each of the above situations requires consultation with a doctor.
Use of the medicine in children and adolescents under 18 years of age
The use of Nakom mite in children and adolescents under 18 years of age is not recommended, as its safety and efficacy have not been established.

Nakom mite and other drugs

Tell your doctor about all the medicines you are taking or have recently taken, as well as those you plan to take.
This is especially important for the following medicines:

• antihypertensive drugs -due to the possibility of decreased blood pressure when changing position (orthostatic hypotension);
• antidepressant drugs (from the group of so-called monoamine oxidase inhibitors) -due to the possibility of increased blood pressure, uncoordinated and involuntary movements of the limbs or the whole body (dyskinesia);
• anticholinergic drugs (e.g., used to treat asthma) - due to the possibility of increased involuntary movement disorders and reduced efficacy of the medicine due to delayed absorption;
• certain psychoactive drugs (e.g., phenothiazine derivatives, butyrophenone, and risperidone) and isoniazid (a drug used to treat tuberculosis), as they may weaken the therapeutic effect of levodopa, and phenytoin (a drug used to treat epilepsy) and papaverine (a smooth muscle relaxant and antispasmodic) may inhibit its action used in the treatment of parkinsonism;
• selegiline (an antidepressant) -due to the possibility of significant decrease in blood pressure when changing position;
• certain other drugs used to treat Parkinson's disease (tolcapone, entacapone) -due to the possibility of increasing the amount of Nakom mite that enters the bloodstream, which may require a change in the dose of the medicine;
• amantadine (a drug used to treat Parkinson's disease or influenza) - due to the possibility of increasing the side effects of Nakom mite, which may require a change in the dose of the medicine;
• metoclopramide (a drug used to treat gastrointestinal disorders) -due to the possibility of increasing the amount of Nakom mite that enters the bloodstream through accelerated gastric emptying;
• certain drugs acting on the central nervous system, bronchodilators, and drugs used to treat asthma (adrenergic drugs) -due to the possibility of increasing side effects on the circulatory system;
• iron sulfate or iron gluconate (used, for example, to treat iron deficiency) -due to the possibility of reduced levodopa absorption.

In case of doubt about whether the patient is taking any of the mentioned medicines, consult a doctor or pharmacist.

Nakom mite with food and drink

The effect of levodopa in patients taking a high-protein diet may be weaker.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
Pregnancy
The doctor will decide whether to continue or discontinue treatment, considering the benefits of taking the medicine for the mother's health versus the risk associated with taking the medicine for the child.
Every woman of childbearing age taking Nakom mite should use effective contraception.
The use of Nakom mite is not recommended in pregnant women.
Breastfeeding
If you are breastfeeding, the doctor will decide whether you should continue taking Nakom mite, considering the importance of treatment for your health.

Driving and using machines

Levodopa may cause extreme drowsiness and sudden sleep attacks, as well as double vision, which is associated with a risk of serious injury or death during activities that require full concentration. While taking Nakom mite, avoid driving and operating machines until the above-mentioned side effects have subsided.

Nakom mite contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is essentially 'sodium-free'.

3. How to take Nakom mite

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

General recommendations

Your doctor has prescribed the appropriate dose of Nakom mite, which you should take. The following doses are usually used:

Initial dose:

Patients not previously treated with levodopa
1 tablet of Nakom mite three times a day.
The doctor may increase this dose by one tablet per day or every other day, depending on the individual needs of the patient, up to a maximum of 8 tablets of Nakom mite per day.
Switching from another levodopa preparation to Nakom mite
If you are currently taking levodopa alone, your doctor will advise you to discontinue it at least 12 hours before starting Nakom mite (24 hours in the case of extended-release levodopa).
The switch should be made gradually and only under the supervision of a doctor.
If you have been taking less than 1500 mg of levodopa per day
1 tablet of Nakom mite three or four times a day, depending on the individual needs of the patient.
If you have been taking more than 1500 mg of levodopa per day
Your doctor will use Nakom (250 mg of levodopa + 25 mg of carbidopa).

Maintenance treatment

Your doctor will determine the dosage individually for each patient and adjust it according to the response to treatment.

Recommended maximum dose

8 tablets of Nakom per day (2 g of levodopa and 200 mg of carbidopa), which in a patient with a body weight of 70 kg is approximately 30 mg/kg of levodopa and 3 mg/kg of carbidopa.
After several months or years of treatment, a slowing of movement ("on-off" periods) has been observed, probably related to the progression of the disease.
Your doctor may adjust the dose of the medicine and the intervals between doses.
In patients with kidney and/or liver function disorders, a change in dosage is not necessary.

Taking a higher dose of Nakom mite than recommended

If you have taken too many tablets, contact your doctor or the nearest hospital immediately.
In some patients, an early sign of taking too high a dose may be eyelid twitching.
In the event of significant overdose of Nakom mite, the procedure is essentially the same as in the case of levodopa overdose, except that pyridoxine does not reverse the effects of Nakom mite.
The patient's heart function should be monitored using an electrocardiogram and carefully observed to detect any arrhythmias. If necessary, appropriate anti-arrhythmic treatment should be initiated. It should be taken into account that the patient may also be taking other medicines with Nakom mite. The importance of dialysis in the treatment of overdose is unknown.

Missing a dose of Nakom mite

Nakom mite should be taken exactly as prescribed by your doctor. If you forget to take a dose, take it as soon as possible. If it is almost time for the next dose, do not take the missed dose, just continue treatment as prescribed. Do not take a double dose to make up for the missed dose.

Discontinuing Nakom mite

Do not stop taking Nakom mite or reduce the dose without consulting your doctor. After sudden discontinuation of the medicine, the following symptoms may occur: muscle stiffness, fever, personality changes.

4. Possible side effects

Like all medicines, Nakom mite can cause side effects, although not everybody gets them.
The most common side effects include: abnormal movements, including tremors or muscle spasms (which may resemble Parkinson's disease symptoms).
Other side effects have been listed according to frequency:

If you experience any of the following symptoms, consult your doctor to discuss how to control or limit these symptoms.

The following side effects may occur during treatment with Nakom mite:

• allergic reactions (hypersensitivity reactions): hives, burning, rash, and swelling of the face, lips, tongue, and/or throat, which can cause difficulty breathing or swallowing. If you experience any of the above symptoms, contact your doctor immediately.

Very common (may affect more than 1 in 10 people):
urinary tract infections
Common (may affect up to 1 in 10 people):
nausea, vomiting, dry mouth, bitter taste in the mouth, loss of appetite (anorexia), palpitations, irregular heartbeat, decreased blood pressure, dizziness, fainting, hallucinations, confusion, drowsiness, nightmares, fatigue, insomnia, depression (rarely with suicidal attempts), euphoria, dementia, episodes of severe mental illness, during which control over one's own behavior and actions is impaired (psychosis), increased motivation, movement disorders (dyskinesia), a disorder characterized by sudden involuntary movements (chorea), muscle tone disorder (dystonia), movement disorders of the extrapyramidal type, sudden changes in the severity of Parkinson's disease symptoms.
Uncommon (may affect up to 1 in 100 people):
weight loss or gain, ataxia, increased hand tremors, increased blood pressure, phlebitis, hoarseness, chest pain, constipation, diarrhea, drooling, difficulty swallowing, bloating, fluid accumulation (edema), muscle spasms, dark urine.
Rare (may affect up to 1 in 1000 people):
leukopenia (a decrease in white blood cells with increased susceptibility to infections), hemolytic and non-hemolytic anemia, thrombocytopenia (a decrease in platelets with increased tendency to bruise and bleed), agitation, anxiety, thinking disorders, disorientation, headaches, numbness, seizures, severe disorder caused by the use of antipsychotic drugs (neuroleptics), which may manifest as muscle stiffness, inability to sit still, high fever, sweating, drooling, and impaired consciousness (malignant neuroleptic syndrome), paresthesia, fainting, ataxia, jaw stiffness, blurred vision, spasm of the eye muscle surrounding the eyeball, exacerbation of existing Horner's syndrome (eye disease), double vision, pupil dilation, worsening of eye movements, shortness of breath, breathing difficulties, digestive disorders with symptoms such as a feeling of fullness in the upper abdomen, abdominal pain, belching, nausea, vomiting, and heartburn (dyspepsia), stomach and intestinal pain, dark saliva, teeth grinding, hiccups, gastrointestinal bleeding, tongue burning, duodenal ulcers, sudden fluid accumulation in the skin and mucous membranes (e.g., throat and tongue), breathing difficulties, and/or itching and skin rash, often as an allergic reaction (angioedema), skin rash with severe itching and blistering (urticaria), itching, facial redness, hair loss, rash, excessive sweating, dark sweat, exacerbation of malignant melanoma, in children, bleeding in the skin and gastrointestinal wall on an allergic basis (Henoch-Schönlein purpura), urinary retention, involuntary urination, persistent, painful erection of the penis, weakness, malaise, recurrence of disease symptoms, drowsiness.
Very rare (may affect up to 1 in 10,000 people):
agranulocytosis (a lack of white blood cells with sudden, high fever, severe throat pain, and oral ulcers), a feeling of constant fatigue during the day and sudden sleep attacks.
Frequency not known (cannot be estimated from the available data):
malignant melanoma, dizziness, numbness, hot flashes, gait disturbances, falls.
The following side effects may also occur:

• inability to resist impulse, temptation, or compulsion to perform actions that may be harmful to the patient or others; this includes:

strong impulse to uncontrolled gambling, despite serious personal or family consequences,
changed or increased sexual interests and behaviors of great importance to the patient or others, e.g., activities related to increased sexual drive,
compulsive, uncontrolled spending or shopping,
episodic overeating (consuming large amounts of food in a short time) or compulsive eating (consuming more food than normal and more than needed to satisfy hunger).

• desire to take large doses of Nakom mite (larger than necessary to control motor symptoms), known as dopamine dysregulation syndrome. In some patients, after taking large doses of Nakom mite, severe disorders may occur, such as involuntary movements (dyskinesia), mood swings, or other side effects.

Reporting side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of 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
tel.: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nakom mite

• Keep the medicine out of the sight and reach of children.
• Store in a temperature below 25°C. Protect from light and moisture.
• Do not use Nakom mite after the expiry date stated on the packaging after EXP. The expiry date refers to 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. This will help protect the environment.

6. Contents of the pack and other information

What Nakom mite contains

The active substances are levodopa and carbidopa. One tablet of Nakom mite contains 100 mg of levodopa and 25 mg of carbidopa in the form of carbidopa monohydrate.
The other ingredients are: cornstarch, pregelatinized starch, magnesium stearate, quinoline yellow (E 104), microcrystalline cellulose.

What Nakom mite looks like and contents of the pack

Yellow, oval, biconvex tablets with a notch on one side.
Blister packs of aluminum/PVC foil in a cardboard box containing 100 tablets.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturer

Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek Pharmaceuticals d. d.
Trimlini 2d, 9220 Lendava
Slovenia
To obtain more detailed information, contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the leaflet: 04/2024
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