Package Insert: Information for the User

Decentán 8 mg Tablets

Perphenazine

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Decentán is a medication whose active ingredient is perphenazine – a derivative of phenothiazine – which belongs to the group of medications known as antipsychotics.

It is indicated for the treatment of acute psychotic syndromes, catatonic syndromes, delirium, and other exogenous psychotic syndromes, and psychomotor agitation.

Do not takeDecentán

• If you are allergic to perphenazine or any of the other ingredients in this medication (listed in section 6).
• If you have severe depression.
• In cases of coma.
• In cases of alcohol intoxication and/or with hypnotic, tranquilizing, and antidepressant medications.
• If you have severe blood cell disorders (e.g., low white blood cell count) or bone marrow diseases.
• If you have severe liver diseases.
• If you have heart diseases, slow heart rate, certain electrocardiogram abnormalities, or other heart disorders (congenital long QT syndrome, coronary artery disease, conduction disorders-arrhythmias).
• If you are taking other medications that also cause electrocardiogram abnormalities (prolongation of the QT interval).

Warnings and precautions

• If you have low potassium levels in your blood. If you are taking other medications that cause low potassium levels in the blood and/or increased perphenazine levels in the blood.
• If you have severe low blood pressure or orthostatic circulatory problems (related to sudden changes in position).
• If you have any blood-related diseases.
• In patients with a risk of venous thromboembolism (disease of the blood vessels related to the formation of a clot that blocks them).
• If you take high doses of Decentán and are especially sensitive to this medication, as you may experience certain types of arrhythmias.
• If you have kidney diseases.
• If you have been diagnosed with a chest tumor.
• If you have pheochromocytoma (a certain type of kidney tumor).
• If you have any liver diseases.
• If you have thyroid-related diseases.
• If you have chronic respiratory problems and asthma.
• If you have gastrointestinal stenosis (narrowing in some point of the esophagus, stomach, or intestines).
• If you have angle-closure glaucoma (eye disease that causes increased pressure inside the eyes).
• If you have prostate problems.
• Older patients with significant deterioration of their general condition. Note that Decentán is not indicated for the treatment of conduct disorders associated with dementia (brain disorder that causes memory loss, affects language and attention capacity, among others) and extreme caution should be exercised, especially in elderly patients with dementia (possibility of increased risk of death).
• Extreme caution should be exercised if Decentán is administered to patients with risk factors related to adverse cerebrovascular events (e.g., vascular brain disease or embolism) and especially if they have dementia.
• If you have any brain damage (e.g., Parkinson's disease).
• If you have or have had epilepsy.
• If you have depression.
• If you experience fever and muscle rigidity while taking Decentán, contact your doctor immediately.
• If you have any muscle weakness diseases (myasthenia gravis).

Decentán should be used under strict medical supervision.

Children and adolescents

Administration in children should only be done exceptionally and with extreme caution due to the risk of neurological adverse effects.

Other medications and Decentán

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

- The use of Decentán with medications that also act on the central nervous system (psychoactive, hypnotic, some analgesics, narcotics) or other medications such as: allergy or cold medications (antihistamines) may make the effects of these medications stronger than expected.

- Decentán may increase the adverse effects caused by some antidepressants (e.g., delirium).

- If you take Decentán with selective serotonin reuptake inhibitors (e.g., fluoxetine or paroxetine), your doctor may need to reduce the dose of Decentán, as these medications increase Decentán levels in the blood.

- Do not take Decentán with medications that alter the electrocardiogram such as: antiarrhythmics, macrolide antibiotics, malaria medications, antihistamines, antidepressants, or other neuroleptics, with medications that cause low potassium levels in the blood (e.g., specific diuretics), or with medications that decrease Decentán metabolism in the liver (e.g., certain antidepressants (monoamine oxidase inhibitors and selective serotonin reuptake inhibitors), imidazole antimycotics).

- The effects of Decentán may decrease if you take biperiden (medication used for Parkinson's disease treatment), if you take epilepsy medications (e.g., barbiturates, carbamazepine).

- If you take Decentán with medications that lower blood pressure, you may experience: dizziness, "black dots" vision, and increased heart rate.

- Also, the blood pressure-lowering effect of guanetidin, clonidin, and alpha-metildopa may be weaker if you take Decentán.

- It is not recommended to take Decentán and medications containing reserpine together.

- For the treatment of hypotension (low blood pressure), do not administer adrenaline (epinephrine) together with Decentán, as adrenaline administration may cause a greater decrease in blood pressure.

- The concurrent use of Decentán and anticonvulsant medications such as barbiturates or carbamazepine increases the metabolism of phenothiazines.

- The concurrent use of Decentán and phenitoine may cause increased phenitoine levels in the blood and reach toxic levels.

- The concurrent use of Decentán and clozapine may cause blood disorders.

- The concurrent use of Decentán and propranolol increases the levels of both medications in the blood.

- Decentán decreases the effect of medications for Parkinson's disease treatment such as: bromocriptine, amantadine, levodopa, while increasing the effect of medications against vomiting and nausea of the type: metoclopramide, bromoprida, alizaprida.

- The concurrent use of Decentán and pentetrazol may cause seizures.

- The concurrent use of Decentán and medications containing piperazine increases the risk of experiencing involuntary movement-related adverse effects (tonicity disorders of a tissue or muscle), chorea (convulsions), as well as the concurrent use of Decentán and lithium salts, although in this case, it may also cause increased lithium levels in the blood and, very rarely, reach toxic levels for the nervous system.

- Decentán increases the effect of oral anticoagulants.

- It is believed that caffeine may counteract the antipsychotic effects of Decentán.

- Decentán may potentiate the respiratory depression caused by some antibiotics such as: capreomycin, colistin, and polymyxin B.

- Decentán may cause a decrease in the effect of gonadorelin.

- In diabetic patients treated with insulin and taking Decentán (especially at high doses), they may become unstable and may require dietary measures and treatment with other medications or adjustment of antidiabetic agents.

- Avoid consuming alcohol during Decentán treatment.

Pregnancy, lactation, and fertility

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

Pregnancy

Decentán should not be used in the first trimester of pregnancy. In the second and third trimesters of pregnancy, your doctor should only prescribe Decentán if it is strictly necessary, taking into account the risk it may pose to the mother and the baby. If Decentán therapy is indispensable, note that Decentán may intensify constipation, which is a typical condition during pregnancy. Also, the effect on the mother's blood pressure may affect placental circulation. Decentán should not be used during the last ten days of pregnancy to avoid extrapyramidal symptoms (movement disorders) or withdrawal symptoms in newborns.

If you want to become pregnant or suppose you are pregnant, contact your doctor immediately.

Lactation

Women who are breastfeeding should consult their doctor before taking this medication, as perphenazine passes into breast milk. Therefore, if the doctor considers it necessary to treat with this medication, they should consider suspending breastfeeding.

Fertility

Decentán may increase levels of a hormone called prolactin, which may affect fertility in both men and women. Consult your doctor if you have any doubts.

Warning

Avoid exposure to the sun (even on cloudy days) and ultraviolet lamps (UVA) while taking this medication.

Driving and operating machinery

This medication may cause symptoms such as drowsiness, dizziness, or vision 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 evaluates your response to this medication.

Similarly, the effect is even greater if combined with alcohol. Therefore, it is recommended not to take perphenazine and alcohol simultaneously.

Decentán contains lactose

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

Influence on laboratory results

Decentán may cause a false positive result in the pregnancy test.

Follow exactly the administration instructions for Decentán as indicated by your doctor. Your doctor will inform you of the treatment duration and dosage based on the characteristics of your disease and your individual response. In case of doubt, consult your doctor or pharmacist again.

Generally, an initial dose of 1-3 tablets per day is recommended. The dosage should be adjusted individually based on the response achieved.

It is recommended to take Decentán after meals with a little liquid.

If you take more Decentán than you should

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 used.

Generally, symptoms of Decentán intoxication only occur at very high doses (above 1,000 mg).

Symptoms of intoxication range from drowsiness to coma, occasionally: excitement and delirium, confusion, more rarely seizures, fever, decrease in body temperature (hypothermia), decrease in blood pressure, tachycardia (increased heart rate), electrocardiogram alterations, arrhythmia, heart and circulatory failure (rapidly in case of severe intoxication), acute dyskinetic symptoms (abnormal involuntary movements: tremors, tics, etc.), protrusion of the tongue (abnormal advancement of the tongue), eye spasms, laryngeal or pharyngeal spasms, blurred vision, glaucoma (eye disease characterized by an increase in intraocular pressure), intestinal paralysis, urinary retention, cyanosis (blue discoloration of the skin and mucous membranes), respiratory depression, (broncho)neumonia (inflammation of the lungs that produces cough, fever, and difficulty breathing).

The treatment of intoxication should be done through gastric lavage and administration of diuretics, analgesics, antiparkinsonian medication, and maintenance of vital functions.

Like all medications, Decentán may cause side effects, although not everyone will experience them.

The following adverse reactions are classified by organs and systems and by frequencies. Frequencies are defined as:infrequent (between 1 and 100 per 1,000 patients), rare (between 1 and 1,000 per 10,000 patients), or very rare (up to 1 in 10,000 people).

Nervous system and psychiatric disorders

Decentán may cause physical symptoms in hypersensitive patients or if the dose is too high; these symptoms primarily present as extrapyramidal motor disorders.

At the beginning of treatment, the following may occur:

• early "dyskinesias" (muscle cramps in the face/mouth, neck, and arms, for example, torticollis).
• symptoms similar to those caused by Parkinson's disease (for example, lack of facial expression, hypokinesia (motor weakness, decreased movement), muscle rigidity, tremors).
• difficulty falling asleep: this effect can be prevented if the last dose is taken before 5 pm.

After a long period of treatment, the following may occur:

• akathisia (difficulty remaining still and compulsion to move).
• late "dyskinesias" (constant movement disorders such as facial tics or involuntary body movements).

Except for late dyskinesias, the movement disorders that Decentán may cause are normally reversible or can be remedied by reducing the dose or administering additional medication for Parkinson's disease. In individual cases, late dyskinesias persist after long-term therapy.

Patients who are predisposed may experience seizures when taking Decentán.

Treatment with Decentán may cause temporary drowsiness.

In addition, treatment with Decentán may cause: agitation, excitement, dizziness, headaches, depression, deep and prolonged sleep, delirium syndromes.

A very rare reaction is the "neuroleptic malignant syndrome" that causes: fever, muscle rigidity, lack of movement, sweating, excessive salivation, alterations in consciousness, and coma, which requires interrupting treatment with Decentán and immediate hospitalization.

Blood and lymphatic system disorders

The risk of developing blood cell disorders (for example, agranulocytosis) cannot be ruled out, especially in long-term treatments. Therefore, your doctor should perform regular blood tests.

Metabolism and nutrition disorders

Infrequent: weight gain, glucose metabolism disorders.

Eye disorders

Infrequent: difficulty focusing, increased pressure inside the eye (angle-closure glaucoma).

Very rare: pigment deposits in the cornea and lens (during long-term treatment with high doses).

Cardiac disorders

Conduction disorders (arrhythmias), increased heart rate, increased or decreased blood pressure.

Vascular disorders

There have been reports of cases of venous thromboembolism (disease related to the formation of a clot that blocks the vessels), including cases of pulmonary embolism (disease due to obstruction in the pulmonary vessels) and cases of deep vein thrombosis (disease due to the formation of a blood clot in a deep vein of the body, usually in the veins of the legs) with the use of antipsychotic medications (unknown frequency).

Respiratory, thoracic, and mediastinal disorders

Laryngeal inflammation, asthma.

Gastrointestinal disorders

Infrequent: dry mouth, constipation.

Rare: gastrointestinal discomfort (for example, nausea and vomiting, especially after abrupt discontinuation of treatment).

Very rare: paralytic ileus.

Hepatobiliary disorders

Rare: liver disorders (for example, increased liver enzymes; bile accumulation).

Skin and subcutaneous tissue disorders

Rare: hypersensitivity reactions such as: skin reactions, skin discoloration when exposed to light (increased sensitivity to light) and photosensitivity ("sun allergy"), sweating.

Very rare: autoimmune disease of connective tissue.

Renal and urinary disorders

Infrequent: urinary dysfunction.

Endocrine disorders

Infrequent: hormonal disorders (for example, galactorrhea (excessive milk secretion), menstrual irregularities, sexual dysfunction).

If you consider that any of the side effects you are experiencing is severe or if you notice any of the side effects mentioned in this prospectus, inform your doctor or pharmacist.

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 System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

Store below 86°F and in the original packaging to protect it from light.

If you observe a slight darkening of the tablets caused by exposure to light, this does not affect the validity period of the same.

Medicines should not be thrown into the drains or trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Decentán

• Theactive ingredient is perphenazine. Each tablet contains 8 mg of perphenazine.
• The other components are: lactose monohydrate, powdered cellulose, cornstarch, anhydrous colloidal silica, sodium carmellose and magnesium stearate.

Appearance of the product and contents of the packaging

Decentán is presented in the form of white-yellowish, round, convex tablets with beveled edges, with a cross engraved on one face and an oval on the other.

Decentán is presented in packaging with 25, 50 or 500 tablets, in aluminum-PVC blisters.

Holder of the marketing authorization

LABORATORIOS ERN, S.A.

Perú, 228

08020 Barcelona

Spain

Responsible for manufacturing

Merck, S.L.

Merck Industrial Estate

08100 Mollet del Vallés (Barcelona)

Spain

Or

CYNDEA PHARMA, S.L.

Emiliano Revilla Sanz Industrial Estate

Avenida de Ágreda, 31 - 42110 Ólvega (Soria)

Or

LABORATORIOS ERN, S.A.

Gorgs Lladó, 188

08210 Barberá del Vallés, Barcelona. Spain

Last review date of this leaflet:April 2018

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