Sinemet Retard 50 mg/200 mg prolonged-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sinemet Retard 50 mg/200 mg prolonged-release tablets

carbidopa/levodopa

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Contents of the leaflet

1. What Sinemet Retard is and what it is used for
2. What you need to know before taking Sinemet Retard
3. How to take Sinemet Retard
4. Possible adverse effects
5. How to store Sinemet Retard
6. Contents of the pack and other information

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

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 previously been treated with levodopa/decarboxylase inhibitors or with levodopa alone and who have experienced motor fluctuations.

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

Sinemet Retard contains two active substances: levodopa and carbidopa, and belongs to a group of medicines called antiparkinsonian agents. Levodopa works by replenishing dopamine in the brain, while carbidopa ensures that a sufficient amount of levodopa reaches the brain when needed. In many patients, this reduces the symptoms of Parkinson's disease. The Sinemet Retard formulation helps maintain the level of levodopa in the body for as long as possible.

Parkinson's disease is a chronic condition characterized by slow and unsteady movements, muscle rigidity, and tremors. If left untreated, it can lead to difficulties in carrying out normal daily activities.

It is believed that the symptoms of Parkinson's disease are caused by a lack of dopamine, a substance that occurs naturally in the brain. Dopamine transmits signals in the brain that control muscle movement. When insufficient dopamine is produced, movement difficulties occur.

2. What you need to know before taking Sinemet Retard

Do not take Sinemet Retard

• if you are allergic to the active substances (carbidopa, levodopa) or to any of the other ingredients of this medicine (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 antidepressant medicines of the MAO inhibitor (monoamine oxidase) group (except for certain low doses of MAO type B inhibitors).
• if you have closed-angle glaucoma (elevated intraocular pressure).

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Sinemet Retard.

• if you have or have had health problems such as allergies, bronchial asthma, depression or mental disturbances, lung, liver, kidney, heart or hormonal problems, peptic ulcer, seizures, or elevated intraocular pressure (glaucoma).
• if you require general anesthesia, treatment with this medicine may be continued as long as you are able to take oral medication. If treatment needs to be temporarily interrupted, Sinemet Retard can be restarted as soon as you are able to take oral medication again.
• if you are receiving treatment with medicines to lower blood pressure.
• if you fall asleep suddenly during the day (sudden sleep episodes) or experience excessive drowsiness (somnolence) during the day.

Inform your doctor if you, or your family/caregiver, notice that you are developing behaviors resembling addiction, leading to a desire for high doses of Sinemet Retard and other medicines 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 way, or if you feel the urge, impulse, or temptation to harm others or yourself.

These behaviors are known as impulse control disorders and may include gambling addiction, compulsive eating or spending, increased sexual desire, or an increase in sexual thoughts or urges. Your doctor may need to review your treatment.

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

Consult your doctor, even if any of the circumstances mentioned above have occurred to you in the past.

Children and adolescents

The safety and efficacy of Sinemet Retard have not been established in this population, and its use is not recommended in individuals under 18 years of age.

Taking Sinemet Retard with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

This medicine should be used with caution together with the following medicines:

medicines used to treat psychiatric disorders or depression, tuberculosis, hypertension, muscle spasms, seizures, or other diseases involving involuntary movements, as well as iron preparations or iron supplements. Your doctor or pharmacist has a more complete list of medicines that should be avoided while taking Sinemet Retard.

Taking Sinemet Retard with food, drinks and alcohol

Because levodopa competes with certain amino acids, the absorption of levodopa may be altered in some patients on a high-protein diet. Therefore, it is recommended to avoid taking the tablets with heavy meals.

Pregnancy and breast-feeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine, who will assess the potential benefits against the potential risks of treatment.

The effect of this medicine on pregnancy is unknown.

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

Driving and using machines

This medicine may cause drowsiness and sudden episodes of sleep. If this occurs, you must not drive or perform activities where lack of attention could pose a risk or place you or others at risk of death or serious injury (e.g., operating machinery), until these episodes and/or drowsiness have resolved.

3. How to take Sinemet Retard

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The optimal daily dose of this medicine varies and must be determined by individual dose adjustment for each patient, depending on the severity of their disease and their response to treatment.

During the dose adjustment period, special attention should be paid to symptoms such as involuntary movements. Inform your doctor immediately of any changes in your condition, such as abnormal movements, as this may require an adjustment of your prescription.

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

For best results, Sinemet Retard should be taken every day. It is important that you follow your doctor's advice regarding the amount and frequency with which you should take Sinemet Retard.

Remember to take your medicine. Sinemet Retard is to be taken orally.

If you think that the effect 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Sinemet Retard

Take Sinemet Retard as prescribed. If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose and wait until your next scheduled dose.

Do not take a double dose to make up for a missed dose.

If you stop taking Sinemet Retard

Your doctor will advise you on 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 group of symptoms including muscle rigidity, fever, and mental disturbances.

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

4. Possible adverse effects

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

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

Cases of gambling addiction and increased sexual desire have been reported with medicines that enhance the action in the body of a chemical substance called dopamine, including Sinemet Retard.

You may experience the following adverse effects:

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

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

• strong urge to gamble excessively despite serious personal or family consequences.

• altered or increased sexual interest and behavior with excessive interest in oneself or others, for example, increased libido.

• excessive and uncontrollable shopping or spending.

• 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 ways to manage or reduce the symptoms.

Other possible adverse effects are:

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

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

Blood and lymphatic system disorders: decreased white blood cells (leukopenia) and platelets (thrombocytopenia), reduced number of red blood cells (hemolytic and non-hemolytic anemia), loss of white blood cells (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.

Psychiatric disorders: mental disturbances, sleep disturbances (insomnia, nightmares), euphoria, depression, hallucinations and delusional thoughts, confusion, agitation and anxiety, unconscious teeth grinding (bruxism), increased sexual behavior, gambling addiction.

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

Eye disorders: blurred vision, double vision (diplopia), pupil dilation (mydriasis), involuntary eye movements (oculogyric crises).

Cardiac disorders: irregular heartbeat and/or palpitations.

Vascular disorders: inflammation of blood vessels (phlebitis), orthostatic hypotension (dizziness when standing up quickly), elevated blood pressure (hypertension), skin redness (rubefaction), hot flushes.

Respiratory, thoracic and mediastinal disorders: difficulty breathing (dyspnea), hoarseness, 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, urticaria, itching (pruritus), skin bleeding or bruising (Schönlein-Henoch purpura).

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

Renal and urinary disorders: darkening of urine, urinary retention or urinary incontinence.

Reproductive system 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.

Investigations: alterations in the results of various laboratory tests have occurred.

Injury, poisoning and procedural complications: falls.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sinemet Retard

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

Do not store above 25°C.

Store in the original packaging.

Do not use this medicine after the expiry date stated on the container after EXP.

The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of Sinemet Retard

• The active substances 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, poly (vinyl acetate-crotonic acid) copolymer, and magnesium stearate.

Appearance of the product and contents of the pack

The tablets are peach-coloured, oval-shaped, with the code "521" engraved on one side and a score line on the other.

Each pack contains 100 prolonged-release tablets.

Other presentations

Sinemet 25 mg/250 mg tablets. Packs of 60 and 120 tablets.

Sinemet Plus 25 mg/100 mg tablets. Pack of 100 tablets.

Sinemet Plus Retard 25 mg/100 mg prolonged-release tablets. Pack of 100 prolonged-release tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Manufacturer:

N.V. Organon

Kloosterstraat 6

5349 AB Oss

The Netherlands

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN - Haarlem

The Netherlands

Date of the most recent revision of this leaflet: May 2023

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