MODAL CAPSULES

Israel - English - Ministry of Health

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Active ingredient:
SULPIRIDE
Available from:
RAFA LABORATORIES LTD
ATC code:
N05AL01
Pharmaceutical form:
CAPSULES
Composition:
SULPIRIDE 50 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
RAFA LABORATORIES LTD, JERUSALEM
Therapeutic group:
SULPIRIDE
Therapeutic area:
SULPIRIDE
Therapeutic indications:
Anti - dopaminergic agent for use in vertigo and prepsychotic states.
Authorization number:
029 27 21906 00
Authorization date:
2012-11-30

Documents in other languages

Patient Information leaflet Patient Information leaflet - Hebrew

14-08-2016

Patient Leaflet According to the Pharmacists' Regulations (Preparations) –

1986

This medicine is sold with a doctor's prescription only

MODAL

Capsules

MODAL Forte

Tablets

Active ingredient:

Each Modal capsule contains: Sulpiride 50 mg

Each Modal Forte tablet contains: Sulpiride 200 mg

For the list of inactive ingredients, please see section 6. See also 'Important information

about some of the medicine's ingredients' in section 2.

Read this entire leaflet carefully before using the medicine.

This leaflet contains concise information about the medicine. If you have any further

questions, please refer to your doctor or pharmacist.

This medicine has been prescribed to treat your illness. Do not pass it on to others. It may

harm them, even if you think their medical condition is similar to yours.

1. What is the medicine intended for?

Modal: an antidopaminergic medicine for treatment of vertigo (dizziness) and

prepsychotic states.

Modal Forte: an antidopaminergic medicine for treatment of vertigo (dizziness) and

prepsychotic states. At high doses, for treatment of depression and apathy in psychiatric

patients.

Therapeutic group: benzamides

2. Before using the medicine

Do not use the medicine if:

Do not use if you are sensitive (allergic) to the active ingredient or to any of the other

ingredients the medicine contains (for a list of inactive ingredients, please see section

Do not use if you suffer from pheochromocytoma (tumor of the adrenal gland),

prolactin-dependent cancerous tumors, e.g, pituitary gland cancer or breast cancer,

or porphyria (a rare metabolic disease).

Do not use the medicine if you are taking levodopa or ropinirole (or other medicines

for treatment of Parkinson's disease).

Special warnings regarding the use of this medicine:

Patients aged 65 and over may be more sensitive to the effects of the medicine.

Be careful not to become overheated during physical exercise, in hot weather and

in a hot shower (may cause a heatstroke). If you become overheated, contact your

doctor.

If you are sensitive to any type of food or medicine, inform your doctor before

taking this medicine.

Before starting the treatment, tell your doctor:

If you have bouts of aggressive behavior or are very agitated.

If you suffer from problems in the functioning of your kidneys.

If you suffer or a member of your family suffers from problems in the heart

function.

If you have ever had a stroke.

If you or someone in your family had or has a tendency to blood clots (this

medicine is liable to cause forming of blood clots).

If you are aged 65 or over.

If you suffer from dementia.

If you suffer from Parkinson's disease.

If you have low or imbalanced levels of blood electrolytes, e.g.: potassium, calcium

and magnesium.

If you suffer from epilepsy or have had convulsions.

If you have low white blood cell levels (agranulocytosis). This condition may cause

you to be more vulnerable to infections.

If you suffer from frequent infections, such as: fever, severe chills, sore throat or

mouth ulcers. These can indicate a blood system disorder called "leukopenia".

If you are taking, or have recently taken any other medicines, including non-

prescription medicines and nutrition supplements, please tell your doctor or

pharmacist. Especially inform your doctor or pharmacist if you are taking the following

medicines, because Modal may affect the efficacy of other medicines and other

medicines may affect the efficacy of Modal. (It should be noted that the following list

mentions the active ingredients in the medicines. If you are not sure whether you are

using one of these medicines please check with your doctor or pharmacist).

Levodopa or ropinirole (or other medicines for treatment of Parkinson's disease):

do not use the medicine if you are taking these medicines.

Medicines for treatment of heart arrhythmia, e.g. amiodarone, beta blockers (e.g.

sotalol), disopyramide, quinidine.

Medicines to treat heart problems or high blood pressure, such as: clonidine,

calcium channel blockers (e.g. diltiazem, verapamil), digitalis such as digoxin.

Other medicines for treatment of psychotic states (e.g. schizophrenia), such as:

pimozide, haloperidol, thioridazine.

Lithium (used for treatment of certain mental disorders).

Medicines acting on the central nervous system (e.g.: sedatives, sleeping pills,

medicines to treat mental and emotional problems, epilepsy, medicines to lower

anxiety, benzodiazepines, barbiturates, opioid analgesics).

Certain antidepressants such as: imipramine.

Certain diuretics, certain antidiarrheals (the medicines may lower the blood

potassium level).

Certain antibiotics for treatment of infections, e.g.: pentamidine, erythromycin,

amphotericin B.

Cisapride (to treat digestive problems), tetracosactide.

Steroids to reduce inflammatory reaction, e.g.: prednisolone, betamethasone,

dexamethasone.

Sucralfate (to treat digestive system ulcers), and medicines for digestive problems

and heartburn, such as: antacids (which contain aluminum or magnesium): take

Modal (tablets or capsules) at least two hours before taking these medicines.

Analgesics (that can also be present in medicines for colds and influenza);

methadone; halofantrine (to treat malaria), preparations containing alcohol.

Certain antihistamines (to treat allergies), e.g.: chlorphenamine, promethazine,

ketotifen.

Use of the medicine and alcohol consumption:

Do not drink wine or alcoholic

beverages during the treatment with the medicine, and do not use medicines containing

alcohol when using the medicine. Alcohol may increase the effects of the medicine, for

instance its sedative effect.

Pregnancy and breastfeeding:

Consult your doctor before use of this medicine if you are pregnant, think you may be

pregnant or are planning to become pregnant.

Do not breastfeed during treatment with the medicine. Small amounts of the medicine

might pass into the breast milk.

The following symptoms might appear in babies whose mothers used the medicine in

the last three months of pregnancy (third trimester): trembling, muscle stiffness or

weakness, sleepiness, agitation, breathing problems, feeding difficulty. If your baby

develops these symptoms, contact your doctor.

Driving and use of machines: The use of this medicine is liable to impair alertness and

cause drowsiness. If you feel this way, do not drive or operate machinery. In any case,

employ caution in driving a vehicle, operating dangerous machinery and in any activity

requiring alertness. As for children, they should be warned against riding a bicycle or

playing near roads, etc.

Important information about some of the medicine’s ingredients:

Modal Forte tablets contain lactose. If you are sensitive to lactose, or if the doctor told you

that you have intolerance to certain sugars, inform your doctor before taking this medicine

(please see section 6).

3. How to use this medicine?

Always use according to the doctor's instructions. Check with your doctor or pharmacist if

you are not sure.

The dosage and the manner of treatment will be determined by the doctor only.

Use this medicine at set times as determined by your doctor.

The dosage will be determined by your doctor according to the purpose of the treatment

and your state of health.

Do not exceed the recommended dose. If you feel that the effect of the medicine is too

strong or too weak, do not change the dosage by yourself, but contact your doctor.

Do not chew! Swallow the medicine with water.

Modal Capsules: there is no information regarding opening the capsule and dispersing its

contents.

Modal Forte tablets: may be cut in half using the scored line. There is no information

regarding crushing/ chewing.

Do not retain the medicine in your mouth beyond the time necessary to swallow it.

This medicine may be taken with food.

Tests and follow-up: before starting the treatment and during the treatment your doctor

may refer you for various tests such as: heart functions, level of blood electrolytes (salts)

or other blood tests.

If you have accidentally taken a higher dosage: If you (or any other person) have

taken an overdose or if a child has accidentally swallowed the medicine, go immediately

to a doctor or a hospital emergency room and bring the medicine package with you.

Overdose symptoms include: restlessness, confusion or agitation, reduced level of

consciousness, trembling, muscle stiffness or spasms, movement difficulties, uncontrolled

movements (for instance in eyes, neck, arms and legs), producing more saliva than usual.

In some cases, there may also be the following symptoms: dizziness, lightheadedness

and fainting (as a result of low blood pressure), coma.

If you forgot to take the medicine at the set time, take the dose as soon as you

remember, however, if it is nearly time for the next dose, skip the forgotten dose. Do not

take two doses together!

Continue with the treatment as recommended by your doctor.

If you stop taking the medicine: even if your state of health improves, do not stop the

treatment with this medicine without consulting your doctor. Do not stop taking this

medicine if you feel better. If you stop taking the medicine suddenly, your illness might

return and you might also experience undesirable effects such as: nausea, vomiting,

sweating, difficulty sleeping. In some cases also: restlessness, uncontrolled movements.

The doctor will gradually reduce the medicine dosage, until complete cessation, in order to

avoid these symptoms.

Do not take medicines in the dark! Check the label and the dose each time you take a

medicine. Wear glasses if you need them.

If you have further questions concerning the use of the medicine, consult your doctor or

pharmacist.

4. Side effects

Like any medicine, the use may cause side effects in some users. Do not be alarmed while

reading the list of side effects, you may not suffer from any of them.

Legend for frequency of the side effects: Common side effects (appear in 1-10 users out of

100); Uncommon side effects (appear in 1-10 users out of 1,000); Rare side effects (appear in

1-10 users out of 10,000); Very rare side effects (appear in less than 1 user out of 10,000); Side

effects of unknown frequency (effects whose frequency has not been determined yet).

Stop the treatment and contact your doctor or a hospital emergency room

immediately, if the following side effects appear:

Common side effects:

Tremor, stiffness and shuffling (Parkinsonism); trembling, muscle spasms, slow movement

(extrapyramidal effects).

Rare side effects:

Heart problems such as: strong, irregular, rapid or very slow heartbeats; breathing

difficulties such as: wheezing, shortness of breath, tightness in the chest and chest pains.

Side effects of unknown frequency:

Severe allergic reaction (anaphylactic reaction or anaphylactic shock) whose symptoms

may include: breathing difficulties, dizziness, cold and clammy skin, pale skin color, rapid

heartbeats, urticaria.

Low blood pressure; heart problems (rhythm disorders such as QT interval prolongation

seen on ECG or torsade de pointes and cardiac arrest); fits (convulsions).

High fever, sweating, muscle stiffness, rapid heartbeats, rapid breathing, confusion, drowsiness,

agitation. These can be signs of a serious but rare side effect called: neuroleptic malignant

syndrome.

Blood clots in the veins, particularly in the legs (the symptoms include: swelling, pain and

redness in the leg). If the clot reaches the lungs it may cause chest pain and breathing

difficulties.

Shortness of breath or breathing difficulties; blood disorders (e.g. agranulocytosis) or

decrease in number of white blood cells (neutropenia, leukopenia) which cause higher

vulnerability to infections, and therefore you must contact the doctor immediately in any

case of infection or fever. Leukopenia is uncommon.

Contact your doctor immediately if the following side effects appear:

Common side effects: restlessness, akathisia (inability to stand still).

Uncommon side effects: feeling of dizziness, lightheadedness or faintness as a result of

low blood pressure (particularly when sitting up or standing up quickly); increased muscle

tension and decreased ability to stretch (hypertonia); involuntary and uncontrolled

movements.

Rare side effects: eye rolling.

Side effects of unknown frequency: neck inclined to one side; tightness and stiffness of the

jaw; decreased movement capacity of the body or muscles; confusion.

Contact your doctor or pharmacist if the following side effects worsen or continue

for more than a few days:

Common side effects: increased prolactin level, breast pain and/or abnormal secretion of

breast milk (in men and women); weight gain; feeling of drowsiness or falling asleep;

difficulty sleeping; rash.

Uncommon side effects: breast enlargement in women; absence of menstrual periods;

sexual function disorders; producing more saliva than usual; uncontrolled movements

(principally of the tongue, mouth, jaw, arms, legs).

Side effects of unknown frequency: breast enlargement in men; uncontrolled movements of

the mouth, tongue, limbs appearing later in the course of the treatment or even after the

end of the treatment (tardive dyskinesia); increase in liver enzymes (seen in blood tests)

that can indicate liver problems.

Very rare side effects: sudden death, which may be caused by problems in the functioning of

the heart and in elderly patients suffering from dementia and treated with antipsychotic

medicines.

Side effects and drug interactions in children

Parents must inform the attending doctor of any side effect as well as any additional medicine

given to the child.

If a side effect appears, if one of the side effects worsens, or you suffer from a side effect

not mentioned in the leaflet, or if there is any change in your general feeling, consult your

doctor immediately.

Side effects may be reported to the Ministry of Health by clicking on the link "Report on

side effects following medicinal treatment" on the homepage of the Ministry of Health

website (

www.health.gov.il

) which leads to an online form for reporting side effects,

or by entering the link:

https://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectM

edic@moh.gov.il

5. How to store the medicine?

Avoid poisoning! This medicine, and any other medicine, must be stored in a safe

place out of the reach of children and/or infants, to avoid poisoning. Do not induce

vomiting unless explicitly instructed to do so by the doctor.

Do not use the medicine after the expiry date (exp. date) stated on the package. The

expiry date refers to the last day of that month.

Storage conditions: store below 25°C.

6. Additional information

In addition to the active ingredient, Modal capsules also contain the following

inactive ingredients:

Cellulose microcrystalline, magnesium stearate, FD&C Blue 2 (E132), titanium

dioxide (E171), gelatin.

In addition to the active ingredient, Modal Forte tablets also contain the

following inactive ingredients:

Cellulose microcrystalline, magnesium stearate, lactose, potato starch,

methylcellulose, talc, silicon dioxide.

Each tablet contains 27 mg of lactose.

What does the medicine look like and what does the package contain?

Modal Capsules: marine blue capsules containing a white powder, packed in blisters; 30

capsules per box.

Modal Forte Tablets: white tablets with a scored line with ‘Modal F’ imprinted on them,

packed in blisters; 40 tablets per box.

Registration holder: Rafa Laboratories Ltd., P.O. Box 405, Jerusalem 9100301.

Medicine registration number in the National Medicines Registry of the Ministry of

Health:

Modal Capsules: 0292721906

Modal Forte Tablets: 0292921895

This leaflet was checked and approved by the Ministry of Health in June 2016.

043008-I

Modal-DL-March 2016-01

Doctor leaflet

1. Name of the medicinal product

Modal Capsules

Modal Forte Tablets

2. Qualitative and quantitative composition

Active ingredient:

Each capsule of Modal contains sulpiride 50 mg.

Each tablet of Modal Forte contains sulpiride 200mg.

Modal Forte contains approximately 27 mg of lactose.

For full list of excipients, see section 6.1.

3. Pharmaceutical form

Modal: Capsules

Modal Forte: Tablets

4. Clinical particulars

4.1 Therapeutic indications

Modal Capsules

Anti - dopaminergic agent for use in vertigo and prepsychotic states.

Modal Forte Tablets

Anti-dopaminergic agent.

1) For use in vertigo and prepsychotic states.

2) At high doses - in psychiatric patients for treatment of depression and apathy.

4.2 Posology and method of administration

Vertigo

Average dosage:

The treatment is initiated with low dosages in adults, with 50-100mg per day,

in divided doses.

As a rule, the maintenance dose for adults is 150-300 mg per day, in divided

doses.

Severe cases:

The dosage may be increased. The duration of treatment should not be less

than 15 days and should be continued for several weeks if necessary.

Psychiatry

Initial dose of 200-400 mg twice daily, increasing if necessary to a maximum

of 1200 mg twice daily. Maintenance dose 600-800 mg per day in divided

doses.

Psychiatry - Elderly:

The same dose ranges may be required in the elderly, but, as a general rule

with the use of psychotropics in elderly patients, starting doses should be

lower and increased gradually, particularly in those with renal impairment.

Psychiatry - Children aged above 6 years old:

3-5 mg/kg body weight/day in devided doses

Renal Failure:

Sulpiride is primarily excreted renally, and dose adjustments have been

suggested in renal insufficiency.

creatinine clearance 30 to 60 mL/minute – 50% of normal dose

creatinine clearance 10 to 30 mL/minute – 30% of normal dose

creatinine clearance <10 mL/minute – 20% of normal dose.

4.3 Contraindications

Phaeochromocytoma and acute porphyria.

Hypersensitivity to sulpiride or to any of the excipients.

Concomitant prolactin-dependent tumours e.g. pituitary gland prolactinomas and

breast cancer (See section 4.8 Undesirable effects).

Association with levodopa or antiparkinsonian drugs (including ropinirole) (See

section 4.5 Interactions with other medicinal products and other forms of interaction).

4.4 Special warnings and precautions for use

Warnings:

Increased motor agitation has been reported at high dosage in a small number of

patients: in aggressive, agitated or excited phases of the disease process, low doses

of sulpiride may aggravate symptoms. Care should be exercised where hypomania is

present.

Extrapyramidal reactions, principally akathisia have been reported in a small number

of cases. If warranted, reduction in dosage or anti-parkinsonian medication may be

necessary.

As with other neuroleptics, neuroleptic malignant syndrome, a potentially fatal

complication, which is characterised by hyperthermia, muscle rigidity, autonomic

instability, altered consciousness and elevated CPK levels, has been reported. In

such an event, or in the event of hyperthermia of undiagnosed origin, all

antipsychotic drugs, including sulpiride, should be discontinued.

Elderly patients are more susceptible to postural hypotension, sedation and

extrapyramidal effects.

In patients with aggressive behaviour or agitation with impulsiveness, sulpiride could

be given with a sedative.

Acute withdrawal symptoms, including nausea, vomiting, sweating and insomnia

have been described after abrupt cessation of antipsychotic drugs. Recurrence of

psychotic symptoms may also occur, and the emergence of involuntary movement

disorders (such as akathisia, dystonia and dyskinesia) have been reported.

Therefore, gradual withdrawal is advisable.

Increased Mortality in Elderly people with dementia:

Data from two large observational studies showed that elderly people with dementia

who are treated with antipsychotics are at a small increased risk of death compared

with those who are not treated. There are insufficient data to give a firm estimate of

the precise magnitude of the risk and the cause of the increased risk is not known.

Sulpiride is not licenced for the treatment of dementia-related behavioural

disturbances.

Venous thromboembolism:

Cases of venous thromboembolism (VTE) have been reported with antipsychotic

drugs. Since patients treated with antipsychotics often present with acquired risk

factors for VTE, all possible risk factors for VTE should be identified before and

during treatment with sulpiride and preventative measures undertaken.

Precautions:

In elderly patients, as with other neuroleptics, sulpiride should be used with particular

caution (see section 4.2).

In children, efficacy and safety of sulpiride have not been thoroughly investigated.

Therefore, caution should be exercised when prescribing to children (see section

4.2).

When neuroleptic treatment is absolutely necessary in a patient with Parkinson's

disease, sulpiride can be used, although caution is in order.

Neuroleptics may lower the epileptogenic threshold. Cases of convulsions,

sometimes in patients with no previous history, have been reported with sulpiride.

Caution is advised in prescribing it for patients with unstable epilepsy, and patients

with a history of epilepsy should be closely monitored during therapy with sulpiride.

In patients requiring sulpiride who are receiving anti-convulsant therapy, the dose of

the anti-convulsant should not be changed.

Cases of convulsions, sometimes in patients with no previous history, have been

reported.

Sulpiride has no significant anticholinergic effect.

As with all drugs for which the kidney is the major elimination pathway, the dose

should be reduced and titrated in small steps in cases of renal insufficiency.

Prolongation of the QT interval:

Sulpiride induces a prolongation of the QT interval (see section 4.8). This effect is

known to potentiate the risk of serious ventricular arrhythmias such as torsade de

pointes.

Before any administration, and if possible according to the patient's clinical status, it

is recommended to monitor factors which could favour the occurrence of this rhythm

disorder, for example:

- Bradycardia less than 55 bpm

- Electrolyte imbalance in particular hypokalaemia

- Congenital prolongation of the QT interval

- On-going treatment with a medication likely to produce pronounced bradycardia

(< 55 bpm), hypokalaemia, decreased intracardiac conduction, or prolongation of the

QTc interval (see section 4.5)

Sulpiride should be prescribed with caution in patients presenting with these factors

and patients with cardiovascular disorders which may predispose to prolongation of

the QT interval.

Avoid concomitant treatment with other neuroleptics (see section 4.5).

Stroke:

In randomised clinical trials versus placebo performed in a population of elderly

patients with dementia and treated with certain atypical antipsychotic drugs, a 3-fold

increase of the risk of cerebrovascular events has been observed. The mechanism of

such risk increase is not known. An increase in the risk with other antipsychotic drugs

or other populations of patients cannot be excluded. Sulpiride should be used with

caution in patients with stroke risk factors.

Modal Forte tablets contain lactose. Patients with rare hereditary problems of

galactose intolerance, the Lapp lactose deficiency or glucose-galactose

malabsorption should not take this medicine.

Leukopenia, neutropenia and agranulocytosis have been reported with

antipsychotics, including sulpiride. Unexplained infections or fever may be evidence

of blood dyscrasia (see section 4.8) and requires immediate haematological

investigation.

4.5 Interaction with other medicinal products and other forms of interaction

Associations contra-indicated:

Levodopa, antiparkinsonian drugs (including ropinirole): reciprocal antagonism of

effects between levopoda or antiparkinsonian drugs (including ropinirole) and

neuroleptics.

Associations not recommended:

Alcohol: alcohol enhances the sedative effects of neuroleptics.

Avoid the consumption of alcoholic beverages and drugs containing alcohol.

Combination with the following medications which could induce torsades de pointes

or prolong the QT interval (see section 4.4):

− Bradycardia-inducing medications such as beta-blockers, bradycardia-inducing

calcium channel blockers such as diltiazem and verapamil, clonidine; digitalis.

− Medications which induce electrolyte imbalance, in particular those causing

hypokalaemia: hypokalaemic diuretics, stimulant laxatives, IV amphotericin B,

glucocorticoids, tetracosactides.

Electrolyte imbalance should be corrected

− Class Ia antiarrhythmic agents such as quinidine, disopyramide.

− Class III antiarrhythmic agents such as amiodarone, sotalol.

− Other medications such as pimozide, haloperidol; methadone, imipramine

antidepressants; lithium, cisapride, thioridazine, IV erythromycin, halofantrine,

pentamidine.

Associations to be taken into account:

Antihypertensive agents: antihypertensive effect and possibility of enhanced postural

hypotension (additive effect).

CNS depressants including narcotics, analgesics, sedative H1 antihistamines,

barbiturates, benzodiazepines and other anxiolytics, clonidine and derivatives.

Antacids or sucralfate: The absorption of sulpiride is decreased after co-administration.

Therefore, Modal caplets or Modal Forte Tablets should be administered two hours

before these drugs.

Lithium: lithium increases the risk of extrapyramidal side effects. Discontinuation of

both drugs is recommended at first signs of neurotoxicity.

4.6 Fertility, pregnancy and lactation

Pregnancy:

A decrease in fertility linked to the pharmacological effects of the drug (prolactin

mediated effect) was observed in treated animals.

Animal studies do not indicate direct or indirect harmful effects with respect to

pregnancy, embryonal/fetal development and/or postnatal development. In humans,

very limited clinical data on exposed pregnancies are available. In almost all cases of

foetal or neonatal disorders reported in the context of sulpiride use during pregnancy,

alternative explanations can be suggested and seem more likely. Therefore the use

of sulpiride is not recommended during pregnancy because of the limited experience.

Neonates exposed to antipsychotics (including sulpiride) during the third trimester of

pregnancy are at risk of adverse reactions including extrapyramidal and/or

withdrawal symptoms that may vary in severity and duration following delivery (see

section 4.8). There have been reports of agitation, hypertonia, hypotonia, tremor,

somnolence, respiratory distress, or feeding disorder. Consequently, newborns

should be monitored carefully.

Lactation:

Sulpiride has been found in the breast milk of treated women. Therefore breast-

feeding is not recommended during treatment.

4.7 Effects on ability to drive and use machines

Even used as recommended, sulpiride may cause sedation so that the ability to drive

vehicles or operate machinery can be impaired. (see section 4.8)

4.8 Undesirable effects

The following CIOMS frequency rating is used, when applicable:

Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100);

rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated

from the available data).

Blood and lymphatic system disorders (see section 4.4)

Uncommon: leukopenia

Not known: neutropenia, agranulocytosis

Immune system disorders

Not known: anaphylactic reactions; urticaria, dyspnoea, hypotension and

anaphylactic shock

Endocrine disorders

Common: hyperprolactinaemia

Psychiatric disorders

Common: insomnia

Not known: confusion

Nervous system disorders

Common: sedation or drowsiness, extrapyramidal disorder (these symptoms are

generally reversible upon administration of antiparkinsonian medication),

Parkinsonism, tremor, akathisia

Uncommon: hypertonia, dyskinesia, dystonia

Rare: oculogyric crisis

Not known: neuroleptic malignant syndrome, hypokinesia, tardive dyskinesia (have

been reported, as with all neuroleptics, after a neuroleptic administration of more

than 3 months. Antiparkinsonian medication is ineffective or may induce aggravation

of the symptoms), convulsion

Cardiac disorders

Rare: ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia

Not known: electrocardiogram QT prolonged, cardiac arrest, torsade de pointes,

sudden death (see section 4.4).

Vascular disorders

Uncommon: orthostatic hypotension

Not known: venous embolism, pulmonary embolism, deep vein thrombosis (see

section 4.4)

Gastrointestinal disorders

Uncommon: salivary hypersecretion

Hepatobiliary disorders

Common: hepatic enzyme increased

Skin and subcutaneous tissue disorders

Common: maculo-papular rash

Musculoskeletal and connective tissue disorders

Not known: torticollis, trismus

Pregnancy, puerperium and perinatal conditions

Not known: extrapyramidal symptoms, drug withdrawal syndrome neonatal (see

section 4.6)

Reproductive system and breast disorders

Common: breast pain, galactorrhoea

Uncommon: breast enlargement, amenorrhoea, orgasm abnormal, erectile

dysfunction.

Not known: gynaecomastia

General disorders and administration site conditions

Common: weight gain

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is

important. It allows continued monitoring of the benefit/risk balance of the medicinal

product. Any suspected adverse events should be reported to the Ministry of Health

according to the National Regulation by using an online form

(http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffect

Medic@moh.gov.il )

4.9 Overdose

Experience with sulpiride in overdosage is limited.

The range of single toxic doses is 1 to 16g but no death has occurred even at the

16g dose.

The clinical manifestations of poisoning vary depending upon the size of the dose

taken. After single doses of 1 to 3g restlessness and clouding of consciousness have

been reported and (rarely) extrapyramidal symptoms. Doses of 3 to 7g may produce

a degree of agitation, confusion and extrapyramidal symptoms (see section 4.8

Undesirable Effects); more than 7g can cause, in addition, coma and low blood

pressure.

The duration of intoxication is generally short, the symptoms disappearing within a

few hours. Comas which have occurred after large doses have lasted up to four

days.

No haematological or hepatic toxicity has been reported.

Sulpiride is partly removed by haemodialysis.

There is no specific antidote to sulpiride. Treatment is only symptomatic. Appropriate

supportive measures should therefore be instituted, close supervision of vital

functions and cardiac monitoring (risk of QT interval prolongation and subsequent

ventricular arrythmias) is recommended until the patient recovers.

If severe extrapyramidal symptoms occur anticholinergics should be administrated.

Overdose may be treated with alkaline osmotic diuresis and, if necessary, anti-

parkinsonian drugs. Coma needs appropriate nursing, and cardiac monitoring is

recommended until the patient recovers. Emetic drugs are unlikely to be effective in

sulpiride overdosage.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Psycholeptics; Benzamides,

ATC code: N05AL01

Sulpiride is a member of the group of substituted benzamides, which are structurally

distinct from the phenothiazines, butyrophenones and thioxanthenes. Current

evidence suggests that the actions of sulpiride hint at an important distinction

between different types of dopamine receptors or receptor mechanisms in the brain.

Behaviourally and biochemically, sulpiride shares with these classical neuroleptics a

number of properties indicative of cerebral dopamine receptor antagonism. Essential and

intriguing differences include lack of catalepsy at doses active in other behavioural tests,

lack of effect in the dopamine sensitive adenylate cyclase systems, lack of effect upon

noradrenaline or 5HT turnover, negligible anticholinesterase activity, no effect on

muscarinic or GABA receptor binding, and a radical difference in the binding of tritiated

sulpiride to striatal preparations in-vitro, compared to

H-spiperone or

H-haloperidol.

These findings indicate a major differentiation between sulpiride and classical neuroleptics

which lack such specificity.

One of the characteristics of sulpiride is its bimodal activity, as it has both

antidepressant and neuroleptic properties. Schizophrenia characterised by a lack of

social contact can benefit strikingly. Mood elevation is observed after a few days

treatment, followed by disappearance of the florid schizophrenic symptoms. The

sedation and lack of affect characteristically associated with classical neuroleptics of

the phenothiazine or butyrophenone type are not features of sulpiride therapy.

5.2 Pharmacokinetic properties

Peak sulpiride serum levels are reached 3 - 6 hours after an oral dose. The plasma

half-life in man is approximately 8 hours. Approximately 40% sulpiride is bound to

plasma proteins. 95% of the compound is excreted in the urine and faeces as

unchanged sulpiride.

5.3 Preclinical safety data

In long-term animal studies with neuroleptic drugs, including sulpiride, an increased

incidence of various endocrine tumours (some of which have occasionally been

malignant) has been seen in some but not all strains of rats and mice studied. The

significance of these findings to man is not known; there is no current evidence of an

association between neuroleptic use and tumour risk in man.

6. Pharmaceutical particulars

6.1 List of excipients

Each capsule of Modal contains:

Cellulose microcrystalline, magnesium stearate, FD&C Blue 2 (E132), titanium

dioxide (E171), gelatin.

Each tablet of Modal Forte contains:

Cellulose microcrystalline, magnesium stearate, lactose, potato starch,

methylcellulose, talc, silicon dioxide colloidal.

Each tablet of Modal Forte contains approximately 27 mg of lactose.

6.2 Incompatibilities

Not applicable

6.3 Special precautions for storage

Store below 25°C.

6.4 Contents of container

Modal Capsules: box of 30

Modal Forte Tablets: box of 40

6.5 Special precautions for disposal and other handling

No special requirements.

7. Registration holder:

Rafa Laboratories Ltd, P.O. Box 405, Jerusalem, 9100301

Registration numbers:

Modal capsules:

0292721906

Modal Forte tablets:

292921895

The format of this leaflet was determined by the Ministry of Health and its content was checked and approved in March 2016.

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