AMISULPRIDE NORMON 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Amisulpride Normon 400 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package 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 package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Amisulpride Normon and what is it used for
2. What you need to know before taking Amisulpride Normon
3. How to take Amisulpride Normon
4. Possible side effects
5. Storage of Amisulpride Normon
6. Contents of the pack and further information

1. What is Amisulpride Normon and what is it used for

Amisulpride belongs to a group of medications called antipsychotics.

Amisulpride Normon is indicated for the treatment of schizophrenia.

2. What you need to know before taking Amisulpride Normon

Do not take Amisulpride Normon

• If you are allergic to amisulpride or any of the other components of this medication (listed in section 6).
• If you have a prolactin-dependent tumor (hormone secreted by the pituitary gland that stimulates milk production in the mammary glands), such as pituitary prolactinoma or breast cancer.
• If you have pheochromocytoma (a tumor of the adrenal gland).
• If you are a child, until puberty.
• If you are being treated with levodopa.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to take Amisulpride Normon.

• As with other antipsychotic medications, a malignant neuroleptic syndrome (a potentially fatal complication) may occur, characterized by high fever, muscle stiffness, instability of the autonomic nervous system, altered consciousness, rhabdomyolysis, and increased levels of an enzyme called creatine phosphokinase. In the event of high fever, especially when using high doses, all antipsychotic medications, including amisulpride, should be discontinued.

Rhabdomyolysis has also been observed in patients without malignant neuroleptic syndrome.

• If you have Parkinson's disease.
• If you have known cardiovascular disease or a family history of QT interval prolongation, and the use of neuroleptic medications should be avoided.
• If you have risk factors for stroke.
• In elderly patients with psychosis related to dementia, who are being treated with antipsychotics (possibility of increased risk of death).
• In patients with risk factors for thromboembolism (see "Possible side effects").
• If you have a history or family history of breast cancer.
• If a pituitary tumor is diagnosed, treatment with amisulpride should be discontinued.
• If you have a established diagnosis of diabetes mellitus or risk factors for diabetes.
• If you have a history of seizures.
• If you have renal insufficiency.
• Withdrawal symptoms (nausea, vomiting, or insomnia) have been described after abrupt discontinuation of treatment at high doses. Psychotic symptoms and involuntary movement disorders may also reappear suddenly, such as akathisia, dystonia, and dyskinesia. Therefore, gradual withdrawal is recommended.
• As with other antipsychotic medications, leukopenia, neutropenia, and agranulocytosis may occur. The onset of unexplained fever or infections may indicate these blood disorders, and immediate blood tests may be necessary.
• Severe liver problems have been reported with amisulpride. Consult your doctor immediately if you experience fatigue, loss of appetite, nausea, vomiting, abdominal pain, or yellowing of the eyes or skin.

Using Amisulpride Normon with Other Medications

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

Certain medications may alter the effect of Amisulpride Normon, and your doctor may adjust the dose during combined treatment.

The use of Amisulpride Normon with levodopa is contraindicated.

Amisulpride may counteract the effect of dopaminergic agonists (e.g., bromocriptine, ropinirole).

It is not recommended to use medications containing alcohol with Amisulpride Normon, as amisulpride may potentiate the central effects of alcohol.

It is essential to inform your doctor if you are currently taking any of the following medications:

• Central nervous system depressants, including narcotics, analgesics, sedating antihistamines, barbiturates, benzodiazepines, and other anxiolytics, clonidine, and derivatives.
• Blood pressure-lowering medications.
• Clozapine.
• Medications that prolong the QT interval, such as antiarrhythmic medications (quinidine, disopyramide, amiodarone, and sotalol), certain antihistamines, other antipsychotics, and some medications for the treatment of malaria (mefloquine).
• Lithium salts.
• Sucralfate.
• Antacids.

Taking Amisulpride Normon with Food and Drinks

This medication may potentiate the effects of alcohol; therefore, it is not recommended to consume alcoholic beverages during treatment.

Pregnancy, Breastfeeding, and Fertility

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

Pregnancy:

Amisulpride Normon is not recommended during pregnancy or in fertile women who do not use contraceptive methods.

If you take Amisulpride Normon during the last three months of pregnancy, your baby may experience agitation, muscle stiffness, and/or muscle weakness, tremors, numbness, breathing difficulties, or feeding problems. If your baby develops any of these symptoms, you should contact your doctor.

Breastfeeding:

You should not breastfeed during treatment with Amisulpride Normon. Consult your doctor about the best way to feed your baby if you are taking Amisulpride Normon.

Use in Children

The safety and efficacy of amisulpride have not been established between puberty and 18 years of age. The available data on the use of amisulpride in adolescents with schizophrenia are limited. Therefore, the use of amisulpride is not recommended between puberty and 18 years of age. In children, until puberty, amisulpride is contraindicated.

Driving and Using Machines

Amisulpride Normon may cause symptoms such as drowsiness, dizziness, visual disturbances, blurred vision, and decreased reaction capacity. These effects, as well as the underlying disease, 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.

Amisulpride Normon Contains Lactose and Sodium

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

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to Take Amisulpride Normon

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again. Remember to take your medication. Your doctor will indicate the duration of treatment and how to increase the dose. Do not stop treatment abruptly, as your symptoms may reappear.

Amisulpride Normon is administered orally.

Adults:

The dose should be adjusted according to your clinical response and tolerability to treatment. A dose between 400 mg/day and 800 mg/day is recommended. In individual cases, the daily dose may be increased up to 1200 mg/day.

The daily dose should be administered in a single intake or divided into two intakes in case of doses above 400 mg/day.

Elderly Patients:

This medication should be used with special caution due to the possible risk of hypotension and sedation. Your doctor will adjust the dose due to renal insufficiency.

Patients with Renal Insufficiency:

Your doctor will adjust the dose.

If You Take More Amisulpride Normon Than You Should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you take more doses than prescribed, symptoms such as drowsiness, sedation, and even coma, decreased blood pressure, as well as abnormal movements, may appear. Cases of death have been reported, mainly in combination with other psychotropic agents.

If You Forget to Take Amisulpride Normon

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

If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Amisulpride Normon may cause side effects, although not everyone experiences them.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

Side effects observed according to their frequency of occurrence: very common (may affect more than 1 in 10 patients); common (may affect up to 1 in 10 patients); uncommon (may affect up to 1 in 100 patients); rare (may affect up to 1 in 1,000 patients); very rare (may affect up to 1 in 10,000 patients); frequency not known (cannot be estimated from available data), have been:

Blood and Lymphatic System Disorders:

Uncommon: leukopenia and neutropenia (see "Warnings and Precautions").

Rare: agranulocytosis (see "Warnings and Precautions").

Immune System Disorders:

Uncommon: allergic reactions.

Endocrine Disorders:

Common: milk secretion, absence of menstruation, breast growth (in males), breast pain, and erectile dysfunction.

Rare: benign pituitary tumor, such as prolactinoma (see "Do not take Amisulpride Normon" and "Warnings and Precautions").

Metabolic and Nutritional Disorders:

Uncommon: hyperglycemia (see "Warnings and Precautions"), increased triglycerides and cholesterol in the blood.

Rare: hyponatremia and syndrome of inappropriate antidiuretic hormone secretion.

Psychiatric Disorders:

Common: insomnia, anxiety, agitation, orgasmic dysfunction.

Uncommon: confusion.

Nervous System Disorders:

Very Common: tremor, rigidity, poverty of movements, increased salivation, and inability to remain seated quietly, incoordination of movements.

Common: acute dystonia and drowsiness.

Uncommon: rhythmic, involuntary movements in the tongue and/or face after long-term administration, and epileptic seizures.

Rare: malignant neuroleptic syndrome, which is a potentially fatal complication (see "Warnings and Precautions").

Frequency Not Known: restless legs syndrome.

Eye Disorders:

Common: blurred vision.

Cardiac Disorders:

Uncommon: bradycardia.

Rare: QT interval prolongation, ventricular arrhythmias, such as torsades de pointes, ventricular tachycardia, which can lead to ventricular fibrillation or cardiac arrest, and sudden death (see "Warnings and Precautions").

Vascular Disorders:

Common: hypotension.

Uncommon: increased blood pressure.

Rare: venous thromboembolism, including pulmonary embolism, sometimes fatal, and deep vein thrombosis (see "Warnings and Precautions").

Respiratory, Thoracic, and Mediastinal Disorders:

Uncommon: nasal congestion and aspiration pneumonia.

Gastrointestinal Disorders:

Common: constipation, nausea, vomiting, dry mouth.

Hepatobiliary Disorders:

Uncommon: liver damage.

Skin and Subcutaneous Tissue Disorders:

Rare: angioedema and urticaria.

Frequency Not Known: increased sensitivity of the skin to sunlight and ultraviolet light.

Musculoskeletal and Connective Tissue Disorders:

Uncommon: bone disorders.

Frequency Not Known: rhabdomyolysis.

Renal and Urinary Disorders:

Uncommon: urinary retention.

Pregnancy, Puerperium, and Perinatal Conditions:

Frequency Not Known: withdrawal syndrome in newborns.

Investigations:

Common: weight gain.

Uncommon: elevated liver enzymes, mainly transaminases.

Frequency Not Known: elevated creatine phosphokinase levels.

Accidents, Poisoning, and Complications of Procedures:

Frequency Not Known: falls due to reduced body balance, which sometimes result in fractures.

Important: you should see a doctor immediately:

• If, during treatment with Amisulpride Normon tablets, you experience any of the following symptoms: high fever, generalized muscle stiffness, rapid breathing, abnormal sweating, or decreased alertness, a potentially fatal complication called malignant neuroleptic syndrome (see "Warnings and Precautions").
• Or if you notice an altered heart rhythm, experience dizziness, vertigo, difficulty breathing, or chest pain, as isolated cases of severe ventricular arrhythmias, such as torsades de pointes, ventricular tachycardia, which can lead to ventricular fibrillation or cardiac arrest, and fatal outcome have been reported (see "Warnings and Precautions").

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Amisulpride Normon

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Amisulpride Normon after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Place the packaging and any unused medications in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Container Content and Additional Information

Composition of Amisulprida Normon 400 mg tablets

The active ingredient is amisulpride. Each film-coated tablet contains 400 mg of amisulpride.

The other components (excipients) are:

• Core: lactose monohydrate, microcrystalline cellulose, sodium carmellose, sodium carboxymethyl starch type A (potato), colloidal anhydrous silica, talc, stearic acid, and magnesium stearate.
• • Coating: hypromellose, titanium dioxide, and macrogol 6000.

Appearance of the Product and Container Content

Amisulprida Normon 400 mg is presented in the form of white or almost white, elongated film-coated tablets with serigraphy.

Each container contains 30 film-coated tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the Last Review of this Prospectus:September 2024

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