LEVODOPA KARBIDOPA EXAL 100 mg/25 mg Tabletki o przedłużonym uwalnianiu

Levodopa/Carbidopa Hexal 100 mg/25 mg prolonged-release tablets
Levodopa/Carbidopa Hexal 200 mg/50 mg prolonged-release tablets
Generic medicine
Read this leaflet carefully before you start using this medicinebecause 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, because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.4. Contents of this leaflet:
• 1. What is Levodopa/Carbidopa Hexal and what it is used for
• 2. What you need to know before you take Levodopa/Carbidopa Hexal
• 3. How to take Levodopa/Carbidopa Hexal
• 4. Possible side effects
• 5. How to store Levodopa/Carbidopa Hexal
• 6. Contents of the pack and other information

1WHAT IS LEVODOPA/CARBIDOPA HEXAL AND WHAT IT IS USED FOR
Levodopa/Carbidopa Hexal is used to treat Parkinson's disease. If you are currently taking
therapy based on levodopa alone or with levodopa/decarboxylase inhibitor tablets with immediate
release (for example carbidopa) and if you suffer from sudden and uncontrolled movements,
Levodopa/Carbidopa Hexal shortens the “off” period (a sudden muscle stiffness that can
last a few minutes or even hours).
Levodopa/Carbidopa Hexal belongs to a class of drugs used to treat Parkinson's disease. The
symptoms of this disorder are probably caused by a deficiency of dopamine, a
substance that is normally produced by the brain and plays an essential role in controlling
muscle movements. Dopamine deficiency causes problems with motor functions. Levodopa
compensates for the dopamine deficiency, while the function of carbidopa is to ensure that levodopa
reaches the brain in sufficient quantities.

2WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVODOPA/CARBIDOPA HEXAL
Do not take Levodopa/Carbidopa Hexal

• if you are allergic(hypersensitive) to levodopa or carbidopa, or to any of the other ingredients in the tablets;
• if you suffer from an increase in eye pressure(closed-angle glaucoma);
• if you suffer from severe heart failure;
• if you suffer from severe heart rhythm disturbances;
• in the case of a sudden stroke;
• if you are not allowed to use drugs that act on the central nervous system(sympathomimetic agents);
• if you are taking non-selective and selective monoamine oxidase inhibitors or MAO inhibitors of type A (drugs used to treat depression). Therapy with these drugs must be stopped at least two weeks before starting treatment with Levodopa/Carbidopa Hexal;
• Levodopa/Carbidopa Hexal can be administered in conjunction with the recommended dosage of a selective MAO inhibitor type B (for example selegiline).

Warnings and precautions
Take special care with Levodopa/Carbidopa Hexal:

• if you are currently taking or have taken in the past therapy based on levodopa alone. In this case, you must wait at least 12 hours before starting to take Levodopa/Carbidopa Hexal; if you suffer from motor disorders, such as spasms of the facial muscles, stiffness and muscle soreness, difficulty starting to move, tremors of the fingers or hands. In these cases, it may be necessary to reduce the dosage;
• if you have suffered from involuntary movements in the past;
• if you have suffered from psychotic episodes or psychosis in the past. Psychosis is a serious mental disorder that can impair the ability to control one's behavior. Very rarely, cases of patients who have become depressed and subsequently developed suicidal tendencies have been reported. If you believe this may be the case, you must immediately inform your doctor;
• if you are in a state of constant fatigue or if you tend to fall asleep suddenly. In this case, you must not drive or operate machinery: if necessary, your doctor will modify the dosage or stop the treatment altogether;
• if you suffer from a serious cardiovascular disorder;
• if you suffer from a serious lung disorder or sudden attacks of breathlessness due to muscle spasms and swelling of the mucous membranes within the airways, often accompanied by coughing and phlegm (bronchial asthma);
• if you suffer from kidney or liver problems, or if you have endocrine system disorders (glands that secrete hormones into the bloodstream);
• if you have previously suffered from stomach or intestinal ulcers, as this increases the risk of gastric bleeding;
• if you vomit blood;
• if you have previously suffered from seizures/convulsions;
• if you have recently had a heart attack and still have heart rhythm disturbances;
• if you suffer from chronic glaucoma (increased intraocular pressure);
• if your dosage of levodopa/carbidopa is suddenly reduced or if the treatment is stopped, especially if you are taking drugs to treat psychosis; this may mask changes in your mental condition; muscle stiffness and increased body temperature may occur.
• if you suffer from a hereditary disorder characterized by sudden, involuntary but coordinated movements (Huntington's chorea). In this case, the use of Levodopa/Carbidopa Hexal is not recommended;
• if you have ever been affected by a malignant melanoma;
• if you suffer from a skin condition not yet diagnosed by your doctor.
• Levodopa/Carbidopa Hexal can determine abnormalities in several laboratory tests. These include:
• liver function tests
• false positive Coombs test
• reduction of hemoglobin and hematocrit, elevated levels of glucose in the serum, white blood cells, bacteria and blood in the urine.
• a false positive for ketone bodies in the urine may occur if a strip test is used for determining ketonuria. This reaction is not altered by boiling the urine sample
• a false negative may also occur in the glucosuria test using the glucose oxidase method

Tell your doctor if you or a family member/caregiver notices that you are
developing urges or desires to behave in ways that are unusual for you and you cannot
resist the urge or temptation to perform certain activities that could harm you
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.
Tell your doctor if you or a family member/caregiver notices the development of addiction-like symptoms that cause a desire for high doses of levodopa/carbidopa Hexal and other
medicines used to treat Parkinson's disease.

Children and adolescents
The safety and efficacy of Levodopa/Carbidopa Hexal in neonates and children/adolescents under 18
years has not been established, therefore the use of Levodopa/Carbidopa Hexal in patients under 18
years of age is not recommended.
If any of the above warnings apply to your case, or have applied in the past, tell your
doctor.

Other medicines and Levodopa/Carbidopa Hexal
Levodopa/Carbidopa Hexal can interfere with the effects/side effects of other medicines and
vice versa. This occurs particularly with the following drugs:

• medicines used to treat high blood pressure (your doctor will need to adjust the dosage);
• medicines used to treat depression (see also the section “Do not take Levodopa/Carbidopa Hexal”);
• medicines that act on the central nervous system (anticholinergics, bronchodilators used for the treatment of asthma), such as ipratropium and tiotropium. These medicines can reduce the effects of levodopa; your doctor will adjust the dosage as needed;
• medicines used for the treatment of psychosis
• isoniazid (a medicine used to treat tuberculosis);
• benzodiazepines (certain sleeping pills and tranquilizers), such as diazepam, oxazepam and lormetazepam, which can reduce the effects of Levodopa/Carbidopa Hexal;
• phenytoin (a medicine used to treat epilepsy), which can reduce the effects of Levodopa/Carbidopa Hexal;
• papaverine (a medicine used to treat spasms of the gastrointestinal tract), which can reduce the effects of Levodopa/Carbidopa Hexal;
• selegiline (a medicine used to treat Parkinson's disease); if used in conjunction with Levodopa/Carbidopa Hexal, a severe drop in blood pressure may occur;
• COMT inhibitors (used to treat Parkinson's disease); when administered in conjunction with Levodopa/Carbidopa Hexal, the levels of levodopa reaching the brain may increase. It may therefore be necessary to adjust the dosage of Levodopa/Carbidopa Hexal;
• amantadine (used to treat Parkinson's disease); the side effects of levodopa may increase. It may therefore be necessary to adjust the dosage of Levodopa/Carbidopa Hexal;
• metoclopramide (a gastrointestinal drug);
• medicines that act on the central nervous system (sympathomimetics, bronchodilators used to treat asthma), such as apraclonidine, dipivefrine and brimonidine; cardiovascular side effects may increase;
• medicines that reduce dopamine (e.g. tetrabenazine which causes a reduction of dopamine in the central nervous system by inhibiting specific transport proteins called monoamine transporters that transport monoamines (e.g. dopamine) into or out of cells) or other medicines known to reduce monoamine reserves.
• ferrous sulfate. The absorption of levodopa may decrease.

If you are taking or have recently taken other medicines, including those without a prescription, tell your
doctor or pharmacist.

Taking Levodopa/Carbidopa Hexal with food and drink
The effects of levodopa can sometimes be compromised in patients who follow a diet high in
protein.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.

• Women of childbearing potential who are given Levodopa/Carbidopa 100 mg/25 mg / 200 mg/50 mg must use effective contraceptive methods.
• Data relating to the use of Levodopa/Carbidopa Hexal during pregnancy are not known. In animal studies, the substance has been shown to be harmful.
• Do not take Levodopa/Carbidopa Hexal if you are pregnant or planning to become pregnant.
• Levodopa is excreted in breast milk. Therefore, do not breastfeed during treatment with Levodopa/Carbidopa Hexal.

Driving and using machines
Levodopa/Carbidopa Hexal can cause side effects such as

• dizziness,
• sleepiness,
• double vision, which can impair your ability to react. You should therefore consider these effects if you intend to drive or operate machinery. Patients who tend to fall asleep or fall
  asleep suddenly must not drive or operate machinery.

Levodopa Carbidopa Hexal contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release tablet, which is
essentially “sodium-free”.

3HOW TO TAKE LEVODOPA/CARBIDOPA HEXAL
Dosage
Adults and the elderly
Your doctor has prescribed the correct dosage of Levodopa/Carbidopa Hexal.
In general, the dosages described below apply.

If you have never been treated with levodopa:
Take this medicine always exactly as your doctor or pharmacist has told you. If you have
any doubts ask your doctor or pharmacist.

Initial dosage
1 tablet of Levodopa/Carbidopa Hexal 100 mg/25 mg twice a day or1 tablet of
Levodopa/Carbidopa Hexal 200 mg/50 mg twice a day.

Maximum initial dosage
6 tablets of Levodopa/Carbidopa Hexal 100 mg/25 mg per day or3 tablets of
Levodopa/Carbidopa Hexal 200 mg/50 mg per day (600 mg of levodopa per day).
The doses should be taken at intervals of at least six hours.

If you are switching from regular Levodopa/Carbidopa Hexal tablets to prolonged
release tablets:
This switch must be done gradually and under medical supervision.

If you are currently undergoing therapy based solely on levodopa:
Levodopa treatment must be interrupted at least 12 hours before the administration of
Levodopa/Carbidopa Hexal.
Initial dosage for patients suffering from Parkinson's disease in mild to moderate form:
1 tablet of Levodopa/Carbidopa Hexal 200 mg/50 mg twice a day or2 tablets of
Levodopa/Carbidopa Hexal 100 mg/25 mg twice a day.

Maintenance dose:
Your doctor will regularly monitor you, modifying the dosage if necessary.
At least three days must elapse between one dosage change and the next.
Swallow the tablets whole with a glass of water, regardless of meals; do not break or chew the
tablets.
If you feel that the effects of Levodopa/Carbidopa Hexal are too strong or too weak,
consult your doctor or pharmacist.

Use in children and adolescents (under 18 years)
The use of Levodopa/Carbidopa Hexal in patients under the age of 18 is not recommended (see
paragraph “Pay special attention with Levodopa/Carbidopa Hexal in the following cases”).

Duration of treatment
Your doctor will tell you how long you should take Levodopa/Carbidopa Hexal. Do not interrupt the
treatment prematurely; symptoms may reappear.

If you take more Levodopa/Carbidopa Hexal than you should
If you have taken a higher dose of Levodopa/Carbidopa Hexal, contact your doctor
immediately or your pharmacist. Symptoms of overdose may include: spasms of the orbicularis muscle
surrounding the eye (see also paragraph 4: “Possible undesirable effects”).

If you forget to take Levodopa/Carbidopa Hexal
Do not take a double dose of Levodopa/Carbidopa Hexal to make up for a missed dose. If
you have forgotten to take a dose, you can take it, unless it is almost time to take the
next one. If this is the case, continue normally with the prescribed dosage.

If you stop treatment with Levodopa/Carbidopa Hexal
If your dosage is suddenly reduced or treatment is interrupted, your doctor will keep
you under regular observation. Read the paragraph: “Pay special attention with Levodopa/Carbidopa Hexal
especially in the following cases”, particularly if you are using medications for the treatment of psychosis
(antipsychotic agents).
If you have any doubts about the use of Levodopa/Carbidopa Hexal, consult your doctor or pharmacist.

4POSSIBLE UNDESIRABLE EFFECTS
Like all medicines, Levodopa/Carbidopa Hexal can cause undesirable effects, although not all
people will experience them.
The undesirable effects that may occur are:

Infections and Infestations

Very common:may affect up to 1 in 10 people

• urinary tract infections

Blood and lymphatic system disorders

Rare: may affect 1 in 1,000

• white blood cell deficiency, accompanied by an increased risk of infection (leukopenia)
• anemia (hemolytic and non-hemolytic)
• platelet deficiency, accompanied by bruising and a tendency to bleed (thrombocytopenia) Very rare: may affect 1 in 10,000
• severe white blood cell deficiency, accompanied by sudden high fever, severe sore throat and ulcers in the mouth (agranulocytosis)

Metabolism and nutrition disorders

Common: may affect 1 in 10

• loss of appetite (anorexia) Uncommon: may affect 1 in 100
• weight loss
• weight gain

Psychiatric disorders

Common: may affect 1 in 10

• seeing things that do not exist (hallucinations)
• confusion
• dizziness
• nightmares
• drowsiness
• fatigue
• insomnia
• depression with (very rare) suicidal tendencies
• feeling of well-being (euphoria)
• episodes of severe mental disorder, during which you lose control of your behavior (psychosis)
• agitation Rare: may affect 1 in 1,000
• excitement (agitation)
• anxiety
• decreased ability to concentrate
• disorientation
• headache
• increased libido
• numbness
• seizures/convulsions

Frequency not known: the frequency cannot be estimated on the basis of available data

• dementia
• inability to resist the urge or temptation to perform actions that could be harmful to themselves or others, which may include: o a strong urge to gamble excessively, despite serious personal or family consequences o altered or increased sexual interest and behavior that causes significant distress to you or others, for example, increased sexual desire. o compulsive shopping or excessive spending o compulsive eating (eating large amounts of food in a short period of time) o bulimia (eating more food than normal and more than necessary to satisfy your hunger) A desire for high doses of Levodopa/Carbidopa Hexal in excess of what is required to control motor symptoms, known as dopaminergic dysregulation syndrome. Some patients experience severe involuntary abnormal movements (dyskinesias), mood changes, or other undesirable effects after taking high doses of Levodopa/Carbidopa Hexal.

Inform your doctor if you experience any of these behaviors, so he can decide how
to intervene to manage or reduce the symptoms.
Nervous system disorders

Common: may affect 1 in 10

• alteration of movements (dyskinesia)
• disorder characterized by sudden irregular movements (chorea)
• alteration of muscle tone (dystonia)
• alterations in movements caused by factors external to the nervous system (extrapyramidal)
• sudden alterations in the symptoms of Parkinson's disease ( “on-off” symptoms)
• slowing of movements during “on-off” periods (bradykinesia) Uncommon: may affect 1 in 100
• ataxia
• increased hand tremor Rare: may affect 1 in 1,000
• a serious disorder caused by the use of neuroleptics, which can manifest as muscle rigidity, marked inability to sit and stay still, high fever, sweating, increased salivation and altered state of consciousness (neuroleptic malignant syndrome)
• sensations of tingling, prickling and itching without apparent cause (paresthesia)
• seizures/convulsions
• alterations in gait
• trismus

Frequency not known: the frequency cannot be estimated on the basis of available data

• Drowsiness and (very rarely) constant fatigue during the day/sudden sleep attacks.

Eye disorders

Rare: may affect 1 in 1,000

• blurred vision
• spasms of the orbicularis muscle surrounding the eye (this may be a symptom of overdose)
• activation of a pre-existing Horner's syndrome (an eye disorder)
• double vision
• dilated pupils
• alteration of eye movements

Cardiac disorders

Common: may affect 1 in 10

• palpitations
• irregular heartbeat

Vascular disorders

Common: may affect 1 in 10

• decrease in blood pressure, for example when getting up quickly from sitting or lying down, sometimes accompanied by dizziness (orthostatic hypotension)
• tendency to faint
• sudden loss of consciousness Uncommon: may affect 1 in 100
• increased blood pressure Rare: may affect 1 in 1,000
• inflammation of the veins (phlebitis)

Respiratory, thoracic and mediastinal disorders

Uncommon: may affect 1 in 100

• hoarseness
• chest pain Rare: may affect 1 in 1,000
• shortness of breath
• irregular breathing rhythm

Gastrointestinal disorders

Common: may affect 1 in 10

• nausea
• vomiting
• dry mouth
• bitter taste in the mouth

Uncommon: may affect 1 in 100

• constipation
• diarrhea
• increased salivation
• difficulty swallowing (dysphagia)
• flatulence Rare: may affect 1 in 1,000
• difficulty digesting, with symptoms such as feeling of fullness in the upper abdomen, pain in the upper abdomen, tendency to belch, nausea, vomiting and heartburn (dyspepsia)
• stomach and intestinal pains
• dark saliva
• bruxism (teeth grinding)
• hiccups
• gastrointestinal bleeding
• burning of the tongue
• - duodenal ulcers

Skin and subcutaneous tissue disorders

Uncommon: may affect 1 in 100

• fluid retention (edema) Rare: may affect 1 in 1,000
• sudden accumulation of fluid in the skin and mucous membranes (for example, throat and tongue), difficulty breathing and/or itching and rash, often in the form of an allergic reaction (angioedema)
• skin rashes with severe itching and blistering (urticaria)
• itching
• facial flushing
• hair loss
• skin rash
• increased sweating
• dark sweating
• in children, bleeding (due to allergy) of the skin and the wall of the gastrointestinal tract (Schönlein-Henoch purpura) Frequency not known: the frequency cannot be estimated on the basis of available data
• skin cancer (melanoma)
• Musculoskeletal and connective tissue disordersUncommon: may affect 1 in 100
• muscle spasms

Renal and urinary disorders

Uncommon: may affect 1 in 100

• dark urine Rare: may affect 1 in 1,000
• urinary retention
• involuntary passage of urine
• persistent erection (priapism)

Systemic disorders and conditions related to the site of administration

Uncommon: may affect 1 in 100

• weakness
• malaise
• hot flashes

Reporting of undesirable effects
If you experience any undesirable effects, including those not listed in this leaflet, please inform
your doctor or pharmacist. You can also report undesirable effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting undesirable effects you can contribute to providing more information on the safety of
this medicine.

5HOW TO STORE LEVODOPA/CARBIDOPA HEXAL
Keep Levodopa/Carbidopa Hexal out of the sight and reach of children.
Do not use Levodopa/Carbidopa Hexal after the expiry date, which is stated on the packaging and blister
after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6CONTENTS OF THE PACK AND OTHER INFORMATION
What Levodopa/Carbidopa Hexal contains
The active ingredientsare: Levodopa and Carbidopa.
Each prolonged-release tablet contains 100 mg of levodopa and 25 mg of carbidopa (as carbidopa
monohydrate).
Each prolonged-release tablet contains 200mg/50 mg contains 200 mg of levodopa and 50 mg of
carbidopa (as carbidopa monohydrate).
The other ingredients are: hypromellose, anhydrous colloidal silicon dioxide, fumaric acid, sodium stearyl fumarate, macrogol
6000, quinoline yellow (E104), yellow iron oxide and red iron oxide (E172), titanium dioxide (E171).

Description of the appearance of Levodopa/Carbidopa Hexal and contents of the pack
Appearance:
Levodopa/Carbidopa Hexal 100mg/25 mg prolonged-release tablets: round tablets, orange-brown
in color.
Levodopa/Carbidopa Hexal 200mg/50 mg prolonged-release tablets: round tablets, orange-brown
in color.
The prolonged-release tablets are packaged in blisters containing 30, 50, 60 or 100 tablets, in turn
packaged in cardboard boxes.
Not all pack sizes may be marketed

Marketing Authorisation Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturers responsible for batch release
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany
Lek S.A.
Ul. Domaniewska 50 C
02-672 Warsaw
Poland

This medicinal product is authorised in the Member States of the EEA under the following
denominations:
NetherlandsLevodopa/Carbidopa Sandoz retard 100/25 mg, tablets with prolonged release
Levodopa/Carbidopa Sandoz retard 200/50 mg, tablets with prolonged release

GermanyLevocomp® retard 100/25 mg Retardtablets
Levocomp® retard 200/50 mg Retardtablets

ItalyLevodopa/Carbidopa Hexal 100/25 mg prolonged-release tablets
Levodopa/Carbidopa Hexal 200/50 mg prolonged-release tablets

SwedenLevocar