Nakom

Leaflet attached to the packaging: patient information

Nakom, 250 mg + 25 mg, tablets

Levodopa + Carbidopa

You should carefully read the contents of the leaflet before taking 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 Nakom and what is it used for
• 2. Important information before taking Nakom
• 3. How to take Nakom
• 4. Possible side effects
• 5. How to store Nakom
• 6. Contents of the pack and other information

1 What is Nakom and what is it used for
Nakom 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 too little dopamine production.
Nakom tablets contain a combination of two active substances: levodopa (a precursor to 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

When not to take Nakom

Nakom should not be taken if:

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

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

Warnings and precautions

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

• the patient is or has been treated with levodopa alone. The patient should wait at least 12 hours before starting Nakom (24 hours in the case of prolonged-release levodopa);
• the patient has 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 Nakom;
• the patient has experienced involuntary movements or psychiatric disorders;
• the patient has experienced depression and suicidal tendencies, and should contact their doctor immediately;
• the patient has experienced a psychotic episode or psychosis (a serious mental illness in which the patient's control over their behavior and actions is impaired) in the past;
• the patient has taken psychotropic medicines.
• the patient has severe cardiovascular diseases;
• the patient has severe lung disease or sudden shortness of breath caused by muscle spasm and swelling of the mucous membrane in the airways, often accompanied by coughing and expectoration of sputum (asthma);
• the patient has kidney or liver function disorders;
• the patient has endocrine system disorders (glands that secrete hormones into the blood);
• the patient has had stomach or intestinal ulcers in the past (due to the increased risk of gastrointestinal bleeding);
• the patient vomits blood;
• the patient has recently had a heart attack and still has cardiac arrhythmias;
• the patient has chronic glaucoma with a wide angle of attack (increased pressure in the eyeball). Patients with this condition may take Nakom provided that the intraocular pressure is well controlled.
• the patient experiences excessive sleepiness and/or a tendency to fall asleep suddenly - in such cases, the doctor will consider reducing the dose of Nakom or discontinuing it;
• the patient needs to undergo general anesthesia;
• the patient has had seizures in the past;
• the patient has a hereditary disease characterized by sudden, but coordinated, involuntary movements (Huntington's chorea). The use of Nakom is not recommended.

Sudden reduction or discontinuation of Nakom (especially if the patient is also taking antipsychotic medicines) may cause changes in consciousness.
Sudden reduction or discontinuation of Nakom 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 activity of creatine kinase enzyme 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).
The patient should consult their doctor if they or their relatives/caregivers notice unusual behaviors resulting from irresistible impulses, compulsions, or repetitive behaviors that are harmful to the patient or others. Such behaviors are called impulse control disorders and may include gambling addiction, overeating, or compulsive shopping, as well as excessive sexual drive or intense sexual thoughts and feelings. In such cases, the patient should inform their doctor, as it may be necessary to re-evaluate the treatment.

Nakom and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• antihypertensive medicines - due to the possibility of decreased blood pressure when changing position (orthostatic hypotension);
• antidepressant medicines (from the group of monoamine oxidase inhibitors) - due to the possibility of increased blood pressure, uncoordinated and involuntary movements of the limbs or the whole body (dyskinesia);
• anticholinergic medicines (e.g., used to treat asthma) - due to the possibility of increased involuntary movement disorders and reduced efficacy of Nakom due to delayed absorption of the medicine;
• certain psychoactive medicines (e.g., phenothiazine, butyrophenone, and risperidone derivatives) and isoniazid (a medicine used to treat tuberculosis), as they may weaken the therapeutic effect of levodopa, and phenytoin (a medicine 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 medicine) - due to the possibility of significant decrease in blood pressure when changing position;
• certain other medicines used in Parkinson's disease (tolcapone, entacapone) - due to the possibility of increasing the amount of Nakom that enters the bloodstream, which may require a change in the dose of Nakom;
• amantadine (a medicine used to treat Parkinson's disease or influenza) - due to the possibility of increasing the side effects of Nakom, which may require a change in the dose of Nakom;
• metoclopramide (a medicine used to treat gastrointestinal disorders) - due to the possibility of increasing the amount of Nakom that enters the bloodstream through accelerated gastric emptying;
• certain medicines that act on the central nervous system, bronchodilators, and medicines used to treat asthma (adrenergic medicines) - due to the possibility of increasing side effects on the cardiovascular 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 as to whether the patient is taking any of the above medicines, they should consult their doctor or pharmacist.

Nakom with food and drink

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 risks associated with taking the medicine for the child.
Every female patient of childbearing age taking Nakom should use effective contraception. It is not recommended to take Nakom during pregnancy.
Breastfeeding
If the patient is breastfeeding, the doctor will decide whether they should continue taking Nakom, considering the importance of treatment for their health.

Driving and using machines

Levodopa may cause severe 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, the patient should avoid driving and operating machines until the above side effects have subsided.

Nakom contains sodium

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

3. How to take Nakom

This medicine should always be taken according to the doctor's instructions. In case of doubt, the patient should consult their doctor or pharmacist.

General recommendations

The doctor has prescribed the appropriate dose of Nakom, which should be taken. Usually, the following doses are used:

Initial dose:

Patients not previously treated with levodopa
½ tablet of Nakom once or twice a day.
The doctor may increase this dose daily or every other day by ½ tablet, depending on the individual needs of the patient.
Switching from a previously used levodopa preparation to Nakom
If the patient is currently taking levodopa alone, the doctor will recommend discontinuing it at least 12 hours before starting Nakom (24 hours in the case of prolonged-release levodopa).
The switch should be made gradually and only under the doctor's supervision.
If the patient has been taking less than 1500 mg of levodopa per day
Treatment should be started with Nakom mite (100 mg + 25 mg).
Initial dose: 1 tablet three or four times a day, depending on the individual needs of the patient.
If the patient has been taking more than 1500 mg of levodopa per day
1 tablet of Nakom (250 mg + 25 mg) three or four times a day, depending on the individual needs of the patient.

Maintenance treatment

The doctor will determine the individual dosage for each patient and adjust it according to the desired response to treatment.

Recommended maximum dose

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

Taking a higher dose of Nakom than recommended

In case of taking too many tablets, the patient should immediately contact their doctor or the nearest hospital.
In some patients, an early sign of taking too high a dose may be eyelid twitching.
In the event of significant overdose of Nakom, the procedure is essentially the same as in the case of levodopa overdose, except that pyridoxine does not reverse the effects of Nakom.
The patient's heart rate 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. The importance of dialysis in the treatment of overdose is unknown.

Missing a dose of Nakom

Nakom should be taken exactly as prescribed by the doctor. If the patient forgets to take a dose, they should take it as soon as possible. If it is almost time for the next dose, the patient should not take the missed dose, but continue treatment as prescribed. The patient should not take a double dose to make up for the missed dose.

Discontinuing Nakom

The patient should not stop taking Nakom or reduce the dose without consulting their doctor. After sudden discontinuation of Nakom, the following symptoms may occur: muscle stiffness, fever, personality changes.

4. Possible side effects

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

In case of experiencing any of the listed symptoms, the patient should consult their doctor to discuss how to control or limit these symptoms.

During treatment with Nakom, the following hypersensitivity reactions (allergic reactions) may occur: hives, burning, rash, and swelling of the face, lips, tongue, and/or throat, which can cause difficulty breathing or swallowing. In case of the above symptoms, the patient should immediately contact their doctor.
Very common (may occur more frequently than in 1 in 10 people):
urinary tract infections
Common (may occur less frequently than in 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, increased motivation, movement disorders (dyskinesia), disorders characterized by sudden involuntary movements (chorea), muscle tone disorder (dystonia), extrapyramidal movement disorders, sudden changes in the severity of Parkinson's disease symptoms.
Uncommon (may occur less frequently than in 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, muscle spasm, dark urine.
Rare (may occur less frequently than in 1 in 1000 people):
leukopenia (low white blood cell count with increased susceptibility to infections), hemolytic and non-hemolytic anemia, thrombocytopenia (low platelet count with increased tendency to bruise and bleed), agitation, anxiety, thinking disorders, disorientation, headaches, numbness, seizures, severe disorder caused by the use of antipsychotic medicines (neuroleptics), which may manifest as muscle stiffness, inability to sit still, high fever, sweating, drooling, and changes in 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, difficulty breathing, gastrointestinal 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), difficulty breathing and/or itching and skin rash, often as an allergic reaction (angioedema), skin rash with severe itching and blistering (urticaria), itching, facial flushing, hair loss, rash, excessive sweating, dark sweat, exacerbation of malignant melanoma, in children, bleeding in the skin and gastrointestinal tract 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 occur less frequently than in 1 in 10,000 people):
agranulocytosis (lack of white blood cells with sudden, high fever, severe throat pain, and oral ulcers), feeling of constant fatigue during the day and sudden sleep attacks.
Frequency not known (cannot be estimated from the available data):
malignant melanoma, dizziness, feeling of numbness, hot flashes, gait disorders, falls.
The following side effects are also possible:

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

strong impulse to gamble uncontrollably, 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 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).

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

Reporting side effects
If side effects occur, including any side effects not listed in the leaflet, the patient should tell their 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, more information can be collected on the safety of the medicine.

5. How to store Nakom

• The medicine should be stored out of sight and reach of children.
• Store in a temperature below 25°C. Protect from light and moisture.
• Do not use Nakom 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. 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 Nakom contains

The active substances are levodopa and carbidopa. One tablet of Nakom contains 250 mg of levodopa and 25 mg of carbidopa in the form of carbidopa monohydrate.
Other ingredients are: cornstarch, pregelatinized starch, magnesium stearate, indigotine (E 132), microcrystalline cellulose.

What Nakom looks like and contents of the pack

Blue, speckled, oval, biconvex tablets with a notch on one side.
Blisters 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, the patient should 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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