AMISULPRIDE NORMON 200 mg FILM-COATED TABLETS

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

Do not take Amisulprida Normon

• If you are allergic to amisulprida or any of the other ingredients of this medicine (listed in section 6).
• If you have a prolactin-dependent tumor (hormone secreted by the pituitary gland and that stimulates milk production in the mammary glands), such as pituitary prolactinoma or breast cancer.
• If you have pheochromocytoma (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 Amisulprida 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 (autonomic instability), altered 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 amisulprida, 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 section “Possible side effects”).
• If you have a history or family history of breast cancer.
• If a pituitary tumor is diagnosed, treatment with amisulprida 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 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 (dysscrasias) (see section “Warnings and precautions”) and may require immediate blood analysis.
• Severe liver problems have been reported with amisulprida. Consult your doctor immediately if you experience fatigue, loss of appetite, nausea, vomiting, abdominal pain, or yellowing of the eyes or skin.

Using Amisulprida 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 alter the effect of Amisulprida Normon, and your doctor may change the dose during combined treatment.

The use of Amisulprida Normon with levodopa is contraindicated.

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

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

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

• CNS 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), some antihistamines, other antipsychotics, and some medications for the treatment of malaria (mefloquine).
• Lithium salts.
• Sucralfate.
• Antacids.

Taking Amisulprida 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:

Amisulprida Normon is not recommended during pregnancy or in women of childbearing age 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 muscle weakness, tremors, numbness, breathing problems, or difficulty with breastfeeding. If your baby develops any of these symptoms, you should contact your doctor.

Breastfeeding:

You should not breastfeed during treatment with Amisulprida Normon. Consult 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 of age: the available data on the use of amisulprida in adolescents with schizophrenia are limited. Therefore, the use of amisulprida is not recommended between puberty and 18 years of age. In children, until puberty, amisulprida is contraindicated.

Driving and using machines

Amisulprida 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 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 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 Amisulprida Normon

Follow the administration instructions of this medication exactly 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 indicate the duration of treatment and how to increase the dose. Do not stop treatment abruptly, as symptoms of your disease may reappear.

Amisulprida 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 dose or divided into two doses 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 Amisulprida 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.

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 Amisulprida Normon

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

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

4. Possible side effects

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

If you experience side effects, consult 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 the available data), have been:

Blood and lymphatic system disorders:

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

Rare: agranulocytosis (decrease in a type of white blood cells, 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 Amisulprida Normon” and “Warnings and precautions”).

Metabolism and nutrition disorders:

Uncommon: hyperglycemia (increased 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 movements, 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: malignant neuroleptic 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).

Eye 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 the 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).

Injury, poisoning, and procedural complications:

Frequency not known: falls due to reduced body balance, which sometimes causes fractures.

Important: you should go to the doctor immediately:

• If during treatment with Amisulprida 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 malignant neuroleptic 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, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Amisulprida Normon

Keep out of the reach and sight of children.

No special storage conditions are required.

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

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

6. Packaging Content and Additional Information

Composition of Amisulprida Normon 200 mg tablets

The active ingredient is amisulpride. Each film-coated tablet contains 200 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 Packaging Content

Amisulprida Normon 200 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 Health Products (AEMPS) http://www.aemps.gob.es/