SINEMET RETARD 50 mg/200 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Sinemet Retard 50 mg/200 mg prolonged-release tablets

carbidopa/levodopa

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

1. What Sinemet Retard is and what it is used for
2. What you need to know before you take Sinemet Retard
3. How to take Sinemet Retard
4. Possible side effects
5. Storing 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 been previously treated with levodopa/decarboxylase inhibitors, or with levodopa alone and who have experienced motor fluctuations.

Experience with Sinemet Retard in patients who have not been previously 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 acts by replacing dopamine in the brain, while carbidopa ensures that enough levodopa reaches the brain when it is needed. In many patients, this reduces the symptoms of Parkinson's disease. The Sinemet Retard formula helps to keep the amount of levodopa in the body as long as possible.

Parkinson's disease is a chronic disease characterized by slow and unstable movements, muscle stiffness, and tremors. If left untreated, it can cause difficulties in leading a normal life.

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

2. What you need to know before you take 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 monoamine oxidase inhibitor (MAOI) antidepressants (except for certain low doses of MAOI Type B inhibitors).
• if you have narrow-angle glaucoma (high 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 disorders, lung, liver, kidney, heart, or hormonal problems, peptic ulcer, seizures, high intraocular pressure (glaucoma).
• if you require general anesthesia, treatment with this medicine may continue while you are able to take medication orally. If treatment needs to be temporarily interrupted, Sinemet Retard can be restarted as soon as you can take oral medication.
• if you are receiving treatment with medicines to lower blood pressure.
• if you suddenly fall asleep during the day (sudden sleep episodes) or experience excessive drowsiness (somnolence) during the day.

Tell your doctor if you, or your family member/caregiver, notice that you are developing symptoms similar to addiction, leading to a desire for high doses of Sinemet Retard and other medicines used to treat Parkinson's disease.

Tell your doctor if you, or your family member/caregiver, notice that you are starting to behave abnormally, if you feel the impulse, initiative, or temptation to harm others or yourself.

These behaviors are called impulse control disorders and may include addiction to gambling, eating, or spending excessively, increased sexual desire, or an increase in thoughts or desires for sex. Your doctor may need to review your treatments.

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

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

Children and adolescents

The safety and efficacy of Sinemet Retard in this population have not been established, and its use is not recommended in children 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 use any other medicines.

This medicine should be administered with caution with the following medicines:

medicines used to treat psychiatric problems or depression, tuberculosis, high blood pressure, 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 medicines that you should avoid 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 with a high-protein diet. It is therefore recommended to avoid taking the tablets with heavy meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 sleep episodes. If this happens, do not drive vehicles or perform activities where a lack of attention may pose a risk or put you or others in danger of death or serious injury (e.g., using machines), until such episodes and/or drowsiness have disappeared.

3. How to take Sinemet Retard

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The optimal daily dose of this medicine is variable and should be determined by individual dose adjustment for each patient according to 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 disease, such as abnormal movements, as this may require an adjustment of your prescription.

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

To get the best results, you should take Sinemet Retard every day. It is important that you follow your doctor's advice on the amount and frequency you should take Sinemet Retard.

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

If you think that the action of Sinemet Retard is too strong or too weak, tell 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 Toxicology Information Service, phone: 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 tablet, take it as soon as you remember. However, if it is almost time for the next dose, do not take the missed dose and wait until the next dose.

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

If you stop taking Sinemet Retard

Your doctor will tell you how long to take 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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

There have been reports of gambling addiction and increased sexual desire for medicines that increase the action of a chemical substance called dopamine in the body, including Sinemet Retard.

You may experience the following side effects:

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

• 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.
• altered or increased sexual interest and behavior towards yourself or others, for example, an increase in sexual desire.
• uncontrolled and excessive 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).

Tell your doctor if you experience any of these behaviors, as they will look for ways to control or reduce the 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: decreased white blood cells (leucopenia) and platelets (thrombocytopenia), decreased red blood cell count (anemia, both hemolytic and non-hemolytic), 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 changes, sleep disturbances (insomnia, nightmares), euphoria, depression, hallucinations, and delusional ideas, confusion, agitation, and anxiety, unconscious teeth grinding (bruxism), increased sexual behavior, gambling addiction.

Nervous system disorders: malignant neuroleptic syndrome, lack of coordination (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, fainting, headache, feeling of stimulation, drowsiness, lethargy, sedation, narcolepsy episodes, dementia, epilepsy (seizures), decreased mental acuity.

Eye disorders: blurred vision, double vision (diplopia), pupil dilation (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), flushing (rubefaction), hot flashes.

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

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

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

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

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

Reproductive system and breast disorders: prolonged erection of the penis (priapism).

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

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

Accidents, poisonings, and complications of surgical and medical care: falls.

Reporting of side effects

If you experience any side effects, consult 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: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Sinemet Retard

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

Do not store above 25°C.

Store in the original package.

Do not use this medicine after the expiry date which is stated on the carton after EXP.

The expiry date is the last day of the month stated.

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. Contents of the pack and other information

Composition of Sinemet Retard

• The active substances are 50 mg of anhydrous carbidopa and 200 mg of levodopa.
• The other ingredients are red iron oxide (E-172), aluminum lake of quinoline yellow (E-104), hydroxypropylcellulose, copolymer of poly (vinyl acetate-vinylpyrrolidone), and magnesium stearate.

Appearance and packaging of the product

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

Each pack contains 100 prolonged-release tablets.

Other presentations

Sinemet 25 mg/250 mg tablets. Pack 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

Phone: 915911279

Manufacturer:

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN - Haarlem

Netherlands

Date of last revision of this leaflet:May 2023

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