Package leaflet: Information for the patient

Nakom, 250 mg + 25 mg, tablets
Levodopum + Carbidopum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, so you can read it again if needed.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Nakom is and what it is used for
Important information before taking Nakom
How to take Nakom
Possible side effects
How to store Nakom
Contents of the pack and other information

1. What Nakom is and what it is used for
Nakom is used to treat the symptoms of Parkinson's disease and Parkinsonism. Parkinson's disease is a chronic condition characterized by slow and uncoordinated movements, muscle stiffness, and tremors. Untreated Parkinson's disease may cause difficulties in performing daily activities.
The symptoms of Parkinson's disease are caused by a lack of dopamine (a naturally occurring chemical substance) produced by certain brain cells. Dopamine acts as a messenger in brain areas responsible for controlling muscle movements. Movement difficulties result from insufficient dopamine production.
Nakom tablets contain a combination of two active substances: levodopa (a dopamine precursor) and carbidopa (an aromatic amino acid decarboxylase inhibitor).
Levodopa compensates for the dopamine deficiency, while carbidopa ensures that an adequate 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
Do not take Nakom if:

the patient is allergic (hypersensitive) to levodopa, carbidopa, or to 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 ever been diagnosed with malignant melanoma;
the patient has skin lesions that have not yet been diagnosed by a doctor;
the patient has severe psychosis;
the patient must not take medicines acting on the central nervous system (sympathomimetic drugs);
the patient is taking antidepressant medicines (monoamine oxidase inhibitors - MAOIs), see below.

Concomitant use of Nakom and non-selective monoamine oxidase inhibitors (MAOIs), as well as selective type A MAO inhibitors, is contraindicated. These medicines must be discontinued at least two weeks before starting treatment with Nakom.
Nakom may be used concomitantly with selective MAO-B inhibitors (e.g., selegiline hydrochloride) at the recommended dose; see "Nakom with other medicines".

Warnings and precautions
Before starting treatment with Nakom, consult your doctor or pharmacist if:

the patient is or has ever been treated with levodopa alone. At least 12 hours should elapse before starting Nakom;
the patient has movement disorders such as facial muscle twitching, muscle stiffness, difficulty initiating movement, finger or hand tremors. A dose reduction may be necessary;
the patient has ever experienced involuntary movements or psychiatric disturbances;
the patient has depression or suicidal tendencies, in which case they should contact their doctor immediately;
the patient has ever had a psychotic episode or psychosis (a serious mental illness in which control over one's behavior and conduct is impaired);
the patient has taken psychotropic medicines;
the patient has severe cardiovascular diseases;
the patient has severe lung disease or sudden attacks of breathlessness due to bronchial muscle spasm and mucosal swelling in the airways, often accompanied by cough and sputum production (bronchial asthma);
the patient has impaired kidney or liver function;
the patient has endocrine disorders (glands that secrete hormones into the blood);
the patient has ever had gastric or intestinal ulcers (due to an increased risk of gastrointestinal bleeding);
the patient vomits blood;
the patient has recently suffered a myocardial infarction and still has cardiac arrhythmias;
the patient has chronic open-angle glaucoma (increased intraocular pressure). Patients with this condition may take Nakom provided intraocular pressure is well controlled;
the patient experiences excessive drowsiness and/or sudden sleep attacks – in such a case, the doctor may consider reducing the dose or discontinuing treatment;
the patient is to undergo general anesthesia;
the patient has ever had seizures in the past;
the patient has Huntington's disease (an inherited disorder characterized by sudden but coordinated involuntary movements). Use of Nakom is not recommended.

Sudden reduction in dose or discontinuation of Nakom (especially if the patient is also receiving antipsychotic medicines) may cause disturbances in consciousness.
Sudden reduction in dose or discontinuation of Nakom may lead to symptoms resembling neuroleptic malignant syndrome. This syndrome is characterized by muscle rigidity, elevated body temperature, mental status changes, and increased serum creatine kinase activity.
Due to the risk of developing melanoma (a malignant skin or mucosal tumor), the patient's skin should be regularly examined for changes indicating melanoma development. The best approach is periodic skin examination by a qualified professional (e.g., a dermatologist).
Consult your doctor if the patient or their family/caregivers notice unusual behaviors resulting from uncontrollable impulses, compulsions, or obsessive performance of certain actions harmful to the patient or others. These behaviors are known as impulse control disorders and may include gambling addiction, compulsive eating or shopping, abnormally increased sexual drive, or intense sexual thoughts and feelings. In such cases, inform the doctor, as reassessment of the treatment may be necessary.
If the patient or their family (caregiver) notice symptoms resembling addiction, leading to a desire to take high doses of Nakom or other medicines used in Parkinson's disease treatment, they should inform the doctor.
During long-term therapy, the doctor may recommend periodic monitoring of liver, kidney, hematological, and cardiovascular function.
Nakom may cause falsely positive results in certain laboratory tests. Inform medical personnel about taking Nakom before undergoing any laboratory tests.
Each of the above situations requires consultation with a doctor.

Use in children and adolescents under 18 years of age
The use of Nakom in children and adolescents under 18 years of age is not recommended, as safety and efficacy have not been established in this age group.

Nakom with other medicines
Inform your doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
This particularly applies to the following medicines:

antihypertensive medicines – due to the risk of reduced blood pressure upon changing position (orthostatic hypotension);
antidepressants (monoamine oxidase inhibitors - MAOIs) – due to the risk of hypertension, uncoordinated and involuntary limb or whole-body movements (so-called dyskinesias);
anticholinergic medicines (e.g., used in asthma treatment) – due to the risk of worsening involuntary movement disorders and reduced efficacy of the medicine caused by delayed absorption;
certain psychoactive medicines (e.g., phenothiazine derivatives, butyrophenones, and risperidone), as well as isoniazid (a medicine used in tuberculosis treatment), as they may reduce the therapeutic effect of levodopa, while phenytoin (a medicine used in epilepsy) and papaverine (a muscle relaxant and spasmolytic in the gastrointestinal tract) may inhibit its action in the treatment of parkinsonism;
selegiline (an antidepressant medicine) – due to the risk of significant reduction in blood pressure upon changing body position;
certain other medicines used in Parkinson's disease (tolcapone, entacapone) – due to the risk of increasing the amount of Nakom entering the circulation, which may necessitate dose adjustment;
amantadine (a medicine used in Parkinson's disease or influenza treatment) – due to the risk of intensifying adverse effects of Nakom, which may necessitate dose adjustment;
metoclopramide (a medicine used in gastrointestinal disorders) – due to the risk of increasing the amount of Nakom entering the circulation through accelerated gastric emptying;
certain other central nervous system-acting medicines, bronchodilators, and medicines used in asthma treatment (adrenergic agonists) – due to the risk of intensifying cardiovascular adverse effects;
iron sulfate or iron gluconate (used, e.g., in iron deficiency treatment) – due to the risk of reduced levodopa absorption.

If in doubt whether the patient is taking any of the listed medicines, consult a doctor or pharmacist.

Nakom with food and drink
The effect of levodopa may be weaker in patients on a high-protein diet.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before taking this medicine.

Pregnancy
The doctor will decide whether to continue or discontinue treatment, weighing the benefits of taking the medicine for the mother's health against the risks to the child.
Every woman of childbearing age taking Nakom should use effective contraception. Nakom is not recommended for use in pregnant women.

Breastfeeding
If the patient is breastfeeding, the doctor will decide whether she should continue taking Nakom, taking into account the importance of treatment for her health.

Driving and operating machinery
Levodopa may cause severe drowsiness and sudden sleep attacks, as well as double vision, which poses a risk of serious bodily injury or death during any activity requiring full concentration. While taking Nakom, patients should avoid driving and operating machinery until these adverse effects subside.

Nakom contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Nakom

This medicine should always be used exactly as prescribed by the doctor. In case of doubt, consult
your doctor or pharmacist.
General recommendations
Your doctor has prescribed the appropriate dose of Nakom to be taken. Generally, the following
doses are used:
Initial dose:
Patients not previously treated with levodopa
½ tablet of Nakom one or two times daily.
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 treatment with Nakom (24 hours if using levodopa with prolonged release).
The change of medication should be carried out gradually and only under medical supervision.
If the patient has previously taken less than 1500 mg of levodopa per day
Treatment should be initiated with Nakom mite (100 mg + 25 mg).
Initial dose: 1 tablet three or four times daily, depending on the individual needs of the patient.
If the patient has previously taken more than 1500 mg of levodopa per day
1 tablet of Nakom (250 mg + 25 mg) three or four times daily, depending on the individual needs
of the patient.
Maintenance treatment
The doctor will individually determine the 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 levodopa and 200 mg carbidopa), which for a patient weighing
70 kg corresponds to approximately 30 mg/kg body weight of levodopa and 3 mg/kg body weight of carbidopa.
After several months or years of treatment, motor fluctuations (so-called "on-off" periods) may occur,
probably related to the progression of the disease.
The doctor may adjust the dose and intervals between doses accordingly.
Dosage adjustment is not necessary in patients with impaired renal and/or hepatic function.
Taking more than the recommended dose of Nakom
If too many tablets are taken, contact your doctor or the nearest hospital immediately.
In some patients, an early sign of an excessive dose may be eyelid spasm.
In the case of significant overdose of Nakom, management is essentially the same as in levodopa overdose,
except that pyridoxine does not reverse the effects of Nakom.
The patient's heart function should be monitored using electrocardiography and carefully observed
for possible cardiac arrhythmias. If necessary, appropriate antiarrhythmic treatment should be initiated.
It should be considered that the patient may be taking other medications together with Nakom.
The role of dialysis in the treatment of overdose is unknown.
Missed 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 missed dose should not be taken;
instead, continue treatment according to the prescribed schedule.
Do not take a double dose to make up for a missed dose.
Stopping treatment with Nakom
Do not stop taking Nakom or reduce the dose without consulting your doctor. After sudden discontinuation
of the medicine, the following symptoms may occur: muscle rigidity, fever, personality changes.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The most commonly observed adverse reactions include abnormal movements, such as tremors or muscle contractions (which may resemble symptoms of Parkinson's disease).
Other adverse reactions are listed below by frequency:
If any of the symptoms listed occur, consult a doctor to discuss how to manage or reduce these symptoms.
During treatment with Nakom, the following hypersensitivity symptoms (allergic reactions) may occur: urticaria, burning sensation, rash, and swelling of the face, lips, tongue, and (or) throat, which may cause difficulty breathing or swallowing. If any of the above symptoms occur, seek immediate medical attention.

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 caused, for example, by rising too quickly from a sitting or lying position, sometimes accompanied by dizziness (orthostatic hypotension), tendency to faint, sudden loss of consciousness, seeing, hearing, or feeling things that are not real (hallucinations), confusion, drowsiness, nightmares, feeling of fatigue, insomnia, depression (very rarely with suicidal attempts), feeling of well-being (euphoria), mental dullness, episodes of severe mental illness with impaired control of behavior and actions (psychosis), increased motivation, movement disorders (dyskinesias), a condition characterized by sudden involuntary movements (chorea), muscle tension disorders (dystonia), extrapyramidal movement disorders, sudden changes in the severity of Parkinson's disease symptoms.

Uncommon (may affect up to 1 in 100 people):
decrease or increase in body weight, lack of coordination (ataxia), pronounced hand tremors, increased blood pressure, inflammation of veins, hoarseness, chest pain, constipation, diarrhea, hypersalivation, difficulty swallowing, bloating, fluid accumulation (edema), muscle cramps, dark discoloration of urine.

Rare (may affect up to 1 in 1,000 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 bruising and bleeding), restlessness, anxiety, thought disorders, disorientation, headache, numbness, seizures, severe disorder caused by antipsychotic (neuroleptic) drugs, which may present with muscle stiffness, inability to sit still, high fever, sweating, hypersalivation, and disturbances in consciousness (neuroleptic malignant syndrome), sensation of pricking, tingling, and burning (paresthesia), fainting, lack of coordination, trismus (jaw tightening), blurred vision, spasm of the ciliary muscle surrounding the eyeball, exacerbation of pre-existing Horner's syndrome (eye disorder), double vision, dilated pupils, worsening of eye movement, shortness of breath, breathing difficulties, digestive disturbances with symptoms such as feeling of fullness in the upper abdomen, upper abdominal pain, belching, nausea, vomiting, and heartburn (dyspepsia), stomach and intestinal pain, dark discoloration of saliva, teeth grinding, hiccups, gastrointestinal bleeding, burning sensation of the tongue, duodenal ulcers, sudden accumulation of fluid 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 intense itching and blister formation (urticaria), itching, facial redness, hair loss, rash, excessive sweating, dark discoloration of sweat, activation of malignant melanoma, in children skin hemorrhages and gastrointestinal bleeding due to allergy (Henoch-Schönlein purpura), urinary retention, involuntary urination, persistent painful erection (priapism), weakness, malaise, recurrence of disease symptoms, drowsiness.

Very rare (may affect up to 1 in 10,000 people):
agranulocytosis (absence of white blood cells with sudden high fever, severe sore throat, and mouth ulcers), feeling of constant fatigue during the day and sudden episodes of falling asleep.

Frequency not known (cannot be estimated from available data):
malignant melanoma, dizziness, numbness, hot flushes, gait disturbances, falls.

The following adverse reactions may also occur:

Inability to resist an impulse, urge, or compulsion to perform actions that may be harmful to the patient or others; this includes:
- strong impulse towards uncontrollable gambling despite serious personal or family consequences,
- altered or increased sexual interests and behaviors significant to the patient or others, e.g., activities related to heightened sexual drive,
- compulsive, uncontrolled spending or shopping,
- binge eating (consuming large amounts of food in a short time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger).
Desire to take high doses of Nakom (higher than necessary to control motor symptoms), known as dopamine dysregulation syndrome. In some patients, taking high doses of Nakom may lead to severe disorders such as involuntary movements (dyskinesias), mood fluctuations, or other adverse reactions.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Nakom

Keep the medicine out of sight and reach of children.
Store below 25°C. Protect from light and moisture.
Do not use Nakom after the expiry date stated on the packaging following EXP. The expiry date refers to the last day of the stated month.
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 contains
The active substances are levodopa and carbidopa. One Nakom tablet contains 250 mg of levodopa
and 25 mg of carbidopa in the form of monohydrate carbidopa.
Other ingredients are: maize starch, 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 score line on one side.
Aluminum/PVC foil blisters in cardboard cartons contain 100 tablets.
Marketing Authorisation 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
For further information, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00