Amipyridine

Package leaflet: Information for the patient

Amipryd, 100 mg, tablets
Amipryd, 200 mg, tablets
Amipryd, 400 mg, tablets
Amisulpridum
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

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

Leaflet contents

1. What Amipryd is and what it is 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 Amipryd is and what it is used for

Amipryd contains the active substance amisulpride, which has antipsychotic and neuroleptic properties.
Amipryd is indicated for the treatment of acute and chronic schizophrenia with positive symptoms (such as delusions, hallucinations, thought disorders, hostility, and suspicion) and/or negative symptoms (such as emotional blunting, emotional and social withdrawal), including patients with predominant negative symptoms.

2. Important information before using Amipryd

When not to use Amipryd

• if the patient is allergic to amisulpride or any of the other ingredients of this medicine (listed in section 6). Allergic reaction may manifest as rash, difficulty swallowing or breathing, swelling of lips, face, throat or tongue;
• if the patient has a tumour whose growth is dependent on prolactin levels, i.e. pituitary adenoma type prolactinoma, breast cancer;
• if the patient has a phaeochromocytoma;
• if the patient is taking levodopa or medicines that may cause severe cardiac arrhythmias (see section "Amipryd with other medicines");
• in children before puberty.

This medicine should not be taken if any of the above conditions apply to the patient.
If in doubt, consult a doctor or pharmacist before starting treatment with Amipryd.
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Warnings and precautions

Before starting treatment with Amipryd, discuss this with a doctor, especially if:

• the patient has kidney disease;
• the patient has Parkinson's disease;
• the patient has seizures (epilepsy);
• the patient has abnormal heart function (heart rhythm);
• the patient has or has had heart disease or there is a family history of heart disease;
• the patient has a slow heart rate (less than 55 beats per minute);
• the patient has low blood potassium levels;
• the patient has an increased risk of stroke;
• the patient or anyone in their family has ever had blood clots, as use of medicines such as Amipryd may be associated with blood clot formation;
• the patient has diabetes or an increased risk of diabetes;
• the patient is elderly, as such patients have a higher risk of low blood pressure and excessive drowsiness. In elderly patients with dementia treated with antipsychotic medicines, a slight increase in mortality has been observed compared to patients not treated with antipsychotics;
• the patient has a low white blood cell count (agranulocytosis), which may increase susceptibility to infections;
• the patient or anyone in their family has had breast cancer;
• the patient has frequent infections with symptoms such as fever, severe chills, sore throat or mouth ulcers. These may be symptoms of a blood disorder called leukopenia;
• the patient has visual field defects and headaches. These may be symptoms of a benign pituitary tumour.

Severe liver function disorders have been reported with use of amisulpride. Contact a doctor immediately if fatigue, loss of appetite, nausea, vomiting, abdominal pain, yellowing of the eyes or skin occur.

Children and adolescents

This medicine must not be used in children before puberty.

Amipryd with other medicines

Tell your doctor or pharmacist about all medicines currently used, recently used or planned to be used.

Amisulpride may affect the action of certain medicines, and certain medicines may affect the action of amisulpride. In particular, the use of Amipryd is contraindicated:

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

Also inform the doctor if the patient is taking any of the following medicines:

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

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• medicines causing potassium loss, including diuretics, laxatives, intravenous amphotericin B, glucocorticosteroids (used to treat asthma or rheumatoid arthritis) and tetracosactide (which may be used in clinical testing);
• other medicines used for mental health problems, e.g. to treat schizophrenia (such as pimozide or haloperidol) or depression (such as imipramine or lithium);
• antihistamines (used for allergies), e.g. astemizole, terfenadine;
• mefloquine (used to treat malaria);
• painkillers such as tramadol and indometacin, and opioids used for severe pain such as morphine or pethidine;
• anaesthetics;
• medicines that help sleep, such as barbiturates and benzodiazepines.

Amipryd with food, drink and alcohol

Amisulpride may enhance the effect of alcohol; therefore, alcohol should not be consumed during treatment. The medicine can be taken with or without food.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy

Use of this medicine during pregnancy is not recommended unless, in the opinion of the doctor, the benefits outweigh the risks.

In newborns whose mothers took antipsychotic medicines (including amisulpride) during the third trimester of pregnancy, adverse effects of varying severity and duration may occur.

Symptoms observed include agitation, hypertonia, hypotonia, tremor, drowsiness, breathing difficulties or feeding disorders. If such symptoms are observed in your child, contact a doctor.

Breastfeeding

Amipryd should not be taken during breastfeeding or when planning to breastfeed.

Discuss with your doctor the best way to feed your baby during treatment with Amipryd.

Fertility

In animal studies, reduced fertility related to the pharmacological action of the medicine has been observed.

Driving and operating machinery

Amipryd may cause drowsiness and blurred vision. If such symptoms occur, do not drive or operate machinery.

Amipryd contains lactose

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Amipryd contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Amipryd

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
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Dosage
Always follow your doctor's instructions. Your doctor will determine the dose based on the severity of the illness and your individual response to the medicine.
The usual dose ranges from 50 mg to 800 mg per day.
Your doctor may start treatment with a lower dose or, if necessary, recommend a dose up to 1200 mg per day.
Doses up to 400 mg may be taken as a single dose. Higher doses should be divided and taken twice daily – half in the morning and half in the evening.
The medicine should be taken at the same time each day.
Amipryd is taken orally, with or without food. Tablets should be swallowed whole or halved, with water. The tablet may be divided into equal doses.

Elderly patients
Your doctor will monitor your condition carefully due to an increased risk of low blood pressure or drowsiness caused by the medicine. Dose reduction may be required due to impaired kidney function.

Patients with renal impairment
Your doctor may reduce the dose.

Use in children and adolescents
The efficacy and safety of amisulpride in patients from puberty up to 18 years of age have not been established. Data on the use of amisulpride in adolescents with schizophrenia are limited. If absolutely necessary, treatment of patients from puberty up to 18 years of age must be initiated and supervised by a physician experienced in treating schizophrenia in this age group. This medicine must not be given to children before puberty, as safety has not yet been established in this age group (see section "When not to use Amipryd").

Taking more Amipryd than prescribed
If you take more medicine than prescribed, contact your doctor immediately or go to the nearest hospital, as specialist medical help may be required. Take the medicine pack with you so the doctor knows which medicine has been taken. Symptoms may include anxiety, tremor, muscle stiffness, or drowsiness, which may lead to loss of consciousness.

If you miss a 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 a missed dose.

Stopping Amipryd
Continue taking Amipryd as long as your doctor advises. Do not stop taking the medicine just because you feel better. Stopping the medicine may cause your condition to worsen or return. Do not stop taking Amipryd suddenly unless your doctor tells you to. Sudden discontinuation may lead to withdrawal symptoms such as nausea or vomiting, sweating, difficulty sleeping, restlessness, muscle stiffness, or unusual body movements, and a return to the pre-treatment condition.

Blood tests
Taking Amipryd may affect certain blood test results, including prolactin hormone levels and liver function tests. If you are scheduled for blood tests, inform your doctor that you are taking Amipryd.
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If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Amisulpride is generally a well-tolerated medicine, and sometimes it may be difficult to distinguish
the adverse reactions of the medicine from the symptoms of the underlying disease. The following
adverse reactions may also occur with other antipsychotics.
You should stop taking the medicine and contact your doctor or go to the nearest hospital emergency
department if the patient experiences any of the following adverse reactions:
Not common (affects less than 1 in 100 patients):

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

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

• High fever, sweating, muscle stiffness, rapid heartbeat, fast 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 may 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 in the limbs). Blood clots may travel through blood vessels to the lungs, causing chest pain and difficulty breathing;
• Allergic (hypersensitivity) reactions: symptoms may include itchy rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue, urticaria, angioedema.

You should contact your doctor immediately if any of the following adverse reactions occur:
Very common (affects more than 1 in 10 patients):

• Tremor, muscle stiffness or spasms, slowed movement, increased salivation, restlessness; uncontrolled movements, mainly of the hands and feet (these symptoms can be reduced if the doctor reduces the dose or prescribes an additional medicine).

Not common (affects less than 1 in 100 patients):

• Uncontrolled movements, mainly of the face and tongue;
• Confusion (disconnected from reality, chaotic: speech, thinking, and behavior).

Frequency unknown (cannot be estimated from available data):

• Withdrawal syndrome in newborns.

Other adverse reactions have also been reported:
Common (affects less than 1 in 10 patients):

• Disrupted milk production in women and men and breast pain;
• Absence of menstruation;
• Breast enlargement in men;
• Erectile dysfunction;
• Insomnia, anxiety, agitation;
• Orgasm disorders; 5/7
• Uncontrolled contractions of certain muscle groups: eyes (forced upward gaze), face, neck (trismus, torticollis);
• Drowsiness;
• Blurred vision;
• Low blood pressure;
• Constipation, nausea, or vomiting, dry mouth;
• Weight gain.

Not common (affects less than 1 in 100 patients):

• Leukopenia (reduced number of white blood cells in blood), neutropenia (reduced number of a type of white blood cells – neutrophils – in blood);
• Hypertriglyceridemia (elevated blood triglyceride levels above normal, associated with increased risk of atherosclerosis) and hypercholesterolemia (elevated blood cholesterol levels above normal);
• High levels of glucose, triglycerides, or cholesterol in blood;
• Slowed heart function;
• Increased blood pressure;
• Nasal mucosal congestion;
• Aspiration pneumonia;
• Osteopenia (reduced bone density), osteoporosis;
• Urinary retention;
• Increased liver enzyme activity, mainly transaminases.

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

• Agranulocytosis (reduced number of a type of white blood cells – granulocytes – in blood);
• QT interval prolongation in electrocardiogram;
• Benign pituitary gland tumor (a gland located in the brain);
• Hyponatremia (reduced blood sodium concentration below normal), syndrome of inappropriate antidiuretic hormone secretion (SIADH – a condition caused by excessive release of antidiuretic hormone – vasopressin – from the pituitary gland).

Frequency unknown (cannot be estimated from available data):

• Restless legs syndrome (uncomfortable sensation in legs temporarily relieved by movement, symptoms worsening in the evening);
• Increased skin sensitivity to sunlight and ultraviolet radiation.

Reporting of adverse reactions
If any adverse reactions occur, including any not mentioned in this leaflet, you should inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: (22) 49 21 301, Fax: (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Amipryd

Keep the medicine out of the 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 stated month.
Medicines must 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 packaging and other information

What Amipryd contains

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

What Amipryd looks like and contents of the pack
Amipryd is available as tablets:

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

Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
ul. Żmigrodzka 242 E, 51-131 Wrocław
Medicinal product information
tel.: (22) 742 00 22
e-mail: [email protected]
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