Package Insert: Information for the User

Sinemet Retard 50 mg/200 mg Extended-Release Tablets

carbidopa/levodopa

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms of the disease as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Sinemet Retard and for what it is used

2. What you need to know before starting to take Sinemet Retard

3. How to take Sinemet Retard

4. Possible adverse effects

5. Storage of Sinemet Retard

6. Contents of the package and additional information

Sinemet Retard is a prolonged-release tablet formulation indicated for the treatment of idiopathic Parkinson's disease, particularly to reduce the "off" period, in patients who have been previously treated with levodopa/dopa decarboxylase inhibitors, or with levodopa alone and who have experienced motor fluctuations.

The experience with Sinemet Retard in patients who have not been treated with levodopa previously is limited.

Sinemet Retard contains two active ingredients: levodopa and carbidopa and belongs to the group of medications known as antiparkinsonians. Levodopa acts by replenishing dopamine in the brain, while carbidopa ensures that the required amount of levodopa reaches the brain when needed. In many patients, this reduces the symptoms of Parkinson's disease. The Sinemet Retard formula helps to maintain the levodopa level in the body for as long as possible.

Parkinson's disease is a chronic disease characterized by slow and unstable movements, muscular rigidity, and tremors. If left untreated, it can lead to difficulties in living a normal life.

It is believed that the symptoms of Parkinson's disease are caused by a lack of dopamine, a naturally produced substance in the brain. Dopamine acts by transmitting messages in the brain that control muscular movement. When a small amount of dopamine is produced, difficulties in movement appear.

Do not take Sinemet Retard

• if you are allergic to the active ingredients (carbidopa, levodopa) or any of the other components of this medication (listed in section 6).
• if you have suspicious skin lesions that have not been examined by your doctor or if you have ever had skin cancer (melanoma).
• if you are being treated with MAO inhibitors (monoamine oxidase) antidepressants (except for certain low doses of MAO Type B inhibitors).
• if you have closed-angle glaucoma (elevated intraocular pressure).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sinemet Retard.

• if you have or have had health problems such as allergies, bronchial asthma, depression, or mental changes, lung problems, liver problems, kidney problems, heart problems, or hormonal problems, peptic ulcers, seizures, elevated intraocular pressure (glaucoma).
• if you require general anesthesia, treatment with this medication may be continued as long as you can take oral medication. If treatment needs to be temporarily interrupted, Sinemet Retard may be restarted as soon as you can take oral medication.
• if you are receiving treatment with blood pressure-lowering medications.
• if you experience sudden daytime sleep episodes or excessive daytime drowsiness.

Inform your doctor if you, or your family/caregiver, notice that you are developing symptoms similar to addiction, which lead to a desire for large doses of Sinemet Retard and other medications used to treat Parkinson's disease.

Inform your doctor if you, or your family/caregiver, notice that you are starting to behave in an unusual manner, if you feel the impulse, initiative, or temptation to harm others or engage in self-aggression.

These behaviors are called impulse control disorders and may include excessive gaming, eating, or spending, increased normal sexual desire or an increase in sexual thoughts or desires.Your doctor may need to review your treatments.

Inform your doctor if you have been previously treated with levodopa.

Consult your doctor, even if any of the circumstances mentioned above have occurred at any time.

Children and adolescents

The safety and efficacy of Sinemet Retard have not been established in this population and are not recommended for use in individuals under 18 years.

Taking Sinemet Retard with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

This medication should be administered with caution along with the following medications:

medications used to treat psychiatric problems or depression, tuberculosis, hypertension, muscle spasms, seizures, or other diseases related to involuntary movements, as well as iron preparations or iron supplements. Your doctor or pharmacist has a more complete list of medications that you should avoid while taking Sinemet Retard.

Taking Sinemet Retard with food, drinks, and alcohol

Since levodopa competes with certain amino acids, the absorption of levodopa may be altered in some patients with a high-protein diet. It is therefore recommended to avoid taking the associated tablets with heavy meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication, which will evaluate the potential benefits against the potential risks of treatment.

The effect of this medication on pregnancy is unknown.

Levodopa, one of the components of Sinemet Retard, passes into breast milk.

Driving and operating machinery

This medication may cause drowsiness and cause you to experience sudden daytime sleep episodes. If this happens, do not drive vehicles or perform activities in which a lack of attention may pose a risk or put you or others in danger of death or serious harm (e.g., operating machinery), until these episodes and/or drowsiness have disappeared.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The optimal daily dose of this medication is variable and must be determined through an individualized dose adjustment for each patient according to the severity of their disease and their response to treatment.

During the dose adjustment period, pay special attention to symptoms such as involuntary movements. Immediately inform your doctor of any changes in your condition, including abnormal movements, as this may require an adjustment to your prescription.

The tablet can be divided into equal doses. If your doctor instructs you to do so, split the Sinemet Retard tablets in half before taking them. Do not chew or crush the tablets, as this may compromise the prolonged-release properties of the product.

To achieve better results, you must take Sinemet Retard every day. It is essential to follow your doctor's advice on the amount and frequency at which you should take Sinemet Retard.

Remember to take your medication. Sinemet Retard should be taken orally.

If you estimate that the action of Sinemet Retard is too strong or too weak, inform your doctor or pharmacist.

If you take more Sinemet Retard than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Sinemet Retard

Take Sinemet Retard as prescribed. If you forget to take a tablet, take it as soon as you remember. However, if there is little time left before the next dose, do not take the missed dose and wait until the next dose.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Sinemet Retard

Your doctor will indicate the duration of treatment with Sinemet Retard. Do not stop treatment suddenly or reduce the dose without consulting your doctor. If you do, you may experience a set of symptoms that include muscle stiffness, fever, and mental disorders.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The most common side effects are: abnormal movements including tremors or spasms (which may or may not resemble your Parkinson's symptoms), nausea, hallucinations, confusion, dizziness, and dry mouth.

Cases of compulsive gambling and excessive sexual desire have been described for medicines that increase the action in the body of a chemical called dopamine, including Sinemet Retard.

You may experience the following side effects:

• desire for large doses of Sinemet Retard above those required to control motor symptoms, known as dopamine dysregulation syndrome. Some patients experience severe involuntary abnormal movements (dyskinesias), mood changes, or other side effects after taking large doses of Sinemet Retard. Frequency not known (cannot be estimated from available data).

• inability to resist the impulse to carry out an action that could be harmful, including:

• strong impulse to gamble excessively despite severe personal or family consequences.
• altered or increased sexual interest and excessive interest behavior towards yourself or others, for example, increased sexual desire.
• excessive and uncontrolled spending or purchases.
• binge eating (eating large amounts of food in a short 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 behaviors, as they will seek to control or reduce your symptoms.

Other possible side effects are:

Infections and infestations:urinary tract infections (very common).

Benign, malignant, and unspecified neoplasms (including cysts and polyps): malignant melanoma.

Blood and lymphatic system disorders: leukopenia and thrombocytopenia, anemia (hemolytic and non-hemolytic), agranulocytosis.

Immune system disorders:swelling of the face, lips, tongue, and/or throat (angioedema).

Metabolism and nutrition disorders: loss of appetite (anorexia), weight gain or loss.

Mental and behavioral disorders:mental changes, sleep disturbances (insomnia, nightmares), euphoria, depression, hallucinations, and delusional ideas, confusion, agitation, and anxiety, unconscious tooth grinding (bruxism), increased sexual interest, compulsive gambling.

Nervous system disorders: neuroleptic malignant syndrome, inability to coordinate movements (ataxia), increased tremor of the hands, activation of latent Horner syndrome (constricted pupils, drooping eyelid, and facial dryness), abnormal slow movements (bradykinesia episodes), numbness, tingling (paresthesia), bitter taste, spasms, dizziness, fainting, headache, feeling of stimulation, drowsiness, lethargy, sedation, narcolepsy episodes, dementia, epilepsy (seizures), decreased mental acuity.

Eye disorders:blurred vision, double vision (diplopia), dilated pupils (mydriasis), involuntary eye movements (oculogyric crisis).

Cardiac disorders: irregular heartbeat and/or palpitations.

Vascular disorders:inflammation of blood vessels (phlebitis), orthostatic hypotension (dizziness when standing up quickly), high blood pressure (hypertension), redness (rubor), hot flashes.

Respiratory, thoracic, and mediastinal disorders:difficulty breathing (dyspnea), snoring, hiccups, altered normal breathing.

Gastrointestinal disorders: vomiting, nausea, diarrhea, constipation, upper abdominal pain, abdominal pain and digestive discomfort, gastrointestinal bleeding, development of duodenal ulcer, flatulence, dark saliva, dry mouth, increased saliva production (sialorrhea), burning sensation in the tongue, stomach pain (dyspepsia), difficulty swallowing (dysphagia).

Skin and subcutaneous tissue disorders: hair loss (alopecia), rash, increased sweating, dark and foul-smelling sweat, hives, itching (pruritus), skin bleeding or petechiae (Schönlein-Henoch purpura).

Musculoskeletal and connective tissue disorders:muscle cramps, muscle tremors, jaw muscle spasm (trismus).

Renal and urinary disorders: dark-colored urine, urinary retention or incontinence.

Reproductive and breast disorders:: prolonged penile erection (priapism).

General disorders and administration site conditions:discomfort, chest pain, asthenia, changes in gait, weakness, edema, fatigue, general malaise.

Laboratory tests:alterations in the results of various laboratory tests have been reported.

Accidental injuries, intoxications, and complications of therapeutic procedures:falls.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 25°C.

Store in the original packaging.

Do not use this medication after the expiration date that appears on the packaging after CAD.

The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Sinemet Retard

• The active principles are 50 mg of anhydrous carbidopa and 200 mg of levodopa.
• The other components are red iron oxide (E-172), quinoline yellow aluminium lake (E-104), hydroxypropylcellulose, co-polymer of poly (vinyl acetate-crotinic acid) and magnesium stearate.

Appearance of the product and content of the packaging

The tablets are orange in color, oval in shape, with one face engraved with the code "521" and the other face a groove.

Each package contains 100 prolonged-release tablets.

Other presentations

Sinemet 25 mg/250 mg tablets. Package with 60 and 120 tablets.

Sinemet Plus 25 mg/100 mg tablets. Package with 100 tablets.

Sinemet Plus Retard 25 mg/100 mg prolonged-release tablets. Package with 100 prolonged-release tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Organon Health, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Phone: 915911279

Responsible manufacturer:

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN - Haarlem

Netherlands

Last review date of this leaflet: May 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/