DENIBAN 50 mg Tablet

Зміст інструкції

1. DENIBAN 50 mg tablets
   1. What is Deniban and what is it used for?
   2. What you need to know before you take Deniban
   3. How to take Deniban
   4. Possible side effects
   5. How to store Deniban
   6. Contents of the pack and other information

DENIBAN 50 mg tablets

amisulpride

Read this leaflet carefully before you start 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 may 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 Deniban is and what it is used for
• 2. What you need to know before you take Deniban
• 3. How to take Deniban
• 4. Possible side effects
• 5. How to store Deniban
• 6. Contents of the pack and other information

1. What is Deniban and what is it used for?

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

2. What you need to know before you take Deniban

Do not take Deniban:

• 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 your kidneys (pheochromocytoma);
• if you have breast cancer (mammary tumor) or a disorder called "prolactin-dependent tumor";
• if it is for a child; Deniban 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 (onset of torsade de pointes):
• medicines used in the treatment of irregular heartbeat such as: o antiarrhythmics of class Ia such as quinidine, disopyramide; o antiarrhythmics of class III such as amiodarone, sotalol;
• other medicines such as bepridil (for the treatment of irregular heartbeat), cisapride (for the treatment of gastric disorders), sultopride, thioridazine (for the treatment of mental disorders), methadone administered by injection (for the treatment of severe pain or to counteract drug addiction), vincamine administered by injection (for

increasing blood flow to the brain), alofantrine (for the treatment of malaria),
erythromycin, pentamidine, sparfloxacin (for the treatment of bacterial infections)
(see “Other medicines and Deniban“);

• levodopa, a medicine used to treat Parkinson's disease (see “Other medicines and Deniban”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Deniban.
Be particularly careful before taking Deniban, 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 renal insufficiency;
• you suffer from a disorder of kidney function because your doctor will reduce your dose or prescribe intermittent treatment (“How to take Deniban”);
• you suffer from epilepsy. During treatment with Deniban you may be subject to more frequent seizures. Therefore your doctor will monitor you during treatment;
• 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.

Reported decreases in certain types of white blood cells in the blood (leukopenia, neutropenia and agranulocytosis) have been reported with medicines used to treat psychosis, including Deniban. Unexplained infections or fever may indicate an imbalance in the composition of the blood (hematologic 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
fatal disease, characterized by hyperthermia (increased body temperature), muscle rigidity,
akinesia (movement disorders), irregular heartbeat and blood pressure,
sweating, increased heart rate, changes in heart rhythm, high levels of
creatine phosphokinase (a substance produced by the body that indicates possible muscle
damage), rhabdomyolysis (muscle damage) disorders of consciousness that can
progress to stupor and coma.
In case of high body temperature, especially when daily doses are
high, the doctor will discontinue the administration of any antipsychotic medicine,
including Deniban.
Amisulpride causes a disturbance of the heart called “QT interval prolongation”
(see “Possible side effects”) which increases the risk of heart rhythm disturbances
(serious ventricular arrhythmias, such as torsades de pointes). The doctor will check the condition of your heart, in
particular if you have other cardiovascular diseases or relatives with “QT interval prolongation”. It is necessary to avoid concomitant therapy with other neuroleptic medicines.
Deniban should be used with caution if risk factors for cerebrovascular disorders (stroke) are present.

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 Deniban, your doctor will perform checks to
identify any risk factors for a circulatory system disease called
“Venous Thromboembolism”.

Breast cancer
Deniban 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 Deniban.

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

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

Other medicines and Deniban
Tell your doctor or pharmacist if you are taking, have recently taken, or might
take any other medicines.
The effects of Deniban may be influenced by or influence the effects of the following medicines.
The association with other medicines of the same class as Deniban (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” (like Deniban) the risk of developing heart rhythm disturbances
(cardiac arrhythmias) increases.

• Some medicines that can cause serious heart rhythm disturbances (torsade de pointes) must not be used with Deniban. These include:
• medicines used to treat irregular heartbeat such as antiarrhythmics of class Ia (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, thioridazine (for the treatment of mental disorders), methadone administered by injection (for the treatment of severe pain or to counteract drug addiction), vincamine, administered by injection (to increase blood flow to the brain), alofantrine (for the treatment of malaria), erythromycin, pentamidine and sparfloxacin (for the treatment of bacterial infections).
• levodopa, a medicine used to treat Parkinson's disease, as the effects of levodopa and Deniban may influence each other.
• medicines classified as “dopamine agonists” such as bromocriptine and ropinirole (for the treatment of Parkinson's disease) because Deniban 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 by injection (for the treatment of fungal infections), glucocorticoids (for treating inflammatory disorders), tetracosactides (for treating 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 heart's pumping force);
• medicines with a strong sedative effect on the nervous system (neuroleptics such as pimozide, haloperidol), antidepressants (imipraminics, lithium);
• some medicines for the treatment of allergies (antihistamines);
• some medicines for the treatment of malaria (for example 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 (anti-hypertensives, such as clonidine and derivatives, and other hypotensive medicines).
• clozapine, because it can lead to an increase in amisulpride levels in the blood.

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

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect or are planning
a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not take Deniban if you are pregnant, or if you suspect you are and if you are of childbearing potential and are not using
effective contraceptive methods.
If you have used Deniban 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 with milk during therapy with Deniban. Ask your doctor
if you are taking Deniban.

Driving and using machines
Deniban may cause drowsiness and blurred vision and therefore the ability to
drive vehicles or use machinery may be impaired (see “Possible side effects”).
Deniban tablets contains lactose.
If your doctor has diagnosed you with an intolerance to some sugars, contact him before taking
this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is
essentially ‘sodium-free’.

3. How to take Deniban

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.

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

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

If you take more Deniban than you should
If you have taken more Deniban 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.
Fatal cases 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 Deniban, inform
your doctor immediately or go to the nearest hospital.

If you forget to take Deniban
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, Deniban can cause side effects, although not everybody gets them.

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

• tremor
• rigidity
• slowing down or reduction of spontaneous body movements (hypokinesia)
• increased salivation (hypersalivation)
• feeling of restlessness (akathisia)
• movement alterations (dyskinesia) These disorders are generally mild at recommended dosages and partially reversible with the administration of antiparkinson medicines, even without stopping Deniban.

Common (may affect up to 1 in 10 people)

• muscle cramps, especially in the neck (spasmodic torticollis), eyes (oculogyric crisis) and jaw (trismus) which are reversible with the administration of appropriate medicines, prescribed by the doctor, even without stopping therapy with Deniban
• drowsiness or insomnia
• anxiety
• agitation
• psychomotor excitability
• orgasm anomalies
• blurred vision (see “Driving and using machines”)
• heartbeat disorders (prolongation of the QT interval)
• 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 milk production in women and men (galactorrhea)
• absence of menstruation (amenorrhea)
• breast enlargement in men (gynecomastia)
• breast pain (mastodynia)
• erection dysfunction These disorders disappear after stopping therapy with Deniban.
• 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)
• 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
• elevated blood sugar levels
• slowing of the heartbeat (bradycardia)
• palpitations
• increase in liver enzyme levels (particularly transaminases)
• allergic reactions
• increased triglycerides and cholesterol in the blood (hypertriglyceridemia and hypercholesterolemia)
• confusion
• increased blood pressure
• blocked nose
• aspiration pneumonia due to aspiration of 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)
• benign pituitary tumor such as prolactinoma
• 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”)
• heartbeat disorders (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)
• rapid swelling of legs, arms, face or tongue (angioedema)
• urticaria.

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

• drug withdrawal symptoms in newborns of mothers who have taken Deniban (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)
• falls due to reduced body balance, which can lead to fractures
• rhabdomyolysis (muscle breakdown associated with muscle pain)
• high levels of creatine phosphokinase (blood test indicating muscle damage).

Mild chills, difficulty breathing (dyspnea), muscle pain 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 the address
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 Deniban

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 eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Deniban contains
Deniban 50 mg tablets

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

Description of the appearance of Deniban and contents of the pack
Deniban 50 mg tablets are presented 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