AMISULPRIDE NORMON 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Amisulpride Normon 100 mg Film-Coated Tablets EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this 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 you take 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 medicines called antipsychotics.

Amisulpride Normon is indicated for the treatment of schizophrenia.

2. What you need to know before you take Amisulpride Normon

Do not take Amisulpride Normon

• If you are allergic to amisulpride or any of the other ingredients of this medicine (listed in section 6).
• If you have any prolactin-dependent tumor (hormone secreted by the pituitary gland that stimulates milk production in the mammary glands), such as pituitary prolactinomas or breast cancer.
• If you have pheochromocytoma (tumor of the adrenal gland).
• If you are a child, up to 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, neuroleptic malignant syndrome (a potentially fatal complication) may occur, characterized by high fever, muscle stiffness, alteration of the nervous system (autonomic instability), alteration of consciousness (obnubilation), rhabdomyolysis (breakdown of muscle tissue 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 amisulpride, should be discontinued.

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

• If you have Parkinson's disease.
• If you have known cardiovascular disease or have 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 dementia-related psychosis, who are being treated with antipsychotics (possibility of increased risk of death).
• In patients with risk factors for thromboembolism (see section “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 established diabetes mellitus or risk factors for diabetes.
• If you have a history of seizure disorders.
• If you have renal impairment.
• 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 (inability to remain seated quietly), dystonia (involuntary muscle contractions), and dyskinesia (incoordination of movements). 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 (see section “Possible side effects”) and may require immediate blood analysis.
• 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 medicines

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

Certain medications used may modify the effect of Amisulpride Normon, and your doctor may change 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 that you inform your doctor if you are currently taking any of the following medications:

• CNS depressants, including narcotics, analgesics, sedating antihistamines H1, barbiturates, benzodiazepines, and other anxiolytics, clonidine, and derivatives.
• Medications to lower blood pressure.
• Clozapine.
• Medications that prolong the QT interval, such as antiarrhythmic medications (quinidine, disopyramide, amiodarone, and sotalol), some 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, so it is not recommended to consume alcoholic beverages during treatment.

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 taking this medicine.

Pregnancy:

Amisulpride Normon is not recommended during pregnancy or in women of childbearing potential 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 problems, or difficulty feeding. 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, up to puberty, amisulpride is contraindicated.

Driving and using machines

Amisulpride Normon may cause symptoms such as drowsiness, dizziness, visual disturbances, blurred vision, and decreased reaction ability. 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 evaluates 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; this is essentially “sodium-free”.

3. How to take Amisulpride Normon

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

Amisulpride Normon is a tablet for oral administration.

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 (abnormally low blood pressure) and sedation. Your doctor will adjust the dose due to renal impairment.

Patients with renal impairment:

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, telephone 91 562 04 20, indicating the medication and the amount taken.

In case of taking 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 on the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Amisulpride Normon can cause side effects, although not everybody gets them.

If you experience side effects, talk to your doctor or pharmacist, even if they are not listed 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 not known (cannot be estimated from available data), have been:

Blood and lymphatic system disorders:

Uncommon: leukopenia (decrease in white blood cell count) 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, absence of menstruation, 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 (elevated blood glucose levels) (see section “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 movement, increased salivation, and inability to remain seated quietly, incoordination of movements.

Common: acute dystonia (torticollis, oculogyric crisis, contraction of the masticatory muscles) and somnolence.

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

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

Frequency not known: restless legs syndrome (unpleasant sensation in the legs, which is temporarily relieved by movement, and symptoms worsen at the end of the day).

Eyeball disorders:

Common: blurred vision (see section “Driving and using machines”).

Cardiac disorders:

Uncommon: bradycardia (slow heart rate).

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

Vascular disorders:

Common: hypotension.

Uncommon: increased blood pressure.

Rare: venous thromboembolism (process characterized by blood clotting 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 CNS 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.

Frequency not known: increased sensitivity of your skin to sunlight and ultraviolet light (photosensitivity).

Musculoskeletal and connective tissue disorders:

Uncommon: bone disorders (osteopenia, osteoporosis).

Frequency not known: rhabdomyolysis (breakdown of muscle tissue associated with muscle pain).

Renal and urinary disorders:

Uncommon: urinary retention.

Pregnancy, puerperium, and perinatal disorders:

Frequency not known: withdrawal syndrome in newborns (see section “Pregnancy and breastfeeding”).

Investigations:

Common: weight gain.

Uncommon: elevated liver enzymes, mainly transaminases.

Frequency not known: elevated creatine phosphokinase levels (blood test indicating muscle damage).

Traumatic, toxic, and therapeutic procedural complications:

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 mental alertness, a potentially fatal complication called neuroleptic malignant syndrome (see section “Warnings and Precautions”).
• Or if you notice your heart rhythm is altered, you suffer from dizziness, vertigo, difficulty breathing, or chest pain, as isolated cases of ventricular arrhythmias, such as torsades de pointes, ventricular tachycardia, which can lead to atrial fibrillation or cardiac arrest, and fatal outcome have been reported (see section “Warnings and Precautions”).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are 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 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.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Amisulpride Normon 100 mg film-coated tablets

The active ingredient is amisulpride. Each film-coated tablet contains 100 mg of amisulpride.

The other ingredients (excipients) are:

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

Appearance of the product and packaging contents

Amisulpride Normon 100 mg is presented in the form of white or almost white, round, film-coated tablets with serigraphy.

Each package contains 60 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 revision of this leaflet:September 2024

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