DEKINET

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

BIPERIDEN HYDROCHLORIDE

Tillgänglig från:

RAFA LABORATORIES LTD

ATC-kod:

N04AA02

Läkemedelsform:

TABLETS

Sammansättning:

BIPERIDEN HYDROCHLORIDE 2 MG

Administreringssätt:

PER OS

Receptbelagda typ:

Required

Tillverkad av:

RAFA LABORATORIES LTD, JERUSALEM

Terapeutisk grupp:

BIPERIDEN

Terapiområde:

BIPERIDEN

Terapeutiska indikationer:

All types of Parkinson's disease.

Tillstånd datum:

2021-03-31

Bipacksedel

1
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine is sold with a doctor's prescription only
DEKINET
TABLETS
ACTIVE INGREDIENT:
Each tablet contains: Biperiden Hydrochloride (HCl) 2 mg.
For the list of the other ingredients, 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 it seems to you that their illness is similar to yours.
1. WHAT IS THE MEDICINE INTENDED FOR?
This medicine is intended for relief of Parkinson’s disease symptoms
in all its forms.
THERAPEUTIC GROUP: the medicine belongs to the anticholinergic
medicines group.
The medicine acts by relaxing muscles and controlling spasms.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to any of the
other ingredients the
medicine contains (for the list of the other ingredients, see section
6).
•
You suffer from narrow-angle glaucoma.
•
You suffer from an irregular heartbeat or any other heart problems or
illnesses that could
lead to tachycardia.
•
You have a narrowing of the stomach or bowels, intestinal obstruction,
or any other
bowel problems such as megacolon.
•
You have a benign tumor of the prostate gland.
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:
BEFORE (AND DURING) TREATMENT WITH DEKINET, TELL YOUR DOCTOR IF:
•
You suffer from thyroid gland problems.
•
You suffer from glaucoma - see 'Do not use the medicine if'.
•
You belong to any of the following groups which might be more
sensitive to the effects of
the medicine and therefore you may need to be monitored more closely:
- The elderly, particularly those who suffer or have suffered from a
disease, injur

Produktens egenskaper

1
Dekinet-DL-Feb 2022-01
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
DEKINET
Tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg of biperiden hydrochloride.
Excipients with known effect: Each tablet contains about 38 mg of
lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Almost white scored tablet, marked D/2.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
All types of Parkinson's disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_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.
_Special populations_
_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.
2
_Paediatric population_
Safety and effectiveness of use in children have not been established.
Method of administration
Oral use.
Dekinet should be taken with a small amount of food to avoid gastric
irritation.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
Dekinet is contra-indicated in the presence of untreated narrow-angle
glaucoma,
mechanical stenoses in the gastrointestinal tract, paralytic ileus,
megacolon, prostatic
adenoma and diseases that can lead to perilous tachycardia.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Dekinet should only be used with caution in the elderly, and in
patients with
thyrotoxicosis, cardiac failure, tachycardia, prostatic adenoma or
patients who show
an increased tendency to convulsions.
Central excitation effects are frequently seen in pati