ETUMINA 40 mg TABLETS

2. What you need to know before you take Etumina

Do not take Etumina

• if you are allergic to clotiapine or any of the other ingredients of this medicine listed in section 6.
• if you have a coma or severe central nervous system depression (sedation or decreased consciousness).

Warnings and precautions

Consult your doctor or pharmacist before taking 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 (increased pressure in the eye),
• if you have intestinal obstruction,
• if you have been diagnosed with epilepsy or any brain injury,
• in case of dementia, you or your caregiver should inform your doctor if you have had a stroke or have a history of blood flow problems in the brain, especially if you are elderly,
• if you have orthostatic hypotension (decreased blood pressure when standing up),
• if you have a heart problem called QT interval prolongation,
• if you or a family member has or has had blood clotting problems (thromboembolism),
• if you have had or have altered white blood cell count (neutropenia),
• if you have high blood sugar (hyperglycemia) or diabetes,
• if you have an increased level of prolactin in the blood (hyperprolactinemia), including absence of menstruation (amenorrhea) and milk secretion from the breast not associated with lactation (galactorrhea),
• if you have Parkinson's disease,
• as with other antipsychotic medications, neuroleptic malignant syndrome (a potentially fatal complication) may occur, characterized by high fever, muscle stiffness, nervous system instability, and increased creatine phosphokinase. In 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.

Caution should be exercised when administering Etumina to elderly patients with heart, lung, or dementia problems, as they are at higher risk of experiencing side effects.

Other medicines and Etumina

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Etumina may increase the effects of the following medicines:

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

It may also increase the toxicity of lithium.

As with other antipsychotic medications, Etumina should be administered with special caution if you are taking other medicines that prolong the QT interval (alteration of the electrocardiogram) or cause electrolyte imbalance.

Taking Etumina with food, drinks, and alcohol

Avoid alcoholic beverages. Alcohol enhances the sedative effect.

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 medicine.

Clotiapine should only be administered during pregnancy or breastfeeding when the expected benefit outweighs the potential risks to the fetus. Therefore, in case of pregnancy or breastfeeding, only take this medicine if prescribed by your doctor and always follow their instructions.

Driving and using machines

Etumina may cause effects such as drowsiness, dizziness, or vision changes, and may decrease your reaction ability. These effects, as well as the underlying illness, 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 evaluates your response to this medicine.

Etumina contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Etumina

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 recommended initial dose is 3 to 5 tablets (120 to 200 mg/day) divided into 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 maintenance and long-term treatment, your doctor may reduce the initial dose. The recommended dose is half a tablet to 4 tablets (20 to 160 mg/day) divided into 2 or 3 doses.

Maintenance treatment can be prolonged for weeks or even months.

Use in children and adolescents under 18 years

The efficacy and safety of this medicine in children under 18 years have not been established.

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

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

Method of administration

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

If you take more Etumina than recommended, the following effects may occur: drowsiness, low blood pressure, rapid heartbeat, irregular heartbeat, difficulty breathing, movement and body position changes, convulsions, coma.

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 ingested.

If you forget to take Etumina

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

4. Possible side effects

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

The side effects that have been reported with the use of Etumina are the following:

• Agitation
• Confusion
• Involuntary 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

There have been reports of Neuroleptic Malignant Syndrome, characterized by muscle stiffness, high fever, altered consciousness, increased blood pressure, and excessive salivation.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Etumina

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

Store below 25°C.

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

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Etumina

• The active substance is clotiapine. Each tablet contains 40 mg of clotiapine.
• The other ingredients are magnesium stearate, talc, liquid paraffin, anhydrous colloidal silica, gelatin, microcrystalline cellulose, cornstarch, and lactose.

Appearance and packaging of the product

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

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratoires Juvisé Pharmaceuticals

149 boulevard Stalingrad

69100 Villeurbanne

France

Manufacturer

Delpharm L'Aigle

Zone Industrielle nº1

Route de Crulai

61300 L'Aigle

France

Date of the last revision of this leaflet:November 2020

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