DEKINET

Israel - English - Ministry of Health

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Active ingredient:
BIPERIDEN HYDROCHLORIDE
Available from:
RAFA LABORATORIES LTD
ATC code:
N04AA02
Pharmaceutical form:
TABLETS
Composition:
BIPERIDEN HYDROCHLORIDE 2 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
RAFA LABORATORIES LTD, JERUSALEM
Therapeutic group:
BIPERIDEN
Therapeutic area:
BIPERIDEN
Therapeutic indications:
All types of Parkinson's disease.
Authorization number:
015 32 24634 00
Authorization date:
2011-03-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

22-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

17-08-2016

רישכתה םש

DEKINET

אפר ט"קמ

194022

הרודהמ 'סמ

022006-

הסירפ )3( 'ג / 3 חפסנ יפל מ"ס

21X16

עבצ רוחש תופש )תיברעו תילגנא ,תירבע(

סופד לאידיא םילופיק 'סמ אלל ריינ גוס םרג 60 ע"נ דוקהמרפ

דוקהמרפ יוקל תודימ םומיסקמ וטנ ךרוא ;מ"מ 1 םיווקה ןיב חוור ;מ"מ 1.5 הבע וק ;מ"מ 0.5 קד וק )תילמיסקמ הדימל תופידע - מ"מ 8 םומינימ( מ"מ 10 י"ע ןכוה םייטבצמרפ םיתוריש ואלב ךיראת

26.06.2011

Patient Leaflet According to the Pharmacists’ Regulations

(Preparations) - 1986

This medicine requires a doctor’s prescription

Please read the entire leaflet carefully before using this medicine

DEKINET

Tablets

Composition:

Active ingredient

Each tablet contains: Biperiden HCl 2 mg

Inactive ingredients

Corn

starch,

lactose,

microcrystalline

cellulose,

calcium

phosphate,

povidone, talc, magnesium stearate.

Each tablet contains approximately 38 mg of lactose.

Therapeutic group: This medicine belongs to the group of

anti-cholinergic drugs.

Therapeutic activity: This medicine is indicated for the relief of symptoms

of all forms of Parkinson’s disease.

When should this medicine not be used?

Do not use this medicine if you are hypersensitive to any of its ingredients.

Do not use this medicine if you suffer from bowel obstruction, achalasia

(impaired

gastrointestinal

movements),

megacolon

(dilated

colon),

myasthenia gravis (severe muscle weakness) or narrow angle glaucoma.

Do not take this medicine without consulting a doctor before starting

treatment, in the following cases: If you are pregnant or breastfeeding.

If you suffer or have suffered in the past from impaired function of the:

heart and/or vascular system, eyes (e.g. glaucoma), liver, kidney/urinary

tract, digestive system, blood system, prostate gland, or if you suffer or

have suffered in the past from epilepsy, or from involuntary movements

mouth

face

following

treatment

with

antipsychotic

drugs.

How might this medicine affect your daily life?

Use of this drug may reduce alertness and therefore caution should be

exercised when driving a vehicle, operating dangerous machinery, or

performing any other activity that requires special vigilance. Children

should be warned against riding a bicycle or playing near roads or

engaging in other potentially hazardous activities.

Do not drink wines or other alcoholic beverages while under treatment with

this medicine.

Warnings: If you are sensitive to any type of food or medicine, inform your

doctor before starting treatment with this medication.

of this medicine may cause blurred vision.

During treatment with this medication, gonioscopy (eye examination for

glaucoma) and ophthalmologic tests should be performed repeatedly.

Special care should be taken in elderly patients because of their increased

sensitivity to this medicine.

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

while taking a hot shower (due to risk of heat stroke).

This medicine contains lactose. If you are sensitive to lactose, inform your

doctor before taking this medication.

Drug interactions: If you are taking any other medications including non-

prescription drugs and nutrition supplements, or if you have recently finished

treatment with another drug, please notify your doctor in order to prevent

any potential risks or a potential reduction in efficacy that may result from

drug interactions. In particular, medicines of the following therapeutic groups

may interact with your medicine: drugs affecting the central nervous system

(e.g. antipsychotics, sedatives, hypnotics, medicines for the treatment of

Parkinson’s disease or epilepsy, anesthetics for surgeries and narcotic

analgesics), anti-depressants, cough & cold medicines, anti-histamines,

medicines with an anticholinergic action (e.g. preparations against stomach

cramps), quinidine (for the heart), cisapride or metoclopramide (for nausea

and vomiting).

Side effects: In addition to the desired effect of the medicine, side effects

may also appear during the course of taking this medicine. These may

include: dryness of the mouth, nose and throat; constipation, blurred vision,

nausea, drowsiness, decrease in blood pressure, decreased sweating or

eye sensitivity to light.

These side effects usually pass within a short time following the period of

adaptation to the medicine.

If these side effects persist and/or are bothersome, please consult your doctor.

The following side effects require special attention:

Skin rash or irritation, confusion, restlessness, eye pain, difficulty in urination,

euphoria and behavioral changes (rare): Stop the treatment and refer to your

doctor immediately!

If at any time you experience side effects that are not mentioned in this

leaflet or if you feel an adverse change in your general health, consult your

doctor immediately!

Dosage:

This medicine is usually not intended for infants and children.

Administer according to the doctor’s instructions only.

Do not exceed the recommended dose.

This medicine should be administered at set intervals according to your

doctor’s instructions. If you forget to

take your medicine at the proper time,

take the missed dose as soon as you remember, but never take two doses

at the same time!

Attention: Wait at least two hours between taking this medicine and taking

antacids or anti diarrhea medicines.

Directions for use: Do not chew or crush the tablet!

The tablet may be cut in half using the scored line.

Swallow the medicine with a glass of water.

The medicine may be taken with a small amount of food in order to avoid

gastric irritation.

How can you contribute to the success of the treatment?

Even if your condition improves do not stop taking this drug without

consulting your doctor, and even then only in a gradual manner.

Avoid poisoning! This medicine, and all other medicines, must be stored in

a safe place out of the reach of children and/or infants, to avoid poisoning.

If you have taken an overdose, or if a child has accidentally swallowed the

medicine, proceed immediately to a hospital emergency room and bring the

package of the medicine with you.

Do not induce vomiting unless explicitly instructed to do so by a doctor!

This medicine was prescribed for the treatment of your ailment; in another

patient it may cause harm. Do not give this

medicine to your relatives,

neighbours or acquaintances.

Do not take medicines in the dark! Carefully check the label and dose each

time you take the medicine.

Wear your glasses if you need them.

Storage: This medicine should be stored below 25°C.

Even if stored properly according to the manufacturer’s recommendations,

all medicines have a limited shelf life. Please pay attention to the expiry date

of your medicine! If you have any doubts, please consult the dispensing

pharmacist.

Do not store different medicines in the same container.

Drug registration number: 153224634

Rafa Laboratories Ltd., P.O.Box 405, Jerusalem 91003

The format of this leaflet was determined by the Ministry of Health that

checked and approved its content in March 2011.

Dekinet PIL PB0611-06

يريغت أرط اذإ وأ ,ةرشنلا هذه في ركذت لم ةيبناج ضارعأب تسسحأ لاح في

روف بيبطلا ةراشتسا كيلع بجيف ماعلا كروعش ىلع :ةعرلجا .عضرلاو لافطلأل ةداع صصمخ يرغ ءاودلا اذه .اهب ىصولما ةعرلجا زواتج زويج لا .طقف بيبطلا تاميلعت بسح ةعرلجا لب

ق نم دد

ح الم

اقفو ةدودمح ةينمز تاترفب ءاودلا اذه لامعتسا بيج لوانت بجيف ددلمحا تقولا في ءاودلا اذه لوانت تيسن اذإ .لجاع

لما بيبطلا

عم ينتعرج لوانت ا

عطق زويج لا نكل , كركذت روف ةعرلجا اذه لوانت ينب لقلأا ىلع ينتعاس هتد

م نيمز لصاف راظتنا بيج :هبتنا .لاهسلإا تاداض

م وأ ةضوملحا تاداض

م لوانت ينبو ءاودلا !صرقلا قحس وأ غضم زويج لا :لامعتسلاا ةيفيك .مل

لما فيصنتلا طخ بسح صرقلا رطش زويج .ءالما نم ساك عم ءاودلا علب بيج .ةدعلما ج

يهت يدافتل ماعطلا نم ليلق عم ءاودلا علب نك

؟جلاعلا حاجنب ةمهاسلما كنكيم فيك أرط ولو تىح بيبطلا ةراشتسا نود ءاودلاب جلاعلا نع فقوتلا زويج لا .ييجردت لكشب طقف اهنيح اضيأو ,ةيحصلا كتلاح ىلع نستح قلغم ناكم في رخآ ءاود لكو ءاودلا اذه ظفح بيج !ممستلا بنتج .ممستلا عنتم كلذبو ,عضرلا وأ/و لافطلأا يديأ لوانتم نع ا

ديعب ,ءاودلا نم أطلخا قيرط نع

لفط علب وأ ةيئاودلا ةعرلجا لوانت في تطرفأ اذإ .كعم ءاودلا ةوبع ا

بحطصم ,ىفشتسلما في ئراوطلا ةفرغ لىإ ا

روف هجوت !بيبطلا نم ةيحرص تاميلعت نودب ؤيقتلا ببست لا زويج لا .رخآ ضيرلم ررضلا ببسي دقو ;كضرم جلاعل فصو ءاودلا اذه .كفراعم وأ كنايرج ,كبراقأ لىإ ءاودلا اذه ءاطعإ ةعرلجا نمو ءاودلا ىلع قصللما نم ققتح !ملاظلا في ءاودلا لوانت زويج لا .ءاودلا اهيف لوانتت ةرم لك في ةيئاودلا .اله ةجابح تنك اذإ ةيبطلا تاراظنلا عض .ةيوئم ةجرد ٢٥ تتح نيزختلا بيج :نيزختلا /بيلعتلا فورظ في تىح ,طقف ةدودمح تاترفل ةلحاص ةيودلأا ىقبت في !رضحتسلما ة

يحلاص ءاهتنا خيرات ةظحلام ءاجرلا .اهب ىصولما نيزختلا .ءاودلا اذه كل فرص يذلا ليديصلا ةراشتسا كيلع ,كش ةلاح

يأ .ةوبعلا سفن في ةفلتمخ ةيودأ نيزتخ زويج لا ۱٥۳۲۲٤٦٣٤ :ءاودلا ليجست مقر ۹۱۰۰٣ سدقلا ,٤۰٥ .ب.ص ,.ض.م افار تابرت

مخ

.٢۰۱۱ راذآ في اهلبق نم صخ

رو اهاوتمح صح

فو ةرشنلا هذه ةغيص ةحصلا ةرازو ترقأ

DEKINET TABLETS

Product Information

Composition

Dekinet Tablets

Each tablet contains:

Biperiden hydrochloride 2mg

Inactive ingredients:

Corn starch, lactose, microcrystalline cellulose, calcium phosphate, povidone, talc, magnesium stearate.

Action

Dekinet is a centrally-acting anticholinergic agent with weak visceral effects, effective in the treatment of

symptoms of parkinsonism. Clinically, Dekinet reduces akinesia and rigidity, and to a lesser extent, tremor.

Indications

For use as an adjunct in the therapy of all forms of parkinsonism (postencephalitic, arteriosclerotic and

idiopathic).

Useful in the control of extrapyramidal disorders due to central nervous system drugs such as

phenothiazines and other groups of psychotropics.

Contraindications

Known hypersensitivity to biperiden.

Narrow-angle glaucoma.

Bowel obstruction, achalasia and myasthenia gravis.

Megacolon.

Warnings

Isolated instances of mental confusion, euphoria, agitation and disturbed behavior may occur. A set of

concurrent symptoms known as the central anticholinergic syndrome may also occur as an adverse reaction

to properly prescribed biperiden, although it is more frequently due to overdosage (see Overdosage) or the

concurrent administration of another anticholinergic drug or a drug that has secondary anticholinergic

actions.

Tardive dyskinesia induced by neuroleptics may be intensified by biperiden in some individuals.

Animal studies have demonstrated that centrally-acting anticholinergic drugs such as biperiden may lead to

an increased tendency to cerebral seizure. This should be taken into account in the management of

predisposed patients.

As with other centrally-acting anticholinergics, abuse of biperiden has been observed.

Caution should be observed in patients with manifest glaucoma, although no prohibitive rise in intraocular

pressure has been reported following either oral or parenteral administration. Periodic intraocular pressure

determinations are recommended in elderly patients and in all patients with glaucoma.

Exercise caution when administering this drug to patients with prostatism or with epilepsy.

Care should be taken when administering Dekinet to patients with cardiac arrhythmias. Patients with recent

myocardial infarction should be given Dekinet only if the heart rate is well controlled.

Occasionally drowsiness may occur, especially if biperiden is taken with other centrally-acting drugs.

Patients should be warned that their ability to perform potentially-hazardous tasks requiring mental alertness

or physical coordination, such as driving a vehicle or operating machinery, may be impaired. As with other

drugs action on the central nervous system, the consumption of alcohol should be avoided during Dekinet

therapy.

Use in Pregnancy

Safety of use of this drug in pregnancy has not been established.

FDA pregnancy category C.

Animal reproduction studies have not been conducted with Dekinet. It is also not known whether Dekinet

can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dekinet

should be given to a pregnant woman only if clearly needed.

Use in Breastfeeding

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human

milk, caution should be exercised when Dekinet is administered to a nursing woman.

Use in Pediatrics

Safety and effectiveness of use in children have not been established.

Use in the Elderly

Elderly patients, particularly those with cerebral lesions of a vascular or degenerative nature, may exhibit

increased sensitivity even to therapeutic doses of the drug. Cautious dosing is recommended. Chronic use

may predispose geriatric patients to glaucoma.

Adverse Reactions

Atropine-like side effects such as dry mouth; blurred vision; drowsiness; euphoria or disorientation; urinary

retention; postural hypotension; constipation; agitation; disturbed behavior may been seen. A case of

generalized choreic movements has been reported in a Parkinson's disease patient when biperiden was

added to carbidopa/levodopa. A reduction in rapid eye movement (REM) sleep, characterized by increased

REM latency and decreased percentage of REM sleep, has been reported.

If gastric irritation occurs following oral administration, it can be avoided by administering the drug during or

after meals.

The central anticholinergic syndrome can occur as an adverse reaction to properly prescribed anticholinergic

medication. See Overdosage for a description of the signs and symptoms of this syndrome, and for

treatment.

Precautions

Regular monitoring of blood counts is recommended.

Treatment should not be discontinued abruptly. The transfer of patients from other antiparkinsonism agents

should be made gradually, the original agent being reduced in dose as Dekinet is substituted.

Anhidrosis and subsequent hyperthermia may occur with antidyskinetics when patients, especially geriatric,

chronically ill, and alcoholic, are exposed to high environmental temperatures.

Drug Interactions

Biperiden/Antiparkinsonism Drugs/Opiate Agonists/ Phenothiazines and other Antipsychotics/Tricyclic

Antidepressants/Antihistamines/Antispasmodics

Concomitant administration of biperiden with other drugs having anticholinergic effects may increase the risk

of adverse anticholinergic reactions, including the central anticholinergic syndrome (see Overdosage).

Biperiden/Quinidine

Concomitant use may potentiate anticholinergic effects, including slowing of AV conduction.

Biperiden/Levodopa

Concomitant use may potentiate dyskinesia.

Biperiden/Alcohol/ CNS depressants

Concomitant use may enhance the sedative effects.

Biperiden/Metoclopramide/Cisapride

Biperiden may antagonize the effects of metoclopramide, cisapride and other prokinetics.

Biperiden/antacids or antidiarrheals

Wait at least 1-2 hours between taking these medications.

Dosage and Administration

Parkinsonism

Dosage should be individualized. Begin with 1/2 a tablet twice daily, and gradually increase to 1 tablet, 3-4

times daily. Then decrease continuously to the lowest dosage regimen which adequately controls the

symptoms.

Drug-induced Extrapyramidal Symptoms

The oral dosage is 1 tablet, 1-3 times daily.

Dekinet may be taken with a small amount of food to avoid gastric irritation.

Overdosage

Manifestations

Overdosage with Dekinet produces typical central symptoms of atropine intoxication known as the central

anticholinergic syndrome. Correct diagnosis depends on recognition of the peripheral signs of

parasympathetic blockade, including dilated and sluggish pupils, warm dry skin, facial flushing, decreased

secretions of the mouth, pharynx, nose and bronchi, foul-smelling breath, elevated temperature, tachycardia,

cardiac arrhythmias, decreased bowel sounds and urinary retention. Neuropsychiatric signs such as

delirium, disorientation, anxiety, hallucinations, illusions, confusion, incoherence, agitation, hyperactivity,

ataxia, loss of memory, paranoia, combativeness and seizures may be present. The condition can progress

to stupor, coma and cardiac and respiratory arrest and death.

Treatment

Treatment of acute overdose revolves around symptomatic and supportive therapy. If Dekinet was

administered orally, gastric lavage or emesis induction should be instituted.

A small dose of diazepam or of a short-acting barbiturate may be administered if CNS excitation is

observed. Phenothiazines are contraindicated, because the toxicity may be intensified due to their

antimuscarinic action, causing coma.

Respiratory support, artificial respiration or vasopressor agents may be necessary. Hyperpyrexia must be

reversed, fluid volume replaced and acid-base balance maintained. Urinary catheretization may be

necessary. Routine use of physostigmine for overdose is controversial. Delirium, hallucinations, coma, and

supraventricular tachycardia (not ventricular tachycardias or conduction defects) seem to respond. If

indicated, 1mg (half this amount for children and the elderly) may be given intramuscularly or by slow

intravenous infusion. If there is no response within 20 minutes, an additional 1mg dose may be given. This

may be repeated until a total of 4mg has been administered a reversal of the toxic effects occur or excessive

cholinergic signs are seen.

Frequent monitoring of clinical signs should be considered. Since physostigmine is rapidly destroyed,

additional injections may be required every 1-2 hours to maintain control. The relapse intervals tend to

lengthen as the toxic anticholinergic agent is metabolized, so patients should be carefully observed for 8-12

hours following the last relapse.

Presentation

Dekinet Tablets: 30 tablets.

Store below 25ºC

Registration no. 435221351

Manufacturer:

Rafa Laboratories Ltd. POB 405Jerusalem 91003

The format and content of this document have been approved by the Ministry of Health in March 2011.

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