SINOGAN 40 mg/ml ORAL DROPS IN SOLUTION

Introduction

Patient Information: Summary of Product Characteristics

Sinogan 40 mg/ml Oral Drops in Solution

Levomepromazine, Hydrochloride

Read this entire leaflet carefully before starting to take this medication, as 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 medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet:

1. What is Sinogan and what is it used for
2. What you need to know before taking Sinogan
3. How to take Sinogan
4. Possible side effects
5. Storage of Sinogan
6. Package contents and additional information

1. What is Sinogan and what is it used for

Levomepromazine is an antipsychotic medication belonging to the group of medications known as phenothiazines, with sedative properties, anxiety reduction, significant pain relief, and important sleep induction.

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

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

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

2. What you need to know before taking Sinogan

Read carefully the instructions provided in section 3 (see "How to take Sinogan").

Do not take Sinogan

• if you are allergic to levomepromazine or any other component of this medication (listed in section 6),
• if you have Parkinson's disease,
• if you have had porphyria (blood disease),
• if you are being treated with levodopa,
• in combination with alcoholic beverages.

Warnings and precautions

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

Consult your doctor or pharmacist before starting to take Sinogan.

• If your body temperature rises inexplicably, consult your doctor immediately, due to the risk of developing a syndrome called neuroleptic malignant syndrome, described during treatment with this type of medication, whose effects include muscle rigidity, increased body temperature, and altered consciousness. Sweating and irregular pulse or blood pressure may be early warning signs. Although this syndrome appears with this type of medication, it should be taken into account that there may be patients with some predisposition.
• If you have risk factors for suffering a stroke.
• In case of fever, sore throat, infection, or the appearance of ulcers in the mouth, your doctor will perform a blood test to rule out a possible decrease in a type of white blood cell, granulocytes, or an increase in another type of white blood cell, leukocytes. If this happens, your doctor will suspend treatment.
• If you have heart problems and/or blood circulation problems.
• If you have liver and/or kidney disorders (hepatic and/or renal insufficiency).
• If you suffer from epileptic seizures. It may increase the risk of their appearance, so your doctor will subject you to special control, performing an electroencephalogram.
• If your treatment is prolonged, your doctor may recommend an eye exam and a blood test.
• This type of medication can potentiate the appearance of cardiac rhythm alterations (prolongation of the QT interval) that can be serious (torsades de pointes) and cause death. Therefore, your doctor will perform the necessary checks to exclude possible risk factors before starting treatment and, if necessary, during it.

• Elderly patients are more likely to suffer from drowsiness and dizziness when getting up due to a decrease in blood pressure. They may also be susceptible to chronic constipation and prostate problems.

• In elderly patients with psychosis related to dementia, who are being treated with antipsychotics (possibility of presenting a higher risk of death).
• If you have risk factors for suffering from venous thromboembolism (blood clot formation) (see "Possible side effects").
• Consult your doctor immediately if you suffer from abdominal distension and pain (risk of paralytic ileus).
• It should be used with caution in case of constipation, hypothyroidism, heart failure, pheochromocytoma (you have a tumor of the adrenal gland), myasthenia gravis (muscular disease that causes drooping eyelids, double vision, difficulty speaking and swallowing, and sometimes muscle weakness in arms or legs), and prostate hypertrophy.
• It should be taken into account the risk of appearance of 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 adequately control your blood glucose levels if you take Sinogan.
• At the start of treatment, liver function tests will be performed due to the risk of overdose. During chronic treatment, exams will be performed every 6-12 months.

Children and adolescents

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

In this population, it is recommended to use Sinogan 40 mg/ml oral drops in solution.

Due to the impact on learning, a clinical examination is recommended once a year. The dose will be regularly adjusted according to the child's clinical condition. Its use in children under 6 years of age will be carried out in a specialized environment.

Using Sinogan with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Like other medications used in the treatment of psychoses, if Sinogan and levodopa (medication used to treat Parkinson's disease) are administered together, the effect of these medications may be canceled. In case of movement disorders, your doctor will not prescribe, or will substitute levodopa with another medication.

The use of dopaminergic medications with Sinogan should be avoided. In case of needing to withdraw a dopaminergic medication, it should be gradually reduced (sudden interruption of dopaminergic agents exposes the patient to a risk of "neuroleptic malignant syndrome").

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

Tell your doctor if you are taking any of these medications, as they may prolong the QT interval (produce changes in your electrocardiogram). There is a higher risk of arrhythmias when using Sinogan with medications that prolong the QT interval (certain antiarrhythmics, antidepressants, and other antipsychotics) and medications that cause electrolyte imbalance.

Medications that may prolong the QT interval:

• Antiarrhythmics (medications for heart rhythm): quinidine, procainamide, amiodarone, mibefradil.
• Antibiotics: erythromycin, cotrimoxazole, trimethoprim-sulfamethoxazole, azithromycin, ketoconazole, pentamidine.
• Medications that act on gastrointestinal motility: cisapride.
• Antihistamines (medications for allergies): terfenadine, astemizole.
• Hypolipidemics (medications to lower cholesterol levels): probucol.
• Other psychotropic agents (medications that improve your psychological state): tricyclic and tetracyclic antidepressants, haloperidol, and other phenothiazines.
• Other medications: organophosphates and vasopressin.

The concomitant administration of Sinogan with antacids (salts, oxides, and hydroxides of aluminum, magnesium, and calcium) produces a decrease in the absorption of Sinogan. Therefore, it is recommended to take them at least 2 hours apart.

The administration of Sinogan with medications used to lower blood pressure (antihypertensives) increases the effect of these and the risk of decreased blood pressure when standing up, which can cause dizziness.

Medications that act on the brain, such as tranquilizers, morphine derivatives (medications for pain and cough treatment), barbiturates, medications for allergy treatment, sleep inducers, medications for anxiety treatment, clonidine, and related substances, methadone, and thalidomide, enhance the effect of Sinogan, which can lead to respiratory depression.

Medications for depression treatment (such as imipramine), medications for allergy treatment that act on the brain, sedatives, some medications for Parkinson's disease treatment, and spasm, and disopyramide, when administered concomitantly with Sinogan, increase the appearance of atropine-like adverse reactions such as urinary retention, constipation, dry mouth, etc.

There is a possibility of interaction between CYP2D6 inhibitors, such as phenothiazines (including levomepromazine), and CYP2D6 substrates. Therefore, if you take Sinogan with any of the following medications:

• Certain antidepressants: amitriptyline/amitriptylinoxide, clomipramine, desipramine, imipramine, fluoxetine, fluvoxamine, sertraline, paroxetine.
• Certain medications for cardiac arrhythmia treatment: encainide, flecainide, propafenone.
• Certain medications for hypertension treatment: metoprolol, propranolol.
• Certain medications for cough treatment: codeine, dextromethorphan.
• Other medications for psychosis treatment: perphenazine.

You may need a dose adjustment of these medications due to an increase in their 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 medications or those that decrease the epileptic threshold with Sinogan should be carefully weighed due to the severity of the risk of seizure appearance.

Taking Sinogan with food, drinks, and alcohol

Do not consume alcoholic beverages during treatment with Sinogan, as the effect of alcohol potentiates sedation.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

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

• if you are a woman of childbearing age who does not use effective contraceptives
• if you are pregnant, may become pregnant, or think you may be pregnant.

The following symptoms have been reported in newborns of mothers treated with Sinogan during the third trimester of pregnancy (last three months of pregnancy): tremors, muscle rigidity and/or weakness, drowsiness, agitation, breathing and feeding problems at the start, slow or fast heartbeat, abdominal distension, meconial ileus, delayed meconium elimination, and constipation. If your baby develops any of these symptoms, you should contact your doctor.

Breastfeeding

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

A decision should be made to either discontinue breastfeeding or discontinue treatment, considering the benefit of breastfeeding for the child and the benefit of treatment for the mother.

A risk to breastfed children cannot be excluded.

Fertility

In humans, levomepromazine may produce an increase in prolactin levels in the blood (hyperprolactinemia) that may be associated with fertility problems in women.

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

Driving and using machines

Sinogan may produce symptoms such as drowsiness, dizziness, or vision changes, and reduce your reaction ability. These effects, as well as the disease itself, may impair your ability to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor assesses your response to this medication.

Sinogan contains ethanol and sucrose:

• Etanol. This medication contains 122 mg of alcohol (ethanol) per ml, which is equivalent to 12.2% p/v. The amount in ml of this medication is equivalent to less than 3.05 ml of beer or 1.22 ml of wine.

The small amount of alcohol in this medication does not produce any noticeable effect.

• Sucrose. This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. It may cause cavities.

3. How to take Sinogan

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

In order to facilitate and obtain a correct dosage, the bottle has a built-in dropper.

The bottle should be inverted to obtain the indicated dose.

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

Remember to take your medication.

The recommended doses are as follows:

• in psychotic patients: the recommended dose is 100 to 200 drops (100 to 200 mg of levomepromazine) per day, sometimes more, divided into 2 or 3 doses.
• in non-psychotic patients: the recommended dose is 25 to 75 drops (25 to 75 mg of levomepromazine) per day, divided into 2 or 3 doses.

The dose in children will be 0.5 to 2 mg/kg/day in 2 or 3 daily doses with meals (see "Warnings and precautions"). The dose should not exceed 40 mg per day in children under 12 years of age.

Never change the dose that your doctor has prescribed for you. If you think the effect of Sinogan is too strong or too weak, tell your doctor or pharmacist.

Your doctor will indicate the duration of your treatment with Sinogan. Do not stop your treatment before.

If you take more Sinogan 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 medication and the amount ingested.

Consult your doctor immediately or go to the nearest hospital. The symptoms of a Sinogan overdose can be convulsions, severe parkinsonian syndrome, and even coma. Although there is no specific antidote, in case of acute overdose, it is recommended to treat the symptoms and administer medications that restore cardiac activity intravenously.

If you forget to take Sinogan

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

4. Possible Adverse Effects

Like all medicines, Sinogan can produce adverse effects, although not all people suffer from 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) that could lead to lack of menstrual period (amenorrhea), unusual milk secretion (galactorrhea), excessive breast volume in men (gynecomastia), and impotence.

Metabolic and Nutritional Disorders:

• glucose intolerance
• high blood glucose levels (hyperglycemia)
• low blood sodium levels (hyponatremia)
• syndrome of inadequate secretion of antidiuretic hormone (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 start of treatment,
• early dyskinesia (incoordination or difficulty moving, characterized by contraction of neck, eye, mouth,... muscles)
• late dyskinesia (involuntary movements)

• extrapyramidal syndrome:
  • akinesia with or without hypertonia (loss of movement with or without muscle stiffness),
  • hyperkinetic - hypertonic movements (movements with muscle stiffness), motor excitement
  • akathisia (feeling of restlessness both physically and mentally)

• malignant neuroleptic syndrome (see "Warnings and Precautions").
• anticholinergic effects such as paralytic ileus, risk of urinary retention, dry mouth, constipation, eye accommodation problems,

Cardiac Disorders:

• Torsades de Pointes (a type of arrhythmia)
• changes in the electrocardiogram that include prolongation of the QT interval as occurs with other neuroleptics
• cardiac arrhythmias that can lead to ventricular fibrillation or cardiac arrest possibly related to the dose.

Vascular Disorders:

• blood clot formation (venous thromboembolism) that can affect the lungs (pulmonary embolism), which can sometimes be fatal
• deep vein thrombosis (see "Warnings and Precautions")
• decrease in blood pressure when standing up from sitting or lying down (postural hypotension).

Hepatic Disorders:

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

Skin Disorders:

• increased skin sensitivity to the sun
• allergic reactions on the skin.

Genital Disorders:

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

Eye Disorders:

• decrease in eye muscle tension
• brown deposits in the anterior segment of the eye caused by the accumulation of medication and generally without effect on vision.

Complementary Examinations:

• weight gain

General Disorders and Administration Site Conditions

• sudden death with possible cardiac causes (see "Warnings and Precautions")
• sudden unexplained death in patients receiving phenothiazine neuroleptics.

Blood Disorders:

• decrease in the number of white blood cells in general (leukopenia)
• decrease in a type of white blood cell, granulocytes (agranulocytosis).
• Thrombocytopenia, which is a decrease in the number of platelets (blood cells that help with clotting) found in a blood test, which can lead to bleeding and bruising (thrombocytopenic purpura).
• Eosinophilia, which is an increase in the number of eosinophils (a type of white blood cell) found in a blood test.

Digestive Disorders:

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

Pregnancy, Puerperium, and Perinatal Disorders:

• withdrawal symptoms in newborns (see "Pregnancy, Breastfeeding, and Fertility").

Reporting of Adverse Effects

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

5. Storage of Sinogan

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

Do not store above 25 ºC. Keep in the original packaging to protect it from light.

After opening Sinogan for the first time, it must be used within 6 months.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medicines at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Sinogan 40 mg/ml Oral Drops in Solution

• The active ingredient is levomepromazine. Each ml contains 40 mg of levomepromazine (in the form of hydrochloride). 1 drop is equivalent to 1 mg of levomepromazine.
• The other components are: monohydrated citric acid, ascorbic acid, sucrose, glycerol (E-422), ethanol, orange essence, vanillin, ammoniacal caramel, and purified water.

Solution at 4% in a 30 ml bottle.

Appearance of the Product and Package Contents

Sinogan 40 mg/ml Oral Drops in Solution is an oral solution of brown color. It is presented in a glass bottle with 30 ml.

Marketing Authorization Holder and Manufacturer

Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Manufacturer:

Lichtenheldt GmbH Pharmazeutische Fabrik

Industriestrasse 7-11, Wahlstedt, Schleswig-Holstein,

23812 Germany

Neuraxpharm Pharmaceuticals S.L.

Avenida. de Barcelona 69

Sant Joan Despí, 08970

Barcelona, Spain

Nattermann & Cie. GmbH

Nattermannalle 1

50829 (Cologne) Germany

Date of the Last Revision of this Prospectus: July 2025

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