Levodopa and carbidopa Doc Generici

Patient Information Leaflet: Information for the User

LEVODOPA AND CARBIDOPA DOC 100 mg/25 mg tablets, 250 mg/25 mg tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What LEVODOPA AND CARBIDOPA DOC is and what it is used for
2. What you need to know before taking LEVODOPA AND CARBIDOPA DOC
3. How to take LEVODOPA AND CARBIDOPA DOC
4. Possible side effects
5. How to store LEVODOPA AND CARBIDOPA DOC
6. Contents of the pack and other information

1. What LEVODOPA AND CARBIDOPA DOC is and what it is used for

LEVODOPA AND CARBIDOPA DOC contains the active substances carbidopa and levodopa, which are anti-Parkinson agents.
LEVODOPA AND CARBIDOPA DOC improves the signs of parkinsonism (but is not indicated for drug-induced extrapyramidal symptoms) in adults. Parkinson's disease is a long-term condition in which:

• you become slow and unsteady
• muscles become stiff
• tremors may occur. If left untreated, Parkinson's disease can make it difficult to carry out normal daily activities.

How LEVODOPA AND CARBIDOPA DOC works:

• levodopa is converted in the brain into a substance called "dopamine". Dopamine helps improve the signs of Parkinson's disease.
• carbidopa belongs to a group of medicines called "aromatic amino acid decarboxylase inhibitors". It helps levodopa work more effectively by slowing down the rate at which levodopa is metabolized in the body.

2. What you need to know before taking LEVODOPA AND CARBIDOPA DOC

Do not take LEVODOPA AND CARBIDOPA DOC:

if you are allergic to carbidopa, levodopa, or any of the other ingredients of this
medicine (listed in section 6).
if you are taking certain medicines called "MAOIs" (monoamine oxidase inhibitors, such as
selegiline) used in depression. You must stop taking these medicines at least two
weeks before starting LEVODOPA AND CARBIDOPA DOC.
if you have a condition called "narrow-angle glaucoma" which can cause a sudden
build-up of pressure in the eye
if you have undiagnosed suspicious skin lesions or have previously suffered from skin cancer
if you have episodes of hypertension caused by a tumour of the adrenal medulla (pheochromocytoma),
overproduction of cortisol or thyroid hormone
if you have severe heart disease.
Do not take LEVODOPA AND CARBIDOPA DOC if you experience any of the symptoms listed above.
If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or pharmacist before
taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking LEVODOPA AND CARBIDOPA DOC:

• if you suffer from drug-induced movement disorders
• if you have lung problems, such as bronchial asthma
• if you have liver, kidney, or gland problems
• if you have previously suffered from intestinal ulcer (called “peptic ulcer”)
• if you have previously suffered from heart attacks (myocardial infarction)
• if you are taking a medicine that may cause low blood pressure when standing up from a chair or bed (orthostatic hypotension)
• if you have had depression or other mental health problems
• if you have previously taken levodopa alone
• if you have a history of severe involuntary movements or psychotic episodes
• if you have a history of seizures (convulsions)
• if you have a condition called “chronic open-angle glaucoma” which can cause a build-up of pressure in the eye. You will need regular eye pressure checks
• if you sometimes experience sudden sleep attacks or feel excessively sleepy
• if you are due to undergo surgery.

Inform your doctor if you or a family member/carer notice the development of urges or desires
to behave in ways that are unusual for you and that you cannot resist the impulse or temptation to carry out
certain activities that could harm yourself or others. These behaviours are called
impulse control disorders and may include gambling addiction, excessive
eating or spending, abnormally increased sexual desire, or an increase in sexual thoughts
or feelings. Your doctor may consider it necessary to reassess your treatment.
Inform your doctor if you or a family member/carer notice the development of symptoms resembling
dependence, leading to a craving for high doses of LEVODOPA AND CARBIDOPA DOC and other
medicines used to treat Parkinson's disease.
This medicine may affect certain laboratory tests that your doctor may perform on blood
or urine samples. Remember to inform your doctor if you are taking LEVODOPA AND CARBIDOPA DOC and are undergoing tests.

Children and adolescents

The use of LEVODOPA AND CARBIDOPA DOC is not recommended in children and adolescents under
18 years of age.

Other medicines and LEVODOPA AND CARBIDOPA DOC

Inform your doctor if you are taking, have recently taken, or might take any other medicine.
This is because LEVODOPA AND CARBIDOPA DOC can affect the action of other drugs and other drugs
can alter the mechanism of action of LEVODOPA AND CARBIDOPA DOC.
In particular, inform your doctor or pharmacist if you are taking:

• medicines for high blood pressure (antihypertensives). Dose adjustment of the antihypertensive agent may be required
• medicines for depression (antidepressants, such as tricyclic antidepressants and non-selective monoamine oxidase inhibitors)
• anticholinergic agents. Dose adjustment of Carbidopa/Levodopa may be required
• medicines for Parkinson’s disease (COMT inhibitors, such as tolcapone, entacapone, amantadine, or medicines containing selegiline). Dose adjustment of Carbidopa/Levodopa may be required
• medicines for anaemia (such as iron preparations). Administration of LEVODOPA AND CARBIDOPA DOC and iron-containing preparations should be separated by the longest possible interval
• medicines for the treatment of severe allergic reactions, asthma, chronic bronchitis, heart disease, and low blood pressure (such as sympathomimetics)
• medicines for seizures (such as phenytoin)
• medicines for mental disorders such as phenothiazines, butyrophenones, and risperidone
• medicines for tuberculosis (such as isoniazid)
• medicines for erectile dysfunction (such as papaverine).

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or pharmacist before
taking this medicine.

LEVODOPA AND CARBIDOPA DOC with food, drinks and alcohol

Try to avoid taking LEVODOPA AND CARBIDOPA DOC with a meal high in protein (such as
meat, eggs, milk, cheese), as the effectiveness of LEVODOPA AND CARBIDOPA DOC may decrease.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before
taking this medicine.
LEVODOPA AND CARBIDOPA DOC is not recommended during pregnancy or in women of childbearing age who
do not use contraception, unless the benefits to the mother outweigh the possible risks to the unborn child.
Do not take LEVODOPA AND CARBIDOPA DOC if you are breastfeeding.

Driving and using machines

LEVODOPA AND CARBIDOPA DOC may lower blood pressure, causing dizziness or vertigo.
Therefore, take particular care when driving or operating tools or machinery.
LEVODOPA AND CARBIDOPA DOC may also make you feel sleepy or cause "sudden sleep attacks". If
this happens to you, you must not drive or use tools or machinery until these recurring episodes of
"sudden sleep" and drowsiness have disappeared.

3. How to take LEVODOPA AND CARBIDOPA DOC

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
The usual daily dose may vary and is individually determined by the doctor according to the
severity of the disease and the response to treatment. During the dose adjustment period, the patient
must pay particular attention to symptoms such as involuntary movements and must inform the
doctor immediately if these occur. The doctor will adjust the dosage if necessary.
Your doctor may prescribe more than one dosage strength of LEVODOPA AND CARBIDOPA DOC. If you have been given
different dosage strengths of LEVODOPA AND CARBIDOPA DOC, make sure to take the correct tablet at the
correct time.
For doses that cannot be achieved/practically administered with this medicine, other medicinal products are available.

How to take this medicine

• Take this medicine by mouth, swallowing the tablet whole. The tablet must be taken whole and must not be divided, as the tablets do not have a break line.
• Although the medicine may start to work after one day, it may take up to seven days to take full effect.
• Take the tablet at regular intervals as directed by your doctor.
• Do not change the times at which you take the tablets or any other Parkinson's disease medication without first consulting your doctor.
• Try to avoid taking the tablets with a high-protein meal (see section 2 “LEVODOPA AND CARBIDOPA DOC with food, drink and alcohol”).

If you take more LEVODOPA AND CARBIDOPA DOC than you should
If you or your child takes too many tablets, contact a doctor immediately.
If you forget to take LEVODOPA AND CARBIDOPA DOC
Do not take a double dose of LEVODOPA AND CARBIDOPA DOC to make up for a forgotten dose.
If you stop taking LEVODOPA AND CARBIDOPA DOC
Do not stop treatment or change the dose unless advised by your doctor. If you suddenly stop taking LEVODOPA AND CARBIDOPA DOC, the following symptoms may occur: muscle rigidity, high temperature (fever) and mental disturbances.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop taking the medicine and consult your doctor if you notice any of the following side effects:

• chest pain
• irregular heartbeat or palpitations
• intestinal bleeding, which may present as blood in the stool or dark stools (gastrointestinal bleeding)
• muscle rigidity, severe inability to remain still, high fever, sweating, increased salivation, and impaired consciousness (neuroleptic malignant syndrome)
• mental changes including delusions, hallucinations, and depression (with very rare suicidal tendencies)
• seizures (convulsions)
• sudden fluid accumulation in the skin and mucous membranes (e.g. throat and tongue), breathing difficulties and/or itching and skin rashes, often manifesting as an allergic reaction (angioedema)
• a very serious blood disorder (lack of white blood cells) accompanied by sudden high fever, severe sore throat, and mouth ulcers (agranulocytosis).

Other side effects that may occur:
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, drowsiness, fatigue, insomnia, feeling of well-being (euphoria), dementia, feeling of stimulation, abnormal dreams
• movement disorders (dyskinesia), a condition characterized by sudden involuntary movements (chorea), muscle tone disorder (dystonia), movement disorders caused by extrapyramidal nervous system disturbances, sudden changes in Parkinson's symptoms ("on-off" phenomena), slowing of movements during "on-off" periods (bradykinesia)
• sensation of rapid heartbeat (palpitations), irregular heartbeat
• drop in blood pressure, for example when rising too quickly from a sitting or lying position, sometimes accompanied by dizziness (orthostatic hypotension), tendency to faint
• nausea, vomiting, dry mouth, bitter taste.

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

• weight loss or weight gain
• muscle coordination disorder (ataxia), increased hand tremors
• increased blood pressure (hypertension)
• hoarseness
• constipation, diarrhoea, flatulence
• increased salivation (sialorrhoea), difficulty swallowing (dysphagia)
• fluid accumulation (oedema)
• muscle spasms
• dark urine
• loss of strength (asthenia), weakness
• feeling of malaise (malaise)
• hot flushes.

Rare (may affect up to 1 in 1,000 people):

• a blood disorder (lack of white blood cells) accompanied by increased susceptibility to infections (leucopenia), anaemia, a blood disorder (lack of platelets) accompanied by bruising and tendency to bleed (thrombocytopenia)
• excitement (agitation), fear, reduced ability to think, disorientation, headache, increased sexual desire, numbness, seizures/convulsions
• episodes of severe mental illness, during which control over one's conduct and behaviour is impaired
• sensations of tingling, prickling, and itching without any apparent cause (paraesthesiae)
• more frequent falls, gait disturbances, trismus
• blurred vision, spasm of the orbicularis muscle surrounding the eye (blepharospasm, which may be a sign of overdose), activation of a pre-existing Horner's syndrome (an eye disorder), double vision, dilated pupils, deterioration of eye movements
• inflammation of the veins (phlebitis)
• shortness of breath (dyspnoea), abnormal breathing patterns
• altered digestion with symptoms such as a feeling of fullness in the upper abdomen, upper abdominal pain, belching, nausea, vomiting, and heartburn (dyspepsia), stomach and intestinal pain, dark saliva, teeth grinding (bruxism), hiccups, bleeding in the stomach and intestine, burning tongue, duodenal ulcers
• skin rash with intense itching and wheal formation (urticaria), itching, facial redness, hair loss, skin rash, increased sweating, dark sweat
• in children, allergy-related bleeding in the skin and gastrointestinal tract wall (Schönlein-Henoch purpura)
• urinary retention, involuntary urination, persistent erection (priapism).

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

• drowsiness and constant daytime fatigue/sudden attacks of sleep.

Not known (frequency cannot be determined from available data):

• muscle contractions
• Desire for higher doses of LEVODOPA AND CARBIDOPA DOC than needed to control motor symptoms (dopamine dysregulation syndrome). Some patients experience severe abnormal involuntary movements, mood swings, or other adverse effects after taking high doses of LEVODOPA AND CARBIDOPA DOC.
• Inability to resist the impulse to carry out an action that could be harmful, which may include:
  o Strong impulse to gamble excessively despite serious personal or family consequences.
  o Altered or increased sexual interest and behaviour of significant concern to you or others, for example increased sexual desire.
  o Excessive, uncontrollable shopping or spending.
  o Binge eating (consuming large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger).

Inform your doctor if you experience any of these behaviours; doctors will discuss ways to manage or reduce the symptoms.
If symptoms persist or if other side effects occur, inform your doctor or pharmacist. It may help to keep a record of what you have experienced, when it started, and how long it lasted.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store LEVODOPA AND CARBIDOPA DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and packaging after EXP.
The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What LEVODOPA AND CARBIDOPA DOC contains

• The active substances are levodopa and carbidopa.

Each tablet contains 100 mg of levodopa and 25 mg of carbidopa (as carbidopa monohydrate).
Each tablet contains 250 mg of levodopa and 25 mg of carbidopa (as carbidopa monohydrate).
The other components are:
250 mg/25 mg: crospovidone [Type B] (E1202), indigo carmine aluminium lake (E132), magnesium stearate (E470b), microcrystalline cellulose (E460), pregelatinized starch [maize]
100 mg/25 mg: crospovidone [Type B] (E1202), quinoline yellow aluminium lake (E104), magnesium stearate (E470b), microcrystalline cellulose (E460), pregelatinized starch [maize]

Description of the appearance of LEVODOPA AND CARBIDOPA DOC and contents of the pack

LEVODOPA AND CARBIDOPA DOC 100 mg/25 mg tablets are light yellow, round-shaped, with a diameter of 8 mm, marked with a "C" on one side and "19" on the other side of the tablet.
LEVODOPA AND CARBIDOPA DOC 250 mg/25 mg tablets are blue, round-shaped, with a diameter of 10.40 mm, marked with a "C" on one side and "20" on the other side of the tablet.

Pack sizes:
100 mg/25 mg: 20, 50, 100 or 200 tablets in aluminium blisters packed in a cardboard box.
250 mg/25 mg: 20, 50, 60, 100, 120 or 200 tablets in aluminium blisters packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milan, Italy.

Manufacturer
Fair-Med Healthcare GmbH
Maria-Goeppert-Straße 3
23562 Lübeck, Germany