Sinogan 100 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Sinogan 100 mg film-coated tablets

levomepromazine, maleate

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, ask 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 any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Sinogan is and what it is used for

Levomepromazine is an antipsychotic drug belonging to the group of medicines known as phenothiazines, endowed with sedative properties, anxiety-reducing effects, strong analgesic activity, and a significant ability to induce sleep.

Always under the prescription of your doctor, this medicine is indicated for the treatment of:

• Schizophrenia, transient acute psychoses, and paranoid states, including manic psychoses, organic psychoses, and short-term treatment of prominent psychotic symptoms as part of a personality disorder.

• Adjunctive treatment for relief of delirium, agitation, nervousness, and confusion associated with pain in the terminal phase.

2. What you need to know before taking Sinogan

Carefully read the instructions provided in section 3 ("How to take Sinogan").

Do not take Sinogan

• if you are allergic to levomepromazine or any of the other components of this medicine (listed in section 6),

• if you have Parkinson's disease,

• if you have had porphyria (a blood disorder),

• if you are being treated with levodopa,

• in combination with alcoholic beverages.

Before and during chronic treatment, your doctor will request blood tests to monitor your liver function.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Sinogan

• If your body temperature rises inexplicably, contact your doctor immediately due to the risk of developing a condition called neuroleptic malignant syndrome, which has been described during treatment with this type of medicine. Symptoms include muscle rigidity, increased body temperature, and altered consciousness. Sweating and irregular pulse or blood pressure may be early warning signs. Although this syndrome occurs with this type of medicine, it is important to consider individual predispositions.

• If you have risk factors for stroke.

• If you develop fever, sore throat, infection, or mouth ulcers, your doctor will perform a blood test to rule out a possible decrease in a type of white blood cells called granulocytes, or an increase in another type of white blood cells, leukocytes. If this occurs, your doctor will discontinue treatment.

• If you have heart and/or circulatory problems.

• If you have liver and/or kidney disorders (hepatic and/or renal insufficiency).

• If you suffer from epileptic seizures. The risk of seizures may increase, so your doctor will monitor you closely and may perform an electroencephalogram.

• If your treatment is prolonged, your doctor may recommend an eye examination and blood tests.

• This type of medicine may increase the risk of cardiac rhythm disturbances (prolongation of the QT interval), which can be serious (torsades de pointes) and potentially fatal. Therefore, your doctor will perform necessary checks to rule out possible risk factors before starting treatment and, if needed, during treatment.

• Elderly patients are more likely to experience drowsiness and dizziness upon standing due to a drop in blood pressure. They may also be prone to chronic constipation and prostate problems.

• In elderly patients with psychosis related to dementia who are being treated with antipsychotics (possible increased risk of death).

• If you have risk factors for venous thromboembolism (blood clot formation) (see "Possible side effects").

• Contact your doctor immediately if you experience abdominal distension and pain (risk of paralytic ileus).

• Use with caution if you have constipation, hypothyroidism, heart failure, pheochromocytoma (a tumor of the adrenal gland), myasthenia gravis (a muscle disease causing drooping eyelids, double vision, difficulty speaking and swallowing, and sometimes muscle weakness in arms or legs), or prostate enlargement.

• Be aware of the risk of developing tardive dyskinesia (involuntary movements), even at low doses, particularly in children and elderly patients.

• If you have diabetes mellitus or risk factors for it, as you should monitor your blood glucose levels carefully while taking Sinogan.

• Liver function tests will be performed at the beginning of treatment due to the risk of overdose. During chronic treatment, tests should be repeated every 6–12 months.

Children and adolescents

Do not use in children under 3 years of age. Strict medical monitoring of adverse reactions, especially neurological ones, is recommended in children over 3 years of age treated with Sinogan.

In this population, Sinogan 40 mg/ml oral solution drops are recommended.

Due to potential impact on learning, a clinical examination is recommended once a year. The dose should be regularly adjusted according to the child's clinical condition. Use in children under 6 years of age should be managed in a specialized setting.

Taking Sinogan with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

As with other medicines used in the treatment of psychosis, if Sinogan and levodopa (a medicine used to treat Parkinson's disease) are taken together, their effects may cancel each other out. If movement disorders occur, your doctor will not prescribe or will replace levodopa with another medicine.

The use of dopaminergic medicines should be avoided with Sinogan. If a dopaminergic medicine needs to be discontinued, it should be tapered gradually (sudden withdrawal of dopaminergic agents exposes the patient to a risk of "neuroleptic malignant syndrome").

The use of cabergoline or quinagolide (medicines used to treat abnormal milk flow) should be avoided.

Inform your doctor if you are taking any of the following medicines, as they may prolong the QT interval (cause changes in your electrocardiogram). The risk of arrhythmias is higher when Sinogan is used with medicines that prolong the QT interval (certain antiarrhythmics, antidepressants, and other antipsychotics) and medicines that cause electrolyte imbalances.

Medicines that may prolong the QT interval:

• Antiarrhythmics (medicines for heart rhythm): quinidine, procainamide, amiodarone, mibefradil.
• Antibiotics: erythromycin, cotrimoxazole, trimethoprim-sulfamethoxazole, azithromycin, ketoconazole, pentamidine.
• Gastrointestinal motility agents: cisapride.
• Antihistamines (allergy medicines): terfenadine, astemizole.
• Hypolipidemics (cholesterol-lowering medicines): probucol.
• Other psychotropic agents (medicines affecting psychological state):
• tricyclic and tetracyclic antidepressants, haloperidol, and other phenothiazines.
• Other medicines: organophosphates and vasopressin.

Concomitant administration with antacids (salts, oxides, and hydroxides of aluminum, magnesium, and calcium) reduces the absorption of Sinogan. Therefore, it is recommended to take them at least two hours apart.

Taking Sinogan with medicines used to lower blood pressure (antihypertensives) increases their effect and the risk of low blood pressure upon standing, which may cause dizziness.

Medicines acting on the brain, such as tranquilizers, morphine derivatives (medicines for pain and cough), barbiturates, allergy medicines, sleep inducers, anxiety treatments, clonidine and related substances, methadone, and thalidomide, enhance the effect of Sinogan and may lead to respiratory depression.

Medicines used to treat depression (e.g., imipramine), allergy medicines acting on the brain, sedatives, some medicines for Parkinson's disease and spasms, and disopyramide, when taken with Sinogan, increase the risk of anticholinergic side effects such as urinary retention, constipation, dry mouth, etc.

There is a potential for interaction between CYP2D6 inhibitors such as phenothiazines (including levomepromazine) and CYP2D6 substrates. Therefore, if you are taking Sinogan together with any of the following medicines:

• Some antidepressants: amitriptyline/amitriptyline-N-oxide, clomipramine, desipramine, imipramine, fluoxetine, fluvoxamine, sertraline, paroxetine.
• Some medicines used to treat cardiac arrhythmias: encainide, flecainide, propafenone.
• Some medicines for treating hypertension: metoprolol, propranolol.
• Some cough medicines: codeine, dextromethorphan.
• Other medicines for treating psychosis: perphenazine.

A dose adjustment of these medicines may be needed due to increased blood levels.

Sinogan inhibits the antihypertensive effect of guanethidine.

Lithium: There is a risk of developing symptoms suggestive of neuroleptic malignant syndrome or lithium poisoning.

The combined use of proconvulsant medicines or those that lower the seizure threshold with Sinogan should be carefully evaluated due to the serious risk of seizures.

Taking Sinogan with food, drinks, and alcohol

Do not consume alcoholic beverages during treatment with Sinogan, as alcohol enhances sedation.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Sinogan is not recommended during pregnancy. Consult your doctor before taking this medicine:

• if you are a woman of childbearing age not using effective contraception,
• if you are pregnant, could become pregnant, or think you might be pregnant.

The following symptoms have been reported in newborns whose mothers were treated with Sinogan during the third trimester of pregnancy (last three months): tremors, muscle stiffness and/or muscle weakness, drowsiness, agitation, breathing difficulties, feeding problems at birth, slow or fast heart rate, abdominal distension, meconium ileus, delayed meconium passage, and constipation. If your baby develops any of these symptoms, contact your doctor immediately.

Breastfeeding

Do not take Sinogan if you are breastfeeding, as Sinogan passes into breast milk in small amounts.

A decision must be made whether to discontinue breastfeeding or discontinue treatment, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother.

A risk to breastfed infants cannot be excluded.

Fertility

In humans, levomepromazine may increase blood levels of the hormone prolactin (hyperprolactinemia), which may be associated with fertility problems in women.

Some data suggest that levomepromazine treatment may be associated with fertility problems in men.

Driving and using machines

Sinogan may cause symptoms such as drowsiness, dizziness, visual disturbances, disorientation, and confusion, and may reduce reaction ability. These effects, as well as the underlying illness, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities requiring special attention until your doctor has assessed your response to this medicine.

Sinogan contains gluten and lactose:

Gluten: This medicine contains very low levels of gluten (from wheat starch). It is considered "gluten-free," and it is very unlikely to cause problems if you have celiac disease. Sinogan 100 mg tablets contain no more than 9.0 micrograms of gluten.

If you have a wheat allergy (other than celiac disease), you should not take this medicine.

Lactose: This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Sinogan

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

When starting to take Sinogan, you should remain lying down for the hour following each dose. If your dose is high, it is important to monitor your blood pressure due to the risk of it dropping when you stand up.

Remember to take your medicine.

The recommended doses are as follows:

• in psychotic patients: the recommended dose is 1 to 2 tablets (100 to 200 mg of levomepromazine) daily, occasionally more, divided into 2 or 3 doses.
• in non-psychotic patients: the recommended dose is 1 to 3 tablets of Sinogan 25 mg (25 to 75 mg of levomepromazine) daily, divided into 2 or 3 doses.

Never change the dose prescribed by your doctor on your own. If you feel that the effect of Sinogan is too strong or too weak, inform your doctor or pharmacist.

Your doctor will advise you on the duration of your treatment with Sinogan. Do not stop your treatment prematurely.

If you take more Sinogan than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

Seek immediate medical advice or go to the nearest hospital. Symptoms of Sinogan poisoning may include seizures, severe parkinsonism, and even coma. Although there is no specific antidote, in cases of acute intoxication symptomatic treatment and administration of intravenous drugs to restore cardiac function are recommended.

If you forget to take Sinogan

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

4. Possible adverse effects

Like all medicines, Sinogan may cause adverse effects, although not everyone experiences them.

Uncommon (may affect up to 1 in 100 people)

Nervous system disorders:

• seizures

Vascular disorders:

• blood clot formation (venous thromboembolism)

Frequency not known (cannot be estimated from available data)

Endocrine disorders:

• difficulty regulating body temperature
• increased blood levels of a hormone called prolactin (hyperprolactinemia), which may lead to absence of menstrual periods (amenorrhea), abnormal milk secretion (galactorrhea), excessive breast enlargement in men (gynecomastia), and impotence.

Metabolism and nutrition disorders:

• glucose intolerance
• high blood glucose levels (hyperglycaemia)
• low sodium levels in blood (hyponatraemia)
• syndrome of inappropriate antidiuretic hormone secretion (fluid retention and decreased levels of certain electrolytes in the blood).

Psychiatric disorders:

• anxiety reactions
• mood changes
• confusion
• delirium.

Nervous system disorders:

• parkinsonism (with high and prolonged doses)

• sedation or drowsiness, especially at the beginning of treatment

• early dyskinesia (lack of coordination or movement difficulty, characterized by muscle contractions in the neck, eye, mouth, etc.)

• tardive dyskinesia (involuntary movements)

• extrapyramidal syndrome:

  • akinesia with or without hypertonia (loss of movement with or without muscle rigidity)
    • hyperkinetic – hypertonic movements (movements with muscle rigidity), motor excitement
    • akathisia (feeling of restlessness, both physically and mentally)

• neuroleptic malignant syndrome (see “Warnings and precautions”)

• anticholinergic effects such as paralytic ileus, risk of urinary retention, dry mouth, constipation, and ocular accommodation problems.

Cardiac disorders:

• torsades de pointes (a type of arrhythmia)
• electrocardiogram changes including QT interval prolongation, as seen with other neuroleptics
• cardiac arrhythmias which may lead to ventricular fibrillation or cardiac arrest, possibly dose-related.

Vascular disorders:

• blood clot formation that may affect the lungs (pulmonary embolism), which can sometimes be fatal
• deep vein thrombosis (see “Warnings and precautions”)
• drop in blood pressure upon standing up after sitting or lying down (postural hypotension).

Hepatic disorders:

• yellowing of eyes and skin (cholestatic jaundice)
• liver damage (hepatocellular, cholestatic, and mixed types).

Skin disorders:

• increased skin sensitivity to sunlight
• allergic skin reactions.

Genitourinary disorders:

• erection in the absence of sexual desire (priapism).

Eye disorders:

• decreased eye muscle tone
• brown-colored deposits in the anterior segment of the eye caused by drug accumulation, generally without effect on vision.

Investigations:

• weight gain

General disorders and administration site conditions:

• sudden death with possible cardiac causes (see “Warnings and precautions”)
• unexplained sudden death in patients receiving phenothiazine neuroleptics.

Blood disorders:

• general decrease in white blood cell count (leucopenia)
• decrease in a type of white blood cells called granulocytes (agranulocytosis)
• thrombocytopenia, which is a decrease in the number of platelets (blood cells that help with clotting) observed in blood tests, potentially leading to bleeding and bruising (thrombocytopenic purpura)
• eosinophilia, which is an increase in the number of eosinophils (a type of white blood cells) observed in blood tests.

Gastrointestinal disorders:

• inflammation of the small intestine and colon which may be fatal (necrotizing enterocolitis)
• constipation
• intestinal obstruction (paralytic ileus).

Pregnancy, puerperium and perinatal conditions:

• withdrawal symptoms in newborns (see “Pregnancy, breastfeeding and fertility”).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect 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 Sinogan

Keep this medicine out of sight and reach of children.

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Sinogan

• The active substance is levomepromazine. Each tablet contains 100 mg of levomepromazine (as maleate).
• The other components are: wheat starch (contains gluten), lactose, levilite, dextrin, magnesium stearate. Coating: hypromellose, polyethylene glycol, deionized water and ethanol.

Appearance of the product and contents of the pack

The tablets are white, round, with a score on one side and engraved with 'Sinogan 100'; the other side is smooth.

Each pack contains 20 tablets.

Marketing Authorization Holder and Manufacturer

Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Manufacturer:

Famar Health Care Services Madrid, S.A.U.

Avda. de Leganés nº 62

28923 Alcorcón (Madrid)

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

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