AMISULPRIDE NORMON 100 MG FILM-COATED TABLETS EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amisulpride Normon 100 mg film-coated tablets EFG

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

• Keep this 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Amisulpride Normon is and what it is 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 starting to take Amisulpride Normon

Do not take Amisulpride Normon

• If you are allergic to amisulpride or to any of the other ingredients of this medicine (listed in section 6).
• If you have a prolactin-dependent tumour (a hormone secreted by the anterior pituitary gland that stimulates milk production in the mammary glands), for example, pituitary prolactinomas or breast cancer.
• If you have phaeochromocytoma (a tumour of the adrenal gland).
• If you are a child, up to puberty.
• If you are being treated with levodopa.

Warnings and precautions

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

• Like other antipsychotic medicines, neuroleptic malignant syndrome (a potentially fatal complication) may occur, characterised by high fever, muscle rigidity, nervous system disturbances (autonomic instability), altered consciousness (obnubilation), rhabdomyolysis (muscle breakdown associated with muscle pain), and increased levels of an enzyme called creatine phosphokinase (CPK). In cases of high fever, especially when high doses are used, all antipsychotic medicines 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 a family history of QT interval prolongation, and the use of neuroleptic medicines should be avoided.
• If you have risk factors for stroke.
• In elderly patients with psychosis associated with dementia who are being treated with antipsychotics (increased risk of death).
• In patients with risk factors for thromboembolism (see section “Possible side effects”).
• If you have a personal or family history of breast cancer.
• If a pituitary tumour diagnosis is confirmed, treatment with amisulpride must be stopped.
• If you have a confirmed 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 reported after abrupt discontinuation of treatment at high doses. Psychotic symptoms and sudden onset of involuntary movement disorders such as akathisia (inability to remain still), dystonia (involuntary sustained contractions of muscles in one or more parts of the body), and dyskinesia (involuntary incoordination of movements) may also reappear. Therefore, gradual withdrawal is recommended.
• As with other antipsychotic medicines, leucopenia, neutropenia, and agranulocytosis may occur. The onset of fever or unexplained infections may indicate these blood disorders (dyscrasias) (see section “Possible side effects”) and require immediate blood testing.
• Serious liver problems have been reported with amisulpride. Contact your doctor immediately if you experience fatigue, loss of appetite, nausea, vomiting, abdominal pain, or yellowing of the eyes or skin.

Taking Amisulpride Normon with other medicines

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

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

The use of Amisulpride Normon with levodopa is contraindicated.

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

The use of alcohol-containing medicines together with Amisulpride Normon is not recommended, as amisulpride may enhance the central effects of alcohol.

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

• Central nervous system depressants including narcotics, analgesics, sedating H1 antihistamines, barbiturates, benzodiazepines and other anxiolytics, clonidine and its derivatives.
• Medicines to lower blood pressure.
• Clozapine.
• Medicines that prolong the QT interval such as: antiarrhythmic medicines (quinidine, disopyramide, amiodarone, and sotalol), some antihistamines, other antipsychotics, and some medicines used to treat malaria (mefloquine).
• Lithium salts.
• Sucralfate.
• Antacids.

Taking Amisulpride Normon with food and drinks

This medicine may enhance the effects of alcohol; therefore, drinking alcoholic beverages during treatment is not recommended.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 are not using contraceptive methods.

If you take Amisulpride Normon during the last three months of pregnancy, your baby may develop restlessness, muscle rigidity and/or muscle weakness, involuntary tremors, numbness, breathing difficulties, or feeding problems. If your baby develops any of these symptoms, contact your doctor immediately.

Breastfeeding:

You must not breastfeed while taking 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 in adolescents between puberty and 18 years of age: 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 reduced reaction capacity. These effects, as well as the illness itself, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or perform other activities requiring special attention until your doctor has assessed your response to this medicine.

Amisulpride Normon contains lactose and sodium

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

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

3. How to take Amisulprida Normon

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Remember to take your medicine. Your doctor will tell you how long the treatment should last and how to increase the dose. Do not stop the treatment abruptly, as symptoms of your illness may reappear.

Amisulprida Normon are tablets for oral administration.

Adults:

The dose should be adjusted according to your clinical response and tolerance to treatment. A daily 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 taken as a single dose, or divided into two doses if the daily dose exceeds 400 mg/day.

Elderly patients:

This medicine 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 insufficiency.

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, contact your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken.

If you take more than the prescribed dose, symptoms such as drowsiness, sedation, and even coma, decreased blood pressure, and abnormal movements may occur. 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 missed doses.

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

4. Possible adverse effects

Like all medicines, Amisulpride Normon may cause adverse effects, although not everyone experiences them.

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

The adverse effects observed according to their frequency of occurrence—very common (may affect more than 1 in 10 people); common (may affect up to 1 in 10 people); uncommon (may affect up to 1 in 100 people); rare (may affect up to 1 in 1,000 people); very rare (may affect up to 1 in 10,000 people); frequency not known (cannot be estimated from available data)—are as follows:

Disorders of the blood and lymphatic system:

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

Rare: agranulocytosis (reduction 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 enlargement (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 (increased blood glucose levels) (see section “Warnings and precautions”), increased blood triglycerides and cholesterol.

Rare: hyponatremia and syndrome of inappropriate antidiuretic hormone secretion.

Psychiatric disorders:

Common: insomnia, anxiety, agitation, orgasmic dysfunction.

Nervous system disorders:

Very common: tremor, rigidity, poverty of movement, increased salivation, inability to sit still, and lack of motor coordination.

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

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

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

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

Eye disorders:

Common: blurred vision (see section “Driving and 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: increase in blood pressure.

Rare: venous thromboembolism (a condition characterized by blood clotting in 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 swelling of feet, hands, throat, lips, and airways) 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 (muscle breakdown associated with muscle pain).

Renal and urinary disorders:

Uncommon: urinary retention.

Pregnancy, puerperium and perinatal conditions:

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

Investigations:

Common: weight gain.

Uncommon: increased liver enzymes, mainly transaminases.

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

Injury, poisoning and procedural complications:

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

Important: you must seek immediate medical attention:

• If, during treatment with Amisulpride Normon tablets, you experience any of the following symptoms: high fever, generalized muscle rigidity, rapid breathing, abnormal sweating, or decreased mental alertness, a potentially fatal condition known as neuroleptic malignant syndrome (see section “Warnings and precautions”).
• Or if you notice an irregular heartbeat, dizziness, vertigo, difficulty breathing, or chest pain, as isolated cases have been reported of: serious ventricular arrhythmias such as torsades de pointes, ventricular tachycardia which may lead to atrial fibrillation or cardiac arrest, and fatal outcome (see section “Warnings and precautions”).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

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 expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amisulpride Normon 100 mg tablets

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

The other components (excipients) are:

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

Appearance of the product and contents of the pack

Amisulpride Normon 100 mg is presented as white or almost white, round, film-coated tablets with printing.

Each pack 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 latest revision of this leaflet: September 2024

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