SULAMID 50 mg Tabletka

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1. SULAMID 50 mg tablets
   1. Cos’è SULAMID e a cosa serve
   2. Cosa deve sapere prima di prendere SULAMID
   3. How to take SULAMID
   4. Possible side effects
   5. How to store SULAMID
   6. Contents of the pack and other information

SULAMID 50 mg tablets

amisulpride

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. Cos’è SULAMID e a cosa serve

SULAMID contains amisulpride, which belongs to a class of medicines called “Psycholeptics, benzamides”.
SULAMID is indicated for the treatment (short – medium term) of forms of mental illness
resulting from a severe disorder of affective tone, characterized by states of pessimism or
depression (dysthymia).

2. Cosa deve sapere prima di prendere SULAMID

Do not take SULAMID:

• if you are allergic to amisulpride or to any of the other ingredients of this medicine (listed in section 6);
• if you have a tumor of the gland located above the kidneys (pheochromocytoma);
• if you have breast cancer (mammary tumor) or a disorder called “prolactin-dependent tumor” (see “Warnings and precautions”);
• if you are breastfeeding;
• if you are a child; SULAMID cannot be taken before the end of the developmental age (puberty);
• if you are taking any of the following medicines, as they may cause serious heart rhythm disturbances (development of torsade de pointes):
• medicines used in the treatment of irregular heartbeat such as: -
• class Ia antiarrhythmics such as quinidine, disopyramide;
• class III antiarrhythmics such as amiodarone, sotalol;
• other medicines such as bepridil (for the treatment of irregular heartbeat), cisapride (for the treatment of gastric disorders), sultopride and thioridazine (for the treatment of mental disorders), methadone (for the treatment of severe pain or to counteract drug addiction), vincamine administered intravenously (to increase blood flow to the brain), halofantrine (for the treatment of malaria), erythromycin administered intravenously, pentamidine and sparfloxacin (for the treatment of bacterial infections) (see “Other medicines and SULAMID”);
• levodopa, a medicine used to treat Parkinson's disease (see “Other medicines and SULAMID”).

Warnings and precautions
Talk to your doctor or pharmacist before taking SULAMID.
Be particularly careful before taking SULAMID especially if:

• you are elderly as you are more likely to experience low blood pressure and drowsiness. A reduction in dosage may also be required in case of kidney failure;
• you suffer from a disorder of kidney function because your doctor will reduce your dose or prescribe intermittent treatment (see “How to take SULAMID”);
• you suffer from epilepsy. During treatment with SULAMID you may be subject to more frequent seizures. Therefore your doctor will monitor you during treatment;
• if you suffer from Parkinson's disease because this medicine may worsen your condition;
• you suffer from hyperglycemia. Therefore patients with a definite diagnosis or risk factors for diabetes should undergo appropriate blood sugar control if undergoing treatment with amisulpride.

Reported decreases in certain types of white blood cells in the blood (leukopenia, neutropenia and agranulocytosis) have been reported with medicines used to treat psychoses, including SULAMID. Unexplained infections or fever may indicate an imbalance in the composition of the blood (hematological dyscrasia - see “Possible side effects”), which requires immediate blood tests.
As with other medicines that act on the Central Nervous System, a set of disorders called Neuroleptic Malignant Syndrome may occur, a potentially life-threatening condition characterized by hyperthermia (increased body temperature), muscle rigidity, akinesia (movement disorders), irregular heartbeat and blood pressure, sweating, increased heart rate, altered heart rhythm, high levels of creatine phosphokinase (a substance produced by the body that indicates possible muscle damage), rhabdomyolysis (muscle damage) and disturbances in consciousness that can progress to stupor and coma.
If you have a high body temperature, especially when daily doses are high, your doctor will stop administering any antipsychotic medicine, including SULAMID.
Amisulpride causes a heart disorder called “QT interval prolongation” (see “Possible side effects”) which increases the risk of heart rhythm disturbances (serious ventricular arrhythmias, such as torsade de pointes). Your doctor will check your heart condition, especially if you have other cardiovascular diseases or relatives with “QT interval prolongation”. It is necessary to avoid concomitant therapy with other neuroleptic medicines.
SULAMID should be used with caution if there are risk factors for cerebrovascular disorders (stroke).

Elderly patients with dementia-related psychosis
The risk of death is higher in elderly patients with dementia.

Disease of the circulatory system called “Venous Thromboembolism” (VTE)
Before and during treatment with SULAMID, your doctor will perform checks to identify any risk factors for a circulatory system disease called “Venous Thromboembolism” (see “Possible side effects”).

Breast cancer
SULAMID may increase levels of prolactin (a hormone that acts on the breast). If you have a personal or family history of breast cancer, your doctor will monitor you during therapy with SULAMID.

Benign pituitary tumor
SULAMID may increase levels of prolactin (a hormone that acts on the breast). Cases of abnormal growth of a gland called the pituitary gland or hypophysis (benign pituitary tumor such as prolactinoma) have been observed during therapy with SULAMID (see “Possible side effects”). If very high levels of prolactin or clinical signs of a pituitary tumor (such as visual field defects and headache) are found, your doctor will perform checks. If the diagnosis of pituitary tumor is confirmed, your doctor will stop treatment with SULAMID.
Following the abrupt discontinuation of high therapeutic doses of antipsychotic medicines, withdrawal symptoms have been described, including nausea, vomiting and insomnia.
Mental disorders (psychotic) may also reappear, and with SULAMID, the onset of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported.
Therefore your doctor will gradually stop you from taking SULAMID.
Serious liver toxicity has been reported following the use of SULAMID. Contact your doctor immediately if you experience fatigue, loss of appetite, nausea, vomiting, abdominal pain or yellowish discoloration of the eyes and skin (see “Possible side effects”).

Children and adolescents
SULAMID should not be given to children until puberty and is not recommended until the age of 18.

Other medicines and SULAMID
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The effects of SULAMID may be affected by or affect the effects of the following medicines.
Association with other medicines of the same class as SULAMID (psychotropic drugs) requires particular caution and vigilance on the part of the doctor to avoid unexpected side effects.
When drugs called neuroleptics are administered in conjunction with drugs that “prolong the QT” (such as SULAMID), the risk of developing alterations in heart rhythm (cardiac arrhythmias) increases.
Contraindicated associations

• Some medicines that can cause serious heart rhythm disturbances (torsade de pointes) must not be used with SULAMID. These include:
• medicines used to treat irregular heartbeat such as class Ia antiarrhythmics (e.g. quinidine, disopyramide) and class III antiarrhythmics (e.g. amiodarone, sotalol);
• other medicines such as bepridil (for the treatment of irregular heartbeat), cisapride (for the treatment of gastric disorders), sultopride and thioridazine (for the treatment of mental disorders), methadone (for the treatment of severe pain or to counteract drug addiction), vincamine administered intravenously (to increase blood flow to the brain), halofantrine (for the treatment of malaria), erythromycin administered intravenously, pentamidine and sparfloxacin (for the treatment of bacterial infections);
• levodopa, a medicine used to treat Parkinson's disease, as the effects of levodopa and SULAMID may influence each other;
• medicines classified as “dopamine agonists” such as bromocriptine and ropinirole (for the treatment of Parkinson's disease) because SULAMID may counteract their effect;
• medicines that may cause a decrease in blood potassium levels (hypokalemia) such as: potassium-depleting diuretics, stimulant laxatives, amphotericin B administered intravenously (for the treatment of fungal infections), glucocorticoids (to treat inflammatory disorders), tetracosactides (to treat a severe form of epilepsy). The reduction in potassium in the blood will be corrected with adequate therapy by the doctor.

Associations not recommended

• Medicines that can cause serious heart rhythm disturbances (increase the risk of torsade de pointes or may prolong the QT interval):
• medicines that can reduce the heartbeat: beta-blockers, calcium channel blockers, such as: diltiazem, verapamil, guanfacine, clonidine (for the treatment of high blood pressure) and digitalis (to improve the pumping force of the heart);
• medicines with a strong sedative effect on the nervous system (neuroleptics such as pimozide, haloperidol, clozapine), antidepressants (tricyclic antidepressants, lithium);
• some medicines for the treatment of allergies (antihistamines);
• some medicines for the treatment of malaria (e.g. mefloquine).

Associations to be considered with caution

• medicines that act on the Central Nervous System (including: hypnotics, tranquilizers, anesthetics, analgesics, H1 antihistamines with a sedative effect), medicines that calm, induce sleep or relax muscles (barbiturates, benzodiazepines and other anxiolytics);
• medicines to regulate blood pressure (antihypertensives, such as clonidine and derivatives, and other hypotensive medicines);

SULAMID with alcohol
SULAMID may increase some disorders caused by alcohol.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take SULAMID if you are pregnant, or suspect you are and if you are of childbearing potential and are not using effective contraception.
If you have used SULAMID during the last three months of pregnancy, the baby may experience agitation, increased muscle tension, involuntary tremor of the body, drowsiness, breathing problems or difficulty feeding. If your baby shows any of these symptoms, contact your doctor.
Breastfeeding
Do not breastfeed while taking SULAMID. Ask your doctor if you are taking SULAMID.

Driving and using machines
SULAMID may cause drowsiness and blurred vision and therefore the ability to drive vehicles and use machinery may be impaired (see “Possible side effects”).

SULAMID contains lactose
If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodiumper tablet, i.e. essentially “sodium-free”.

3. How to take SULAMID

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is one 50 mg tablet per day or as prescribed by your doctor.

Use in the elderly
If you are elderly, your doctor will carefully assess the recommended dose, as there is a possible
risk of low blood pressure (hypotension) and excessive drowsiness
(sedation). If necessary, your doctor may consider a possible dose reduction, in
particular in patients with kidney problems.

Use in children and adolescents
SULAMID should not be given to children until puberty.
The use of SULAMID from development (puberty) up to the age of 18 years is not recommended.

Impaired renal function (renal insufficiency)
Your doctor will prescribe you a lower dose, depending on the degree of renal impairment.

If you take more SULAMID than you should
If you have taken more SULAMID than prescribed by your doctor, you may
experience drowsiness or sedation, low blood pressure (hypotension), tremors,
stiffness, increased saliva, movement disorders (extrapyramidal symptoms) and coma. Cases with
fatal outcome have been reported, especially in association with other medicines for mental
illnesses (psychotropic agents).
In case of accidental ingestion/intake of an excessive dose of SULAMID, immediately inform
your doctor or go to the nearest hospital.

If you forget to take SULAMID
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 people)

• tremor
• muscle rigidity
• slowing or reduction of spontaneous body movements (hypokinesia)
• increased salivation (salivary hypersecretion)
• feeling of restlessness (akathisia)
• movement alterations (dyskinesia).

Common (may affect up to 1 in 10 people)

• muscle spasms, especially in the neck (torticollis), eyes (oculogyric crisis) and jaw (trismus)
• drowsiness or insomnia
• anxiety
• agitation
• excitability (hyperactivity) at the psychomotor level
• orgasm anomalies
• blurred vision (see “Driving and using machines”)
• constipation
• nausea
• vomiting
• dry mouth
• difficulty digesting food (dyspepsia)
• increase in the levels of a hormone in the blood called prolactin which can cause:
• unusual production of milk in women and men (galactorrhea)
• absence of menstruation (amenorrhea)
• breast enlargement in men (gynecomastia)
• breast pain
• erection dysfunction.
• low blood pressure (hypotension)
• weight gain.

Uncommon (may affect up to 1 in 100 people)

• decrease in some types of cells present in the blood (leukopenia, neutropenia) (see “Warnings and precautions”)
• movement disorders including uncontrollable movements of the tongue, mouth and face (tardive dyskinesia). These can occur during or after a period of prolonged treatment
• convulsions
• high blood sugar level (hyperglycemia)
• slowing of the heartbeat (bradycardia)
• palpitations
• increase in liver enzyme levels (particularly transaminases)
• allergic reactions (hypersensitivity)
• increase in triglycerides and cholesterol in the blood (hypertriglyceridemia and hypercholesterolemia)
• confusional state
• increased blood pressure
• blocked nose
• aspiration pneumonia due to foreign material (mainly in association with other psychotropic drugs and drugs that act on the Central Nervous System)
• osteopenia and osteoporosis (increased bone fragility)
• inability to completely empty the bladder (urinary retention)
• liver tissue damage (hepatocellular trauma).

Rare (may affect more than 1 in 1,000 people)

• decrease in some types of cells present in the blood (agranulocytosis) (see “Warnings and precautions”)
• benign pituitary tumor such as prolactinoma (see “Do not take SULAMID” and “Warnings and precautions”)
• reduction in sodium concentration in the plasma (hyponatremia), inappropriate secretion of the antidiuretic hormone (SIADH)
• combination of fever, rapid breathing, sweating, muscle rigidity and decreased state of consciousness associated with a serious disorder known as “neuroleptic malignant syndrome”, sometimes fatal (see “Warnings and precautions”)
• heart rhythm disturbances (prolongation of the QT interval, ventricular arrhythmias such as torsade de pointes, ventricular tachycardia which can lead to ventricular fibrillation or cardiac arrest and sudden death) (see “Warnings and precautions”)
• blood clots in the veins (venous thromboembolism, including pulmonary embolism, also fatal and deep vein thrombosis) (see “Warnings and precautions”)
• rapid swelling of legs, arms, face or tongue (angioedema)
• urticaria.

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

• drug withdrawal symptoms in newborns of mothers who have taken SULAMID (neonatal withdrawal syndrome, extrapyramidal disorders)
• feeling of discomfort in the legs temporarily relieved by movement and symptoms that worsen at the end of the day (restless legs syndrome)
• increased skin sensitivity to the sun and ultraviolet rays (photosensitivity reaction)
• rhabdomyolysis (muscle breakdown associated with muscle pain)
• high levels of creatine phosphokinase (blood test indicating muscle damage)
• falls due to reduced body balance, which can sometimes result in fractures.

Mild chills, difficulty breathing (dyspnea), muscle pain (myalgia) have also been observed.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store SULAMID

This medicine does not require any particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister after
“Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What SULAMID contains

• The active ingredient is amisulpride. Each tablet contains 50 mg of amisulpride.
• The other ingredients are: sodium carboxymethylcellulose (type A), lactose monohydrate, microcrystalline cellulose, hypromellose, magnesium stearate.

Description of the appearance of SULAMID and contents of the pack
SULAMID 50 mg tablets are in the form of tablets: pack of 12 tablets.

Marketing Authorisation Holder
Sanofi S.r.l. – Viale L. Bodio, 37/B – Milan
Manufacturer
Delpharm Dijon, 6 Boulevard de l’Europe – 21800 Quétigny (France)