Leaflet:information for the user

Etumina 40 mg tablets

Clotiapine

Read this 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 yourdoctor orpharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Etumina is and for what it is used

2.What you need to knowbeforestarting totake Etumina

3.How to take Etumina

4.Possible side effects

5Storage of Etumina

6.Contents of the pack and additional information

Etimina belongs to a group of medications called antipsychotics.

Etimina is used for the acute or chronic treatment of schizophrenia, which is a disease by which you may hear or feel things that are not there, believe things that are not true, or feel abnormally suspicious, anxious, confused, guilty, tense, or depressed.

Etimina may also be used to treat other psychotic disorders.

Do not take Etumina

• if you are allergic to clozapine or any of the other components of this medication listed in section 6.
• in case of coma or severe depression of the central nervous system (sedation or decrease in consciousness).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Etumina.

Your doctor will closely monitor your treatment with Etumina:

• if you have any prostate disease with difficulty urinating (prostatic hypertrophy),
• if you have a disease called narrow-angle glaucoma (increase in eye pressure),
• if you have intestinal blockage,
• if you have been diagnosed with epilepsy or any brain injury,
• in case of dementia, you or your caregiver must inform your doctor if you have suffered a stroke or have a history of cerebral blood flow problems, especially if you are advanced in age,
• if you have orthostatic hypotension (decrease in blood pressure when standing),
• if you have a heart problem called QT interval prolongation,
• if you or a family member has or has had problems due to blood clot formation (thromboembolism),
• if you have altered white blood cell count (neutropenia),
• if you have high blood sugar (hyperglycemia) or diabetes,
• if you have an increase in prolactin hormone in the blood (hyperprolactinemia), including absence of menstruation (amenorrhea) and non-lactational milk secretion (galactorrhea),
• if you have Parkinson's disease,
• like other antipsychotic medications, Etumina may cause malignant neuroleptic syndrome (a complication that can be fatal) characterized by high fever, muscle rigidity, nervous system alteration (autonomic instability), and increase in an enzyme called creatine phosphokinase. In the case of high fever, all antipsychotic medications should be discontinued.

Use in elderly patients

In elderly patients, it is advisable to closely monitor blood pressure.

Care should be taken when administering Etumina to elderly patients with heart, lung, or dementia problems, as they have a higher risk of experiencing adverse effects.

Other medications and Etumina

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

Etumina may increase the effects of the following medications:

• medications that act on your brain such as sedatives (used for sleep), narcotics (for severe pain), analgesics (for pain and fever), hypnotics (used for sleep), MAO inhibitors (a type of antidepressant), and antihistamines (used for allergies and colds)
• medications to treat high blood pressure

It may also increase the toxicity of lithium.

Like other antipsychotic medications, Etumina should be administered with special caution if you take other medications that prolong the QT interval (electrocardiogram alteration) or cause electrolyte imbalance.

Taking Etumina with food, drinks, and alcohol

Avoid alcoholic beverages. Alcohol potentiates the sedative effect.

Pregnancy, breastfeeding, and fertility

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

Clozapine should only be administered during pregnancy or breastfeeding when the expected benefit outweighs the potential risks for the fetus. Therefore, in case of pregnancy or breastfeeding, you should only take this medication if your doctor prescribes it and always follow their instructions.

Driving and operating machinery

Etumina may cause effects such as drowsiness, dizziness, or visual disturbances, and may decrease your reaction time. These effects, as well as the underlying disease, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention until your doctor assesses your response to this medication.

Etumina contains lactose

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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

The recommended initial dose is 3 to 5 tablets (120 to 200 mg/day) taken in 2-3 doses. The daily oral dose may be increased up to a maximum of 360 mg (9 tablets) in cases of excitement/agitation.

For long-term and maintenance treatment, your doctor may reduce the initial dose. The recommended dose is half a tablet to 4 tablets (20 to 160 mg/day) taken in 2 or 3 doses.

Maintenance treatment may be prolonged for weeks or even months.

Use in children and adolescents under 18 years

The efficacy and safety of this medication have not been established in individuals under 18 years.

Use in patients with renal insufficiency, hepatic insufficiency, elderly patients (65 years and older) or patients with low body weight

Your doctor may prescribe a lower dose than usual and increase it gradually if necessary.

Administration form

The tablet can be divided into equal doses.

The tablets should be taken orally with a glass of water.

If you take more Etumina than you should

In case of taking more Etumina than recommended, the following effects may occur:drowsiness, low blood pressure, rapid heart rate, irregular heartbeat, difficulty breathing, movement and body position disturbances, seizures, coma.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Etumina

If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, wait until then. Do not take a double dose to make up for the missed dose.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The adverse effects that have been reported with the use of Etumina are as follows:

• Agitation
• Confusion
• Uncontrolled movements of the lower face and neck, unusual movements, sustained muscle contractions, inability to remain still, tremors, sedation
• Blurred vision
• Dizziness when standing up
• Dry mouth
• Constipation

Cases of Malignant Neuroleptic Syndrome have been reported, characterized by muscle rigidity, high fever, altered consciousness, increased blood pressure, and excessive salivation.

Reporting 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 System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Store below 25°C.

Do not usethis medicationafter the expiration date that appears on the packagingafter CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, please ask your pharmacisthow to dispose ofthepackaging and unusedmedications. By doing so, you will help protect the environment.

Composition of Etumina

-The active principle is clotiapine. Each tablet contains 40 mg of clotiapine.

-The other components are magnesium stearate, talc, liquid paraffin, anhydrous colloidal silica, gelatin, microcrystalline cellulose, cornstarch, and lactose.

Appearance of the product and content of the container

Etumina is presented in the form of round, flat, bisected-edge tablets, white to yellowish in color, and with a mark on one of the faces.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratoires Juvisé Pharmaceuticals

149 boulevard Stalingrad

69100 Villeurbanne

France

Responsible for manufacturing

Delpharm L´Aigle

Zone Industrielle nº1

Route de Crulai

61300 L´Aigle

France

Last review date of thisleaflet:November 2020

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