CARBIDOPA/LEVODOPA FAIRMED 12.5 mg/50 mg TABLETS

Introduction

Package Leaflet: Information for the User

Carbidopa/Levodopa Fairmed 12.5mg/50mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Carbidopa/Levodopa Fairmed and what is it used for
2. What you need to know before you take Carbidopa/Levodopa Fairmed
3. How to take Carbidopa/Levodopa Fairmed
4. Possible side effects
   1. Storage of Carbidopa/Levodopa Fairmed

1. Contents of the pack and further information

1. What is Carbidopa/Levodopa Fairmed and what is it used for

Carbidopa/Levodopa Fairmed contains the active substances carbidopa and levodopa, which are antiparkinsonian substances.

This medication improves the signs of parkinsonism (but not drug-induced extrapyramidal symptoms) in adults. Parkinson's disease is a chronic disease in which:

• you become slow and unsteady
• you notice stiff muscles
• you may experience convulsive crises or tremors.

If left untreated, Parkinson's disease can make it difficult to continue with your normal daily activities.

How Carbidopa/Levodopa Fairmed works:

• In the brain, levodopa is converted into a substance called "dopamine". Dopamine helps improve the signs of Parkinson's disease.
• Carbidopa belongs to a group of medications called "aromatic amino acid decarboxylase inhibitors". It helps levodopa work more effectively by reducing the rate of levodopa degradation in the body.

2. What you need to know before you take Carbidopa/Levodopa Fairmed

Do not take Carbidopa/Levodopa Fairmed:

• if you are allergic to carbidopa or levodopa or any of the other ingredients of this medication (listed in section 6).
• if you are taking certain medications called "MAOIs" (monoamine oxidase inhibitors, such as selegiline) used for depression. You must stop using these medications at least two weeks before starting to take carbidopa/levodopa.
• if you have a disease called "narrow-angle glaucoma", which can cause a sudden increase in eye pressure
• if you have suspicious undiagnosed skin lesions or a history of skin cancer
• if you have pheochromocytoma-induced hypertensive crises
• if you have excessive cortisol or thyroid hormone production
• if you have severe heart disease

Do not take carbidopa/levodopa if any of the above applies to you.

If you are in doubt, consult your doctor or pharmacist before starting to take this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Carbidopa/Levodopa Fairmed:

• if you have drug-induced movement disorders
• if you have pulmonary conditions, such as bronchial asthma
• if you have liver, kidney, or glandular conditions
• if you have a history of intestinal ulcers (called "peptic ulcers")
• if you have a history of heart attacks (myocardial infarction)
• if you are taking a medication that can lower blood pressure when standing up from a chair or bed (orthostatic hypotension)
• if you have had depression or other mental 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
• if you have a disease called "open-angle glaucoma", which can cause an increase in eye pressure. You should undergo regular eye pressure checks.
• if you sometimes experience sudden sleep crises or excessive sleepiness
• if you are going to undergo surgery

Tell your doctor if you or your family/caregiver notice that you are developing impulses or an overwhelming need to behave in a way that is not typical of you or cannot resist the impulse, desire, or temptation to perform certain activities that could harm you or others. These behaviors are called impulse control disorders and may include pathological gambling, overeating, or excessive spending, abnormally high sexual desire, or an increase in thoughts or feelings of sex. Your doctor may need to review your treatments.

Tell your doctor if you or your family/caregiver notice that you are developing symptoms similar to those of addiction, which lead you to crave large doses of carbidopa/levodopa and other medications used to treat Parkinson's disease.

This medication may affect some laboratory tests that your doctor may perform on blood or urine samples. Remind your doctor that you are taking carbidopa/levodopa if you are going to have any tests.

Children and adolescents

Carbidopa/levodopa is not recommended for children and adolescents under 18 years of age.

Other medications and Carbidopa/Levodopa Fairmed

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.

The reason is that carbidopa/levodopa can affect the way some other medications work. Similarly, some other medications can affect the way carbidopa/levodopa works.

In particular, tell your doctor or pharmacist if you are taking:

• medications for high blood pressure (antihypertensives). The dose of the antihypertensive may need to be adjusted.
• medications for depression (antidepressants, such as tricyclic antidepressants and non-selective monoamine oxidase inhibitors)
• anticholinergics. The dose of carbidopa/levodopa may need to be adjusted.
• medications for Parkinson's disease (COMT inhibitors, such as tolcapone, entacapone, amantadine, or medications containing selegiline). The dose of carbidopa/levodopa may need to be adjusted.
• medications for anemia (such as iron preparations). There should be as long a time as possible between the administration of carbidopa/levodopa and iron preparations
• medications for severe allergic reactions, asthma, chronic bronchitis, heart disease, and low blood pressure (such as sympathomimetics).
• medications for seizures (such as phenytoin)
• medications for mental problems (such as phenothiazines, butyrophenones, and risperidone)
• medications for tuberculosis (such as isoniazid)
• medications for erectile dysfunction (such as papaverine).

If you are in doubt about whether any of the above applies to you, consult your doctor or pharmacist before starting to take this medication.

Taking Carbidopa/Levodopa Fairmed with food and drinks

Try to avoid taking carbidopa/levodopa with a meal that contains protein (such as meat, eggs, milk, cheese), as the effect of carbidopa/levodopa may be reduced.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Carbidopa/levodopa is not recommended during pregnancy or in women of childbearing age who do not use contraceptive methods, unless the benefits to the mother outweigh the potential risk to the fetus.

Do not take carbidopa/levodopa if you are breastfeeding.

Driving and using machines

Carbidopa/levodopa can lower blood pressure, which can make you feel dizzy or lightheaded. Therefore, be careful when driving or using any tool or machine.

Carbidopa/levodopa can also cause sleepiness or "sudden sleep crises". If this happens, do not drive or use tools or machines until the "sudden sleep crises" and sleepiness have disappeared.

3. How to take Carbidopa/Levodopa Fairmed

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

The usual daily dose may vary and is determined individually by the doctor, based on the severity of the disease and the response to treatment. During the dose adjustment period, the patient should pay special attention to symptoms such as involuntary movements and inform their doctor immediately if they occur. Your doctor will adjust the dose as necessary.

Your doctor may prescribe more than one dose of carbidopa/levodopa. If you have been given different doses of carbidopa/levodopa, make sure to take the correct tablet at the right time.

For doses that cannot be achieved with this medication, other medications are available.

How to take this medication

• Take this medication orally, swallowing the tablet. The tablet should be taken whole and not divided, as the tablets do not have a score line.
• The medication may take effect within a day, but it may also take up to seven days to take effect.
• Take the tablet at regular intervals, according to your doctor's instructions.
• Do not change the schedule of taking the tablets or take any other medication for Parkinson's disease without consulting your doctor first.
• Try to avoid taking the tablets with a meal rich in protein (see section 2 "Carbidopa/Levodopa Fairmed with food and drinks")

If you take more Carbidopa/Levodopa Fairmed than you should

If you or your child take too many tablets, go to a doctor immediately.

If you forget to take Carbidopa/Levodopa Fairmed

Do not take a double dose to make up for forgotten doses.

If you stop taking Carbidopa/Levodopa Fairmed

Do not stop taking this medication or change the dose without your doctor's advice. If you stop taking this medication abruptly, you may experience: muscle stiffness, high fever, and mental changes.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Carbidopa/Levodopa Fairmed and go to your doctor immediately if you notice any of the following side effects:

• chest pain
• irregular heartbeats or palpitations
• gastrointestinal bleeding, which can manifest as blood in the stool or dark stools
• muscle stiffness, inability to sit still, high fever, sweating, increased salivation, and altered consciousness (neuroleptic malignant syndrome)
• mental disorders including delirium, hallucinations, and depression (with very rare suicidal tendencies)
• seizures
• sudden fluid accumulation in the skin and mucous membranes (e.g., throat and tongue), breathing difficulties, or itching and skin rash, which often manifest as an allergic reaction (angioedema)
• a very serious blood disorder (lack of white blood cells) accompanied by a sudden high fever, severe sore throat, and ulcers in the mouth (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, sleep disturbances
• movement disorders (dyskinesia), disorder characterized by sudden involuntary movements (chorea), muscle tone disorder (dystonia), movement disorders caused from outside the nervous system, sudden changes in Parkinson's symptoms ("on-off" symptoms), slowing of movements during "on-off" periods (bradykinesia)
• feeling of rapid heartbeats (palpitations), irregular heartbeats
• decrease in blood pressure caused, for example, by standing up 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 gain
• alteration of muscle coordination (ataxia), increase in hand tremors
• increase in blood pressure (hypertension)
• hoarseness
• constipation, diarrhea, flatulence
• increased salivation (sialorrhea), difficulty swallowing (dysphagia)
• fluid accumulation (edema)
• muscle cramps
• dark urine
• loss of strength (asthenia), weakness
• feeling of discomfort (general malaise)
• hot flashes

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

• a blood disorder (lack of white blood cells) accompanied by a greater propensity to infections (leucopenia), anemia, a blood disorder (lack of platelets) accompanied by bruising and tendency to bleed (thrombocytopenia)
• nervousness (restlessness), fear, deterioration of thinking ability, disorientation, headache, increased sexual desire, numbness, seizures/epileptic crises
• episodes of severe mental illness, during which control over one's behavior and conduct is impaired
• feeling of pinching, tingling, and itching without apparent cause (paresthesia),
• more frequent falls, gait disorders, trismus
• blurred vision, spasms of the muscle surrounding the eye (blepharospasm, 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, abnormal breathing patterns
• digestive disorders with symptoms such as feeling of fullness in the upper abdomen, pain in the upper abdomen, belching, nausea, vomiting, and heartburn (dyspepsia), stomach and intestinal pain, dark saliva, teeth grinding (bruxism), hiccups, stomach and intestinal bleeding, burning tongue, duodenal ulcers
• skin rash with intense itching and hives (urticaria), itching, facial redness, hair loss, skin rash, increased sweating, dark sweating
• in children, allergic reactions in the skin and wall of the gastrointestinal tube (Schönlein-Henoch purpura)
• urinary retention, involuntary urination, prolonged erection (priapism)

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

• excessive daytime sleepiness and constant/sudden sleep crises

Frequency not known (cannot be estimated from the available data):

• muscle fasciculations
• Need for large doses of carbidopa/levodopa, higher than necessary, to control motor symptoms (dopamine dysregulation syndrome). Some patients experience severe abnormal involuntary movements, mood changes, or other side effects after taking large doses of carbidopa/levodopa.
• Inability to resist the impulse to perform an action that could be harmful, including:

• Strong impulse to gamble excessively, despite serious personal or family consequences.
• Alteration or increase in sexual desire or behavior that concerns you or others, for example, increased libido.
• Uncontrolled excessive shopping or spending
• Binge eating (eating large amounts of food in a short period) or compulsive eating (eating more food than normal and more than needed to satisfy hunger)

Tell your doctor if you experience any of these behaviors; they will study how to control or reduce the symptoms.

If the symptoms persist or if you experience any other side effect, tell your doctor or pharmacist. They will help you record what you experienced, when it started, and how long it lasted.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Carbidopa/Levodopa Fairmed

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiry date which is stated on the blister and carton after EXP. The expiry date is the last day of the month shown.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition of Carbidopa/Levodopa Fairmed

• The active ingredients are carbidopa and levodopa.

Each tablet contains 10 mg of carbidopa (as carbidopa monohydrate) and 100 mg of levodopa.

• The other ingredients are: crospovidone [type B] (E1202), indigo carmine (E132), magnesium stearate (E470b), microcrystalline cellulose (E460), pregelatinized corn starch

Appearance of Carbidopa/Levodopa Fairmed and Container Content

Carbidopa/Levodopa Fairmed 10 mg/100 mg: light blue in color, round in shape, with a diameter of 8 mm, with a "C" on one side of the tablet and "18" on the other.

Container sizes: 20, 100, or 200 tablets in aluminum blisters, inside a cardboard box.

Only some container sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Fairmed Healthcare GmbH

Dorotheenstr. 48

22301 Hamburg

Germany

[email protected]

Manufacturer

Fairmed Healthcare GmbH

Maria-Goeppert-Straße 3

23562 Lübeck

Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Levodopa/Carbidopa Fairmed Healthcare 50 mg/12.5 mg; 100 mg/10 mg; 100 mg/25 mg; 250 mg/25 mg Tablets

Austria: Carbidopa/Levodopa Fairmed 12.5 mg/50 mg; 10 mg/100 mg; 25 mg/100 mg; 25 mg/250 mg Tablets

Estonia: Levodopa/Carbidopa Fairmed 100 mg/25 mg; 250 mg/25 mg tablets

Spain: Carbidopa/Levodopa Fairmed 12.5 mg/50 mg; 10 mg/100 mg; 25 mg/100 mg; 25 mg/250 mg EFG tablets

Finland: Carbidopa/Levodopa Fairmed 12.5 mg/50 mg; 10 mg/100 mg; 25 mg/100 mg; 25 mg/250 mg tablets

Netherlands: Carbidopa/Levodopa Fairmed 12.5 mg/50 mg; 10 mg/100 mg; 25 mg/100 mg; 25 mg/250 mg tablets

Italy: Carbilev 25 mg/100 mg; 25 mg/250 mg

Latvia: Levodopa/Carbidopa Fairmed 100 mg/25 mg; 250 mg/25 mg tablets

Lithuania: Levodopa/Carbidopa Fairmed 100 mg/25 mg; 250 mg/25 mg tablets

Poland: Bascar 25 mg/100 mg; 25 mg/250 mg

Sweden: Tremopen 12.5 mg/50 mg; 10 mg/100 mg; 25 mg/100 mg; 25 mg/250 mg tablets

Date of the Last Revision of this Leaflet: November 2023

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/