SINEMET PLUS RETARD 25 mg/100 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Sinemet Plus Retard 25 mg/100 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 experience 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 Plus Retard is and what it is used for
2. What you need to know before you take Sinemet Plus Retard
3. How to take Sinemet Plus Retard
4. Possible side effects
5. Storage of Sinemet Plus Retard
6. Contents of the pack and other information

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

Sinemet Plus Retard is a prolonged-release tablet formulation indicated for the treatment of idiopathic Parkinson's disease, in particular 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 Plus Retard in patients who have not been treated with levodopa before is limited.

Sinemet Plus Retard contains two active substances: levodopa and carbidopa and belongs to the 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 Plus Retard formula helps to keep the amount of levodopa in the body for 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 Plus Retard

Do not take Sinemet Plus 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 monoamine oxidase (MAO) inhibitor group (except for certain low doses of MAO 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 Plus 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 Plus 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 episodes of sleep) 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 Plus 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 Plus Retard in this population have not been established and its use is not recommended in children under 18 years of age.

Taking Sinemet Plus 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, 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 medicines that you should avoid while taking Sinemet Plus Retard.

Taking Sinemet Plus 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 Plus Retard, passes into breast milk.

Driving and using machines

This medicine may cause drowsiness and sudden episodes of sleep. 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., use of machines), until such episodes and/or drowsiness have disappeared.

3. How to take Sinemet Plus 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. Immediately inform your doctor of any changes in your disease, such as abnormal movements, as this may require an adjustment of your prescription.

Do not split the Sinemet Plus Retard tablets. To maintain the prolonged-release properties of the product, the tablets should not be chewed or crushed.

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

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

If you think the action of Sinemet Plus Retard is too strong or too weak, tell your doctor or pharmacist.

If you take more Sinemet Plus Retard than you should

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

If you forget to take Sinemet Plus Retard

Take Sinemet Plus 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 Plus Retard

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

If you have any further questions about 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.

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

You may experience the following side effects:

• desire for high doses of Sinemet Plus 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 Plus Retard. Frequency not known (cannot be estimated from 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 necessary to satisfy your hunger).

Tell your doctor if you experience any of these behaviors, as they will seek 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, 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 changes (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, 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 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, general malaise.

Investigations: alterations in the results of several 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, talk to your doctor or pharmacist. This includes any 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. Storage of Sinemet Plus 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 shown.

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 Plus Retard

• The active substances are 25 mg of anhydrous carbidopa and 100 mg of levodopa.
• The other ingredients are red iron oxide (E-172), hydroxypropylcellulose, polyvinyl acetate-crotonic acid copolymer, and magnesium stearate.

Appearance of the product and pack contents

The tablets are pink, oval-shaped, with one smooth face and the code "601" on the other face.

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 Retard 50 mg/200 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:

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN - Haarlem

Netherlands

Date of the 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/