Israel - English - Ministry of Health
הסירפ )3( 'ג / 3 חפסנ יפל מ"ס
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
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
Each tablet contains: Biperiden HCl 2 mg
povidone, talc, magnesium stearate.
Each tablet contains approximately 38 mg of lactose.
Therapeutic group: This medicine belongs to the group of
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
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
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
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
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
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
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
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
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
اقفو ةدودمح ةينمز تاترفب ءاودلا اذه لامعتسا بيج لوانت بجيف ددلمحا تقولا في ءاودلا اذه لوانت تيسن اذإ .لجاع
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
.٢۰۱۱ راذآ في اهلبق نم صخ
رو اهاوتمح صح
فو ةرشنلا هذه ةغيص ةحصلا ةرازو ترقأ
Each tablet contains:
Biperiden hydrochloride 2mg
Corn starch, lactose, microcrystalline cellulose, calcium phosphate, povidone, talc, magnesium stearate.
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.
For use as an adjunct in the therapy of all forms of parkinsonism (postencephalitic, arteriosclerotic and
Useful in the control of extrapyramidal disorders due to central nervous system drugs such as
phenothiazines and other groups of psychotropics.
Known hypersensitivity to biperiden.
Bowel obstruction, achalasia and myasthenia gravis.
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
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
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
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.
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
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
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.
Biperiden/Antiparkinsonism Drugs/Opiate Agonists/ Phenothiazines and other Antipsychotics/Tricyclic
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).
Concomitant use may potentiate anticholinergic effects, including slowing of AV conduction.
Concomitant use may potentiate dyskinesia.
Biperiden/Alcohol/ CNS depressants
Concomitant use may enhance the sedative effects.
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
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
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 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 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.
Dekinet Tablets: 30 tablets.
Store below 25ºC
Registration no. 435221351
Rafa Laboratories Ltd. POB 405Jerusalem 91003
The format and content of this document have been approved by the Ministry of Health in March 2011.