Sulamid

Patient Information Leaflet

SULAMID 50 mg tablets

amisulpride
Please read all of this leaflet carefully before taking this medicine because 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 taking SULAMID
3. How to take SULAMID
4. Possible side effects
5. How to store SULAMID
6. Contents of the pack and other information

1. What SULAMID is and what it is used for

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

2. What you should know before taking 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 it is for a child; SULAMID must not be taken before completion of development (puberty);
• if you are taking any of the following medicines, because they may cause serious disturbances in heart rhythm (torsade de pointes):
• medicines used to treat irregular heartbeat such as:
• class Ia antiarrhythmics such as quinidine, disopyramide;
• class III antiarrhythmics such as amiodarone, sotalol;
• other medicines such as bepridil (for treatment of irregular heartbeat), cisapride (for treatment of gastric disorders), sultopride and thioridazine (for treatment of mental disorders), methadone (for treatment of severe pain or to counteract drug addiction), intravenous vincamine (to increase blood flow to the brain), halofantrine (for treatment of malaria), intravenous erythromycin, pentamidine and sparfloxacin (for 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.
Pay particular attention before taking SULAMID, especially if:

• you are elderly, as you may be more likely to experience low blood pressure and drowsiness. A dose reduction may also be required in case of renal impairment;
• you suffer from impaired kidney function, because your doctor will reduce your dose or prescribe an intermittent treatment (see "How to take SULAMID");
• you have epilepsy. During treatment with SULAMID, you may experience more frequent seizures. Therefore, your doctor will monitor you during treatment;
• you have Parkinson's disease, because this medicine may worsen your condition;
• you have hyperglycemia. Therefore, patients with a confirmed diagnosis or risk factors for diabetes should undergo appropriate blood glucose monitoring while on amisulpride therapy.

With medicines used to treat psychosis, including SULAMID, decreases in certain types of white blood cells in the blood (leukopenia, neutropenia, and agranulocytosis) have been reported. Unexplained infections or fever may indicate an imbalance in blood composition (hematological dyscrasia - see "Possible side effects"), which requires immediate blood tests.
As with other medicines acting on the Central Nervous System, a group of symptoms known as Neuroleptic Malignant Syndrome, a potentially life-threatening condition, may occur. This is characterized by hyperthermia (elevated body temperature), muscle rigidity, akinesia (movement disorders), irregular heartbeat and blood pressure, sweating, increased heart rate, heart rhythm abnormalities, elevated creatine phosphokinase levels (a substance produced by the body indicating possible muscle damage), rhabdomyolysis (muscle damage), and disturbances in consciousness that may progress to stupor and coma.
If you develop high body temperature, particularly when daily doses are high, your doctor will discontinue any antipsychotic medicine, including SULAMID.
Amisulpride causes a heart disturbance 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 monitor your heart condition, especially if you have other cardiovascular diseases or family members with "QT interval prolongation". Concomitant therapy with other neuroleptic medicines should be avoided.
SULAMID should be used with caution if risk factors for cerebrovascular disorders (stroke) are present.

Elderly patients with psychosis associated with dementia
In elderly patients with dementia, the risk of death is increased.

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

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

Benign pituitary tumor
SULAMID may increase levels of prolactin (a hormone acting on the breast). During treatment with SULAMID, cases of abnormal growth of a gland called the pituitary or hypophysis (benign pituitary tumor such as prolactinoma) have been observed (see "Possible side effects"). If you have very high levels of prolactin or clinical signs of pituitary tumor (such as visual field defects and headache), your doctor will perform appropriate checks. If a diagnosis of pituitary tumor is confirmed, your doctor will discontinue treatment with SULAMID.

After abrupt discontinuation of high therapeutic doses of antipsychotic medicines, withdrawal symptoms (such as nausea, vomiting, and insomnia) have been reported.
Psychotic symptoms may also recur, and with SULAMID, the onset of involuntary movement disorders (such as akathisia, dystonia, and dyskinesia) has been reported.
Therefore, your doctor will gradually discontinue SULAMID.

Severe 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 yellowing of the eyes and skin (jaundice) (see "Possible side effects").

Children and adolescents
SULAMID must not be given to children before puberty and is not recommended for use under 18 years of age.

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 influenced by, or may influence the effects of, the following medicines.
Combination with other medicines of the same class as SULAMID (psychotropic drugs) requires particular caution and monitoring by your doctor to avoid unexpected side effects.
When drugs known as neuroleptics are administered concomitantly with drugs that "prolong the QT interval" (such as SULAMID), the risk of developing heart rhythm disturbances (cardiac arrhythmias) increases.

Contraindicated combinations

• Certain medicines that may cause serious disturbances in heart rhythm (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 treatment of irregular heartbeat), cisapride (for treatment of gastric disorders), sultopride and thioridazine (for treatment of mental disorders), methadone (for treatment of severe pain or to counteract drug addiction), intravenous vincamine (to increase blood flow to the brain), halofantrine (for treatment of malaria), intravenous erythromycin, pentamidine and sparfloxacin (for treatment of bacterial infections);
• levodopa, a medicine used to treat Parkinson's disease, because the effects of levodopa and SULAMID may interact;
• medicines classified as "dopamine agonists" such as bromocriptine and ropinirole (for treatment of Parkinson's disease), since SULAMID may counteract their effect;
• medicines that may cause low potassium levels in the blood (hypokalemia), such as: potassium-depleting diuretics, stimulant laxatives, intravenous amphotericin B (for treatment of fungal infections), glucocorticoids (for treatment of inflammatory disorders), tetracosactide (for treatment of a severe form of epilepsy). Low potassium levels will be corrected with appropriate medical therapy.

Not recommended combinations

• Medicines that may cause serious disturbances in heart rhythm (increasing the risk of torsade de pointes or prolonging the QT interval):
• medicines that may reduce heart rate: beta-blockers, calcium channel blockers such as diltiazem, verapamil, guanfacine, clonidine (for treatment of high blood pressure), and digitalis (to improve the heart's pumping strength);
• medicines with strong central nervous system depressant effects (neuroleptics such as pimozide, haloperidol, clozapine), antidepressants (tricyclics, lithium);
• some medicines used to treat allergies (antihistamines);
• some medicines used to treat malaria (e.g., mefloquine).

Combinations requiring caution

• medicines acting on the Central Nervous System (including: hypnotics, tranquilizers, anesthetics, analgesics, sedating H1 antihistamines), medicines that calm, induce sleep, or relax muscles (barbiturates, benzodiazepines, and other anxiolytics);
• medicines used to regulate blood pressure (antihypertensives, such as clonidine and its derivatives, and other antihypertensive medicines);

SULAMID and alcohol
SULAMID may increase some disturbances caused by alcohol.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take SULAMID if you are pregnant, suspect you are pregnant, or are of childbearing age and not using effective contraception.
If you have taken SULAMID during the last three months of pregnancy, the newborn may show agitation, increased muscle tone, involuntary tremors, drowsiness, breathing difficulties, or feeding problems. If your baby shows any of these symptoms, contact your doctor.

Breastfeeding
You must not breastfeed while taking SULAMID. Consult your doctor if you are taking SULAMID.

Driving and using machines
SULAMID may cause drowsiness and blurred vision, thus impairing your ability to drive or operate machinery (see "Possible side effects").

SULAMID contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".

3. How to take SULAMID

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one 50 mg tablet daily, or as otherwise 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 reducing the dose, particularly in patients with kidney problems.

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

Impaired kidney function (renal insufficiency)
Your doctor will prescribe a lower dose depending on the degree of kidney 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, rigidity, increased salivation, movement disorders (extrapyramidal symptoms), and coma. Fatal cases have been reported, particularly when associated with other medicines for mental disorders (psychotropic agents).
In case of accidental overdose of SULAMID, contact your doctor immediately or go to the nearest hospital.

If you forget to take SULAMID
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult 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 stiffness
• slowing down or reduction of the body's spontaneous movements (hypokinesia)
• increased salivation (hypersalivation)
• feeling of restlessness (akathisia)
• movement disorders (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
• psychomotor hyperactivity (excitability)
• orgasm abnormalities
• blurred vision (see "Driving and use of machines")
• constipation
• nausea
• vomiting
• dry mouth
• indigestion (dyspepsia)
• increased levels of a hormone in the blood called prolactin, which may cause:
  • unusual milk production in women and men (galactorrhoea)
  • absence of menstruation (amenorrhoea)
  • breast enlargement in men (gynaecomastia)
  • breast pain
  • erectile dysfunction
• low blood pressure (hypotension)
• weight gain

Uncommon (may affect up to 1 in 100 people)

• decrease in certain types of blood cells (leucopenia, neutropenia) (see "Warnings and precautions")
• movement disorders including uncontrollable movements of the tongue, mouth and face (tardive dyskinesia). These may occur during or after prolonged treatment
• seizures
• high blood sugar levels (hyperglycaemia)
• slow heart rate (bradycardia)
• palpitations
• increased liver enzyme levels (particularly transaminases)
• allergic reactions (hypersensitivity)
• increased triglycerides and cholesterol in the blood (hypertriglyceridaemia and hypercholesterolaemia)
• confusion
• increased blood pressure
• nasal congestion
• aspiration pneumonia due to inhalation of foreign material (mainly in association with other psychotropic drugs and medicines acting on the Central Nervous System)
• osteopenia and osteoporosis (increased bone fragility)
• inability to completely empty the bladder (urinary retention)
• liver tissue damage (hepatocellular injury)

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

• decrease in certain types of blood cells (agranulocytosis) (see "Warnings and precautions")
• benign pituitary tumour such as prolactinoma (see "Do not take SULAMID" and "Warnings and precautions")
• reduced concentration of sodium in plasma (hyponatraemia), inappropriate secretion of antidiuretic hormone (SIADH)
• combination of fever, rapid breathing, sweating, muscle stiffness and reduced level of consciousness associated with a serious disorder known as "neuroleptic malignant syndrome", which can sometimes be fatal (see "Warnings and precautions")
• heart rhythm disorders (prolongation of QT interval, ventricular arrhythmias such as torsades de pointes, ventricular tachycardia which may lead to ventricular fibrillation or cardiac arrest and sudden death) (see "Warnings and precautions")
• blood clots in the veins (venous thromboembolism, including pulmonary embolism, which may be fatal, and deep vein thrombosis) (see "Warnings and precautions")
• sudden swelling of legs, arms, face or tongue (angioedema)
• hives (urticaria)

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

• medicine withdrawal symptoms in newborns of mothers who took SULAMID (neonatal withdrawal syndrome, extrapyramidal disorders)
• uncomfortable feeling in the legs temporarily relieved by movement and symptoms worsening in the evening (restless legs syndrome)
• increased sensitivity of the skin to sunlight and ultraviolet rays (photosensitivity reaction)
• rhabdomyolysis (muscle breakdown associated with muscle pain)
• elevated levels of creatine phosphokinase (a blood test indicating muscle damage)
• falls due to impaired body balance, which may sometimes result in fractures

Mild chills, breathing difficulties (dyspnoea), and muscle pain (myalgia) have also been observed.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
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 medicinal product does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SULAMID contains

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

Description of the appearance of SULAMID and contents of the pack
SULAMID 50 mg tablets are available as tablets: pack containing 12 tablets.
Marketing Authorization Holder
Sanofi S.r.l. – Viale L. Bodio, 37/B – Milan
Manufacturer
Delpharm Dijon, 6 Boulevard de l’Europe – 21800 Quétigny (France)