Package Leaflet: Information for the User

Amisulpride Normon 400 mg Film-Coated Tablets

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do 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 package leaflet. See section 4.

Amisulprida belongs to a group of medications known as antipsychotics.

Amisulprida Normonis indicated for the treatment of schizophrenia.

Do not take Amisulprida Normon

Warnings and precautions

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

• Like other antipsychotic medications, it may cause neuroleptic malignant syndrome (a complication that can be fatal) characterized by high fever, muscle rigidity, alteration of the nervous system (autonomic instability), alteration of consciousness (obnubilation), rhabdomyolysis (muscle breakdown associated with muscle pain) and increased levels of an enzyme called creatine phosphokinase (CPK). In the case of high fever, especially when using high doses, all antipsychotic medications, including amisulprida, should be discontinued.Amisulprida Normon

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

Use of Amisulprida Normon with other medications

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

Certain medications used may modify the effect of Amisulprida Normon and, therefore, your doctor may change the dose during combined treatment.

Amisulprida Normon is contraindicated with levodopa.

Amisulprida may oppose the effect of dopamine agonists (e.g., bromocriptine, ropinirol).

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

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

Amisulprida Normon intake with food and beverages

This medication may potentiate the effects of alcohol, so it is not recommended to consume alcoholic beverages during 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 taking this medication.

Pregnancy:

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

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

Lactation:

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

Use in children

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

Driving and operating machinery

Amisulprida Normon may cause symptoms such as drowsiness, dizziness, visual disturbances, blurred vision and decreased 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.

Amisulprida Normon contains lactose and sodium

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

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Remember to take your medication. Your doctor will inform you of the treatment duration and how to increase the dose. Do not stop treatment abruptly, as symptoms of your disease may reappear.

Amisulpride Normon are tablets for oral administration.

Adults:

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

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

Elderly patients:

This medication should be used with special caution due to the possible risk of hypotension (abnormal decrease in blood pressure) 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

In case of taking more than the prescribed dose, 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 forgot to take Amisulpride Normon:

Do not take a double dose to compensate for the missed doses.

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

Like all medicines, Amisulpride Normon may cause side effects, although not everyone will experience them.

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

Side effects observed according to their frequency of presentation: 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 unknown (cannot be estimated from available data),have been:

Blood and lymphatic system disorders:

Uncommon: leucopenia (decrease in the number of white blood cells) and neutropenia (decrease in a type of white blood cell, neutrophils) (see section “Warnings and precautions”).

Rare: agranulocytosis (decrease in a type of white blood cell, granulocytes) (see section “Warnings and precautions”).

Immune system disorders:

Uncommon: allergic reactions.

Endocrine disorders:

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

Rare: benign pituitary tumor such as prolactinoma (see sections “Do not take Amisulpride Normon” and “Warnings and precautions”).

Metabolism and nutrition disorders:

Uncommon: hyperglycemia (increase in blood glucose levels) (see section “Warnings and precautions”), increase in triglycerides and cholesterol in the blood.

Rare: hyponatremia and syndrome of inadequate antidiuretic hormone secretion.

Psychiatric disorders:

Common: insomnia, anxiety, agitation, orgasmic dysfunction.

Uncommon: confusion.

Nervous system disorders:

Very common: tremor, rigidity, bradykinesia, increased salivation and inability to remain seated quietly, ataxia.

Common:acute dystonia (torticollis, ocular crisis (involuntary deviation of the gaze to one side), contraction of the masseter muscles) and somnolence.

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

Rare: malignant neuroleptic syndrome, a potentially fatal complication (see section “Warnings and precautions”).

Unknown frequency:restless legs syndrome (unpleasant sensation in the legs, which is temporarily relieved by movement and symptoms worsen at the end of the day).

Eye disorders:

Common: blurred vision (see section “Driving and the use of machines”).

Cardiac disorders:

Uncommon: bradycardia (slowing of heart rate).

Rare: QT interval prolongation, ventricular arrhythmias such as torsades de pointes, ventricular tachycardia, which may lead to ventricular fibrillation or cardiac arrest, sudden death (see section “Warnings and precautions”).

Vascular disorders:

Common: hypotension.

Uncommon: hypertension.

Rare: venous thromboembolism (characterized by blood coagulation in the veins), including pulmonary embolism, sometimes fatal and deep vein thrombosis (see section “Warnings and precautions”).

Respiratory, thoracic and mediastinal disorders:

Uncommon: nasal congestion and aspiration pneumonia (mainly associated with other antipsychotics and central nervous system depressants).

Gastrointestinal disorders:

Common: constipation, nausea, vomiting, dry mouth.

Hepatobiliary disorders:

Uncommon: liver tissue damage.

Skin and subcutaneous tissue disorders:

Rare: angioedema (generalized urticaria accompanied by inflammation of the feet, hands, throat, lips and respiratory tract) and urticaria.

Unknown frequency:increased sensitivity of the skin to the sun and ultraviolet light (photosensitivity).

Musculoskeletal and connective tissue disorders:

Uncommon:bone alterations (osteopenia, osteoporosis).

Unknown frequency:myolysis (muscle rupture associated with muscle pain).

Renal and urinary disorders:

Uncommon: urinary retention.

Pregnancy, puerperium and perinatal diseases:

Unknown frequency: neonatal withdrawal syndrome (see section “Pregnancy and lactation”).

Complementary examinations:

Common: weight gain.

Uncommon: elevation of liver enzymes, mainly transaminases.

Unknown frequency:elevated levels of creatine phosphokinase (blood test indicating muscle damage).

Accidents, poisoning and complications of therapeutic procedures:

Unknown frequency:falls due to reduced body balance, which sometimes causes fractures.

Important: you must seek medical attention immediately:

• If during treatment with Amisulpride Normon tablets, the following symptoms occur: high fever, generalized muscle rigidity, rapid breathing, abnormal sweating or decreased mental alertness, a potentially fatal complication, known as malignant neuroleptic syndrome (see section “Warnings and precautions”).
• Or 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 that may lead to atrial fibrillation or cardiac arrest, and fatal outcome (see section “Warnings and precautions”).

Reporting of side effects

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

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Amisulprida Normon 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 drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

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:

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

Appearance of the product and contents of the packaging

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

Each package contains 30 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Date of the last review of this leaflet:September 2024

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