AMIPRYD 400 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Amipryd, 100 mg, tablets
3. Amipryd, 200 mg, tablets
4. Amipryd, 400 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
5. What is Amipryd and what is it used for
6. Important information before taking Amipryd
   1. When not to take Amipryd
   2. Warnings and precautions
   3. Children and adolescents
   4. Amipryd and other medicines
   5. Amipryd with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Amipryd contains lactose
   9. Amipryd contains sodium
7. How to take Amipryd
   1. Dosage
   2. Use in children and adolescents
   3. Overdose of Amipryd
   4. Missed dose of Amipryd
   5. Stopping Amipryd
   6. Blood tests
8. Possible side effects
   1. Stop taking the medicine and contact your doctor or go to the nearest emergency department if you experience any of the following side effects:
   2. Contact your doctor immediately if you experience any of the following side effects:
   3. Other side effects have also been reported:
   4. Reporting side effects
9. How to store Amipryd
10. Contents of the pack and other information
    1. What Amipryd contains
    2. What Amipryd looks like and contents of the pack
    3. Marketing authorization holder and manufacturer
    4. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Amipryd, 100 mg, tablets

Amipryd, 200 mg, tablets

Amipryd, 400 mg, tablets

Amisulpridum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Amipryd and what is it used for
• 2. Important information before taking Amipryd
• 3. How to take Amipryd
• 4. Possible side effects
• 5. How to store Amipryd
• 6. Contents of the pack and other information

1. What is Amipryd and what is it used for

Amipryd contains the active substance amisulpride, which has antipsychotic and neuroleptic effects.
Amipryd is indicated for the treatment of acute and chronic schizophrenia with positive symptoms
(such as: delusions, hallucinations, thought disorders, hostility, and suspiciousness) and (or) negative symptoms
(such as: emotional flattening, social withdrawal, and alogia), including patients with predominantly negative symptoms.

2. Important information before taking Amipryd

When not to take Amipryd

• if you are allergic to amisulpride or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as a rash, difficulty swallowing or breathing, swelling of the lips, face, throat, and tongue;
• if you have a tumor that grows in response to prolactin levels, i.e., prolactinoma, breast cancer;
• if you have a pheochromocytoma;
• if you are taking levodopa or drugs that may cause severe heart rhythm disturbances (see section "Amipryd and other medicines");
• in children before puberty.

Do not take this medicine if you have any of the above conditions. If in doubt, consult your doctor or pharmacist before taking Amipryd.
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Warnings and precautions

Before taking Amipryd, discuss it with your doctor, especially if:

• you have kidney disease;
• you have Parkinson's disease;
• you have a history of seizures (convulsions);
• you have abnormal heart rhythm;
• you have or have had heart disease or have a family history of heart disease;
• you have a slow heart rate (less than 55 beats per minute);
• you have low potassium levels in the blood;
• you have an increased risk of stroke;
• you or a family member have had blood clots, as the use of medicines like Amipryd is associated with the formation of blood clots;
• you have diabetes or are at risk of diabetes;
• you are elderly, as this group is more likely to experience decreased blood pressure and excessive sedation. In elderly patients with dementia, treated with antipsychotic drugs, a small increase in the risk of death has been reported compared to those not treated with these drugs;
• you have a low white blood cell count (agranulocytosis), as this may increase the risk of infection;
• you or a family member have had breast cancer;
• you have frequent infections with symptoms such as fever, chills, sore throat, or mouth ulcers. These may be signs of a blood disorder called leukopenia;
• you have visual field defects and headaches. These may be symptoms of a benign pituitary tumor.

Severe liver disorders have been reported with amisulpride. If you experience fatigue, loss of appetite, nausea, vomiting, abdominal pain, or yellowing of the eyes or skin, contact your doctor immediately.

Children and adolescents

Do not use this medicine in children before puberty.

Amipryd and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Amisulpride may affect the action of some medicines, and some medicines may affect the action of amisulpride. In particular, it is contraindicated to use Amipryd:

• with medicines that may cause severe heart rhythm disturbances (torsade de pointes):
• used to treat irregular heartbeat (e.g., quinidine, disopyramide, amiodarone, sotalol);
• other medicines such as bepridil (used to treat angina pectoris and heart rhythm disorders), cisapride (used to treat gastrointestinal problems), sultopride or tiorydazine (used to treat schizophrenia), methadone (used to treat pain and drug addiction), intravenous erythromycin or sparfloxacin (antibiotics), intravenous vincamine (used to treat various brain disorders), halofantrine (used to prevent malaria), pentamidine (used to treat infections in HIV patients), azole antifungals such as clotrimazole;
• with levodopa, bromocriptine, ropinirole (used to treat Parkinson's disease).

You should also inform your doctor if you are taking any of the following medicines:

• medicines used to treat high blood pressure or other heart problems that may affect heart function, such as beta-blockers (e.g., nebivolol or bisoprolol), diltiazem, verapamil, clonidine, guanfacine, digitalis glycosides;

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• medicines that cause potassium loss, including diuretics, laxatives, amphotericin B (intravenous), glucocorticoids (used to treat asthma or rheumatoid arthritis), and tetracosactide (which may be used in clinical trials);
• other medicines used to treat mental health problems, such as schizophrenia (e.g., pimozide or haloperidol) or depression (e.g., imipramine or lithium);
• antihistamines (used to treat allergies), such as astemizole or terfenadine;
• mefloquine (used to treat malaria);
• analgesics, such as tramadol and indomethacin, and opioids used to treat severe pain, such as morphine or pethidine;
• anesthetics;
• sleep aids, such as barbiturates and benzodiazepines.

Amipryd with food, drink, and alcohol

Amisulpride may enhance the effects of alcohol; therefore, you should not consume alcohol while taking this medicine. The medicine can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take this medicine during pregnancy unless your doctor considers it necessary. Newborns whose mothers took antipsychotic drugs (including amisulpride) during the third trimester of pregnancy may experience side effects of varying severity and duration. These include agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorders. If you notice any of these symptoms in your child, contact your doctor.
Breastfeeding
Do not take Amipryd while breastfeeding or planning to breastfeed. Discuss with your doctor the best way to feed your child while taking Amipryd.
Fertility
In animal studies, amisulpride has been shown to decrease fertility.

Driving and using machines

Amipryd may cause drowsiness and blurred vision. If you experience these symptoms, do not drive or operate machinery.

Amipryd contains lactose

If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking this medicine.

Amipryd contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Amipryd

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
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Dosage

Follow your doctor's instructions, who will adjust the dose according to the severity of your illness and your individual response to the medicine.
The usual dose of Amipryd is between 50 mg and 800 mg per day.
Your doctor may start you on a lower dose or recommend a dose of up to 1200 mg per day if necessary.
Doses up to 400 mg can be taken as a single dose. Higher doses should be divided into two doses - half in the morning and half in the evening.
Take the medicine at the same time every day.
The medicine is taken orally, with or without food. Swallow the tablets whole or halved, with a glass of water. The tablet can be divided into equal doses.
Elderly patients
Your doctor will carefully monitor your condition due to the increased risk of low blood pressure or sedation caused by the medicine. A dose reduction may be necessary due to kidney failure.
Patients with kidney problems
Your doctor may reduce the dose.

Use in children and adolescents

The efficacy and safety of amisulpride in patients from puberty to 18 years have not been established. Data on the use of amisulpride in adolescents with schizophrenia are limited. If it is absolutely necessary, treatment of patients from puberty to 18 years must be initiated and carried out by a doctor with experience in treating schizophrenia in this age group. Children before puberty should not take this medicine, as the safety of the medicine in this age group has not been established (see section "When not to take Amipryd").

Overdose of Amipryd

If you take more than the prescribed dose, contact your doctor or go to the nearest hospital immediately, as you may need medical attention. Take the medicine packaging with you so that the doctor knows what medicine you have taken. You may experience symptoms such as anxiety, tremors, muscle stiffness, or drowsiness, which can lead to loss of consciousness.

Missed dose of Amipryd

If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for the missed dose.

Stopping Amipryd

Continue taking Amipryd until your doctor tells you to stop. Do not stop taking the medicine just because you feel better.
Stopping the medicine may cause your illness to worsen or return. Do not stop taking Amipryd suddenly, unless your doctor decides otherwise. After sudden discontinuation of Amipryd, withdrawal symptoms may occur, such as nausea or vomiting, sweating, difficulty sleeping, or feelings of anxiety, muscle stiffness, or unusual body movements, and a return to the pre-treatment state.

Blood tests

Taking Amipryd may affect some blood test results. This includes measurements of prolactin levels and liver function tests. If you are going to have a blood test, inform your doctor that you are taking Amipryd.
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If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Amipryd can cause side effects, although not everybody gets them.
Amisulpride is generally well-tolerated, and it can be difficult to distinguish between the side effects of the medicine and the symptoms of the underlying illness. The following side effects may also occur with the use of other neuroleptics.

Stop taking the medicine and contact your doctor or go to the nearest emergency department if you experience any of the following side effects:

Uncommon (affects less than 1 in 100 people):

• seizures (convulsions);
• liver damage (symptoms include fatigue, loss of appetite, nausea, vomiting, abdominal pain, or yellowing of the eyes or skin).

Rare (affects less than 1 in 1,000 people):

• high fever, sweating, muscle stiffness, rapid heartbeat, rapid breathing, confusion, drowsiness, or agitation. These may be symptoms of a serious but rare condition called neuroleptic malignant syndrome;
• irregular heartbeat, rapid heartbeat, or chest pain, which can lead to a heart attack or life-threatening heart disease;
• blood clots in the veins, especially in the legs (symptoms include itching, pain, and redness of the legs). Clots can move through the bloodstream to the lungs, causing chest pain and difficulty breathing;
• allergic reactions (hypersensitivity): symptoms may include itchy rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue, hives, angioedema.

Contact your doctor immediately if you experience any of the following side effects:

Very common (affects more than 1 in 10 people):

• tremors, muscle stiffness, or spasms, slowed movements, increased saliva production, feelings of anxiety; uncontrolled movements, mainly of the hands and feet (these symptoms can be reduced if your doctor reduces the dose or prescribes an additional medicine).

Uncommon (affects less than 1 in 100 people):

• uncontrolled movements, mainly of the face and tongue;
• confusion (inadequate to reality, chaotic: speech, thinking, and behavior).

Frequency not known (cannot be estimated from the available data):

• withdrawal syndrome in newborns.

Other side effects have also been reported:

Common (affects less than 1 in 10 people):

• disrupted milk production in women and men and breast pain;
• amenorrhea;
• breast enlargement in men;
• erectile dysfunction;
• insomnia, anxiety, agitation;
• orgasm disorders; 5/7
• uncontrolled spasms of certain muscle groups: eye muscles (forced upward gaze), face, neck (jaw spasms, torticollis);
• drowsiness;
• blurred vision;
• low blood pressure;
• constipation, nausea, or vomiting, dry mouth;
• weight gain.

Uncommon (affects less than 1 in 100 people):

• leukopenia (reduced white blood cell count), neutropenia (reduced granulocyte count);
• hypertriglyceridemia (elevated triglyceride levels) and hypercholesterolemia (elevated cholesterol levels);
• high blood sugar, triglyceride, or cholesterol levels;
• slow heart rate;
• high blood pressure;
• nasal congestion;
• aspiration pneumonia;
• osteopenia (reduced bone density), osteoporosis;
• urinary retention;
• increased liver enzyme activity, mainly transaminases.

Rare (affects less than 1 in 1,000 people):

• agranulocytosis (reduced granulocyte count);
• prolonged QT interval on the electrocardiogram;
• benign pituitary tumor;
• hyponatremia (low sodium levels), syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Frequency not known (cannot be estimated from the available data):

• restless legs syndrome (a feeling of discomfort in the legs, temporarily relieved by movement, symptoms worsening at the end of the day);
• increased skin sensitivity to sunlight and ultraviolet radiation.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
phone: (22) 49 21 301, fax: (22) 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Amipryd

Keep the medicine out of sight and reach of children.
Store in the original packaging to protect from light, at a temperature below 25°C.
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Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Amipryd contains

• The active substance of the medicine is amisulpride. One tablet contains 100 mg, 200 mg, or 400 mg of amisulpride.
• The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (type A), hypromellose (2910), magnesium stearate.

What Amipryd looks like and contents of the pack

Amipryd is available as tablets:

• 100 mg: white, oval, and biconvex with a smooth, uniform surface, with a score line on both sides, approximately 11.1 x 6.3 mm in size,
• 200 mg: white, oval, and biconvex, with a uniform surface on one side and a "HL" engraving (with "H" on one side of the score line and "L" on the other) on the other, with a score line on both sides, approximately 14.0 x 8.0 mm in size,
• 400 mg: white, elongated, and biconvex with a smooth, uniform surface, with a score line on both sides, approximately 16.7 x 9.5 mm in size. The tablet can be divided into equal doses. One pack of the medicine contains 30 tablets in blisters in a cardboard box.

Marketing authorization holder and manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
Żmigrodzka Street 242 E, 51-131 Wrocław
Information about the medicine
phone: (22) 742 00 22
e-mail: [email protected]

Date of last revision of the leaflet:

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